Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Attached
as exhibits to this Form 10-K are certifications of our Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”)
that are required in accordance with Rule 13a-14 of the Exchange Act. This “Disclosure Controls and Procedures” section includes
information concerning the controls and controls evaluation referred to in the certifications.
EVALUATION
OF DISCLOSURE CONTROLS
Our
management evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934, as amended, or the Exchange Act as of the end of the period covered by this report. Our management recognizes
that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
The disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives. Our CEO and
CFO concluded that our disclosure controls and procedures are effective at a reasonable assurance level as of May 31, 2024. Based on
that evaluation the CEO and CFO concluded that information required to be disclosed in the reports that we file and submit under the
Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the Commission’s rules and
forms; and (2) accumulated and communicated to the Company’s management, including its CEO and CFO, as appropriate, to allow timely
decisions regarding required disclosure.
Company
management, including the CEO and CFO concluded that, as of May 31, 2024, the Company’s internal control over financial reporting
was effective.
CHANGES
IN INTERNAL CONTROL OVER FINANCIAL REPORTING
There
have been no changes in our internal control over financial reporting identified in connection with the evaluation that occurred during
the quarter ended May 31, 2024, that have materially affected, or that are reasonably likely to affect, our internal control over financial
reporting.
MANAGEMENT’S
REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Company
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f)
under the Securities Exchange Act of 1934. The Company’s internal control over financial reporting is designed to provide reasonable
assurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparation
and fair presentation of financial statements for external purposes in accordance with accounting principles generally accepted in the
United States of America.
A
company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with accounting principles generally accepted in the United States of America, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have
a material effect on the consolidated financial statements.
The
effectiveness of any system of internal control over financial reporting is subject to inherent limitations, including the exercise of
judgment in designing, implementing, operating, and evaluating the controls and procedures. Because of these inherent limitations, internal
control over financial reporting cannot provide absolute assurance regarding the reliability of financial reporting and may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls
may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
30
Company
management, with the participation of the CEO and the CFO, evaluated the effectiveness of the Company’s disclosure controls and
procedures as defined in Rules 13(a)-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act,
as of the end of the period covered by this report. In making this assessment, Management used the criteria set forth by the Committee
of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control - Integrated Framework (2013). Based
on this assessment, management, with the participation of the CEO and CFO, believes that, as of May 31, 2024, the Company’s internal
control over financial reporting was effective based on those criteria.
Company
management will continue to monitor and evaluate the effectiveness of its disclosure controls and procedures and its internal controls
over financial reporting on an ongoing basis and are committed to taking further action and implementing improvements, as necessary and
as funds allow.
Note:
This 10-K does not include an attestation report of the Company’s independent registered public accounting firm regarding internal
control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered
public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only
management’s report in this 10-K.
ITEM
9B. OTHER INFORMATION.
On
August 28, 2024, the Company entered into an employment agreement with their Chief Financial Officer, Mr. Gary Lu, wherein if Mr. Lu
is terminated by the Company without cause, or if Mr. Lu voluntarily terminates his employment with the Company with cause, then the
Company will be required to pay Mr. Lu a severance payment equal to twelve months of base salary. The definition of “cause”
for each type of termination is found in the agreement, along with other material terms. This agreement is attached hereto as Exhibit
10.8.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
The
information required by this item will be disclosed in our definitive proxy statement on Schedule 14A (the “Proxy Statement”)
for our 2024 Annual Meeting of Stockholders and is incorporated by reference herein. Our Proxy Statement will be filed with the SEC within
120 days after the end of the Company’s fiscal year ended May 31, 2024, pursuant to Regulation 14A under the Exchange Act.
ITEM
11. EXECUTIVE COMPENSATION
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The table below provides information relating to our equity compensation plans as of May 31, 2024:
Securities Plan Category
Number of Securities to be Issued Upon Exercise of Outstanding Options
Compensation Plans Weighted-Average Exercise Price of Outstanding Options
Securities Remaining Available for Future Issuance Under Compensation Plans
Equity Compensation Plans Approved by Securities Holders
3,479,616
$ 2.53
89,801
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information required by this item will be disclosed in the Proxy Statement and is incorporated herein by reference.
