Biomerica Reports Fiscal 2023 Year End Results
25 Agosto 2023 - 11:00PM
Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider
of advanced medical products, today reported its fiscal 2023
financial results.
Net sales for the fiscal year ended May 31, 2023
were $5.3 million as compared to net sales of $18.9 million in
fiscal 2022. Net loss was $7.1 million for fiscal 2023 compared to
a net loss of $4.6 million for fiscal 2022. The decrease in sales
for fiscal 2023 was related to the Company’s decrease in sales of
COVID-19 antigen tests in fiscal 2023 compared to the prior fiscal
year. Sales revenues excluding Covid test sales increased by 15%
for fiscal 2023 compared to fiscal 2022.
The Company also announced the successful
advancement of the inFoods® IBS pilot commercialization program at
the flagship office of Gastro Health, one of the largest
gastrointestinal physician groups in the US. The Company is working
with Gastro Heath to expand the offering of inFoods IBS into other
Gastro Health offices.
With the ordering and operational processes now
optimized, Biomerica is building the infrastructure and preparing
for a full national launch of inFoods IBS across the US during the
next six months. The Company has hired a seasoned VP of Sales and
National Accounts to lead the national launch and has begun hiring
several additional territory sales representatives. The Company is
also in discussions with several large medical/hospital groups for
the use of inFoods IBS at their centers.
In addition to achieving revenue increases in
non-Covid product lines, Biomerica has achieved the following
important milestones during fiscal year 2023:
- Successfully Completed inFoods® IBS
pilot commercialization program over the last two quarters and has
accomplished the following: (1) completed all validation testing
necessary to launch the inFoods IBS product as a CLIA lab developed
test (LDT); (2) Launched the inFoods® IBS product at the flagship
office of Gastro Health in Miami; (3) Validated the inFoods® IBS
product for use with simple finger stick blood collection
technology, eliminating the need for phlebotomy and making it
easier for doctors to collect samples from patients; (4)
Streamlined the sales, operations and back-end processing for the
inFoods IBS product; (5) Completed patient and physician in office
marketing materials; (6) honed the process for practitioners to
easily order the inFoods IBS test.
- Building Sales Organization for a
national launch by calendar Q1 2024: The company has hired a
veteran VP of sales and national accounts to lead this effort. It
is now actively recruiting for territory manager roles across the
United States.
- Intellectual Property: Biomerica
now has 19 issued or allowed patents for its inFoods® technology.
In addition to patents on IBS, the Company has filed patents on the
inFoods® technology platform that cover the following other
diseases: functional dyspepsia, Crohn’s Disease, ulcerative
colitis, gastroesophageal reflux disease (“GERD”), migraine
headaches and osteoarthritis.
- Expansion of Scientific Advisory
Board (SAB): Biomerica appointed Mayo Clinic gastroenterologist,
Dr. Brian E. Lacy, to the Company’s SAB. Dr. Lacy is the former
co-Editor in Chief of the American Journal of Gastroenterology, the
former Editor in Chief of Clinical and Translational
Gastroenterology, and has served as the co-Chairman for the Rome IV
Committee on Functional Bowel Disorders. Dr. Lacy has authored over
225 peer reviewed articles.
- Helicobacter pylori (“H. pylori”):
After review by the FDA and at their request, the Company is now
concluding one final set of data for the hp+detect™ which will be
sent to the FDA in the coming weeks. The Biomerica hp+detect™
product is designed to detect the presence of the H. pylori
bacteria which infects approximately 35% of the U.S. population.
Over 80% of gastric cancers are attributed to H. pylori infection,
and gastric cancer is the third most common cause of cancer-related
death worldwide.
- EZ Detect™ Colorectal Disease Screening Test: In addition to
Walmart, the Company announced that CVS is now selling the EZ
Detect™ Colon Disease at-home test (https://ezdetect.com) in over
7,000 CVS stores and online. Colorectal cancer (CRC) is the second
most common cause of cancer death in the United States. Since the
COVID-19 pandemic, consumers have become much more comfortable with
at-home diagnostic testing and acquiring these tests from
retailers. This has increased the demand for many tests that
consumers can perform at home.
