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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
☒
Annual Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
For
The Fiscal Year Ended May 31, 2023 or
☐
Transition Report Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
For
The Transition Period From ______ To ______
Commission
File Number: 001-37863
BIOMERICA,
INC.
(Exact
Name of registrant as specified in its charter)
Delaware
(State
or other jurisdiction of
Incorporation
of organization) |
95-2645573
(I.R.S.
Employer
Identification No.) |
17571
Von Karman Avenue, Irvine, CA
(Address
of principal executive offices) |
92614
(Zip
Code) |
(949)
645-2111
(Registrant’s
telephone number, including area code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each class |
|
Trading
Symbols |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.08 |
|
BMRA |
|
Nasdaq
Capital Market |
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act
Yes
☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Act.
Yes
☐ No ☒
Indicate
by check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated Filer ☐ |
|
Accelerated
Filer ☐ |
Non-Accelerated
Filer ☒ |
|
Smaller
Reporting Company ☒ |
Emerging
Growth Company ☐ |
|
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. ☐
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes
☐ No ☒
State
the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s
most recently completed second fiscal quarter (based upon 12,281,164 shares held by non-affiliates and the closing price of $3.48 per
share for Common Stock as of November 30, 2022): $42,738,451.
The
outstanding number of shares of common stock, par value $0.08, as of August 25, 2023 was 16,821,646.
DOCUMENTS
INCORPORATED BY REFERENCE: Portions of the registrant’s definitive Proxy Statement on Schedule 14A relating to the registrant’s
2023 annual meeting of stockholders, to be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal
year covered by this Annual Report on Form 10-K, are incorporated by reference in Part III, Items 10 through 14 of this Annual Report
on Form 10-K. Except for the portions of the Proxy Statement specifically incorporated by reference in this Form 10-K, the Proxy Statement
and related proxy solicitation materials shall not be deemed to be filed as part hereof.
CAUTIONARY
NOTE REGARDING FORWARD LOOKING STATEMENTS
Except
for historical financial information contained herein, the matters discussed in this Form 10-K may be considered forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended, and subject to the safe harbor created by the Securities Litigation Reform Act of 1995. Such statements include declarations
regarding our intent, belief, or current expectations, and those of our management. In
some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,”
“expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology.
Investors are cautioned that any such forward-looking statements are not guarantees of future performance
and involve a number of risks, uncertainties and other factors, some of which are beyond our control. Actual results could differ materially
from those indicated by such forward-looking statements. Important factors that could cause actual results to differ materially from
those indicated by such forward-looking statements include, but are not limited to, those risks and uncertainties identified under “Risk
Factors,” in this Form 10-K and the other risks detailed from time-to-time in our reports and registration statements filed with
the Securities and Exchange Commission, or SEC. Except as required by law, we undertake no obligation to revise or update publicly any
forward-looking statements, whether as a result of new information, future events or otherwise.
PART
I
ITEM
1. BUSINESS
BUSINESS
OVERVIEW
THE
COMPANY
Biomerica,
Inc. (“Biomerica,” the “Company,” “we,” “us,” or “our”) was incorporated
in Delaware in September 1971 as Nuclear Medical Systems, Inc., and later changed its name to Biomerica, Inc. The Company has two wholly
owned subsidiaries, Biomerica de Mexico, which is used for assembly/manufacturing, and BioEurope GmbH, which acts as a distributor of
Biomerica products in certain markets.
We
are a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products
used at the point-of-care (in home and in physicians’ offices) and in hospital/clinical laboratories for detection and/or treatment
of medical conditions and diseases. Our products are designed to enhance the health and well-being of people, while reducing total healthcare
costs.
Our
primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided
therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other
inflammatory diseases. These products are directed at chronic inflammatory illnesses that are widespread and common, and as such address
very large markets. Our InFoods® IBS product uses a simple blood sample and is designed to identify patient-specific foods that,
when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Instead of broad and difficult
to manage dietary restrictions, the InFoods® IBS product works by identifying specific foods that may be an abnormally high immune
response in the patient. A food identified as positive, which is causing the abnormal immune response in the patient, can
be simply removed from the diet to help alleviate IBS symptoms.
During
fiscal 2022, we completed an endpoint determination clinical trial on our InFoods® IBS product. This trial was conducted
at Mayo Clinics in Florida and Arizona, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, University
of Texas Health Science Center at Houston, Houston Methodist, the University of Michigan and other institutions. This trial monitored
IBS patients over an 8-week treatment period to determine the efficacy of our InFoods® IBS product to improve the patients’
IBS symptoms or endpoints. The top-line trial results were reported in February 2022. Multiple endpoints demonstrated statistically significant
improvements, indicating that the elimination of specific foods may meaningfully reduce the symptoms of IBS in each patient subtype (including
patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed). The greatest clinical improvements, including but not limited to abdominal
pain and bloating, were seen in patients diagnosed with IBS-Mixed and IBS-Constipation, in the top line data. The purpose of the endpoint
study was to validate the efficacy of the product, and to determine the primary symptom endpoint, or endpoints to be used in a final
pivotal trial that will be conducted to attain the validation data needed to apply for U.S. Food and Drug Administration (“FDA”)
clearance for the product. We are continuing to review and refine the complete dataset and have selected the final endpoint
that we would intend to use in a final pivotal trial. We are starting to develop the protocol for submission to the FDA, and once
approved the trial will be run thereafter. The trial is expected to include the large medical institution participants that conducted
the endpoint clinical trial, in addition to other new institutions and a Clinical Research Organization.
Following
the successful completion and positive results from the Company’s InFoods® IBS clinical trial, we saw
significant interest from Gastroenterology (“GI”) physicians who would like to provide the InFoods® IBS product
to their patients. Therefore, while we continue the work of advancing this product toward FDA clearance, during our fourth quarter of
fiscal 2023, we launched the InFoods® IBS product through a CAP-Certified high-complexity Clinical Laboratory Improvement Amendments (“CLIA”) laboratory facility and
began offering the product as a laboratory developed test (“LDT”) to GI physicians. The first physician group to offer InFoods®
IBS to their IBS patients is Gastro Health at their flagship location in Miami, Florida. Gastro Health is a leading GI physician
group with over 390 physicians operating in over 150 offices in seven states.
InFoods®
IBS product is currently offered on a “cash-pay” basis (without insurance reimbursement) to IBS patients. However,
we have begun the process of speaking to reimbursement consultants who can help us seek and attain reimbursement through government pay
(i.e., Medicare and Medicaid), and from private insurers.
We
are also beginning the work of validating one new disease (such as ulcerative colitis or migraines), where there is evidence that
certain foods can trigger or contribute to the symptoms found in patients suffering from those illnesses. Each InFoods® test
is developed specifically for patients suffering from the disease being targeted. For instance, the panel of foods that would be
tested for patients with migraines will be different from the known problematic foods that we test for in IBS. We have already
performed much of the initial research and development work necessary to determine what foods are commonly problematic for each of
eight different diseases. We have found that some diseases show approximately 20 foods that are commonly problematic for patients,
while other diseases show over 70 foods for which patients commonly show an abnormal immune response. Once the panel of problematic
foods is identified for a specific disease, the panel must then be tested to confirm which of the problematic food are
causing an abnormal and harmful immune response. We expect
any new disease we target will follow a similar development pathway as InFoods® IBS in simultaneously seeking FDA
clearance of the product while also launching the product as an LDT.
We
are also continuing to evaluate partnership/licensing opportunities, as they arise, with U.S. and multinational companies that could
help us commercialize, or accelerate revenue growth of, the InFoods® products in the United States and overseas.
Our
existing medical diagnostic products are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point-of-care (physicians’
offices and over-the-counter drugstores like Walmart and Walgreens). The diagnostic test kits are used to analyze blood, urine, nasal
or fecal specimens from patients in the diagnosis of various diseases, food intolerances and other medical complications, by measuring
or detecting the existence and/or level of specific bacteria, hormones, antibodies, antigens, or other substances, which may exist in
a patient’s body, stools, or blood, often in extremely small concentrations.
During
fiscal 2022, we finalized development of our H. Pylori diagnostic test that indicates if a patient is infected with the H. Pylori bacteria.
H. Pylori infection is extremely common, and if left untreated, can lead to ulcers and possibly stomach cancers. During our fourth quarter
of fiscal 2022, we applied for FDA clearance of this product though a 510(k) premarket submission. We have been in communication with
the FDA answering certain follow-up questions and providing additional data as requested. We are working with the FDA to perform one
additional set of in-lab tests that the FDA has requested prior to making their final determination on clearance of the product. Provided we receive FDA clearance, we will begin marketing the product in the U.S. market. We have already begun discussions with international distributors for
this product and expect to see revenues through these international channels during 2024.
We
have recently added new employees in our sales and marketing department in order to increase sales of existing products. In fiscal 2023,
we also hired a Chief Commercial Officer (“CCO”) with broad experience launching new products at large diagnostic companies.
Our CCO is focused on the commercial launch of the InFoods® IBS product to the GI physician groups in the U.S. market.
Due
to the global 2019 SARS-CoV-2 novel coronavirus (“COVID-19”) pandemic, in March 2020, we began developing, marketing, and
selling COVID-19 diagnostic tests. In fiscal 2022, we generated revenues from the international sale of our COVID-19 antigen tests. Due
to falling demand for such tests, the Company generated 4% of our sales during fiscal year 2023, as compared to 75% of our revenue during
fiscal year 2022. Due to the dramatic increase in fiscal 2022 revenues, and subsequent decrease in fiscal 2023 revenues from this COVID-related
product, we saw significant volatility in our revenues and our earnings during those two fiscal years. By the end of fiscal year 2023,
and during our fourth quarter, none of our revenues came from the sale of COVID-related tests.
Our
non-COVID-19 products that accounted for approximately 96% and 25% of our revenues during the fiscal years ended May 31, 2023, and 2022,
respectively, are primarily focused on gastrointestinal diseases, food intolerances, and certain esoteric tests. These diagnostic test
products utilize immunoassay technology. Most of our products are CE marked and/or sold for diagnostic use where they are registered
by each country’s regulatory agency. In addition, some products are cleared for sale in the United States by the FDA.
Technological
advances in medical diagnostics have made it possible to perform diagnostic tests within the home and the physician’s office (the
point-of-care), rather than in the clinical laboratory. One of our objectives also has been to develop and market rapid diagnostic tests
that are accurate, utilize easily obtained patient specimens, and are simple to perform without instrumentation. Our over-the-counter
(home use) and professional use (doctor’s office, clinics, etc.) rapid diagnostic test products help to manage existing medical
conditions and may save lives through early detection and diagnosis of specific diseases. Typically, tests of this kind require the services
of medical technologists and sophisticated instrumentation. Further, results are often not available until at least the following day.
We believe rapid point-of-care tests can be as accurate as laboratory tests when developed and used properly, may require limited to
no instrumentation, can give reliable results in minutes, and can be performed with confidence in the home or the physician’s office.
We
expend considerable funds in research and development of certain new products that diagnose and, in certain cases, are designed to be
used as a therapy for several major medical diseases. These products are both internally developed and licensed from others. We employ
experienced and highly trained technical personnel (including Ph.D.’s and other scientists) to develop new products and evaluate
and implement technology technical transfer activities. Our technical staff, many of whom have been previously employed at large diagnostic
manufacturing companies, has extensive industry experience. We also rely on our Scientific Advisory Board of leading medical doctors
and clinicians to assist in guiding our clinical studies and product development.
Biomerica
maintains its headquarters in Irvine, California, where it houses administration, finance, regulatory compliance, product development,
sales and marketing, customer services and its primary manufacturing operations. Biomerica maintains manufacturing and assembly operations
in Mexicali, Mexico, in order to reduce the cost of manufacturing and compete more effectively worldwide. Biomerica also has a legal
entity in Europe, BioEurope GmbH, for the purpose of selling certain products internationally.
Additional
information about Biomerica is available on our website at www.biomerica.com. The content on any website referred to in this Form 10-K
is not a part of or incorporated by reference in this Form 10-K unless expressly noted. Our Annual Report on Form 10-K, Quarterly Reports
on Forms 10-Q, Current Reports on Forms 8-K, Proxy Statements and all other filings we make with the Securities and Exchange Commission
(“SEC”) are available on our website, free of charge, as soon as reasonably practical after we file them with or furnish
them to the SEC and are also available online at the SEC’s website at www.sec.gov.
PRODUCTION
Most
of our diagnostic test kits are manufactured and/or assembled at our facilities in Irvine, California and in Mexicali, Mexico. We established
our manufacturing facility in Mexicali, Mexico in fiscal 2003 and moved a significant portion of our diagnostic packaging and assembly
to that facility.
Production
of diagnostic tests can involve formulating component antibodies and antigens in specified concentrations, attaching a tracer to the
antigen, filling components into vials, packaging and labeling. We continually engage in quality control procedures to assure the consistency
and quality of our products and to comply with applicable FDA and international regulations.
Our
manufacturing operations and facilities are regulated by the FDA Good Manufacturing Practices for medical devices. We have an internal
quality department that monitors and evaluates product quality and output. We also have an internal Quality Systems department whose
goal is to ensure that our operating procedures are in compliance with current FDA, CE Mark and International Organization for Standardization
(“ISO”) regulations. We either produce our own antibodies and antigens or purchase these materials from qualified vendors.
We have alternate, approved sources for most critical raw materials and are working to procure alternate sources for the few that we
do not have.
RESEARCH
AND DEVELOPMENT
Beyond
our focus on development of our InFoods® IBS product, we also focused a portion of our Research and Development (“R&D”)
resources on continued validation of our H. Pylori diagnostic test. Our research and development spending driven by our focus on these
tests and outside clinical studies intended to demonstrate the feasibility of FDA clearance for such tests. We also utilize technical
personnel, with Ph.D. and other degrees and extensive experience in development and production of health diagnostic
tests, to conduct other development activities and improve existing products, as well as explore potential new technologies that we may
wish to develop and commercialize. Research and development expenses include the costs of materials, supplies, personnel, consultants,
facilities, outside clinical trial sites and equipment as well as outside contract services. Consolidated research and development expenses
incurred by Biomerica for the years ended May 31, 2023 and 2022, aggregated to approximately $1,584,000, and $1,812,000, respectively.
As Biomerica moves forward with development, validation and commercialization of additional key products that address diseases with large
market opportunities, research and development expenses are expected to be consistent during upcoming quarters.
During
the fourth quarter of fiscal 2022, we also submitted our proprietary H. Pylori test to the FDA for clearance through a 510(k) submission.
The clinical studies for our H. Pylori were conducted at the University of Southern California, a European University, and several other
U.S. locations. Biomerica’s test is designed to provide highly accurate sensitivity and specificity for H. Pylori testing and for
monitoring of treatment. We are in the process of finalizing one additional set of in-house validation tests that the FDA has requested
us to complete before they review the submission and decide on the allowance on this product.
We
have developed a unique diagnostic-guided therapy which we call the InFoods® technology, that is designed to allow physicians
to identify patient-specific foods (e.g. pork, milk, onions, sugar, chickpeas, etc.), that when removed from the patient’s diet,
may alleviate or improve their symptoms of IBS and other diseases. We have filed patents throughout the world pertaining to the use of
our InFoods® diagnostic technology to detect abnormal immune responses in patients suffering from various diseases. Many
of these patents have recently been issued with many more in the review and prosecution phase. The United States Patent and Trademark
Office (“USPTO”) has issued the Company two patents with broad claims that protect this InFoods® IBS product.
Patents have also been issued in the countries of Australia, Japan, Korea, Mexico, and Singapore. Additional patent applications pertaining
to the InFoods® IBS product have been filed in the United States and in other countries. We are also developing and have
filed patents for products that target other diseases utilizing the InFoods® technology platform which include: Functional
Dyspepsia, Crohn’s disease, Ulcerative Colitis, Gastroesophageal Reflux disease (“GERD”), Migraine Headaches, Depression,
and Osteoarthritis. Our first patent to be allowed for a disease/illness other than IBS was allowed in Japan in August 2021. This patent
covers the use of our InFoods® technology to diagnose and treat persons suffering from depression.
MARKETS
AND METHODS OF DISTRIBUTION
Biomerica
has approximately 80 current customers for its diagnostic business, of which approximately 40 are foreign distributors, 10 are domestic
distributors and the balance are primarily domestic hospital and clinical laboratories, medical research institutions, medical schools,
pharmaceutical companies, chain drugstores, wholesalers, physicians’ offices, and e-commerce customers.
We
employ a director of sales and marketing for Europe and South America who is headquartered in Germany. She has over 20 years of experience
selling and marketing diagnostic and life science products across multiple diagnostics technologies and disciplines. She possesses broad
international business experience, with communication skills in German, English, Spanish, French, and Portuguese, and scientific and technical
understanding of gastrointestinal diagnostic products. She also has strong relationships with key strategic entities in Europe, Eastern
Europe, Latin America, Canada, and the United States and we expect that she will continue to help Biomerica add new distributors for existing
products and add new product-lines for future distribution by us.
We
rely on affiliated and unaffiliated distributors, advertising in medical and trade journals, exhibitions at trade shows, direct mailings,
and an internal sales staff to market our diagnostic products. We target two main markets: (a) clinical laboratories and (b) point-of-care
testing (physicians’ offices and over-the-counter drug stores).
Due
to global and economic disruptions caused by the global COVID-19 pandemic, the ongoing war in Ukraine, and tensions between the
country of China and the United States, the Company’s operations have been negatively impacted. The Company has faced
disruptions in certain of the following areas, and may face further challenges from supply chain disruptions, cost inflation, loss
of contracts and/or customers, closure of the facilities of the Company’s suppliers, partners and customers, travel, shipping
and logistical disruptions, government responses of all types, international business risks in countries where the Company makes
and/or sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of
production, customer credit risk, and general economic calamities. The pandemic, war, and geopolitical related disruptions have
materially negatively impacted the Company’s operations and financial performance and may continue to have significant
material negative impacts on the Company depending on possible disruptions from future outbreaks or issues. Our
net sales were approximately $5,339,000 for fiscal 2023 compared to $18,871,000 for fiscal 2022.
For
the fiscal years ended May 31, 2023 and 2022, the Company had one distributor and two distributors, respectively, which accounted for
a total of 35% and 65% of total net sales, respectively. Of this, for the fiscal years ended May 31, 2023 and 2022, the largest of the
distributors mentioned above accounted for 35% and 55%, respectively, of net sales.
Total
gross receivables on May 31, 2023 and 2022 were approximately $751,000 and $927,000, respectively. As of May 31, 2023 and 2022, the Company
had one distributor which accounted for 36% and 50%, respectively, of gross accounts receivable. Of the 36% as of May 31, 2023, 100%
was owed by a distributor in Asia.
BACKLOG
On
May 31, 2023 and 2022, Biomerica had a backlog of unshipped orders of approximately $655,000 and $754,000, respectively. On May 31, 2023,
this consisted primarily of orders to a distributor in Asia.
RAW
MATERIALS
The
principal raw materials utilized by Biomerica consist of various chemicals, serums, reagents, and packaging supplies. Almost all of our
raw materials are available from several sources, and we are not dependent upon any single source of supply or a few suppliers. However,
due to the limited number of suppliers of some materials, especially those such as antibodies, there is always the possibility that we
may encounter difficulty in the future obtaining key raw materials for its manufacturing processes or that such materials may be exceedingly
costly. For the fiscal year ended May 31, 2023, the Company did not have any significant concentration of vendor spend for raw materials.
For the fiscal year ended May 31, 2022, the Company had one vendor, which accounted for 84% of our purchases of raw materials largely
related to COVID-19 products.
Our
inventory consists of various types of materials including antibodies, antigens, bottles, boxes, various chemicals, and reagents utilized
in the manufacture of our test kits as well as products in various stages of completion.
Our
sourcing and receiving of raw materials were negatively impacted during the global COVID-19 pandemic. While most of these disruptions
have since been resolved, it is unclear to what extent raw material availability will be impacted in the foreseeable future, and how
that will impact our production and sales.
INFLATION
Due
to the global and domestic supply chain disruptions, and overall inflationary pressures in the economy, we have experienced material
increases in the cost of our raw materials and in our operating and labor costs. While we have attempted to respond by increasing the
selling price of our own products, the gross margins on our products sold have been negatively impacted.
COMPETITION
We
have certain proprietary products, such as our EZ Detect colon disease home test, the Aware Breast Self Exam product and our InFoods®
IBS product. These products have certain and significant competitive advantages compared to tests offered by competitors.
Our
competitors vary greatly in size. Many are divisions or subsidiaries of well-established medical and pharmaceutical companies which are
much larger than Biomerica and expend substantially greater amounts than we do for research and development, manufacturing, advertising,
and marketing.
The
primary competitive factors affecting the sale of diagnostic products are uniqueness, technology, quality of product, performance, price,
service, and marketing. We believe we compete primarily on the basis of the uniqueness of our products, the quality of our products,
the speed of our test results, our patent position, our pricing and our prompt shipment of orders. We offer a broad range of products
but have had limited marketing capability. However, recently we have expanded our sales and marketing capability, through
marketing and strategic cooperation with larger companies and distributors and by hiring new employees with marketing and sales expertise.
We have also hired a social media manager who focuses on social media campaigns that are directed at increasing awareness of our products
and driving sales of these products. In addition, during fiscal 2023, we hired an experienced Chief Commercial Officer, who is focused
on growing sales of our InFoods® IBS product that is now being offered as an LDT through a certified CLIA lab.
GOVERNMENT
REGULATION OF OUR DIAGNOSTIC BUSINESS
Our
primary business consists of selling products that are generally legally defined as medical devices and in vitro diagnostic medical devices.
As a result, we are considered to be a medical devices and in vitro diagnostic medical devices manufacturer, and as such, we are subject
to the regulations issued and enforced by of numerous governmental entities. These agencies include the FDA, Environmental Protection
Agency, Federal Trade Commission, Occupational Safety and Health Administration, U.S. Department of Agriculture (“USDA”),
and Consumer Product Safety Commission, as well as European Government agencies. Our activities are also regulated by various agencies
of the states and localities in which our products are sold. These regulations govern the introduction of new in vitro diagnostic medical
devices and medical devices, the observance of certain standards with respect to the manufacture and labeling of medical devices, the
maintenance of certain records, the reporting of potential product problems, and other matters.
The
Food, Drug & Cosmetic Act of 1938 (the “FDCA”) regulates medical devices in the United States by classifying them into
one of three classes based on the extent of regulation believed necessary to ensure safety and effectiveness. Class I devices are those
devices for which safety and effectiveness can reasonably be assured through general controls, such as device listing, adequate labeling,
and adherence to the Quality System Regulation (“QSR”) as well as Medical Device Reporting (“MDR”), labeling
and other regulatory requirements. Some Class I medical devices are exempt from the requirement of Pre-Market Notification or clearance.
Class II devices are those devices for which safety and effectiveness can reasonably be ensured through the use of special controls,
such as performance standards, post-market surveillance and patient registries, as well as adherence to the general controls’ provisions
applicable to Class I devices. Class III devices are devices that generally must receive clearance prior to marketing by the FDA pursuant
to a pre-market approval to ensure their safety and effectiveness. Generally, Class III devices are limited to life-sustaining, life-supporting,
or implantable devices. However, this classification can also apply to novel technology or new intended uses or applications for existing
devices. Our products are primarily either Class I or Class II medical devices.
Pursuant
to FDA requirements, we have registered our manufacturing facility with the FDA as a medical device manufacturer and listed the medical
devices we manufacture. We are also subject to inspection on a routine basis for compliance with FDA regulations. This includes the QSR,
which requires that we manufacture our products and maintain our documents in a prescribed manner with respect to issues such as design
controls, manufacturing, testing, and validation activities. Further, we are required to comply with other FDA requirements with respect
to labeling and MDR regulations which requires that we provide information to the FDA on deaths or serious injuries alleged to have been
associated with the use of our products, as well as any product malfunctions that are likely to cause or contribute to death or serious
injury if the malfunction were to recur. We believe that we are currently in material compliance with all relevant QSR and MDR requirements.
In
addition, our facility is required to have a California Medical Device Manufacturing License. The license is not transferable and must
be renewed biannually. Our current license is valid until November 19, 2024. Through compliance with FDA and California regulations,
we can market some of our medical devices throughout the United States. International sales of medical devices are also subject to the
regulatory requirements of each country where the product is sold. In Europe, the directives of the European Union (“EU’)
require that a device have a CE Mark in order to be sold in EU countries. We comply with In Vitro Diagnostic Medical Devices Directive
(“IVDD”) 98/79/EC and Medical Devices Regulation 2017/745 (“MDR”). We also comply with ISO 13485:2016 Medical
Devices Quality Management Systems - Requirements for Regulatory Purposes.
At
present, outside of the EU, the international regulatory review process varies from country to country. We work with our distributors
and sales representatives in the foreign countries in which we market our products to ensure that we comply with the regulatory laws
of those countries. We believe that our international sales to date have been in compliance with the laws of all foreign countries in
which we have made sales. Exports of most medical devices are also subject to certain FDA regulatory controls.
The
designing, development, manufacturing, marketing, post-market surveillance, distribution, advertising, and labeling of Biomerica’s
immunoassay in vitro diagnostic (“IVD”) medical device products are subject to regulation in the United States by the Center
for Devices and Radiological Health of the FDA and state agencies. FDA regulations require that some new products have pre-marketing
clearance or approval by the FDA and require these products to be manufactured in accordance with the FDA’s current Good Manufacturing
Practice (cGMP) regulations, to be extensively tested and to be properly labeled to disclose test results and performance claims and
limitations. After a product that is subject to FDA regulation is placed on the market, numerous regulatory requirements apply, including,
for example, the requirement that we comply with recordkeeping and reporting requirements, such as the FDA’s medical device reporting
regulations and reporting of corrections and removals. The FDA enforces these requirements by inspection and post-market surveillance.
The last FDA announced inspection was in November 2019 and no observations were noted. We believe that all Biomerica products sold in
the United States comply with the FDA and state regulations.
We
are an FDA regulated and ISO 13485:2016 certified In Vitro Diagnostic Medical Devices company. Our goal is to provide high quality medical
diagnostic products that generally meet or exceed customer requirements and comply with all applicable regulatory requirements: FDA 21
CFR Part 820 Quality Management System, ISO 13485:2016, Medical Devices Quality Management Systems - Requirements for Regulatory Purposes,
In Vitro Diagnostic Medical Devices Directive 98/79/EC & and Medical Device Regulation 2017/745, Guidelines related to Medical Devices
Directive/Regulation Guidance on CE Marking, among others. Biomerica involves its employees in a continuous improvement process to increase
productivity, improve quality and maintain the suitability, adequacy, and effectiveness of our quality management system.
The
EU In Vitro Diagnostic Medical Device Regulation (“IVDR”) 2017/746 was effective on May 26, 2022. Manufacturers need to update
their technical documentation and processes to meet the more stringent regulatory requirements of the European Union. Notified Bodies
can begin certifying devices to the new IVDR requirements once they have been designated under IVDR by their Competent Authority. Our
Notified Body is officially designated under the IVDR and listed in the European Commission NANDO database since August 19, 2021. We
are working closely with our Notified Body to update our technical documentation to comply with these more stringent IVDR requirements.
Per
IVDR 2017/746 Amendment 2021/0323 (COD), devices with a CE certificate that was issued in accordance with IVDD may be placed on the market
or put into service until May 26, 2025.
Exceptional
Renewal of CE Certificate for IVDD Quality System was granted to Biomerica. Biomerica received an extended CE Certificate on May 24,
2022, which remains effective until May 26, 2025. We have until May 26, 2025, to update the technical documentation and processes to
meet these regulatory requirements of IVDR 2017/746.
Per
IVDR 2017/746 Amendment 2021/0323 (COD), devices without a CE certificate that was issued in accordance with IVDD, for which a declaration
of conformity was drawn up prior to May 26, 2022, per IVDD and for which the conformity assessment procedure pursuant to IVDR requires
the involvement of a Notified Body, may be placed on the market, or put into service until the following dates. Biomerica also has until
the following dates to update the technical documentation and processes to meet these regulatory requirements of IVDR 2017/746:
|
(1) |
May 26, 2025, for class D devices. |
|
(2) |
May 26, 2026, for class C devices. |
|
(3) |
May 26, 2027, for class B devices; and |
|
(4) |
May 26, 2027, for class A devices placed on the market
in sterile condition. |
SEASONALITY
OF BUSINESS
Our
business has not been subject to significant seasonal fluctuations.
INTERNATIONAL
BUSINESS
The
following table sets forth the dollar volume of revenue attributable to sales to domestic customers and foreign customers during our
last two fiscal years:
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Asia | |
$ | 2,021,000 | | |
38 | % | |
$ | 13,375,000 | | |
71 | % |
Europe | |
| 1,798,000 | | |
34 | % | |
| 4,339,000 | | |
23 | % |
North America | |
| 1,470,000 | | |
28 | % | |
| 997,000 | | |
5 | % |
Middle East | |
| 39,000 | | |
1 | % | |
| 70,000 | | |
0 | % |
South
America | |
| 11,000 | | |
0 | % | |
| 90,000 | | |
1 | % |
Total | |
$ | 5,339,000 | | |
100 | % | |
$ | 18,871,000 | | |
100 | % |
We
recognize that our foreign sales could be subject to some special or unusual risks, which are not present in the ordinary course of business
in the United States. Changes in economic factors, government regulations, terrorism, tariffs, embargos, trade wars, import/export restrictions,
disruptions in shipping and distribution channels, drops in demand for our products due to regional or national shut-downs from the
COVID-19 pandemic, other disease outbreaks that cause patients’ fear or refusal to visit hospitals and healthcare providers
due to the pandemic where our products are sold and used, the erosion of economic conditions in those countries, and many other factors
all could impact sales within certain foreign countries. In addition, these factors could also impact our ability to collect foreign
accounts receivable. Foreign countries have licensing requirements applicable to the sale of diagnostic products, which vary substantially
from domestic requirements; depending upon the product and the foreign country, these may be more or less restrictive than requirements
within the United States and may change without notice. Foreign sales of our diagnostic products are made primarily through a network
of approximately 40 independent distributors in approximately 30 countries.
INTELLECTUAL
PROPERTY
We
regard the protection of our methodologies, designs, product formulations, manufacturing processes, diagnostic procedures,
copyrights, service marks, trademarks, and trade secrets as important to our future success. We rely on a combination of copyright,
trademark, patent, service mark and trade secret laws, and contractual restrictions to establish and protect our proprietary rights
in products and services. We have entered into confidentiality and invention assignment agreements with our employees and
contractors, and nondisclosure agreements with most of our fulfillment partners and strategic partners to limit access to and
disclosure of proprietary information. We cannot be certain that these contractual arrangements or the other steps taken by us to
protect our intellectual property (“IP”) will prevent misappropriation of our technology. We have licensed in the past,
and expect that we may license in the future, certain of our proprietary rights, such as trademarks, patents, trade secrets, or
copyrighted material, to third parties. While we attempt to ensure that the quality of our product brands is maintained by such
licensees, we cannot be certain that such licensees will not take actions that might hurt the value of our proprietary rights or
reputation.
LICENSE
OF THIRD-PARTY INTELLECTUAL PROPERTY
On
occasion, we in-licensed both exclusive and non-exclusive rights to intellectual property and patents owned by third parties. These license
agreements typically require royalties and other payments.
We
have a royalty agreement in which we obtained rights to manufacture and market an ACTH test (used to detect chronic metabolic conditions).
Royalty expenses of approximately $13,000 and $19,000, respectively, are included in cost of sales for this agreement for the fiscal
years ended May 31, 2023 and 2022. Sales of products manufactured under this agreement are not material to total sales for the fiscal
years ended May 31, 2023 and 2022, respectively. We may license other products or technology in the future as it is deemed necessary
or opportunistic for conducting business.
Some
of the products that we manufacture, sell, or use may be covered by claims in issued patents held by other persons or entities, and as
such, upon notice from such persons or entity we may be required to pay a license fee or may be required to cease all manufacture, sale
or use of such products, which could negatively impact us. While we have not been notified of any such claims by third parties, we cannot
guarantee that such claims will not be made in the future.
BRANDS
AND TRADEMARKS
We
occasionally register our tradenames with the U.S. Patent and Trademark Office (“USPTO”). Of note, we registered the tradename
“InFoods” on December 24, 2016. Our unregistered tradenames are “EZ Detect,” “EZ-H.P.,” and “EZ-PSA”.
A trademark for “Aware” was issued and assigned in 2001, renewed in 2011 and 2021. On January 11, 2020, the USPTO renewed
our “FORTEL” trademark for another ten years.
The
laws of some foreign countries do not protect our proprietary rights to the same extent as do the laws of the United States. Effective
copyright, trademark, and trade secret protection may not be available in such jurisdictions.
PATENTS
AND INFOODS TECHNOLOGY
We
have filed over 100 international and Patent Corporation Treaty patents (“PCT”) and have over multiple provisional and non-provisional
patents currently filed with the USPTO. Substantially all of our patents that are pending or registered pertain to the InFoods® technology
platform.
Our
most important family of patent applications pertains to our InFoods® technology platform, which is a method of diagnosing
and treating symptoms of many different inflammatory diseases. Our first product launch using this technology is the InFoods®
IBS product which is designed to diagnose and treat IBS. Using a patient blood sample, a physician or lab can run our test to identify
specific foods (e.g., pork, milk, shrimp, broccoli, eggs) that, if eliminated from an IBS patient’s diet, can alleviate or reduce
the individual’s IBS symptoms, including, but not limited to, constipation, diarrhea, bloating, cramping, severe pain, and indigestion.
We have filed many patent applications with the USPTO and with other such similar agencies in other countries outside of the United States
pertaining to this InFoods® technology. These patent applications include claims that address the diagnosis and treatment
of several disease states including IBS, functional dyspepsia, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease,
osteoarthritis, psoriasis, migraine headaches, and depression. These applications include the use of this technology in both humans and
animals. The first InFoods® patents filed by us pertained to IBS. Several of these patents pertaining to the InFoods®
IBS technology have been issued and many more are in active review and prosecution.
In
August 2018, we received our first patent pertaining to the InFoods® technology platform from the Korean Intellectual
Property Office, covering IBS. Since then, we have been granted a total of 19 patents; The United States Patent and Trademark
Office (“USPTO”) has issued the Company two patents with broad claims that protect our InFoods® technology
in testing and treating patients with IBS. Patents have also been issued in the countries of Australia (two patents), Canada, Japan (two
patents), Korea (two patents), Mexico, Panama, Peru, and Singapore, covering our InFoods® IBS technology. Additional patent
applications pertaining to the InFoods® IBS product are in prosecution and review at the USPTO and with the patent issuance
authorities in other countries.
We
are also developing and have filed patents with claims that cover products that target other diseases utilizing the InFoods®
technology platform. We have dozens of patents in prosecution or review pertaining to these other diseases, including: Functional
Dyspepsia, Crohn’s disease, Ulcerative Colitis, Gastroesophageal Reflux disease (“GERD”), Migraine Headaches, Depression,
and Osteoarthritis. In addition, we have a family of patents that cover the use of certain information technology (“IT”)
platforms and artificial intelligence/machine learning (“AI/ML”) tools that could assist patients in identifying and avoiding
packaged or processed food that contain specific foods that they are trying to eliminate from their diet.
In
addition to our IBS related issued patents, we have also been issued InFoods® technology patents in the following countries
pertaining to the following diseases: Australia – Attention Deficit Disorder (“ADD”) and Attention Deficit Hyperactivity
Disorder (“ADHD”); Australia – GERD; Japan - psychological depression, IT based food monitoring and elimination technology;
China – IT based food monitoring and elimination technology.
We
believe the claims in these issued InFoods® IBS patents and claims in our pending patents that protect the use of the InFoods®
technology to diagnose and treat various other diseases, provide us with broad protections from other companies making or selling competing
products in this highly disruptive new field of medicine.
In
addition to the use of our own patents, we have acquired from third parties the rights to manufacture and sell certain products that
are protected by patents or intellectual property owned by these third parties. In some cases, royalties are paid on the sales of these
products. We anticipate that we will license or purchase the rights to other products or technologies in the future.
We
also engage in contract research and development and contract manufacturing for third party companies. The technologies that relate to
this contract R&D and manufacturing are protected by patents and other intellectual property. In these situations, this intellectual
property is typically licensed to us under a limited license agreement enabling us to perform the services being contracted.
We
recently completed an endpoint determination clinical trial on our InFoods® IBS product. Our business model for this product includes
the possible out-licensing of this product and the related patents to a large international life sciences or technology company that
would commercialize the product or assist us with the commercialization. We may also out-license the patents or other intellectual property
pertaining to one or more of our other products including but not limited to our H. Pylori product.
EMPLOYEES
As
of May 31, 2023 and 2022, we employed a total of 62 and 64 employees, respectively, in the United States, Mexico, and Germany, of which
62 and 64 were full-time employees, respectively. Various employees listed in the production department also perform research and development
duties as a routine function of their job. We occasionally employ temporary employees when needed.
The
following is a breakdown of employees by departments:
| |
May
31, | |
| |
2023 | | |
2022 | |
Administrative | |
| 5 | | |
| 8 | |
Research & Development | |
| 9 | | |
| 8 | |
Sales & Marketing | |
| 7 | | |
| 6 | |
Production
& Operations | |
| 41 | | |
| 42 | |
Total | |
| 62 | | |
| 64 | |
We
also engage the services of many outside Ph.D.’s, M.D.’s, and other types of industry expert consultants and organizations
as well as medical institutions for technical support, regulatory advisors, marketing and public relations advisors, financial advisors,
contract product development and manufacturing organization, and other advisors on a regular basis. We try to protect the Company with
the use of confidentiality, intellectual property ownership, and indemnifications agreements. However, we cannot guarantee that the use
of such experts will fully protect the Company from third-party claims or from theft of our intellectual property.
ITEM
1A. RISK FACTORS
The
risks described below are not the only ones we face. Additional risks and uncertainties we are not presently aware of or that we currently
believe are immaterial may also impair our business operations. Our business could be harmed by any of these risks and uncertainties.
The trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment. In assessing
these risks, you should also refer to the other information contained or incorporated by reference into this annual report on Form 10-K,
including our consolidated financial statements and related notes.
RISKS
RELATED TO OUR BUSINESS
Our
business could be adversely affected by the effects of widespread public health epidemics or other broad government-imposed restrictions
on societies.
During
recent years, certain aspects of our business were negatively impacted by the COVID-19 pandemic. We may be materially impacted by ongoing
outbreaks of illness or other health issues, such as the COVID-19 outbreak. The outbreak of the COVID-19 virus caused various governments,
including the United States, to implement quarantines, various restrictions on transportation, and shelter in place orders and other
broad restrictions. Governments have also implemented sweeping work restrictions that prohibit most employees from going to work. The
Company faces significant future risks from such government imposed restrictions, laws and regulations pertaining to health epidemics
or various other government declared crisis’, that include but are not limited to: a) supply chain disruptions making it difficult
for the Company to receive materials needed for production of its products, and needed to ship finished products to our customers, b)
loss of contracts and customers from the financial strains or other disruptions they are experiencing as a result of the government restrictions,
c) financial risks pertaining to receivables due from customers that may fall into insolvency or otherwise be unable to pay their bills,
d) government orders that make it difficult to remain open for business, restrict imports of raw materials or exports of finished goods,
refusal to allow the Company’s product to be licensed for sale in their countries, and other seen and unforeseen actions taken
by government agencies, e) absenteeism or loss of employees at the Company, or at our partner’s companies, due to health reasons
or government restrictions, that are needed to develop, validate, manufacture, and perform other necessary functions for our operations,
f) equipment failures, loss of utilities, and other disruptions that could impact our operations or render them inoperable, g) litigation
or government actions against the Company pertaining to existing products and new products sold by the Company that are directed at limiting
or treating the spread of the pandemic outbreak, h) a local or global recession or depression that could harm the international banking,
economic and financial systems, i) a drop in demand for our products, that are all medical related, due to patients’ reluctance
or refusal to visit hospitals, labs, and doctors’ offices where our products are used, due to their fear of contracting a disease,
and j) many other seen and unforeseen events and circumstances, all of which could negatively impact the Company.
We
have a history of operating losses.
We
have historically incurred net losses. There can be no assurance that we will generate net profits in future periods. Further, there
can be no assurance that we will be cash flow positive in future periods. In the event that we fail to achieve profitability in future
periods, the value of our common stock may decline. In addition, if we are unable to achieve or maintain positive cash flows, we would
be required to seek additional funding, which may not be available on favorable terms, if at all.
Our
operating results may fluctuate adversely as a result of many factors that are outside our control, which may negatively impact our stock
price.
Our
operating results are dependent upon many factors that are substantially outside of our control that could materially and adversely affect
our business, results of operations, and financial condition. Factors that are beyond our control and that could affect our operating
results in the future include:
● |
regulatory
clearance of our products in the U.S. and in other markets; |
● |
regulatory
compliance in the U.S., Europe and other territories; |
● |
changes
in the level of competition, such as would occur if one of our competitors introduced a new, better performing or lower priced product
to compete with one or more of our products; |
● |
changes
in the reimbursement systems or reimbursement amounts that end-users may rely upon in choosing to use our products; |
● |
changes
in economic conditions in our domestic and international markets, such as economic downturns, decreased healthcare spending, reduced
consumer demand, inflation and currency fluctuations; changes in government laws and regulations affecting our business; reluctance
for consumers to visit healthcare providers; |
● |
lower
than anticipated market penetration of our new or more recently introduced products; |
● |
significant
quantities of our product or that of our competitors in our distributors’ inventories or distribution channels; |
● |
changes
in distributor buying patterns; |
● |
government
mandated shelter-in-place, lock downs or other crisis related orders; |
● |
potential resurgence of the COVID-19 virus or mutations of the virus; and |
● |
changes
in the healthcare market including consolidation in our customer base. |
Fluctuations
in our operating results, for any reason, could cause operating losses as a result of significant fixed expenses.