PART
IV
ITEM
15. EXHIBITS LIST AND FINANCIAL SCHEDULES
The
following documents are filed as part of this Annual Report on Form 10-K:
1. Consolidated
Financial Statements
Reference
is made to the Index to the consolidated financial statements as set forth on page FS-1 of this Annual Report on Form
10-K.
2. Consolidated
Financial Statement Schedules
All
schedules have been omitted as the pertinent information is either not required, not applicable,
or otherwise included in the financial statements and notes thereto.
3. Exhibits
See
below.
31
Exhibit
No.
Description
3.1
First Amended and Restated Certificate of Incorporation of Registrant filed with the Secretary of State of Delaware on August 1, 2000 (incorporated by reference to Exhibit 3.8 filed with the Registrant’s Annual Report on Form 10-KSB for the fiscal year ended May 31, 2000).
3.2
Amended and Restated Bylaws, as adopted on July 24, 2023 (incorporated by reference to Exhibit 3.1 of the Company’s Form 8-K filed July 26, 2023).
4.1
Specimen Stock Certificate of Common Stock of Registrant (incorporated by reference to Exhibit 4.1 filed with Registrant’s Registration Statement on Form SB-2, Commission No. 333-87231 filed on September 16, 1999).
4.2
Description of Capital Stock.
10.1
Standard Industrial/Commercial Single-Tenant Lease, dated June 18, 2009, by and between Registrant and CNH, LLC for 17571 Von Karman Avenue, Irvine, CA 92614 (incorporated by reference to Exhibit 10.1 of the Company’s August 31, 2009 Form 10-Q filed October 16, 2009).
10.2
2014 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 29, 2014).
10.3
2017 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 28, 2017).
10.4
2020 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 25, 2020).
10.5
Form of Executive Stock Option Agreement (attached herein).
10.6
Employment Agreement, dated March 1, 2023, by and between Biomerica, Inc. and Gary Lu.
10.7
2023 Stock Incentive Plan of Registrant (incorporated by reference to Exhibit A of the Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on September 27, 2023 ).
10.8
Employment Agreement dated August 28, 2024 by and between Biomerica Inc. and Gary Lu.
21.1
List of Subsidiaries (attached herein).
23.1
Consent of Independent Registered Public Accounting Firm (Haskell & White LLP) .
31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Exchange Act, adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended .
31.2
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Exchange Act, adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended.
32.1
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended .
32.2
Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended .
101.INS
Inline
XBRL Instance Document.
101.SCH
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
The
certifications attached as Exhibits 32.1 and 32.2 accompany this Annual Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, as amended, and shall not be deemed “filed” by the registrant for purposes
of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities
Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.
32
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
BIOMERICA, INC.
Registrant
By /s/
Zackary S. Irani
Zackary
S. Irani,
Chief
Executive Officer
Dated:
August 28, 2024
In
accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated:
Signature
and Capacity
/s/
Zackary S. Irani
Date:
August 28, 2024
Zackary
S. Irani
Director,
Chief Executive Officer
/s/
Gary Lu, CPA
Date:
August 28, 2024
Gary
Lu, CPA
Chief
Financial Officer
/s/
Allen Barbieri
Date:
August 28, 2024
Allen
Barbieri
Director,
Vice-Chairman
/s/
Jane Emerson, M.D., Ph.D.
Date:
August 28, 2024
Jane
Emerson, M.D., Ph.D.
