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 AUGUST 31, 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
(Address
of principal executive offices)
92614
(Zip
Code)
REGISTRANT’S
TELEPHONE NUMBER:
( 949 )
645-2111
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each class
Trading
Symbols
Name
of each exchange on which registered
Common
Stock, par value $0.08
BMRA
Nasdaq
Capital Market
Indicate
by check 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, 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 October 12, 2023 was 16,821,646 .
BIOMERICA,
INC.
INDEX
PART
I
Financial
Information
Item 1.
Financial
Statements:
Condensed
Consolidated Balance Sheets (unaudited) – August 31, 2023 and May 31, 2023
1
Condensed
Consolidated Statements of Operations and Comprehensive Loss (unaudited) – Three Months Ended August 31, 2023 and 2022
2
Condensed
Consolidated Statements of Shareholders’ Equity (unaudited) – Three Months Ended August 31, 2023 and 2022
3
Condensed
Consolidated Statements of Cash Flows (unaudited) – Three Months Ended August 31, 2023 and 2022
4
Notes
to Condensed Consolidated Financial Statements (unaudited)
5-12
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
13-16
Item
3.
Quantitative
and Qualitative Disclosures about Market Risk
17
Item
4.
Controls
and Procedures
17
PART
II
Other
Information
Item
1.
Legal
Proceedings
17
Item
1A.
Risks
Factors
17
Item
5.
Other
Information
17
Item
6.
Exhibits
18
Signatures
19
PART
I - FINANCIAL INFORMATION
SUMMARIZED
FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
August
31, 2023
May
31, 2023
Assets
Current Assets:
Cash and cash
equivalents
$ 7,988,000
$ 9,719,000
Accounts receivable, net
1,430,000
722,000
Inventories, net
1,877,000
2,056,000
Prepaid
expenses and other
279,000
300,000
Total current assets
11,574,000
12,797,000
Property and equipment,
net of accumulated depreciation and amortization
218,000
213,000
Right-of-use assets, net of accumulated amortization
of $ 688,000 and $ 617,000 as of August 31, 2023 and May 31, 2023, respectively
964,000
1,035,000
Investments
165,000
165,000
Intangible assets, net
of accumulated amortization
202,000
165,000
Other
assets
96,000
79,000
Total Assets
$ 13,219,000
$ 14,454,000
Liabilities and Shareholders’
Equity
Current Liabilities:
Accounts payable and accrued
expenses
$ 713,000
$ 892,000
Accrued compensation
667,000
696,000
Advance from customers
60,000
60,000
Lease
liabilities, current portion
306,000
297,000
Total current liabilities
1,746,000
1,945,000
Lease
liabilities, net of current portion
705,000
785,000
Total Liabilities
2,451,000
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 August 31, 2023 and May 31, 2023
-
-
Preferred stock, undesignated, no par value,
4,428,571 shares authorized, none issued and outstanding as of August 31, 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 August 31, 2023 and May 31, 2023, respectively
1,346,000
1,346,000
Additional paid-in-capital
52,875,000
52,705,000
Accumulated other comprehensive
loss
( 104,000 )
( 110,000 )
Accumulated
deficit
( 43,349,000 )
( 42,217,000 )
Total Shareholders’
Equity
10,768,000
11,724,000
Total Liabilities and
Shareholders’ Equity
$ 13,219,000
$ 14,454,000
The
accompanying notes are an integral part of these statements.