We
base the scope of our operations and related expenses on our estimates of future revenues. A significant portion of our operating expenses
are fixed, and we may not be able to rapidly adjust our expenses if our revenues fall short of our expectations. Our revenue estimates
for future periods are based, among other factors, on estimated end-user demand for our products. If end-user consumption is less than
estimated, revenues from our distribution partners and other distribution channels would be expected to fall short of expectations, and
because such a significant portion of our costs are fixed, could result in operating losses.
To
remain competitive, we must continue to develop, obtain, and protect our proprietary technology rights; otherwise, we may lose market
share or need to reduce prices as a result of competitors selling technologically superior products that compete with our products, or
selling products at lower prices.
Our
ability to compete successfully in the diagnostic market depends on continued development and introduction of new products, technology,
and the improvement of existing technology. If we cannot continue to improve upon or develop, obtain, and protect our technology, our
operating results could be adversely affected.
Our
competitive position is heavily dependent on obtaining and protecting our own proprietary technology or obtaining licenses from others.
Our ability to obtain patents and licenses, and their benefits, is uncertain.
To
remain competitive, we must expend considerable resources to research new technologies and products and develop new markets, and there
is no assurance our efforts to develop new technologies, products, or markets will be successful or such technologies, products, or markets
will be commercially viable.
We
devote a significant amount of financial and other resources to researching and developing new technologies, new products, and new markets.
The development, manufacture and sale of diagnostic products require a significant investment of resources. The development of new products
and markets also requires a substantial investment of resources, such as new employees, offices and manufacturing facilities, consultants,
and clinical trials. No assurances can be given that our efforts to develop new technologies or products will be successful, that such
technologies and products will be commercially viable, or our expansion into new markets will be profitable.
There
is also no guarantee that our new products, including our InFoods® IBS products, will get approval and be well accepted into the
marketplace.
Our
operations will be adversely affected if our operating results do not correspondingly increase with our increased expenditures or if
our technology, product, and market development efforts are unsuccessful or delayed. Furthermore, our failure to successfully introduce
new technologies or products and develop new markets could have a material adverse effect on our business and prospects.
The
Company is required to obtain government or regulatory certification in many countries and the European community to sell its products
in those countries or regions. There is no assurance that the Company will be able to retain its certification in the future. This includes
the possibility and risk that the Company’s products do not meet the new EU IVDR testing and documentation requirements in the
future as described in the above “Research and Development” section of this document.
Significant
government regulation exists in countries in which we conduct business. A large part of the Company’s sales is to distributors
in Europe, China, and other countries, which require us to maintain certain certifications to sell our products. Failure to comply with
current governmental regulations and quality assurance guidelines could cause the loss of these certifications, which could materially
adversely affect the results of the Company. Loss of certifications could lead to temporary manufacturing shutdowns, product recalls,
product shortages, or delays in product manufacturing and a decline in sales.
The
Company maintains a manufacturing plant in Mexico which presents risks to the Company including risks associated with doing business
outside the United States.
The
Company has a significant investment in its manufacturing facility in Mexico through its subsidiary, Biomerica de Mexico. In addition,
the Company warehouses a significant amount of its inventory at the Mexico facility. There are a number of risks associated with doing
business in Mexico, including, exposure to local economic and political conditions, social unrest, including risks of terrorism or other
hostilities, export and import restrictions, the potential for shortages of trained labor, and the possible effects of currency exchange
rate fluctuations. These risks could lead to additional costs that we cannot foresee at this time and may materially adversely impact
our business, results of operations, and financial condition.
We
use hazardous materials in our research and production that may result in unexpected and substantial claims against us relating to handling,
storage, or disposal.
We
use hazardous materials in our research and production. The risk of accidental contamination or injury from these materials cannot be
completely eliminated. In the event of such an accident, the Company could be held liable for any harm or damages that result and any
such liability could exceed the resources of the Company. The Company may incur substantial costs to comply with environmental regulations.
If
any governmental authorities were to impose new environmental regulations requiring compliance in addition to that required by existing
regulations or alter their interpretation of the requirements of such existing regulations, such environmental and safety regulations
could impair our research, development, or production efforts by imposing additional, and possibly substantial, costs, restrictions,
or compliance procedures on our business. In addition, because of the nature of the penalties provided for in some of these environmental
and safety regulations, we could be required to pay sizable fines, penalties, or damages in the event of noncompliance with regulations
and environmental laws. Any environmental or safety violation or remediation requirement could also partially or completely shut down
our research and manufacturing facilities and operations, which would have a material adverse effect on our business. The risk of accidental
contamination or injury from these hazardous materials cannot be completely eliminated and exposure of individuals to these materials
could result in substantial fines, penalties, or damages that may not be covered by insurance.
We
rely on a limited number of key distributors that account for a substantial majority of our total revenue. The loss of any key distributor
or an unsuccessful effort by us to directly distribute our products could lead to reduced sales.
Our
net sales were approximately $5,339,000 for fiscal 2023 compared to $18,871,000 for fiscal 2022. For the fiscal years ended May 31, 2023
and 2022, the Company had one distributor and two distributors, respectively, which accounted for a total of 35% and 65% of our net sales,
respectively. Of this, for the fiscal years ended May 31, 2023 and 2022, the largest of the distributors mentioned above accounted for
35% and 55%, respectively, of net sales.
Total
gross receivables on May 31, 2023 and 2022 were approximately $751,000 and $927,000, respectively. As of May 31, 2023 and 2022, the Company
had one distributor which accounted for a total of 36% and 50%, respectively, of gross accounts receivable. Of the 36% as of May 31,
2023, 100% was owed by a distributor in Asia. Adverse changes in our relationships with these distributors and other partners, or adverse
developments in their financial condition, performance, or purchasing patterns, could adversely affect our business and consolidated financial
statements.
We
sell to countries in Asia including China where trade policies and political issues could impact our revenues.
Our
revenues could be negatively impacted by complex relationships between the United States and other Asian countries including China. While
trade between the countries remains extremely strong, there are no assurances that these trade relations continue to be strong.
We
extend credit to customers outside the United States which can be difficult to collect.
We
extend credit to many of our customers including those outside of the United States. It is often difficult to obtain adequate credit
information on these customers. Further, our ability to collect receivables from these customers through the court systems in those countries
can be more difficult than here in the United States. Our inability to collect on receivables from customers, in particular those outside
of the United States, could negatively impact the Company.
If
we are not able to manage our growth strategy our operating results may be adversely affected.
Our
business strategy contemplates further growth, which would likely result in expanding into larger facilities, expanding the scope of
operating and financial systems and the geographical area of our operations, including further expansion outside the United States, as
new products and technologies are developed and commercialized or new geographical markets are entered. Because we have a small executive
staff, acquisitions, and other future growth may divert management’s attention from core aspects of our business and place a strain
on existing management and our operational, financial, and management information systems. Furthermore, we may expand into markets in
which we have less experience or incur higher costs. Any and all of these potential growth and expansion strategies and events could
impose material risks and cause the Company to incur adverse operating and financial results.
Intellectual
property risks and third-party claims of infringement, misappropriation of proprietary rights, or other claims against us could adversely
affect our ability to market our products, require us to redesign our products or attempt to seek licenses from third parties, result
in significant costs, and materially adversely affect our operating results.
Companies
in or related to our industry often aggressively protect and pursue their intellectual property rights. There are often intellectual
property risks associated with developing and producing new products and entering new markets, and we may not be able to obtain, at reasonable
cost or upon commercially reasonable terms, if at all, licenses to intellectual property of others that is alleged to be part of such
new or existing products.
We
rely on IP for the current products we sell and for the new products in research, development, and in clinical trials. While the Company
tries to protect its IP with confidentiality agreements and internal policies, we still face risks that our IP will be stolen or otherwise
misappropriated, by parties inside or outside of the United States. Further, we have filed many patents around the world on much of the
research and development done by the Company, and the proposed products to come from this research. The majority of these filed patents
are still under review and have not yet been allowed or issued. We may not be able to attain patent claims that adequately protect the
company from competitors developing similar products or copying our products. Finally, there is a great number of issued patents owned
by others that pertain to the product categories in which we operate. While we do not know of any patents with claims that we are violating
by manufacturing or selling our current products, there is a risk that certain third-party patents will come to our attention that prohibit
us from selling our products or that require us to pay royalty payments. Such third-party claims could have a material negative impact
on the Company. Any of these IP-related risks could cause material damage to future revenues and to the long-term enterprise values of
the Company.
We
have hired and will continue to hire individuals or contractors who have experience in medical diagnostics and these individuals or contractors
may have confidential trade secret or proprietary information of third parties. We cannot assure that these individuals or contractors
will not use this third-party information in connection with performing services for us or otherwise reveal this third-party information
to us. Thus, we could be sued for misappropriation of proprietary information and trade secrets. Such claims are expensive to defend
and could divert our attention and result in substantial damage awards and injunctions that could have a material adverse effect on our
business, financial condition, or results of operations. In addition, to the extent that individuals or contractors apply technical or
scientific information independently developed by them to our projects, disputes may arise as to the proprietary rights to such data
and may result in litigation.
The
defense and prosecution of patent and trade secret claims are both costly and time consuming. We or our customers may be sued by other
parties that claim that our products have infringed their patents or misappropriated their proprietary rights or that may seek to invalidate
one or more of our patents. An adverse determination in any of these types of disputes could prevent us from manufacturing or selling
some of our products, limit or restrict the type of work that employees involved with such products may perform for us, increase our
costs, and expose us to significant liability. In addition, the defense of such claims could result in significant costs and divert the
attention of our management and other key employees.
In addition to the foregoing, we may also be required to indemnify some
customers, distributors, and strategic partners under our agreements with such parties if a third party alleges or if a court finds that
our products or activities have infringed upon, misappropriated, or misused another person’s proprietary rights. Further, our products
may contain technology provided to us by other parties such as contractors, suppliers, or customers. We may have little or no ability
to determine in advance whether such technology infringes the intellectual property rights of a third party. Our contractors, suppliers,
and licensors may not be required or financially able to indemnify us in the event that a claim of infringement is asserted against us,
or they may be required to indemnify us only up to a maximum amount, above which we would be responsible for any further costs or damages.
Some
of the products that we manufacture, sell, or use may be covered by claims in issued patents held by other persons or entities, and as
such, upon notice from such persons or entity, we may be required to pay a license fee or may be required to cease all manufacture, sale
or use of such products, which could negatively impact our financial results or operations. We cannot guarantee that such claims will
not be made in the future.
We
need to continue to raise additional funds to finance our future capital or operating needs, which could have adverse consequences on
our operations and the interests of our stockholders.
As
a company focused on research and development of new products that do not yet generate revenues, we need to continue to raise funds through
public or private debt or sale of equity to achieve our business strategy. When we raise funds or acquire other technologies or businesses
through issuance of equity, this dilutes the interests of our stockholders. Moreover, the availability of additional capital, whether
debt or equity from private capital sources (including banks) or the public capital markets, fluctuates as our financial condition and
industry or market conditions in general change. There may be times when the private capital markets and the public debt or equity markets
lack sufficient liquidity or when our securities cannot be sold at attractive prices, in which case we would not be able to access capital
from these sources on favorable terms, if at all. We can give no assurance as to the terms or availability of additional capital.
Our
inability to raise additional funds to finance our future capital or operating needs could force us to delay, reduce, or eliminate our
development programs or commercialization efforts.
Costs
related to development projects and approvals are hard to estimate due to factors that are unknown to us at this time. These future costs
could be much higher than anticipated and current operations are unlikely to be able to cover these costs.
Clinical
trials involve a lengthy and expensive process with an uncertain outcome, and results of studies and trials may not be predictive of
future trial results.
Clinical
trials are expensive, time consuming, and difficult to design and implement. Regulatory agencies may analyze or interpret the results
differently than we do. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates
may take a significant amount of time to complete. Regulatory authorities, including state and local authorities, may suspend, delay
or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial to
continue for a longer duration than originally planned, or require a change to our development plans such that we conduct clinical trials
for a product candidate in a different order. There is no assurance that the results of the clinical trials will be positive. A negative
clinical trial could affect our ability to obtain regulatory clearances and/or potential licensing partners. There is also no assurance
that our clinical trials will not be delayed or will be completed. Any of the foregoing could have a material adverse effect on our business,
results of operations and financial condition.
Our
results of operations and financial conditions may be adversely affected by the financial soundness of our customers, distributors, and
suppliers.
If
our customers’ or suppliers’ operating and financial performance deteriorates, or if they are unable to make scheduled payments
or obtain credit, our customers may not be able to pay, or may delay payment of, accounts receivable owed to us, and our suppliers may
restrict credit or impose different payment terms or reduce or terminate production of products they supply to us, or may cease all operations.
Any inability of customers to pay us for our products and services, or any demands by suppliers for different payment terms, or inability
for such suppliers to continue operations may adversely affect our operating results and financial condition. Additionally, both state
and federal government sponsored and private payers, as a result of budget deficits or reductions, may seek to reduce their healthcare
expenditures by cutting or eliminating reimbursements for, or cutting purchase of our products. Any reduction in payments by such government
sponsored or private payers may adversely affect our earnings and cash flow.
We
may not achieve market acceptance of our new products among healthcare providers and physicians, and this would have a negative effect
on future sales.
We
believe our ability to introduce new products that gain acceptance among consumers, healthcare providers, and physicians is an important
part of our ability to grow our revenue in future periods. However, any new products we introduce may not gain market acceptance to the
extent we anticipate or project. The acceptance in the medical community for any of our new products is unpredictable at this time. In
addition, the Company will need to spend considerable funds in order to introduce new products into the marketplace. Sales, if any, of
these products in the future are uncertain. In addition, our competitors may offer different products and product formats at suggested
prices that are lower than our products or whose products are more accurate than our products. We can provide no assurances that consumers
and the medical community will purchase our products or that they will not prefer to purchase a competitive product.
The
industry and market segments in which we operate are highly competitive, and intense competition with other providers of diagnostic products
may reduce our sales and margins.
Our
diagnostic tests compete with similar products made by our competitors. There are a large number of multinational and regional competitors
making investments in competing technologies and products. We also face competition from our distributors as some have created, and others
may decide to create their own products to compete with ours. A number of our competitors have a potential competitive advantage because
they have substantially greater financial, technical, research and other resources, larger, more established marketing, sales, distribution
and service organizations; more established relationships with healthcare professionals; and greater
experience in conducting research and development, manufacturing, clinical trials, and obtaining regulatory approval for products.
Moreover, some competitors offer broader product lines and have greater name recognition than we have. If our competitors’ products
are more effective than ours or take market share from our products through more effective marketing or competitive pricing, our operating
results could be materially and adversely affected.
In
addition, there has been a trend toward industry consolidation in our markets over the last few years. We may not be able to compete
successfully in an increasingly consolidated industry. We expect this trend toward industry consolidation may continue as companies attempt
to strengthen or hold their market positions in an evolving industry and as companies are acquired or are unable to continue operations.
Our
business and products are highly regulated by various governmental agencies. Our results of operations would be negatively affected by
failures or delays in the receipt of regulatory approvals or clearances, the loss of previously received approvals, or other changes to
the existing laws and regulations that adversely impact our ability to manufacture and market our products.
The testing, manufacturing, and sale of our products are subject to regulation
by numerous governmental authorities in the United States, principally the FDA, and corresponding state and foreign regulatory agencies.
Our future performance depends on, among other matters, if, when, and at what cost we will receive regulatory approval for new products,
and if we can continue to comply with the many regulatory requirements that enable us to manufacture and sell medical related products
and tests. Regulatory review can be a lengthy, expensive, and uncertain process, making the timing and costs of clearances and approvals
difficult to predict. Meeting all regulatory requirements, laws and mandates, and maintaining compliance with such in order to manufacture
and sell medical products can be difficult and expensive. Our results of operations would be negatively affected by failures or delays
in the receipt of regulatory approvals or clearances, the loss of previously received approvals or clearances, the placement of limits
on the marketing and use of our products, and restrictions on our ability to manufacture our products.
Changes
in government policy could adversely affect our business and potential profitability.
Changes in government policy could have a significant impact on our business
by increasing the cost of doing business, affecting our ability to sell our products and negatively impacting our profitability. Such
changes could include tariffs, embargos, trade wars, modifications to existing legislation, such as U.S. tax policy, or entirely new legislation,
such as the Affordable Healthcare Act in the United States. We cannot predict the many ways that healthcare reform in the United States
and internationally, and changing trade legislation and policies could adversely affect our business. It is unclear whether and to what
extent, if at all, other anticipated developments, including changes due to new presidential administration priorities, or changes resulting
from healthcare reform, such as a change in the number of people with health insurance, may impact us.
We
are subject to numerous government regulations in addition to FDA regulations, and compliance with laws, including changed or new laws,
could increase our costs and adversely affect our operations. There is also the risk that our facilities could fail to get the proper
licensing at our next inspection or renewal.
In
addition to FDA and other regulations referred to above, numerous laws relating to such matters as safe working conditions, manufacturing
practices, data privacy, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances
impact our business operations. If these laws or their interpretation change or new laws regulating any of our businesses are adopted,
the costs of compliance with these laws could substantially increase our overall costs. Failure to comply with any laws, including laws
regulating the manufacture and marketing of our products, could result in substantial costs and loss of sales or customers. Because of
the number and extent of the laws and regulations affecting our industry, and the number of governmental agencies whose actions could
affect our operations, it is impossible to reliably predict the full nature and impact of future legislation or regulatory developments
relating to our industry and our products. To the extent the costs and procedures associated with meeting new or changing requirements
are substantial, our business, results of operations and financial condition could be adversely affected.
Our
total revenue could be affected by third-party reimbursement policies and potential cost constraints.
The
end-users of our products are primarily physicians, labs, and other healthcare providers. In the United States, healthcare providers
such as hospitals and physicians who purchase diagnostic products generally rely on third-party payers, principally private health insurance
plans, federal Medicare, and state Medicaid, to reimburse all or part of the cost of the procedure. Use of our products would be adversely
impacted if physicians and other healthcare providers do not receive adequate reimbursement for the cost of our products by their patients’
third-party payers both in the United States and in foreign markets. Our total revenue could also be adversely affected by changes or
trends in reimbursement policies of governmental or private healthcare payers. We believe that the overall escalating cost of medical
products and services has led to, and will continue to lead to, increased pressures on the healthcare industry, both foreign and domestic,
to reduce the cost of products and services. Given the efforts to control and reduce healthcare costs in recent years, currently available
levels of reimbursement may not continue to be available in the future for our existing products or products under development. Third-party
reimbursement and coverage may not be available or adequate in either the United States or foreign markets, current reimbursement amounts
may be decreased in the future and future legislation, regulation, or reimbursement policies of third-party payers may reduce the demand
for our products or adversely impact our ability to sell our products on a profitable basis.
Unexpected
increases in, or inability to meet, demand for our products could require us to spend considerable resources to meet the demand or harm
our reputation and customer relationships if we are unable to meet demand.
Our
inability to meet customer demand for our products, whether as a result of manufacturing problems or supply shortfalls, could harm our
customer relationships and impair our reputation within the industry. In addition, our product manufacturing of certain product lines
is concentrated in our two manufacturing sites. Weather, natural disasters (including pandemics), fires, terrorism, political change,
governmental restrictions or stay-at-home orders in response to natural disasters (including pandemics), failure to follow specific internal
protocols and procedures, equipment malfunction, environmental factors, or damage to one or more of our facilities could adversely affect
our ability to manufacture our products. This, in turn, could have a material adverse effect on our business.
If
we experience unexpected increases in the demand for our products, we may be required to expend additional capital resources or engage
third-party manufacturers to meet these demands. These capital resources could involve the cost of new machinery or even the cost of
new manufacturing facilities. In addition, engaging third-party manufacturers would increase manufacturing costs and reduce margins.
This would increase our capital costs or third-party expenses, which could adversely affect our earnings and cash resources. If we are
unable to develop or obtain necessary manufacturing capabilities in a timely manner or to engage third-party manufacturers to meet demand,
our total revenue could be adversely affected. Failure to cost-effectively increase production volumes, if required, or lower than anticipated
yields or production problems, including those encountered as a result of changes that we may make in our manufacturing processes to
meet increased demand or changes in applicable laws and regulations, could result in shipment delays as well as increased manufacturing
costs, which could also have a material adverse effect on our business, operating results and financial condition.
Unexpected
increases in demand for our products could also require us to obtain additional raw materials in order to manufacture products to meet
the demand. Some raw materials require significant ordering lead time and we may not be able to timely access sufficient raw materials
in the event of an unexpected increase in demand, particularly those obtained from a sole supplier or a limited group of suppliers.
If
one or more of our products is claimed to be defective or does not meet the performance criteria we claim in our marketing materials,
we could be subject to product recalls, claims of liability, harm to patients or users of our products, or harm to our reputation
that could adversely affect our business.
A
claim of a defect in the design or manufacture of our products could have a material adverse effect on our reputation in the industry
and subject us to claims of liability for injuries and otherwise. Further, a claim that one of our products is defective or does not
actually meet the performance criteria we claim in our marketing materials, could require a product recall or otherwise have a substantial
impact on our revenues and financial performance. Any substantial underinsured loss resulting from such a claim or defect would have
a material adverse effect on our operating results and financial conditions and the damage to our reputation or product lines in the
industry could have a material adverse effect on our business.
We
are exposed to business risks which, if not covered by insurance, could have an adverse effect on our results of operations. We face
potential product liability exposure, and, if claims brought against us are successful, we could incur substantial liabilities.
We
face a number of business risks, including exposure to product liability claims, employment law claims, claims that the Company or its
officers, directors or employees have engaged in illegal or wrongful acts, claims of violation of environmental laws, and many other possible
claims. Although we maintain insurance for a number of these risks, we may face claims for types of damages, or for amounts of damages,
that are not covered by our insurance. For example, although we currently carry product liability insurance for liability losses, there
is a risk that product liability or other claims may exceed the amount of our insurance coverage or may be excluded from coverage under
the terms of our policy. Also, our existing insurance may not be renewed at the same cost and level of coverage as currently in effect
or may not be renewed at all. Further, we do not currently have insurance against many environmental risks we confront in our business.
If we are held liable for a claim against which we are not insured or for damages exceeding the limits of our insurance coverage, whether
arising out of product liability matters, cybersecurity matters, or from some other matter, that claim could have a material adverse
effect on our results of operations.
We
may rely on third parties to conduct or be part of our clinical trials. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates.
We rely on third-party contract research organizations (“CROs”),
universities or/clinical sites (“Vendors”), to coordinate, monitor and conduct of our clinical trials and to manage, analyze,
and interpret data for our clinical programs. We, our Vendors, and our clinical sites are required to comply with current Good Clinical
Practices (“GCPs”), regulations, and guidelines issued by the FDA and by similar governmental authorities in other countries
where we are conducting clinical trials. We have an ongoing obligation to monitor the activities conducted by our Vendors and at our clinical
sites to confirm compliance with these requirements. In the future, if we, our Vendors or our clinical sites fail to comply with applicable
GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical
trials before approving our marketing applications. If our Vendors do not successfully carry out their contractual duties or obligations
or meet expected deadlines, if they need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised
due to their failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended,
delayed or terminated, and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase,
and our ability to generate revenue could be delayed.
Failures
in our information technology and storage systems could significantly disrupt our business or force us to expend excessive costs.
We utilize complex information technology systems to support our business
and store information. We cannot be sure that our systems will meet our future business needs or that necessary upgrades will operate
as designed, which could result in excessive costs or disruptions in portions of our business. In particular, any disruptions, delays,
or deficiencies caused by our enterprise resource planning system could adversely affect our ability to process orders, ship products,
provide services and customer support, send invoices and track payments, fulfill contractual obligations, or otherwise operate our business.
In addition, despite the implementation of security measures, information technology systems are vulnerable to damage from a variety of
sources, including computer viruses, unauthorized access, telecommunications or network failures, malicious human acts, terrorism, and
natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical
or electronic break-ins, computer viruses and similar disruptive problems. Cyber security is a great and growing risk to operating companies.
Cyber-attacks may result in loss of vital Company documentation and data, or confidential third-party documents held by the Company, that
are necessary for the Company to operate. Despite the precautionary measures we have taken to prevent unanticipated problems that could
affect our systems, sustained or repeated system failures that interrupt our ability to generate and maintain data, could result in a
material disruption in our operations and material adverse financial costs to the Company. Furthermore, to the extent that any disruption
or security breach resulted in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary
information, we could face a variety of negative consequences, including regulatory actions or litigation, fines or penalties, adverse
publicity, increased cybersecurity protection costs, and lost revenue.
There
is a risk that our measures to protect our systems from cyber-attack are not sufficient to avoid attacks by new sources and methods.
Our
business could be negatively affected by the loss of or the inability to hire key personnel.
Our
future success depends in part on our ability to retain our key technical, sales, marketing, and executive personnel and our ability to
identify and hire additional qualified personnel. Competition for these personnel is intense, both in the industry in which we operate
and where our operations are located. Further, we expect to grow our operations, and our needs for additional management and other key
personnel are expected to increase. If we are not able to retain existing key personnel, or timely identify and hire replacement or additional
qualified personnel to meet expected growth, our business could be adversely impacted. In addition, the loss of any of our key personnel,
particularly key research and development personnel, could harm our business and prospects and could impede the achievement of our research
and development, operation or strategic objectives.
We
face risks relating to our international sales, including inherent economic, political, and regulatory risks, which could impact our
financial performance, cause interruptions in our current business operations and impede our growth strategy.
Our
products are primarily sold internationally, with the majority of our international sales to our distributors in Asia and Europe. We
currently sell and market our products through distributor organizations and sales agents which creates foreign risks include, among
others:
● |
compliance
with multiple different registration requirements and new and changing registration requirements, our inability to benefit from registration
for our products inasmuch as registrations may be controlled by a distributor, and the difficulty in transitioning our product registrations; |
● |
compliance
with complex foreign and U.S. laws and regulations that apply to our international operations, including U.S. laws such as import/export
limitations, the Foreign Corrupt Practices Act, and local laws; |
● |
tariffs
or other barriers as we continue to expand into new countries and geographic regions, especially related to China as tariffs are
changing constantly; |
● |
exposure
to currency exchange fluctuations against the U.S. dollar; |
● |
longer
payment cycles, generally lower average selling prices and greater difficulty in accounts receivable collection; |
● |
lack
of ability to enforce receivables collections contracts in foreign legal courts; |
● |
reduced,
or lack of protection for, and enforcement of, intellectual property rights; |
● |
political
and economic instability in some of the regions where we currently sell our products or that we may expand into in the future; |
● |
complex
and potentially adverse tax consequences; and |
● |
diversion
to the United States of our products sold into international markets at lower prices. |
Currently,
most of our international sales are negotiated for and paid in U.S. dollars. Nonetheless, these sales are subject to currency risks,
since changes in the values of foreign currencies relative to the value of the U.S. dollar can render our products comparatively more
expensive. These exchange rate fluctuations could negatively impact international sales of our products, as could changes in the general
economic conditions in those markets. In order to maintain a competitive price for our products internationally, we may have to continue
to provide discounts or otherwise effectively reduce our prices, resulting in a lower margin on products sold internationally. Continued
change in the values of the Euro, the Mexican peso and other foreign currencies could have a negative impact on our business, financial
condition, and results of operations.
In
addition, we have certain supply agreements with foreign vendors whereby we share the foreign currency exchange fluctuation risk. We
may, in the future, enter into similar arrangements.
A
material portion of our revenues come specifically from sales to our distribution partner located in China, who sells into the Chinese
market. Future political tensions between the U.S. and China governments could cause a disruption or reduction in our sales into that
market.
Sales
of our common stock in the public market could lower the market price for our common stock and adversely impact the trading price of
our securities.
Future
sales by the Company of a substantial number of shares of our common stock in the public market, or the perception that such sales may
occur, could adversely affect the then prevailing market price of our common stock and could make it more difficult for us to raise funds
in the future through a public offering of our securities.
On
July 21, 2020, we filed with the SEC a “shelf” registration statement on Form S-3. The registration statement registers common
shares that may be issued by the Company in a maximum aggregate amount of up to $90,000,000. Shares of our common stock may be sold from
time to time under this registration statement for up to three years from the filing date. On January 22, 2021, we filed a prospectus
supplement for the sale of up to $15,000,000 of shares of our common stock in an at-the-market (“ATM”) offering under the
shelf registration statement, of which approximately $5,290,000 were sold under the ATM. In March 2023, we terminated the ATM offering
and sold 3,333,333 shares of our common stock in a firm commitment public offering under the shelf registration statement. Shares sold
in the underwritten public offering were sold at a gross sales price of $2.40 per share, resulting in net proceeds from the offering,
after deducting issuance fees and expenses, of approximately $7,300,000. At fiscal year-end 2023, the Company did not have an open ATM
offering in place. However, the Company may in the future commence a new ATM offering or otherwise sell securities under a registration
statement or in private placements, which sales would be dilutive to existing shareholders.
The
issuance of additional shares of our common stock, or issuances of additional securities, could dilute the ownership interest of our
common stockholders and could depress the market price of shares of our common stock and impair our ability to raise capital through
the sale of additional equity securities. We cannot predict the size of future issuances or the effect, if any, that they may have on
the market price for our common stock.
We
also have a number of stockholders who own large blocks of our common stock. If one or more of these stockholders were to sell large
portions of their holdings in a relatively short time, for liquidity or other reasons, the prevailing market price of shares of our common
stock could be negatively affected.
The
price of our stock may fluctuate unpredictably in response to factors unrelated to our operating performance.
The
stock market periodically experiences significant price and volume fluctuations that are unrelated to the operating performance of particular
companies. These broad market fluctuations may cause the market price of our common stock to drop. In particular, the market price of
our common stock has been very volatile and unpredictable and may vary substantially in the future in response to:
● |
announcements
by us or our competitors concerning technological innovations; |
● |
introductions
of new products by us or by our competitors; |
● |
FDA,
SEC, Financial Industry Regulation Authority, and foreign regulatory actions against the Company; |
● |
developments
or disputes relating to patents or proprietary rights; |
● |
failure
to meet the expectations of stock market analysts and investors; |
● |
the
Company reporting material weakness in our internal control; |
● |
changes
in stock market analyst recommendations regarding our common stock; |
● |
changes
in healthcare policy in the United States or other countries; |
● |
lawsuits
or liability claims from shareholders or other parties; |
● |
legal
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent
protection for our product candidates, and the results of any proceedings or lawsuits, including patent or shareholder litigation; |
● |
possible
recalls of our products or false positive/false negative results; |
● |
sales
of our common stock or other securities by us or our stockholders in the future; |
● |
trading
volume of our common stock; |
● |
actual
or anticipated variations in quarterly operating results; |
● |
publication
of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities
analysts; |
● |
effects
of natural or man-made catastrophic events, including widespread public health epidemics like the pandemic related to COVID-19; |
● |
general
stock market conditions and other factors unrelated to our operating performance; |
● |
volatility
and disruptions in the capital and credit markets due to rising inflation and interest rates |
● |
wars
or expansion of wars or other related actions and events that impact the markets in which we operate; and |
● |
political
or societal unrest in the markets in which we operate. |
Trading
of our common stock is not significant, therefore sales of a larger volume of the stock could adversely affect the stock price.
As
of August 26, 2016, our Company’s stock has been traded on the Nasdaq Capital Market. Trading of our stock is limited and liquidation
of the Company’s stock may be difficult as there is a limited market for our stock.
Our
ability to use our net operating loss carry forwards in the future may be subject to limitation.
Although
we have Federal income tax net operating loss carryforwards of approximately $21,778,000 and California state income tax net operating
loss carryforwards of approximately $17,090,000, use of these loss carryforwards will depend on future income in relationship to expirations
dates of these carryforwards.
ITEM
1B. UNRESOLVED STAFF COMMENTS
None.
ITEM
2. PROPERTIES
The
Company leases its facilities. On May 31, 2023, the Company had approximately 22,000 square feet of floor space at its corporate headquarters
at 17571 Von Karman Avenue in Irvine, California, 92614 which it has been leasing since 2009. This lease was scheduled to expire on August
31, 2016, but the Company had an option to extend the term of its lease for two additional sixty-month periods. On November 30, 2015,
the Company exercised its option to extend its lease for an additional sixty-month period and entered into the First Amendment to Lease
wherein it extended its lease until August 31, 2021. On April 9, 2021, the Company exercised its second option to extend its lease for
an additional five years. When the Company extended its lease in April 2021, it was also granted an additional five- year lease extension
option. The current rent is approximately $26,000 per month and will increase on September 1, 2023, to $27,000 per month. The security
deposit is approximately $22,000.
In
November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 square
feet of manufacturing space located in Mexicali, Mexico. The Company has one 10-year option to renew at the end of the initial lease
period. The current rent is approximately $3,100 per month. Biomerica de Mexico also leases a smaller unit on a month-to-month basis
for use in one manufacturing process. In addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, as
headquarters for BioEurope GmbH, its Germany subsidiary.
We
believe our space is adequate for our current needs.
ITEM
3. LEGAL PROCEEDINGS
The
Company is, from time to time, involved in legal proceedings, claims and litigation arising in the ordinary course of business that have
a negative impact on the financial results of the Company. While the amounts claimed may be substantial, the ultimate liability cannot
be estimated because of considerable uncertainties that exist. Therefore, it is possible the outcome of such legal proceedings, claims,
and litigation could have a material negative effect on quarterly or annual operating results or cash flows when resolved in a future
period. However, based on facts currently available, management believes such matters will not have a material adverse effect on the
Company’s consolidated financial position, results of operations or cash flows.
There
were no legal proceedings pending as of May 31, 2023.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
PART
II
ITEM
5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The
Company’s common stock is listed for trading on the Nasdaq Capital Market stock exchange under the symbol BMRA.
As
of August 25, 2023, the number of holders of record of Biomerica’s common stock was approximately 800, excluding stock held in
street name. The number of record holders does not bear any relationship to the number of beneficial owners of the common stock as most
of the Company’s common stock is held in street name at securities brokerage firms.
The
Company has not paid any cash dividends on its common stock in the past and does not plan to pay any cash dividends on its common stock
in the foreseeable future. The Company intends, for the foreseeable future, to retain any earnings to finance the continued operation
and expansion of the Company’s business.
We
did not purchase any of our shares of common stock or other securities during our fiscal year ended May 31, 2023.
The
table below provides information relating to our equity compensation plans as of May 31, 2023:
Securities
Plan Category | |
Number
of Securities to be Issued Upon Exercise of Outstanding Options | | |
Compensation
Plans Weighted-Average Exercise Price of Outstanding Options | | |
Securities
Remaining Available for Future Issuance Under Compensation Plans (Excluding those Reflected in Second Column) | |
Equity compensation
Plans approved by Securities holders | |
| 2,342,616 | | |
$ | 3.52 | | |
| 28,301 | |
ITEM
6. RESERVED
Not
required.
ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis in conjunction with our consolidated financial statements and the accompanying notes
thereto included in Part II, Item 8 of this Report. This discussion and analysis contains forward-looking statements that are based on
our management’s current beliefs and assumptions, which statements are subject to substantial risks and uncertainties. Our actual
results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including
those discussed in “Risk Factors” included in Part I, Item 1A of this Report.
OVERVIEW
Biomerica,
Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH), is a biomedical technology
company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (physicians’
offices and over-the-counter through drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical
conditions and diseases. Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis
of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens,
or other substances, which may exist in the human body in extremely small concentrations. The Company’s products are designed to
enhance the health and well-being of people, while reducing total healthcare costs.
Our
primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided
therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other
inflammatory diseases. These products are directed at chronic inflammatory illnesses that are widespread and common, and as such address
very large markets. Our InFoods® IBS product uses a simple blood sample and is designed to identify patient-specific foods that,
when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, and constipation. Instead of broad and difficult
to manage dietary restrictions, the InFoods® IBS product works by identifying a patient’s above normal immunoreactivity to
specific foods. A food identified as positive, and causing an abnormal immune response in the patient is simply removed from the diet
to help alleviate IBS symptoms.
During
fiscal 2022, we completed an endpoint determination clinical trial on our InFoods® IBS product. This trial was conducted at Mayo
Clinics in Florida and Arizona, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, University of
Texas Health Science Center at Houston, Houston Methodist, the University of Michigan, and other institutions. This trial monitored
IBS patients over an 8-week treatment period to determine the efficacy of our InFoods® IBS product to improve the
patients’ IBS symptoms or endpoints. The top-line trial results were reported in February 2022. Multiple endpoints
demonstrated statistically significant improvements, indicating that the elimination of specific foods may meaningfully reduce the
symptoms of IBS in each patient subtype (including patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed). The greatest
clinical improvements, including but not limited to abdominal pain and bloating, were seen in patients diagnosed with IBS-Mixed and
IBS-Constipation, in the top line data. The purpose of the endpoint study was to validate the efficacy of the product, and to
determine the primary symptom endpoint, or endpoints to be used in a final pivotal trial that will be conducted to attain the
validation data needed to apply for U.S. Food and Drug Administration (“FDA”) clearance for the product. We are
continuing to review and refine the complete dataset and have selected the final endpoint that we would intend to use in a final
pivotal trial. We are starting to develop the protocol for submission to the FDA, and once approved the trial will be run thereafter. The trial is expected to include
the large medical institution participants that conducted the endpoint clinical trial, in addition to other new institutions and a
Clinical Research Organization.
Following
the successful completion and positive statistical results from the Company’s InFoods® IBS clinical trial (run at several prominent
centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. – a Harvard Medical School Teaching Hospital, Houston Methodist
Hospital, and the University of Michigan) which was completed in early calendar 2022, Biomerica received interest from Gastroenterology
(“GI”) physicians who would like to order the InFoods® IBS test for their patients. As such, we are currently working with
key GI physician groups who are interested in offering this product to their patients.
In
fiscal 2023, we worked to set up the InFoods® IBS test to be performed in a CLIA
certified, and College of American Pathologists (“CAP”) accredited high-complexity laboratory facility and offered as a laboratory
developed test (“LDT”). During the quarter ended February 28, 2023, the CLIA lab completed all validation testing necessary
for the InFoods® IBS product to be offered as an LDT and, as of quarter end, is now accepting patient samples. We also worked to
optimize the process for GI physicians to order the InFoods® IBS test, send patient blood samples to the CLIA lab, and receive the test
results for their patients. We believe ease of order and workflow for physicians, with easy to understand and actionable results for
patients, is critical to our success. During the fiscal third quarter, we also set up customer service and payment systems, along with
a dedicated website for patients to receive answers to questions they may have about the test and attain information about how to eliminate
a specific food from their diet. This is especially important for foods that are ingredients in common processed foods like milk, eggs,
and wheat. As of the end of the fiscal third quarter, the product is now available to physicians and their patients.
We
are also beginning the work of selecting and validating one new disease (such as ulcerative colitis or migraines), where there
is evidence that certain foods can trigger or contribute to the symptoms found in these indications. We expect any new disease we target
will follow a similar development pathway as InFoods® IBS in simultaneously seeking FDA clearance of the product while also launching
the product as an LDT.
We
will also continue to evaluate partnership/licensing opportunities, as they arise, with U.S and multinational companies that could help
us commercialize, or accelerate revenue growth of, the InFoods® products in the United States and overseas.
Our existing medical diagnostic products are sold worldwide primarily in
two markets: 1) clinical laboratories and 2) point-of-care (physicians’ offices and OTC at Walmart, CVS Pharmacy, Amazon, etc.).
The diagnostic test kits are used to analyze blood, urine, nasal, or fecal specimens from patients in the diagnosis of various diseases,
food intolerances and other medical complications, by measuring or detecting the existence and/or level of specific bacteria, hormones,
antibodies, antigens, or other substances, which may exist in a patient’s body, stools, or blood, often in extremely small concentrations.
Due to the global COVID-19 pandemic, in March 2020, we began developing
COVID-19 products to indicate if a person has been infected by COVID-19 or is currently infected. In fiscal 2022, we generated revenues
from the international sale of our COVID-19 antigen tests. However, in fiscal 2023, due to the decline in severity of COVID-19 and the
corresponding lower sales volumes we no longer sell these products.
During
fiscal 2022, we finalized development of our H. Pylori diagnostic test that indicates if a patient is infected with the H. Pylori bacteria.
H. Pylori infection is extremely common, and if left untreated, can lead to ulcers and possibly stomach cancers. During our fourth quarter
of fiscal 2022, we applied for FDA clearance of this product though a 510(k) premarket submission. We have been in communication with
the FDA answering certain follow-up questions and providing additional data as requested. We are working with the FDA to perform one
additional set of in-lab tests that the FDA has requested prior to making their final determination on clearance of the product. Once cleared, we will begin marketing the product in the U.S. market. We have already begun discussions with international distributors for
this product and expect to see revenues through these international channels during 2024.
The
majority of our research and development efforts are focused on development and commercialization of non-COVID related products such
as our H. Pylori product, and our InFoods® IBS product.