Director
/s/
David Moatazedi
Date:
August 28, 2024
David
Moatazedi
Director
/s/
Catherine Coste, CPA
Date:
August 28, 2024
Catherine
Coste, CPA
Director
33
BIOMERICA,
INC. AND SUBSIDIARIES
TABLE
OF CONTENTS
Report
of Independent Registered Public Accounting Firm (PCAOB ID 0 200 )
FS-2
– FS-3
CONSOLIDATED
FINANCIAL STATEMENTS
Consolidated Balance Sheets as of May 31, 2024 and 2023
FS-4
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended May 31, 2024 and 2023
FS-5
Consolidated Statements of Shareholders’ Equity for the Years Ended May 31, 2024 and 2023
FS-6
Consolidated Statements of Cash Flows for the Years Ended May 31, 2024 and 2023
FS-7
Notes to Consolidated Financial Statements
FS-8
– FS-20
FS- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors
Biomerica,
Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Biomerica, Inc. (the “Company”) as of May 31,
2024 and 2023, the related consolidated statements of operations and comprehensive loss, shareholders’ equity, and cash flows for
each of the years then ended, and the related notes (collectively, the “consolidated financial statements”). In our opinion,
the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as
of May 31, 2024 and 2023, and the consolidated results of its operations and its cash flows for each of the years then ended, in conformity
with U.S. generally accepted accounting principles.
Going
Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as
a going concern. As described in Note 2 to the consolidated financial statements, the Company has experienced recurring losses and negative
cash flows from operations and has an accumulated deficit and limited liquid resources. These matters raise substantial doubt about the
Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note
2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility
is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm
registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent
with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current-period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material
to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical
audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating
the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which
they relate.
Inventory
Valuation
Critical
Audit Matter Description
As described in Note 2 to the Company’s consolidated financial statements, the Company values inventory at
the lower of cost or net realizable value with cost inclusive of estimates for reasonable allocations of labor and overhead costs. Also,
management periodically reviews inventory for excess quantities and obsolescence. Management evaluates quantities on hand, physical condition,
and technical functionality as these characteristics may be impacted by anticipated customer demand for current products and new product
introductions. Auditing the Company’s estimates for capitalized labor and overhead was challenging due to the extensive use of estimates
throughout this process, including the amount of labor and overhead costs allocable to inventory production and the specific amount of
labor and overhead costs allocable to ending inventory quantities. Auditing the Company’s estimates for slow-moving and obsolete
inventories was challenging due to the inherently judgmental nature of forecasting future sales and usage of a significant number of diverse
inventory items.
FS- 2
How
the Critical Audit Matter Was Addressed in the Audit
To
test the valuation of the Company’s inventory, we performed the following audit procedures:
●
Obtained
an understanding of the methodologies and policies used by management to estimate capitalized labor and overhead and inventory reserves;
we obtained an understanding of key internal controls and assessed their overall appropriateness;
●
Tested the reasonableness of the production labor and overhead cost pools and the reasonableness of inventory quantities
produced; we recalculated the allocable labor and overhead rate per unit produced; we recalculated the amount of capitalized labor and
overhead based on quantities on hand at the end of the fiscal year; we performed sensitivity analyses to determine the impact of adjustments
to management’s estimates; and
●
Tested the accuracy of key data inputs that are the primary drivers for determining the quantitative inventory reserves;
these inputs included inventory quantities on hand, approximate age of the inventory quantities, and estimated inventory reserve percentages.
/s/ Haskell & White LLP
HASKELL
& WHITE LLP
We
have served as the Company’s auditor since 2022.
Irvine,
California
August 28, 2024
FS- 3
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
2024
2023
May 31,
2024
2023
Assets
Current Assets:
Cash and cash equivalents
$ 4,170,000
$ 9,719,000
Accounts receivable, net
947,000
722,000
Inventories, net
2,376,000
2,056,000
Prepaid expenses and other
238,000
300,000
Total current assets
7,731,000
12,797,000
Property and equipment, net of accumulated depreciation and amortization
201,000
213,000
Right-of-use assets, net of accumulated amortization of $ 910,000 and $ 617,000 as of May 31, 2024 and 2023, respectively
742,000
1,035,000
Investments
165,000
165,000
Intangible assets, net of accumulated amortization of $ 48,000 and $ 30,000 as of May 31, 2024 and 2023, respectively
212,000
165,000
Other assets
203,000
79,000
Total Assets
$ 9,254,000
$ 14,454,000
Liabilities and Shareholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses
$ 1,138,000
$ 892,000
Accrued compensation
655,000
696,000
Advances from customers
85,000
60,000
Lease liabilities, current portion
326,000
297,000
Total current liabilities
2,204,000
1,945,000
Lease liabilities, net of current portion
459,000
785,000
Total Liabilities
2,663,000
2,730,000
Commitments and contingencies (Note 9)
-
-
Shareholders’ Equity:
Preferred stock, Series A 5% convertible, $ 0.08 par value, 571,429 shares
authorized, none issued and outstanding as of May 31, 2024 and 2023
-
-
Preferred stock, undesignated, no par value, 4,428,571 shares authorized, none issued and outstanding as of May 31, 2024 and
2023
-
-
Common stock, $ 0.08 par value, 25,000,000 shares authorized, 16,821,646 issued and outstanding at May 31, 2024 and 2023, respectively
1,346,000
1,346,000
Additional paid-in capital
53,542,000
52,705,000
Accumulated other comprehensive loss
( 102,000 )
( 110,000 )
Accumulated deficit
( 48,195,000 )
( 42,217,000 )
Total Shareholders’ Equity
6,591,000
11,724,000
Total Liabilities and Shareholders’ Equity
$ 9,254,000
$ 14,454,000
See
accompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.