1
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
AND
COMPREHENSIVE LOSS (UNAUDITED)
2023
2022
For
the Three Months Ended August 31,
2023
2022
Net sales
$ 1,713,000
$ 1,637,000
Cost of sales
( 1,301,000 )
( 1,692,000 )
Gross profit (loss)
412,000
( 55,000 )
Operating expenses:
Selling, general and administrative
1,172,000
1,654,000
Research
and development
472,000
361,000
Total
operating expenses
1,644,000
2,015,000
Loss from operations
( 1,232,000 )
( 2,070,000 )
Other income:
Interest
and dividend income
123,000
-
Total
other income
123,000
-
Loss before income taxes
( 1,109,000 )
( 2,070,000 )
Provision for income
taxes
( 23,000 )
( 2,000 )
Net loss
$ ( 1,132,000 )
$ ( 2,072,000 )
Basic net loss per common
share
$ ( 0.07 )
$ ( 0.16 )
Diluted net loss per
common share
$ ( 0.07 )
$ ( 0.16 )
Weighted average number of common and
common equivalent shares:
Basic
16,821,646
13,100,407
Diluted
16,821,646
13,100,407
Net loss
$ ( 1,132,000 )
$ ( 2,072,000 )
Other comprehensive income (loss), net of tax:
Foreign currency translation
6,000
( 13,000 )
Comprehensive loss
$ ( 1,126,000 )
$ ( 2,085,000 )
The
accompanying notes are an integral part of these statements.
2
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)
For
the Three Months Ended August 31, 2022
Shares
Amount
Capital
Loss
Deficit
Equity
Common
Stock
Additional
Paid
in
Accumulated
Other
Comprehensive
Accumulated
Total
Shareholders’
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
Shares issued in connection
with public offering
-
-
-
-
-
-
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
For
the Three Months Ended August 31, 2023
Common
Stock
Additional
Paid
in
Accumulated
Other
Comprehensive
Accumulated
Total
Shareholders’
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
Balances
16,821,646
$ 1,346,000
$ 52,705,000
$ ( 110,000 )
$ ( 42,217,000 )
$ 11,724,000
Exercise of stock options
-
-
-
-
-
-
Net proceeds from ATM
-
-
-
-
-
-
Shares issued in connection
with public offering
-
-
-
-
-
-
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
Balances
16,821,646
$ 1,346,000
$ 52,875,000
$ ( 104,000 )
$ ( 43,349,000 )
$ 10,768,000
The
accompanying notes are an integral part of these statements.
3
BIOMERICA,
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
2023
2022
For
the Three Months Ended August 31,
2023
2022
Cash flows from operating
activities:
Net loss
$ ( 1,132,000 )
$ ( 2,072,000 )
Adjustments to reconcile
net loss to net cash used in operating activities:
Depreciation and amortization
21,000
29,000
Provision for allowance on accounts receivable
-
230,000
Inventory reserve
( 140,000 )
136,000
Share-based compensation
170,000
304,000
Amortization of right-of-use asset
71,000
67,000
Changes in assets and liabilities:
Accounts receivable
( 708,000 )
( 388,000 )
Inventories
319,000
358,000
Prepaid expenses and other
21,000
82,000
Other assets
( 17,000 )
2,000
Accounts payable and accrued expenses
( 179,000 )
( 301,000 )
Accrued compensation
( 29,000 )
( 55,000 )
Advance from customers
-
100,000
Reduction in lease liabilities
( 71,000 )
( 65,000 )
Net cash used in by
operating activities
( 1,674,000 )
( 1,573,000 )
Cash flows from investing
activities:
Purchases of property and equipment
( 21,000 )
( 34,000 )
Expenditures related to intangibles
( 42,000 )
-
Net cash used in investing
activities
( 63,000 )
( 34,000 )
Cash flows from financing
activities:
Gross proceeds from sale of common stock
-
1,811,000
Costs from sale of common stock
-
( 47,000 )
Proceeds from exercise
of stock options
-
14,000
Net cash provided by financing activities
-
1,778,000
Effect of exchange rate
changes in cash
6,000
( 13,000 )
Net decrease (increase) in cash and cash equivalents
( 1,731,000 )
158,000
Cash and cash equivalents
at beginning of year
9,719,000
5,917,000
Cash and cash equivalents
at end of the period
$ 7,988,000
$ 6,075,000
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period
for:
Income taxes
$ 23,000
$ 2,000
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.
