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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED NOVEMBER 30, 2023 or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
File Number: 001-37863
BIOMERICA,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
95-2645573 |
(State
or other jurisdiction of
incorporation
of organization) |
|
(I.R.S.
Employer
Identification No.) |
17571
Von Karman Avenue, Irvine, CA |
|
92614 |
(Address
of principal executive offices) |
|
(Zip
Code) |
REGISTRANT’S
TELEPHONE NUMBER:
(949)
645-2111
Securities
registered under Section 12(b) of the Exchange Act:
(Title
of each class)
COMMON
STOCK, PAR VALUE $0.08
(Name
of each exchange on which registered)
NASDAQ
Capital Market
(Trading
symbol)
BMRA
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 (paragraph 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post 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 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 is a shell company (as defined in Rule 12b-2 of the Act).
Yes
☐ No ☒
The
number of shares of the registrant’s common stock outstanding as of January 16, 2024 was 16,821,646.
BIOMERICA,
INC.
INDEX
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
| |
November 30, 2023 | | |
May 31, 2023 | |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 7,134,000 | | |
$ | 9,719,000 | |
Accounts receivable, net | |
| 1,067,000 | | |
| 722,000 | |
Inventories, net | |
| 1,841,000 | | |
| 2,056,000 | |
Prepaid expenses and other | |
| 223,000 | | |
| 300,000 | |
Total current assets | |
| 10,265,000 | | |
| 12,797,000 | |
Property and equipment, net of accumulated depreciation and amortization | |
| 210,000 | | |
| 213,000 | |
Right-of-use assets, net of accumulated amortization of $761,000 and $617,000 as of November 30, 2023 and May 31, 2023, respectively | |
| 891,000 | | |
| 1,035,000 | |
Investments | |
| 165,000 | | |
| 165,000 | |
Intangible assets, net of accumulated amortization | |
| 204,000 | | |
| 165,000 | |
Other assets | |
| 96,000 | | |
| 79,000 | |
Total Assets | |
$ | 11,831,000 | | |
$ | 14,454,000 | |
Liabilities and Shareholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 783,000 | | |
$ | 892,000 | |
Accrued compensation | |
| 668,000 | | |
| 696,000 | |
Advance from customers | |
| 60,000 | | |
| 60,000 | |
Lease liabilities, current portion | |
| 311,000 | | |
| 297,000 | |
Total current liabilities | |
| 1,822,000 | | |
| 1,945,000 | |
Lease liabilities, net of current portion | |
| 626,000 | | |
| 785,000 | |
Total Liabilities | |
| 2,448,000 | | |
| 2,730,000 | |
| |
| | | |
| | |
Commitments and contingencies (Note 6) | |
| - | | |
| - | |
| |
| | | |
| | |
Shareholders’ Equity: | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock, Series A 5% convertible, $0.08 par value, 571,429 shares authorized, none issued and outstanding as of November 30, 2023 and May 31, 2023 | |
| - | | |
| - | |
Preferred stock, undesignated, no par value, 4,428,571 shares authorized, none issued and outstanding as of November 30, 2023 and May 31, 2023 | |
| - | | |
| - | |
Preferred stock, value | |
| - | | |
| - | |
Common stock, $0.08 par value, 25,000,000 shares authorized, 16,821,646 issued and outstanding at November 30, 2023 and May 31, 2023, respectively | |
| 1,346,000 | | |
| 1,346,000 | |
Additional paid-in-capital | |
| 52,997,000 | | |
| 52,705,000 | |
Accumulated other comprehensive loss | |
| (104,000 | ) | |
| (110,000 | ) |
Accumulated deficit | |
| (44,856,000 | ) | |
| (42,217,000 | ) |
Total Shareholders’ Equity | |
| 9,383,000 | | |
| 11,724,000 | |
Total Liabilities and Shareholders’ Equity | |
$ | 11,831,000 | | |
$ | 14,454,000 | |
The
accompanying notes are an integral part of these statements.
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
AND
COMPREHENSIVE LOSS (UNAUDITED)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended November 30, | | |
For the Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net sales | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Cost of sales | |
| (1,242,000 | ) | |
| (1,130,000 | ) | |
| (2,541,000 | ) | |
| (2,822,000 | ) |
Gross profit | |
| 325,000 | | |
| 352,000 | | |
| 740,000 | | |
| 297,000 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 1,521,000 | | |
| 1,556,000 | | |
| 2,696,000 | | |
| 3,210,000 | |
Research and development | |
| 412,000 | | |
| 462,000 | | |
| 883,000 | | |
| 823,000 | |
Total operating expenses | |
| 1,933,000 | | |
| 2,018,000 | | |
| 3,579,000 | | |
| 4,033,000 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (1,608,000 | ) | |
| (1,666,000 | ) | |
| (2,839,000 | ) | |
| (3,736,000 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income: | |
| | | |
| | | |
| | | |
| | |
Interest and dividend income | |
| 109,000 | | |
| 41,000 | | |
| 231,000 | | |
| 41,000 | |
Total other income | |
| 109,000 | | |
| 41,000 | | |
| 231,000 | | |
| 41,000 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Provision for income taxes | |
| (8,000 | ) | |
| (1,000 | ) | |
| (31,000 | ) | |
| (3,000 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,507,000 | ) | |
$ | (1,626,000 | ) | |
$ | (2,639,000 | ) | |
$ | (3,698,000 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic net loss per common share | |
$ | (0.09 | ) | |
$ | (0.12 | ) | |
$ | (0.16 | ) | |
$ | (0.28 | ) |
| |
| | | |
| | | |
| | | |
| | |
Diluted net loss per common share | |
$ | (0.09 | ) | |
$ | (0.12 | ) | |
$ | (0.16 | ) | |
$ | (0.28 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common and common equivalent shares: | |
| | | |
| | | |
| | | |
| | |
Basic | |
| 16,821,646 | | |
| 13,455,166 | | |
| 16,821,646 | | |
| 13,271,845 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted | |
| 16,821,646 | | |
| 13,455,166 | | |
| 16,821,646 | | |
| 13,271,845 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,507,000 | ) | |
$ | (1,626,000 | ) | |
$ | (2,639,000 | ) | |
$ | (3,698,000 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss), net of tax: | |
| | | |
| | | |
| | | |
| | |
Foreign currency translation | |
| - | | |
| (9,000 | ) | |
| 6,000 | | |
| (21,000 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss | |
$ | (1,507,000 | ) | |
$ | (1,635,000 | ) | |
$ | (2,633,000 | ) | |
$ | (3,719,000 | ) |
The
accompanying notes are an integral part of these statements.
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
For
the Six Months Ended November 30, 2023
| |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
| |
Common Stock | | |
Additional Paid in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholder’s | |
| |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
Balances at May 31, 2023 | |
| 16,821,646 | | |
$ | 1,346,000 | | |
$ | 52,705,000 | | |
$ | (110,000 | ) | |
$ | (42,217,000 | ) | |
$ | 11,724,000 | |
Exercise of stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| 6,000 | | |
| - | | |
| 6,000 | |
Share-based compensation | |
| - | | |
| - | | |
| 170,000 | | |
| - | | |
| - | | |
| 170,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,132,000 | ) | |
| (1,132,000 | ) |
Balances at August 31, 2023 | |
| 16,821,646 | | |
| 1,346,000 | | |
| 52,875,000 | | |
| (104,000 | ) | |
| (43,349,000 | ) | |
| 10,768,000 | |
Exercise of stock options | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Share-based compensation | |
| - | | |
| - | | |
| 122,000 | | |
| - | | |
| - | | |
| 122,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (1,507,000 | ) | |
| (1,507,000 | ) |
Balances at November 30, 2023 | |
| 16,821,646 | | |
$ | 1,346,000 | | |
$ | 52,997,000 | | |
$ | (104,000 | ) | |
$ | (44,856,000 | ) | |
$ | 9,383,000 | |
For the Six Months Ended November 30,
2022
| |
Common Stock | | |
Additional Paid in | | |
Accumulated Other Comprehensive | | |
Accumulated | | |
Total Stockholder’s | |
| |
Shares | | |
Amount | | |
Capital | | |
Loss | | |
Deficit | | |
Equity | |
Balances at May 31, 2022 | |
| 12,867,924 | | |
$ | 1,029,000 | | |
$ | 42,447,000 | | |
$ | (74,000 | ) | |
$ | (35,077,000 | ) | |
$ | 8,325,000 | |
Exercise of stock options | |
| 15,000 | | |
| 1,000 | | |
| 13,000 | | |
| - | | |
| - | | |
| 14,000 | |
Net proceeds from ATM | |
| 523,977 | | |
| 42,000 | | |
| 1,722,000 | | |
| - | | |
| - | | |
| 1,764,000 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (13,000 | ) | |
| - | | |
| (13,000 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 304,000 | | |
| - | | |
| - | | |
| 304,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,072,000 | ) | |
| (2,072,000 | ) |
Balances at August 31, 2022 | |
| 13,406,901 | | |
| 1,072,000 | | |
| 44,486,000 | | |
| (87,000 | ) | |
| (37,149,000 | ) | |
| 8,322,000 | |
Balances | |
| 13,406,901 | | |
| 1,072,000 | | |
| 44,486,000 | | |
| (87,000 | ) | |
| (37,149,000 | ) | |
| 8,322,000 | |
Exercise of stock options | |
| 31,500 | | |
| 3,000 | | |
| 63,000 | | |
| - | | |
| - | | |
| 66,000 | |
Net proceeds from ATM | |
| 41,012 | | |
| 3,000 | | |
| 170,000 | | |
| - | | |
| - | | |
| 173,000 | |
Foreign currency translation | |
| - | | |
| - | | |
| - | | |
| (9,000 | ) | |
| - | | |
| (9,000 | ) |
Share-based compensation | |
| - | | |
| - | | |
| 318,000 | | |
| - | | |
| - | | |
| 318,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
$ | (1,626,000 | ) | |
| (1,626,000 | ) |
Balances at November 30, 2022 | |
| 13,479,413 | | |
$ | 1,078,000 | | |
$ | 45,037,000 | | |
$ | (96,000 | ) | |
$ | (38,775,000 | ) | |
$ | 7,244,000 | |
Balances | |
| 13,479,413 | | |
$ | 1,078,000 | | |
$ | 45,037,000 | | |
$ | (96,000 | ) | |
$ | (38,775,000 | ) | |
$ | 7,244,000 | |
The
accompanying notes are an integral part of these statements.
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
2023 | | |
2022 | |
| |
For the Six Months Ended November 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (2,639,000 | ) | |
$ | (3,698,000 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 39,000 | | |
| 48,000 | |
Provision (recovery) for allowance on accounts receivable | |
| (7,000 | ) | |
| 369,000 | |
Inventory reserve | |
| (174,000 | ) | |
| (72,000 | ) |
Share-based compensation | |
| 292,000 | | |
| 622,000 | |
Amortization of right-of-use asset | |
| 144,000 | | |
| 134,000 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (338,000 | ) | |
| (445,000 | ) |
Inventories | |
| 390,000 | | |
| 427,000 | |
Prepaid expenses and other | |
| 77,000 | | |
| 200,000 | |
Other assets | |
| (17,000 | ) | |
| 16,000 | |
Accounts payable and accrued expenses | |
| (110,000 | ) | |
| (302,000 | ) |
Accrued compensation | |
| (28,000 | ) | |
| 50,000 | |
Advance from customers | |
| - | | |
| (2,000 | ) |
Reduction in lease liabilities | |
| (145,000 | ) | |
| (133,000 | ) |
Net cash used in operating activities | |
| (2,516,000 | ) | |
| (2,786,000 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (27,000 | ) | |
| (58,000 | ) |
Expenditures related to intangibles | |
| (48,000 | ) | |
| - | |
Net cash used in investing activities | |
| (75,000 | ) | |
| (58,000 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Gross proceeds from sale of common stock | |
| - | | |
| 1,988,000 | |
Costs from sale of common stock | |
| - | | |
| (52,000 | ) |
Proceeds from exercise of stock options | |
| - | | |
| 79,000 | |
Net cash provided by financing activities | |
| - | | |
| 2,015,000 | |
| |
| | | |
| | |
Effect of exchange rate changes in cash | |
| 6,000 | | |
| (21,000 | ) |
Net decrease in cash and cash equivalents | |
| (2,585,000 | ) | |
| (850,000 | ) |
| |
| | | |
| | |
Cash and cash equivalents at beginning of year | |
| 9,719,000 | | |
| 5,917,000 | |
| |
| | | |
| | |
Cash and cash equivalents at end of period | |
$ | 7,134,000 | | |
$ | 5,067,000 | |
| |
| | | |
| | |
Supplemental Disclosure of Cash Flow Information: | |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Income taxes | |
$ | 30,000 | | |
$ | 3,000 | |
| |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
| |
| | | |
| | |
Write off of intangible assets, cost | |
$ | - | | |
$ | 6,000 | |
Write off of intangible assets, accumulated amortization | |
$ | - | | |
$ | 1,000 | |
The
accompanying notes are an integral part of these statements.