FS- 4
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2024
2023
For the Year Ended May 31,
2024
2023
Net sales
$ 5,415,000
$ 5,339,000
Cost of sales
( 4,804,000 )
( 4,893,000 )
Gross profit
611,000
446,000
Operating expenses:
Selling, general and administrative
5,487,000
6,085,000
Research and development
1,491,000
1,584,000
Total operating expense
6,978,000
7,669,000
Loss from operations
( 6,367,000 )
( 7,223,000 )
Other income:
Dividend and interest income
431,000
133,000
Other income
-
1,000
Total other income
431,000
134,000
Loss before income taxes
( 5,936,000 )
( 7,089,000 )
Provision for income taxes
( 42,000 )
( 51,000 )
Net loss
$ ( 5,978,000 )
$ ( 7,140,000 )
Basic net loss per common share
$ ( 0.36 )
$ ( 0.50 )
Diluted net loss per common share
$ ( 0.36 )
$ ( 0.50 )
Weighted average number of common and common equivalent shares:
Basic
16,821,646
14,154,269
Diluted
16,821,646
14,154,269
Net loss
$ ( 5,978,000 )
$ ( 7,140,000 )
Other comprehensive loss, net of tax:
Foreign currency translation
8,000
( 36,000 )
Comprehensive loss
$ ( 5,970,000 )
$ ( 7,176,000 )
See
accompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.
FS- 5
Biomerica,
Inc.
Consolidated
Statements Shareholders’ Equity
For
the Year Ended May 31, 2024
Common Stock
Additional Paid-in
Accumulated Other Comprehensive
Accumulated
Total Stockholders’
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
46,500
4,000
77,000
-
-
81,000
Net proceeds from ATM
573,889
46,000
1,915,000
-
-
1,961,000
Shares issued in connection with public offering
3,333,333
267,000
7,081,000
-
-
7,348,000
Foreign currency translation
-
-
-
( 36,000 )
-
( 36,000 )
Compensation expense in connection with options granted
-
-
1,185,000
-
-
1,185,000
Net loss
-
-
-
-
( 7,140,000 )
( 7,140,000 )
Balances at May 31, 2023
16,821,646
1,346,000
52,705,000
( 110,000 )
( 42,217,000 )
11,724,000
Balance
16,821,646
1,346,000
52,705,000
( 110,000 )
( 42,217,000 )
11,724,000
Foreign currency translation
-
-
-
8,000
-
8,000
Compensation expense in connection with options granted
-
-
837,000
-
-
837,000
Net loss
-
-
-
-
( 5,978,000 )
( 5,978,000 )
Balances at May 31, 2024
16,821,646
$ 1,346,000
$ 53,542,000
$ ( 102,000 )
$ ( 48,195,000 )
$ 6,591,000
Balance
16,821,646
$ 1,346,000
$ 53,542,000
$ ( 102,000 )
$ ( 48,195,000 )
$ 6,591,000
See
accompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.