4
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 in certain cases 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 material 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, Amazon, and Walgreens). The diagnostic test kits are used to analyze blood,
urine, nasal or fecal specimens from patients in the diagnosis of various diseases, food intolerances and other medical complications,
by measuring or detecting the existence and/or level of specific bacteria, hormones, antibodies, antigens, or other substances, which
may exist in a patient’s body, stools, or blood, often in extremely small concentrations.
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. While we initially offered a COVID-19 antibody diagnostic test to determine if
a person has previously been infected by the COVID-19 virus, all of our COVID-19 revenues in fiscal 2022 and 2023 have come from international
sales of our COVID-19 antigen tests that use a patient’s nasal fluid sample to detect if the patient is currently infected with
the virus. Due to falling demand, there were no sales of our COVID-19 related products in the three months ended August 31, 2023. As
such, our COVID-19 product sales have caused significant swings in our revenues over the past eight quarters.
Our
non-COVID-19 products that accounted for all of our revenues during the three months ended August 31, 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 months ended August 31, 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.
5
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 accounting principles generally accepted in the United
States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date of the 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 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, closure of the facilities of the Company’s suppliers, partners and customers, travel,
shipping and logistical disruptions, government responses of all types, international business risks in countries where the Company makes
and/or sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of production,
customer credit risk, and general economic calamities. The Company’s current sales and marketing focus is on the sale of the inFoods ®
IBS product within the U.S. As such, going forward, the Company hopes to see reduced disruptions from the issues listed above.
LIQUIDITY
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $ 43.3 million
as of August 31, 2023. Management expects to continue to incur significant costs as it advances its clinical trials, product development,
and commercial product launch activities. As of August 31, 2023, the Company had cash and cash equivalents of approximately $ 7,988,000
and working capital of approximately $ 9,828,000 .
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, the ATM 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.
6
Management
has analyzed the cash requirements of the Company’s business through at least November 2024. As a result of cash and cash equivalents
on hand on August 31, 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 November
2024.
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 $ 1,713,000 for the three months ended August 31, 2023, as compared to $ 1,637,000 for the three months ended
August 31, 2022. For the three months ended August 31, 2023 and 2022, the Company had one and two key customers who are located in foreign
countries which accounted for 59 % and 64 % of net sales, respectively.
Total
gross receivables on August 31, 2023 and May 31, 2023 were approximately $ 1,459,000 and $ 751,000 , respectively. On August 31, 2023 and
May 31, 2023, the Company had one key customer, who are located in foreign countries which accounted for a total of 67 % and 35 % , respectively,
of gross accounts receivable.
For
the three months ended August 31, 2023 and 2022, the Company had one key vendor which accounted for 12 % and 9 % of the purchases of raw
materials, respectively. As of August 31, 2023 and May 31, 2023, the Company had one key vendor which accounted for 47 % 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, NET
The
Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until they
establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria. 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 receivables balances relative to the total
gross receivables. Management monitors the payments for these large balances closely and very often requires payment of existing invoices
before shipping new sales orders.
As
of August 31, 2023 and May 31, 2023, the Company has established a reserve of approximately $ 29,000 for credit losses.
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 August 31, 2023 and May 31, 2023, the prepaids were approximately $ 279,000 and $ 300,000 , respectively, composed of prepayments to
insurance and various other suppliers.
7
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
August
31, 2023
May
31, 2023
Raw materials
$ 1,454,000
$ 1,677,000
Work in progress
793,000
869,000
Finished products
162,000
182,000
Total gross inventory
2,409,000
2,728,000
Inventory reserves
( 532,000 )
( 672,000 )
Net
inventory
$ 1,877,000
$ 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 August 31, 2023, and May 31, 2023, inventory reserves were approximately $ 532,000 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 was approximately $ 16,000 and $ 20,000 for the three months ended August 31, 2023
and 2022, respectively.
INTANGIBLE
ASSETS, NET
Intangible
assets include trademarks, product rights, technology rights and patents, and are accounted for based on Accounting Standards Codification
(“ASC”), ASC 350 Intangibles – Goodwill and Other (“ASC 350”). In that regard, intangible assets that have
indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in
circumstances indicate that the asset might be impaired.