Our
existing products that contributed to our fiscal 2023 revenues are primarily focused on gastrointestinal diseases, food intolerances,
and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our products are CE marked and/or
sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for
sale in the United States by the FDA.
RESULTS
OF OPERATIONS
Net
Sales and Cost of Sales
The
following is a breakdown of revenues according to markets to which the products are sold:
| |
For the Year Ended May 31, | | |
Increase (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
Clinical lab | |
$ | 3,310,000 | | |
$ | 3,064,000 | | |
$ | 246,000 | | |
| 8% | |
Over-the-counter | |
| 1,169,000 | | |
| 1,089,000 | | |
$ | 80,000 | | |
| 7% | |
Contract manufacturing | |
$ | 610,000 | | |
$ | 459,000 | | |
$ | 151,000 | | |
| 33% | |
Physician’s office | |
| 250,000 | | |
| 14,259,000 | | |
$ | (14,009,000 | ) | |
| -98% | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | | |
$ | (13,532,000 | ) | |
| -72% | |
Our
net sales were approximately $5,339,000 for fiscal 2023 compared to $18,871,000 for fiscal 2022, a decrease of $13,532,000, or 72%. This
decrease in annual sales is primarily attributable to the decrease of $13,950,000 in sales of COVID-19 tests.
Our
cost of sales were approximately $4,893,000 for fiscal 2023 compared to $15,894,000 for fiscal 2022, a decrease of $11,001,000, or 69%.
This decrease was driven by the significant decrease in the demand for our COVID-19 tests. The percentage of cost of sales compared to
revenue in fiscal 2023 was 92%, versus 84% in fiscal 2022.
Operating
Expenses
The
following is a summary of operating expenses:
| |
Year
Ended May 31, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Increase
(Decrease) | |
| |
Operating
Expense | | |
As
a % of Total Revenues | | |
Operating
Expense | | |
As
a % of Total Revenues | | |
$ | | |
% | |
Selling, General
and Administrative Expenses | |
$ | 6,085,000 | | |
| 114% | | |
$ | 5,699,000 | | |
| 30% | | |
$ | 386,000 | | |
| 7% | |
Research and Development | |
$ | 1,584,000 | | |
| 30% | | |
$ | 1,812,000 | | |
| 10% | | |
$ | (228,000 | ) | |
| -13% | |
Selling,
General and Administrative Expenses
Our
selling, general and administrative expenses were approximately $6,085,000 for fiscal 2023 compared to $5,699,000 for fiscal 2022, an
increase of $386,000, or 7%. The increase was primarily due to $350,000 in legal expenses and a $290,000 non-recurring write-off of bad
debt expense related to COVID-19 sales. This was partially offset by a decrease of $75,000 in share-based compensation expense.
Research
and Development
Our
research and development expenses were approximately $1,584,000 for fiscal 2023 compared to $1,812,000 for fiscal 2022, a decrease of
$228,000, or 13%, primarily as a result of decreases in costs related to the research, development and validation of COVID-19. See “Research
and Development” for a more extensive description of the research being conducted.
Interest
and Dividend Income
Interest
and dividend income for fiscal 2023 and 2022 was approximately $133,000 and $27,000, respectively. The $106,000 increase was due to higher
market interest rates on our higher cash balance due to the current fiscal year financings.
LIQUIDITY
AND CAPITAL RESOURCES
The
following are the principal sources of liquidity:
| |
May
31, | |
| |
2023 | | |
2022 | |
Cash
and cash equivalents | |
$ | 9,719,000 | | |
$ | 5,917,000 | |
Working
capital including cash and cash equivalents | |
$ | 10,852,000 | | |
$ | 7,416,000 | |
As
of May 31, 2023 and 2022, the Company had cash and cash equivalents of approximately $9,719,000 and $5,917,000, respectively. As of May
31, 2023 and 2022, the Company had working capital of approximately $10,852,000 and $7,416,000, respectively. Based on management’s analysis of the Company’s cash flow requirements through August 2024 and beyond,
we believe that the aggregate
of our existing cash and cash equivalents is sufficient to meet our operating cash requirements and strategic objectives for growth for
at least the next year. To satisfy our capital requirements, including ongoing future operations, beyond next year, we may seek to raise
additional financing through debt and equity financings.
Operating
Activities
During
fiscal 2023, cash used in operating activities was approximately $5,474,000, as compared to $479,000 for fiscal 2022. The primary
factors that contributed to this were a loss of approximately $7,140,000, an increase in accounts receivable of $291,000, a decrease
in inventory reserves of $174,000, and a decrease in accounts payable and accrued expenses of $79,000. These were partially offset
by an increase in the allowance on accounts receivable of $342,000, a decrease in inventories of $534,000, and non-cash expenses of
approximately $1,237,000.
During
fiscal 2022, the Company had a net loss of approximately $4,531,000, a decrease in inventory reserves of $772,000, and a decrease in
the allowance on accounts receivable of $684,000. These were partially offset by a decrease in accounts receivable of $1,365,000, a decrease
in inventories of $1,562,000, an increase in accounts payable and accrued expenses of $389,000, and non-cash expenses of approximately
$1,855,000.
Investing
Activities
During
fiscal 2023, cash used in investing activities was approximately $78,000, as compared to $170,000 for fiscal 2022. During fiscal 2023,
the Company purchased approximately $64,000 of property and equipment and had $14,000 in expenditures related to patents. During fiscal
2022, the Company purchased approximately $57,000 of property and equipment and $113,000 in expenditures related to patents.
Financing
Activities
Cash
provided by financing activities for fiscal 2023 was approximately $9,390,000 as compared to $2,394,000 for fiscal 2022. In fiscal 2023
and 2022, the Company had proceeds from the exercise of stock options of approximately $81,000 and $77,000, respectively.
During
fiscal 2023 and 2022, the Company received approximately $9,309,000 and $2,317,000, respectively, in net proceeds from the sale of common
stock. The common stock sold and issued in fiscal 2022 and 2023 was issued under the Company’s shelf registration statement filed
with the SEC on July 21, 2020 (the “2020 Shelf Registration Statement”) and declared effective by the SEC on September 30,
2020, and under the prospectus supplement filed with the SEC on January 22, 2021 (“2021 Prospectus Supplement”), and the
prospectus supplement filed in conjunction with the Company’s underwritten public offering of common shares on March 7, 2023 (the
“2023 Prospectus Supplement”) (See Shareholders’ Equity in the notes to the consolidated financial statements for further
details about SEC registration statements). The 2020 Shelf Registration Statement registers common shares that may be issued by the Company
in a maximum aggregate amount of up to $90,000,000. On January 22, 2021, we filed the 2021 Prospectus Supplement for the sale of up to
$15,000,000 of shares of our common stock in an at-the-market offering under the 2020 Shelf Registration Statement, of which $5,290,000
was issued through March 7, 2023.
In
March 2023, we terminated the at-the-market offering and sold 3,333,333 shares of our common stock in a firm commitment public offering
under the 2020 Shelf Registration Statement at a price to the public of $2.40 per share, for total
gross proceeds of $8,000,000, before deducting underwriting discounts and commissions and other offering-related expenses payable by
the Company.
As
of August 25, 2023, the date on which this Annual Report on Form 10-K for the fiscal year ended May 31, 2023, is filed with the SEC,
our 2020 Registration Statement remains subject to the offering limits set forth in General Instruction I.B.6 of Form S-3 because our
public float is less than $75 million. For so long as the Company’s public float is less than $75 million, the aggregate market
value of securities sold by the Company under the 2020 Shelf Registration Statement pursuant to Instruction I.B.6 to Form S-3 during
any 12 consecutive months may not exceed one-third of the Company’s public float. We have sold $7,631,000 of our common stock pursuant
to General Instruction I.B.6 of Form S-3 in the 12 calendar months preceding the date of filing this Annual Report on Form 10-K. For
purposes of this limitation, the aggregate market value of our outstanding common stock held by non-affiliates, or public float, was
$25,638,909, based on 15,538733 non-restricted shares of our outstanding common stock held by non-affiliates and a price of $1.65 per
share, which was the price at which our common stock was last sold on the Nasdaq Capital Market on August 3, 2023 (a date within 60 days
of the date hereof), calculated in accordance with General Instruction I.B.6 of Form S-3. After giving effect to the $8,546,303 offering
limit imposed by General Instruction I.B.6 of Form S-3, and after deducting the shares we sold within the preceding 12 months, as of
the date of filing this Annual Report, we may sell $915,3030 shares of our common stock at this time under the 2020 Shelf Registration
Statement.
SUBSEQUENT
EVENTS
On
August 3, 2023, the Company announced it had entered into a sales agreement with CVS Pharmacy wherein the Company’s EZ Detect™
colorectal disease screening test will be offered at approximately 7,000 CVS Pharmacy retail stores. Biomerica has shipped the EZ Detect
product to CVS Health distribution centers in the United States, and the product is projected to be on store shelves in September.
OFF
BALANCE SHEET ITEMS
There
were no off-balance sheet arrangements as of May 31, 2023.
CRITICAL
ACCOUNTING ESTIMATES
The
preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of
America requires us to make a number of estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements. Such estimates and assumptions affect the reported amounts
of revenues and expenses during the reporting period. We base our estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions
or conditions. We continue to monitor significant estimates made during the preparation of our financial statements. On an ongoing basis,
we evaluate estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates
and assumptions are reasonable under the current conditions; however, actual results may differ from these estimates under different
future conditions.
We
believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of
operations, in that they require subjective or complex judgments, form the basis for the accounting policies deemed to be most
critical to us. These relate to revenue recognition, bad debts, inventory overhead application, inventory reserve, lease liabilities,
and right-of-use assets. We believe estimates and assumptions related to these critical accounting policies are appropriate under
the circumstances; however, should future events or occurrences result in unanticipated consequences, there could be a material
impact on our future financial conditions or results of operations. We suggest that our significant accounting policies be read in
conjunction with this Management’s Discussion and Analysis of Financial Condition and Results of Operations. Please refer to
Note 2 of the Company’s consolidated financial statements for information on Significant Accounting Policies.
REVENUE
RECOGNITION
The
Company has various contracts with customers. All the contracts specify that revenues from product sales are recognized at the time the
product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred, and at which point title
passes. The Company does not allow for returns except in the event of defective merchandise and therefore does not establish an allowance
for returns. In addition, the Company has contracts with customers wherein they receive purchase discounts for achieving specified sales
volumes. The Company regularly evaluates the status of these contracts and does not believe that any discounts will be given through
the end of the contract periods. Services for some contract work are invoiced and recognized for work that has been performed as the
project progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical
laboratories, medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold directly to drug stores
and e-commerce customers as well as to distributors. Physicians’ office products are sold to physicians and distributors, all of
whom are categorized below according to the type of products sold to them. We also manufacture certain components on a contract basis
for domestic and international manufacturers.
SHARE-BASED
COMPENSATION
The
Company follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value based
method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments
(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that uses
assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The
Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based
on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.
The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the
“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as
historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized under
the straight-line attribution method.
VALUATION
OF INVENTORIES, NET
Our
inventories are made up of raw materials, work in progress, and finished goods and are valued at the
lower of cost (determined using a combination of specific lot identification and the first-in, first-out methods) or net realizable value.
We
record valuation reserves for inventory items with excess quantities and obsolescence exposure. These reserves are estimates of a reduction
in value to reflect inventory valuation at the lower of cost or net realizable value. Management
evaluates quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated
customer demand for current products and new product introductions. Our inventory valuation reserves totaled $672,000 and $846,000
as of May 31, 2023 and 2022, representing approximately 25% and 26% of our inventory, respectively.
RECENT
ACCOUNTING PRONOUNCEMENTS
See
Note 2 to our consolidated financial statements for a listing of adopted and soon to be adopted accounting pronouncements.
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required.
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Exhibit
99.3, “Biomerica, Inc. and Subsidiaries Consolidated Financial Statements” is incorporated herein by this reference.
ITEM
9A. CONTROLS AND PROCEDURES
Attached
as exhibits to this Form 10-K are certifications of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”)
that are required in accordance with Rule 13a-14 of the Exchange Act. This “Disclosure Controls and Procedures” section includes
information concerning the controls and controls evaluation referred to in the certifications.
EVALUATION
OF DISCLOSURE CONTROLS
Our
management evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934, as amended, or the Exchange Act as of the end of the period covered by this report. Our management recognizes
that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
The disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Our CEO and
CFO concluded that our disclosure controls and procedures are effective at a reasonable assurance level as of May 31, 2023. Based on
that evaluation the CEO and CFO concluded that information required to be disclosed in the reports that we file and submit under the
Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the Commission’s rules and
forms; and (2) accumulated and communicated to the Company’s management, including its CEO and CFO, as appropriate, to allow timely
decisions regarding required disclosure.
Company
management, including the CEO and CFO concluded that, as of May 31, 2023, the Company’s internal control over financial reporting
was effective.
CHANGES
IN INTERNAL CONTROL OVER FINANCIAL REPORTING
There
have been no changes in our internal control over financial reporting identified in connection with the evaluation that occurred during
the quarter ended May 31, 2023, that have materially affected, or that are reasonably likely to affect, our internal control over financial
reporting.
MANAGEMENT’S
REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Company
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f)
under the Securities Exchange Act of 1934. The Company’s internal control over financial reporting is designed to provide reasonable
assurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparation
and fair presentation of financial statements for external purposes in accordance with accounting principles generally accepted in the
United States of America.
A
company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with accounting principles generally accepted in the United States of America, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have
a material effect on the consolidated financial statements.
The
effectiveness of any system of internal control over financial reporting is subject to inherent limitations, including the exercise of
judgment in designing, implementing, operating, and evaluating the controls and procedures. Because of these inherent limitations, internal
control over financial reporting cannot provide absolute assurance regarding the reliability of financial reporting and may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls
may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Company
management, with the participation of the CEO and the CFO, evaluated the effectiveness of the Company’s disclosure controls and
procedures as defined in Rules 13(a)-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act,
as of the end of the period covered by this report. In making this assessment, Management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control - Integrated Framework (2013). Based
on this assessment, management, with the participation of the CEO and CFO, believes that, as of May 31, 2023, the Company’s internal
control over financial reporting was effective based on those criteria.
Company
management will continue to monitor and evaluate the effectiveness of its disclosure controls and procedures and its internal controls
over financial reporting on an ongoing basis and are committed to taking further action and implementing improvements, as necessary and
as funds allow.
Note:
This 10-K does not include an attestation report of the Company’s independent registered public accounting firm regarding internal
control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered
public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only
management’s report in this 10-K.
ITEM
9B. OTHER INFORMATION.
None.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
The
information required by this item will be disclosed in our definitive proxy statement on Schedule 14A (the “Proxy Statement”)
for our 2023 Annual Meeting of Stockholders and is incorporated by reference herein. Our Proxy Statement will be filed with the SEC within
120 days after the end of the Company’s fiscal year ended May 31, 2023, pursuant to Regulation 14A under the Exchange Act.
ITEM
11. EXECUTIVE COMPENSATION
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
PART
IV
ITEM
15. EXHIBITS LIST AND FINANCIAL SCHEDULES
The
following documents are filed as part of this Annual Report on Form 10-K:
|
1.
Consolidated Financial Statements |
|
|
Reference
is made to the Index to the consolidated financial statements as set forth on page FS-1 of this Annual Report on Form
10-K. |
|
2.
Consolidated Financial Statement Schedules |
|
|
All
schedules have been omitted as the pertinent information is either not required, not applicable, or otherwise included in the financial
statements and notes thereto. |
|
3.
Exhibits |
|
|
See
below. |
Exhibit
No. |
|
Description |
|
|
|
3.1 |
|
First Amended and Restated Certificate of Incorporation of Registrant filed with the Secretary of State of Delaware on August 1, 2000 (incorporated by reference to Exhibit 3.8 filed with the Registrant’s Annual Report on Form 10-KSB for the fiscal year ended May 31, 2000). |
|
|
|
3.2 |
|
Amended and Restated Bylaws, as adopted on July 24, 2023 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed July 26, 2023). |
|
|
|
4.1 |
|
Specimen Stock Certificate of Common Stock of Registrant (incorporated by reference to Exhibit 4.1 filed with Registrant’s Registration Statement on Form SB-2, Commission No. 333-87231 filed on September 16, 1999). |
|
|
|
4.2
|
|
Description of Capital Stock. |
|
|
|
10.1 |
|
Standard Industrial/Commercial Single-Tenant Lease, dated June 18, 2009, by and between Registrant and CNH, LLC for 17571 Von Karman Avenue, Irvine, CA 92614 (incorporated by reference to Exhibit 10.1 of the Company’s August 31, 2009 Form 10-Q filed October 16, 2009). |
|
|
|
10.2 |
|
2014 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 29, 2014). |
|
|
|
10.3 |
|
2017 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 28, 2017). |
|
|
|
10.4 |
|
2020 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 25, 2020). |
|
|
|
10.5 |
|
Form of Executive Stock Option Agreement (attached herein). |
|
|
|
10.6 |
|
Employment Agreement, dated March 1, 2023, by and between Biomerica, Inc. and Gary Lu. |
|
|
|
21.1 |
|
List of Subsidiaries (attached herein). |
|
|
|
23.1 |
|
Consent of Independent Registered Public Accounting Firm (Haskell & White LLP). |
|
|
|
31.1 |
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Exchange Act, adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended. |
|
|
|
31.2 |
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Exchange Act, adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended. |
|
|
|
32.1 |
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended. |
|
|
|
32.2 |
|
Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended. |
|
|
|
99.3 |
|
Registrant and Subsidiaries Consolidated Financial Statements. |
|
|
|
101.INS |
|
Inline
XBRL Instance Document. |
|
|
|
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document. |
|
|
|
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
|
|
|
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
|
|
|
101.LAB |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
|
|
|
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
The
certifications attached as Exhibits 32.1 and 32.2 accompany this Annual Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, as amended, and shall not be deemed “filed” by the registrant for purposes
of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities
Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
BIOMERICA, INC. |
|
Registrant |
|
|
|
|
By | /s/
Zackary S. Irani |
|
|
Zackary
S. Irani, |
|
|
Chief
Executive Officer |
|
|
|
|
|
Dated:
August 25, 2023 |
In
accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated:
Signature
and Capacity
/s/
Zackary S. Irani |
Date:
August 25, 2023 |
Zackary
S. Irani |
|
Director,
Chief Executive Officer |
|
|
|
/s/
Gary Lu, CPA |
Date:
August 25, 2023 |
Gary
Lu, CPA |
|
Chief
Financial Officer |
|
|
|
/s/
Allen Barbieri |
Date:
August 25, 2023 |
Allen
Barbieri |
|
Director,
Vice-Chairman |
|
|
|
/s/
Jane Emerson, M.D., Ph.D. |
Date:
August 25, 2023 |
Jane
Emerson, M.D., Ph.D. |
|
Director |
|
|
|
/s/
David Moatazedi |
Date:
August 25, 2023 |
David
Moatazedi
Director |
|
|
|
/s/
Catherine Coste, CPA |
Date:
August 25, 2023 |
Catherine
Coste, CPA |
|
Director |
|
BIOMERICA,
INC. AND SUBSIDIARIES
TABLE
OF CONTENTS
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors
Biomerica,
Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Biomerica, Inc. (the “Company”) as of May 31,
2023 and 2022, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows
for each of the years then ended, and the related notes (collectively, the “consolidated financial statements”). In our
opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the
Company as of May 31, 2023 and 2022, and the consolidated results of its operations and its cash flows for each of the years then
ended, in conformity with U.S. generally accepted accounting principles.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current-period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material
to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical
audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating
the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which
they relate.
Inventory
Valuation
Critical
Audit Matter Description
As described in Note 2 to the Company’s consolidated financial
statements, the Company values inventory at the lower of cost or net realizable value with cost inclusive of estimates for reasonable
allocations of labor and overhead costs. Also, management periodically reviews inventory for excess quantities and obsolescence. Management
evaluates quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated
customer demand for current products and new product introductions. Auditing the Company’s estimates for capitalized labor and overhead
was challenging due to the extensive use of estimates throughout this process, including the quantity of labor time allocable to each
inventory item. Auditing the Company’s estimates for slow-moving and obsolete inventories was challenging due to the inherently
judgmental nature of forecasting future sales and usage of a significant number of diverse inventory items.
How
the Critical Audit Matter Was Addressed in the Audit
To test the valuation of the Company’s inventory, we performed
the following audit procedures:
| ● | Obtained an understanding of the methodologies and policies used by
management to estimate capitalized labor and overhead and inventory reserves; we obtained an understanding of key internal controls and
assessed their overall appropriateness; |
| | |
| ● | Tested the reasonableness of the production labor and overhead cost
pools and the quantities produced and recalculated the allocable labor and overhead rate per unit; we recalculated the amount of capitalized
labor and overhead based on quantities on hand at the end of the fiscal year; and |
| | |
| ● | Tested
the accuracy of key data inputs that are the primary drivers for determining the quantitative inventory reserves; these inputs included
inventory quantities on hand, approximate age of the inventory quantities, and estimated inventory reserve percentages. |
We
have served as the Company’s auditor since 2022.
Irvine,
California
August
25, 2023
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 9,719,000 | | |
$ | 5,917,000 | |
Accounts receivable, net | |
| 722,000 | | |
| 774,000 | |
Inventories, net | |
| 2,056,000 | | |
| 2,416,000 | |
Prepaid
expenses and other | |
| 300,000 | | |
| 320,000 | |
Total current assets | |
| 12,797,000 | | |
| 9,427,000 | |
Property and equipment,
net of accumulated depreciation and amortization | |
| 213,000 | | |
| 214,000 | |
Right-of-use assets, net
of accumulated amortization of $617,000 and $725,000 as of May 31, 2023 and 2022, respectively | |
| 1,035,000 | | |
| 1,302,000 | |
Investments | |
| 165,000 | | |
| 165,000 | |
Intangible assets, net
of accumulated amortization | |
| 165,000 | | |
| 170,000 | |
Other
assets | |
| 79,000 | | |
| 96,000 | |
Total Assets | |
$ | 14,454,000 | | |
$ | 11,374,000 | |
| |
| | | |
| | |
Liabilities and Shareholders’
Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable and accrued
expenses | |
$ | 892,000 | | |
$ | 972,000 | |
Accrued compensation | |
| 696,000 | | |
| 647,000 | |
Advance from customers | |
| 60,000 | | |
| 51,000 | |
Lease
liabilities, current portion | |
| 297,000 | | |
| 341,000 | |
Total current liabilities | |
| 1,945,000 | | |
| 2,011,000 | |
Lease
liabilities, net of current portion | |
| 785,000 | | |
| 1,038,000 | |
Total Liabilities | |
| 2,730,000 | | |
| 3,049,000 | |
| |
| | | |
| | |
Commitments and contingencies
(Note 9) | |
| - | | |
| - | |
| |
| | | |
| | |
Shareholders’ Equity: | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock, Series
A 5% convertible, $0.08 par value, 571,429 shares authorized, none issued and outstanding as of May 31, 2023 and 2022 | |
| - | | |
| - | |
Preferred stock, undesignated,
no par value, 4,428,571 shares authorized, none issued and outstanding as of May 31, 2023 and 2022 | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
Common stock, $0.08 par value, 25,000,000
shares authorized, 16,821,646 and 12,867,924 issued and outstanding at May 31, 2023 and 2022, respectively | |
| 1,346,000 | | |
| 1,029,000 | |
Additional paid-in-capital | |
| 52,705,000 | | |
| 42,447,000 | |
Accumulated other comprehensive
loss | |
| (110,000 | ) | |
| (74,000 | ) |
Accumulated
deficit | |
| (42,217,000 | ) | |
| (35,077,000 | ) |
Total Shareholders’
Equity | |
| 11,724,000 | | |
| 8,325,000 | |
Total Liabilities and
Shareholders’ Equity | |
$ | 14,454,000 | | |
$ | 11,374,000 | |
See
accompanying notes to consolidated financial statements
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Net sales | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
Cost of sales | |
| (4,893,000 | ) | |
| (15,894,000 | ) |
Gross profit | |
| 446,000 | | |
| 2,977,000 | |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
Selling, general and administrative | |
| 6,085,000 | | |
| 5,699,000 | |
Research
and development | |
| 1,584,000 | | |
| 1,812,000 | |
Total
operating expense | |
| 7,669,000 | | |
| 7,511,000 | |
| |
| | | |
| | |
Loss from operations | |
| (7,223,000 | ) | |
| (4,534,000 | ) |
| |
| | | |
| | |
Other income: | |
| | | |
| | |
Dividend and interest income | |
| 133,000 | | |
| 27,000 | |
Other
income | |
| 1,000 | | |
| - | |
Total
other income | |
| 134,000 | | |
| 27,000 | |
| |
| | | |
| | |
| |
| | | |
| | |
Provision for income
taxes | |
| (51,000 | ) | |
| (24,000 | ) |
| |
| | | |
| | |
Net loss | |
$ | (7,140,000 | ) | |
$ | (4,531,000 | ) |
| |
| | | |
| | |
Basic net loss per common
share | |
$ | (0.50 | ) | |
$ | (0.36 | ) |
| |
| | | |
| | |
Diluted net loss per
common share | |
$ | (0.50 | ) | |
$ | (0.36 | ) |
| |
| | | |
| | |
Weighted average number of common and | |
| | | |
| | |
common equivalent shares: | |
| | | |
| | |
Basic | |
| 14,154,269 | | |
| 12,673,245 | |
| |
| | | |
| | |
Diluted | |
| 14,154,269 | | |
| 12,673,245 | |
| |
| | | |
| | |
Net loss | |
$ | (7,140,000 | ) | |
$ | (4,531,000 | ) |
| |
| | | |
| | |
Other comprehensive loss, net of tax: | |
| | | |
| | |
Foreign currency translation | |
| (36,000 | ) | |
| (26,000 | ) |
| |
| | | |
| | |
Comprehensive loss | |
$ | (7,176,000 | ) | |
$ | (4,557,000 | ) |
See
accompanying notes to consolidated financial statements
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY
FOR
THE YEARS ENDED MAY 31, 2023 AND 2022
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Common
Stock | | |
| | |
| | |
| | |
| |
| |
Shares | | |
Amount | | |
Additional
Paid-in-Capital | | |
Accumulated
Other Comprehensive Loss | | |
Accumulated
Deficit | | |
Total
Stockholder’s Equity | |
Balances at May 31, 2021 | |
| 12,307,157 | | |
$ | 985,000 | | |
$ | 38,837,000 | | |
$ | (48,000 | ) | |
$ | (30,546,000 | ) | |
$ | 9,228,000 | |
Exercise of stock options | |
| 39,500 | | |
| 3,000 | | |
| 74,000 | | |
| - | | |
| - | | |
| 77,000 | |
Net proceeds from ATM | |
| 521,267 | | |
| 41,000 | | |
| 2,276,000 | | |
| - | | |
| - | | |
| 2,317,000 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (26,000 | ) | |
| - | | |
| (26,000 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 1,260,000 | | |
| - | | |
| - | | |
| 1,260,000 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,531,000 | ) | |
| (4,531,000 | ) |
Balances at May 31, 2022 | |
| 12,867,924 | | |
| 1,029,000 | | |
| 42,447,000 | | |
| (74,000 | ) | |
| (35,077,000 | ) | |
| 8,325,000 | |
Balance | |
| 12,867,924 | | |
| 1,029,000 | | |
| 42,447,000 | | |
| (74,000 | ) | |
| (35,077,000 | ) | |
| 8,325,000 | |
Exercise of stock options | |
| 46,500 | | |
| 4,000 | | |
| 77,000 | | |
| - | | |
| - | | |
| 81,000 | |
Net proceeds from ATM | |
| 573,889 | | |
| 46,000 | | |
| 1,915,000 | | |
| - | | |
| - | | |
| 1,961,000 | |
Shares issued in connection
with public offering, net of offering costs | |
| 3,333,333 | | |
| 267,000 | | |
| 7,081,000 | | |
| - | | |
| - | | |
| 7,348,000 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (36,000 | ) | |
| - | | |
| (36,000 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 1,185,000 | | |
| - | | |
| - | | |
| 1,185,000 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,140,000 | ) | |
| (7,140,000 | ) |
Balances at May 31,
2023 | |
| 16,821,646 | | |
$ | 1,346,000 | | |
$ | 52,705,000 | | |
$ | (110,000 | ) | |
$ | (42,217,000 | ) | |
$ | 11,724,000 | |
Balance | |
| 16,821,646 | | |
$ | 1,346,000 | | |
$ | 52,705,000 | | |
$ | (110,000 | ) | |
$ | (42,217,000 | ) | |
$ | 11,724,000 | |
See
accompanying notes to consolidated financial statements.
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Cash flows from operating
activities: | |
| | | |
| | |
Net loss | |
$ | (7,140,000 | ) | |
$ | (4,531,000 | ) |
Adjustments to reconcile
net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 84,000 | | |
| 339,000 | |
Loss on disposal of property and equipment | |
| - | | |
| 53,000 | |
Provision for allowance on accounts receivable | |
| 342,000 | | |
| (684,000 | ) |
Inventory reserve | |
| (174,000 | ) | |
| (772,000 | ) |
Share-based compensation | |
| 1,185,000 | | |
| 1,260,000 | |
Amortization of right-of-use asset | |
| 267,000 | | |
| 256,000 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (291,000 | ) | |
| 1,365,000 | |
Inventories | |
| 534,000 | | |
| 1,562,000 | |
Prepaid expenses and other | |
| 20,000 | | |
| 50,000 | |
Other assets | |
| 18,000 | | |
| 169,000 | |
Accounts payable and accrued expenses | |
| (80,000 | ) | |
| 389,000 | |
Accrued compensation | |
| 49,000 | | |
| 258,000 | |
Advance from customers | |
| 9,000 | | |
| 51,000 | |
Reduction in lease liabilities | |
| (297,000 | ) | |
| (244,000 | ) |
Net cash used in operating
activities | |
| (5,474,000 | ) | |
| (479,000 | ) |
| |
| | | |
| | |
Cash flows from investing
activities: | |
| | | |
| | |
Expenditure related to intangibles | |
| (14,000 | ) | |
| (113,000 | ) |
Purchases of property
and equipment | |
| (64,000 | ) | |
| (57,000 | ) |
Net cash used in investing
activities | |
| (78,000 | ) | |
| (170,000 | ) |
| |
| | | |
| | |
Cash flows from financing
activities: | |
| | | |
| | |
Gross proceeds from sale of common stock | |
| 10,014,000 | | |
| 2,402,000 | |
Costs from sale of common stock | |
| (705,000 | ) | |
| (85,000 | ) |
Proceeds from exercise
of stock options | |
| 81,000 | | |
| 77,000 | |
Net cash provided by
financing activities | |
| 9,390,000 | | |
| 2,394,000 | |
| |
| | | |
| | |
Effect of exchange rate
changes in cash | |
| (36,000 | ) | |
| (26,000 | ) |
Net increase in cash and cash equivalents | |
| 3,802,000 | | |
| 1,719,000 | |
| |
| | | |
| | |
Cash and cash equivalents
at beginning of year | |
| 5,917,000 | | |
| 4,199,000 | |
| |
| | | |
| | |
Cash and cash equivalents
at end of year | |
$ | 9,719,000 | | |
$ | 5,917,000 | |
| |
| | | |
| | |
Supplemental Disclosure of Cash Flow Information: | |
| | | |
| | |
Cash paid during the year
for: | |
| | | |
| | |
Income taxes | |
$ | 51,000 | | |
$ | 24,000 | |
| |
| | | |
| | |
Non-cash investing and financing
activities: | |
| | | |
| | |
Increase in right-of-use
asset due to lease extension or establishment | |
$ | - | | |
$ | 4,000 | |
Increase in lease liability
due to lease extension or establishment | |
$ | - | | |
$ | 4,000 | |
Write off of fixed assets,
cost | |
$ | 40,000 | | |
$ | 820,000 | |
Write off of fixed assets,
accumulated depreciation | |
$ | 40,000 | | |
$ | 767,000 | |
Write off of intangible
assets, cost | |
$ | 6,000 | | |
$ | 247,000 | |
Write off of intangible
assets, accumulated amortization | |
$ | 6,000 | | |
$ | 37,000 | |
See
accompanying notes to consolidated financial statements
BIOMERICA,
INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS
ENDED MAY 31, 2023 AND 2022
NOTE
1: ORGANIZATION
Biomerica,
Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH) is a biomedical technology
company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (physicians’
offices and over-the-counter through drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical
conditions and diseases. Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis
of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens,
or other substances, which may exist in the human body in extremely small concentrations. The Company’s products are designed to
enhance the health and well-being of people, while reducing total healthcare costs.
Our
primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided
therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other
inflammatory diseases. These products are directed at chronic inflammatory illnesses that are widespread and common, and as such address
very large markets. Our InFoods® IBS product uses a simple blood sample and is designed to identify patient-specific foods that,
when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, and constipation. Instead of broad and difficult
to manage dietary restrictions, the InFoods® IBS product works by identifying specific foods that may be causing an abnormally high
immune response in the patient. A food identified as positive, which is causing the abnormal immune response in the patient,
is simply removed from the diet to help alleviate IBS symptoms.
Our existing medical diagnostic products are sold worldwide primarily in
two markets: 1) clinical laboratories and 2) point-of-care (physicians’ offices and over-the-counter drugstores like Walmart and
CVS Pharmacy). The diagnostic test kits are used to analyze blood, urine, nasal, or fecal specimens from patients in the diagnosis of
various diseases, food intolerances, and other medical complications, by measuring or detecting the existence and/or level of specific
bacteria, hormones, antibodies, antigens, or other substances, which may exist in a patient’s body, stools, or blood, often in extremely
small concentrations.
Due
to the global COVID-19 pandemic, in March 2020, we began developing COVID-19 products to indicate if a person has been infected by COVID-19
or is currently infected. In fiscal 2022, we generated revenues from the international sale of our COVID-19 antigen tests. However, in
fiscal 2023, due to the decline in severity of COVID-19 and the corresponding lower sales volumes, we no longer sell these products.
Due to the relatively high volume of sales from these products in fiscal 2021 and fiscal 2022, we have seen significant fluctuations
in quarterly revenues over the past twelve quarters.
The
other existing products that contributed to our 2023 revenues are primarily focused on gastrointestinal diseases, food intolerances,
and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our products are CE marked and/or
sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for
sale in the United States by the FDA.
NOTE
2: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES
OF CONSOLIDATION
The
consolidated financial statements for the years ended May 31, 2023 and 2022, include the accounts of Biomerica, Inc. (“Biomerica”)
as well as its wholly-owned German subsidiary (“BioEurope GmbH”) and Mexican subsidiary (“Biomerica de Mexico”).
All significant intercompany accounts and transactions have been eliminated in consolidation.
ACCOUNTING
ESTIMATES
The
preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United
States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and
the reported amounts of revenues and expenses during the reported period. Estimates that are made include the allowance for doubtful
accounts, which is estimated based on current as well as historical past practices with a customer; stock option forfeiture rates,
which are calculated based on historical data; inventory obsolescence, which is based on projected and historical usage of
materials; and lease liabilities and right-of-use assets, which are calculated based on certain assumptions such as the borrowing
rate on the lease commencement date and, the likelihood of lease extensions to occur, asset valuations, among other things; and other items that may be necessary to
estimate using current, historical and judgment based information. Actual results could materially differ from those
estimates.
Due
to the global COVID-19 pandemic, the Company’s operations have been negatively impacted. The Company has faced disruptions in the
following areas, (and may face further challenges): supply chain disruptions, loss of contracts and/or customers, closure of the Company’s
manufacturing or distribution facilities or of the facilities of the Company’s suppliers, partners and customers, travel, shipping
and logistical disruptions, government responses of all types, international business risks in countries where the Company makes and/or
sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of production, customer
credit risk, and general economic calamities. These pandemic related disruptions can materially negatively impact the Company’s
operations and financial performance and may continue to have significant material negative impacts on the Company.
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $42 million as
of May 31, 2023. Management expects to continue to incur significant costs as it advances its trials and development activities. As of
May 31, 2023, the Company had cash and cash equivalents of approximately $9,719,000 and working capital of approximately $10,852,000.
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any shares under the ATM Offering, and may at any time suspend offers
under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $3.15 to $4.26 pursuant to the
ATM Agreement, which resulted in gross proceeds of approximately $2,014,000 and net proceeds to the Company of $1,961,000, after deducting
commissions for each sale and legal, accounting, and other fees related to offering in the amount of $53,000.
During
the year ended May 31, 2022, the Company sold 521,267 shares of its common stock at prices ranging from $4.02 to $5.63 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,402,000 and net proceeds to the Company of $2,317,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $85,000.
On
March 7, 2023, the Company sold 3,333,333 shares of common stock in a firm commitment public offering at a gross sales price of $2.40
per share, with net total proceeds, after deducting issuance fees and expenses of $700,000, of approximately $7,300,000. Since the closing
of the March 7, 2023 offering, the ATM has been withdrawn and is not active.
The
Company intends to use the net proceeds from such offerings for general corporate purposes, including, without limitation, sales and
marketing activities, clinical studies, product development, making acquisitions of assets, businesses, companies or securities,
capital expenditures, and for working capital needs.
Management
has analyzed the cash requirements of the Company’s business through at least August 2024. As a result of cash and cash
equivalents on hand on May 31, 2023, largely from the public offering, and the ability to raise additional funds through another new
ATM agreement, management believes the Company has sufficient funds to operate through at least August 2024.
FAIR
VALUE OF FINANCIAL INSTRUMENTS
The
Company has financial instruments whereby the fair market value of the financial instruments could be different than that recorded on
a historical basis. The Company’s consolidated financial instruments consist of its cash and cash equivalents, accounts receivable,
and accounts payable. The carrying amounts of the Company’s financial instruments approximate their fair values. The Company also
maintains an investment in privately held company (see below).
CONCENTRATION
OF CREDIT RISK
The
Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. From time to time,
the Company has uninsured balances. The Company does not believe it is exposed to any significant credit risks.
The
Company provides credit in the normal course of business to customers throughout the United States and in foreign markets. The Company
performs ongoing credit evaluations of its customers and requires accelerated prepayment in some circumstances.
Our
net sales were approximately $5,339,000
for fiscal 2023 compared to $18,871,000
for fiscal 2022. For the fiscal years ended May 31, 2023 and 2022, the Company had one and two distributors, respectively, which
accounted for a total of 35%
and 65%
of our net sales, respectively. Of this, for the fiscal years ended May 31, 2023 and 2022, the largest of the distributors mentioned
above accounted for 35%
and 55%,
respectively, of net sales.
Total
gross receivables on May 31, 2023 and 2022 were approximately $751,000 and $927,000, respectively. On May 31, 2023 and 2022, the Company
had one distributor which accounted for a total of 36% and 50%, respectively, of gross accounts receivable. Of the 36% as of May 31,
2023, 100% was owed by a distributor in Asia.
For
the fiscal year ended May 31, 2023, the Company did not have any significant concentration of vendor spend for raw materials. For the
fiscal year ended May 31, 2022, the Company had one vendor, which accounted for 84% of our purchases of raw materials largely related
to COVID-19 products.
GEOGRAPHIC
CONCENTRATION
As
of May 31, 2023 and 2022, approximately $626,000 and $621,000, respectively, of Biomerica’s gross inventory was located in Mexicali,
Mexico, respectively. As of May 31, 2023 and 2022, approximately $17,000 of Biomerica’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico.
CASH
AND CASH EQUIVALENTS
Cash
and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.
ACCOUNTS
RECEIVABLE, NET
The
Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until
they establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria.
Initial credit levels for individual distributors are approved by designated officers and managers of the Company. All increases in
credit limits are also approved by designated upper-level management. Management evaluates receivables on a quarterly basis and
adjusts the allowance for doubtful accounts accordingly. Balances over ninety days
old are usually reserved for unless collection is reasonably assured.
Occasionally
certain long-standing customers, who routinely place large orders, will have unusually large receivables balances relative to the total
gross receivables. Management monitors the payments for these large balances closely and very often requires payment of existing invoices
before shipping new sales orders.
As
of May 31, 2023 and 2022, the Company has established a reserve of approximately $29,000 and $153,000, respectively, for doubtful accounts.
PREPAID
EXPENSES AND OTHER
The
Company occasionally prepays for items such as inventory, insurance, and other items. These items are reported as prepaids, until either
the inventory is physically received or the insurance and other items are utilized.
As
of May 31, 2023 and 2022, the prepaids were approximately $300,000 and $320,000, respectively, composed of prepayments to insurance and
various other suppliers.
INVENTORIES,
NET
The
Company values inventory at the lower of cost (determined using a combination of specific lot identification and the first-in, first-out
methods) or net realizable value. Management periodically reviews inventory for excess quantities and obsolescence. Management evaluates
quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated customer
demand for current products and new product introductions. The reserve is adjusted based on such evaluation, with a corresponding provision
included in cost of sales. Abnormal amounts of idle facility expenses, freight, handling costs, and wasted material are recognized as
current period charges and the allocation of fixed production overhead is based on the normal capacity of the production facilities.
The
following is a summary of approximate net inventories:
SCHEDULE
OF NET INVENTORIES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 1,677,000 | | |
$ | 1,717,000 | |
Work in progress | |
| 869,000 | | |
| 763,000 | |
Finished products | |
| 182,000 | | |
| 782,000 | |
Total gross inventory | |
$ | 2,728,000 | | |
$ | 3,262,000 | |
Inventory reserve | |
| (672,000 | ) | |
| (846,000 | ) |
Net
inventory | |
$ | 2,056,000 | | |
$ | 2,416,000 | |
Reserves
for inventory obsolescence are recorded as necessary to reduce obsolete inventory to estimated net realizable value or to specifically
reserve for obsolete inventory. As of May 31, 2023 and 2022, inventory reserves were approximately $672,000 and $846,000, respectively.