FS- 6
BIOMERICA,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2024
2023
For the Year Ended May 31
2024
2023
Cash flows from operating activities:
Net loss
$ ( 5,978,000 )
$ ( 7,140,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
81,000
84,000
(Recovery) provision for allowance for credit losses
( 10,000 )
342,000
Inventory reserve
( 205,000 )
( 174,000 )
Share-based compensation
837,000
1,185,000
Amortization of right-of-use asset
293,000
267,000
Changes in assets and liabilities:
Accounts receivable
( 215,000 )
( 291,000 )
Inventories
( 115,000 )
534,000
Prepaid expenses and other
62,000
20,000
Other assets
( 44,000 )
18,000
Accounts payable and accrued expenses
246,000
( 80,000 )
Accrued compensation
( 41,000 )
49,000
Advances from customers
25,000
9,000
Reduction in lease liabilities
( 297,000 )
( 297,000 )
Net cash used in operating activities
( 5,361,000 )
( 5,474,000 )
Cash flows from investing activities:
Purchases of property and equipment
( 51,000 )
( 64,000 )
Expenditures related to intangibles
( 64,000 )
( 14,000 )
Net cash used in investing activities
( 115,000 )
( 78,000 )
Cash flows from financing activities:
Gross proceeds from sale of common stock
-
10,014,000
Deferred offering costs
( 81,000 )
-
Costs from sale of common stock
-
( 705,000 )
Proceeds from exercise of stock options
-
81,000
Net cash (used in) provided by financing activities
( 81,000 )
9,390,000
Effect of exchange rate changes in cash
8,000
( 36,000 )
Net (decrease) increase in cash and cash equivalents
( 5,549,000 )
3,802,000
Cash and cash equivalents at beginning of year
9,719,000
5,917,000
Cash and cash equivalents at end of year
$ 4,170,000
$ 9,719,000
Supplemental Disclosure of Cash Flow Information:
Cash paid during the period for:
Income taxes
$ 41,000
$ 51,000
Non-cash investing and financing activities:
Write off of fixed assets, cost
$ -
$ 40,000
Write off of fixed assets, accumulated depreciation
$ -
$ 40,000
Write off of intangible assets, cost
$ -
$ 6,000
Write off of intangible assets, accumulated amortization
$ -
$ 6,000
See
accompanying notes to consolidated financial statements and Report of Independent Registered Public Accounting Firm.
FS- 7
BIOMERICA,
INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS
ENDED MAY 31, 2024 AND 2023
NOTE
1: ORGANIZATION
Biomerica,
Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH) is a biomedical technology
company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (physicians’
offices and over-the-counter through drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical
conditions and diseases. Our diagnostic test kits are used to analyze blood, urine, nasal, or fecal material from patients in the diagnosis
of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens,
or other substances, which may exist in the human body in extremely small concentrations. The Company’s products are designed to
enhance the health and well-being of people, while reducing total healthcare costs.
Our
primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided
therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other
inflammatory diseases. These products are directed at chronic inflammatory illnesses that are widespread and common, and as such address
very large markets. Our inFoods ® IBS product uses a simple blood sample and is designed to identify patient-specific foods
that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, and constipation. Instead of broad and
difficult to manage dietary restrictions, the inFoods ® IBS product works by identifying specific foods that may be causing
an abnormally high immune response in the patient. A food identified as positive, which is causing the abnormal immune response in the
patient, is simply removed from the diet to help alleviate IBS symptoms.
Our
existing medical diagnostic products are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point-of-care (physicians’
offices and over-the-counter drugstores like Walmart and CVS Pharmacy). The diagnostic test kits are used to analyze blood, urine, nasal,
or fecal specimens from patients in the diagnosis of various diseases, food intolerances, and other medical complications, by measuring
or detecting the existence and/or level of specific bacteria, hormones, antibodies, antigens, or other substances, which may exist in
a patient’s body, stools, or blood, often in extremely small concentrations.
Due
to the global COVID-19 pandemic, in March 2020, we began 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 fiscal 2024. As such, our COVID-19 product sales caused significant swings in our revenues
over the past 4 years.
The
other existing products that contributed to our 2024 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 Conformite Europeenne (“CE”) marked and/or
sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for
sale in the United States by the FDA.