BIOMERICA,
INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
1: BASIS OF PRESENTATION
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 eventual regulatory approval, of patented, diagnostic-guided therapy
(“DGT”) products based on our inFoods® Technology platform that treat gastrointestinal diseases, such as irritable
bowel syndrome (“IBS”), and other inflammatory diseases. These inFoods based products are directed at chronic inflammatory
illnesses that are widespread and common, and as such address very large markets. The first product we are launching using this patented
inFoods Technology is our inFoods IBS product which uses a simple blood sample to identify patient-specific foods that, when removed
from their diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, cramping 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 a panel
of specific foods that have been shown to often be problematic to IBS sufferers. A food identified as positive (causing an abnormally
high immune response in the patient) is simply removed from the diet to help alleviate IBS symptoms. We have launched this product with
certain large gastroenterology (“GI”) physician groups that are now offering this product to their patients. We have also
recently hired an internal sales force to sign up additional GI physician groups who are interested in offering this product to their
patients. As such, we are expecting growth in revenues from the launch of our inFoods IBS product in coming quarters.
Our
other 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 at Walmart, CVS Pharmacy and Amazon). 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 2019 SARS-CoV-2 novel coronavirus 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. We began selling these COVID-19 related diagnostic tests during fiscal 2021,
and we experienced significant revenues from such sales during fiscal 2021 and 2022 with lesser sales in fiscal 2023. Due to falling
demand, there were no sales of our COVID-19 related products in the six months ended November 30, 2023. As such, our COVID-19
product sales have caused significant swings in our revenues over the past nine quarters.
Our
products that accounted for all of our revenues during the six months ended November 30, 2023, are primarily focused on gastrointestinal
diseases, colorectal 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.
The
unaudited condensed consolidated financial statements herein have been prepared by management pursuant to the rules and regulations of
the United States Securities and Exchange Commission (“SEC”). The accompanying unaudited condensed consolidated financial
statements have been prepared under the presumption that users of the interim financial information have either read or have access to
the audited consolidated financial statements for the latest fiscal year ended May 31, 2023. Accordingly, certain information and note
disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles
(“GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments
considered necessary for a fair presentation have been included. Operating results for the three and six months ended November 30, 2023
are not necessarily indicative of the results that may be expected for the fiscal year ending May 31, 2024. For further information,
refer to the audited consolidated financial statements and notes thereto for the fiscal year ended May 31, 2023 included in the Company’s
Annual Report on Form 10-K filed with the SEC on August 25, 2023. Management has evaluated all subsequent events and transactions through
the date of filing this report.
NOTE
2: SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES
OF CONSOLIDATION
The
condensed consolidated financial statements include the accounts of Biomerica, Inc. as well as its 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 condensed consolidated financial statements in conformity with 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 condensed
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 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 liability and right-of-use assets, which are calculated based on certain assumptions such as borrowing
rate, the likelihood of lease extensions to occur, asset valuation, 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.
MARKETS
AND METHODS OF DISTRIBUTION
The
majority of the Company’s revenues come from the sale of products that the company manufactures in the U.S. and in Mexico. Some
of the raw materials used in manufacturing come from Asia and other regions of the world. Finally, most of the Company’s revenues
are generated from the international sales of its products. Due to global and economic disruptions caused by the COVID-19 pandemic, the
ongoing war in Ukraine and Israel, 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 the following areas, and may face further challenges from supply chain
disruptions, cost inflation, loss of contracts and/or 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
Company’s current sales and marketing focus is on the sale of the inFoods IBS product which is manufactured and sold within the U.S. and the launch
of our new H. Pylori test that was recently cleared for sale in the US by the FDA, which is also manufactured and sold within the
U.S.
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $44,856,000 million
as of November 30, 2023. Management expects to continue to incur significant costs as it advances its clinical trials, product development,
and commercial product launch activities. As of November 30, 2023, the Company had cash and cash equivalents of approximately $7,134,000
and working capital of approximately $8,443,000.
On
July 20, 2020, the Company filed with the Securities and Exchange Commission (“SEC”) a Form S-3 shelf registration statement
and base prospectus which was declared effective by the SEC on September 30, 2020. This shelf registration statement registered the sale
of up to $90,000,000 of the Company’s equity securities during the three years ended September 30, 2023.
Under
the Company’s outstanding Registration Statement, 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, a previously ATM facility has been withdrawn and is not
active.
To
replace the shelf registration statement that was set to expire on September 30, 2023, on September 27, 2023, the Company filed with
the SEC a new Form S-3 shelf registration statement and base prospectus which was declared effective by the SEC on September 29, 2023.
This new shelf registration statement registers the sale of up to $20,000,000 of the Company’s equity securities during the three
years ending September 29, 2026.
The
Company intends to use the net proceeds from past offerings and any future 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 February 2025. As a result of cash and cash equivalents
on hand on November 30, 2023, largely from the public offering, and the ability to raise additional funds if needed through the sale
of shares of the Company’s common stock, management believes the Company has sufficient funds to operate through at least February
2025.
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.
Consolidated
net sales were approximately $1,567,000 and $1,482,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately
$3,281,000 and $3,119,000 for the six months ended November 30, 2023 and 2022, respectively.
For
the three months ended November 30, 2023, the Company had two key customers who are located in foreign countries which accounted for
52% of net consolidated sales. For the three months ended November 30, 2022, the Company had two key customers, one located in Asia and
one located in United States which accounted for 48% of net consolidated sales. For the six months ended November 30, 2023 and 2022,
the Company had one key customer who is located in Asia which accounted for 49% and 44% of net consolidated sales, respectively.
Total
gross receivables on November 30, 2023 and May 31, 2023 were approximately $1,089,000 and $751,000, respectively. As of November 30,
2023, the Company had two key customers, who are located in foreign countries which accounted for a total of 64% of gross accounts receivable.
As of May 31, 2023, the Company had one key customer, who is located in Asia which accounted for a total of 36% of gross accounts receivable.
For
the three months ended November 30, 2023, the Company had five key vendors which accounted for 75% of the purchases of raw materials.
For the three months ended November 30, 2022, the Company had one key vendor which accounted for 12% of the purchases of raw materials.
For the six months ended November 30, 2023, the Company had five vendors which accounted for 76% of the purchases of raw materials. For
the six months ended November 30, 2022, the Company had one key vendor which accounted for 8% of the purchases of raw materials.
As
of November 30, 2023 and May 31, 2023, the Company had three and one key vendors which accounted for 55%
and 23%,
respectively, of accounts payable.
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
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. Based on various
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.
The
Company adopted Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (codified
as Accounting Standards Codification (“ASC”) 326) on June 1, 2023. ASC 326 adds to U.S. GAAP the current expected credit
loss (“CECL”) model, a measurement model based on expected losses rather than incurred losses. Prior to the adoption of ASC
326, the Company evaluated receivables on a quarterly basis and adjusted the allowance for doubtful accounts accordingly. Balances over
ninety days old were usually reserved for unless collection was reasonably assured. Under the application of ASC 326, the Company’s
historical credit loss experience provides the basis for the estimation of expected credit losses, as well as current economic and business
conditions, and anticipated future economic events that may impact collectability. In developing its expected credit loss estimate, the
Company evaluated the appropriate grouping of financial assets based upon its evaluation of risk characteristics, including consideration
of the types of products and services sold. Account balances are written off against the allowance for expected credit losses after all
means of collection have been exhausted and the potential for recovery is considered remote.
Occasionally,
certain long-standing customers who routinely place large orders will have unusually large receivable 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 November 30, 2023 and May 31, 2023, the Company has established a reserve of approximately $22,000 and $29,000, 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 prepaid expenses and
other, until either the inventory is physically received, or the insurance and other items are expensed.
As
of November 30, 2023 and May 31, 2023, the prepaids were approximately $223,000 and $300,000, 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.
Net
inventories are approximately the following:
SCHEDULE OF NET INVENTORIES
| |
November 30, 2023 | | |
May 31, 2023 | |
Raw materials | |
$ | 1,377,000 | | |
$ | 1,677,000 | |
Work in progress | |
| 781,000 | | |
| 869,000 | |
Finished products | |
| 181,000 | | |
| 182,000 | |
Total gross inventory | |
| 2,339,000 | | |
| 2,728,000 | |
Inventory reserves | |
| (498,000 | ) | |
| (672,000 | ) |
Net inventory | |
$ | 1,841,000 | | |
$ | 2,056,000 | |
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 November 30, 2023, and May 31, 2023, inventory reserves were approximately $498,000 and $672,000,
respectively.
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 were approximately $15,000 and $16,000 for the three months ended November 30, 2023
and 2022, respectively, and approximately $30,000 and $36,000 for the six months ended November 30, 2023 and 2022, respectively.
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights and patents, and are accounted for based on 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 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 patents are based on their individual useful lives which average around 15
years. Amortization expense was approximately $4,000 and $3,000 for the three months ended November 30, 2023 and 2022, respectively,
and approximately $9,000 and $12,000 for the six months ended November 30, 2023 and 2022, respectively. Amortizing intangible assets
are tested for impairment if management determines that events or changes in circumstances indicate that the asset might be impaired.
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 six months ended November 30, 2023, there was no impairment. During the six months ended
November 30, 2022, an impairment adjustment was made of $6,000.
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 November 30, 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 Holdings during the period ended November 30, 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 $292,000 and $622,000 of share-based compensation during the six months ended November 30, 2023 and 2022,
respectively.
The
following summary presents the options granted, exercised, expired, canceled and outstanding for the six months ended November 30, 2023:
SUMMARY OF OPTIONS ACTIVITY
| |
Option Shares | | |
Weighted Average
Exercise Price | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | |
Granted | |
| 86,000 | | |
| 1.09 | |
Exercised | |
| - | | |
| - | |
Cancelled or expired | |
| (148,500 | ) | |
| 4.90 | |
Options Outstanding at November 30, 2023 | |
| 2,280,116 | | |
$ | 3.33 | |
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 six months ended November 30, 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. Physician’s 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 November 30, 2023, the Company had approximately $60,000 of advances from domestic customers, which are prepayments on orders for
future shipments.
Disaggregation
of revenue:
The
following is a breakdown of revenues according to markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Clinical lab | |
$ | 992,000 | | |
$ | 902,000 | | |
$ | 2,283,000 | | |
$ | 2,048,000 | |
Over-the-counter | |
| 443,000 | | |
| 466,000 | | |
| 745,000 | | |
| 679,000 | |
Contract manufacturing | |
| 131,000 | | |
| 52,000 | | |
| 248,000 | | |
| 147,000 | |
Physician’s office | |
| 1,000 | | |
| 62,000 | | |
| 5,000 | | |
| 245,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
See
Note 4 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 $412,000 and $462,000 of research and development
costs during the three months ended November 30, 2023 and 2022, respectively, and approximately $883,000 and $823,000 of research and
development costs during the six months ended November 30, 2023 and 2022, respectively.
INCOME
TAXES
For
the three months ended November 30, 2023, the Company had an income tax expense of approximately $8,000. For the six months ended November
30, 2023, the Company had an income tax expense of approximately $31,000. These expenses consisted of state minimum taxes and miscellaneous
foreign taxes. During the three and six months ended November 30, 2023, the Company had a net operating loss (“NOL”) that
generated deferred tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences
between the financial statements and income tax carrying values using tax rates in effect for the years such differences are expected
to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income
tax assets, the Company has determined that it is more likely than not that these deferred tax assets will not be realized. Accordingly,
the Company has established a full valuation allowance against its deferred tax assets as of November 30, 2023.