Intangible
assets are being amortized using the straight-line method over the useful life, not to exceed 18 years for marketing and distribution
rights, 10 years for purchased technology use rights, and 20 years for patents. Amortization expense was approximately $ 5,000 and $ 9,000
for the three months ended August 31, 2023 and 2022, respectively.
The
Company assesses the recoverability of these intangible assets by determining whether the amortization of the asset’s balance over
its remaining life can be recovered through projected undiscounted future cash flows. The Company uses a qualitative assessment to determine
whether there was any impairment. During the three months ended August 31, 2023 and 2022, an impairment adjustment was made of $ 0 and
$ 6,000 , respectively.
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.
8
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 August 31, 2023 and determined that the Company’s proportionate economic interest in the entity indicates that the equity holding
was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the
Company’s Cost Method Holdings during the period ended August 31, 2023.
SHARE-BASED
COMPENSATION
The
Company follows the guidance of ASC 718, Share-based Compensation (“ASC 718”), which requires the use of the fair-value based
method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments
(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model that uses
assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The
Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based
on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options.
The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the
“simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as
historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield
curve in effect at the time of grant for the period of the expected term. The grant date fair value of the award is recognized under
the straight-line attribution method.
The
Company expensed approximately $ 170,000 and $ 304,000 of share-based compensation during the three months ended August 31, 2023 and 2022,
respectively.
The
following summary presents the options granted, exercised, expired, canceled and outstanding for the three months ended August 31, 2023:
SUMMARY
OF OPTIONS ACTIVITY
Option
Shares
Weighted
Average
Exercise Price
Options Outstanding at May
31, 2023
2,342,616
$ 3.52
Granted
68,000
1.18
Exercised
-
-
Cancelled or expired
( 47,500 )
3.31
Options Outstanding
at August 31, 2023
2,363,116
$ 3.45
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 three months ended August 31, 2023 and 2022 and
does not believe that any additional discounts will be given through the end of the contract periods.
Services
for contract work performed by the Company for others are invoiced and recognized as that work has been performed and as the project
progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories,
medical research institutions, medical schools and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce
customers as well as to distributors. 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 August 31, 2023, the Company had approximately $ 60,000 of advances from certain foreign customers. The majority of these advances
are prepayments on orders that are expected to ship during our second fiscal quarter ended November 30, 2023.
9
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
Three Months Ended
August 31,
2023
2022
Clinical lab
$ 1,289,000
$ 1,146,000
Over-the-counter
303,000
213,000
Contract manufacturing
117,000
95,000
Physician’s office
4,000
183,000
Total
$ 1,713,000
$ 1,637,000
See
Note 4 for additional information regarding 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 $ 472,000 and $ 361,000 of research and development
costs during the three months ended August 31, 2023 and 2022, respectively.
INCOME
TAXES
The
Company had income tax expense for the three months ended August 31, 2023 of approximately $ 23,000 , consisting of state minimum and foreign
miscellaneous taxes. During the three months ended August 31, 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 August 31, 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 August 31, 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
$ 30,000 and $ 18,000 for the three months ended August 31, 2023 and 2022, respectively.
FOREIGN
CURRENCY TRANSLATION
The
subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the
U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries
are translated using exchange rates in effect at the end of the 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 consolidated statements of operations for
the three months ended August 31, 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.
10
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
at August 31, 2023 and 2022 was 2,363,116 and 2,388,616 , 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 three months ended August 31, 2022, the Company sold 523,977 shares of its common stock at prices ranging from $ 3.15 to $ 3.55 under
its Form S-3 Registration Statement and ATM Offering which resulted in gross proceeds of approximately $ 1,811,000 and net proceeds to
the Company of approximately $ 1,764,000 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 August 31, 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 three months ended August 31, 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
Three
Months Ended August 31,
2023
2022
Revenues from sales to unaffiliated
customers:
Asia
$ 1,026,000
$ 814,000
Europe
327,000
552,000
North
America
355,000
268,000
South
America
5,000
3,000
Revenues
from sales to unaffiliated customers total
$ 1,713,000
$ 1,637,000
As
of August 31, 2023 and May 31, 2023, approximately $ 610,000 and $ 626,000 of Biomerica’s gross inventory was located in Mexicali,
Mexico, respectively.