The Company has fully reserved COVID-19 antibody inventory in fiscal 2023.
PROPERTY
AND EQUIPMENT, NET
Property
and equipment are stated at cost. Expenditures for additions and major improvements are capitalized. Repairs and maintenance costs are
charged to operations as incurred. When property and equipment are sold, retired, or otherwise disposed of, the related cost and accumulated
depreciation or amortization are removed from the accounts, and gains or losses from sales, retirements, and dispositions are credited
or charged to income.
Depreciation
and amortization are provided over the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line
method. Leasehold improvements are amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation
and amortization expense on property and equipment amounted to approximately $66,000 and $100,000 for the years ended May 31, 2023 and
2022, respectively.
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights, and patents, and are accounted for based on Accounting Standards Codification
(“ASC”), ASC 350 Intangibles – Goodwill and Other (“ASC 350”). In that regard, intangible assets that have
indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in
circumstances indicate that the asset might be impaired.
Intangible
assets are being amortized using the straight-line method over the useful life, not to exceed 18 years for marketing and distribution
rights, 10 years for purchased technology use rights, and 20 years for patents. Amortization amounted to approximately $18,000 and $239,000
for the years ended May 31, 2023 and 2022, respectively.
The
Company assesses the recoverability of these intangible assets by determining whether the amortization of the asset’s balance over
its remaining life can be recovered through projected undiscounted future cash flows. The Company uses a qualitative assessment to determine
whether there was any impairment. During the year ended May 31, 2023, there was no impairment of intangible assets. During the year ended May 31, 2022, an impairment
adjustment was made of $210,000.
INVESTMENTS
The
Company has made investments in a privately held Polish
distributor, which is primarily engaged in distributing medical products and devices, including the distribution of the products
sold by the Company. The Company invested approximately $165,000
into the Polish distributor and owns approximately 6%
of the investee.
Equity
holdings in nonmarketable unconsolidated entities in which the Company is not able to exercise significant influence (“Cost Method
Holdings”) are accounted for at the Company’s initial cost, minus any impairment (if any), plus or minus changes resulting
from observable price changes in orderly transactions for the identical or a similar holding or security of the same issuer. Dividends
received are recorded as other income.
The
Company assesses its equity holdings for impairment whenever events or changes in circumstances indicate that the carrying value of an
equity holding may not be recoverable. Management reviewed the underlying net assets of the Company’s equity method holding as
of May 31, 2023 and determined that the Company’s proportionate economic interest in the entity indicates that the equity holding
was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the
Company’s Cost Method Holding during the year ended May 31, 2023.
SHARE-BASED
COMPENSATION
The
Company follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value based
method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments
(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that uses
assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The
Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based
on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.
The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the
“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as
historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized under
the straight-line attribution method.
The
Company expensed approximately $1,185,000 and $1,260,000 of share-based compensation during the years ended May 31, 2023 and 2022, respectively.
In
applying the Black-Scholes option-pricing model, the following assumptions used in the valuation of awards issued for period ending May 31, 2023 and 2022:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
| |
For
the year ended May 31, | |
| |
2023 | | |
2022 | |
Dividend yield | |
| 0% | | |
| 0% | |
Expected volatility | |
| 98.81
- 101.77% | | |
| 102.54
- 105.48% | |
Risk free interest rate | |
| 3.12
- 3.35% | | |
| 0.97
- 2.75% | |
Expected term | |
| 6.25
years | | |
| 5.50
- 6.25 years | |
REVENUE
RECOGNITION
The
Company has various contracts with customers. All of the contracts specify that revenues from product sales are recognized at the time
the product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred and at which point
title passes.
The
Company does not typically allow for returns from customers except in the event of defective merchandise and therefore does not establish
an allowance for returns. In addition, the Company has contracts with customers wherein customers receive purchase discounts for achieving
specified sales volumes. The Company evaluated the status of these contracts during the years ended May 31, 2023 and 2022 and does not
believe that any additional discounts will be given through the end of the contract periods.
Services
for contract work performed by the Company for others are invoiced and recognized as that work has been performed and as the project
progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories,
medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce
customers as well as to distributors. Physicians’ office products are sold to physicians and distributors, all of whom are categorized
below according to the type of products sold to them. We also manufacture certain components on a contract basis for domestic and international
manufacturers.
As
of May 31, 2023, the Company had approximately $60,000 of advances from certain foreign customers. These advances are prepayments on
orders that are expected to ship during our second fiscal quarter ending November 30, 2023.
Disaggregation
of revenue:
The
following is an approximate breakdown of revenues according to primary markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Clinical lab | |
$ | 3,310,000 | | |
$ | 3,064,000 | |
Over-the-counter | |
| 1,169,000 | | |
| 1,089,000 | |
Contract manufacturing | |
| 610,000 | | |
| 459,000 | |
Physician’s office | |
| 250,000 | | |
| 14,259,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
See
Note 8 for additional information regarding geographic revenue concentrations.
SHIPPING
AND HANDLING FEES
The
Company includes shipping and handling fees billed to customers in net sales.
RESEARCH
AND DEVELOPMENT
Research
and development costs are expensed as incurred. The Company expensed approximately $1,584,000 and $1,812,000 of research and development
costs during the years ended May 31, 2023 and 2022, respectively.
INCOME
TAXES
The
Company accounts for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and
liabilities arise from temporary differences between the tax bases of assets and liabilities and their reported amounts in the
consolidated financial statements that will result in taxable or deductible amounts in future years and the benefits of net
operating loss and tax credit carryforwards. These temporary differences and the benefits of net operating loss and tax credit
carryforwards are measured using enacted tax rates. A valuation allowance is recorded to reduce deferred tax assets to the extent
that management considers it is more likely than not that a deferred tax asset will not be realized. In determining the valuation
allowance, the Company considers factors such as the reversal of deferred income tax assets, projected taxable income, and the
character of income tax assets and tax planning strategies. A change to these factors could impact the estimated valuation allowance
and income tax expense. As of May 31, 2023 and 2022, in accordance with ASC 740, the Company has a valuation allowance for
substantially all of its net deferred tax assets. During the year ended May 31, 2023, this valuation allowance was increased to
$8,940,000,
which fully covers the net deferred tax asset of $8,940,000.
The
Company accounts for its uncertain tax provisions by using a two-step approach to recognizing and measuring uncertain tax positions.
The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more
likely than not, based solely on the technical merits, that the position will be sustained in an audit, including resolution of related
appeals or litigation processes, if any. The second step is to measure the appropriate amount of the benefit to recognize. The amount
of benefit to recognize is measured as the maximum amount which is more likely than not to be realized. The tax position is derecognized
when it is no longer more likely than not capable of being sustained. On subsequent recognition and measurement, the maximum amount which
is more likely than not to be recognized at each reporting date will represent the Company’s best estimate, given the information
available at the reporting date, although the outcome of the tax position is not absolute or final. The Company elected to follow an
accounting policy to classify accrued interest related to liabilities for income taxes within the “Interest expense” line
and penalties related to liabilities for income taxes within the “Other expense” line of the consolidated statements of operations
and comprehensive loss.
ADVERTISING
COSTS
The
Company reports the cost of all advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$156,000 and $76,000 for the years ended May 31, 2023 and 2022, respectively.
FOREIGN
CURRENCY TRANSLATION
The
subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the
U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries
are translated using exchange rates in effect at the end of the year, and revenues and costs are translated using average exchange rates
for the year. The resulting adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive
loss. There are no foreign currency transactions that are included in the consolidated statements of operations for the years ended May
31, 2023 and 2022.
RIGHT-OF-USE
ASSETS AND LEASE LIABILITIES
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued an accounting standard update which requires lessees
to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from
the lease. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value
of fixed lease payments over the lease term. Leases are classified as financing or operating which will drive the expense recognition
pattern. The Company has elected to exclude short-term leases. The Company leases office space and copy machines, all of which are operating
leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options
to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The
leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited
by the expected lease term. For additional information, see Note 9-Commitments and Contingencies.
NET
LOSS PER SHARE
Basic
loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss
per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible
securities using the treasury stock method. The total amounts of anti-dilutive stock options not included in the loss per share calculation
for the years ended May 31, 2023 and 2022 were 2,342,616 and 2,321,616, respectively.
SEGMENT
REPORTING
ASC
280, Segment Reporting (“ASC 280”), establishes standards for reporting, by public business enterprises, information about
operating segments, products and services, geographic areas, and major customers. The Company’s operations are analyzed by management
and its chief operating decision maker as being part of a single industry segment: the design, development, marketing, and sales of diagnostic
kits.
REPORTING
COMPREHENSIVE LOSS
Comprehensive
loss represents net loss and any revenues, expenses, gains and losses that, under GAAP, are excluded from net loss and recognized directly
as a component of shareholders’ equity. Items of other comprehensive loss consist solely of foreign currency translation adjustments
for the years ended May 31, 2023 and 2022.
RECENT
ACCOUNTING PRONOUNCEMENTS
Except as follows, recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by management to, have a material effect on
the Company’s present or future consolidated financial statements.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.
This ASU will require the measurement of all expected credit losses for financial assets, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The guidance was initially effective
for the Company for annual reporting periods beginning after December 15, 2019, and interim periods within those fiscal years. In November
2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases
(Topic 842): Effective Dates, which, among other things, defers the effective date of ASU 2016-13 for public filers that are considered
smaller reporting companies as defined by the Securities and Exchange Commission to fiscal years beginning after December 15, 2022, including
interim periods within those years. Early adoption is permitted. The Company is currently reviewing the requirements of this ASU to determine
its impact on the Company’s consolidated results of operations and financial position.
NOTE
3: PROPERTY AND EQUIPMENT, NET
The
following is an approximate breakdown of property and equipment, net of accumulated depreciation:
SCHEDULE
OF PROPERTY AND EQUIPMENT, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Equipment | |
$ | 1,333,000 | | |
$ | 1,292,000 | |
Furniture, fixtures and leasehold improvements | |
| 211,000 | | |
| 227,000 | |
Less accumulated depreciation | |
| (1,331,000 | ) | |
| (1,305,000 | ) |
Net
property and equipment | |
$ | 213,000 | | |
$ | 214,000 | |
NOTE
4: INTANGIBLE ASSETS, NET
The
following is an approximate breakdown of intangible assets, net of accumulated amortization:
SCHEDULE
OF INTANGIBLE ASSETS, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Patents | |
| 196,000 | | |
| 189,000 | |
Less accumulated amortization-patents | |
| (31,000 | ) | |
| (19,000 | ) |
Intangible
assets, net | |
$ | 165,000 | | |
$ | 170,000 | |
Expected
amortization of intangible assets for the years ending May 31:
SCHEDULE
OF EXPECTED AMORTIZATION OF INTANGIBLE ASSETS
| |
| | |
2024 | |
$ | 13,000 | |
2025 | |
| 13,000 | |
2026 | |
| 13,000 | |
2027 | |
| 13,000 | |
2028 | |
| 13,000 | |
Thereafter | |
| 100,000 | |
Total | |
$ | 165,000 | |
NOTE
5: ACCOUNTS PAYABLE AND ACCRUED EXPENSES
The
following is an approximate breakdown of accounts payable and accrued expenses balances:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Accounts
payable | |
$ | 344,000 | | |
$ | 736,000 | |
Accrued
expenses | |
| 548,000 | | |
| 236,000 | |
Total | |
$ | 892,000 | | |
$ | 972,000 | |
As
of May 31, 2023, the Company had one vendor which accounted for 23% of accounts payable. As of May 31, 2022, the Company had two vendors
which accounted for 69% of accounts payable.
NOTE
6: SHAREHOLDERS’ EQUITY
STOCK
OPTION AND RESTRICTED STOCK PLANS
In
December 2014, the Company adopted and shareholders approved a stock option and restricted stock plan (the “2014 Plan”).
Subsequently, in December 2017, the Company adopted and shareholders approved an stock option and restricted stock plan (the “2017
Plan”). In February 2020, the Board approved the 2020 Stock Incentive Plan (the “2020 Plan”, and collectively with
the 2014 Plan and 2017 Plan, the “Equity Incentive Plans”) and on December 11, 2020, the shareholders of the Company approved
the 2020 Plan. The Equity Incentive Plans provide that non-qualified options and incentive stock options and restricted stock may be
granted to directors, affiliates, employees, or consultants of the Company. The Equity Incentive Plans authorize awards representing
up to 850,000, 900,000 and 900,000 shares of the Company’s common stock to be issued under the 2014 Plan, 2017 Plan, and 2020 Plan,
respectively. Awards granted under the Equity Incentive Plans typically vest over 4 years. Options granted under the Equity Incentive
Plans will be granted at prices not less than 80% of the then fair market value of the common stock and will expire not more than 10
years after the date of grant. The 2014 Plan expires in December 2024, the 2017 Plan expires in December 2027, and the 2020 Plan expires
in December 2030.
Stock-based
compensation expense for the years ended May 31, 2023 and 2022 is as follows:
SCHEDULE
OF STOCK BASED COMPENSATION EXPENSE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Cost of sales | |
$ | 143,000 | | |
$ | 159,000 | |
Selling, general and administrative | |
| 971,000 | | |
| 1,021,000 | |
Research and development | |
| 71,000 | | |
| 80,000 | |
Total
stock option expense | |
$ | 1,185,000 | | |
$ | 1,260,000 | |
Activity
as to aggregate stock options outstanding is as follows:
SCHEDULE
OF ACTIVITY TO AGGREGATE STOCK OPTIONS
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Options Outstanding at May 31, 2021 | |
| 2,081,366 | | |
$ | 3.59 | | |
$ | 2,132,000 | |
Options granted | |
| 344,000 | | |
$ | 4.43 | | |
| | |
Options exercised | |
| (39,500 | ) | |
$ | 1.99 | | |
$ | 90,000 | |
Options canceled or expired | |
| (64,250 | ) | |
$ | 4.41 | | |
| | |
Options Outstanding at May 31, 2022 | |
| 2,321,616 | | |
$ | 3.72 | | |
$ | 1,838,000 | |
Options granted | |
| 243,000 | | |
$ | 2.70 | | |
| | |
Options exercised | |
| (46,500 | ) | |
$ | 1.73 | | |
$ | 90,000 | |
Options canceled or expired | |
| (175,500 | ) | |
$ | 5.56 | | |
| | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | | |
$ | 146,000 | |
Options vested and exercisable at May 31, 2023 | |
| 1,841,933 | | |
$ | 3.38 | | |
$ | 146,000 | |
The
weighted average grant date fair value of options granted during 2023 and 2022 were $2.19 and $4.43, respectively.
On
May 31, 2023, total compensation cost related to non-vested stock option awards not yet recognized totaled approximately $1,145,000.
The weighted-average period over which this amount is expected to be recognized is 2.52 years. The weighted average remaining contractual
term of options that were exercisable on May 31, 2023 was 4.97 years. The weighted average remaining contractual term of options that
were vested, exercisable, or expected to vest on May 31, 2023 was 5.67 years.
COMMON
STOCK ACTIVITY
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
On
May 21, 2021, in conjunction with the Company’s 2020 Stock Incentive Plan, that was approved by shareholders at the Company’s
annual meeting in December 2020, the Company filed an S-8 Registration Statement to register up to 900,000 shares of the Company’s
common stock that could be issued under this Plan.
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all of the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any of the shares under the ATM Offering, and may at any time suspend
offers under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $3.15 to $4.26 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,014,000 and net proceeds to the Company of $1,961,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $53,000.
During
the year ended May 31, 2022, the Company sold 521,267 shares of its common stock at prices ranging from $4.02 to $5.63 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,402,000 and net proceeds to the Company of $2,317,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $85,000.
On
March 7, 2023, the Company closed on an underwritten sale of 3,333,333 shares of our registered common stock through an investment banking
firm, which shares were issued under our shelf registration. In this offering, the Company sold the registered shares at a gross sales
price of $2.40 per share, with net proceeds, after deducting issuance fees and expenses of $700,000, of approximately $7,300,000.
PREFERRED
STOCK ACTIVITY
On
February 24, 2020, the Company entered into and closed on a Stock Purchase Agreement (the “Stock Purchase Agreement”) with
Palm Global Small Cap Master Fund LP (“Palm”) pursuant to which the Company agreed to sell and issue to Palm, and Palm agreed
to purchase from the Company, 571,429 shares of the Company’s Series A 5% Convertible Preferred Stock, $0.08 par value per share
for a purchase price of approximately $2 million, or $3.50 per Series A Convertible Preferred Stock. Under the terms of the Stock Purchase
Agreement, each share of issued Convertible Preferred Stock can be converted at any time by Palm into one share of the Company’s
common stock, subject to certain adjustments.
The
Series A 5% Convertible Preferred Stock accrued annual preferred dividends at a rate of $0.175 per Series A 5% Convertible Preferred
Share. However, accruing dividends were payable only when, as, and if declared by the Board and the Company had no obligation to pay
such accruing dividends.
On
March 24, 2020, Palm converted 250,000 shares of Convertible Preferred Stock into 250,000 shares of unregistered common stock. On July
21, 2020, the Company filed with the SEC a registration statement on Form S-3, that among other things, registered 571,429 common shares
issued, or to be issued, to Palm upon conversion of the Convertible Preferred Stock into common shares. On September 30, 2020, the Company
received a Notice of Effectiveness from the Securities and Exchange Commission for registration of these shares. On January 21, 2021,
Palm Converted their remaining 321,429 Convertible Preferred Shares into registered common shares. On May 30, 2021, the Company had no
shares of Preferred Stock outstanding. Under the terms of the Preferred Stock Purchase Agreement, none of the cumulative dividends were
paid to Palm during the period they owned the Preferred Stock. Once converted to common shares, Palm lost all rights to receive any past
cumulative dividends.
NOTE
7: INCOME TAXES
Provision
for income taxes for the years ended May 31 consists of the following:
SCHEDULE
OF PROVISION FOR INCOME TAXES
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Current: | |
| | | |
| | |
U.S. Federal | |
$ | - | | |
$ | - | |
Foreign Taxes
Subsidiaries | |
| (50,000 | ) | |
| (23,000 | ) |
State
and local | |
| (1,000 | ) | |
| (1,000 | ) |
Total
current | |
| (51,000 | ) | |
| (24,000 | ) |
Deferred: | |
| | | |
| | |
U.S. Federal | |
| - | | |
| - | |
State and local | |
| - | | |
| - | |
Total
deferred | |
| - | | |
| - | |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
Provision
for income taxes differs from the amounts computed by applying the U.S. Federal income tax rate applicable for each year (21% for 2023
and 2022) to pretax income as a result of the following:
SCHEDULE
OF EFFECTIVE INCOME TAX RECONCILIATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Computed “expected”
tax benefit | |
$ | 1,490,000 | | |
| 947,000 | |
Increase (reduction) in income taxes resulting
from: | |
| | | |
| | |
Change in valuation allowance | |
| (1,973,000 | ) | |
| (1,022,000 | ) |
State income taxes, net of federal benefit | |
| 583,000 | | |
| 300,000 | |
Research and development tax credits | |
| - | | |
| 50,000 | |
Permanent tax differences and other | |
| (17,000 | ) | |
| (197,000 | ) |
Stock based compensation benefit | |
| (5,000 | ) | |
| 11,000 | |
Foreign taxes of subsidiaries | |
| (129,000 | ) | |
| (113,000 | ) |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
The
tax effect of significant temporary differences is presented below:
SCHEDULE
OF DEFERRED TAX ASSETS
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Deferred tax assets: | |
| | | |
| | |
Accounts receivable,
principally due to allowance for doubtful accounts | |
$ | 8,000 | | |
$ | 43,000 | |
Inventory valuation | |
| 188,000 | | |
| 237,000 | |
Compensated absences | |
| 118,000 | | |
| 120,000 | |
Net operating loss carryforwards | |
| 5,817,000 | | |
| 4,349,000 | |
Tax credit carryforwards | |
| 1,239,000 | | |
| 1,096,000 | |
Deferred rent expense/Capitalized leases | |
| 11,000 | | |
| 20,000 | |
Stock Options | |
| 1,296,000 | | |
| 1,035,000 | |
Sec 174 capitalized costs | |
| 284,000 | | |
| - | |
Losses of foreign subsidiaries & other,
net | |
| - | | |
| 41,000 | |
Accumulated
depreciation and amortization | |
| (21,000 | ) | |
| 26,000 | |
Total deferred tax assets | |
| 8,940,000 | | |
| 6,967,000 | |
Less valuation allowance | |
| (8,940,000 | ) | |
| (6,967,000 | ) |
Net
deferred tax asset | |
$ | - | | |
$ | - | |
The
Company has provided a valuation allowance of approximately $8,940,000 and $6,967,000 as of May 31, 2023 and 2022, respectively. The
net change in the valuation allowance for the years ended May 31, 2023 and 2022 was an increase of $1,973,000 and $1,063,000, respectively.
On
May 31, 2023, the Company has Federal income tax net operating loss carryforwards of approximately $21,958,000. On May 31, 2023, the
Company has California state income tax net operating loss carryforwards of approximately $17,269,000. For tax reporting purposes, operating
loss carryforwards are available to offset future taxable income; such carryforwards expire in varying amounts beginning in 2024 and
2038 for federal and state purposes, respectively. Federal net operating losses beginning in 2018 have no expiration date.
On
May 31, 2023, the Company has Federal research and development tax credit carryforward of approximately $817,000. The Federal credits
begin to expire in 2028. The Company also had similar credit carryforwards for state purposes of $533,000 on May 31, 2023, which do not
expire.
Pursuant
to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss (“NOL”)
and credit carryforwards may be limited by statute because of a cumulative change in ownership of more than 50%. Pursuant to Sections
382 and 383 of the IRC, the annual use of the Company’s NOLs and credit carryforwards would be limited if there is a cumulative
change of ownership (as that term is defined in Section 382(g) of the IRC of greater than 50% in a three-year period). Management has
not performed an analysis to determine if the Company has had a cumulative change in ownership of greater than 50%.
For
the year ended May 31, 2023, the Company performed an analysis and has not identified any uncertain tax positions as
defined under ASC 740. Should such position be identified in the future, and should the Company owe interest and penalties as a result
of this, these would be recognized as interest expense and other expense, respectively, in the consolidated financial statements. The
Company is no longer subject to any significant U.S. federal tax examinations by tax authorities for years before fiscal 2018.
NOTE
8: GEOGRAPHIC INFORMATION
The
Company operates as one segment. Geographic information regarding net sales is approximately as follows:
SCHEDULE
OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | |
Asia | |
$ | 2,021,000 | | |
$ | 13,375,000 | |
Europe | |
| 1,798,000 | | |
| 4,339,000 | |
North America | |
| 1,470,000 | | |
| 997,000 | |
Middle East | |
| 39,000 | | |
| 70,000 | |
South America | |
| 11,000 | | |
| 90,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
NOTE
9: COMMITMENTS AND CONTINGENCIES
OPERATING
LEASES
The
Company leases facilities in Irvine, California and Mexicali, Mexico.
As
of May 31, 2023, the Company had approximately 22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue
in Irvine, California. The lease for its headquarters expires in August 2026. The Company has the option to extend the lease for an additional
five-year term. The Company made a security deposit of approximately $22,000.
In
November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 square
feet of manufacturing space. The Company has one 10-year option to renew at the end of the initial lease period. Biomerica de Mexico
also leases a smaller unit on a month-to-month basis for use in the Company’s manufacturing process.
In
addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, as headquarters for BioEurope GmbH, its Germany
subsidiary.
For
purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of
the facility, including any periods of free rent and any renewal options periods that the Company is reasonably certain of exercising.
The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases are included
in the measurement of the right-of-use asset and related lease liabilities. Additionally, under these lease arrangements, the Company
may be required to pay directly, or reimburse the lessors, for some maintenance and operating costs. Such amounts are generally variable
and therefore not included in the measurement of the right-of-use asset and related lease liabilities but are instead recognized as variable
lease expense in the consolidated statements of operations and comprehensive loss when they are incurred.
The
following table presents information on our operating leases for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OPERATING LEASES
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Operating lease cost | |
$ | 353,000 | | |
$ | 352,000 | |
Short-term lease cost | |
| 5,000 | | |
| 5,000 | |
Total lease cost | |
$ | 358,000 | | |
$ | 357,000 | |
The
future minimum lease payments of the Company’s operating lease liabilities by fiscal year are as follows:
SCHEDULE
OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending May 31: | |
| |
| |
Operating
Leases | |
2024 | |
$ | 356,000 | |
2025 | |
| 366,000 | |
2026 | |
| 376,000 | |
2027 | |
| 101,000 | |
Thereafter | |
| - | |
Total minimum future lease payments | |
$ | 1,199,000 | |
Less: imputed interest | |
| 117,000 | |
Total operating lease
liabilities | |
$ | 1,082,000 | |
The
following table summarizes the Company’s other supplemental lease information for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Cash paid for operating lease liabilities | |
$ | 347,000 | | |
$ | 338,000 | |
Weighted-average remaining lease term (years) | |
| 3.27 | | |
| 4.28 | |
Weighted-average discount rate | |
| 6.50% | | |
| 6.50% | |
The
Company also has various insignificant leases for office equipment.
RETIREMENT
SAVINGS PLAN
Effective
September 1, 1986, the Company established a 401(k) plan for the benefit of its employees. The plan permits eligible employees to contribute
to the plan up to the maximum percentage of total annual compensation allowable under the limits of IRC Sections 415, 401(k) and 404.
The Company, at the discretion of its Board of Directors, may make contributions to the plan in amounts determined by the Board each
year. No contributions by the Company have been made since the plan’s inception.
LITIGATION
The
Company is, from time to time, involved in legal proceedings, claims, and litigation arising in the ordinary course of business. While
the amounts claimed may be substantial, the ultimate liability cannot presently be determined because of considerable uncertainties that
exist. Therefore, it is possible the outcome of such legal proceedings, claims, and litigation could have a material effect on quarterly
or annual operating results or cash flows when resolved in a future period. However, based on facts currently available, management believes
such matters will not have a material adverse effect on the Company’s consolidated financial position, results of operations or
cash flows.
There
were no legal proceedings pending as of May 31, 2023.
CONTRACTS
Contracts
and Licensing Agreements
The
Company has one royalty agreement in which it has obtained rights to manufacture and market certain products for the life of the products.
Royalty expense of approximately $13,000 and $19,000 is included in cost of sales for the agreement for each of the years ended May 31,
2023 and 2022, respectively. Sales of products manufactured under these agreements comprise approximately 2.1% and 1.5% of total sales
for the years ended May 31, 2023 and 2022, respectively. The Company may license other products or technology in the future as it deems
necessary for conducting business. The Company has other royalty agreements however they are not considered material.
Clinical
Trial Agreements
In
September 2017, the Company signed a Clinical Samples Agreement with the University of Southern California for the purpose of providing
clinical samples for use by the Company in conducting future clinical trials for one of the products which the Company is developing.
The initial budget was estimated to be approximately $82,000. The work started in October 2017 with charges for work performed being
invoiced and paid monthly. This study ended in February 2020. Approximately $17,000 in fees has been accrued for unbilled charges as
of May 31, 2022. There are no unbilled charges as of May 31, 2023.
The
Company entered into a Clinical Trial Agreement with a research institute for the purpose of conducting a clinical trial of the Biomerica
InFoods® product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly
for work performed in the previous month. The maximum budgeted costs will be approximately $107,000. This study ended in March 2022.
Approximately $28,000 in fees has been accrued for unbilled charges as of May 31, 2022. There are no unbilled charges as of May 31, 2023.
NOTE
10: SUBSEQUENT EVENTS
On
August 3, 2023, the Company announced it had entered into a sales agreement with CVS Pharmacy wherein the Company’s EZ Detect™
colorectal disease screening test will be offered at approximately 7,000 CVS Pharmacy retail stores. Biomerica has shipped the EZ Detect
product to CVS Health distribution centers in the United States, and the product is projected to be on store shelves in September.
Exhibit
3.1
FIRST
AMENDED AND RESTATED
CERTIFICATE
of INCORPORATION
OF
BIOMERICA,
INC.
Biomerica,
Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”)
does hereby certify as follows:
1.
The Corporation filed its original Certificate of Incorporation with the Secretary of State of the State of Delaware on September 22,
1971 under the name of Nuclear Medical Systems, Inc.
2.
At a duly called meeting of the Board of Directors of the Corporation at which a quorum was present at all times, a resolution was duly
adopted, pursuant to Sections 242 and 245 of the General Corporation Law of the State of Delaware (“General Corporation
Law”), setting forth the First Amended and Restated Certificate of Incorporation of the Corporation, declaring said First Amended
and Restated Certificate of Incorporation advisable and directing that said First Amended and Restated Certificate of Incorporation be
considered at the next annual meeting of the stockholders. The stockholders of the Corporation duly approved said proposed First Amended
and Restated Certificate of Incorporation at such annual meeting of the stockholders in accordance with Sections 222, 242 and 245 of
the General Corporation Law.
3.
The text of the Certificate of Incorporation of the Corporation, as amended, is hereby further amended and restated in its entirety as
follows:
ARTICLE
I
NAME
The
name of this Corporation is Biomerica, Inc.
ARTICLE
II
REGISTERED
OFFICE IN STATE AND REGISTERED AGENT
The
address of the registered office of this Corporation in the State of Delaware is 1013 Centre Road, City of Wilmington, County of New
Castle. The name of this Corporation’s registered agent at such registered office is The Prentice-Hall Corporation System, Inc.
ARTICLE
III
PURPOSE
The
purpose for which this Corporation is organized is to engage in any lawful act or activity for which corporations may be organized under
the General Corporation Law.
ARTICLE
IV
CAPITAL
STOCK
This
Corporation is authorized to issue two classes of shares designated respectively “Common Stock” and “Preferred Stock”
and referred to herein as Common Stock or Common Shares and Preferred Stock or Preferred Shares, respectively. The total number of shares
of all classes of stock which the Corporation shall have authority to issue is 30,000,000 shares, par value $.08, consisting of:
(a)
25,000,000 shares of Common Stock; and
(b)
5,000,000 shares of Preferred Stock. The Preferred Shares may be issued from time to time in one or more series. The board of directors
is authorized to fix the number of shares of any series of Preferred Stock and to determine the designation of any such series. The board
of directors is also authorized to determine or alter the rights, preferences, privileges and restrictions granted to or imposed upon
any wholly unissued series of Preferred Shares and, within the limits and restrictions stated in any resolution or resolutions of the
board of directors originally fixing the number of shares constituting any series, to increase or decrease (but not below the number
of shares of any such series then outstanding) the number of shares of any series subsequent to the issue of shares of that series.
ARTICLE
V
PROVISIONS
FOR DEFINING, LIMITING AND
REGULATING
CERTAIN POWERS of THIS
CORPORATION
AND of THE DIRECTORS AND STOCKHOLDERS
Section
1. Number of Directors. The number of directors which shall comprise the full Board of Directors of this Corporation shall be
fixed by, or in the manner provided in, the Bylaws of this Corporation.
Section
2. Power to Authorize Issuance of Stock. The Board of Directors of this Corporation is hereby empowered to authorize the
issuance from time to time of shares of capital stock, whether now or hereafter authorized, for such consideration as the Board of Directors
may deem advisable, subject to such limitations as may be set forth in this Certificate of Incorporation or in the Bylaws of this Corporation
or in the General Corporation Law.
Section
3. Limitation on Liability of Directors. A director of this Corporation shall not be personally liable to this Corporation or
its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the director’s
duty of loyalty to this Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct
or a knowing violation of law as now in effect, or any successor provision thereto, (iii) under Section 174 of the General Corporation
Law, or (iv) for any transaction from which the director derived any improper personal benefit. If the General Corporation Law is amended
after approval by the stockholders of this Article V to authorize corporate action further eliminating or limiting the personal liability
of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the
General Corporation Law, as so amended.
Any
repeal or modification of this Section 3 of Article V by the stockholders of this Corporation shall not adversely affect any right or
protection of a director of this Corporation existing at the time of such repeal or modification.
Section
4. Indemnification. Each director, officer and employee of this Corporation shall be indemnified by this Corporation to the fullest
extent permitted by the General Corporation Law as now or hereafter in force.
Section
5. Bylaws. In furtherance and not in limitation of the powers conferred by the laws of the State of Delaware, the board of directors
of this Corporation is expressly authorized and empowered to make, alter, amend and repeal the Bylaws of this Corporation, subject to
the power of the stockholders of this Corporation to alter or repeal any Bylaw made by the board of directors.
ARTICLE
VI
AMENDMENTS
This
Corporation reserves the right at any time, and from time to time, to amend, alter, change or repeal any provision contained in this
Certificate of Incorporation, in the manner now or hereafter prescribed by statute.
IN
WITNESS WHEREOF, this Corporation has caused this First Amended and Restated Certificate of Incorporation to be signed by its President
and attested by its Secretary this 21 day of July, 2000.
|
BIOMERICA,
INC. |
|
|
|
|
By: |
/s/
Zackary Irani |
|
|
Zackary
Irani, President |
|
|
|
|
|
ATTEST: |
|
|
|
|
By: |
/s/
Janet Moore |
|
|
Janet
Moore, Secretary |
|
Exhibit
3.2
AMENDED
AND RESTATED BYLAWS
OF
BIOMERICA,
INC.
(a
Delaware corporation)
Adopted
by the Board of Directors on July 24, 2023
ARTICLE
I
Offices
1.
The principal office of the Corporation shall be at 251 Little Falls Dr., City of Wilmington, State of Delaware, and the name of the
resident agent in charge thereof is CSC-Global.
2.
The Corporation may also have an office or offices at such other place or places, within or without the State of Delaware, as the Board
of Directors of the Corporation (the “Board”) may from time to time designate or the business of the Corporation may
require.
ARTICLE
II
Stockholders’
Meeting
1.
Meetings of the stockholders of the Corporation may be held at such place, either within or without the State of Delaware, as may be
determined from time to time by the Board. The Board may, in its sole discretion, determine that the meeting shall not be held at any
place, but may instead be held solely by means of remote communication as provided under the Delaware General Corporation Law (the “DGCL”).
2.
Unless members of the Board are elected by written consent in lieu of an annual meeting, as permitted by Section 211 of the Delaware
General Corporation Law (the “DGCL”) and these Bylaws, an annual meeting of stockholders shall be held for the election
of directors at such date and time as the Board shall each year fix. At such meeting the stockholders may elect the directors and transact
any business properly brought before the meeting.
3.
Special meetings of the stockholders shall be held upon call of the Board, and shall be called by the Chairperson of the Board or the
President or the Secretary at the request in writing of the stockholders owning of record at least twenty-five percent of the issued
and outstanding capital stock of the Corporation entitled to vote thereat.
4.
Notice of the purpose or purposes and of the time and place within or without the State of Delaware of every meeting of stockholders
shall be given by the Chairperson of the Board or the President or the Secretary or an Assistant Secretary either personally or by mail
or by telegraph or by any other lawful means of communication not less than ten nor more than sixty days before the meeting, to each
stockholder of record entitled to vote at such meeting. If mailed, such notice shall be directed to each stockholder at such stockholder’s
address as it appears on the stock book unless such stockholder shall have filed with the Secretary of the Corporation a written request
that notices intended for him or her be mailed to some other address, in which case it shall be mailed or transmitted to the address
designated in such request. Such further notice shall be given as may be required by law. Except as otherwise expressly provided by statute,
no publication of any notice of meeting of stockholders shall be required to be given any stockholder who shall attend such meeting in
person or by proxy, or who shall, in person or by attorney thereunto authorized, waive notice in writing or by wireless communication
either before or after such meeting. Except where otherwise required by law, notice of any adjourned meeting of the stockholders of the
Corporation shall not be required to be given.
5.
A quorum at all meetings of stockholders shall consist of the holders of record of a majority of the shares of stock of the Corporation,
issued and outstanding, entitled to vote at the meeting, present in person or by proxy, except as otherwise provided by statute or the
Certificate of Incorporation. In the absence of a quorum at any meeting or any adjournment thereof, a majority of those present in person
or by proxy and entitled to vote may adjourn such meeting from time to time. At any such adjourned meeting at which a quorum is present
any business may be transacted which might have been transacted at the meeting as originally called.
6.
Meetings of the stockholders shall be presided over by a chairperson which shall be the chief executive officer (the “CEO”).
If the CEO is not present, the meetings of the stockholders shall be presided over by the Chairperson of the Board (the “Chairperson”),
or the Vice Chairperson (the “Vice Chairperson”). If neither the CEO the Chairperson, or the Vice Chairperson is present,
the meeting may be presided over by a chairperson to be chosen by a majority of the stockholders entitled to vote who are present in
person or by proxy at the meeting. The Secretary of the Corporation, or in his or her absence, an Assistant Secretary, shall act as secretary
of every meeting, but if neither the Secretary nor an Assistant Secretary is present, the meeting shall choose any person present to
act as secretary of the meeting.
7.
Except as otherwise provided in these Bylaws, the Certificate of Incorporation, or in the laws of the State of Delaware, at every meeting
of the stockholders, each stockholder of the Corporation entitled to vote at such meeting shall have one vote in person or by proxy for
each share of stock having voting rights held by him or her and registered in his or her name on the books of the Corporation at the
time of such meeting. Any vote on shares of stock of the Corporation may be given by the stockholder entitled thereto in person or by
proxy appointed by an instrument in writing, subscribed by such stockholder or by his or her attorney thereunto authorized and delivered
to the secretary of the meeting. Except for the election of directors or as otherwise required by statute, by the Certificate of Incorporation
or these Bylaws, all matters coming before any meeting of the stockholders shall be decided by a majority vote of the stockholders of
the Corporation present in person or by proxy at such meetings and entitled to vote on the subject matter, a quorum being present.
8.
A complete list of the stockholders entitled to vote at a meeting of stockholders, arranged in alphabetical order, and showing the address
of each stockholder and the number of shares registered in the name of each stockholder shall be prepared by the Secretary or other officer
of the Corporation having charge of the stock ledger. Such list shall be open to the examination of any stockholder for any purpose germane
to the meeting, for a period of at least ten days ending on the day before the meeting, either on a reasonably accessible electronic
network as permitted by law (provided that the information required to gain access to the list is provided with the notice of the meeting)
or during ordinary business hours at the principal place of business of the Corporation.
9.
At all elections of directors, or in any other case in which inspectors may act, an inspector, or inspectors, of election shall be appointed
by the Board or the chairperson of the meeting, except as otherwise provided by law. The inspectors of election shall take and subscribe
an oath faithfully to execute the duties of inspectors at such meeting with strict impartiality, and according to the best of their ability
and shall take charge of the polls and after the vote shall have been taken shall make a certificate of the result thereof. If there
be a failure to appoint an inspector or if any inspector appointed be absent or refuse to act, or if his or her office becomes vacant,
the chairperson present at the meeting may choose an inspector of election to fill the vacancy.
ARTICLE
III
Directors
1.
The property, affairs and business of the Corporation shall be managed by the Board, consisting of not less than three nor more than
nine persons. The exact number of directors within the maximum and minimum limitations specified shall be fixed from time to time by
resolution of the Board. Except as hereinafter provided, directors shall be elected at the annual meeting of the stockholders by plurality
vote of the stockholders of the Corporation present in person or by proxy at such meeting and entitled to vote on the election of directors,
and each director shall be elected to serve for one year and until his or her successor shall be elected and shall qualify. Directors
need not be stockholders.
2.
Meetings of the Board shall be held at such place within or outside the State of Delaware as may from time to time be fixed by resolution
of the Board, or as may be specified in the notice of the meeting. Regular meetings of the Board shall be held at such times as may from
time to time be fixed by resolution of the Board, and special meetings may be held at any time upon the call of the Chairperson of the
Board, the President, or a majority of the directors by oral, electronic or written notice duly served on or sent or mailed to each director
not less than one day before such meeting. A meeting of the Board may be held without notice immediately after annual meeting of the
stockholders. Notice need not be given of regular meetings of the Board. Meetings may be held at any time without prior notice if all
the directors are present, or if at any time before or after the meeting those not present waive notice of the meeting in writing.
3.
A majority of the members of the Board then acting at a meeting duly assembled, shall constitute a quorum for the transaction of business,
but if at any meeting of the Board there shall be less than a quorum present, a majority of those present may adjourn the meeting, without
further notice, from time to time until a quorum shall have been obtained.
4.
In case one or more vacancies shall occur or exist in the Board by reason of death, resignation, increase in the number of directors
or otherwise except in so far as otherwise provided in these Bylaws, the remaining directors, even if less than a quorum, may, by a majority
vote, elect a successor or successors for the unexpired term or terms.
5.
At any special meeting of the stockholders, duly called as provided in these Bylaws, any director or directors may by the affirmative
vote of the holders of a majority of all the shares of stock outstanding and entitled to vote for election of directors be removed from
office, either with or without cause, and his or her successor or their successors may be elected at such meeting; or the remaining directors
may, to the extent vacancies are not filled by such election, fill any vacancy or vacancies created by such removal.
6.
Indemnification.
6.1.