The
Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
For the three months ended November 30, 2023, the Company had no accrued interest or penalties related to uncertain tax positions.
ADVERTISING
COSTS
The
Company reports the cost of advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$26,000 and $18,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately $56,000 and $36,000 during
the six months ended November 30, 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 period, and revenues and costs are translated using average exchange
rates for the period. The resulting translation 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 condensed consolidated statements of operations
for the three and six months ended November 30, 2023 and 2022.
RIGHT-OF-USE
ASSETS AND LEASE LIABILITY
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.
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 amount of anti-dilutive stock options not included in the loss per share calculation
on November 30, 2023 and 2022 was 2,280,116 and 2,338,616, respectively.
RECENT
ACCOUNTING PRONOUNCEMENTS
Recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by the 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. This ASU requires 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 SEC to fiscal years beginning after December
15, 2022, including interim periods within those years. Early adoption is permitted. The Company adopted ASU 2016-03 on June 1, 2023,
and the adoption of this update did not have a material impact on the Company’s condensed consolidated financial statements.
NOTE
3: SHAREHOLDERS’ EQUITY
During
the six months ended November 30, 2022, the Company sold 564,989 shares of its common stock at prices ranging from $3.15 to 4.26 under
its Form S-3 Registration Statement and ATM Offering which resulted in gross proceeds of approximately $1,988,000 and net proceeds to
the Company of approximately $1,937,000 after deducting commissions for each sale and legal, accounting, and other fees related to the
ATM Offering. In March 2023, we terminated the ATM offering agreement and sold 3,333,333 shares of our common stock in a firm commitment
public offering under the Company’s 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. On November 30, 2023, the Company did not have an open ATM offering in place. No shares of common stock or other equity securities
of the Company were sold under the shelf registration statement during the six months ended November 30, 2023.
NOTE
4: GEOGRAPHIC INFORMATION
The
Company operates as one segment. Geographic information regarding net sales is approximately as follows:
SCHEDULE OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | | |
| | | |
| | |
Asia | |
$ | 606,000 | | |
$ | 663,000 | | |
$ | 1,632,000 | | |
$ | 1,477,000 | |
Europe | |
| 428,000 | | |
| 415,000 | | |
| 754,000 | | |
| 967,000 | |
North America | |
| 320,000 | | |
| 401,000 | | |
| 676,000 | | |
| 669,000 | |
Middle East | |
| 212,000 | | |
| - | | |
| 213,000 | | |
| - | |
South America | |
| 1,000 | | |
| 3,000 | | |
| 6,000 | | |
| 6,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
As
of November 30, 2023 and May 31, 2023, approximately $555,000 and $626,000 of the Company’s gross inventory was located in Mexicali,
Mexico, respectively.
As
of November 30, 2023 and May 31, 2023, approximately $16,000 and $17,000 of the Company’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico, respectively.
NOTE
5: LEASES
The
Company leases its facilities. On November 30, 2023, the Company had approximately 22,000 square feet of floor space at its corporate
headquarters at 17571 Von Karman Avenue in Irvine, California, which it has been leasing since 2009. The lease for its headquarters expired
on August 31, 2016. 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 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 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.
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 three month and six month ended November 30, 2023 and 2022:
SCHEDULE OF OPERATING LEASES
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating lease cost | |
$ | 88,000 | | |
$ | 88,000 | | |
$ | 176,000 | | |
| 176,000 | |
Variable lease cost | |
| 2,000 | | |
| - | | |
| 5,000 | | |
| 1,000 | |
Short-term lease cost | |
$ | 1,000 | | |
$ | 1,000 | | |
$ | 2,000 | | |
| 2,000 | |
Total lease cost | |
$ | 91,000 | | |
$ | 89,000 | | |
$ | 183,000 | | |
$ | 179,000 | |
The
approximate maturity of lease liabilities as of November 30, 2023 are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending November 30: | |
| |
| |
Operating Leases | |
2024 | |
$ | 361,000 | |
2025 | |
| 371,000 | |
2026 | |
| 290,000 | |
2027 | |
| - | |
Total minimum future lease payments | |
| 1,022,000 | |
Less: imputed interest | |
| 85,000 | |
Total operating lease liabilities | |
$ | 937,000 | |
The
following table summarizes the Company’s other supplemental lease information for the six months ended November 30, 2023 and 2022:
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash paid for operating lease liabilities | |
$ | 177,000 | | |
$ | 174,000 | |
Weighted-average remaining lease term (years) | |
| 2.77 | | |
| 3.77 | |
Weighted-average discount rate | |
| 6.50 | % | |
| 6.50 | % |
The
Company also has various insignificant leases for office equipment.
NOTE
6: COMMITMENTS AND CONTINGENCIES
LITIGATION
The
Company is, from time to time, involved in legal proceedings, claims, and litigation arising in the ordinary course of business.
There
were no material legal proceedings pending as of November 30, 2023.
NOTE
7: SUBSEQUENT EVENTS
On
December 18, 2023, the Company received FDA clearance for its new HP Detect Stool Antigen ELISA test, a new product that is designed
to detect the presence of the H. Pylori bacteria. The Company is now marketing this product in the U.S. and intends to initiate marketing
of the product in certain international markets in the near future.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis in conjunction with our unaudited condensed consolidated financial statements and the
accompanying notes thereto included in Part I, Item 1 of this Report and the audited consolidated
financial statements in our Annual Report on Form 10-K for the fiscal year ended May 31, 2023 (our 2023 Annual 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 our 2023 Annual 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 inFoods based 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 to
identify patient-specific foods that, when removed from the patient’s 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 a panel of specific foods that have been shown to often be
problematic to IBS suffers. A food identified as positive, and causing an abnormally high 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 double blinded,
placebo-controlled 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 trial was designed to determine the difference in the improvement in
IBS symptoms for patients in the treatment arm, versus patients in the placebo arm of the trial. The top-line trial results were
reported in February 2022. Multiple endpoints demonstrated statistically significant improvements for participants in the treatment
arm, 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 designed to provide efficacy data for the product, and to determine the primary symptom
endpoint, or endpoints to be used in a possible final pivotal trial that would be conducted to attain the validation data needed to
apply for U.S. Food and Drug Administration (“FDA”) product clearance. We are continuing to review and refine the
complete dataset and have selected the final endpoint that we would intend to use in a possible final pivotal trial. No date has yet
been set for commencing this final trial.
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 patient samples are now being run at the lab. In late fiscal
2023, we trial launched this product with one large GI physician group that is now offering this product to their patients. During fiscal
2024, we are working 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. We have also recently hired an internal sales force to sign up additional GI physician
groups who are interested in offering this product to their patients. As such, we are expecting growth in revenues from the launch of
our inFoods IBS product in coming quarters.
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
are also evaluating and pursuing partnership/licensing opportunities 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, Walgreens, 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 2019 SARS-CoV-2 novel coronavirus 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. We began selling these COVID-19 related diagnostic tests during fiscal
2021, and we experienced significant revenues from such sales during fiscal 2021 and 2022 with lesser sales in fiscal 2023. Due to falling
demand, there were no sales of our COVID-19 related products in the three months ended November 30, 2023. As such, our COVID-19
product sales have caused significant swings in our revenues over the past nine quarters.
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.
On December 18, 2023, the Company received FDA clearance for the H. Pylori product to be sold in the US. Subsequently, we have now begun
marketing the product in the U.S. market. We have also begun discussions with international distributors for this product and expect to
see revenues both in the U.S. market and through these international channels during 2024.
The
majority of our research and development efforts are focused on development and commercialization of products such as our H. Pylori product,
improving and expanding the inFoods IBS product, developing other new products that utilize the inFoods platform, and developing
new diagnostic products with outside medical diagnostic companies that we intend to manufacture for them.
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
Three months ended November 30, 2023
Net
Sales and Cost of Sales
The
following is a breakdown of revenues according to markets to which the products are sold:
| |
Three Months Ended November 30, | | |
Increase (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
Clinical lab | |
$ | 992,000 | | |
$ | 902,000 | | |
$ | 90,000 | | |
| 10 | % |
Over-the-counter | |
| 443,000 | | |
| 466,000 | | |
| (23,000 | ) | |
| -5 | % |
Contract manufacturing | |
| 131,000 | | |
| 52,000 | | |
| 79,000 | | |
| 152 | % |
Physician’s office | |
| 1,000 | | |
| 62,000 | | |
| (61,000 | ) | |
| -98 | % |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 85,000 | | |
| 6 | % |
Consolidated
net sales were approximately $1,567,000 for the three months ended November 30, 2023, as compared to $1,482,000 for the three months
ended November 30, 2022, an increase of approximately $85,000, or 6%. This increase for the three months ended November 30, 2023, was
driven primarily by larger sales in the food intolerance products and increased contract manufacturing billings. Periodic and infrequent
orders may cause volatility in quarterly sales.
Consolidated
cost of sales were approximately $1,242,000, or 79% of net sales, for the three months ended November 30, 2023, as compared to $1,130,000,
or 76% of net sales, for the three months ended November 30, 2022, an increase of approximately $112,000, or 10%. The increase for the
three months ended November 30, 2023, was driven primarily by correlated increased sales for the quarter.
Operating
Expenses
The
following is a summary of operating expenses:
| |
Three Months Ended November 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Increase (Decrease) | |
| |
Operating Expense | | |
As a % of Total Revenues | | |
Operating Expense | | |
As a % of Total Revenues | | |
$ | | |
% | |
Selling, General and Administrative Expenses | |
$ | 1,521,000 | | |
| 97 | % | |
$ | 1,556,000 | | |
| 105 | % | |
$ | (35,000 | ) | |
| -2 | % |
Research and Development | |
$ | 412,000 | | |
| 26 | % | |
$ | 462,000 | | |
| 31 | % | |
$ | (50,000 | ) | |
| -11 | % |
Selling,
General and Administrative Expenses
Consolidated
selling, general and administrative expenses were approximately $1,521,000 for the three months ended November 30, 2023, as compared
to $1,556,000 for the three months ended November 30, 2022, a decrease of approximately $35,000, or 2%. For the three months ended
November 30, 2023, the decrease was primarily due to an approximate $209,000 reduction in bad debt expense related to a customer in
Vietnam, a $158,000 decrease in share-based compensation expenses, and a $128,000 decrease in legal expenses. These decreases were
partially offset by a $160,000 increase in marketing expenses for the recent CVS retail launch, a $124,000 increase in salaries and wages for the sales and
marketing team, and a $92,000 increase in expenses for marketing outside services.
Research
and Development
Consolidated
research and development expenses were approximately $412,000 for the three months ended November 30, 2023, as compared to $462,000 for
the three months ended November 30, 2022, a decrease of approximately $50,000, or 11%. The decrease in the three months ended November
30, 2023, was primarily due to an approximate decrease of $59,000 in inFoods research expenses.
Interest
and Dividend Income
Interest
and dividend income were approximately $109,000 for the three months ended November 30, 2023, as compared to $41,000 for the three months
ended November 30, 2022, an increase of $68,000, or 166%. The increase was primarily driven by higher market interest rates on our cash
and cash equivalents.
Six
months ended November 30, 2023
Net
Sales and Cost of Sales
The
following is a breakdown of revenues according to markets to which the products are sold:
| |
Six Months Ended November 30, | | |
Increase (Decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
% | |
Clinical lab | |
$ | 2,283,000 | | |
$ | 2,048,000 | | |
$ | 235,000 | | |
| 11 | % |
Over-the-counter | |
| 745,000 | | |
| 679,000 | | |
| 66,000 | | |
| 10 | % |
Contract manufacturing | |
| 248,000 | | |
| 147,000 | | |
| 101,000 | | |
| 69 | % |
Physician’s office | |
| 5,000 | | |
| 245,000 | | |
| (240,000 | ) | |
| -98 | % |
Total | |
$ | 3,281,000 | | |
$ | 3,119,000 | | |
$ | 162,000 | | |
| 5 | % |
Consolidated
net sales were approximately $3,281,000 for the six months ended November 30, 2023, as compared to $3,119,000 for the six months ended
November 30, 2022, an increase of approximately $162,000, or 5%. This increase for the six months ended November 30, 2023, was primarily
driven by an increase in demand for our food intolerance products and contract manufacturing billings, which was partially offset by
a reduction in Physician’s office sales associated with COVID products. Periodic and infrequent orders may cause volatility in
quarterly sales.