As
of August 31, 2023 and May 31, 2023, approximately $ 16,000 and $ 17,000 of Biomerica’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 August 31, 2023, the Company had approximately 22,000 square feet of floor space at its corporate headquarters
at 17571 Von Karman Avenue in Irvine, California, 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.
11
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 months ended August 31, 2023 and 2022:
SCHEDULE
OF OPERATING LEASES
2023
2022
Three
Months Ended August 31,
2023
2022
Operating lease
cost
$ 88,000
$ 88,000
Variable lease cost
3,000
-
Short-term
lease cost
5,000
4,000
Total
lease cost
$ 96,000
$ 92,000
The
approximate maturity of lease liabilities as of August 31, 2023 are as follows:
SCHEDULE
OF FUTURE MINIMUM LEASE PAYMENTS
Year
Ending August 31:
Operating
Leases
2024
$ 359,000
2025
368,000
2026
378,000
2027
6,000
Thereafter
-
Total
minimum future lease payments
$ 1,111,000
Less:
imputed interest
100,000
Total
operating lease liabilities
$ 1,011,000
The
following table summarizes the Company’s other supplemental lease information for the three months ended August 31, 2023 and 2022:
SCHEDULE
OF OTHER SUPPLEMENTAL LEASE INFORMATION
2023
2022
Three
Months Ended August 31,
2023
2022
Cash
paid for operating lease liabilities
$ 87,000
$ 86,000
Weighted-average
remaining lease term (years)
3.02
4.02
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 legal proceedings pending as of August 31, 2023.
NOTE
7: SUBSEQUENT EVENTS
On
September 15, 2023 the Company submitted to the FDA the final H. Pylori data set requested by the FDA during the FDA’s recent review
of the 510-K filed by the Company. The Company received confirmation from the FDA that the data was received. The Biomerica hp+detect™
diagnostic test is designed to detect the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population.
12
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 to validate the
efficacy of 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. We are identifying the trial protocol for submission to the FDA, and once approved the trial would be run thereafter.
The trial is expected to include the large medical institution participants that conducted the endpoint clinical trial, in addition to
other new institutions and a Clinical Research Organization.
13
Following
the successful completion and positive statistical results from the Company’s inFoods® IBS clinical trial, Biomerica received
interest from Gastroenterology (“GI”) physicians who would like to order the inFoods® IBS test for their patients.
In
fiscal 2023, we worked to set up the inFoods® IBS test to be performed in a CLIA certified, and College of American Pathologists
(“CAP”) accredited high-complexity laboratory facility and offered as a laboratory developed test (“LDT”). During
the quarter ended February 28, 2023, the CLIA lab completed all validation testing necessary for the inFoods® IBS product to be offered
as an LDT and, as of February 28, 2023, patient samples were being accepted. We also worked to optimize the process for GI physicians
to order the inFoods® IBS test, send patient blood samples to the CLIA lab, and receive the test results for their patients. We believe
ease of order and workflow for physicians, with easy to understand and actionable results for patients, is critical to our success. During
the fiscal third quarter, we also set up customer service and payment systems, along with a dedicated website for patients to receive
answers to questions they may have about the test and attain information about how to eliminate a specific food identified as needing
to be eliminated from their diet. This is especially important for foods that are ingredients in common processed foods like milk, eggs,
and wheat. As of the end of the fiscal third quarter, we trial launched this product with one large GI physician group 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 material 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
will also continue to evaluate partnership/licensing opportunities, as they arise, with U.S and multinational companies that could help
us commercialize, or accelerate revenue growth of, the inFoods® products in the United States and overseas.