NOTE
2: SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
PRINCIPLES
OF CONSOLIDATION
The
consolidated financial statements for the years ended May 31, 2024 and 2023, include the accounts of Biomerica, Inc. (“Biomerica”)
as well as its wholly-owned German subsidiary (“BioEurope GmbH”) and Mexican subsidiary (“Biomerica de Mexico”).
All significant intercompany accounts and transactions have been eliminated in consolidation.
ACCOUNTING
ESTIMATES
The
preparation of our consolidated financial statements in accordance with generally accepted accounting principles in the United States of
America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities, as well as the disclosure of contingent assets and liabilities at the date of the financial statements. These estimates
also impact the reported amounts of revenues and expenses during the reporting period. Key estimates include the allowance for
doubtful accounts, based on both current and historical practices with customers; variable consideration in revenue recognition,
estimated based on agreements that include guarantees of specified profit margins, requiring adjustments based on actual sales
performance and market conditions, stock option forfeiture rates, calculated using historical data; and inventory obsolescence,
where inventory is stated at the lower of cost or net realizable value (NRV) and assessed through judgments based on projected and
historical usage of materials. The valuation of lease liabilities and right-of-use assets also involves
assumptions such as the borrowing rate at lease commencement and the likelihood of lease extensions.
These
estimates are critical to our financial reporting, and actual results could materially differ from those
estimates.
FS- 8
LIQUIDITY AND GOING CONCERN
The
Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $ 48 million as
of May 31, 2024. As of May 31, 2024, the Company had cash and cash equivalents of approximately $ 4,170,000 and working capital of approximately
$ 5,527,000 .
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with the
SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $ 15,000,000 in “at-the-market”
offerings, as defined in Rule 415 promulgated under the Securities Act (the “ATM Offering”).
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any shares under the ATM Offering, and may at any time suspend offers
under, or terminate the ATM Offering.
During
the year ended May 31, 2023, the Company sold 573,889 shares of its common stock at prices ranging from $ 3.15 to $ 4.26 pursuant to the
ATM Agreement, which resulted in gross proceeds of approximately $ 2,014,000 and net proceeds to the Company of $ 1,961,000 , after deducting
commissions for each sale and legal, accounting, and other fees related to offering in the amount of $ 53,000 .
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 . As a result
of this public offering, the Company terminated the ATM offering agreement.
On
September 28, 2023, we filed a “shelf” registration statement on Form S-3 with the SEC, allowing the Company to issue up
to $ 20,000,000 in
common shares. Under this registration statement, shares of our common stock may be sold from time to time for up to three years
from the filing date. On May 10, 2024, the Company filed a prospectus supplement with the SEC, as part of the registration statement
filed on September 28, 2023, which was declared effective on September 29, 2023. This supplement was intended to facilitate the sale
of up to $ 5,500,000 in
common stock through ATM offerings, as defined in Rule 415 under the Securities Act. As part of this transaction, the Company
incurred $ 81,000 in
deferred offering costs. The amount of capital that we can raise under the ATM offering is highly dependent upon the trading
volume and the trading price of our stock. The average trading volume of our stock over the last three full calendar months is
approximately 229,000 shares per day and the high and low trading price of our stock during the same period of time was $1.25 and
$0.50, respectively. If our stock continues to trade at low volumes and price, the amount of capital that we can raise under the ATM
offering will be constrained.
The
Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, sales and marketing
activities, clinical studies and product development, acquisitions of assets, businesses, companies, or securities, capital expenditures,
and working capital needs.
As
of May 31, 2024 and 2023, the Company had cash and cash equivalents of approximately $ 4,170,000 and $ 9,719,000 , respectively. As of May
31, 2024 and 2023, the Company had working capital of approximately $ 5,527,000 and $ 10,852,000 , respectively.
The
Company’s ability to continue as a going concern over the next twelve months is influenced by several factors, including:
●
Our need and ability to generate additional revenue from international
opportunities and our new product launches;
●
Our need to access the capital and debt markets to meet current
obligations and fund operations;
●
Our capacity to manage operating expenses and maintain gross
margins as we grow; and
●
Our ability to retain key employees and maintain critical operations
with a substantially reduced workforce.