Consolidated
cost of sales were approximately $2,541,000, or 77% of net sales, for the six months ended November 30, 2023, as compared to $2,822,000,
or 90% of net sales, for the six months ended November 30, 2022, a decrease of approximately $281,000, or 10%. The decrease for the
six months ended November 30, 2023, was primarily driven by a $90,000 increase in salary and wages for the production team, that
was more than offset by a $332,000 decrease in costs associated with reduced sales of our COVID-19 products.
Operating
Expenses
The
following is a summary of operating expenses:
| |
Six Months Ended November 30, | | |
| | |
| |
| |
2023 | | |
2022 | | |
Increase (Decrease) | |
| |
Operating Expense | | |
As a % of Total Revenues | | |
Operating Expense | | |
As a % of Total Revenues | | |
$ | | |
% | |
Selling, General and Administrative Expenses | |
$ | 2,696,000 | | |
| 82 | % | |
$ | 3,210,000 | | |
| 103 | % | |
$ | (514,000 | ) | |
| -16 | % |
Research and Development | |
$ | 883,000 | | |
| 27 | % | |
$ | 823,000 | | |
| 26 | % | |
$ | 60,000 | | |
| 7 | % |
Selling,
General and Administrative Expenses
Consolidated
selling, general and administrative expenses were approximately $2,696,000 for the six months ended November 30, 2023, as compared
to $3,210,000 for the six months ended November 30, 2022, a decrease of approximately $514,000, or 16%. For the six months ended
November 30, 2023, the decrease was primarily due to an approximate $429,000 reduction in bad debt expense related to a customer in
Vietnam, a $327,000 decrease in share-based compensation expenses, and a $297,000 decrease in legal expenses. These decreases were
partially offset by a $160,000 increase in marketing expenses for the recent CVS retail launch, a $174,000 increase in salaries and wages for the sales and
marketing team, and a $61,000 increase in expenses for marketing outside services.
Research
and Development
Consolidated
research and development expenses were approximately $883,000 for the six months ended November 30, 2023, as compared to $823,000 for
the six months ended November 30, 2022, an increase of approximately $60,000, or 7%. The increase for the six months ended November 30,
2023, was primarily due to an increase in salaries and wages of $104,000, partially offset by a decrease in share-based compensation
expenses of $21,000 and lab supplies expenses of $15,000.
Interest
and Dividend Income
Interest
and dividend income were approximately $231,000 for the six months ended November 30, 2023, as compared to $41,000 for the six months
ended November 30, 2022, an increase of $190,000, or 463%. The increase was primarily driven by higher market interest rates on our cash
and cash equivalents.
LIQUIDITY
AND CAPITAL RESOURCES
The
following are the principal sources of liquidity:
| |
November 30, 2023 | | |
May 31, 2023 | |
Cash and cash equivalents | |
$ | 7,134,000 | | |
$ | 9,719,000 | |
Working capital including cash and cash equivalents | |
$ | 8,443,000 | | |
$ | 10,852,000 | |
As
of November 30, 2023 and May 31, 2023, the Company had cash and cash equivalents of approximately $7,134,000 and $9,719,000, respectively.
As of November 30, 2023 and May 31, 2023, the Company had working capital of approximately $8,443,000 and $10,852,000, respectively.
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 are working on increasing sales, reducing expenses and may seek to raise additional financing through debt and equity financing.
Operating
Activities
During
the six months ended November 30, 2023, cash used in operating activities was approximately $2,516,000. The primary factors that contributed
to this was a loss of approximately $2,639,000, non-cash expenses of $294,000, primarily associated
with depreciation and amortization, provision for allowance on accounts receivable, inventory reserves, share-based compensation, and
amortization of right-of-use assets. This was partially offset by changes in asset and liability accounts of approximately $171,000.
During
the six months ended November 30, 2022, cash used in operating activities was approximately $2,786,000. The primary factors that contributed
to this was a loss of approximately $3,698,000, non-cash expenses of $1,101,000, primarily associated
with share-based compensation and provision for allowance on accounts receivable. This was partially offset by changes in asset
and liability accounts of approximately $189,000.
Investing
Activities
During
the six months ended November 30, 2023, cash used in investing activities was approximately $27,000 for purchases of property and equipment,
and $48,000 in expenditures related to patents.
During
the six months ended November 30, 2022, cash used in investing activities was approximately $58,000 for purchases of property and equipment.
Financing
Activities
During
the six months ended November 30, 2023, cash provided by financing activities was $0, with no net proceeds from the sale of common stock
or from stock option exercises.
During
the six months ended November 30, 2022, cash provided by financing activities was approximately $2,015,000 which was a result of net
proceeds from the sale of common stock of $1,937,000, and stock option exercises of $79,000.
OFF
BALANCE SHEET ARRANGEMENTS
There
were no off-balance sheet arrangements as of November 30, 2023.
CRITICAL
ACCOUNTING POLICIES
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 reserves, 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 condition
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 for information on Significant Accounting Policies.
Our critical accounting policies are discussed in our Annual Report on Form 10-K for the fiscal year ended May 31, 2023.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information
under this item.
ITEM
4. CONTROLS AND PROCEDURES
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 and
the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective at the
“reasonable assurance” level. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded
that the disclosure controls and procedures were effective to ensure 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 Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
There
have been no changes in our internal control over financial reporting identified in connection with the evaluation that occurred during
our last fiscal quarter that has materially affected, or that is reasonably likely to materially affect, our internal control over financial
reporting.
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
The
Company is, from time to time, involved in legal proceedings, claims and litigation arising in the ordinary course of business.
There
were no material legal proceedings pending as of November 30, 2023.
ITEM
1A. RISK FACTORS
An
investment in our common stock involves risks. Before making an investment decision, you should carefully consider all the information
within this Quarterly Report, including the information contained in Part I, Item 2, “Management’s Discussion and Analysis
of Financial Condition and Results of Operations,” as well as in our condensed consolidated financial statements and the related
notes contained in Part I, Item 1 within this Quarterly Report. In addition, you should carefully consider the risks and uncertainties
described in Part I, Item 1A, “Risk Factors,” of our 2023 Annual Report on Form 10-K, as well as in our other public filings
with the SEC. If any of the identified risks are realized, our business, results of operations, financial condition, liquidity, and prospects
could be materially and adversely affected. In that case, the trading price of our common stock may decline, and you could lose all or
part of your investment. In addition, other risks of which we are currently unaware, or which we do not currently view as material, could
have a material adverse effect on our business, results of operations, financial condition, and prospects.
During
the three and six months ended November 30, 2023, there were no material changes to the risks and uncertainties described in Part I,
Item 1A, “Risk Factors,” of our 2023 Annual Report on Form 10-K.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS.
The
following exhibits are filed or furnished as part of this quarterly report on Form 10-Q:
101
Interactive data files pursuant to Rule 405 Regulation S-T, as follows: |
101.INS-XBRL Instance Document |
101.SCH-XBRL Taxonomy Extension Schema Document |
101.CAL-XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF–XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB-XBRL Taxonomy Extension Label Linkbase Document |
101.PRE-XBRL Taxonomy Extension Presentation Linkbase Document |
104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101) |
* Filed herein.
**
Filed herewith.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has fully caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
BIOMERICA, INC. |
|
|
|
Date: January 16, 2024 |
|
|
|
By: |
/S/
Zackary S. Irani |
|
|
Zackary
S. Irani |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
Date:
January 16, 2024 |
|
|
|
By: |
/S/
Gary Lu |
|
|
Gary
Lu |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer) |
Exhibit 31.1
CERTIFICATION 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 Quarterly Report on Form 10-Q
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 accounting
principles generally accepted in the United States of America;
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.
Date: January 16, 2024 |
|
|
|
/s/ Zackary
S. Irani |
|
Zackary S. Irani |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
|
EXHIBIT 31.2
CERTIFICATION 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 Quarterly Report on Form 10-Q
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 accounting
principles generally accepted in the United States of America;
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.
Date: January 16, 2024 |
|
|
|
/s/ Gary
Lu |
|
Gary Lu |
|
Chief Financial Officer |
|
(Principal Financial Officer)
|
|
EXHIBIT 32.1
CERTIFICATION 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 Quarterly Report of Biomerica,
Inc. (the “Company”) on Form 10-Q for the period ended November 30, 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,
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: January 16, 2024 |
|
EXHIBIT 32.2
CERTIFICATION 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 Quarterly Report of Biomerica,
Inc. (the “Company”) on Form 10-Q for the period ended November 30, 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,
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: January 16, 2024 |
|
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v3.23.4
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Nov. 30, 2023 |
May 31, 2023 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 7,134,000
|
$ 9,719,000
|
Accounts receivable, net |
1,067,000
|
722,000
|
Inventories, net |
1,841,000
|
2,056,000
|
Prepaid expenses and other |
223,000
|
300,000
|
Total current assets |
10,265,000
|
12,797,000
|
Property and equipment, net of accumulated depreciation and amortization |
210,000
|
213,000
|
Right-of-use assets, net of accumulated amortization of $761,000 and $617,000 as of November 30, 2023 and May 31, 2023, respectively |
891,000
|
1,035,000
|
Investments |
165,000
|
165,000
|
Intangible assets, net of accumulated amortization |
204,000
|
165,000
|
Other assets |
96,000
|
79,000
|
Total Assets |
11,831,000
|
14,454,000
|
Current Liabilities: |
|
|
Accounts payable and accrued expenses |
783,000
|
892,000
|
Accrued compensation |
668,000
|
696,000
|
Advance from customers |
60,000
|
60,000
|
Lease liabilities, current portion |
311,000
|
297,000
|
Total current liabilities |
1,822,000
|
1,945,000
|
Lease liabilities, net of current portion |
626,000
|
785,000
|
Total Liabilities |
2,448,000
|
2,730,000
|
Commitments and contingencies (Note 6) |
|
|
Shareholders’ Equity: |
|
|
Preferred stock, value |
|
|
Common stock, $0.08 par value, 25,000,000 shares authorized, 16,821,646 issued and outstanding at November 30, 2023 and May 31, 2023, respectively |
1,346,000
|
1,346,000
|
Additional paid-in-capital |
52,997,000
|
52,705,000
|
Accumulated other comprehensive loss |
(104,000)
|
(110,000)
|
Accumulated deficit |
(44,856,000)
|
(42,217,000)
|
Total Shareholders’ Equity |
9,383,000
|
11,724,000
|
Total Liabilities and Shareholders’ Equity |
11,831,000
|
14,454,000
|
Series A Preferred Stock [Member] |
|
|
Shareholders’ Equity: |
|
|
Preferred stock, value |
|
|
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v3.23.4
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($)
|
Nov. 30, 2023 |
May 31, 2023 |
Accumulated amortization |
$ 761,000
|
$ 617,000
|
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
|
16,821,646
|
Common stock, shares outstanding |
16,821,646
|
16,821,646
|
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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v3.23.4
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Nov. 30, 2023 |
Nov. 30, 2022 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Net sales |
$ 1,567,000
|
$ 1,482,000
|
$ 3,281,000
|
$ 3,119,000
|
Cost of sales |
(1,242,000)
|
(1,130,000)
|
(2,541,000)
|
(2,822,000)
|
Gross profit |
325,000
|
352,000
|
740,000
|
297,000
|
Operating expenses: |
|
|
|
|
Selling, general and administrative |
1,521,000
|
1,556,000
|
2,696,000
|
3,210,000
|
Research and development |
412,000
|
462,000
|
883,000
|
823,000
|
Total operating expenses |
1,933,000
|
2,018,000
|