Our
existing medical diagnostic products are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point-of-care (physicians’
offices and OTC at Walmart, CVS Pharmacy, Amazon, etc.). The diagnostic test kits are used to analyze blood, urine, nasal, or fecal specimens
from patients in the diagnosis of various diseases, food intolerances and other medical complications, by measuring or detecting the
existence and/or level of specific bacteria, hormones, antibodies, antigens, or other substances, which may exist in a patient’s
body, stools, or blood, often in extremely small concentrations.
Due
to the global 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. While we initially offered a COVID-19 antibody diagnostic test to determine if
a person has previously been infected by the COVID-19 virus, all of our COVID-19 revenues in fiscal 2022 and 2023 have come from international
sales of our COVID-19 antigen tests that use a patient’s nasal fluid sample to detect if the patient is currently infected with
the virus. Due to falling demand, there were no sales of our COVID-19 related products in the three months ended August 31, 2023. As
such, our COVID-19 product sales have caused significant swings in our revenues over the past eight quarters.
During
fiscal 2022, we finalized development of our H. Pylori diagnostic test that indicates if a patient is infected with the H. Pylori bacteria.
H. Pylori infection is extremely common, and if left untreated, can lead to ulcers and possibly stomach cancers. During our fourth quarter
of fiscal 2022, we applied for FDA clearance of this product though a 510(k) premarket submission. We have been in communication with
the FDA answering certain follow-up questions and providing additional data as requested. Working with the FDA, in August 2023, we completed
one additional set of in-lab tests that the FDA requested prior to making their final determination on clearance of the product. This
set of data was sent to the FDA and our 510(k) for the H. Pylori product was resubmitted to the FDA in September 2023. Once cleared,
we will begin 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 non-COVID related products such
as our H. Pylori product, and our inFoods® IBS product.
Our
existing products that contributed to our fiscal 2023 revenues are primarily focused on gastrointestinal diseases, food intolerances,
and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our products are CE marked and/or
sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for
sale in the United States by the FDA.
14
RESULTS
OF OPERATIONS
Net
Sales and Cost of Sales
The
following is a breakdown of revenues according to markets to which the products are sold:
Three Months Ended August 31,
Increase (Decrease)
2023
2022
$
%
Clinical lab
$ 1,289,000
$ 1,146,000
$ 143,000
12 %
Over-the-counter
303,000
213,000
90,000
42 %
Contract Manufacturing
117,000
95,000
22,000
23 %
Physician’s office
4,000
183,000
(179,000 )
-98 %
Total
$ 1,713,000
$ 1,637,000
$ 76,000
5 %
Consolidated
net sales was approximately $1,713,000 for the three months ended August 31, 2023, as compared to $1,637,000 for the three months
ended August 31, 2022, an increase of approximately $76,000, or 5%. This increase for the three months ended August 31, 2023, was
driven primarily by demand for our clinical lab products in Asia and OTC products in the United States which was partially offset by a reduction in Physician’s office sales associated to COVID products. Periodic and infrequent
orders may cause volatility in quarterly sales.
Consolidated
cost of sales was approximately $1,301,000, or 76% of net sales, for the three months ended August 31, 2023, as compared to
$1,692,000, or 107% of net sales, for the three months ended August 31, 2022, a decrease of approximately $391,000, or 23%. The
decrease for the three months ended August 31, 2023, was driven primarily by the decrease in volume of COVID products and related
inventory write-offs.
Operating
Expenses
The
following is a summary of operating expenses:
Three
Months Ended August 31,
2023
2022
Increase
(Decrease)
Operating
Expense
As
a % of Total
Revenues
Operating
Expense
As
a % of Total
Revenues
$
%
Selling,
General and Administrative Expenses
$ 1,172,000
68 %
$ 1,654,000
101 %
$ (482,000 )
-29 %
Research
and Development
$ 472,000
28 %
$ 361,000
22 %
$ 111,000
31 %
Selling,
General and Administrative Expenses
Consolidated
selling, general and administrative expenses were approximately $1,172,000 for the three months ended August 31, 2023, as compared to
$1,654,000 for the three months ended August 31, 2022, a decrease of approximately $481,000, or 29%. The decrease in the three months
ended August 31, 2023, was primarily due to approximate decreases in bad debt expense of $220,000, share-based compensation of $123,000,
and legal expense of $170,000.