Obligation and Power to Indemnify.
a)
Actions, Suits, and Proceedings Other than By or In the Right of the Corporation. Subject to the limitations set forth in Section
6.2, the Corporation will indemnify any Director or Executive Officer, and will indemnify and hold harmless any employee or agent
of the Corporation who is not a Director or Executive Officer, who was or is a party or is threatened to be made a party, including as
a witness, to any Proceeding (other than an action by or in the right of the Corporation) by reason of such person’s Corporate
Status from and against all Expenses and Liabilities actually and reasonably incurred or paid by or on behalf of such person in connection
with such Proceeding or any claim, issue or matter therein, if such indemnitee acted in good faith and in a manner the indemnitee reasonably
believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding,
had no reasonable cause to believe the person’s conduct was unlawful, to the fullest extent permitted by law as the same exists
or may hereafter be amended; provided, however, that except with respect to Proceedings to enforce rights to indemnification,
the Corporation will indemnify any such indemnitee in connection with a Proceeding (or part thereof) initiated by such indemnitee only
if such Proceeding (or part thereof) was authorized by the Board.
b)
Actions, Suits, and Proceedings By or In the Right of the Corporation. Subject to the limitations set forth in Section 6.2,
the Corporation will indemnify any Director or Executive Officer, and will indemnify and hold harmless any employee or agent of the Corporation
who is not a Director or Executive Officer, who was or is a party or is threatened to be made a party to any Proceeding (including as
a witness) by or in the right of the Corporation to procure a judgment in its favor by reason of such person’s Corporate Status
from and against all Expenses actually and reasonably incurred or paid by or on behalf of such person in connection with such Proceeding
or any claim, issue or matter therein, if such indemnitee acted in good faith and in a manner the indemnitee reasonably believed to be
in, or not opposed to, the best interests of the Corporation; provided, however, that no indemnification will be made under this
Section 6.1(b) in respect of any claim, issue or matter as to which such person has been finally adjudged by a court of competent
jurisdiction to be liable to the Corporation, unless, and only to the extent that, the Court of Chancery of the State of Delaware or
another court in which such Proceeding was brought determines upon application that, despite adjudication of liability, but in view of
all the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such Expenses that such court
deems proper.
c)
No Presumption. The termination of any Proceeding by a judgment, order, settlement, conviction, or upon a plea of nolo contendere
or its equivalent, will not, of itself create a presumption that such person did not act in good faith and in a manner which such person
reasonably believed to be in or not opposed to the best interests of the Corporation, and, with respect to any criminal action or proceeding,
had reasonable cause to believe that such person’s conduct was lawful.
6.2.
Limitation on Indemnification.
a)
Requirement for Determination of Eligibility for Indemnification by Disinterested Directors. Any indemnification to be provided
under Section 6.1 will (unless ordered by a court) be made by the Corporation only as authorized in the specific case upon a determination
that indemnification of the indemnitee is proper in the circumstances because such person has met the applicable standard of conduct
set forth in Section 6.1. Such determination will be made (a) by a majority vote of the Disinterested Directors (even though less
than a quorum); (b) by a committee of Disinterested Directors designated by a majority vote of the Disinterested Directors (even though
less than a quorum); (c) if there are no Disinterested Directors or if the Disinterested Directors so direct, by independent legal counsel
in a written opinion; or (d) by the vote of a majority of the stockholders of the Corporation entitled to vote and voting on the matter.
To the extent, however, that the indemnitee has been successful on the merits or otherwise in defense of any Proceeding described in
Section 6.1, or in defense of any claim, issue or matter therein, such person will (in the case of a Director or Executive Officer)
and will (in the case of an employee or agent of the Corporation who is not a Director or Executive Officer) be indemnified against Expenses
actually and reasonably incurred by such person in connection therewith, without the necessity of authorization in the specific case.
b)
No Indemnification for Matters Initiated by Indemnitee. Notwithstanding the provisions of Section 6.1, the Corporation
will indemnify any person seeking indemnification in connection with a Proceeding initiated by such person only if such Proceeding (including
any parts of such Proceeding not initiated by such person) was authorized in advance by the Board, unless such Proceeding was brought
to enforce such person’s rights to indemnification or advancement of Expenses under these Bylaws in accordance with the provisions
set forth herein.
c)
The Corporation’s obligation, if any, to indemnify or provide advancement of Expenses to any person under this Section 6
as a result of such person’s Corporate Status will be reduced by any amount such person may collect as indemnification or advancement
of Expenses from another corporation, partnership, joint venture, trust, employee benefit plan or enterprise (the “Primary Indemnitor”).
Any indemnification or advancement of Expenses under this Section 6 owed by the Corporation as a result of a person serving, at
the request of the Corporation, as a director, partner, trustee, officer, employee or agent of another corporation, partnership, joint
venture, trust, employee benefit plan or other enterprise will only be in excess of, and will be secondary to, the indemnification or
advancement of Expenses available from the applicable Primary Indemnitor(s) and any applicable insurance policies.
6.3.
Indemnification by a Court. Notwithstanding any contrary determination in the specific case under Section 6.2, and notwithstanding
the absence of any determination thereunder, any party to a Proceeding by reason of their Corporate Status may apply to any court of
competent jurisdiction in the State of Delaware for indemnification to the extent otherwise permissible under Section 6.1. The
basis of such indemnification by a court will be a determination by such court that indemnification of the person is proper in the circumstances
because such person has met the applicable standards of conduct set forth in Section 6.1. Neither a contrary determination in
the specific case under Section 6.2 nor the absence of any determination thereunder will be a defense to such application or create
a presumption that the person seeking indemnification has not met any applicable standard of conduct. The person seeking application
for indemnification pursuant to this Section 6.3 must give notice of such filing to the Corporation before or promptly after the
filing of such application. If the person seeking indemnification pursuant to the foregoing is successful, in whole or in part, the Corporation
will also be obligated to pay such person’s Expense of prosecuting such application.
6.4.
Expenses Payable in Advance.
| a) | Advancement
of Expenses to Directors and Executive Officers Prior to Final Disposition. |
i.
The Corporation will advance all Expenses incurred by or on behalf of any Director or Executive Officer in connection with any Proceeding
in which such person is involved by reason of such person’s Corporate Status within 30 days after the receipt by the Corporation
of a written statement from such person requesting such advance or advances from time to time, whether prior to or after final disposition
of such Proceeding. Such statement or statements must reasonably evidence the Expenses incurred by such person and be preceded or accompanied
by an undertaking by or on behalf of such person to repay any Expenses so advanced if it is ultimately determined that such person is
not entitled to be indemnified against such Expenses. Notwithstanding the foregoing, the Corporation will advance all Expenses incurred
by or on behalf of any Director or Executive Officer seeking advancement of expenses hereunder in connection with a Proceeding initiated
by such Director or Executive Officer only if such Proceeding (including any parts of such Proceeding not initiated by such Director)
was (A) authorized by the Board, or (B) brought to enforce such Director’s or Executive Officer’s rights to indemnification
or advancement of Expenses under these Bylaws.
ii.
If a claim for advancement of Expenses hereunder by a Director or Executive Officer is not paid in full by the Corporation within 30
days after receipt by the Corporation of documentation of Expenses and the required undertaking, such Director or Executive Officer may
at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim and if successful in whole or in
part, such Director or Executive Officer will also be entitled to be paid the expenses of prosecuting such claim. The failure of the
Corporation (including its Board or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning
the permissibility of such advancement of Expenses under this Section 6 will not be a defense to an action brought by a Director
or Executive Officer for recovery of the unpaid amount of an advancement claim and will not create a presumption that such advancement
is not permissible.
iii.
The burden of proving that a Director or Executive Officer is not entitled to an advancement of Expenses will be on the Corporation.
iv.
In any suit brought by the Corporation to recover an advancement of Expenses pursuant to the terms of an undertaking, the Corporation
will be entitled to recover such Expenses upon a final adjudication that the Director or Executive Officer has not met any applicable
standard for indemnification set forth in the Delaware General Corporation Law.
| b) | Advancement
of Expenses to Officers and Non-Officer Employees Prior to Final Disposition. |
i.
The Corporation may, at the discretion of the Board, advance any or all Expenses incurred by or on behalf of any employee or agent of
the Corporation that is not a Director or Executive Officer in connection with any Proceeding in which such person is involved by reason
of his or her Corporate Status upon the receipt by the Corporation of a statement or statements from such person requesting such advance
or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements must reasonably
evidence the Expenses incurred by such person and be preceded or accompanied by an undertaking by or on behalf of such person to repay
any Expenses so advanced if it is ultimately determined that such person is not entitled to be indemnified against such Expenses.
ii.
In any suit brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation
will be entitled to recover such expenses upon a final adjudication that the employee or agent of the Corporation that is not a Director
or Executive Officer has not met any applicable standard for indemnification set forth in the DGCL.
6.5.
Contractual Nature of Rights.
a)
The provisions of this Section 6 constitute a contract between the Corporation and each Director and Executive Officer entitled
to the benefits hereof at any time while this Section 6 is in effect, in consideration of such person’s past or current
and any future performance of services in their Corporate Status. Neither amendment, repeal or modification of any provision of this
Section 6, nor the adoption of any provision of the Certificate of Incorporation inconsistent with this Section 6 will
eliminate or reduce any right conferred by this Section 6 in respect of any act or omission occurring, or any cause of action
or claim that accrues or arises or any state of facts existing, at the time of or before such amendment, repeal, modification or adoption
of an inconsistent provision (even in the case of a Proceeding based on such a state of facts that is commenced after such time), and
all rights to indemnification and advancement of Expenses granted herein or arising out of any act or omission will vest at the time
of the act or omission in question, regardless of when or if any Proceeding with respect to such act or omission is commenced. The rights
to indemnification and to advancement of Expenses provided by, or granted pursuant to, this Section 6 will continue notwithstanding
that the person has ceased to be a Director or Executive Officer and will inure to the benefit of the estate, heirs, executors, administrators,
legatees and distributes of such person.
(b)
If a claim for indemnification hereunder by a Director or Executive Officer is not paid in full by the Corporation within 60 days after
receipt by the Corporation of a written claim for indemnification, such Director or Executive Officer may at any time thereafter bring
suit against the Corporation to recover the unpaid amount of the claim, and if successful in whole or in part, such Director or Executive
Officer will also be entitled to be paid the Expenses of prosecuting such claim. The failure of the Corporation (including its Board
or any committee thereof, independent legal counsel, or stockholders) to make a determination concerning the permissibility of such indemnification
under this Section 6 will not be a defense to an action brought by a Director or Executive Officer for recovery of the unpaid
amount of an indemnification claim and will not create a presumption that such indemnification is not permissible. The burden of proving
that a Director or Executive Officer is not entitled to indemnification will be on the Corporation.
(c)
In any suit brought by a Director or Executive Officer to enforce a right to indemnification hereunder, it will be a defense that such
Director or Executive Officer has not met any applicable standard for indemnification set forth in the Delaware General Corporation Law.
6.6.
Non-exclusivity. The indemnification and advancement of expenses permitted by this Section 6 are exclusive of any other
rights to which any person may be entitled under any statute, the Corporation’s Amended and Restated Certificate of Incorporation
or these Bylaws, any agreement, vote of stockholders or Disinterested Directors or otherwise, both as to action in such person’s
official capacity and as to action in another capacity while holding an office, and will continue as to a person who has ceased to be
a Director, Executive Officer, employee or agent of the Corporation and will inure to the benefit of the heirs, executors and administrators
of such person.
6.7.
Indemnification Agreements. The Corporation may enter into agreements with any person described in this Section 6 for the
purpose of providing for the indemnification set forth in Section 6.1(a) and Section 6.1(b).
6.8.
Insurance. The Corporation has the power to purchase and maintain insurance to protect itself and any person who is or was a Director,
Executive Officer, employee or agent of the Corporation, or is or was serving at the request of the Corporation as a director, officer,
employee or agent of another corporation, limited liability company, partnership, joint venture, employee benefit plan, trust or other
enterprise against any Expenses or Liabilities asserted against such person and incurred by such person by reason of their Corporate
Status, whether or not the Corporation would have the power to indemnify such person against such Expense or Liability under the provisions
of this Section 6 or otherwise.
6.9.
Certain Definitions. For purposes of this Section 6, references to:
a)
a person’s “Corporate Status” describes the status of a person who is serving or has served (i) as a Director,
(ii) as an Executive Officer, (iii) as an employee or agent of the Corporation, or (iv) as a director, partner, trustee, officer, employee
or agent of any other corporation, partnership, limited liability company, joint venture, trust, employee benefit plan, foundation, association,
organization or other legal entity that such person is or was serving at the request of the Corporation. For purposes of this Section
6, a Director, Executive Officer, employee or agent of the Corporation who is serving or has served as a director, partner, trustee,
officer, employee or agent of a Subsidiary will be deemed to be serving at the request of the Corporation;
b)
the “Corporation” means the current Corporation and includes any (i) resulting corporation in a merger of the Corporation
and (ii) constituent corporation (including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate
existence had continued, would have had power and authority to indemnify its directors, executive officers, employees or agents, so that
any person who is or was a director, executive officer, employee or agent of such constituent corporation, or is or was serving at the
request of such constituent corporation as a director, executive officer, employee or agent of another corporation, limited liability
company, partnership, joint venture, employee benefit plan, trust or other enterprise, will stand in the same position under the provisions
of this Section 6 with respect to the resulting or surviving corporation as such person would have with respect to such constituent
corporation if its separate existence had continued;
c)
a “Director” means any person who serves or has served the Corporation as a director on the Board;
d)
a “Disinterested Director” means, with respect to each Proceeding in respect of which indemnification is sought hereunder,
a Director of the Corporation who is not a party to such Proceeding;
e)
an “Executive Officer” means executive officer, as such term is defined in Rule 405 promulgated under the Securities
Act of 1933, as amended, of the Corporation;
f)
“Expenses” means all attorneys’ fees, retainers, court costs, transcript costs, fees of expert witnesses, private
investigators and professional advisors (including, without limitation, accountants and investment bankers), travel expenses, duplicating
costs, printing and binding costs, costs of preparation of demonstrative evidence and other courtroom presentation aids and devices,
costs incurred in connection with document review, organization, imaging and computerization, telephone charges, postage, delivery service
fees, and all other disbursements, costs or expenses of the type customarily incurred in connection with prosecuting, defending, preparing
to prosecute or defend, investigating, being or preparing to be a witness in, settling or otherwise participating in, a Proceeding;
g)
a “Proceeding” means any threatened, pending or completed action, suit, arbitration, alternate dispute resolution
mechanism, inquiry, investigation, administrative hearing or other proceeding, whether civil, criminal, administrative, arbitrative or
investigative;
h)
“Liabilities” means judgments, damages, liabilities, losses, penalties, excise taxes, fines and amounts paid in settlement;
and
i)
“Subsidiary” means any corporation, partnership, limited liability company, joint venture, trust or other entity of
which the Corporation owns (either directly or through or together with another Subsidiary of the Corporation) either (i) a general partner,
managing member or other similar interest or (ii) (A) 50% or more of the voting power of the voting capital equity interests of such
corporation, partnership, limited liability company, joint venture or other entity, or (B) 50% or more of the outstanding voting capital
stock or other voting equity interests of such corporation, partnership, limited liability company, joint venture or other entity.
6.10.
Severability. If any word, clause, provision or provisions of this Section 6 is held to be invalid, illegal or unenforceable
for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Section 6 (including
each portion of any section of this Section 6 containing any such provision held to be invalid, illegal or unenforceable, that
is not itself held to be invalid, illegal or unenforceable) will not in any way be affected or impaired thereby; and (b) to the fullest
extent possible, the provisions of this Section 6 (including each such portion of any section of this Section 6 containing
any such provision held to be invalid, illegal or unenforceable) will be construed so as to give effect to the intent manifested by the
provision held invalid, illegal or unenforceable.
7.
Any action required or permitted to be taken at any meeting of the Board or any committee thereof may be taken without a meeting if prior
to such action a written consent thereto is signed by all members of the Board or of the committee, as the case may be, and such written
consent is filed with the minutes of proceedings of the Board or the committee.
8.
Directors may, by resolution of the Board, be allowed a fixed sum and expenses of attendance for attendance at regular or special meetings
of the Board; provided that nothing herein contained shall be construed to preclude any director from serving the corporation in any
other capacity and receiving compensation therefor. Members of special or standing committees, and others who attend pursuant to direction,
may, by vote of the Board, be allowed a like fixed sum and expenses of attendance for attending committee meetings.
9.
The Board, in its discretion, may appoint an Executive Committee consisting of three or more directors of the corporation, one of whom
shall be the President of the corporation, who shall serve during the pleasure of the Board for the terms fixed by it. Two members of
the Executive Committee shall constitute a quorum for the transaction of business. The Executive Committee shall have and may exercise
the powers of the Board in the management of the business and affairs of the corporation and may authorize the seal of the corporation
to be affixed to all papers. The Executive Committee shall meet at such intervals between regular meetings. The Board, as may from time
to time be fixed by the Board, shall keep regular records of its meetings and report the same to the Board when required.
ARTICLE
IV
Officers
1.
The officers of the Corporation shall be chosen by the Board and shall be a President, one or more Vice Presidents, a Secretary and a
Treasurer. From time to time the Board may also appoint a Chairperson of the Board a CEO, a Vice Chairperson of the Board, a Chief Financial
Officer, Assistant Secretaries, Assistant Treasurers and such other officers, agents and employees as it may deem proper. Any number
of offices, except the offices of President and Secretary, may be held by the same person. The Chairperson of the Board, if such office
exists, and the President shall be chosen from among the directors.
2.
The term of office of all officers shall be one year or until their respective successors are elected and qualify by the Board, but any
officer may be removed from office, either with or without cause at any time by the affirmative vote of a majority of the members of
the Board then in office. A vacancy in any office arising from any cause may be filled for the unexpired portion of the term by the Board.
3.
Unless otherwise ordered by the Board, the President shall have full power and authority on behalf of the Corporation to attend and to
act and to vote at any meetings of security holders of the corporations in which the Corporation may hold securities, and at such meeting
shall possess and may exercise any and all rights and powers incident to the ownership of such securities, and which as the owner thereof
the Corporation might have possessed and exercised, if present. The Board by resolution from time to time may confer like power upon
any other person or persons.
ARTICLE
V
Duties
of Officers
1.
The President shall be chief executive officer of the Corporation and as such shall have general and active direction of the management
and supervision of the business operations of the Corporation. The President shall have such other duties and powers as may be assigned
from time to time by the Board and shall preside at all meetings of the stockholders and Board.
2.
During the absence or disability of the President (or the CEO if one is appointed), an officer designated by the Board, shall exercise
all the functions and duties of the President or the CEO. Each officer shall have such powers and discharge such duties as may be assigned
to him or her from time to time by the Board.
3.
The Treasurer shall have the custody of all the funds and securities of the Corporation. When necessary or proper, the Treasurer shall
endorse on behalf of the Corporation, for collection, checks, notes and other obligations and shall deposit the same to the credit of
the Corporation in such bank, or banks, or depositories as may be designated by the Board, or by any officer acting under authority conferred
by the Board. The Treasurer shall enter regularly in books to be kept for the purpose a full and accurate account of all monies received
and paid on account of the Corporation. Whenever required by the Board, the Treasurer shall render an account of all transactions as
Treasurer and of the financial condition of the Corporation. The Treasurer shall at all reasonable times exhibit his or her books and
accounts to any director of the Corporation upon application at the office of the Corporation during business hours and shall perform
all things incident to the position of Treasurer, subject to the control of the Board. The Treasurer shall give bond for the faithful
discharge of his or her duties if the Board so require. The Treasurer shall do and perform such other duties as may be assigned from
time to time by the Board.
4.
The Assistant Treasurers, in the order of their seniority, shall, in the absence of or disability of the Treasurer, perform the duties
and exercise the powers of the Treasurer and shall perform such other duties as the Board shall prescribe.
5.
The Secretary shall attend all meetings of the stockholders and all meetings of the Board, and record all votes and the minutes of all
proceedings in a book to be kept for that purpose; and shall perform like duties for other committees when so required. The Secretary
shall give, or cause to be given, notice of all meetings of stockholders and the Board and of committees and shall perform such other
duties as may be prescribed by the Board. The Secretary shall be sworn to the faithful discharge of his or her duties. The Secretary
shall do and perform such other duties as may be assigned from time to time by the Board.
6.
The Assistant Secretaries, in the order of their seniority, shall in the absence of or disability of the Secretary, perform the duties
and exercise the powers of the Secretary and shall perform such other duties as the Board shall prescribe.
7.
In the case of absence or inability to act of any officer of the Corporation and of any person herein authorized to act in his or her
place, the Board may from time-to-time delegate the powers and duties of such officer to any other officer or any director or any other
person whom it may select.
ARTICLE
VI
Certificates
of Stock
1.
The interest of each stockholder of the Corporation shall be evidenced by certificates for shares of stock certifying the number of shares
represented thereby and in such form not inconsistent with the Certificate of Incorporation as the Board may from time to time prescribe.
Except
as otherwise required by law, transfers of shares of stock of the Corporation shall be made only on the books of the Corporation by the
registered holder thereof, or by his or her attorney thereunto authorized by power of attorney duly executed and filed with the Secretary
of the Corporation, or with a transfer clerk or a transfer agent appointed as in Section 4 of this Article provided, and on surrender
of the certificate or certificates for such shares properly endorsed and the payment of all taxes thereon. The person in whose name.
Shares of stock stand on the books of the Corporation shall be deemed the owner thereof for all purposes as regards the Corporation.
The Board may, from time to time, make such additional rules and regulations as it may deem expedient, not inconsistent with these Bylaws,
concerning the issue, transfer, and registration of certificates for shares of the capital stock of the Corporation.
The
certificates of stock shall be signed by the President or a Vice President and by the Secretary or an Assistant Secretary or the Treasurer
or an Assistant Treasurer, and sealed with the seal of the Corporation. Such seal may be a facsimile, engraved or printed. Where any
such certificate is signed by a transfer agent other than the Corporation or its employee, or by a registrar other than the Corporation
or its employee, the signatures of the President, Vice President, Secretary, Assistant Secretary, Treasurer or Assistant Treasurer upon
such certificate may be facsimiles, engraved or printed. In case any such officer who has signed or whose facsimile signature has been
placed upon such certificate shall have ceased to be such certificate is issued, it may be issued by the Corporation with the same effect
as if such officer had not ceased to be such at the time of its issue.
2.
In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment
thereof, or to express consent to corporate action in writing without a meeting, or entitled to receive payment of any dividend or other
distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock
or for the purpose of any other lawful action, the Board may fix, in advance, a record date, which shall not be more than 60 nor less
than 10 days before the date of such meeting, nor more than 60 days prior to any other action.
If
no record date is fixed:
The
record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business
on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding
the day on which the meeting is held.
The
record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board adopts
the resolution relating thereto.
A
determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment
of the meeting; provided, however, that the Board may fix a new record date for the adjournment meeting.
3.
No certificate for shares of stock of the Corporation shall be issued in place of any certificate alleged to have been lost, destroyed
or stolen, except on production of such evidence of such loss, destruction or theft and on delivery to the Corporation, if the Board
shall so require, of a bond of indemnity in such amount (not exceeding twice the value of the shares represented by such certificate),
upon such terms and secured by such surety as the Board may in its discretion require.
4.
The Board may appoint one or more transfer clerks or one or more transfer agents and one or more registrars, and may require all certificates
for shares of stock to bear the signature or signatures of any of them.
5.
The books, accounts and records of the Corporation, except as may otherwise be required by statute, may be kept outside of the State
of Delaware, at such place or places as the Board may from time to time appoint. The Board shall determine whether and to what extent
the books, accounts and records of the Corporation, or any of them, other than the stock ledger, shall be open to the inspection of stockholders,
and no stockholder shall have any right to inspect any book, account or record of the Corporation except as conferred by statute or by
resolution of the Board.
ARTICLE
VII
Corporate
Seal
The
corporate seal of the Corporation shall consist of two concentric circles, between which shall be the name of the Corporation, and its
state of incorporation, and in the center shall be inscribed the words, “Corporate Seal.”
ARTICLE
VIII
Amendments
The
Bylaws of the Corporation shall be subject to alteration, amendment or repeal, and new Bylaws not inconsistent with any provision of
the Certificates of Incorporation or statute, may be made, either by the affirmative vote of the holders of a majority in interest of
the stockholders of the Corporation present in person or by proxy at any annual or special meeting of the stockholders and entitled to
vote on the subject matter, a quorum being present, provided that notice of such proposed action shall have been given in the call for
the meeting, or by the affirmative vote of a majority of the whole Board, given at any regular or special meeting of the Board.
ARTICLE
IX
Fiscal
Year
The
fiscal year of the Corporation shall end on the last day of May in each year.
ARTICLE
X
Forum
1.
Forum for Adjudication of Disputes. Unless the Corporation consents in writing to the selection of an alternative forum, the Court
of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction,
any state or federal court located within the State of Delaware) shall be the sole and exclusive forum for: (a) any derivative action
or proceeding brought on behalf of the Corporation, (b) any action or proceeding asserting a claim of breach of a fiduciary duty owed
by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (c) any action
or proceeding asserting a claim against the Corporation or any director, officer or other employee of the Corporation arising pursuant
to, or seeking to enforce any right or remedy under, any provision of the DGCL, the Corporation’s Certificate of Incorporation
or these Bylaws (in each case, as they may be amended and restated from time to time), (d) any action or proceeding asserting a claim
against the Corporation or any director, officer or other employee of the Corporation governed by the internal affairs doctrine, or (e)
any action or proceeding to interpret, apply, enforce, or determine the validity of any provision or provisions of the Corporation’s
Certificate of Incorporation or these Bylaws (in each case, as they may be amended and restated from time to time), in all cases to the
full extent permitted by applicable law and subject to the court’s having personal jurisdiction over the indispensable parties
named as defendants. Any person or entity purchasing, otherwise acquiring, or continuing to own any interest in shares of capital stock
of the Corporation shall be deemed to have notice of and to have consented to the provisions of this Section 1 of Article X.
2.
Federal Forum Selection. Unless the Corporation consents in writing to the selection of an alternative forum, the federal district
courts of the United States of America shall be the sole and exclusive forum for the resolution of any complaint asserting a cause of
action arising under the Securities Act of 1933, as amended. Any person or entity purchasing, otherwise acquiring, or continuing to own
any interest in shares of capital stock of the Corporation shall be deemed to have notice of and to have consented to the provisions
of this Section 2 of Article X.
CERTIFICATION
OF BYLAWS
OF
BIOMERICA,
INC.
a
Delaware Corporation
I,
Allen Barbieri, certify that I am Secretary of Biomerica, Inc., a Delaware corporation (the “Corporation”), that I
am duly authorized to make and deliver this certification and that the attached Bylaws are a true and complete copy of the Bylaws of
the Corporation in effect as of the date of this certificate.
Dated:
_____________, 2023 |
|
|
|
|
|
|
Name: |
Allen
Barbieri |
Exhibit 4.2
DESCRIPTION
OF CAPITAL STOCK
The
following is a summary of all material characteristics of the capital stock of Biomerica, Inc. as set forth in our First Amended and
Restated Certificate of Incorporation (our “Charter”), Amended and Restated Bylaws (our “Bylaws”),
Series A Certificate of Designation, as corrected (the “Certificate of Designation”), and certain provisions of the
General Corporation Law of the State of Delaware (the “DGCL”). The summary does not purport to be complete and is
qualified in its entirety by reference to our Charter, Bylaws, and Certificate of Designation, copies of which have been filed as exhibits
to our public filings with the Securities and Exchange Commission, and applicable provisions of the DGCL. References to “we,”
“our,” “us,” or the “Company” refer to Biomerica, Inc.
Common
Stock
General.
We may issue shares of our common stock from time to time. We are authorized to issue 25,000,000 shares of our common stock, par value
$0.08 per share.
Voting
Rights. The holders of common stock are entitled to one vote for each share held of record on all matters submitted to a vote of
the stockholders. The holders of common stock are not entitled to cumulative voting rights with respect to the election of directors
Dividends.
Subject to preferences that may be applicable to any shares of preferred stock issued in the future, holders of common stock are entitled
to receive dividends on a pro rata basis out of funds legally available at the times and in the amounts that our board of directors may
determine.
Rights
to Receive Liquidation Distributions. In the event of a liquidation, dissolution or winding up of our Company holders of our common
stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preference of any then outstanding
preferred stock.
No
Preemptive or Similar Rights. Holders of common stock have no preemptive rights and no right to convert their common stock into any
other securities. There are no redemption or sinking fund provisions applicable to the common stock.
Preferred
Stock
Pursuant
to the terms of our Charter, our board of directors is authorized, subject to limitations prescribed by Delaware law, to issue up to
5,000,000 shares of preferred stock, par value $0.08 per share, in one or more series, to establish from time to time the number of shares
to be included in each series, and to fix the designation, powers, preferences and rights of the shares of each series and any of its
qualifications, limitations or restrictions, in each case without further action by our stockholders. Our board of directors also can
increase or decrease the number of shares of any series of preferred stock, but not below the number of shares of that series then outstanding.
Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the
voting power or other rights of the holders of our common stock. The issuance of preferred stock, while providing flexibility in connection
with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing
a change in our control or the removal of management and could adversely affect the market price of our common stock and the voting and
other rights of the holders of our common stock.
Series
A Preferred Stock
General.
On February 4, 2020, we filed a Certificate of Designations, Preferences and Rights of Series A 5% Convertible Preferred Stock with the
Secretary of State of the State of Delaware, which designated 571,429 of our preferred stock as Series A Preferred Stock (the “Series
A Preferred Stock”). Those shares of Series A Preferred Stock have since been converted into common stock and are no longer
outstanding.
Voting
Rights. Except as otherwise provided by the DGCL, other applicable law or as provided in the Certificate of Designations, the holders
of our Series A Preferred Stock are not entitled to vote on any matter submitted for a vote of holders of our common stock. The consent
of the holders of at least a majority of the outstanding shares of our Series A Preferred Stock will be required to, among other matters,
(i) alter, amend or change adversely any rights, preferences, or privileges of our Series A Preferred Stock, (ii) amend our First Amended
and Restated Certificate of Incorporation or Bylaws in any manner that would impair or reduce the rights of our Series A Preferred Stock,
or (iii) amend, alter, or repeal any provision of the Certificate of Designations.
Dividends.
Shares of our Series A Preferred Stock accrue annual preferred dividends at a rate of $0.175 per share, which are payable when, as and
if declared by our board of directors. The holders of the outstanding shares of our Series A Preferred Stock are also entitled to receive
on each share of our Series A Preferred Stock dividends prior to, or simultaneously with, any dividend declared with respect to our common
stock equal to the greater of (i) the amount of dividends that have accrued on such share of our Series A Preferred Stock and (ii) the
dividend payable with respect to each share of our common stock issuable upon conversion of such share of our Series A Preferred Stock.
Rights
to Receive Liquidation Distributions. In the event of a liquidation, dissolution or winding up of the Company, or a Deemed Liquidation
Event (as defined in the Certificate of Designation) the holders of our Series A Preferred Stock are eligible to receive the greater
of (i) an amount equal to $3.50 per share (subject to appropriate adjustment in the event of any stock dividend, stock split, combination,
or other similar recapitalization with respect to our Series A Preferred Stock) (the “Original Issue Price”), plus
an amount equal to accrued and unpaid dividends thereon, or (ii) such amount per share as would have been payable had all shares of our
Series A Preferred Stock been converted into our common stock immediately prior to such liquidation, dissolution, winding up or Deemed
Liquidation Event.
Conversion.
Shares of our Series A Preferred Stock are convertible at the option of the holder at any time into shares of our common stock at a conversion
rate determined by dividing the Original Issue Price by $3.50 per share (subject to appropriate adjustment in the event of any stock
dividend, stock split, combination, recapitalizations, dividends, distributions and certain issuances of common stock) (the “Conversion
Price”). This formula initially results in a one-to-one conversion ratio. The Conversion Price is subject to customary weighted
average anti-dilution adjustments in the event of certain dilutive issuances of shares of our common stock or convertible securities.
We
may require the conversion of all of the outstanding shares of our Series A Preferred Stock if the closing sale price of our common stock
equals or exceeds $9.00 for a period of five (5) consecutive trading days with a minimum average trading volume of 35,000 shares per
day over such period; provided, that, on such date, the shares of our common stock issuable upon conversion of our Series A Preferred
Stock are registered for resale under the Securities Act or are otherwise eligible for resale pursuant to Rule 144 thereunder.
Notwithstanding
the foregoing, prior to the receipt of all approvals, if any, of the shareholders of the Company necessary for purposes of the rules
and regulations of the applicable trading market, our Series A Preferred Shares shall not be converted into shares of common stock: (i)
in the aggregate into more than 19.99% of the shares of common stock outstanding immediately prior to the issuance date, subject to appropriate
adjustment in the event of a stock split, stock dividend, combination or other similar recapitalization, or (ii) by any beneficial holder
(as such term is defined under Rule 13d-3 of the Exchange Act) or “group” (as such term is defined under Rule 13d-5 of the
Exchange Act) (such beneficial holder or group, a “Capped Holder”), if (A) the aggregate number of shares of common
stock issued to such Capped Holder upon such conversion and any conversion shares then held by the Capped Holders, plus (B) the number
of shares of common stock underlying our Series A Preferred Shares that would be held at such time by the Capped Holders (after giving
effect to such conversion), plus (C) the aggregate number of shares of common stock held by such Capped Holder as of immediately prior
to the issuance date, would in the aggregate exceed more than 19.99% of the shares of common stock outstanding immediately prior to the
issuance date (without regard to any limitation on conversion pursuant to this Section 5(n)), then such Capped Holder shall be entitled
to convert such number of our Series A Preferred Shares as would result in the sum of clauses (A), (B) and (C) (after giving effect to
such conversion) being equal to 19.99% of the shares of common stock outstanding immediately prior to the issuance date, in each case,
subject to appropriate adjustment in the event of a stock split, stock dividend, combination or other similar recapitalization. Any Series
A Preferred Shares which a holder has elected to convert but which, by reason of the previous sentence are not so converted, shall be
treated as if the holder had not made such election to convert and such Series A Preferred Shares shall remain outstanding.
Delaware
Law and Certain Charter and Bylaw Provisions
The
provisions of DGCL, as well as certain terms of our Charter and Bylaws, may have the effect of delaying, deferring or discouraging another
person from acquiring control of us by means of a tender offer, a proxy contest or otherwise, or removing incumbent officers and directors.
These provisions, some of which are summarized below, are expected to discourage certain types of coercive takeover practices and takeover
bids that our board of directors may consider inadequate and to encourage any person seeking to acquire control of us to first negotiate
with our board of directors.
Delaware
Law. We are governed by the provisions of Section 203 of the DGCL. In general, Section 203 prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years after
the date such stockholder became an “interested stockholder”. A “business combination” includes mergers, asset
sales or other transactions resulting in a financial benefit to the stockholder. An “interested stockholder” is a person
who, together with affiliates and associates, owns, or within three years did, prior to the determination of interested stockholder status,
own, 15% or more of the corporation’s outstanding voting stock.
Charter
and Bylaw Provisions. Each of our Charter and Bylaws include a number of other provisions that may have the effect of deterring hostile
takeovers or delaying or preventing changes in control or our management, including the following:
| ● | Issuance
of Undesignated Preferred Stock. Our board of directors has the authority, to issue up
to 5,000,000 shares of our preferred stock with rights and preferences designated from time
to time by our board of directors, 571,429 of which have been designated as Series A Preferred
Stock, and none of which are outstanding. |
| ● | No
Cumulative Voting. The DGCL provides that stockholders are denied the right to cumulate
votes in the election of directors unless our Charter provides otherwise. Our Charter does
not provide for cumulative voting. |
| ● | Size
of Board and Vacancies. Our Charter and Bylaws provide that the number of directors on
our board of directors shall consist of not less than three nor more than nine members as
fixed from time to time by resolution of our board of directors. Newly created directorships
resulting from any increase in our authorized number of directors, and any vacancies resulting
from death, resignation, retirement, disqualification, removal from office or other cause,
will generally be filled by a majority of the remaining members of our board of directors
then in office. |
Exhibit 10.1
Exhibit
10.5
BIOMERICA,
INC.
NON-STATUTORY
STOCK OPTION AGREEMENT FOR MEMBERS OF THE BOARD OF DIRECTORS
Optionee:
[[FIRSTNAME]] [[LASTNAME]]
No.
of shares: [[SHARESGRANTED]]
Issue
Date: [[GRANTDATE]]
Expiration
Date: [[GRANTEXPIRATIONDATE]]
Exercise
Price: [[MARKETPRICEATAWARD]] per share
Vesting
Schedule: 12 Months from Issue Date
[[ALLVESTSEGS]]
This
Stock Option Agreement (the “Agreement”) is made and entered into effective as of the date set forth on the Signature Page
attached hereto by and between Biomerica, Inc., a Delaware corporation (the “Corporation”), and that person identified on
the Signature Page below and attached hereto (the “Optionee”). This option is not intended to qualify and will not be treated
as an “incentive stock option” with the meaning of Section 422 of the Internal Revenue Code (the “Code.”)
The
grant hereunder is in connection with and in furtherance of the Corporation’s compensatory benefit plan for participation of the
Corporation’s employees. This Agreement and the stock option granted hereunder are subject to the terms and conditions found in
the Biomerica, Inc. 2022 Stock Incentive Plan (the “Plan”), and the “Compensation Policy for Executive Officers and
Directors” adopted by the Board of Directors (the “Board”) on December20, 2018. All defined terms not explicitly defined
in this Agreement but defined in the Plan shall have the same definitions as in the Plan.
1. Grant
of Option. Subject to the vesting provisions of Section 3 and/or as set forth on the Signature Page attached hereto, the Corporation
hereby grants to Optionee, as of the date hereof the right and option to purchase, on the terms and conditions hereinafter set forth,
all or any part of the aggregate number of shares of Common Stock set forth on the Signature Page attached hereto (the “Option”),
subject to adjustment in accordance with the provisions of The Plan and Section 18 below. It is understood and acknowledged that the
Option is designated as a Nonstatutory Stock Option which will not qualify as an Incentive Stock Option under Section 422 of the Code.
2. Exercise
Price. The price to be paid for the shares of Common Stock to be issued upon exercise of the Option or any part thereof shall be
as set forth on the Signature Page below (the “Exercise Price.”)
3. Right
to Exercise. The option shall vest 100% on the twelve-month anniversary of the Issue Date. Subject to the provisions of the 2022
Stock Incentive Plan, and the terms of this Agreement, all vested options shall be exercisable in full or in part at any time until [[GRANTEXPIRATIONDATE]].
4. Securities
Law Requirements. No part of the Option shall be exercised if counsel to the Corporation determines that any applicable registration
requirement under the Securities Act of 1933, as amended (the “1933 Act”), or any other applicable requirement of Federal
or state law has not been met.
5. Term
of Option. The Option shall terminate in any event on the earliest of (a) the Expiration Date set forth on the Signature Page, (b)
the expiration of the period described in Section 6 below, or (c) the expiration of the period described in Section 7 below.
6. Exercise
Following Termination, Except by Death, Disability or Retirement. If the Optionee’s service as a member of the Board is terminated
either; a) for reasons other than by death or for Cause, or b) by the Member’s resignation, or c) by vote of the shareholders at
an annual meeting, then all issued, outstanding and vested options shall remain owned by the Member and shall remain exercisable until
the Expiration Date listed herein. For this purpose, “Cause” shall mean conviction of a felony, misappropriation of assets
of the Corporation or any subsidiary, gross negligence in carrying out the duties of a Member and acts of malfeasance toward the Company.
If Optionee is removed from the Board of Directors for Cause, either by resignation or otherwise, all outstanding, unexercised options
shall become void and un-exercisable, and all of Optionee’s rights under this Agreement shall terminate.
7. Exercise
Following Death. If the Optionee’s service with the Corporation terminates by reason of the Optionee’s death, or if the
Optionee dies after termination of service but while the Option would have been exercisable hereunder, the vested portion of the Option
(to the extent it has not previously been exercised and is then exercisable) may be exercised within twelve (12) months after the date
of Optionee’s death (but not later than the Expiration Date set forth on the signature page below). The exercise may be made by
the by the Optionee’s representative or by the person entitled thereto under Optionee’s will or the laws of descent and distribution;
provided that such representative or such person consents in writing to abide by and be subject to the terms of this Agreement and the
2022 Stock Incentive Plan and such writing is delivered to the CEO of the Corporation.
8. Nontransferability.
Unless the Corporation otherwise consents in writing, the Option and all rights and privileges granted hereunder shall be non-assignable
and non-transferable by the Optionee, either voluntarily or by operation of law, except by will, by operation of the laws of descent
and distribution, by instrument to an inter vivos or testamentary trust in which the Option is to be passed to beneficiaries upon the
death of the trustor, or by gift to the Optionee’s immediate family, shall not be pledged or hypothecated in any way, and shall
be exercisable during lifetime only by the Optionee. Except as otherwise provided herein, any attempted alienation, assignment, pledge,
hypothecation, attachment, execution or similar process, whether voluntary or involuntary, with respect to all or any part of the Option
or any right thereunder, shall be null and void and, at the Corporation’s option, shall cause all of Optionee’s rights under
this Agreement to terminate.
9. Effect
of Exercise. Upon exercise of all or any part of the Option, the number of shares of Common Stock subject to option under this Agreement
shall be reduced by the number of shares with respect to which such exercise is made.