Management
has analyzed the Company’s cash flow requirements through August 2025 and beyond. Based on this analysis, we believe our current
cash and cash equivalents are insufficient to meet our operating cash requirements and strategic growth objectives for the next twelve months.
To
address our capital needs and sustain operations beyond the next year, we are actively pursuing strategies to increase sales, reduce expenses, sell non-core assets, seek additional
financing through debt or equity, and seek other strategic alternatives. While we are committed to these plans, there is no assurance
that these efforts will be successful or sufficient to meet our capital requirements.
These
factors raise substantial doubt about the Company’s ability to continue as a going concern. Our future viability depends on the successful
execution of our strategic plans, securing additional financing, and achieving profitable operations.
The
Company’s consolidated financial statements as of May 31, 2024 were prepared on a going concern basis, which contemplates the realization
of assets and the settlement of liabilities and commitments in the normal course of business.
FAIR
VALUE OF FINANCIAL INSTRUMENTS
The
Company has financial instruments whereby the fair market value of the financial instruments could be different than the amount
recorded on a historical basis. The Company’s consolidated financial instruments consist of its cash and cash equivalents,
accounts receivable, and accounts payable. The carrying amounts of the Company’s financial instruments approximate their fair
values. The Company also maintains an investment in privately held company (see below).
CONCENTRATION
OF CREDIT RISK
The
Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. From time to time,
the Company has uninsured balances. The Company does not believe it is exposed to any significant credit risks.
The
Company provides credit in the normal course of business to customers throughout the United States and in foreign markets. The Company
performs ongoing credit evaluations of its customers and requires accelerated prepayment in some circumstances.
Our
net sales were approximately $ 5,415,000 for
fiscal 2024, compared to $ 5,339,000 for
fiscal 2023. For the fiscal years ended May 31, 2024, and 2023, the Company had one distributor each year that accounted for 33 %
and 35 %
of our net sales, respectively.
Total
gross receivables as of May 31, 2024, and 2023 were approximately $ 966,000 and $ 751,000 , respectively. As of May 31, 2024, and 2023,
the Company had four and one distributor, respectively, that accounted for a total of 64 % and 36 % of gross accounts receivable. Of the
64 % as of May 31, 2024, 37 % was owed by a distributor in Asia.
For
the fiscal year ended May 31, 2024, the Company had one vendor which accounted for 16 % of the purchases of raw materials. For the fiscal
year ended May 31, 2023, the Company did not have any significant concentration of vendor spend for raw materials.
FS- 9
GEOGRAPHIC
CONCENTRATION
As
of May 31, 2024 and 2023, approximately $ 537,000 and $ 626,000 , respectively, of Biomerica’s gross inventory was located in Mexicali,
Mexico, respectively.
As
of May 31, 2024 and 2023, approximately $ 14,000 and $ 17,000 , respectively, of Biomerica’s property and equipment, net of accumulated
depreciation and amortization, was located in Mexicali, Mexico.
CASH
AND CASH EQUIVALENTS
Cash
and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.
ACCOUNTS
RECEIVABLE, NET
The
Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until they
establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria. 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 May 31, 2024 and 2023, the Company has established an allowance of approximately $ 19,000 and $ 29,000 , respectively, 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 prepaids, until either
the inventory is physically received or the insurance and other items are utilized.
As
of May 31, 2024 and 2023, the prepaids were approximately $ 238,000 and $ 300,000 , respectively, comprised 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.
FS- 10
The
following is a summary of approximate net inventories:
SCHEDULE OF NET INVENTORIES
2024
2023
May 31,
2024
2023
Raw materials
$ 1,519,000
$ 1,677,000
Work in progress
1,145,000
869,000
Finished products
179,000
182,000
Total gross inventory
$ 2,843,000
$ 2,728,000
Inventory reserve
( 467,000 )
( 672,000 )
Net inventory
$ 2,376,000
$ 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 May 31, 2024 and 2023, inventory reserves were approximately $ 467,000 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 amounted to approximately $ 63,000 and $ 66,000 for the years ended May 31, 2024 and
2023, 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 patents are based on their individual useful lives which average around 15
years. Amortization amounted to approximately $ 18,000 for the years ended May 31, 2024 and 2023.