Research
and Development
Consolidated
research and development expenses were approximately $472,000 for the three months ended August 31, 2023, as compared to $361,000 for
the three months ended August 31, 2022, an increase of approximately $111,000, or 31%. The increase in the three months ended August
31, 2023, was primarily due to R&D wages.
Interest
and Dividend Income
Interest
and dividend income were approximately $123,000 for the three months ended August 31, 2023, as compared to $0 for the three months ended
August 31, 2022, an increase of $123,000, or 100%. The $123,000 increase was due to market interest rates on our cash balance, which,
on August 31, 2022, the cash balance had not been invested.
15
LIQUIDITY
AND CAPITAL RESOURCES
The
following are the principal sources of liquidity:
August
31, 2023
May
31, 2023
Cash
and cash equivalents
$ 7,988,000
$ 9,719,000
Working
capital including cash and cash equivalents
$ 9,828,000
$ 10,852,000
As
of August 31, 2023 and May 31, 2023, the Company had cash and cash equivalents of approximately $7,988,000 and $9,719,000, respectively.
As of August 31, 2023 and May 31, 2023, the Company had working capital of approximately $9,828,000 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 three months ended August 31, 2023, cash used in operating activities was approximately $1,674,000. The primary factors that
contributed to this were a loss of approximately $1,132,000, non-cash expenses of $122,000, primarily associated with
depreciation and amortization, share-based compensation, inventory reserves and amortization of right-of-use assets. This was
partially offset by changes in asset and liability accounts of $664,000.
During
the three months ended August 31, 2022, cash used in operating activities was approximately $1,573,000. The primary factors that
contributed to this were a loss of approximately $2,072,000, non-cash expenses of $766,000, primarily
associated with depreciation and amortization, share-based compensation, account receivables provision, and inventory
reserves . This was partially offset by changes in asset and liability accounts of $267,000.
Investing
Activities
During
the three months ended August 31, 2023, cash used in investing activities was approximately $63,000. During the three months ended August
31, 2023, the Company purchased approximately $21,000 of property and equipment and had $42,000 in expenditures related to patents.
During
the three months ended August 31, 2022, cash used in investing activities was approximately $34,000 for purchases of property and equipment.
Financing
Activities
During
the three months ended August 31, 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 three months ended August 31, 2022, cash provided by financing activities was approximately $1,778,000 which was a result of net
proceeds from the sale of common stock of $1,764,000, and stock option exercises of $14,000.
OFF
BALANCE SHEET ARRANGEMENTS
There
were no off-balance sheet arrangements as of August 31, 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 conditions
or results of operations. We suggest that our significant accounting policies be read in conjunction with this Management’s Discussion
and Analysis of Financial Condition and Results of Operations. Please refer to Note 2 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.
16
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 legal proceedings pending as of August 31, 2023.
ITEM
1A. RISKS 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 months ended August 31, 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.
17
ITEM
6. EXHIBITS
The
following exhibits are filed or furnished as part of this quarterly report on Form 10-Q:
Exhibit
No.
Description
3.2*
Amended and Restated Bylaws of the Company
31.1**
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act — Zackary S. Irani
31.2**
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act — Gary Lu
32.1**
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act — Zackary S. Irani
32.2**
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act — Gary Lu
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.
18
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:
October 12, 2023
By:
/S/ Zackary
S. Irani
Zackary S. Irani
Chief Executive Officer
(Principal Executive Officer)
Date:
October 12, 2023
By:
/S/ Gary
Lu
Gary Lu
Chief Financial Officer
(Principal Financial Officer)
19
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.