Jim Leavitt, Director of Clinical Innovation at
Gastro Health said, “inFoods IBS has been well received by patients
and has shown beneficial outcomes. This personalized approach to
IBS treatment has the potential to significantly improve the lives
of so many people who are suffering from IBS.”
“We have now completed the back-end and
operational set-up to allow us to launch the inFoods IBS product
nationally. The product addresses the $30 billion IBS market where
surprisingly little relief is currently available for patients.
This product offers broad appeal to patients, physicians, and
insurers,” stated Zackary Irani, CEO of Biomerica.
About Biomerica (NASDAQ:
BMRA) Biomerica, Inc.
(www.biomerica.com) is 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. The
Company's products are designed to enhance the health and
well-being of people, while reducing total healthcare costs.
Biomerica primarily focus is on gastrointestinal and inflammatory
diseases where the Company has multiple diagnostic and therapeutic
products in development.
About inFoods® The inFoods IBS
test is designed to assess a patient’s above normal
immunoreactivity to specific foods utilizing a simple finger prick
blood sample. Instead of difficult to manage broad dietary
restrictions, physicians can now use the inFoods IBS information to
make targeted, patient-specific recommendations about specific
foods that, when removed from the diet, may alleviate IBS symptoms
such as pain, bloating, diarrhea and constipation. The inFoods IBS
test and clinical outcomes were studied 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. The clinical
results for improvement in the Abdominal Pain Intensity (API)
responder endpoint of >30% reduction in pain, for IBS patients
in the treatment diet arm was greater than patients in the placebo
diet arm (p-value of 0.0246). The improvement for patients in the
treatment arm versus the placebo arm is considered clinically
significant and for certain endpoints is similar and, in some
cases, better than the current drugs in the market. Further
information about Biomerica’s patented inFoods® Technology Platform
can be found at: https://biomerica.com/inFoods/our-technology/.
The Private Securities Litigation Reform Act of
1995 provides a "safe harbor" for forward-looking statements.
Certain information included in this press release (as well as
information included in oral statements or other written statements
made or to be made by Biomerica) contains statements that are
forward-looking, such as statements relating to the Company’s
current and future sales, revenues, overhead, expenses, cost of
goods, operations and earnings, efficacy of the Company’s products
and tests, FDA and/or international regulatory authorization for
the Company’s products to be marketed and sold, including the
hp-detect product, the inFoods ISB product, and the Company’s other
current and future products, the rapidity of testing results,
uniqueness of the Company’s products, accuracy of the Company’s
tests and products, expected completion of clinical studies,
pricing of the Company’s test kits, domestic and/or international
market acceptance and demand for the Company’s products, potential
revenues from the sale of current or future products, availability
of the Company’s test kits, patent protection and freedom to
operate on any of the Company’s products or technologies, future
production costs and overhead, sales and administrative costs,
R&D expenditures, materials costs, needed inventory reserves,
collectability of receivables, legal costs and other extraordinary
costs. Such forward-looking information involves important risks
and uncertainties that could significantly affect anticipated
results, in the future, including, without limitation: earnings and
other financial results; results of studies testing the efficacy of
the Company’s inFoods tests and other products; regulatory
approvals necessary prior to commercialization of the Company’s
products; availability of the Company’s test kits and other
products; capacity, shipping logistics, resource and other
constraints on our suppliers; dependence on our third party
manufacturers; dependence on international shipping carriers;
governmental import/export regulations; demand for our various
tests and other products; competition from other similar products
and from competitors that have significantly more financial and
other resources available to them; governmental virus control
regulations that make it difficult or impossible for the company to
maintain current operations; regulatory compliance and oversite,
and the Company’s ability to obtain patent protection on any
aspects of its rapid test technologies. Accordingly, such results
may differ materially from those expressed in any forward-looking
statements made by or on behalf of Biomerica. Additionally,
potential risks and uncertainties include, among others,
fluctuations in the Company's operating results due to its business
model and expansion plans, downturns in international and or
national economies, the Company's ability to raise additional
capital, the competitive environment in which the Company will be
competing, and the Company's dependence on strategic relationships.
The Company is under no obligation to update any forward-looking
statements after the date of this release.
Corporate Contact:
Allen Barbieri 949-645-2111
investors@biomerica.com
Source: Biomerica, Inc.
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