10. Partial
Exercise. Any exercisable portion of the Option or the entire Option, if then wholly vested and exercisable, may be exercised in
whole or in part at any time prior to the time when the Option or portion thereof becomes unexercisable under Section 5; provided, however,
that each partial exercise shall be for not less than one hundred (100) shares and shall be for whole shares only.
11. Method
of Exercise. Each exercise of the Option shall be by means of a written notice delivered to the Secretary or the Chief Financial
Officer (CFO) of the Corporation at its principal office and accompanied by payment in full of the Exercise Price for each share of Common
Stock purchased under the Option. Such notice shall specify the number of shares of Common Stock with respect to which the Option is
exercised and shall be signed by the person exercising the Option. If the Option is exercised by a person other than the Optionee, such
notice shall be accompanied by proof, reasonably satisfactory to the Corporation, of such person’s right to exercise the Option.
The Secretary or the CFO may instruct Optionee on other requirements for exercising such option.
The
Exercise Price specified in Section 2 above shall be paid in full upon the exercise of the Option (i) by cash, in United States dollars.
The Board of Directors may, but is not obligated to, accept a secured recourse promissory note of Optionee (bearing such rate of interest
and such other terms as they may reasonably determine) as payment of the Exercise Price; provided, however, no stock certificate
representing the shares be released until the note shall have been paid in full.
12. Withholding
Taxes. If the Optionee is an employee or former employee of the Corporation when all or part of the Option is exercised, the Corporation
may require the Optionee to deliver payment of any withholding taxes (in addition to the Exercise Price) in cash with respect to the
difference between the Exercise Price and the Fair Market Value of the Common Stock acquired upon exercise.
13. Issuance
of Shares. Subject to the foregoing conditions, the Corporation, as soon as reasonably practicable after receipt of a proper notice
of exercise and without transfer or issue tax or other incidental expense to the person exercising the Option, shall deliver to such
person at the principal office of the Corporation, or such other location as may be acceptable to the Corporation and such person, one
or more certificates for the shares of Common Stock with respect to which the Option has been exercised. Such shares shall be fully paid
and nonassessable and shall be issued in the name of such person. However, at the request of the Optionee, such shares may be issued
in the names of the Optionee and his or her spouse (a) as joint tenants with right of survivorship, (b) as community property or (c)
as tenants in common without right of survivorship.
14. Limitation
of Optionee’s Rights. Neither Optionee nor any person entitled to exercise the Option shall be or have any of the rights of
a shareholder of the Corporation in respect of any share issuable upon the exercise of the Option unless and until a certificate or certificates
representing shares of Common Stock shall have been issued and delivered upon exercise of the Option in full or in part. No adjustment
shall be made for dividends or other rights for which the record date is prior to the date such stock certificates are issued.
15.
Consent Required to Transfer. In connection with any underwritten public offering by the Corporation of its equity securities
pursuant to an effective registration statement filed under the 1933 Act, Optionee shall not sell, make any short sale of, loan, hypothecate,
pledge, grant any option for the purchase of, or otherwise dispose or transfer for value or otherwise agree to engage in any of the foregoing
transactions with respect to, any shares of Common Stock purchased under the Option without the prior written consent of the Corporation
or its underwriters. Such limitations shall be in effect for such period of time from and after the effective date of such registration
statement as may be requested by the Corporation or such underwriters.
16. Recapitalizations.
Subject to the provision of the Plan, if the outstanding shares of the class then subject to this Option are adjusted for any increase
or decrease in the number of issued shares of Common Stock resulting from a subdivision or consolidation of Common Stock or the payment
of a stock dividend (but only of Common Stock) or any other increase or decrease in the number of issued shares of Common Stock effected
without receipt of consideration by the Corporation for the issuance of such shares, appropriate adjustments shall be made in the number
and /or kind of shares or securities for which the unexercised portions of this Option may thereafter be exercised, all without any change
in the aggregated Exercise Price applicable to the unexercised portions of this Option, but with a corresponding adjustment in the Exercise
Price per share and/or an adjustment in the number of shares available under this Option agreement. Subject to the provisions of the
Plan, if the Corporation is the surviving corporation in any merger or consolidation, this Option shall pertain and apply to the securities
to which a holder of the number of Common Stock subject to the Option would have been entitled. In the event of a merger or consolidation
in which the Corporation is not the surviving corporation, the date of exercisability of this Option shall be accelerated to a date prior
to such merger or consolidation, unless, in order to qualify for “pooling-of-interest” treatment, the agreement of merger
or consolidation provides for the assumption of the Option by the successor to the Corporation. To the extent that the foregoing adjustments
relate to securities of the Corporation, such adjustments shall be made by the Board, whose determination shall be conclusive and binding
on all persons. Except as expressly provided in this Section 16, the Optionee shall have no rights by reason of subdivision or consolidation
of shares of Common Stock of any class, the payment of any Common Stock dividend or any other increase or decrease in the number of shares
of Common Stock of any class or by reason of any dissolution, liquidation, merger or consolidation or spin-off of assets or common stock
of another corporation, and any issue by the Corporation of shares of Common Stock of any class, or securities convertible into shares
of Common Stock of any class, shall not affect, and no adjustment by reason thereof shall be made with respect to, the Exercise Price
or the number or Common Stock subject to this Option.
17. Restricted
Stock Provisions. In addition to certain Federal and state securities laws restrictions, the shares of Common Stock issued on exercise
of this Option shall upon issuance be subject to the following restrictions (and, as used herein, “restricted stock” means
shares issued on exercise of this Option which are still subject to the restrictions imposed under this Section that have not yet expired
or terminated):
(a)
Such shares of restricted stock may not be sold or otherwise transferred or hypothecated;
(b)
The restrictions imposed under Section 17 shall apply as well to all shares or other securities issued in respect of restricted stock
in connection with any stock split, reverse stock split, stock dividend, recapitalization, reclassification, spin-off, split-off merger,
consolidation or reorganization, but such restrictions imposed under Section 17 shall expire or terminate on the earliest to occur of
the following:
(i)
The ninetieth (90th) day after the date on which shares of the same class of Common Stock as such restricted stock first become registered
pursuant to the Exchange Act (which term for this purpose has the same meaning as set forth in the Plan);
(ii)
The fifth (5th) anniversary of the date of grant hereof; or
(iii)
The occurrence of any event or transaction upon which this Option terminated by reason of the provisions of Section 19 hereof.
(c)
Unless the shares to be acquired by the Optionee have been registered under the 1933 Act and any other applicable securities laws
of any state, all certificates representing shares of Common Stock purchased upon the exercise of the Option shall bear the following
legends:
“THE
SALE OF THE SECURITIES REPRESENTED HEREBY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”). ANY TRANSFER
OF SUCH SECURITIES WILL BE INVALID UNLESS A REGISTRATION STATEMENT UNDER THE ACT IS IN EFFECT AS TO SUCH TRANSFER OR IN THE OPINION OF
COUNSEL FOR THE ISSUER SUCH REGISTRATION IS UNNECESSARY IN ORDER FOR SUCH TRANSFER TO COMPLY WITH THE ACT.”
18. Stock
Incentive Plan. This Agreement is subject to, and the Corporation and the Optionee agree to be bound by, all of the terms and conditions
of the Plan under which this Option was granted, as the same shall have been amended from time to time in accordance with the terms thereof,
provided that no such amendment shall deprive the Optionee, without his or her consent, of this Option or any of his or her rights hereunder.
Pursuant to said Plan, the Board of Directors of the Corporation or its Committee established for such purposes is vested with final
authority to interpret and construe the Plan and this Option, and is authorized to adopt rules and regulations for carrying out the Plan.
A copy of the Plan in its present form is available for inspection during business hours by the Optionee or other persons entitled to
exercise this Option at the Corporation’s principal office.
19. Notices.
Any notice to the Corporation contemplated by this Agreement shall be addressed to it in care of its CEO; any notice to the Optionee
shall be addressed to him or her at the address on file with the Corporation on the date hereof or at such other address as Optionee
may hereafter designate in a writing delivered to the Corporation as provided herein.
20. Interpretation.
The interpretation, construction, performance and enforcement of this Agreement shall lie within the sole discretion of the Board, and
the Board’s determinations shall be conclusive and binding on all interested persons.
21. Governing
Law. This Agreement has been made, executed and delivered in, and the interpretation, performance and enforcement hereof shall be
governed by and construed under the laws of the State of California.
22. Information
to Optionee. The Corporation hereby agrees to provide the Optionee with the Corporation’s audited annual financial statements.
SIGNATURE
PAGE
NON-STATUTORY
STOCK OPTION AGREEMENT
PURSUANT
TO BIOMERICA, INC.
2022
STOCK INCENTIVE PLAN
Date
of Grant: [[GRANTDATE]]
Exercise
Price: [[MARKETPRICEATAWARD]] per share
Shares
Vesting:
[[ALLVESTSEGS]]
Total
number of shares: [[SHARESGRANTED]] shares
Expiration
Date: [[GRANTEXPIRATIONDATE]]
I
have reviewed this Non-Statutory Stock Option Agreement, which was adopted for use in connection with the 2022 Stock Incentive Plan.
I have also received and reviewed a copy of the 2022 Stock Incentive Plan. As Optionee, I hereby acknowledge that as of the date of grant
of this Option, it sets forth the entire understanding between the undersigned Optionee and the Corporation and its Affiliates regarding
the acquisition of stock in the Corporation and supersedes all prior oral and written agreements on that subject with the exception of
any other option awards previously granted and delivered in writing to the undersigned Optionee under the stock incentive plans of the
Corporation.
IN
WITNESS WHEREOF, this Non-Statutory Stock Option Agreement has been delivered, adopted and accepted in full by the Parties hereto.
Date:
[[SIGNATURE_DATE]] |
By: |
[[SIGNATURE]] |
|
|
|
|
|
[[FIRSTNAME]]
[[LASTNAME]] |
The
Corporation hereby agrees to
all
the terms of the Agreement.
Biomerica,
Inc.
Zackary
Irani
Chief
Executive Officer
Exhibit
10.6
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
January
31, 2023
Gary
Lu, CPA
12136
Ahern Ct.
Tustin,
CA 92782
Re:
Employment Offer
Dear
Gary:
We
are pleased to extend to you an offer to join Biomerica, Inc. (the “Company”). The purpose of this letter is to set forth
in writing the terms and conditions of your new employment relationship with the Company.
Your
employment will commence as of March 1, 2023 (or mutually decided day within that week). Your job title will be Chief Financial
Officer (CFO). Your duties will be such assignments as may be assigned to you by the Company.
Your
base full-time salary will be two hundred and sixty thousand ($260,000) per year (the “Base Salary”) and will be payable
at such intervals as is normal for the payment of compensation to the Company’s employees.
In
addition to the Base Salary, the Company shall grant to you an initial stock option to purchase 75,000 shares of the Company’s
common stock at an exercise price equal to the fair market value of the Company’s common stock on the date of grant. The Option
grant date will be determined by the Board of Directors as soon as practicable after your hire date. The option shall vest over a period
of four (4) years, with 25% vesting on the first anniversary of the date of grant and each subsequent year thereafter for the next three
(3) years. The option shall have a term of ten (10) years. Other terms and conditions of the stock option grant will be set forth in
the option issuance agreement you will be issued, and language in the Biomerica stock option plan, which you will receive a copy of.
You will be issued additional options or equity grants annually along with other executive officers.
Your
performance and compensation will be reviewed from time to time, and your compensation may be increased by the Company.
You
will also be entitled to the standard employment benefit package that is available to all Company employees which package is subject
to change from time to time, but which initially will include group health, dental, long-term disability and life insurance for you as
per Company policy. Dependent coverage is also available for medical and dental insurance; however, it will be at fifty percent of the
cost.
You
will have time off with pay on the major holidays which are recognized by the Company, plus an additional 20 days of paid time off based
on full employment and according to company policy.
You
will be entitled to such other employment benefits as the Company generally makes available to its employees and all benefits will be
subject to change from time to time and will be provided in accordance with the Company’s employment policies, to which you will
be subject.
|
17571 VON KARMAN AVE.,
IRVINE, CALIFORNIA 92614
PH 949-645-2111 FAX 949-553-1231
www.biomerica.com |
You
agree to review in detail the Employee Handbook, the Company Insider Trading Policy, and all other employee policies, rules and regulations,
and be bound entirely by such.
You
also agree to execute and be bound by the terms of the Inventions Assignment and Non-Disclosure Agreement attached hereto as Exhibit
A.
Following
acceptance of this offer, either party may terminate the employment relationship, with or without cause, by giving the other party written
notice of intention to do so (“At Will” employment). No other provision of this offer is intended to imply that employment
will continue for any definite term or period. Upon the termination of your employment you shall be entitled to payment of all accrued
compensation to the date of such termination plus any unreimbursed expenses accruing to the date of such termination.
This
Agreement is made and entered into in the State of California, and shall in all respects be interpreted, enforced and governed by and
under the laws of the State of California. All disputes arising under this agreement or relating to the Company’s employment of
you shall be governed by the laws of the State of California.
This
letter, together with the Employee Handbook, any Arbitration Agreement, and the Non-Disclosure Agreement, is intended to set forth our
entire agreement regarding your employment relationship with the Company, thus it supersedes any other agreement on this subject, including
any inconsistent provisions contained in any employee manual or policy of the Company. This agreement will not be modifiable except by
a mutual written agreement between you and the Company.
Please
sign and return this letter to me to indicate your acceptance and agreement to the terms set forth in this letter. You may keep a copy
for your own records.
|
Sincerely, |
|
|
|
Biomerica,
Inc. |
|
|
|
|
By: |
Zack
Irani |
|
Its: |
CEO |
ACCEPTANCE
I
have read the foregoing letter and agree with the terms and conditions of my employment as set forth.
Dated:
_______________ |
|
|
Name: |
Gary Lu |
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
Exhibit
A
BIOMERICA,
INC.
NONDISCLOSURE,
INVENTIONS ASSIGNMENT AND NON-COMPETE AGREEMENT
The
undersigned employee (the “EMPLOYEE”) of BIOMERICA, INC. and/or its subsidiaries (herein collectively called the “Company”),
having been engaged to perform services for the benefit of the Company, and in consideration of said employment, does hereby agree to
perform such duties for the Company as shall be designated by the Company from time to time, and the parties hereto agree as follows:
1.
EMPLOYEE will not, while serving as an EMPLOYEE of the Company, or thereafter, divulge, disclose or communicate to, anyone without the
express written authorization of the Company, any trade secrets or any other information and data of a private, internal or confidential
nature, relating or pertaining to the Company’s business, methods of manufacture, processes, customer list, distributors, formulas, operations
or other information that the EMPLOYEE may have acquired, directly or indirectly, during the course of his employment by the Company.
The EMPLOYEE acknowledges that the Company in its operation maintains in secrecy certain of its methods, processes, marketing and strategic
plans, customer and distributor data and technical information (herein called the “Confidential Information”).
It
is mutually understood and agreed that all documents furnished by and generated by the EMPLOYEE or the Company during the course of EMPLOYEE’s
employment with the Company shall be the property of the Company and its subsidiaries and shall be returned promptly, with all copies
made thereof, if formally requested by the Company.
The
obligations of the EMPLOYEE set forth above shall not apply to any portion of information and matters disclosed or exhibited to the EMPLOYEE
which has become generally available to the public through no act or failure to act on the part of the EMPLOYEE. The EMPLOYEE hereby
acknowledges that all Confidential Information which is disclosed to EMPLOYEE by the Company hereunder, and all tangible forms thereof,
are the property of the Company and EMPLOYEE shall obtain no right, title or interest in any secret or Confidential Information or any
tangible forms thereof. EMPLOYEE shall hereafter (a) exercise all reasonable efforts to prevent unauthorized persons from gaining access
to Confidential Information; (b) promptly mark any Confidential Information placed by it in documentary or other tangible form with the
legend “Secret”; (c) not assert prior knowledge of any item of Confidential Information which the EMPLOYEE cannot so prove
by clear and convincing documentary evidence; (d) promptly deliver or destroy, as the Company may direct in writing, all tangible forms
of Confidential Information, whether or not such tangible forms were prepared by the EMPLOYEE or the Company and whether or not such
tangible forms contain or embody information other than Confidential information; and (e) not represent that he or she, or permit any
representative or agent of the EMPLOYEE to represent that he, she or it, has a claim or interest in such ‘Secret’ or ‘Confidential
Information’.
1.1
U.S. Defend Trade Secrets Act. Notwithstanding the foregoing, the U.S. Defend Trade Secrets Act of 2016 (“DTSA”)
provides that an individual shall not be held criminally or civilly liable under any federal or state trade secret law for the
disclosure of a trade secret that is made (i) in confidence to a federal, state, or local government official, either directly or
indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (iii)
in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. In addition, DTSA
provides that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may
disclose the trade secret to the attorney of the individual and use the trade secret information in the court proceeding, if the
individual (A) files any document containing the trade secret under seal; and (B) does not disclose the trade secret, except
pursuant to court order.
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
1.2
Other Permitted Disclosures.
1.2
(a) Nothing in this Agreement prohibits or restricts the Employee (or Employee’s attorney) from initiating communications directly with,
responding to an inquiry from, or providing testimony before the Securities and Exchange Commission (SEC), the Financial Industry Regulatory
Authority (FINRA), any other self-regulatory organization, or any other federal or state regulatory.
1.2
(b) Nothing in this agreement prevents you from discussing or disclosing information about unlawful acts in the workplace, such as harassment
or discrimination or any other conduct that you have reason to believe is unlawful.
1.2
(c) Nothing in this Agreement in any way prohibits or is intended to restrict or impede the Employee from discussing the terms and conditions
of his or her employment with coworkers or union representatives/exercising protected rights under Section 7 of the National Labor Relations
Act/exercising protected rights to the extent that such rights cannot be waived by agreement disclosing information as permitted by law.
2.
The EMPLOYEE further hereby transfers and assigns to the Company, its successors and assignees, or to any person or entity designated
by it, the EMPLOYEE’s entire right, title and interest in and to all inventions, discoveries, ideas, disclosures, improvements and suggestions,
patentable or not (herein collectively called “Inventions”), and copyrightable material, made or conceived by Employee, solely
or jointly, during the course of his or her employment with the Company (herein the “Invention Period”) which relate to methods,
formulas, designs, products, components or devices, sold, leased, used or under consideration or development by the Company, or which
otherwise relate or pertain to the business, e-commerce strategy, functions, or operations of the Company, including,, but not limited
to, the manufacture, design or development of systems, methods, components, and/or products. All such Inventions and copyrightable material
disclosed or developed within one year after the termination of employment shall be presumed to have been made or conceived during the
Invention Period. PROVIDED, HOWEVER, THAT THIS AGREEMENT DOES NOT APPLY TO ANY INVENTION WHICH QUALIFIES FULLY UNDER THE PROVISIONS OF
SECTION 2870 OF THE CALIFORNIA LABOR CODE, THE PROVISIONS OF WHICH ARE ATTACHED HERETO.
3.
With respect to the inventions, ideas, disclosures, improvements and suggestions referred to in paragraph 2, Employee further agrees
to communicate promptly and disclose to the Company, in such form as Employee may be called upon to do so, all information, details and
data pertaining thereto, and to execute and deliver such formal transfers and assignments, and such other papers and documents as may
be required of the EMPLOYEE to enable the Company, or any person or entity designated by the Company, to file and prosecute patent applications,
and as to copyrightable material to effect copyright thereof.
The
EMPLOYEE attaches hereto a complete list of all inventions, patented or unpatented, made or conceived by Employee prior to his or her
employment by the Company. Such inventions, if any, and improvements, extensions or modifications thereof shall be deemed excluded from
this Agreement.
Such
attached list, if any, shall be entitled “Exclusions to Attached Agreement,” shall be signed by the Employee, and shall bear
an “Exclusions Noted” line at the bottom to be signed by the Company.
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
4.
RESTRICTIVE COVENANTS.
4.1
Executive acknowledges that (i) he has a major responsibility for the operation, administration, development and growth of the Company’s
business, (ii) his work for the Company has brought him and will continue to bring him into close contact with confidential information
of the Company and its customers, and (iii) the agreements and covenants contained in this Section 4 are essential to protect the business
interest of the Company and that the Company will not enter into this Agreement but for such agreements and covenants. Accordingly, the
EMPLOYEE covenants and agrees as follows:
4.1(a)
Except as otherwise provided for in this Agreement, during the Term of employment with the Company or any of its subsidiaries, the EMPLOYEE
shall not, directly or indirectly, compete with respect to any services or products of the Company which are either offered or are being
developed by the Company; or, without limiting the generality of the foregoing, be or become, or agree to be or become, interested in
or associated with, in any capacity (whether as a partner, shareholder, owner, officer, director, Executive, principal, agent, creditor,
trustee, consultant, co-venturer or otherwise) with any individual, corporation, firm, association, partnership, joint venture or other
business entity, which competes with respect to any services or products of the Company which are either offered or are being developed
by the Company; provided, however, that the EMPLOYEE may own, solely as an investment, not more than one percent (1%) of any class of
securities of any publicly held corporation in competition with the Company whose securities are traded on any national securities exchange
in the United States of America, and may retain his ownership interest in those entities.
4.1(b)
During the term of Employment, the EMPLOYEE shall not, directly or indirectly, (i) induce or attempt to influence any other employee
of the Company to leave its employ, (ii) aid or agree to aid any competitor, customer or supplier of the Company in any attempt to hire
any person who shall have been employed by the Company within the one (1) year period preceding such requested aid, or (iii) induce or
attempt to influence any person or business entity who was a customer or supplier of the Company during any portion of said period to
transact business with a competitor of the Company in Company’s business. Employee agrees and covenants to not utilize any Confidential
Information to (i) induce or attempt to influence any other employee of the Company to leave its employ, (ii) aid or agree to aid any
competitor, customer or supplier of the Company in any attempt to hire any person who is or was employed by the Company, or (iii) induce
or attempt to influence any person or business entity who was a customer or supplier of the Company during any portion of said period
to transact business with a competitor of the Company in Company’s business.
4.1(c)
During the Term of Employment, and for ten (10) years thereafter, the EMPLOYEE shall not other than in the performance of his duties
disclose to anyone any Confidential Information, including, without limitation, trade secrets, trade “know-how”, inventions,
customer lists, business plans, operational methods, pricing policies, marketing plans, sales plans, identity of suppliers or customers,
sales, profits or other financial information, which is confidential to the Company or is not generally known in the relevant trade,
nor shall the EMPLOYEE make use of any such information for his own benefit.
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
4.2
If the EMPLOYEE breaches, or threatens to commit a breach of Section 4.1 (the “Restrictive Covenants”), the Company shall have
the following rights and remedies, each of which shall be enforceable, and each of which is in addition to, and not in lieu of, any other
rights and remedies available to the Company at law or in equity.
4.2(a)
The EMPLOYEE shall account for and pay over to the Company all compensation, profits, and other benefits, after taxes, which inure to
EMPLOYEE’s benefit which are derived or received by the EMPLOYEE or any person or business entity controlled by the EMPLOYEE resulting
from any action or transactions constituting a breach of any of the Restrictive Covenants.
4.2(b)
Notwithstanding the provisions of subsection 4.2(a) above, the EMPLOYEE acknowledges and agrees that in the event of a violation or threatened
violation of any of the provisions of this Agreement, the Company shall have no adequate remedy at law and shall therefore be entitled
to enforce each such provision by temporary or permanent injunctive or mandatory relief obtained in any court of competent jurisdiction
without the necessity of proving damages, posting any bond or other security, and without prejudice to any other rights and remedies
which may be available at law or in equity.
4.3
If any of the Restrictive Covenants, or any part thereof, is held to be invalid or unenforceable, the same shall not affect the remainder
of the covenant or covenants, which shall be given full effect, without regard to the invalid or unenforceable portions. Without limiting
the generality of the foregoing, if any of the Restrictive Covenants, or any part thereof, is held to be unenforceable because of the
duration of such provision or the area covered thereby, the parties hereto agree that the court making such termination shall have the
power to reduce the duration and/or area of such provision and, in its reduced form, such provision shall then be enforceable.
4.4
The parties hereto intend to and hereby confer jurisdiction to enforce the Restrictive Covenants upon the courts of any jurisdiction
within the geographical scope of such Restrictive Covenants. In the event that the courts of any one or more of such jurisdictions shall
hold such Restrictive Covenants wholly unenforceable by reason of the breadth of such scope or otherwise, it is the intention of the
parties hereto that such determination not bar or in any way affect the Company’s right to the relief provided above in the courts of
any other jurisdictions within the geographical scope of such Restrictive Covenants, as to breaches of such covenants in such other respective
jurisdictions, the above covenants as they relate to each jurisdiction being, for this purpose, severable into diverse and independent
covenants.
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
IN
WITNESS WHEREOF, I have hereunto set my hand and seal as of the day and year stated below.
SIGNED
IN PRESENCE OF |
|
EMPLOYEE: |
|
|
|
|
|
|
Witness |
|
NAME
– Gary Lu |
DATED:
EXCLUSIONS
TO ATTACHED AGREEMENT |
|
|
|
|
|
|
|
|
|
|
NAME
– Gary Lu |
Exclusions:
(inventions, discoveries etc.)
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_____________________________________
Biomerica,
Inc.
By:
______________________ |
DATED: |
|
17571
VON KARMAN AVE.,
IRVINE,
CALIFORNIA 92614
PH
949-645-2111 FAX 949-553-1231
www.biomerica.com |
CALIFORNIA
LABOR CODE, SECTION 2870
Section
2870 of the California Labor Code applies to any employment agreement entered into after January 1, 1980 which is governed by the laws
of California. Unless otherwise stipulated in a written agreement, the rights and duties of all employees of the Company who are primarily
employed at a facility within California are governed by California law.
Section
2870 of the California Labor Code prohibits an employment agreement from assigning to the employer any rights of an employee in an invention
“for which no equipment, supplies, facility, or trade secret information of the employer was used and which was developed entirely
on the employee’s own time, and (4) which does not relate (1) to the business of the employer (2) ‘to the employer’s actual or demonstrably
anticipated, research or -development, or (b) which does not result from any work performed by the employee for the employer.”
Exhibit
21.1
LIST
OF SUBSIDIARIES |
|
|
|
NAME
OF SUBSIDIARY |
|
COUNTRY
OF INCORPORATION |
BioEurope
GmbH |
|
Germany |
Biomerica
de Mexico |
|
Mexico |
EXHIBIT
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in the Registration Statement on Form S-3 (No. 333-239980), as amended, and the
Registration Statements on Form S-8 (Nos. 333-179443, 333-204410, 333-224836 and 333-256377) of Biomerica, Inc. (the
“Company”) of our report dated August 25, 2023, relating to our audits of the Company’s consolidated financial
statements as of May 31, 2023 and 2022, and for each of the years then ended, included in the Company’s Annual Report on Form
10-K for the fiscal year ended May 31, 2023.
|
/s/ HASKELL & WHITE LLP |
|
|
|
HASKELL & WHITE LLP |
Irvine,
California
August
25, 2023
EXHIBIT
31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Zackary S. Irani, certify that:
1.
I have reviewed this Annual Report on Form 10-K of Biomerica, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects, the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of our internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or other
persons performing the equivalent functions):
a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
/s/
Zackary S. Irani |
|
Zackary S. Irani |
|
Chief Executive Officer |
|
|
|
Date: August 25, 2023 |
|
EXHIBIT
31.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Gary Lu, certify that:
1.
I have reviewed this Annual Report on Form 10-K of Biomerica, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects, the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c)
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d)
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of our internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or other
persons performing the equivalent functions):
a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
/s/ Gary Lu |
|
Gary Lu |
|
Chief Financial Officer |
|
|
|
Date: August 25, 2023 |
|
EXHIBIT
32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Annual Report of Biomerica, Inc. (the “Company”) on Form 10-K for the year ended May 31, 2023, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), I, Zackary Irani, Chief Executive Officer
of the Company, certify, to the best of my knowledge, pursuant to Exchange Act Rule 15d-14(b) and 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes Oxley Act of 2002, as amended:
i.
The Report fully complies with the requirements of Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, and
ii.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
/s/ Zackary S.
Irani |
|
Zackary S. Irani |
|
Chief Executive Officer |
|
|
|
Date: August 25, 2023 |
|
EXHIBIT
32.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Annual Report of Biomerica, Inc. (the “Company”) on Form 10-K for the year ended May 31, 2023, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), I, Gary Lu, Chief Financial Officer of the
Company, certify, to the best of my knowledge, pursuant to Exchange Act Rule 15d-14(b) and 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes Oxley Act of 2002, as amended:
i.
The Report fully complies with the requirements of Sections 13(a) or 15(d) of the Securities Exchange Act of 1934, and
ii.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
/s/ Gary Lu |
|
Gary Lu |
|
Chief Financial Officer |
|
|
|
Date: August 25, 2023 |
|
v3.23.2
Cover - USD ($)
|
12 Months Ended |
|
|
May 31, 2023 |
Aug. 25, 2023 |
Nov. 30, 2022 |
Cover [Abstract] |
|
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|
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|
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|
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FY
|
|
|
Document Fiscal Year Focus |
2023
|
|
|
Current Fiscal Year End Date |
--05-31
|
|
|
Entity File Number |
001-37863
|
|
|
Entity Registrant Name |
BIOMERICA,
INC.
|
|
|
Entity Central Index Key |
0000073290
|
|
|
Entity Tax Identification Number |
95-2645573
|
|
|
Entity Incorporation, State or Country Code |
DE
|
|
|
Entity Address, Address Line One |
17571
Von Karman Avenue
|
|
|
Entity Address, City or Town |
Irvine
|
|
|
Entity Address, State or Province |
CA
|
|
|
Entity Address, Postal Zip Code |
92614
|
|
|
City Area Code |
949
|
|
|
Local Phone Number |
645-2111
|
|
|
Title of 12(b) Security |
Common
Stock, par value $0.08
|
|
|
Trading Symbol |
BMRA
|
|
|
Security Exchange Name |
NASDAQ
|
|
|
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|
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|
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|
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|
|
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and related proxy solicitation materials shall not be deemed to be filed as part hereof.
|
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v3.23.2
Consolidated Balance Sheets - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 9,719,000
|
$ 5,917,000
|
Accounts receivable, net |
722,000
|
774,000
|
Inventories, net |
2,056,000
|
2,416,000
|
Prepaid expenses and other |
300,000
|
320,000
|
Total current assets |
12,797,000
|
9,427,000
|
Property and equipment, net of accumulated depreciation and amortization |
213,000
|
214,000
|
Right-of-use assets, net of accumulated amortization of $617,000 and $725,000 as of May 31, 2023 and 2022, respectively |
1,035,000
|
1,302,000
|
Investments |
165,000
|
165,000
|
Intangible assets, net of accumulated amortization |
165,000
|
170,000
|
Other assets |
79,000
|
96,000
|
Total Assets |
14,454,000
|
11,374,000
|
Current Liabilities: |
|
|
Accounts payable and accrued expenses |
892,000
|
972,000
|
Accrued compensation |
696,000
|
647,000
|
Advance from customers |
60,000
|
51,000
|
Lease liabilities, current portion |
297,000
|
341,000
|
Total current liabilities |
1,945,000
|
2,011,000
|
Lease liabilities, net of current portion |
785,000
|
1,038,000
|
Total Liabilities |
2,730,000
|
3,049,000
|
Commitments and contingencies (Note 9) |
|
|
Shareholders’ Equity: |
|
|
Preferred stock, value |
|
|
Common stock, $0.08 par value, 25,000,000 shares authorized, 16,821,646 and 12,867,924 issued and outstanding at May 31, 2023 and 2022, respectively |
1,346,000
|
1,029,000
|
Additional paid-in-capital |
52,705,000
|
42,447,000
|
Accumulated other comprehensive loss |
(110,000)
|
(74,000)
|
Accumulated deficit |
(42,217,000)
|
(35,077,000)
|
Total Shareholders’ Equity |
11,724,000
|
8,325,000
|
Total Liabilities and Shareholders’ Equity |
14,454,000
|
11,374,000
|
Series A Preferred Stock [Member] |
|
|
Shareholders’ Equity: |
|
|
Preferred stock, value |
|
|
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v3.23.2
Consolidated Balance Sheets (Parenthetical) - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Accumulated amortization |
$ 617,000
|
$ 725,000
|
Preferred stock, par value |
$ 0
|
$ 0
|
Preferred stock, shares authorized |
4,428,571
|
4,428,571
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.08
|
$ 0.08
|
Common stock, shares authorized |
25,000,000
|
25,000,000
|
Common stock, shares issued |
16,821,646
|
12,867,924
|
Common stock, shares outstanding |
16,821,646
|
12,867,924
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.08
|
$ 0.08
|
Preferred stock, shares authorized |
571,429
|
571,429
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
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v3.23.2
Consolidated Statements of Operations and Comprehensive Loss - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Income Statement [Abstract] |
|
|
Net sales |
$ 5,339,000
|
$ 18,871,000
|
Cost of sales |
(4,893,000)
|
(15,894,000)
|
Gross profit |
446,000
|
2,977,000
|
Operating expenses: |
|
|
Selling, general and administrative |
6,085,000
|
5,699,000
|
Research and development |
1,584,000
|
1,812,000
|
Total operating expense |
7,669,000
|
7,511,000
|
Loss from operations |
(7,223,000)
|
(4,534,000)
|
Other income: |
|
|
Dividend and interest income |
133,000
|
27,000
|
Other income |
1,000
|
|
Total other income |
134,000
|
27,000
|
Loss before income taxes |
(7,089,000)
|
(4,507,000)
|
Provision for income taxes |
(51,000)
|
(24,000)
|
Net loss |
$ (7,140,000)
|
$ (4,531,000)
|
Basic net loss per common share |
$ (0.50)
|
$ (0.36)
|
Diluted net loss per common share |
$ (0.50)
|
$ (0.36)
|
Weighted average number of common and |
|
|
Basic |
14,154,269
|
12,673,245
|
Diluted |
14,154,269
|
12,673,245
|
Other comprehensive loss, net of tax: |
|
|
Foreign currency translation |
$ (36,000)
|
$ (26,000)
|
Comprehensive loss |
$ (7,176,000)
|
$ (4,557,000)
|
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v3.23.2
Consolidated Statements of Shareholders' Equity - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balance at May. 31, 2021 |
$ 985,000
|
$ 38,837,000
|
$ (48,000)
|
$ (30,546,000)
|
$ 9,228,000
|
Balance, shares at May. 31, 2021 |
12,307,157
|
|
|
|
|
Exercise of stock options |
$ 3,000
|
74,000
|
|
|
$ 77,000
|
Exercise of stock options, shares |
39,500
|
|
|
|
39,500
|
Net proceeds from ATM |
$ 41,000
|
2,276,000
|
|
|
$ 2,317,000
|
Net proceeds from ATM, shares |
521,267
|
|
|
|
|
Foreign currency translation |
|
|
(26,000)
|
|
(26,000)
|
Share-based compensation |
|
1,260,000
|
|
|
1,260,000
|
Net loss |
|
|
|
(4,531,000)
|
(4,531,000)
|
Balance at May. 31, 2022 |
$ 1,029,000
|
42,447,000
|
(74,000)
|
(35,077,000)
|
8,325,000
|
Balance, shares at May. 31, 2022 |
12,867,924
|
|
|
|
|
Exercise of stock options |
$ 4,000
|
77,000
|
|
|
$ 81,000
|
Exercise of stock options, shares |
46,500
|
|
|
|
46,500
|
Net proceeds from ATM |
$ 46,000
|
1,915,000
|
|
|
$ 1,961,000
|
Net proceeds from ATM, shares |
573,889
|
|
|
|
|
Foreign currency translation |
|
|
(36,000)
|
|
(36,000)
|
Share-based compensation |
|
1,185,000
|
|
|
1,185,000
|
Net loss |
|
|
|
(7,140,000)
|
(7,140,000)
|
Shares issued in connection with public offering, net of offering costs |
$ 267,000
|
7,081,000
|
|
|
7,348,000
|
Shares issued in connection with public offering, net of offering costs, shares |
3,333,333
|
|
|
|
|
Balance at May. 31, 2023 |
$ 1,346,000
|
$ 52,705,000
|
$ (110,000)
|
$ (42,217,000)
|
$ 11,724,000
|
Balance, shares at May. 31, 2023 |
16,821,646
|
|
|
|
|
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v3.23.2
Consolidated Statements of Cash Flows - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (7,140,000)
|
$ (4,531,000)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
84,000
|
339,000
|
Loss on disposal of property and equipment |
|
53,000
|
Provision for allowance on accounts receivable |
342,000
|
(684,000)
|
Inventory reserve |
(174,000)
|
(772,000)
|
Share-based compensation |
1,185,000
|
1,260,000
|
Amortization of right-of-use asset |
267,000
|
256,000
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
(291,000)
|
1,365,000
|
Inventories |
534,000
|
1,562,000
|
Prepaid expenses and other |
20,000
|
50,000
|
Other assets |
18,000
|
169,000
|
Accounts payable and accrued expenses |
(80,000)
|
389,000
|
Accrued compensation |
49,000
|
258,000
|
Advance from customers |
9,000
|
51,000
|
Reduction in lease liabilities |
(297,000)
|
(244,000)
|
Net cash used in operating activities |
(5,474,000)
|
(479,000)
|
Cash flows from investing activities: |
|
|
Expenditure related to intangibles |
(14,000)
|
(113,000)
|
Purchases of property and equipment |
(64,000)
|
(57,000)
|
Net cash used in investing activities |
(78,000)
|
(170,000)
|
Cash flows from financing activities: |
|
|
Gross proceeds from sale of common stock |
10,014,000
|
2,402,000
|
Costs from sale of common stock |
(705,000)
|
(85,000)
|
Proceeds from exercise of stock options |
81,000
|
77,000
|
Net cash provided by financing activities |
9,390,000
|
2,394,000
|
Effect of exchange rate changes in cash |
(36,000)
|
(26,000)
|
Net increase in cash and cash equivalents |
3,802,000
|
1,719,000
|
Cash and cash equivalents at beginning of year |
5,917,000
|
4,199,000
|
Cash and cash equivalents at end of year |
9,719,000
|
5,917,000
|
Cash paid during the year for: |
|
|
Income taxes |
51,000
|
24,000
|
Non-cash investing and financing activities: |
|
|
Increase in right-of-use asset due to lease extension or establishment |
|
4,000
|
Increase in lease liability due to lease extension or establishment |
|
4,000
|
Write off of fixed assets, cost |
40,000
|
820,000
|
Write off of fixed assets, accumulated depreciation |
40,000
|
767,000
|
Write off of intangible assets, cost |
6,000
|
247,000
|
Write off of intangible assets, accumulated amortization |
$ 6,000
|
$ 37,000
|
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v3.23.2
ORGANIZATION
|
12 Months Ended |
May 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
ORGANIZATION |
NOTE
1: ORGANIZATION
Biomerica,
Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH) is a biomedical technology
company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (physicians’
offices and over-the-counter through drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical
conditions and diseases. Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis
of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens,
or other substances, which may exist in the human body in extremely small concentrations. The Company’s products are designed to
enhance the health and well-being of people, while reducing total healthcare costs.
Our
primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided
therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other
inflammatory diseases. These products are directed at chronic inflammatory illnesses that are widespread and common, and as such address
very large markets. Our InFoods® IBS product uses a simple blood sample and is designed to identify patient-specific foods that,
when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, and constipation. Instead of broad and difficult
to manage dietary restrictions, the InFoods® IBS product works by identifying specific foods that may be causing an abnormally high
immune response in the patient. A food identified as positive, which is causing the abnormal immune response in the patient,
is simply removed from the diet to help alleviate IBS symptoms.
Our existing medical diagnostic products are sold worldwide primarily in
two markets: 1) clinical laboratories and 2) point-of-care (physicians’ offices and over-the-counter drugstores like Walmart and
CVS Pharmacy). The diagnostic test kits are used to analyze blood, urine, nasal, or fecal specimens from patients in the diagnosis of
various diseases, food intolerances, and other medical complications, by measuring or detecting the existence and/or level of specific
bacteria, hormones, antibodies, antigens, or other substances, which may exist in a patient’s body, stools, or blood, often in extremely
small concentrations.
Due
to the global COVID-19 pandemic, in March 2020, we began developing COVID-19 products to indicate if a person has been infected by COVID-19
or is currently infected. In fiscal 2022, we generated revenues from the international sale of our COVID-19 antigen tests. However, in
fiscal 2023, due to the decline in severity of COVID-19 and the corresponding lower sales volumes, we no longer sell these products.
Due to the relatively high volume of sales from these products in fiscal 2021 and fiscal 2022, we have seen significant fluctuations
in quarterly revenues over the past twelve quarters.
The
other existing products that contributed to our 2023 revenues are primarily focused on gastrointestinal diseases, food intolerances,
and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our products are CE marked and/or
sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for
sale in the United States by the FDA.
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
12 Months Ended |
May 31, 2023 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES
OF CONSOLIDATION
The
consolidated financial statements for the years ended May 31, 2023 and 2022, include the accounts of Biomerica, Inc. (“Biomerica”)
as well as its wholly-owned German subsidiary (“BioEurope GmbH”) and Mexican subsidiary (“Biomerica de Mexico”).
All significant intercompany accounts and transactions have been eliminated in consolidation.