3,579,000
|
4,033,000
|
Loss from operations |
(1,608,000)
|
(1,666,000)
|
(2,839,000)
|
(3,736,000)
|
Other income: |
|
|
|
|
Interest and dividend income |
109,000
|
41,000
|
231,000
|
41,000
|
Total other income |
109,000
|
41,000
|
231,000
|
41,000
|
Loss before income taxes |
(1,499,000)
|
(1,625,000)
|
(2,608,000)
|
(3,695,000)
|
Provision for income taxes |
(8,000)
|
(1,000)
|
(31,000)
|
(3,000)
|
Net loss |
$ (1,507,000)
|
$ (1,626,000)
|
$ (2,639,000)
|
$ (3,698,000)
|
Basic net loss per common share |
$ (0.09)
|
$ (0.12)
|
$ (0.16)
|
$ (0.28)
|
Diluted net loss per common share |
$ (0.09)
|
$ (0.12)
|
$ (0.16)
|
$ (0.28)
|
Weighted average number of common and common equivalent shares: |
|
|
|
|
Basic |
16,821,646
|
13,455,166
|
16,821,646
|
13,271,845
|
Diluted |
16,821,646
|
13,455,166
|
16,821,646
|
13,271,845
|
Other comprehensive income (loss), net of tax: |
|
|
|
|
Foreign currency translation |
|
$ (9,000)
|
$ 6,000
|
$ (21,000)
|
Comprehensive loss |
$ (1,507,000)
|
$ (1,635,000)
|
$ (2,633,000)
|
$ (3,719,000)
|
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v3.23.4
Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Total |
Balances 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 |
$ 1,000
|
13,000
|
|
|
14,000
|
Exercise of stock options, shares |
15,000
|
|
|
|
|
Foreign currency translation |
|
|
(13,000)
|
|
(13,000)
|
Share-based compensation |
|
304,000
|
|
|
304,000
|
Net loss |
|
|
|
(2,072,000)
|
(2,072,000)
|
Net proceeds from ATM |
$ 42,000
|
1,722,000
|
|
|
1,764,000
|
Net proceeds from ATM, shares |
523,977
|
|
|
|
|
Balances at Aug. 31, 2022 |
$ 1,072,000
|
44,486,000
|
(87,000)
|
(37,149,000)
|
8,322,000
|
Balance, shares at Aug. 31, 2022 |
13,406,901
|
|
|
|
|
Balances 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
|
|
|
|
|
Foreign currency translation |
|
|
|
|
(21,000)
|
Net loss |
|
|
|
|
(3,698,000)
|
Balances at Nov. 30, 2022 |
$ 1,078,000
|
45,037,000
|
(96,000)
|
(38,775,000)
|
7,244,000
|
Balance, shares at Nov. 30, 2022 |
13,479,413
|
|
|
|
|
Balances at Aug. 31, 2022 |
$ 1,072,000
|
44,486,000
|
(87,000)
|
(37,149,000)
|
8,322,000
|
Balance, shares at Aug. 31, 2022 |
13,406,901
|
|
|
|
|
Exercise of stock options |
$ 3,000
|
63,000
|
|
|
66,000
|
Exercise of stock options, shares |
31,500
|
|
|
|
|
Foreign currency translation |
|
|
(9,000)
|
|
(9,000)
|
Share-based compensation |
|
318,000
|
|
|
318,000
|
Net loss |
|
|
|
(1,626,000)
|
(1,626,000)
|
Net proceeds from ATM |
$ 3,000
|
170,000
|
|
|
173,000
|
Net proceeds from ATM, shares |
41,012
|
|
|
|
|
Balances at Nov. 30, 2022 |
$ 1,078,000
|
45,037,000
|
(96,000)
|
(38,775,000)
|
7,244,000
|
Balance, shares at Nov. 30, 2022 |
13,479,413
|
|
|
|
|
Balances 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
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
Exercise of stock options, shares |
|
|
|
|
|
Foreign currency translation |
|
|
6,000
|
|
6,000
|
Share-based compensation |
|
170,000
|
|
|
170,000
|
Net loss |
|
|
|
(1,132,000)
|
(1,132,000)
|
Balances at Aug. 31, 2023 |
$ 1,346,000
|
52,875,000
|
(104,000)
|
(43,349,000)
|
10,768,000
|
Balance, shares at Aug. 31, 2023 |
16,821,646
|
|
|
|
|
Balances 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
|
|
|
|
|
Exercise of stock options, shares |
|
|
|
|
|
Foreign currency translation |
|
|
|
|
$ 6,000
|
Net loss |
|
|
|
|
(2,639,000)
|
Balances at Nov. 30, 2023 |
$ 1,346,000
|
52,997,000
|
(104,000)
|
(44,856,000)
|
9,383,000
|
Balance, shares at Nov. 30, 2023 |
16,821,646
|
|
|
|
|
Balances at Aug. 31, 2023 |
$ 1,346,000
|
52,875,000
|
(104,000)
|
(43,349,000)
|
10,768,000
|
Balance, shares at Aug. 31, 2023 |
16,821,646
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
Foreign currency translation |
|
|
|
|
|
Share-based compensation |
|
122,000
|
|
|
122,000
|
Net loss |
|
|
|
(1,507,000)
|
(1,507,000)
|
Balances at Nov. 30, 2023 |
$ 1,346,000
|
$ 52,997,000
|
$ (104,000)
|
$ (44,856,000)
|
$ 9,383,000
|
Balance, shares at Nov. 30, 2023 |
16,821,646
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Nov. 30, 2023 |
Nov. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (2,639,000)
|
$ (3,698,000)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
39,000
|
48,000
|
Provision (recovery) for allowance on accounts receivable |
(7,000)
|
369,000
|
Inventory reserve |
(174,000)
|
(72,000)
|
Share-based compensation |
292,000
|
622,000
|
Amortization of right-of-use asset |
144,000
|
134,000
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
(338,000)
|
(445,000)
|
Inventories |
390,000
|
427,000
|
Prepaid expenses and other |
77,000
|
200,000
|
Other assets |
(17,000)
|
16,000
|
Accounts payable and accrued expenses |
(110,000)
|
(302,000)
|
Accrued compensation |
(28,000)
|
50,000
|
Advance from customers |
|
(2,000)
|
Reduction in lease liabilities |
(145,000)
|
(133,000)
|
Net cash used in operating activities |
(2,516,000)
|
(2,786,000)
|
Cash flows from investing activities: |
|
|
Purchases of property and equipment |
(27,000)
|
(58,000)
|
Expenditures related to intangibles |
(48,000)
|
|
Net cash used in investing activities |
(75,000)
|
(58,000)
|
Cash flows from financing activities: |
|
|
Gross proceeds from sale of common stock |
|
1,988,000
|
Costs from sale of common stock |
|
(52,000)
|
Proceeds from exercise of stock options |
|
79,000
|
Net cash provided by financing activities |
|
2,015,000
|
Effect of exchange rate changes in cash |
6,000
|
(21,000)
|
Net decrease in cash and cash equivalents |
(2,585,000)
|
(850,000)
|
Cash and cash equivalents at beginning of year |
9,719,000
|
5,917,000
|
Cash and cash equivalents at end of period |
7,134,000
|
5,067,000
|
Cash paid during the period for: |
|
|
Income taxes |
30,000
|
3,000
|
Non-cash investing and financing activities: |
|
|
Write off of intangible assets, cost |
|
6,000
|
Write off of intangible assets, accumulated amortization |
|
$ 1,000
|
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v3.23.4
BASIS OF PRESENTATION
|
6 Months Ended |
Nov. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PRESENTATION |
NOTE
1: BASIS OF PRESENTATION
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 eventual regulatory approval, of patented, diagnostic-guided therapy
(“DGT”) products based on our inFoods® Technology platform that treat gastrointestinal diseases, such as irritable
bowel syndrome (“IBS”), and other inflammatory diseases. These inFoods based products are directed at chronic inflammatory
illnesses that are widespread and common, and as such address very large markets. The first product we are launching using this patented
inFoods Technology is our inFoods IBS product which uses a simple blood sample to identify patient-specific foods that, when removed
from their diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, cramping 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 a panel
of specific foods that have been shown to often be problematic to IBS sufferers. A food identified as positive (causing an abnormally
high immune response in the patient) is simply removed from the diet to help alleviate IBS symptoms. We have launched this product with
certain large gastroenterology (“GI”) physician groups that are now offering this product to their patients. We have also
recently hired an internal sales force to sign up additional GI physician groups who are interested in offering this product to their
patients. As such, we are expecting growth in revenues from the launch of our inFoods IBS product in coming quarters.
Our
other 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 at Walmart, CVS Pharmacy and Amazon). 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 2019 SARS-CoV-2 novel coronavirus 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. We began selling these COVID-19 related diagnostic tests during fiscal 2021,
and we experienced significant revenues from such sales during fiscal 2021 and 2022 with lesser sales in fiscal 2023. Due to falling
demand, there were no sales of our COVID-19 related products in the six months ended November 30, 2023. As such, our COVID-19
product sales have caused significant swings in our revenues over the past nine quarters.
Our
products that accounted for all of our revenues during the six months ended November 30, 2023, are primarily focused on gastrointestinal
diseases, colorectal 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.
The
unaudited condensed consolidated financial statements herein have been prepared by management pursuant to the rules and regulations of
the United States Securities and Exchange Commission (“SEC”). The accompanying unaudited condensed consolidated financial
statements have been prepared under the presumption that users of the interim financial information have either read or have access to
the audited consolidated financial statements for the latest fiscal year ended May 31, 2023. Accordingly, certain information and note
disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles
(“GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments
considered necessary for a fair presentation have been included. Operating results for the three and six months ended November 30, 2023
are not necessarily indicative of the results that may be expected for the fiscal year ending May 31, 2024. For further information,
refer to the audited consolidated financial statements and notes thereto for the fiscal year ended May 31, 2023 included in the Company’s
Annual Report on Form 10-K filed with the SEC on August 25, 2023. Management has evaluated all subsequent events and transactions through
the date of filing this report.
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v3.23.4
SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Nov. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2: SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES
OF CONSOLIDATION
The
condensed consolidated financial statements include the accounts of Biomerica, Inc. as well as its 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 condensed consolidated financial statements in conformity with 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 condensed
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 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 liability and right-of-use assets, which are calculated based on certain assumptions such as borrowing
rate, the likelihood of lease extensions to occur, asset valuation, 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.
MARKETS
AND METHODS OF DISTRIBUTION
The
majority of the Company’s revenues come from the sale of products that the company manufactures in the U.S. and in Mexico. Some
of the raw materials used in manufacturing come from Asia and other regions of the world. Finally, most of the Company’s revenues
are generated from the international sales of its products. Due to global and economic disruptions caused by the COVID-19 pandemic, the
ongoing war in Ukraine and Israel, 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 the following areas, and may face further challenges from supply chain
disruptions, cost inflation, loss of contracts and/or 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
Company’s current sales and marketing focus is on the sale of the inFoods IBS product which is manufactured and sold within the U.S. and the launch
of our new H. Pylori test that was recently cleared for sale in the US by the FDA, which is also manufactured and sold within the
U.S.
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $44,856,000 million
as of November 30, 2023. Management expects to continue to incur significant costs as it advances its clinical trials, product development,
and commercial product launch activities. As of November 30, 2023, the Company had cash and cash equivalents of approximately $7,134,000
and working capital of approximately $8,443,000.
On
July 20, 2020, the Company filed with the Securities and Exchange Commission (“SEC”) a Form S-3 shelf registration statement
and base prospectus which was declared effective by the SEC on September 30, 2020. This shelf registration statement registered the sale
of up to $90,000,000 of the Company’s equity securities during the three years ended September 30, 2023.
Under
the Company’s outstanding Registration Statement, 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, a previously ATM facility has been withdrawn and is not
active.
To
replace the shelf registration statement that was set to expire on September 30, 2023, on September 27, 2023, the Company filed with
the SEC a new Form S-3 shelf registration statement and base prospectus which was declared effective by the SEC on September 29, 2023.
This new shelf registration statement registers the sale of up to $20,000,000 of the Company’s equity securities during the three
years ending September 29, 2026.
The
Company intends to use the net proceeds from past offerings and any future 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 February 2025. As a result of cash and cash equivalents
on hand on November 30, 2023, largely from the public offering, and the ability to raise additional funds if needed through the sale
of shares of the Company’s common stock, management believes the Company has sufficient funds to operate through at least February
2025.
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.
Consolidated
net sales were approximately $1,567,000 and $1,482,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately
$3,281,000 and $3,119,000 for the six months ended November 30, 2023 and 2022, respectively.