ACCOUNTING
ESTIMATES
The
preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United
States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and
the reported amounts of revenues and expenses during the reported period. Estimates that are made include the allowance for doubtful
accounts, which is estimated based on current as well as historical past practices with a customer; stock option forfeiture rates,
which are calculated based on historical data; inventory obsolescence, which is based on projected and historical usage of
materials; and lease liabilities and right-of-use assets, which are calculated based on certain assumptions such as the borrowing
rate on the lease commencement date and, the likelihood of lease extensions to occur, asset valuations, among other things; and other items that may be necessary to
estimate using current, historical and judgment based information. Actual results could materially differ from those
estimates.
Due
to the global COVID-19 pandemic, the Company’s operations have been negatively impacted. The Company has faced disruptions in the
following areas, (and may face further challenges): supply chain disruptions, loss of contracts and/or customers, closure of the Company’s
manufacturing or distribution facilities or of the facilities of the Company’s suppliers, partners and customers, travel, shipping
and logistical disruptions, government responses of all types, international business risks in countries where the Company makes and/or
sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of production, customer
credit risk, and general economic calamities. These pandemic related disruptions can materially negatively impact the Company’s
operations and financial performance and may continue to have significant material negative impacts on the Company.
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $42 million as
of May 31, 2023. Management expects to continue to incur significant costs as it advances its trials and development activities. As of
May 31, 2023, the Company had cash and cash equivalents of approximately $9,719,000 and working capital of approximately $10,852,000.
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any shares under the ATM Offering, and may at any time suspend offers
under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $3.15 to $4.26 pursuant to the
ATM Agreement, which resulted in gross proceeds of approximately $2,014,000 and net proceeds to the Company of $1,961,000, after deducting
commissions for each sale and legal, accounting, and other fees related to offering in the amount of $53,000.
During
the year ended May 31, 2022, the Company sold 521,267 shares of its common stock at prices ranging from $4.02 to $5.63 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,402,000 and net proceeds to the Company of $2,317,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $85,000.
On
March 7, 2023, the Company sold 3,333,333 shares of common stock in a firm commitment public offering at a gross sales price of $2.40
per share, with net total proceeds, after deducting issuance fees and expenses of $700,000, of approximately $7,300,000. Since the closing
of the March 7, 2023 offering, the ATM has been withdrawn and is not active.
The
Company intends to use the net proceeds from such offerings for general corporate purposes, including, without limitation, sales and
marketing activities, clinical studies, product development, making acquisitions of assets, businesses, companies or securities,
capital expenditures, and for working capital needs.
Management
has analyzed the cash requirements of the Company’s business through at least August 2024. As a result of cash and cash
equivalents on hand on May 31, 2023, largely from the public offering, and the ability to raise additional funds through another new
ATM agreement, management believes the Company has sufficient funds to operate through at least August 2024.
FAIR
VALUE OF FINANCIAL INSTRUMENTS
The
Company has financial instruments whereby the fair market value of the financial instruments could be different than that recorded on
a historical basis. The Company’s consolidated financial instruments consist of its cash and cash equivalents, accounts receivable,
and accounts payable. The carrying amounts of the Company’s financial instruments approximate their fair values. The Company also
maintains an investment in privately held company (see below).
CONCENTRATION
OF CREDIT RISK
The
Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. From time to time,
the Company has uninsured balances. The Company does not believe it is exposed to any significant credit risks.
The
Company provides credit in the normal course of business to customers throughout the United States and in foreign markets. The Company
performs ongoing credit evaluations of its customers and requires accelerated prepayment in some circumstances.
Our
net sales were approximately $5,339,000
for fiscal 2023 compared to $18,871,000
for fiscal 2022. For the fiscal years ended May 31, 2023 and 2022, the Company had one and two distributors, respectively, which
accounted for a total of 35%
and 65%
of our net sales, respectively. Of this, for the fiscal years ended May 31, 2023 and 2022, the largest of the distributors mentioned
above accounted for 35%
and 55%,
respectively, of net sales.
Total
gross receivables on May 31, 2023 and 2022 were approximately $751,000 and $927,000, respectively. On May 31, 2023 and 2022, the Company
had one distributor which accounted for a total of 36% and 50%, respectively, of gross accounts receivable. Of the 36% as of May 31,
2023, 100% was owed by a distributor in Asia.
For
the fiscal year ended May 31, 2023, the Company did not have any significant concentration of vendor spend for raw materials. For the
fiscal year ended May 31, 2022, the Company had one vendor, which accounted for 84% of our purchases of raw materials largely related
to COVID-19 products.
GEOGRAPHIC
CONCENTRATION
As
of May 31, 2023 and 2022, approximately $626,000 and $621,000, respectively, of Biomerica’s gross inventory was located in Mexicali,
Mexico, respectively. As of May 31, 2023 and 2022, approximately $17,000 of Biomerica’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico.
CASH
AND CASH EQUIVALENTS
Cash
and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.
ACCOUNTS
RECEIVABLE, NET
The
Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until
they establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria.
Initial credit levels for individual distributors are approved by designated officers and managers of the Company. All increases in
credit limits are also approved by designated upper-level management. Management evaluates receivables on a quarterly basis and
adjusts the allowance for doubtful accounts accordingly. Balances over ninety days
old are usually reserved for unless collection is reasonably assured.
Occasionally
certain long-standing customers, who routinely place large orders, will have unusually large receivables balances relative to the total
gross receivables. Management monitors the payments for these large balances closely and very often requires payment of existing invoices
before shipping new sales orders.
As
of May 31, 2023 and 2022, the Company has established a reserve of approximately $29,000 and $153,000, respectively, for doubtful accounts.
PREPAID
EXPENSES AND OTHER
The
Company occasionally prepays for items such as inventory, insurance, and other items. These items are reported as prepaids, until either
the inventory is physically received or the insurance and other items are utilized.
As
of May 31, 2023 and 2022, the prepaids were approximately $300,000 and $320,000, respectively, composed of prepayments to insurance and
various other suppliers.
INVENTORIES,
NET
The
Company values inventory at the lower of cost (determined using a combination of specific lot identification and the first-in, first-out
methods) or net realizable value. Management periodically reviews inventory for excess quantities and obsolescence. Management evaluates
quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated customer
demand for current products and new product introductions. The reserve is adjusted based on such evaluation, with a corresponding provision
included in cost of sales. Abnormal amounts of idle facility expenses, freight, handling costs, and wasted material are recognized as
current period charges and the allocation of fixed production overhead is based on the normal capacity of the production facilities.
The
following is a summary of approximate net inventories:
SCHEDULE
OF NET INVENTORIES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 1,677,000 | | |
$ | 1,717,000 | |
Work in progress | |
| 869,000 | | |
| 763,000 | |
Finished products | |
| 182,000 | | |
| 782,000 | |
Total gross inventory | |
$ | 2,728,000 | | |
$ | 3,262,000 | |
Inventory reserve | |
| (672,000 | ) | |
| (846,000 | ) |
Net
inventory | |
$ | 2,056,000 | | |
$ | 2,416,000 | |
Reserves
for inventory obsolescence are recorded as necessary to reduce obsolete inventory to estimated net realizable value or to specifically
reserve for obsolete inventory. As of May 31, 2023 and 2022, inventory reserves were approximately $672,000 and $846,000, respectively.
The Company has fully reserved COVID-19 antibody inventory in fiscal 2023.
PROPERTY
AND EQUIPMENT, NET
Property
and equipment are stated at cost. Expenditures for additions and major improvements are capitalized. Repairs and maintenance costs are
charged to operations as incurred. When property and equipment are sold, retired, or otherwise disposed of, the related cost and accumulated
depreciation or amortization are removed from the accounts, and gains or losses from sales, retirements, and dispositions are credited
or charged to income.
Depreciation
and amortization are provided over the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line
method. Leasehold improvements are amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation
and amortization expense on property and equipment amounted to approximately $66,000 and $100,000 for the years ended May 31, 2023 and
2022, respectively.
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights, and patents, and are accounted for based on Accounting Standards Codification
(“ASC”), ASC 350 Intangibles – Goodwill and Other (“ASC 350”). In that regard, intangible assets that have
indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in
circumstances indicate that the asset might be impaired.
Intangible
assets are being amortized using the straight-line method over the useful life, not to exceed 18 years for marketing and distribution
rights, 10 years for purchased technology use rights, and 20 years for patents. Amortization amounted to approximately $18,000 and $239,000
for the years ended May 31, 2023 and 2022, respectively.
The
Company assesses the recoverability of these intangible assets by determining whether the amortization of the asset’s balance over
its remaining life can be recovered through projected undiscounted future cash flows. The Company uses a qualitative assessment to determine
whether there was any impairment. During the year ended May 31, 2023, there was no impairment of intangible assets. During the year ended May 31, 2022, an impairment
adjustment was made of $210,000.
INVESTMENTS
The
Company has made investments in a privately held Polish
distributor, which is primarily engaged in distributing medical products and devices, including the distribution of the products
sold by the Company. The Company invested approximately $165,000
into the Polish distributor and owns approximately 6%
of the investee.
Equity
holdings in nonmarketable unconsolidated entities in which the Company is not able to exercise significant influence (“Cost Method
Holdings”) are accounted for at the Company’s initial cost, minus any impairment (if any), plus or minus changes resulting
from observable price changes in orderly transactions for the identical or a similar holding or security of the same issuer. Dividends
received are recorded as other income.
The
Company assesses its equity holdings for impairment whenever events or changes in circumstances indicate that the carrying value of an
equity holding may not be recoverable. Management reviewed the underlying net assets of the Company’s equity method holding as
of May 31, 2023 and determined that the Company’s proportionate economic interest in the entity indicates that the equity holding
was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the
Company’s Cost Method Holding during the year ended May 31, 2023.
SHARE-BASED
COMPENSATION
The
Company follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value based
method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments
(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that uses
assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The
Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based
on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.
The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the
“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as
historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized under
the straight-line attribution method.
The
Company expensed approximately $1,185,000 and $1,260,000 of share-based compensation during the years ended May 31, 2023 and 2022, respectively.
In
applying the Black-Scholes option-pricing model, the following assumptions used in the valuation of awards issued for period ending May 31, 2023 and 2022:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
| |
For
the year ended May 31, | |
| |
2023 | | |
2022 | |
Dividend yield | |
| 0% | | |
| 0% | |
Expected volatility | |
| 98.81
- 101.77% | | |
| 102.54
- 105.48% | |
Risk free interest rate | |
| 3.12
- 3.35% | | |
| 0.97
- 2.75% | |
Expected term | |
| 6.25
years | | |
| 5.50
- 6.25 years | |
REVENUE
RECOGNITION
The
Company has various contracts with customers. All of the contracts specify that revenues from product sales are recognized at the time
the product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred and at which point
title passes.
The
Company does not typically allow for returns from customers except in the event of defective merchandise and therefore does not establish
an allowance for returns. In addition, the Company has contracts with customers wherein customers receive purchase discounts for achieving
specified sales volumes. The Company evaluated the status of these contracts during the years ended May 31, 2023 and 2022 and does not
believe that any additional discounts will be given through the end of the contract periods.
Services
for contract work performed by the Company for others are invoiced and recognized as that work has been performed and as the project
progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories,
medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce
customers as well as to distributors. Physicians’ office products are sold to physicians and distributors, all of whom are categorized
below according to the type of products sold to them. We also manufacture certain components on a contract basis for domestic and international
manufacturers.
As
of May 31, 2023, the Company had approximately $60,000 of advances from certain foreign customers. These advances are prepayments on
orders that are expected to ship during our second fiscal quarter ending November 30, 2023.
Disaggregation
of revenue:
The
following is an approximate breakdown of revenues according to primary markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Clinical lab | |
$ | 3,310,000 | | |
$ | 3,064,000 | |
Over-the-counter | |
| 1,169,000 | | |
| 1,089,000 | |
Contract manufacturing | |
| 610,000 | | |
| 459,000 | |
Physician’s office | |
| 250,000 | | |
| 14,259,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
See
Note 8 for additional information regarding geographic revenue concentrations.
SHIPPING
AND HANDLING FEES
The
Company includes shipping and handling fees billed to customers in net sales.
RESEARCH
AND DEVELOPMENT
Research
and development costs are expensed as incurred. The Company expensed approximately $1,584,000 and $1,812,000 of research and development
costs during the years ended May 31, 2023 and 2022, respectively.
INCOME
TAXES
The
Company accounts for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and
liabilities arise from temporary differences between the tax bases of assets and liabilities and their reported amounts in the
consolidated financial statements that will result in taxable or deductible amounts in future years and the benefits of net
operating loss and tax credit carryforwards. These temporary differences and the benefits of net operating loss and tax credit
carryforwards are measured using enacted tax rates. A valuation allowance is recorded to reduce deferred tax assets to the extent
that management considers it is more likely than not that a deferred tax asset will not be realized. In determining the valuation
allowance, the Company considers factors such as the reversal of deferred income tax assets, projected taxable income, and the
character of income tax assets and tax planning strategies. A change to these factors could impact the estimated valuation allowance
and income tax expense. As of May 31, 2023 and 2022, in accordance with ASC 740, the Company has a valuation allowance for
substantially all of its net deferred tax assets. During the year ended May 31, 2023, this valuation allowance was increased to
$8,940,000,
which fully covers the net deferred tax asset of $8,940,000.
The
Company accounts for its uncertain tax provisions by using a two-step approach to recognizing and measuring uncertain tax positions.
The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more
likely than not, based solely on the technical merits, that the position will be sustained in an audit, including resolution of related
appeals or litigation processes, if any. The second step is to measure the appropriate amount of the benefit to recognize. The amount
of benefit to recognize is measured as the maximum amount which is more likely than not to be realized. The tax position is derecognized
when it is no longer more likely than not capable of being sustained. On subsequent recognition and measurement, the maximum amount which
is more likely than not to be recognized at each reporting date will represent the Company’s best estimate, given the information
available at the reporting date, although the outcome of the tax position is not absolute or final. The Company elected to follow an
accounting policy to classify accrued interest related to liabilities for income taxes within the “Interest expense” line
and penalties related to liabilities for income taxes within the “Other expense” line of the consolidated statements of operations
and comprehensive loss.
ADVERTISING
COSTS
The
Company reports the cost of all advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$156,000 and $76,000 for the years ended May 31, 2023 and 2022, respectively.
FOREIGN
CURRENCY TRANSLATION
The
subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the
U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries
are translated using exchange rates in effect at the end of the year, and revenues and costs are translated using average exchange rates
for the year. The resulting adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive
loss. There are no foreign currency transactions that are included in the consolidated statements of operations for the years ended May
31, 2023 and 2022.
RIGHT-OF-USE
ASSETS AND LEASE LIABILITIES
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued an accounting standard update which requires lessees
to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from
the lease. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value
of fixed lease payments over the lease term. Leases are classified as financing or operating which will drive the expense recognition
pattern. The Company has elected to exclude short-term leases. The Company leases office space and copy machines, all of which are operating
leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options
to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The
leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited
by the expected lease term. For additional information, see Note 9-Commitments and Contingencies.
NET
LOSS PER SHARE
Basic
loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss
per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible
securities using the treasury stock method. The total amounts of anti-dilutive stock options not included in the loss per share calculation
for the years ended May 31, 2023 and 2022 were 2,342,616 and 2,321,616, respectively.
SEGMENT
REPORTING
ASC
280, Segment Reporting (“ASC 280”), establishes standards for reporting, by public business enterprises, information about
operating segments, products and services, geographic areas, and major customers. The Company’s operations are analyzed by management
and its chief operating decision maker as being part of a single industry segment: the design, development, marketing, and sales of diagnostic
kits.
REPORTING
COMPREHENSIVE LOSS
Comprehensive
loss represents net loss and any revenues, expenses, gains and losses that, under GAAP, are excluded from net loss and recognized directly
as a component of shareholders’ equity. Items of other comprehensive loss consist solely of foreign currency translation adjustments
for the years ended May 31, 2023 and 2022.
RECENT
ACCOUNTING PRONOUNCEMENTS
Except as follows, recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by management to, have a material effect on
the Company’s present or future consolidated financial statements.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.
This ASU will require the measurement of all expected credit losses for financial assets, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The guidance was initially effective
for the Company for annual reporting periods beginning after December 15, 2019, and interim periods within those fiscal years. In November
2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases
(Topic 842): Effective Dates, which, among other things, defers the effective date of ASU 2016-13 for public filers that are considered
smaller reporting companies as defined by the Securities and Exchange Commission to fiscal years beginning after December 15, 2022, including
interim periods within those years. Early adoption is permitted. The Company is currently reviewing the requirements of this ASU to determine
its impact on the Company’s consolidated results of operations and financial position.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.2
PROPERTY AND EQUIPMENT, NET
|
12 Months Ended |
May 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY AND EQUIPMENT, NET |
NOTE
3: PROPERTY AND EQUIPMENT, NET
The
following is an approximate breakdown of property and equipment, net of accumulated depreciation:
SCHEDULE
OF PROPERTY AND EQUIPMENT, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Equipment | |
$ | 1,333,000 | | |
$ | 1,292,000 | |
Furniture, fixtures and leasehold improvements | |
| 211,000 | | |
| 227,000 | |
Less accumulated depreciation | |
| (1,331,000 | ) | |
| (1,305,000 | ) |
Net
property and equipment | |
$ | 213,000 | | |
$ | 214,000 | |
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.2
INTANGIBLE ASSETS, NET
|
12 Months Ended |
May 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS, NET |
NOTE
4: INTANGIBLE ASSETS, NET
The
following is an approximate breakdown of intangible assets, net of accumulated amortization:
SCHEDULE
OF INTANGIBLE ASSETS, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Patents | |
| 196,000 | | |
| 189,000 | |
Less accumulated amortization-patents | |
| (31,000 | ) | |
| (19,000 | ) |
Intangible
assets, net | |
$ | 165,000 | | |
$ | 170,000 | |
Expected
amortization of intangible assets for the years ending May 31:
SCHEDULE
OF EXPECTED AMORTIZATION OF INTANGIBLE ASSETS
| |
| | |
2024 | |
$ | 13,000 | |
2025 | |
| 13,000 | |
2026 | |
| 13,000 | |
2027 | |
| 13,000 | |
2028 | |
| 13,000 | |
Thereafter | |
| 100,000 | |
Total | |
$ | 165,000 | |
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v3.23.2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
|
12 Months Ended |
May 31, 2023 |
Payables and Accruals [Abstract] |
|
ACCOUNTS PAYABLE AND ACCRUED EXPENSES |
NOTE
5: ACCOUNTS PAYABLE AND ACCRUED EXPENSES
The
following is an approximate breakdown of accounts payable and accrued expenses balances:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Accounts
payable | |
$ | 344,000 | | |
$ | 736,000 | |
Accrued
expenses | |
| 548,000 | | |
| 236,000 | |
Total | |
$ | 892,000 | | |
$ | 972,000 | |
As
of May 31, 2023, the Company had one vendor which accounted for 23% of accounts payable. As of May 31, 2022, the Company had two vendors
which accounted for 69% of accounts payable.
|
X |
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v3.23.2
SHAREHOLDERS’ EQUITY
|
12 Months Ended |
May 31, 2023 |
Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE
6: SHAREHOLDERS’ EQUITY
STOCK
OPTION AND RESTRICTED STOCK PLANS
In
December 2014, the Company adopted and shareholders approved a stock option and restricted stock plan (the “2014 Plan”).
Subsequently, in December 2017, the Company adopted and shareholders approved an stock option and restricted stock plan (the “2017
Plan”). In February 2020, the Board approved the 2020 Stock Incentive Plan (the “2020 Plan”, and collectively with
the 2014 Plan and 2017 Plan, the “Equity Incentive Plans”) and on December 11, 2020, the shareholders of the Company approved
the 2020 Plan. The Equity Incentive Plans provide that non-qualified options and incentive stock options and restricted stock may be
granted to directors, affiliates, employees, or consultants of the Company. The Equity Incentive Plans authorize awards representing
up to 850,000, 900,000 and 900,000 shares of the Company’s common stock to be issued under the 2014 Plan, 2017 Plan, and 2020 Plan,
respectively. Awards granted under the Equity Incentive Plans typically vest over 4 years. Options granted under the Equity Incentive
Plans will be granted at prices not less than 80% of the then fair market value of the common stock and will expire not more than 10
years after the date of grant. The 2014 Plan expires in December 2024, the 2017 Plan expires in December 2027, and the 2020 Plan expires
in December 2030.
Stock-based
compensation expense for the years ended May 31, 2023 and 2022 is as follows:
SCHEDULE
OF STOCK BASED COMPENSATION EXPENSE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Cost of sales | |
$ | 143,000 | | |
$ | 159,000 | |
Selling, general and administrative | |
| 971,000 | | |
| 1,021,000 | |
Research and development | |
| 71,000 | | |
| 80,000 | |
Total
stock option expense | |
$ | 1,185,000 | | |
$ | 1,260,000 | |
Activity
as to aggregate stock options outstanding is as follows:
SCHEDULE
OF ACTIVITY TO AGGREGATE STOCK OPTIONS
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Options Outstanding at May 31, 2021 | |
| 2,081,366 | | |
$ | 3.59 | | |
$ | 2,132,000 | |
Options granted | |
| 344,000 | | |
$ | 4.43 | | |
| | |
Options exercised | |
| (39,500 | ) | |
$ | 1.99 | | |
$ | 90,000 | |
Options canceled or expired | |
| (64,250 | ) | |
$ | 4.41 | | |
| | |
Options Outstanding at May 31, 2022 | |
| 2,321,616 | | |
$ | 3.72 | | |
$ | 1,838,000 | |
Options granted | |
| 243,000 | | |
$ | 2.70 | | |
| | |
Options exercised | |
| (46,500 | ) | |
$ | 1.73 | | |
$ | 90,000 | |
Options canceled or expired | |
| (175,500 | ) | |
$ | 5.56 | | |
| | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | | |
$ | 146,000 | |
Options vested and exercisable at May 31, 2023 | |
| 1,841,933 | | |
$ | 3.38 | | |
$ | 146,000 | |
The
weighted average grant date fair value of options granted during 2023 and 2022 were $2.19 and $4.43, respectively.
On
May 31, 2023, total compensation cost related to non-vested stock option awards not yet recognized totaled approximately $1,145,000.
The weighted-average period over which this amount is expected to be recognized is 2.52 years. The weighted average remaining contractual
term of options that were exercisable on May 31, 2023 was 4.97 years. The weighted average remaining contractual term of options that
were vested, exercisable, or expected to vest on May 31, 2023 was 5.67 years.
COMMON
STOCK ACTIVITY
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
On
May 21, 2021, in conjunction with the Company’s 2020 Stock Incentive Plan, that was approved by shareholders at the Company’s
annual meeting in December 2020, the Company filed an S-8 Registration Statement to register up to 900,000 shares of the Company’s
common stock that could be issued under this Plan.
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all of the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any of the shares under the ATM Offering, and may at any time suspend
offers under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $3.15 to $4.26 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,014,000 and net proceeds to the Company of $1,961,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $53,000.
During
the year ended May 31, 2022, the Company sold 521,267 shares of its common stock at prices ranging from $4.02 to $5.63 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,402,000 and net proceeds to the Company of $2,317,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $85,000.
On
March 7, 2023, the Company closed on an underwritten sale of 3,333,333 shares of our registered common stock through an investment banking
firm, which shares were issued under our shelf registration. In this offering, the Company sold the registered shares at a gross sales
price of $2.40 per share, with net proceeds, after deducting issuance fees and expenses of $700,000, of approximately $7,300,000.
PREFERRED
STOCK ACTIVITY
On
February 24, 2020, the Company entered into and closed on a Stock Purchase Agreement (the “Stock Purchase Agreement”) with
Palm Global Small Cap Master Fund LP (“Palm”) pursuant to which the Company agreed to sell and issue to Palm, and Palm agreed
to purchase from the Company, 571,429 shares of the Company’s Series A 5% Convertible Preferred Stock, $0.08 par value per share
for a purchase price of approximately $2 million, or $3.50 per Series A Convertible Preferred Stock. Under the terms of the Stock Purchase
Agreement, each share of issued Convertible Preferred Stock can be converted at any time by Palm into one share of the Company’s
common stock, subject to certain adjustments.
The
Series A 5% Convertible Preferred Stock accrued annual preferred dividends at a rate of $0.175 per Series A 5% Convertible Preferred
Share. However, accruing dividends were payable only when, as, and if declared by the Board and the Company had no obligation to pay
such accruing dividends.
On
March 24, 2020, Palm converted 250,000 shares of Convertible Preferred Stock into 250,000 shares of unregistered common stock. On July
21, 2020, the Company filed with the SEC a registration statement on Form S-3, that among other things, registered 571,429 common shares
issued, or to be issued, to Palm upon conversion of the Convertible Preferred Stock into common shares. On September 30, 2020, the Company
received a Notice of Effectiveness from the Securities and Exchange Commission for registration of these shares. On January 21, 2021,
Palm Converted their remaining 321,429 Convertible Preferred Shares into registered common shares. On May 30, 2021, the Company had no
shares of Preferred Stock outstanding. Under the terms of the Preferred Stock Purchase Agreement, none of the cumulative dividends were
paid to Palm during the period they owned the Preferred Stock. Once converted to common shares, Palm lost all rights to receive any past
cumulative dividends.
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v3.23.2
INCOME TAXES
|
12 Months Ended |
May 31, 2023 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
NOTE
7: INCOME TAXES
Provision
for income taxes for the years ended May 31 consists of the following:
SCHEDULE
OF PROVISION FOR INCOME TAXES
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Current: | |
| | | |
| | |
U.S. Federal | |
$ | - | | |
$ | - | |
Foreign Taxes
Subsidiaries | |
| (50,000 | ) | |
| (23,000 | ) |
State
and local | |
| (1,000 | ) | |
| (1,000 | ) |
Total
current | |
| (51,000 | ) | |
| (24,000 | ) |
Deferred: | |
| | | |
| | |
U.S. Federal | |
| - | | |
| - | |
State and local | |
| - | | |
| - | |
Total
deferred | |
| - | | |
| - | |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
Provision
for income taxes differs from the amounts computed by applying the U.S. Federal income tax rate applicable for each year (21% for 2023
and 2022) to pretax income as a result of the following:
SCHEDULE
OF EFFECTIVE INCOME TAX RECONCILIATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Computed “expected”
tax benefit | |
$ | 1,490,000 | | |
| 947,000 | |
Increase (reduction) in income taxes resulting
from: | |
| | | |
| | |
Change in valuation allowance | |
| (1,973,000 | ) | |
| (1,022,000 | ) |
State income taxes, net of federal benefit | |
| 583,000 | | |
| 300,000 | |
Research and development tax credits | |
| - | | |
| 50,000 | |
Permanent tax differences and other | |
| (17,000 | ) | |
| (197,000 | ) |
Stock based compensation benefit | |
| (5,000 | ) | |
| 11,000 | |
Foreign taxes of subsidiaries | |
| (129,000 | ) | |
| (113,000 | ) |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
The
tax effect of significant temporary differences is presented below:
SCHEDULE
OF DEFERRED TAX ASSETS
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Deferred tax assets: | |
| | | |
| | |
Accounts receivable,
principally due to allowance for doubtful accounts | |
$ | 8,000 | | |
$ | 43,000 | |
Inventory valuation | |
| 188,000 | | |
| 237,000 | |
Compensated absences | |
| 118,000 | | |
| 120,000 | |
Net operating loss carryforwards | |
| 5,817,000 | | |
| 4,349,000 | |
Tax credit carryforwards | |
| 1,239,000 | | |
| 1,096,000 | |
Deferred rent expense/Capitalized leases | |
| 11,000 | | |
| 20,000 | |
Stock Options | |
| 1,296,000 | | |
| 1,035,000 | |
Sec 174 capitalized costs | |
| 284,000 | | |
| - | |
Losses of foreign subsidiaries & other,
net | |
| - | | |
| 41,000 | |
Accumulated
depreciation and amortization | |
| (21,000 | ) | |
| 26,000 | |
Total deferred tax assets | |
| 8,940,000 | | |
| 6,967,000 | |
Less valuation allowance | |
| (8,940,000 | ) | |
| (6,967,000 | ) |
Net
deferred tax asset | |
$ | - | | |
$ | - | |
The
Company has provided a valuation allowance of approximately $8,940,000 and $6,967,000 as of May 31, 2023 and 2022, respectively. The
net change in the valuation allowance for the years ended May 31, 2023 and 2022 was an increase of $1,973,000 and $1,063,000, respectively.
On
May 31, 2023, the Company has Federal income tax net operating loss carryforwards of approximately $21,958,000. On May 31, 2023, the
Company has California state income tax net operating loss carryforwards of approximately $17,269,000. For tax reporting purposes, operating
loss carryforwards are available to offset future taxable income; such carryforwards expire in varying amounts beginning in 2024 and
2038 for federal and state purposes, respectively. Federal net operating losses beginning in 2018 have no expiration date.
On
May 31, 2023, the Company has Federal research and development tax credit carryforward of approximately $817,000. The Federal credits
begin to expire in 2028. The Company also had similar credit carryforwards for state purposes of $533,000 on May 31, 2023, which do not
expire.
Pursuant
to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss (“NOL”)
and credit carryforwards may be limited by statute because of a cumulative change in ownership of more than 50%. Pursuant to Sections
382 and 383 of the IRC, the annual use of the Company’s NOLs and credit carryforwards would be limited if there is a cumulative
change of ownership (as that term is defined in Section 382(g) of the IRC of greater than 50% in a three-year period). Management has
not performed an analysis to determine if the Company has had a cumulative change in ownership of greater than 50%.
For
the year ended May 31, 2023, the Company performed an analysis and has not identified any uncertain tax positions as
defined under ASC 740. Should such position be identified in the future, and should the Company owe interest and penalties as a result
of this, these would be recognized as interest expense and other expense, respectively, in the consolidated financial statements. The
Company is no longer subject to any significant U.S. federal tax examinations by tax authorities for years before fiscal 2018.
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v3.23.2
GEOGRAPHIC INFORMATION
|
12 Months Ended |
May 31, 2023 |
Segment Reporting [Abstract] |
|
GEOGRAPHIC INFORMATION |
NOTE
8: GEOGRAPHIC INFORMATION
The
Company operates as one segment. Geographic information regarding net sales is approximately as follows:
SCHEDULE
OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | |
Asia | |
$ | 2,021,000 | | |
$ | 13,375,000 | |
Europe | |
| 1,798,000 | | |
| 4,339,000 | |
North America | |
| 1,470,000 | | |
| 997,000 | |
Middle East | |
| 39,000 | | |
| 70,000 | |
South America | |
| 11,000 | | |
| 90,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
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v3.23.2
COMMITMENTS AND CONTINGENCIES
|
12 Months Ended |
May 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
9: COMMITMENTS AND CONTINGENCIES
OPERATING
LEASES
The
Company leases facilities in Irvine, California and Mexicali, Mexico.
As
of May 31, 2023, the Company had approximately 22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue
in Irvine, California. The lease for its headquarters expires in August 2026. The Company has the option to extend the lease for an additional
five-year term. The Company made a security deposit of approximately $22,000.
In
November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10-year lease for approximately 8,100 square
feet of manufacturing space. The Company has one 10-year option to renew at the end of the initial lease period. Biomerica de Mexico
also leases a smaller unit on a month-to-month basis for use in the Company’s manufacturing process.
In
addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, as headquarters for BioEurope GmbH, its Germany
subsidiary.
For
purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of
the facility, including any periods of free rent and any renewal options periods that the Company is reasonably certain of exercising.
The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases are included
in the measurement of the right-of-use asset and related lease liabilities. Additionally, under these lease arrangements, the Company
may be required to pay directly, or reimburse the lessors, for some maintenance and operating costs. Such amounts are generally variable
and therefore not included in the measurement of the right-of-use asset and related lease liabilities but are instead recognized as variable
lease expense in the consolidated statements of operations and comprehensive loss when they are incurred.
The
following table presents information on our operating leases for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OPERATING LEASES
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Operating lease cost | |
$ | 353,000 | | |
$ | 352,000 | |
Short-term lease cost | |
| 5,000 | | |
| 5,000 | |
Total lease cost | |
$ | 358,000 | | |
$ | 357,000 | |
The
future minimum lease payments of the Company’s operating lease liabilities by fiscal year are as follows:
SCHEDULE
OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending May 31: | |
| |
| |
Operating
Leases | |
2024 | |
$ | 356,000 | |
2025 | |
| 366,000 | |
2026 | |
| 376,000 | |
2027 | |
| 101,000 | |
Thereafter | |
| - | |
Total minimum future lease payments | |
$ | 1,199,000 | |
Less: imputed interest | |
| 117,000 | |
Total operating lease
liabilities | |
$ | 1,082,000 | |
The
following table summarizes the Company’s other supplemental lease information for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Cash paid for operating lease liabilities | |
$ | 347,000 | | |
$ | 338,000 | |
Weighted-average remaining lease term (years) | |
| 3.27 | | |
| 4.28 | |
Weighted-average discount rate | |
| 6.50% | | |
| 6.50% | |
The
Company also has various insignificant leases for office equipment.
RETIREMENT
SAVINGS PLAN
Effective
September 1, 1986, the Company established a 401(k) plan for the benefit of its employees. The plan permits eligible employees to contribute
to the plan up to the maximum percentage of total annual compensation allowable under the limits of IRC Sections 415, 401(k) and 404.
The Company, at the discretion of its Board of Directors, may make contributions to the plan in amounts determined by the Board each
year. No contributions by the Company have been made since the plan’s inception.
LITIGATION
The
Company is, from time to time, involved in legal proceedings, claims, and litigation arising in the ordinary course of business. While
the amounts claimed may be substantial, the ultimate liability cannot presently be determined because of considerable uncertainties that
exist. Therefore, it is possible the outcome of such legal proceedings, claims, and litigation could have a material effect on quarterly
or annual operating results or cash flows when resolved in a future period. However, based on facts currently available, management believes
such matters will not have a material adverse effect on the Company’s consolidated financial position, results of operations or
cash flows.
There
were no legal proceedings pending as of May 31, 2023.
CONTRACTS
Contracts
and Licensing Agreements
The
Company has one royalty agreement in which it has obtained rights to manufacture and market certain products for the life of the products.
Royalty expense of approximately $13,000 and $19,000 is included in cost of sales for the agreement for each of the years ended May 31,
2023 and 2022, respectively. Sales of products manufactured under these agreements comprise approximately 2.1% and 1.5% of total sales
for the years ended May 31, 2023 and 2022, respectively. The Company may license other products or technology in the future as it deems
necessary for conducting business. The Company has other royalty agreements however they are not considered material.
Clinical
Trial Agreements
In
September 2017, the Company signed a Clinical Samples Agreement with the University of Southern California for the purpose of providing
clinical samples for use by the Company in conducting future clinical trials for one of the products which the Company is developing.
The initial budget was estimated to be approximately $82,000. The work started in October 2017 with charges for work performed being
invoiced and paid monthly. This study ended in February 2020. Approximately $17,000 in fees has been accrued for unbilled charges as
of May 31, 2022. There are no unbilled charges as of May 31, 2023.
The
Company entered into a Clinical Trial Agreement with a research institute for the purpose of conducting a clinical trial of the Biomerica
InFoods® product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly
for work performed in the previous month. The maximum budgeted costs will be approximately $107,000. This study ended in March 2022.
Approximately $28,000 in fees has been accrued for unbilled charges as of May 31, 2022. There are no unbilled charges as of May 31, 2023.
|
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.2
SUBSEQUENT EVENTS
|
12 Months Ended |
May 31, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
10: SUBSEQUENT EVENTS
On
August 3, 2023, the Company announced it had entered into a sales agreement with CVS Pharmacy wherein the Company’s EZ Detect™
colorectal disease screening test will be offered at approximately 7,000 CVS Pharmacy retail stores. Biomerica has shipped the EZ Detect
product to CVS Health distribution centers in the United States, and the product is projected to be on store shelves in September.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
12 Months Ended |
May 31, 2023 |
Accounting Policies [Abstract] |
|
PRINCIPLES OF CONSOLIDATION |
PRINCIPLES
OF CONSOLIDATION
The
consolidated financial statements for the years ended May 31, 2023 and 2022, include the accounts of Biomerica, Inc. (“Biomerica”)
as well as its wholly-owned German subsidiary (“BioEurope GmbH”) and Mexican subsidiary (“Biomerica de Mexico”).
All significant intercompany accounts and transactions have been eliminated in consolidation.
|
ACCOUNTING ESTIMATES |
ACCOUNTING
ESTIMATES
The
preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United
States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and
the reported amounts of revenues and expenses during the reported period. Estimates that are made include the allowance for doubtful
accounts, which is estimated based on current as well as historical past practices with a customer; stock option forfeiture rates,
which are calculated based on historical data; inventory obsolescence, which is based on projected and historical usage of
materials; and lease liabilities and right-of-use assets, which are calculated based on certain assumptions such as the borrowing
rate on the lease commencement date and, the likelihood of lease extensions to occur, asset valuations, among other things; and other items that may be necessary to
estimate using current, historical and judgment based information. Actual results could materially differ from those
estimates.
Due
to the global COVID-19 pandemic, the Company’s operations have been negatively impacted. The Company has faced disruptions in the
following areas, (and may face further challenges): supply chain disruptions, loss of contracts and/or customers, closure of the Company’s
manufacturing or distribution facilities or of the facilities of the Company’s suppliers, partners and customers, travel, shipping
and logistical disruptions, government responses of all types, international business risks in countries where the Company makes and/or
sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of production, customer
credit risk, and general economic calamities. These pandemic related disruptions can materially negatively impact the Company’s
operations and financial performance and may continue to have significant material negative impacts on the Company.
|
LIQUIDITY |
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $42 million as
of May 31, 2023. Management expects to continue to incur significant costs as it advances its trials and development activities. As of
May 31, 2023, the Company had cash and cash equivalents of approximately $9,719,000 and working capital of approximately $10,852,000.
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any shares under the ATM Offering, and may at any time suspend offers
under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $3.15 to $4.26 pursuant to the
ATM Agreement, which resulted in gross proceeds of approximately $2,014,000 and net proceeds to the Company of $1,961,000, after deducting
commissions for each sale and legal, accounting, and other fees related to offering in the amount of $53,000.
During
the year ended May 31, 2022, the Company sold 521,267 shares of its common stock at prices ranging from $4.02 to $5.63 pursuant to the
ATM Offering, which resulted in gross proceeds of approximately $2,402,000 and net proceeds to the Company of $2,317,000, after deducting
commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $85,000.
On
March 7, 2023, the Company sold 3,333,333 shares of common stock in a firm commitment public offering at a gross sales price of $2.40
per share, with net total proceeds, after deducting issuance fees and expenses of $700,000, of approximately $7,300,000. Since the closing
of the March 7, 2023 offering, the ATM has been withdrawn and is not active.
The
Company intends to use the net proceeds from such offerings for general corporate purposes, including, without limitation, sales and
marketing activities, clinical studies, product development, making acquisitions of assets, businesses, companies or securities,
capital expenditures, and for working capital needs.
Management
has analyzed the cash requirements of the Company’s business through at least August 2024. As a result of cash and cash
equivalents on hand on May 31, 2023, largely from the public offering, and the ability to raise additional funds through another new
ATM agreement, management believes the Company has sufficient funds to operate through at least August 2024.
|
FAIR VALUE OF FINANCIAL INSTRUMENTS |
FAIR
VALUE OF FINANCIAL INSTRUMENTS
The
Company has financial instruments whereby the fair market value of the financial instruments could be different than that recorded on
a historical basis. The Company’s consolidated financial instruments consist of its cash and cash equivalents, accounts receivable,
and accounts payable. The carrying amounts of the Company’s financial instruments approximate their fair values. The Company also
maintains an investment in privately held company (see below).
|
CONCENTRATION OF CREDIT RISK |
CONCENTRATION
OF CREDIT RISK
The
Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. From time to time,
the Company has uninsured balances. The Company does not believe it is exposed to any significant credit risks.
The
Company provides credit in the normal course of business to customers throughout the United States and in foreign markets. The Company
performs ongoing credit evaluations of its customers and requires accelerated prepayment in some circumstances.
Our
net sales were approximately $5,339,000
for fiscal 2023 compared to $18,871,000
for fiscal 2022. For the fiscal years ended May 31, 2023 and 2022, the Company had one and two distributors, respectively, which
accounted for a total of 35%
and 65%
of our net sales, respectively. Of this, for the fiscal years ended May 31, 2023 and 2022, the largest of the distributors mentioned
above accounted for 35%
and 55%,
respectively, of net sales.
Total
gross receivables on May 31, 2023 and 2022 were approximately $751,000 and $927,000, respectively. On May 31, 2023 and 2022, the Company
had one distributor which accounted for a total of 36% and 50%, respectively, of gross accounts receivable. Of the 36% as of May 31,
2023, 100% was owed by a distributor in Asia.
For
the fiscal year ended May 31, 2023, the Company did not have any significant concentration of vendor spend for raw materials. For the
fiscal year ended May 31, 2022, the Company had one vendor, which accounted for 84% of our purchases of raw materials largely related
to COVID-19 products.
|
GEOGRAPHIC CONCENTRATION |
GEOGRAPHIC
CONCENTRATION
As
of May 31, 2023 and 2022, approximately $626,000 and $621,000, respectively, of Biomerica’s gross inventory was located in Mexicali,
Mexico, respectively. As of May 31, 2023 and 2022, approximately $17,000 of Biomerica’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico.
|
CASH AND CASH EQUIVALENTS |
CASH
AND CASH EQUIVALENTS
Cash
and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.
|
ACCOUNTS RECEIVABLE, NET |
ACCOUNTS
RECEIVABLE, NET
The
Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until
they establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria.
Initial credit levels for individual distributors are approved by designated officers and managers of the Company. All increases in
credit limits are also approved by designated upper-level management. Management evaluates receivables on a quarterly basis and
adjusts the allowance for doubtful accounts accordingly. Balances over ninety days
old are usually reserved for unless collection is reasonably assured.
Occasionally
certain long-standing customers, who routinely place large orders, will have unusually large receivables balances relative to the total
gross receivables. Management monitors the payments for these large balances closely and very often requires payment of existing invoices
before shipping new sales orders.
As
of May 31, 2023 and 2022, the Company has established a reserve of approximately $29,000 and $153,000, respectively, for doubtful accounts.
|
PREPAID EXPENSES AND OTHER |
PREPAID
EXPENSES AND OTHER
The
Company occasionally prepays for items such as inventory, insurance, and other items. These items are reported as prepaids, until either
the inventory is physically received or the insurance and other items are utilized.
As
of May 31, 2023 and 2022, the prepaids were approximately $300,000 and $320,000, respectively, composed of prepayments to insurance and
various other suppliers.
|
INVENTORIES, NET |
INVENTORIES,
NET
The
Company values inventory at the lower of cost (determined using a combination of specific lot identification and the first-in, first-out
methods) or net realizable value. Management periodically reviews inventory for excess quantities and obsolescence. Management evaluates
quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated customer
demand for current products and new product introductions. The reserve is adjusted based on such evaluation, with a corresponding provision
included in cost of sales. Abnormal amounts of idle facility expenses, freight, handling costs, and wasted material are recognized as
current period charges and the allocation of fixed production overhead is based on the normal capacity of the production facilities.
The
following is a summary of approximate net inventories:
SCHEDULE
OF NET INVENTORIES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 1,677,000 | | |
$ | 1,717,000 | |
Work in progress | |
| 869,000 | | |
| 763,000 | |
Finished products | |
| 182,000 | | |
| 782,000 | |
Total gross inventory | |
$ | 2,728,000 | | |
$ | 3,262,000 | |
Inventory reserve | |
| (672,000 | ) | |
| (846,000 | ) |
Net
inventory | |
$ | 2,056,000 | | |
$ | 2,416,000 | |
Reserves
for inventory obsolescence are recorded as necessary to reduce obsolete inventory to estimated net realizable value or to specifically
reserve for obsolete inventory. As of May 31, 2023 and 2022, inventory reserves were approximately $672,000 and $846,000, respectively.
The Company has fully reserved COVID-19 antibody inventory in fiscal 2023.
|
PROPERTY AND EQUIPMENT, NET |
PROPERTY
AND EQUIPMENT, NET
Property
and equipment are stated at cost. Expenditures for additions and major improvements are capitalized. Repairs and maintenance costs are
charged to operations as incurred. When property and equipment are sold, retired, or otherwise disposed of, the related cost and accumulated
depreciation or amortization are removed from the accounts, and gains or losses from sales, retirements, and dispositions are credited
or charged to income.
Depreciation
and amortization are provided over the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line
method. Leasehold improvements are amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation
and amortization expense on property and equipment amounted to approximately $66,000 and $100,000 for the years ended May 31, 2023 and
2022, respectively.
|
INTANGIBLE ASSETS, NET |
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights, and patents, and are accounted for based on Accounting Standards Codification
(“ASC”), ASC 350 Intangibles – Goodwill and Other (“ASC 350”). In that regard, intangible assets that have
indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in
circumstances indicate that the asset might be impaired.
Intangible
assets are being amortized using the straight-line method over the useful life, not to exceed 18 years for marketing and distribution
rights, 10 years for purchased technology use rights, and 20 years for patents. Amortization amounted to approximately $18,000 and $239,000
for the years ended May 31, 2023 and 2022, respectively.
The
Company assesses the recoverability of these intangible assets by determining whether the amortization of the asset’s balance over
its remaining life can be recovered through projected undiscounted future cash flows. The Company uses a qualitative assessment to determine
whether there was any impairment. During the year ended May 31, 2023, there was no impairment of intangible assets. During the year ended May 31, 2022, an impairment
adjustment was made of $210,000.
|
INVESTMENTS |
INVESTMENTS
The
Company has made investments in a privately held Polish
distributor, which is primarily engaged in distributing medical products and devices, including the distribution of the products
sold by the Company. The Company invested approximately $165,000
into the Polish distributor and owns approximately 6%
of the investee.
Equity
holdings in nonmarketable unconsolidated entities in which the Company is not able to exercise significant influence (“Cost Method
Holdings”) are accounted for at the Company’s initial cost, minus any impairment (if any), plus or minus changes resulting
from observable price changes in orderly transactions for the identical or a similar holding or security of the same issuer. Dividends
received are recorded as other income.
The
Company assesses its equity holdings for impairment whenever events or changes in circumstances indicate that the carrying value of an
equity holding may not be recoverable. Management reviewed the underlying net assets of the Company’s equity method holding as
of May 31, 2023 and determined that the Company’s proportionate economic interest in the entity indicates that the equity holding
was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the
Company’s Cost Method Holding during the year ended May 31, 2023.
|
SHARE-BASED COMPENSATION |
SHARE-BASED
COMPENSATION
The
Company follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value based
method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments
(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that uses
assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The
Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based
on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.
The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the
“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as
historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized under
the straight-line attribution method.
The
Company expensed approximately $1,185,000 and $1,260,000 of share-based compensation during the years ended May 31, 2023 and 2022, respectively.
In
applying the Black-Scholes option-pricing model, the following assumptions used in the valuation of awards issued for period ending May 31, 2023 and 2022:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
| |
For
the year ended May 31, | |
| |
2023 | | |
2022 | |
Dividend yield | |
| 0% | | |
| 0% | |
Expected volatility | |
| 98.81
- 101.77% | | |
| 102.54
- 105.48% | |
Risk free interest rate | |
| 3.12
- 3.35% | | |
| 0.97
- 2.75% | |
Expected term | |
| 6.25
years | | |
| 5.50
- 6.25 years | |
|
REVENUE RECOGNITION |
REVENUE
RECOGNITION
The
Company has various contracts with customers. All of the contracts specify that revenues from product sales are recognized at the time
the product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred and at which point
title passes.
The
Company does not typically allow for returns from customers except in the event of defective merchandise and therefore does not establish
an allowance for returns. In addition, the Company has contracts with customers wherein customers receive purchase discounts for achieving
specified sales volumes. The Company evaluated the status of these contracts during the years ended May 31, 2023 and 2022 and does not
believe that any additional discounts will be given through the end of the contract periods.
Services
for contract work performed by the Company for others are invoiced and recognized as that work has been performed and as the project
progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories,
medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce
customers as well as to distributors. Physicians’ office products are sold to physicians and distributors, all of whom are categorized
below according to the type of products sold to them. We also manufacture certain components on a contract basis for domestic and international
manufacturers.
As
of May 31, 2023, the Company had approximately $60,000 of advances from certain foreign customers. These advances are prepayments on
orders that are expected to ship during our second fiscal quarter ending November 30, 2023.
Disaggregation
of revenue:
The
following is an approximate breakdown of revenues according to primary markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Clinical lab | |
$ | 3,310,000 | | |
$ | 3,064,000 | |
Over-the-counter | |
| 1,169,000 | | |
| 1,089,000 | |
Contract manufacturing | |
| 610,000 | | |
| 459,000 | |
Physician’s office | |
| 250,000 | | |
| 14,259,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
See
Note 8 for additional information regarding geographic revenue concentrations.
|
SHIPPING AND HANDLING FEES |
SHIPPING
AND HANDLING FEES
The
Company includes shipping and handling fees billed to customers in net sales.
|
RESEARCH AND DEVELOPMENT |
RESEARCH
AND DEVELOPMENT
Research
and development costs are expensed as incurred. The Company expensed approximately $1,584,000 and $1,812,000 of research and development
costs during the years ended May 31, 2023 and 2022, respectively.
|
INCOME TAXES |
INCOME
TAXES
The
Company accounts for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and
liabilities arise from temporary differences between the tax bases of assets and liabilities and their reported amounts in the
consolidated financial statements that will result in taxable or deductible amounts in future years and the benefits of net
operating loss and tax credit carryforwards. These temporary differences and the benefits of net operating loss and tax credit
carryforwards are measured using enacted tax rates. A valuation allowance is recorded to reduce deferred tax assets to the extent
that management considers it is more likely than not that a deferred tax asset will not be realized. In determining the valuation
allowance, the Company considers factors such as the reversal of deferred income tax assets, projected taxable income, and the
character of income tax assets and tax planning strategies. A change to these factors could impact the estimated valuation allowance
and income tax expense. As of May 31, 2023 and 2022, in accordance with ASC 740, the Company has a valuation allowance for
substantially all of its net deferred tax assets. During the year ended May 31, 2023, this valuation allowance was increased to
$8,940,000,
which fully covers the net deferred tax asset of $8,940,000.
The
Company accounts for its uncertain tax provisions by using a two-step approach to recognizing and measuring uncertain tax positions.
The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more
likely than not, based solely on the technical merits, that the position will be sustained in an audit, including resolution of related
appeals or litigation processes, if any. The second step is to measure the appropriate amount of the benefit to recognize. The amount
of benefit to recognize is measured as the maximum amount which is more likely than not to be realized. The tax position is derecognized
when it is no longer more likely than not capable of being sustained. On subsequent recognition and measurement, the maximum amount which
is more likely than not to be recognized at each reporting date will represent the Company’s best estimate, given the information
available at the reporting date, although the outcome of the tax position is not absolute or final. The Company elected to follow an
accounting policy to classify accrued interest related to liabilities for income taxes within the “Interest expense” line
and penalties related to liabilities for income taxes within the “Other expense” line of the consolidated statements of operations
and comprehensive loss.
|
ADVERTISING COSTS |
ADVERTISING
COSTS
The
Company reports the cost of all advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$156,000 and $76,000 for the years ended May 31, 2023 and 2022, respectively.
|
FOREIGN CURRENCY TRANSLATION |
FOREIGN
CURRENCY TRANSLATION
The
subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the
U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries
are translated using exchange rates in effect at the end of the year, and revenues and costs are translated using average exchange rates
for the year. The resulting adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive
loss. There are no foreign currency transactions that are included in the consolidated statements of operations for the years ended May
31, 2023 and 2022.
|
RIGHT-OF-USE ASSETS AND LEASE LIABILITIES |
RIGHT-OF-USE
ASSETS AND LEASE LIABILITIES
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued an accounting standard update which requires lessees
to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from
the lease. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value
of fixed lease payments over the lease term. Leases are classified as financing or operating which will drive the expense recognition
pattern. The Company has elected to exclude short-term leases. The Company leases office space and copy machines, all of which are operating
leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options
to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The
leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited
by the expected lease term. For additional information, see Note 9-Commitments and Contingencies.
|
NET LOSS PER SHARE |
NET
LOSS PER SHARE
Basic
loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss
per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible
securities using the treasury stock method. The total amounts of anti-dilutive stock options not included in the loss per share calculation
for the years ended May 31, 2023 and 2022 were 2,342,616 and 2,321,616, respectively.
|
SEGMENT REPORTING |
SEGMENT
REPORTING
ASC
280, Segment Reporting (“ASC 280”), establishes standards for reporting, by public business enterprises, information about
operating segments, products and services, geographic areas, and major customers. The Company’s operations are analyzed by management
and its chief operating decision maker as being part of a single industry segment: the design, development, marketing, and sales of diagnostic
kits.
|
REPORTING COMPREHENSIVE LOSS |
REPORTING
COMPREHENSIVE LOSS
Comprehensive
loss represents net loss and any revenues, expenses, gains and losses that, under GAAP, are excluded from net loss and recognized directly
as a component of shareholders’ equity. Items of other comprehensive loss consist solely of foreign currency translation adjustments
for the years ended May 31, 2023 and 2022.
|
RECENT ACCOUNTING PRONOUNCEMENTS |
RECENT
ACCOUNTING PRONOUNCEMENTS
Except as follows, recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by management to, have a material effect on
the Company’s present or future consolidated financial statements.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.
This ASU will require the measurement of all expected credit losses for financial assets, including trade receivables, held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. The guidance was initially effective
for the Company for annual reporting periods beginning after December 15, 2019, and interim periods within those fiscal years. In November
2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases
(Topic 842): Effective Dates, which, among other things, defers the effective date of ASU 2016-13 for public filers that are considered
smaller reporting companies as defined by the Securities and Exchange Commission to fiscal years beginning after December 15, 2022, including
interim periods within those years. Early adoption is permitted. The Company is currently reviewing the requirements of this ASU to determine
its impact on the Company’s consolidated results of operations and financial position.
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
12 Months Ended |
May 31, 2023 |
Accounting Policies [Abstract] |
|
SCHEDULE OF NET INVENTORIES |
The
following is a summary of approximate net inventories:
SCHEDULE
OF NET INVENTORIES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Raw materials | |
$ | 1,677,000 | | |
$ | 1,717,000 | |
Work in progress | |
| 869,000 | | |
| 763,000 | |
Finished products | |
| 182,000 | | |
| 782,000 | |
Total gross inventory | |
$ | 2,728,000 | | |
$ | 3,262,000 | |
Inventory reserve | |
| (672,000 | ) | |
| (846,000 | ) |
Net
inventory | |
$ | 2,056,000 | | |
$ | 2,416,000 | |
|
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS |
In
applying the Black-Scholes option-pricing model, the following assumptions used in the valuation of awards issued for period ending May 31, 2023 and 2022:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
| |
For
the year ended May 31, | |
| |
2023 | | |
2022 | |
Dividend yield | |
| 0% | | |
| 0% | |
Expected volatility | |
| 98.81
- 101.77% | | |
| 102.54
- 105.48% | |
Risk free interest rate | |
| 3.12
- 3.35% | | |
| 0.97
- 2.75% | |
Expected term | |
| 6.25
years | | |
| 5.50
- 6.25 years | |
|
SCHEDULE OF DISAGGREGATION REVENUE |
The
following is an approximate breakdown of revenues according to primary markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Clinical lab | |
$ | 3,310,000 | | |
$ | 3,064,000 | |
Over-the-counter | |
| 1,169,000 | | |
| 1,089,000 | |
Contract manufacturing | |
| 610,000 | | |
| 459,000 | |
Physician’s office | |
| 250,000 | | |
| 14,259,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
|
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v3.23.2
PROPERTY AND EQUIPMENT, NET (Tables)
|
12 Months Ended |
May 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT, NET |
The
following is an approximate breakdown of property and equipment, net of accumulated depreciation:
SCHEDULE
OF PROPERTY AND EQUIPMENT, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Equipment | |
$ | 1,333,000 | | |
$ | 1,292,000 | |
Furniture, fixtures and leasehold improvements | |
| 211,000 | | |
| 227,000 | |
Less accumulated depreciation | |
| (1,331,000 | ) | |
| (1,305,000 | ) |
Net
property and equipment | |
$ | 213,000 | | |
$ | 214,000 | |
|
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v3.23.2
INTANGIBLE ASSETS, NET (Tables)
|
12 Months Ended |
May 31, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
SCHEDULE OF INTANGIBLE ASSETS, NET |
The
following is an approximate breakdown of intangible assets, net of accumulated amortization:
SCHEDULE
OF INTANGIBLE ASSETS, NET
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Patents | |
| 196,000 | | |
| 189,000 | |
Less accumulated amortization-patents | |
| (31,000 | ) | |
| (19,000 | ) |
Intangible
assets, net | |
$ | 165,000 | | |
$ | 170,000 | |
|
SCHEDULE OF EXPECTED AMORTIZATION OF INTANGIBLE ASSETS |
Expected
amortization of intangible assets for the years ending May 31:
SCHEDULE
OF EXPECTED AMORTIZATION OF INTANGIBLE ASSETS
| |
| | |
2024 | |
$ | 13,000 | |
2025 | |
| 13,000 | |
2026 | |
| 13,000 | |
2027 | |
| 13,000 | |
2028 | |
| 13,000 | |
Thereafter | |
| 100,000 | |
Total | |
$ | 165,000 | |
|
X |
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v3.23.2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
|
12 Months Ended |
May 31, 2023 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES |
The
following is an approximate breakdown of accounts payable and accrued expenses balances:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Accounts
payable | |
$ | 344,000 | | |
$ | 736,000 | |
Accrued
expenses | |
| 548,000 | | |
| 236,000 | |
Total | |
$ | 892,000 | | |
$ | 972,000 | |
|
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v3.23.2
SHAREHOLDERS’ EQUITY (Tables)
|
12 Months Ended |
May 31, 2023 |
Equity [Abstract] |
|
SCHEDULE OF STOCK BASED COMPENSATION EXPENSE |
Stock-based
compensation expense for the years ended May 31, 2023 and 2022 is as follows:
SCHEDULE
OF STOCK BASED COMPENSATION EXPENSE
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Cost of sales | |
$ | 143,000 | | |
$ | 159,000 | |
Selling, general and administrative | |
| 971,000 | | |
| 1,021,000 | |
Research and development | |
| 71,000 | | |
| 80,000 | |
Total
stock option expense | |
$ | 1,185,000 | | |
$ | 1,260,000 | |
|
SCHEDULE OF ACTIVITY TO AGGREGATE STOCK OPTIONS |
Activity
as to aggregate stock options outstanding is as follows:
SCHEDULE
OF ACTIVITY TO AGGREGATE STOCK OPTIONS
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Aggregate Intrinsic Value | |
Options Outstanding at May 31, 2021 | |
| 2,081,366 | | |
$ | 3.59 | | |
$ | 2,132,000 | |
Options granted | |
| 344,000 | | |
$ | 4.43 | | |
| | |
Options exercised | |
| (39,500 | ) | |
$ | 1.99 | | |
$ | 90,000 | |
Options canceled or expired | |
| (64,250 | ) | |
$ | 4.41 | | |
| | |
Options Outstanding at May 31, 2022 | |
| 2,321,616 | | |
$ | 3.72 | | |
$ | 1,838,000 | |
Options granted | |
| 243,000 | | |
$ | 2.70 | | |
| | |
Options exercised | |
| (46,500 | ) | |
$ | 1.73 | | |
$ | 90,000 | |
Options canceled or expired | |
| (175,500 | ) | |
$ | 5.56 | | |
| | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | | |
$ | 146,000 | |
Options vested and exercisable at May 31, 2023 | |
| 1,841,933 | | |
$ | 3.38 | | |
$ | 146,000 | |
|
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v3.23.2
INCOME TAXES (Tables)
|
12 Months Ended |
May 31, 2023 |
Income Tax Disclosure [Abstract] |
|
SCHEDULE OF PROVISION FOR INCOME TAXES |
Provision
for income taxes for the years ended May 31 consists of the following:
SCHEDULE
OF PROVISION FOR INCOME TAXES
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Current: | |
| | | |
| | |
U.S. Federal | |
$ | - | | |
$ | - | |
Foreign Taxes
Subsidiaries | |
| (50,000 | ) | |
| (23,000 | ) |
State
and local | |
| (1,000 | ) | |
| (1,000 | ) |
Total
current | |
| (51,000 | ) | |
| (24,000 | ) |
Deferred: | |
| | | |
| | |
U.S. Federal | |
| - | | |
| - | |
State and local | |
| - | | |
| - | |
Total
deferred | |
| - | | |
| - | |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
|
SCHEDULE OF EFFECTIVE INCOME TAX RECONCILIATION |
SCHEDULE
OF EFFECTIVE INCOME TAX RECONCILIATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Computed “expected”
tax benefit | |
$ | 1,490,000 | | |
| 947,000 | |
Increase (reduction) in income taxes resulting
from: | |
| | | |
| | |
Change in valuation allowance | |
| (1,973,000 | ) | |
| (1,022,000 | ) |
State income taxes, net of federal benefit | |
| 583,000 | | |
| 300,000 | |
Research and development tax credits | |
| - | | |
| 50,000 | |
Permanent tax differences and other | |
| (17,000 | ) | |
| (197,000 | ) |
Stock based compensation benefit | |
| (5,000 | ) | |
| 11,000 | |
Foreign taxes of subsidiaries | |
| (129,000 | ) | |
| (113,000 | ) |
Income
tax expense | |
$ | (51,000 | ) | |
$ | (24,000 | ) |
|
SCHEDULE OF DEFERRED TAX ASSETS |
The
tax effect of significant temporary differences is presented below:
SCHEDULE
OF DEFERRED TAX ASSETS
| |
2023 | | |
2022 | |
| |
May
31, | |
| |
2023 | | |
2022 | |
Deferred tax assets: | |
| | | |
| | |
Accounts receivable,
principally due to allowance for doubtful accounts | |
$ | 8,000 | | |
$ | 43,000 | |
Inventory valuation | |
| 188,000 | | |
| 237,000 | |
Compensated absences | |
| 118,000 | | |
| 120,000 | |
Net operating loss carryforwards | |
| 5,817,000 | | |
| 4,349,000 | |
Tax credit carryforwards | |
| 1,239,000 | | |
| 1,096,000 | |
Deferred rent expense/Capitalized leases | |
| 11,000 | | |
| 20,000 | |
Stock Options | |
| 1,296,000 | | |
| 1,035,000 | |
Sec 174 capitalized costs | |
| 284,000 | | |
| - | |
Losses of foreign subsidiaries & other,
net | |
| - | | |
| 41,000 | |
Accumulated
depreciation and amortization | |
| (21,000 | ) | |
| 26,000 | |
Total deferred tax assets | |
| 8,940,000 | | |
| 6,967,000 | |
Less valuation allowance | |
| (8,940,000 | ) | |
| (6,967,000 | ) |
Net
deferred tax asset | |
$ | - | | |
$ | - | |
|
X |
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v3.23.2
GEOGRAPHIC INFORMATION (Tables)
|
12 Months Ended |
May 31, 2023 |
Segment Reporting [Abstract] |
|
SCHEDULE OF GEOGRAPHIC INFORMATION |
SCHEDULE
OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | |
| |
For
the Year Ended May 31, | |
| |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | |
Asia | |
$ | 2,021,000 | | |
$ | 13,375,000 | |
Europe | |
| 1,798,000 | | |
| 4,339,000 | |
North America | |
| 1,470,000 | | |
| 997,000 | |
Middle East | |
| 39,000 | | |
| 70,000 | |
South America | |
| 11,000 | | |
| 90,000 | |
Total | |
$ | 5,339,000 | | |
$ | 18,871,000 | |
|
X |
- DefinitionTabular disclosure of revenue from external customers by geographic areas attributed to the entity's country of domicile and to foreign countries from which the entity derives revenue.
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v3.23.2
COMMITMENTS AND CONTINGENCIES (Tables)
|
12 Months Ended |
May 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
SCHEDULE OF OPERATING LEASES |
The
following table presents information on our operating leases for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OPERATING LEASES
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Operating lease cost | |
$ | 353,000 | | |
$ | 352,000 | |
Short-term lease cost | |
| 5,000 | | |
| 5,000 | |
Total lease cost | |
$ | 358,000 | | |
$ | 357,000 | |
|
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS |
The
future minimum lease payments of the Company’s operating lease liabilities by fiscal year are as follows:
SCHEDULE
OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending May 31: | |
| |
| |
Operating
Leases | |
2024 | |
$ | 356,000 | |
2025 | |
| 366,000 | |
2026 | |
| 376,000 | |
2027 | |
| 101,000 | |
Thereafter | |
| - | |
Total minimum future lease payments | |
$ | 1,199,000 | |
Less: imputed interest | |
| 117,000 | |
Total operating lease
liabilities | |
$ | 1,082,000 | |
|
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION |
The
following table summarizes the Company’s other supplemental lease information for the years ended May 31, 2023 and 2022:
SCHEDULE
OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Year
Ended May 31, | |
| |
2023 | | |
2022 | |
Cash paid for operating lease liabilities | |
$ | 347,000 | | |
$ | 338,000 | |
Weighted-average remaining lease term (years) | |
| 3.27 | | |
| 4.28 | |
Weighted-average discount rate | |
| 6.50% | | |
| 6.50% | |
|
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v3.23.2
SCHEDULE OF NET INVENTORIES (Details) - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Accounting Policies [Abstract] |
|
|
Raw materials |
$ 1,677,000
|
$ 1,717,000
|
Work in progress |
869,000
|
763,000
|
Finished products |
182,000
|
782,000
|
Total gross inventory |
2,728,000
|
3,262,000
|
Inventory reserve |
(672,000)
|
(846,000)
|
Net inventory |
$ 2,056,000
|
$ 2,416,000
|
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v3.23.2
SCHEDULE OF DISAGGREGATION REVENUE (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Product Information [Line Items] |
|
|
Total |
$ 5,339,000
|
$ 18,871,000
|
Clinical Lab [Member] |
|
|
Product Information [Line Items] |
|
|
Total |
3,310,000
|
3,064,000
|
Over The Counte [Member] |
|
|
Product Information [Line Items] |
|
|
Total |
1,169,000
|
1,089,000
|
Contract Manufacturing [Member] |
|
|
Product Information [Line Items] |
|
|
Total |
610,000
|
459,000
|
Physicians Office [Member] |
|
|
Product Information [Line Items] |
|
|
Total |
$ 250,000
|
$ 14,259,000
|
X |
- DefinitionAmount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.
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v3.23.2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
|
12 Months Ended |
|
Mar. 07, 2023 |
May 31, 2023 |
May 31, 2022 |
Jan. 22, 2021 |
Product Information [Line Items] |
|
|
|
|
Accumulated deficit |
|
$ 42,217,000
|
$ 35,077,000
|
|
Cash and cash equivalents |
|
9,719,000
|
5,917,000
|
|
Working capital |
|
10,852,000
|
|
|
Shelf registration statement maximum authorized common stock issuance value |
|
|
|
$ 15,000,000
|
Proceeds from issuance of common stock |
|
10,014,000
|
2,402,000
|
|
Sale of stock expenses |
$ 700,000
|
|
|
|
Revenues |
|
5,339,000
|
18,871,000
|
|
Other receivables, gross, current |
|
751,000
|
927,000
|
|
Inventory, gross |
|
2,728,000
|
3,262,000
|
|
Property, plant and equipment, net |
|
$ 213,000
|
214,000
|
|
Threshold period past due for write-off of trade accounts receivable |
|
90 days
|
|
|
Accounts receivable, credit loss expense (Reversal) |
|
$ 29,000
|
153,000
|
|
Prepaid expense and other assets |
|
300,000
|
320,000
|
|
Inventory reserves |
|
672,000
|
846,000
|
|
Depreciation, depletion and amortization |
|
84,000
|
339,000
|
|
Amortization of intangible assets |
|
18,000
|
239,000
|
|
Asset impairment charges |
|
0
|
210,000
|
|
Investments |
|
165,000
|
165,000
|
|
Share-based payment arrangement, expense |
|
1,185,000
|
1,260,000
|
|
Proceeds from customers |
|
60,000
|
|
|
Research and development expense |
|
1,584,000
|
1,812,000
|
|
Deferred tax assets, valuation allowance |
|
8,940,000
|
6,967,000
|
|
Deferred tax assets, net |
|
8,940,000
|
6,967,000
|
|
Advertising expense |
|
$ 156,000
|
$ 76,000
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
|
2,342,616
|
2,321,616
|
|
Polish Distributor [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Investments |
|
$ 165,000
|
|
|
Equity method investment, ownership percentage |
|
6.00%
|
|
|
Marketing and Distribution Rights [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Finite-lived intangible asset, useful life |
|
18 years
|
|
|
Purchased Technology Rights [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Finite-lived intangible asset, useful life |
|
10 years
|
|
|
Patents [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Finite-lived intangible asset, useful life |
|
20 years
|
|
|
Property, Plant and Equipment [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Depreciation, depletion and amortization |
|
$ 66,000
|
$ 100,000
|
|
MEXICO |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Inventory, gross |
|
626,000
|
621,000
|
|
Property, plant and equipment, net |
|
$ 17,000
|
$ 17,000
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Distributor One [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
35.00%
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Distributor Two [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
|
65.00%
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | One Distributor [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
35.00%
|
55.00%
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | One Distributor [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
36.00%
|
50.00%
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Distributors In Asia [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
100.00%
|
|
|
Cost of Goods and Service, Product and Service Benchmark [Member] | Supplier Concentration Risk [Member] | One Vendor [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Concentration risk, percentage |
|
|
84.00%
|
|
Minimum [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Property, plant and equipment, useful life |
|
5 years
|
|
|
Maximum [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Property, plant and equipment, useful life |
|
10 years
|
|
|
ATM Agreement [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Sale of stock, number of shares issued in transaction |
|
573,889
|
521,267
|
|
Sale of stock, consideration received on transaction |
|
$ 2,014,000
|
$ 2,402,000
|
|
Proceeds from issuance of common stock |
7,300,000
|
1,961,000
|
2,317,000
|
|
Sale of stock expenses |
$ 700,000
|
$ 53,000
|
$ 85,000
|
|
Net proceeds from ATM (in Shares) |
3,333,333
|
|
|
|
Share price |
$ 2.40
|
|
|
|
ATM Agreement [Member] | Minimum [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Sale of stock, price per share |
|
$ 3.15
|
$ 4.02
|
|
ATM Agreement [Member] | Maximum [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Sale of stock, price per share |
|
$ 4.26
|
$ 5.63
|
|
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SCHEDULE OF PROPERTY AND EQUIPMENT, NET (Details) - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Less accumulated depreciation |
$ (1,331,000)
|
$ (1,305,000)
|
Net property and equipment |
213,000
|
214,000
|
Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Furniture, fixtures and leasehold improvements |
1,333,000
|
1,292,000
|
Furniture and Fixtures Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Furniture, fixtures and leasehold improvements |
$ 211,000
|
$ 227,000
|
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v3.23.2
SCHEDULE OF INTANGIBLE ASSETS, NET (Details) - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
|
Patents |
$ 196,000
|
$ 189,000
|
Less accumulated amortization-patents |
(31,000)
|
(19,000)
|
Intangible assets, net |
$ 165,000
|
$ 170,000
|
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v3.23.2
SCHEDULE OF STOCK BASED COMPENSATION EXPENSE (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Total stock option expense |
$ 1,185,000
|
$ 1,260,000
|
Cost of Sales [Member] |
|
|
Total stock option expense |
143,000
|
159,000
|
Selling, General and Administrative Expenses [Member] |
|
|
Total stock option expense |
971,000
|
1,021,000
|
Research and Development Expense [Member] |
|
|
Total stock option expense |
$ 71,000
|
$ 80,000
|
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v3.23.2
SCHEDULE OF ACTIVITY TO AGGREGATE STOCK OPTIONS (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Equity [Abstract] |
|
|
Options Outstanding, shares |
2,321,616
|
2,081,366
|
Options Outstanding Weighted Average Exercise Price |
$ 3.72
|
$ 3.59
|
Options outstanding, Aggregate Intrinsic Value |
$ 1,838,000
|
$ 2,132,000
|
Options granted, shares |
243,000
|
344,000
|
Options Granted Weighted Average Exercise Price |
$ 2.70
|
$ 4.43
|
Options exercised, shares |
(46,500)
|
(39,500)
|
Options Exercised Weighted Average Exercise Price |
$ 1.73
|
$ 1.99
|
Options exercised, Aggregate IntrinsicValue |
$ 90,000
|
$ 90,000
|
Options cancelled or expired, shares |
(175,500)
|
(64,250)
|
Options canceled or expired Weighted Average Exercise Price |
$ 5.56
|
$ 4.41
|
Options Outstanding, shares |
2,342,616
|
2,321,616
|
Options Outstanding Weighted Average Exercise Price |
$ 3.52
|
$ 3.72
|
Options outstanding, Aggregate Intrinsic Value |
$ 146,000
|
$ 1,838,000
|
Options vested and exercisable, shares |
1,841,933
|
|
Options vested and exercisable Weighted Average Exercise Price |
$ 3.38
|
|
Options vested and exercisable Aggregate Intrinsic Value |
$ 146,000
|
|
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v3.23.2
SHAREHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
12 Months Ended |
|
|
|
|
|
|
Mar. 07, 2023 |
Jan. 22, 2021 |
Feb. 24, 2020 |
Mar. 24, 2020 |
May 31, 2023 |
May 31, 2022 |
May 21, 2021 |
Jan. 21, 2021 |
Jul. 21, 2020 |
Feb. 29, 2020 |
Dec. 31, 2017 |
Dec. 31, 2014 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, net proceeds |
|
|
|
|
$ 10,014,000
|
$ 2,402,000
|
|
|
|
|
|
|
Sale of stock expenses |
$ 700,000
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
0
|
0
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
|
|
$ 0
|
$ 0
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares issued |
|
|
|
250,000
|
|
|
|
|
|
|
|
|
Conversion of stock, shares issued upon conversion |
|
|
|
|
|
|
|
321,429
|
571,429
|
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
0
|
0
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
|
|
$ 0.08
|
$ 0.08
|
|
|
|
|
|
|
ATM Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock expenses |
|
|
|
|
$ 53,000
|
$ 85,000
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock shares issued |
3,333,333
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
$ 2.40
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, net proceeds |
$ 7,300,000
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] | ATM Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, purchase price |
|
|
|
|
$ 2,014,000
|
$ 2,402,000
|
|
|
|
|
|
|
Sale of stock shares issued |
|
|
|
|
573,889
|
521,267
|
|
|
|
|
|
|
Sale of stock, net proceeds |
|
|
|
|
$ 1,961,000
|
$ 2,317,000
|
|
|
|
|
|
|
Convertible Preferred Stock [Member] | Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, shares converted |
|
|
|
250,000
|
|
|
|
|
|
|
|
|
Convertible Preferred Stock [Member] | Stock Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, purchase price |
|
|
$ 2,000,000
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
|
$ 3.50
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
571,429
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value |
|
|
$ 0.08
|
|
|
|
|
|
|
|
|
|
Dividends payable, amount per share |
|
|
$ 0.175
|
|
|
|
|
|
|
|
|
|
Maximum [Member] | Common Stock [Member] | ATM Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
|
|
|
$ 4.26
|
$ 5.63
|
|
|
|
|
|
|
Maximum [Member] | Common Stock [Member] | ATM Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, purchase price |
|
$ 15,000,000
|
|
|
|
|
|
|
|
|
|
|
Minimum [Member] | Common Stock [Member] | ATM Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
|
|
|
|
$ 3.15
|
4.02
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Vesting period |
|
|
|
|
4 years
|
|
|
|
|
|
|
|
Award purchase price, percent |
|
|
|
|
80.00%
|
|
|
|
|
|
|
|
Expiration period |
|
|
|
|
10 years
|
|
|
|
|
|
|
|
Granted, weighted average grant date fair value |
|
|
|
|
$ 2.19
|
$ 4.43
|
|
|
|
|
|
|
Compenation cost related to non-vested stock option |
|
|
|
|
$ 1,145,000
|
|
|
|
|
|
|
|
Weighted average period expected term |
|
|
|
|
2 years 6 months 7 days
|
|
|
|
|
|
|
|
Exercisable weighted average remaining contractual term |
|
|
|
|
4 years 11 months 19 days
|
|
|
|
|
|
|
|
Vested, exercisable or expected to vest weighted average remaining contractual term |
|
|
|
|
5 years 8 months 1 day
|
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] | 2014 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment award, number of shares authorized |
|
|
|
|
|
|
|
|
|
|
|
850,000
|
Share-Based Payment Arrangement, Option [Member] | 2017 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment award, number of shares authorized |
|
|
|
|
|
|
|
|
|
|
900,000
|
|
Share-Based Payment Arrangement, Option [Member] | 2020 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment award, number of shares authorized |
|
|
|
|
|
|
|
|
|
900,000
|
|
|
2020 Stock Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based payment award, number of shares authorized |
|
|
|
|
|
|
900,000
|
|
|
|
|
|
X |
- DefinitionThe number of shares converted in a noncash (or part noncash) transaction. Noncash is defined as transactions during a period that do not result in cash receipts or cash payments in the period. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period.
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v3.23.2
SCHEDULE OF PROVISION FOR INCOME TAXES (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
U.S. Federal |
|
|
Foreign Taxes Subsidiaries |
(50,000)
|
(23,000)
|
State and local |
(1,000)
|
(1,000)
|
Total current |
(51,000)
|
(24,000)
|
U.S. Federal |
|
|
State and local |
|
|
Total deferred |
|
|
Income tax expense |
$ (51,000)
|
$ (24,000)
|
X |
- DefinitionAmount of current federal tax expense (benefit) attributable to income (loss) from continuing operations. Includes, but is not limited to, current national tax expense (benefit) for non-US (United States of America) jurisdiction.
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v3.23.2
SCHEDULE OF EFFECTIVE INCOME TAX RECONCILIATION (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
Computed “expected” tax benefit |
$ 1,490,000
|
$ 947,000
|
Change in valuation allowance |
(1,973,000)
|
(1,022,000)
|
State income taxes, net of federal benefit |
583,000
|
300,000
|
Research and development tax credits |
|
50,000
|
Permanent tax differences and other |
(17,000)
|
(197,000)
|
Stock based compensation benefit |
(5,000)
|
11,000
|
Foreign taxes of subsidiaries |
(129,000)
|
(113,000)
|
Total current |
$ (51,000)
|
$ (24,000)
|
v3.23.2
SCHEDULE OF DEFERRED TAX ASSETS (Details) - USD ($)
|
May 31, 2023 |
May 31, 2022 |
Income Tax Disclosure [Abstract] |
|
|
Accounts receivable, principally due to allowance for doubtful accounts |
$ 8,000
|
$ 43,000
|
Inventory valuation |
188,000
|
237,000
|
Compensated absences |
118,000
|
120,000
|
Net operating loss carryforwards |
5,817,000
|
4,349,000
|
Tax credit carryforwards |
1,239,000
|
1,096,000
|
Deferred rent expense/Capitalized leases |
11,000
|
20,000
|
Stock Options |
1,296,000
|
1,035,000
|
Sec 174 capitalized costs |
284,000
|
|
Losses of foreign subsidiaries & other, net |
|
41,000
|
Accumulated depreciation and amortization |
(21,000)
|
26,000
|
Total deferred tax assets |
8,940,000
|
6,967,000
|
Less valuation allowance |
(8,940,000)
|
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INCOME TAXES (Details Narrative) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Operating Loss Carryforwards [Line Items] |
|
|
Federal income tax rate |
21.00%
|
21.00%
|
Deferred tax assets, valuation allowance |
$ 8,940,000
|
$ 6,967,000
|
Increase in valuation allowance |
1,973,000
|
$ 1,063,000
|
Domestic Tax Authority [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforwards |
21,958,000
|
|
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Tax credit carryforward |
817,000
|
|
State and Local Jurisdiction [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforwards |
17,269,000
|
|
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Tax credit carryforward |
$ 533,000
|
|
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v3.23.2
SCHEDULE OF GEOGRAPHIC INFORMATION (Details) - USD ($)
|
12 Months Ended |
May 31, 2023 |
May 31, 2022 |
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
$ 5,339,000
|
$ 18,871,000
|
Asia [Member] |
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
2,021,000
|
13,375,000
|
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|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
1,798,000
|
4,339,000
|
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|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
1,470,000
|
997,000
|
Middle East [Member] |
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
39,000
|
70,000
|
South America [Member] |
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Total |
$ 11,000
|
$ 90,000
|
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v3.23.2
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS (Details)
|
May 31, 2023
USD ($)
|
Commitments and Contingencies Disclosure [Abstract] |
|
2024 |
$ 356,000
|
2025 |
366,000
|
2026 |
376,000
|
2027 |
101,000
|
Thereafter |
|
Total minimum future lease payments |
1,199,000
|
Less: imputed interest |
117,000
|
Total operating lease liabilities |
$ 1,082,000
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v3.23.2
COMMITMENTS AND CONTINGENCIES (Details Narrative)
|
|
12 Months Ended |
|
|
|
May 31, 2023
USD ($)
ft²
|
May 31, 2023
USD ($)
ft²
|
May 31, 2022
USD ($)
|
Mar. 31, 2023
USD ($)
|
Sep. 30, 2017
USD ($)
|
Nov. 30, 2016 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Operating lease description |
the Company had approximately 22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue
in Irvine, California. The lease for its headquarters expires in August 2026. The Company has the option to extend the lease for an additional
five-year term
|
|
|
|
|
|
Operating lease term |
|
|
|
|
|
10 years
|
Lease area | ft² |
8,100
|
8,100
|
|
|
|
|
Operating lease renewal term |
|
|
|
|
|
10 years
|
Accrued liabilities |
$ 548,000
|
$ 548,000
|
$ 236,000
|
|
|
|
University Of Southern California [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Clinical trial agreement maximum budgeted costs |
|
|
|
|
$ 82,000
|
|
Accrued liabilities |
|
|
17,000
|
|
|
|
Biomerica in Foods [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Clinical trial agreement maximum budgeted costs |
|
|
107,000
|
|
|
|
Accrued liabilities |
|
|
28,000
|
|
|
|
Royalty Agreements [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Royalty expense |
|
$ 13,000
|
$ 19,000
|
|
|
|
Royalty expense percentage of sales |
|
2.10%
|
1.50%
|
|
|
|
Building in Irvine California [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Security deposit |
|
|
|
$ 22,000
|
|
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Grafico Azioni Biomerica (NASDAQ:BMRA)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Biomerica (NASDAQ:BMRA)
Storico
Da Set 2023 a Set 2024