For
the three months ended November 30, 2023, the Company had two key customers who are located in foreign countries which accounted for
52% of net consolidated sales. For the three months ended November 30, 2022, the Company had two key customers, one located in Asia and
one located in United States which accounted for 48% of net consolidated sales. For the six months ended November 30, 2023 and 2022,
the Company had one key customer who is located in Asia which accounted for 49% and 44% of net consolidated sales, respectively.
Total
gross receivables on November 30, 2023 and May 31, 2023 were approximately $1,089,000 and $751,000, respectively. As of November 30,
2023, the Company had two key customers, who are located in foreign countries which accounted for a total of 64% of gross accounts receivable.
As of May 31, 2023, the Company had one key customer, who is located in Asia which accounted for a total of 36% of gross accounts receivable.
For
the three months ended November 30, 2023, the Company had five key vendors which accounted for 75% of the purchases of raw materials.
For the three months ended November 30, 2022, the Company had one key vendor which accounted for 12% of the purchases of raw materials.
For the six months ended November 30, 2023, the Company had five vendors which accounted for 76% of the purchases of raw materials. For
the six months ended November 30, 2022, the Company had one key vendor which accounted for 8% of the purchases of raw materials.
As
of November 30, 2023 and May 31, 2023, the Company had three and one key vendors which accounted for 55%
and 23%,
respectively, of accounts payable.
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
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. Based on various
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.
The
Company adopted Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (codified
as Accounting Standards Codification (“ASC”) 326) on June 1, 2023. ASC 326 adds to U.S. GAAP the current expected credit
loss (“CECL”) model, a measurement model based on expected losses rather than incurred losses. Prior to the adoption of ASC
326, the Company evaluated receivables on a quarterly basis and adjusted the allowance for doubtful accounts accordingly. Balances over
ninety days old were usually reserved for unless collection was reasonably assured. Under the application of ASC 326, the Company’s
historical credit loss experience provides the basis for the estimation of expected credit losses, as well as current economic and business
conditions, and anticipated future economic events that may impact collectability. In developing its expected credit loss estimate, the
Company evaluated the appropriate grouping of financial assets based upon its evaluation of risk characteristics, including consideration
of the types of products and services sold. Account balances are written off against the allowance for expected credit losses after all
means of collection have been exhausted and the potential for recovery is considered remote.
Occasionally,
certain long-standing customers who routinely place large orders will have unusually large receivable 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 November 30, 2023 and May 31, 2023, the Company has established a reserve of approximately $22,000 and $29,000, 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 prepaid expenses and
other, until either the inventory is physically received, or the insurance and other items are expensed.
As
of November 30, 2023 and May 31, 2023, the prepaids were approximately $223,000 and $300,000, 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.
Net
inventories are approximately the following:
SCHEDULE OF NET INVENTORIES
| |
November 30, 2023 | | |
May 31, 2023 | |
Raw materials | |
$ | 1,377,000 | | |
$ | 1,677,000 | |
Work in progress | |
| 781,000 | | |
| 869,000 | |
Finished products | |
| 181,000 | | |
| 182,000 | |
Total gross inventory | |
| 2,339,000 | | |
| 2,728,000 | |
Inventory reserves | |
| (498,000 | ) | |
| (672,000 | ) |
Net inventory | |
$ | 1,841,000 | | |
$ | 2,056,000 | |
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 November 30, 2023, and May 31, 2023, inventory reserves were approximately $498,000 and $672,000,
respectively.
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 were approximately $15,000 and $16,000 for the three months ended November 30, 2023
and 2022, respectively, and approximately $30,000 and $36,000 for the six months ended November 30, 2023 and 2022, respectively.
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights and patents, and are accounted for based on 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 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 patents are based on their individual useful lives which average around 15
years. Amortization expense was approximately $4,000 and $3,000 for the three months ended November 30, 2023 and 2022, respectively,
and approximately $9,000 and $12,000 for the six months ended November 30, 2023 and 2022, respectively. Amortizing intangible assets
are tested for impairment if management determines that events or changes in circumstances indicate that the asset might be impaired.
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 six months ended November 30, 2023, there was no impairment. During the six months ended
November 30, 2022, an impairment adjustment was made of $6,000.
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 November 30, 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 Holdings during the period ended November 30, 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 $292,000 and $622,000 of share-based compensation during the six months ended November 30, 2023 and 2022,
respectively.
The
following summary presents the options granted, exercised, expired, canceled and outstanding for the six months ended November 30, 2023:
SUMMARY OF OPTIONS ACTIVITY
| |
Option Shares | | |
Weighted Average
Exercise Price | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | |
Granted | |
| 86,000 | | |
| 1.09 | |
Exercised | |
| - | | |
| - | |
Cancelled or expired | |
| (148,500 | ) | |
| 4.90 | |
Options Outstanding at November 30, 2023 | |
| 2,280,116 | | |
$ | 3.33 | |
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 six months ended November 30, 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. Physician’s 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 November 30, 2023, the Company had approximately $60,000 of advances from domestic customers, which are prepayments on orders for
future shipments.
Disaggregation
of revenue:
The
following is a breakdown of revenues according to markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Clinical lab | |
$ | 992,000 | | |
$ | 902,000 | | |
$ | 2,283,000 | | |
$ | 2,048,000 | |
Over-the-counter | |
| 443,000 | | |
| 466,000 | | |
| 745,000 | | |
| 679,000 | |
Contract manufacturing | |
| 131,000 | | |
| 52,000 | | |
| 248,000 | | |
| 147,000 | |
Physician’s office | |
| 1,000 | | |
| 62,000 | | |
| 5,000 | | |
| 245,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
See
Note 4 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 $412,000 and $462,000 of research and development
costs during the three months ended November 30, 2023 and 2022, respectively, and approximately $883,000 and $823,000 of research and
development costs during the six months ended November 30, 2023 and 2022, respectively.
INCOME
TAXES
For
the three months ended November 30, 2023, the Company had an income tax expense of approximately $8,000. For the six months ended November
30, 2023, the Company had an income tax expense of approximately $31,000. These expenses consisted of state minimum taxes and miscellaneous
foreign taxes. During the three and six months ended November 30, 2023, the Company had a net operating loss (“NOL”) that
generated deferred tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences
between the financial statements and income tax carrying values using tax rates in effect for the years such differences are expected
to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income
tax assets, the Company has determined that it is more likely than not that these deferred tax assets will not be realized. Accordingly,
the Company has established a full valuation allowance against its deferred tax assets as of November 30, 2023.
The
Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
For the three months ended November 30, 2023, the Company had no accrued interest or penalties related to uncertain tax positions.
ADVERTISING
COSTS
The
Company reports the cost of advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$26,000 and $18,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately $56,000 and $36,000 during
the six months ended November 30, 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 period, and revenues and costs are translated using average exchange
rates for the period. The resulting translation 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 condensed consolidated statements of operations
for the three and six months ended November 30, 2023 and 2022.
RIGHT-OF-USE
ASSETS AND LEASE LIABILITY
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.
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 amount of anti-dilutive stock options not included in the loss per share calculation
on November 30, 2023 and 2022 was 2,280,116 and 2,338,616, respectively.
RECENT
ACCOUNTING PRONOUNCEMENTS
Recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by the 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. This ASU requires 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 SEC to fiscal years beginning after December
15, 2022, including interim periods within those years. Early adoption is permitted. The Company adopted ASU 2016-03 on June 1, 2023,
and the adoption of this update did not have a material impact on the Company’s condensed consolidated financial statements.
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v3.23.4
SHAREHOLDERS’ EQUITY
|
6 Months Ended |
Nov. 30, 2023 |
Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE
3: SHAREHOLDERS’ EQUITY
During
the six months ended November 30, 2022, the Company sold 564,989 shares of its common stock at prices ranging from $3.15 to 4.26 under
its Form S-3 Registration Statement and ATM Offering which resulted in gross proceeds of approximately $1,988,000 and net proceeds to
the Company of approximately $1,937,000 after deducting commissions for each sale and legal, accounting, and other fees related to the
ATM Offering. In March 2023, we terminated the ATM offering agreement and sold 3,333,333 shares of our common stock in a firm commitment
public offering under the Company’s 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. On November 30, 2023, the Company did not have an open ATM offering in place. No shares of common stock or other equity securities
of the Company were sold under the shelf registration statement during the six months ended November 30, 2023.
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v3.23.4
GEOGRAPHIC INFORMATION
|
6 Months Ended |
Nov. 30, 2023 |
Segment Reporting [Abstract] |
|
GEOGRAPHIC INFORMATION |
NOTE
4: GEOGRAPHIC INFORMATION
The
Company operates as one segment. Geographic information regarding net sales is approximately as follows:
SCHEDULE OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | | |
| | | |
| | |
Asia | |
$ | 606,000 | | |
$ | 663,000 | | |
$ | 1,632,000 | | |
$ | 1,477,000 | |
Europe | |
| 428,000 | | |
| 415,000 | | |
| 754,000 | | |
| 967,000 | |
North America | |
| 320,000 | | |
| 401,000 | | |
| 676,000 | | |
| 669,000 | |
Middle East | |
| 212,000 | | |
| - | | |
| 213,000 | | |
| - | |
South America | |
| 1,000 | | |
| 3,000 | | |
| 6,000 | | |
| 6,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
As
of November 30, 2023 and May 31, 2023, approximately $555,000 and $626,000 of the Company’s gross inventory was located in Mexicali,
Mexico, respectively.
As
of November 30, 2023 and May 31, 2023, approximately $16,000 and $17,000 of the Company’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico, respectively.
|
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.23.4
LEASES
|
6 Months Ended |
Nov. 30, 2023 |
Lessee Disclosure [Abstract] |
|
LEASES |
NOTE
5: LEASES
The
Company leases its facilities. On November 30, 2023, the Company had approximately 22,000 square feet of floor space at its corporate
headquarters at 17571 Von Karman Avenue in Irvine, California, which it has been leasing since 2009. The lease for its headquarters expired
on August 31, 2016. 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 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 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.
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 three month and six month ended November 30, 2023 and 2022:
SCHEDULE OF OPERATING LEASES
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating lease cost | |
$ | 88,000 | | |
$ | 88,000 | | |
$ | 176,000 | | |
| 176,000 | |
Variable lease cost | |
| 2,000 | | |
| - | | |
| 5,000 | | |
| 1,000 | |
Short-term lease cost | |
$ | 1,000 | | |
$ | 1,000 | | |
$ | 2,000 | | |
| 2,000 | |
Total lease cost | |
$ | 91,000 | | |
$ | 89,000 | | |
$ | 183,000 | | |
$ | 179,000 | |
The
approximate maturity of lease liabilities as of November 30, 2023 are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending November 30: | |
| |
| |
Operating Leases | |
2024 | |
$ | 361,000 | |
2025 | |
| 371,000 | |
2026 | |
| 290,000 | |
2027 | |
| - | |
Total minimum future lease payments | |
| 1,022,000 | |
Less: imputed interest | |
| 85,000 | |
Total operating lease liabilities | |
$ | 937,000 | |
The
following table summarizes the Company’s other supplemental lease information for the six months ended November 30, 2023 and 2022:
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash paid for operating lease liabilities | |
$ | 177,000 | | |
$ | 174,000 | |
Weighted-average remaining lease term (years) | |
| 2.77 | | |
| 3.77 | |
Weighted-average discount rate | |
| 6.50 | % | |
| 6.50 | % |
The
Company also has various insignificant leases for office equipment.
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.23.4
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.4
SUBSEQUENT EVENTS
|
6 Months Ended |
Nov. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
7: SUBSEQUENT EVENTS
On
December 18, 2023, the Company received FDA clearance for its new HP Detect Stool Antigen ELISA test, a new product that is designed
to detect the presence of the H. Pylori bacteria. The Company is now marketing this product in the U.S. and intends to initiate marketing
of the product in certain international markets in the near future.
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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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v3.23.4
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Nov. 30, 2023 |
Accounting Policies [Abstract] |
|
PRINCIPLES OF CONSOLIDATION |
PRINCIPLES
OF CONSOLIDATION
The
condensed consolidated financial statements include the accounts of Biomerica, Inc. as well as its 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 condensed consolidated financial statements in conformity with 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 condensed
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 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 liability and right-of-use assets, which are calculated based on certain assumptions such as borrowing
rate, the likelihood of lease extensions to occur, asset valuation, 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.
|
MARKETS AND METHODS OF DISTRIBUTION |
MARKETS
AND METHODS OF DISTRIBUTION
The
majority of the Company’s revenues come from the sale of products that the company manufactures in the U.S. and in Mexico. Some
of the raw materials used in manufacturing come from Asia and other regions of the world. Finally, most of the Company’s revenues
are generated from the international sales of its products. Due to global and economic disruptions caused by the COVID-19 pandemic, the
ongoing war in Ukraine and Israel, 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 the following areas, and may face further challenges from supply chain
disruptions, cost inflation, loss of contracts and/or 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
Company’s current sales and marketing focus is on the sale of the inFoods IBS product which is manufactured and sold within the U.S. and the launch
of our new H. Pylori test that was recently cleared for sale in the US by the FDA, which is also manufactured and sold within the
U.S.
|
LIQUIDITY |
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $44,856,000 million
as of November 30, 2023. Management expects to continue to incur significant costs as it advances its clinical trials, product development,
and commercial product launch activities. As of November 30, 2023, the Company had cash and cash equivalents of approximately $7,134,000
and working capital of approximately $8,443,000.
On
July 20, 2020, the Company filed with the Securities and Exchange Commission (“SEC”) a Form S-3 shelf registration statement
and base prospectus which was declared effective by the SEC on September 30, 2020. This shelf registration statement registered the sale
of up to $90,000,000 of the Company’s equity securities during the three years ended September 30, 2023.
Under
the Company’s outstanding Registration Statement, 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, a previously ATM facility has been withdrawn and is not
active.
To
replace the shelf registration statement that was set to expire on September 30, 2023, on September 27, 2023, the Company filed with
the SEC a new Form S-3 shelf registration statement and base prospectus which was declared effective by the SEC on September 29, 2023.
This new shelf registration statement registers the sale of up to $20,000,000 of the Company’s equity securities during the three
years ending September 29, 2026.
The
Company intends to use the net proceeds from past offerings and any future 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 February 2025. As a result of cash and cash equivalents
on hand on November 30, 2023, largely from the public offering, and the ability to raise additional funds if needed through the sale
of shares of the Company’s common stock, management believes the Company has sufficient funds to operate through at least February
2025.
|
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.
Consolidated
net sales were approximately $1,567,000 and $1,482,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately
$3,281,000 and $3,119,000 for the six months ended November 30, 2023 and 2022, respectively.
For
the three months ended November 30, 2023, the Company had two key customers who are located in foreign countries which accounted for
52% of net consolidated sales. For the three months ended November 30, 2022, the Company had two key customers, one located in Asia and
one located in United States which accounted for 48% of net consolidated sales. For the six months ended November 30, 2023 and 2022,
the Company had one key customer who is located in Asia which accounted for 49% and 44% of net consolidated sales, respectively.
Total
gross receivables on November 30, 2023 and May 31, 2023 were approximately $1,089,000 and $751,000, respectively. As of November 30,
2023, the Company had two key customers, who are located in foreign countries which accounted for a total of 64% of gross accounts receivable.
As of May 31, 2023, the Company had one key customer, who is located in Asia which accounted for a total of 36% of gross accounts receivable.
For
the three months ended November 30, 2023, the Company had five key vendors which accounted for 75% of the purchases of raw materials.
For the three months ended November 30, 2022, the Company had one key vendor which accounted for 12% of the purchases of raw materials.
For the six months ended November 30, 2023, the Company had five vendors which accounted for 76% of the purchases of raw materials. For
the six months ended November 30, 2022, the Company had one key vendor which accounted for 8% of the purchases of raw materials.
As
of November 30, 2023 and May 31, 2023, the Company had three and one key vendors which accounted for 55%
and 23%,
respectively, of accounts payable.
|
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 |
ACCOUNTS
RECEIVABLE
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. Based on various
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.
The
Company adopted Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (codified
as Accounting Standards Codification (“ASC”) 326) on June 1, 2023. ASC 326 adds to U.S. GAAP the current expected credit
loss (“CECL”) model, a measurement model based on expected losses rather than incurred losses. Prior to the adoption of ASC
326, the Company evaluated receivables on a quarterly basis and adjusted the allowance for doubtful accounts accordingly. Balances over
ninety days old were usually reserved for unless collection was reasonably assured. Under the application of ASC 326, the Company’s
historical credit loss experience provides the basis for the estimation of expected credit losses, as well as current economic and business
conditions, and anticipated future economic events that may impact collectability. In developing its expected credit loss estimate, the
Company evaluated the appropriate grouping of financial assets based upon its evaluation of risk characteristics, including consideration
of the types of products and services sold. Account balances are written off against the allowance for expected credit losses after all
means of collection have been exhausted and the potential for recovery is considered remote.
Occasionally,
certain long-standing customers who routinely place large orders will have unusually large receivable 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 November 30, 2023 and May 31, 2023, the Company has established a reserve of approximately $22,000 and $29,000, 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 prepaid expenses and
other, until either the inventory is physically received, or the insurance and other items are expensed.
As
of November 30, 2023 and May 31, 2023, the prepaids were approximately $223,000 and $300,000, 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.
Net
inventories are approximately the following:
SCHEDULE OF NET INVENTORIES
| |
November 30, 2023 | | |
May 31, 2023 | |
Raw materials | |
$ | 1,377,000 | | |
$ | 1,677,000 | |
Work in progress | |
| 781,000 | | |
| 869,000 | |
Finished products | |
| 181,000 | | |
| 182,000 | |
Total gross inventory | |
| 2,339,000 | | |
| 2,728,000 | |
Inventory reserves | |
| (498,000 | ) | |
| (672,000 | ) |
Net inventory | |
$ | 1,841,000 | | |
$ | 2,056,000 | |
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 November 30, 2023, and May 31, 2023, inventory reserves were approximately $498,000 and $672,000,
respectively.
|
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 were approximately $15,000 and $16,000 for the three months ended November 30, 2023
and 2022, respectively, and approximately $30,000 and $36,000 for the six months ended November 30, 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 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 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 patents are based on their individual useful lives which average around 15
years. Amortization expense was approximately $4,000 and $3,000 for the three months ended November 30, 2023 and 2022, respectively,
and approximately $9,000 and $12,000 for the six months ended November 30, 2023 and 2022, respectively. Amortizing intangible assets
are tested for impairment if management determines that events or changes in circumstances indicate that the asset might be impaired.
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 six months ended November 30, 2023, there was no impairment. During the six months ended
November 30, 2022, an impairment adjustment was made of $6,000.
|
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 November 30, 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 Holdings during the period ended November 30, 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 $292,000 and $622,000 of share-based compensation during the six months ended November 30, 2023 and 2022,
respectively.
The
following summary presents the options granted, exercised, expired, canceled and outstanding for the six months ended November 30, 2023:
SUMMARY OF OPTIONS ACTIVITY
| |
Option Shares | | |
Weighted Average
Exercise Price | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | |
Granted | |
| 86,000 | | |
| 1.09 | |
Exercised | |
| - | | |
| - | |
Cancelled or expired | |
| (148,500 | ) | |
| 4.90 | |
Options Outstanding at November 30, 2023 | |
| 2,280,116 | | |
$ | 3.33 | |
|
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 six months ended November 30, 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. Physician’s 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 November 30, 2023, the Company had approximately $60,000 of advances from domestic customers, which are prepayments on orders for
future shipments.
Disaggregation
of revenue:
The
following is a breakdown of revenues according to markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Clinical lab | |
$ | 992,000 | | |
$ | 902,000 | | |
$ | 2,283,000 | | |
$ | 2,048,000 | |
Over-the-counter | |
| 443,000 | | |
| 466,000 | | |
| 745,000 | | |
| 679,000 | |
Contract manufacturing | |
| 131,000 | | |
| 52,000 | | |
| 248,000 | | |
| 147,000 | |
Physician’s office | |
| 1,000 | | |
| 62,000 | | |
| 5,000 | | |
| 245,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
See
Note 4 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 $412,000 and $462,000 of research and development
costs during the three months ended November 30, 2023 and 2022, respectively, and approximately $883,000 and $823,000 of research and
development costs during the six months ended November 30, 2023 and 2022, respectively.
|
INCOME TAXES |
INCOME
TAXES
For
the three months ended November 30, 2023, the Company had an income tax expense of approximately $8,000. For the six months ended November
30, 2023, the Company had an income tax expense of approximately $31,000. These expenses consisted of state minimum taxes and miscellaneous
foreign taxes. During the three and six months ended November 30, 2023, the Company had a net operating loss (“NOL”) that
generated deferred tax assets for NOL carryforwards. Deferred income tax assets and liabilities are recognized for temporary differences
between the financial statements and income tax carrying values using tax rates in effect for the years such differences are expected
to reverse. Due to uncertainties surrounding our ability to generate future taxable income and consequently realize such deferred income
tax assets, the Company has determined that it is more likely than not that these deferred tax assets will not be realized. Accordingly,
the Company has established a full valuation allowance against its deferred tax assets as of November 30, 2023.
The
Company’s policy is to recognize any interest and penalties related to unrecognized tax benefits as a component of income tax expense.
For the three months ended November 30, 2023, the Company had no accrued interest or penalties related to uncertain tax positions.
|
ADVERTISING COSTS |
ADVERTISING
COSTS
The
Company reports the cost of advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$26,000 and $18,000 for the three months ended November 30, 2023 and 2022, respectively, and approximately $56,000 and $36,000 during
the six months ended November 30, 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 period, and revenues and costs are translated using average exchange
rates for the period. The resulting translation 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 condensed consolidated statements of operations
for the three and six months ended November 30, 2023 and 2022.
|
RIGHT-OF-USE ASSETS AND LEASE LIABILITY |
RIGHT-OF-USE
ASSETS AND LEASE LIABILITY
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.
|
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 amount of anti-dilutive stock options not included in the loss per share calculation
on November 30, 2023 and 2022 was 2,280,116 and 2,338,616, respectively.
|
RECENT ACCOUNTING PRONOUNCEMENTS |
RECENT
ACCOUNTING PRONOUNCEMENTS
Recent
ASU’s issued by the FASB and guidance issued by the SEC did not, or are not believed by the 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. This ASU requires 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 SEC to fiscal years beginning after December
15, 2022, including interim periods within those years. Early adoption is permitted. The Company adopted ASU 2016-03 on June 1, 2023,
and the adoption of this update did not have a material impact on the Company’s condensed consolidated financial statements.
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v3.23.4
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Nov. 30, 2023 |
Accounting Policies [Abstract] |
|
SCHEDULE OF NET INVENTORIES |
Net
inventories are approximately the following:
SCHEDULE OF NET INVENTORIES
| |
November 30, 2023 | | |
May 31, 2023 | |
Raw materials | |
$ | 1,377,000 | | |
$ | 1,677,000 | |
Work in progress | |
| 781,000 | | |
| 869,000 | |
Finished products | |
| 181,000 | | |
| 182,000 | |
Total gross inventory | |
| 2,339,000 | | |
| 2,728,000 | |
Inventory reserves | |
| (498,000 | ) | |
| (672,000 | ) |
Net inventory | |
$ | 1,841,000 | | |
$ | 2,056,000 | |
|
SUMMARY OF OPTIONS ACTIVITY |
The
following summary presents the options granted, exercised, expired, canceled and outstanding for the six months ended November 30, 2023:
SUMMARY OF OPTIONS ACTIVITY
| |
Option Shares | | |
Weighted Average
Exercise Price | |
Options Outstanding at May 31, 2023 | |
| 2,342,616 | | |
$ | 3.52 | |
Granted | |
| 86,000 | | |
| 1.09 | |
Exercised | |
| - | | |
| - | |
Cancelled or expired | |
| (148,500 | ) | |
| 4.90 | |
Options Outstanding at November 30, 2023 | |
| 2,280,116 | | |
$ | 3.33 | |
|
SCHEDULE OF DISAGGREGATION REVENUE |
The
following is a breakdown of revenues according to markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Clinical lab | |
$ | 992,000 | | |
$ | 902,000 | | |
$ | 2,283,000 | | |
$ | 2,048,000 | |
Over-the-counter | |
| 443,000 | | |
| 466,000 | | |
| 745,000 | | |
| 679,000 | |
Contract manufacturing | |
| 131,000 | | |
| 52,000 | | |
| 248,000 | | |
| 147,000 | |
Physician’s office | |
| 1,000 | | |
| 62,000 | | |
| 5,000 | | |
| 245,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
|
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v3.23.4
GEOGRAPHIC INFORMATION (Tables)
|
6 Months Ended |
Nov. 30, 2023 |
Segment Reporting [Abstract] |
|
SCHEDULE OF GEOGRAPHIC INFORMATION |
SCHEDULE OF GEOGRAPHIC INFORMATION
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenues from sales to unaffiliated customers: | |
| | | |
| | | |
| | | |
| | |
Asia | |
$ | 606,000 | | |
$ | 663,000 | | |
$ | 1,632,000 | | |
$ | 1,477,000 | |
Europe | |
| 428,000 | | |
| 415,000 | | |
| 754,000 | | |
| 967,000 | |
North America | |
| 320,000 | | |
| 401,000 | | |
| 676,000 | | |
| 669,000 | |
Middle East | |
| 212,000 | | |
| - | | |
| 213,000 | | |
| - | |
South America | |
| 1,000 | | |
| 3,000 | | |
| 6,000 | | |
| 6,000 | |
Total | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
Revenues | |
$ | 1,567,000 | | |
$ | 1,482,000 | | |
$ | 3,281,000 | | |
$ | 3,119,000 | |
|
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v3.23.4
LEASES (Tables)
|
6 Months Ended |
Nov. 30, 2023 |
Lessee Disclosure [Abstract] |
|
SCHEDULE OF OPERATING LEASES |
The
following table presents information on our operating leases for the three month and six month ended November 30, 2023 and 2022:
SCHEDULE OF OPERATING LEASES
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended November 30, | | |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating lease cost | |
$ | 88,000 | | |
$ | 88,000 | | |
$ | 176,000 | | |
| 176,000 | |
Variable lease cost | |
| 2,000 | | |
| - | | |
| 5,000 | | |
| 1,000 | |
Short-term lease cost | |
$ | 1,000 | | |
$ | 1,000 | | |
$ | 2,000 | | |
| 2,000 | |
Total lease cost | |
$ | 91,000 | | |
$ | 89,000 | | |
$ | 183,000 | | |
$ | 179,000 | |
|
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS |
The
approximate maturity of lease liabilities as of November 30, 2023 are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending November 30: | |
| |
| |
Operating Leases | |
2024 | |
$ | 361,000 | |
2025 | |
| 371,000 | |
2026 | |
| 290,000 | |
2027 | |
| - | |
Total minimum future lease payments | |
| 1,022,000 | |
Less: imputed interest | |
| 85,000 | |
Total operating lease liabilities | |
$ | 937,000 | |
|
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION |
The
following table summarizes the Company’s other supplemental lease information for the six months ended November 30, 2023 and 2022:
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION
| |
2023 | | |
2022 | |
| |
Six Months Ended November 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Cash paid for operating lease liabilities | |
$ | 177,000 | | |
$ | 174,000 | |
Weighted-average remaining lease term (years) | |
| 2.77 | | |
| 3.77 | |
Weighted-average discount rate | |
| 6.50 | % | |
| 6.50 | % |
|
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v3.23.4
SCHEDULE OF NET INVENTORIES (Details) - USD ($)
|
Nov. 30, 2023 |
May 31, 2023 |
Accounting Policies [Abstract] |
|
|
Raw materials |
$ 1,377,000
|
$ 1,677,000
|
Work in progress |
781,000
|
869,000
|
Finished products |
181,000
|
182,000
|
Total gross inventory |
2,339,000
|
2,728,000
|
Inventory reserves |
(498,000)
|
(672,000)
|
Net inventory |
$ 1,841,000
|
$ 2,056,000
|
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v3.23.4
SUMMARY OF OPTIONS ACTIVITY (Details)
|
6 Months Ended |
Nov. 30, 2023
$ / shares
shares
|
Accounting Policies [Abstract] |
|
Option outstanding, begining balance | shares |
2,342,616
|
Weighted average exercise price, begining balance | $ / shares |
$ 3.52
|
Options granted | shares |
86,000
|
Weighted average exercise price, granted | $ / shares |
$ 1.09
|
Options exercised | shares |
|
Weighted average exercise price, exercised | $ / shares |
|
Options cancelled or expired | shares |
(148,500)
|
Weighted average exercise price, cancelled or expired | $ / shares |
$ 4.90
|
Option outstanding, ending balance | shares |
2,280,116
|
Weighted average exercise price, ending balance | $ / shares |
$ 3.33
|
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v3.23.4
SCHEDULE OF DISAGGREGATION REVENUE (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Nov. 30, 2023 |
Nov. 30, 2022 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Product Information [Line Items] |
|
|
|
|
Revenues |
$ 1,567,000
|
$ 1,482,000
|
$ 3,281,000
|
$ 3,119,000
|
Clinical Lab [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenues |
992,000
|
902,000
|
2,283,000
|
2,048,000
|
Over-the-counter [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenues |
443,000
|
466,000
|
745,000
|
679,000
|
Contract Manufacturing [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenues |
131,000
|
52,000
|
248,000
|
147,000
|
Physician's Office [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenues |
$ 1,000
|
$ 62,000
|
$ 5,000
|
$ 245,000
|
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v3.23.4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Sep. 27, 2023 |
Mar. 07, 2023 |
Jul. 20, 2020 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Nov. 30, 2023 |
Nov. 30, 2022 |
May 31, 2023 |
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
|
$ 44,856,000
|
|
$ 44,856,000
|
|
$ 42,217,000
|
Cash and cash equivalents |
|
|
|
7,134,000
|
|
7,134,000
|
|
9,719,000
|
Working capital |
|
|
|
8,443,000
|
|
8,443,000
|
|
|
Shelf registration statement maximum authorized common stock issuance value |
$ 20,000,000
|
|
$ 90,000,000
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
$ 1,988,000
|
|
Revenues |
|
|
|
1,567,000
|
$ 1,482,000
|
3,281,000
|
3,119,000
|
|
Other receivables, gross, current |
|
|
|
1,089,000
|
|
1,089,000
|
|
751,000
|
Accounts receivable, credit loss expense (Reversal) |
|
|
|
22,000
|
|
22,000
|
|
29,000
|
Prepaid expense and other assets |
|
|
|
223,000
|
|
223,000
|
|
300,000
|
Inventory reserves |
|
|
|
498,000
|
|
498,000
|
|
672,000
|
Amortization of intangible assets |
|
|
|
4,000
|
3,000
|
9,000
|
12,000
|
|
Asset impairment charges |
|
|
|
|
|
0
|
6,000
|
|
Investments |
|
|
|
165,000
|
|
165,000
|
|
$ 165,000
|
Share-based payment arrangement, expense |
|
|
|
|
|
292,000
|
622,000
|
|
Proceeds from customers |
|
|
|
|
|
60,000
|
|
|
Research and development expense |
|
|
|
412,000
|
462,000
|
883,000
|
823,000
|
|
Income tax expense |
|
|
|
8,000
|
1,000
|
31,000
|
3,000
|
|
Advertising expense |
|
|
|
26,000
|
18,000
|
$ 56,000
|
$ 36,000
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount (in shares) |
|
|
|
|
|
2,280,116
|
2,338,616
|
|
Polish Distributor [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Investments |
|
|
|
$ 165,000
|
|
$ 165,000
|
|
|
Equity method investment, ownership percentage |
|
|
|
6.00%
|
|
6.00%
|
|
|
Marketing and Distribution Rights [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Finite-lived intangible asset, useful life |
|
|
|
18 years
|
|
18 years
|
|
|
Purchased Technology Rights [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Finite-lived intangible asset, useful life |
|
|
|
10 years
|
|
10 years
|
|
|
Patents [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Finite-lived intangible asset, useful life |
|
|
|
15 years
|
|
15 years
|
|
|
Property, Plant and Equipment [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Depreciation, depletion and amortization |
|
|
|
$ 15,000
|
$ 16,000
|
$ 30,000
|
$ 36,000
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Property, plant and equipment, useful life |
|
|
|
5 years
|
|
5 years
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Property, plant and equipment, useful life |
|
|
|
10 years
|
|
10 years
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Two Key Customers [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
52.00%
|
48.00%
|
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | One Key Customer [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
|
|
49.00%
|
44.00%
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Two Key Customers [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
|
|
64.00%
|
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | One Key Customer [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
|
|
|
|
36.00%
|
Cost of Goods and Service, Product and Service Benchmark [Member] | Supplier Concentration Risk [Member] | Five Key Vendors [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
75.00%
|
12.00%
|
76.00%
|
8.00%
|
|
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Three Key Vendors [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
|
|
55.00%
|
|
|
Accounts Payable [Member] | Supplier Concentration Risk [Member] | One Key Vendors [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Concentration risk, percentage |
|
|
|
|
|
|
|
23.00%
|
ATM Agreement [Member] |
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
Net proceeds from ATM in shares |
|
3,333,333
|
|
|
|
|
|
|
Share price |
|
$ 2.40
|
|
|
|
|
|
|
Sale of stock expenses |
|
$ 700,000
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
$ 7,300,000
|
|
|
|
|
|
|
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SHAREHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
1 Months Ended |
6 Months Ended |
Mar. 31, 2023 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Sale of stock, net proceeds |
|
|
$ 1,988,000
|
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] |
|
|
|
Sale of stock shares issued |
|
|
564,989
|
Sale of stock gross proceeds |
|
|
$ 1,988,000
|
Sale of stock, net proceeds |
|
|
$ 1,937,000
|
Common Stock [Member] | ATM Offering [Member] | Minimum [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Sale of stock, price per share |
|
|
$ 3.15
|
Common Stock [Member] | ATM Offering [Member] | Maximum [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Sale of stock, price per share |
|
|
$ 4.26
|
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SCHEDULE OF GEOGRAPHIC INFORMATION (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Nov. 30, 2023 |
Nov. 30, 2022 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
$ 1,567,000
|
$ 1,482,000
|
$ 3,281,000
|
$ 3,119,000
|
Asia [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
606,000
|
663,000
|
1,632,000
|
1,477,000
|
Europe [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
428,000
|
415,000
|
754,000
|
967,000
|
North America [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
320,000
|
401,000
|
676,000
|
669,000
|
Middle East [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
212,000
|
|
213,000
|
|
South America [Member] |
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
Revenues |
$ 1,000
|
$ 3,000
|
$ 6,000
|
$ 6,000
|
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GEOGRAPHIC INFORMATION (Details Narrative)
|
6 Months Ended |
|
Nov. 30, 2023
USD ($)
Segment
|
May 31, 2023
USD ($)
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Number of operating segments | Segment |
1
|
|
Inventory, gross |
$ 2,339,000
|
$ 2,728,000
|
Property and equipment, net |
210,000
|
213,000
|
MEXICO |
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
Inventory, gross |
555,000
|
626,000
|
Property and equipment, net |
$ 16,000
|
$ 17,000
|
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v3.23.4
SCHEDULE OF OPERATING LEASES (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Nov. 30, 2023 |
Nov. 30, 2022 |
Nov. 30, 2023 |
Nov. 30, 2022 |
Lessee Disclosure [Abstract] |
|
|
|
|
Operating lease cost |
$ 88,000
|
$ 88,000
|
$ 176,000
|
$ 176,000
|
Variable lease cost |
2,000
|
|
5,000
|
1,000
|
Short-term lease cost |
1,000
|
1,000
|
2,000
|
2,000
|
Total lease cost |
$ 91,000
|
$ 89,000
|
$ 183,000
|
$ 179,000
|
X |
- DefinitionAmount of lease cost recognized by lessee for lease contract.
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LEASES (Details Narrative)
|
1 Months Ended |
6 Months Ended |
Nov. 30, 2016
ft²
|
Nov. 30, 2023
USD ($)
ft²
|
Lessee Disclosure [Abstract] |
|
|
Area of land | ft² |
8,100
|
22,000
|
Lease term description |
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 one manufacturing process.
|
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.
|
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|
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Grafico Azioni Biomerica (NASDAQ:BMRA)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni Biomerica (NASDAQ:BMRA)
Storico
Da Feb 2024 a Feb 2025