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. There was no impairment of intangible assets for the years ended May 31, 2024 and 2023.
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 dividend and interest income.
The
Company assesses its equity holdings for impairment whenever events or changes in circumstances indicate that the carrying value of an
equity holding may not be recoverable. Management reviewed the underlying net assets of the Company’s equity method holding as
of May 31, 2024 and determined that the Company’s proportionate economic interest in the entity indicates that the equity holding
was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the
Company’s Cost Method Holding during the year ended May 31, 2024.
FS- 11
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 $ 837,000 and $ 1,185,000 of share-based compensation during the years ended May 31, 2024 and 2023, respectively.
In
applying the Black-Scholes option-pricing model, the following assumptions used in the valuation of awards issued for years ended May
31, 2024 and 2023:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
For
the year ended May 31,
2024
2023
Dividend yield
0 %
0 %
Expected volatility
100.54
- 111.98 %
98.81
- 101.77 %
Risk free interest rate
4.0
- 4.59 %
3.12
- 3.35 %
Expected term
4.69
- 6.25
years
6.25
years
REVENUE
RECOGNITION
The
Company has various contracts with customers, and these contracts specify the recognition of revenue based on the nature of the transaction.
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 title passes. This applies to clinical lab products sold to domestic and international distributors, including
hospitals, clinical laboratories, medical research institutions, medical schools, and pharmaceutical companies. OTC products are sold
directly to drug stores, e-commerce customers, and distributors, while physicians’ office products are sold to physicians and distributors.
The Company does not allow returns except in cases of defective merchandise, and therefore, does not establish an allowance for
returns. Additionally, the Company has contracts with customers that provide purchase discounts contingent on achieving specified sales volumes.
These contracts are regularly evaluated, and the Company does not anticipate granting any discounts through the end of the
contract period.
Furthermore,
the Company offers margin guarantees to certain retail drug store customers to ensure a minimum profit margin. Should pricing adjustments
cause these margins to fall below the agreed-upon thresholds, the Company is committed to compensating for the shortfall. This arrangement
introduces variable consideration into our revenue recognition process. These considerations are estimated monthly based on actual sales
and potential price reductions, ensuring accurate and compliant revenue reporting.
For
diagnostic testing services sold directly to patients or physician offices that require processing by a third-party CLIA-certified lab,
we recognize revenue once the lab has completed the test results.
For
services related to contract manufacturing, revenue is recognized when the service has been performed. Services for some contract work
are invoiced and recognized as the project progresses.
As
of May 31, 2024, the Company had approximately $ 85,000 of advances from domestic customers, which are prepayments on orders for future
shipments.
FS- 12
Disaggregation
of revenue:
The
following is an approximate breakdown of revenues according to primary markets to which the products are sold:
SCHEDULE OF DISAGGREGATION REVENUE
2024
2023
For
Year Ended May 31,
2024
2023
Clinical
lab
$ 3,236,000
$ 3,310,000
Over-the-counter
1,426,000
1,169,000
Contract
manufacturing
741,000
610,000
Physician’s
office
12,000
250,000
Total
$ 5,415,000
$ 5,339,000
See
Note 8 for additional information regarding geographic revenue concentrations.
SHIPPING
AND HANDLING FEES
The
Company includes shipping and handling fees billed to customers in net sales.
RESEARCH
AND DEVELOPMENT
Research
and development costs are expensed as incurred. The Company expensed approximately $ 1,491,000 and $ 1,584,000 of research and development
costs during the years ended May 31, 2024 and 2023, respectively.
INCOME
TAXES
The
Company accounts for income taxes in accordance with ASC 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities
arise from temporary differences between the tax bases of assets and liabilities and their reported amounts in the consolidated financial
statements that will result in taxable or deductible amounts in future years and the benefits of net operating loss and tax credit carryforwards.
These temporary differences and the benefits of net operating loss and tax credit carryforwards are measured using enacted tax rates.
A valuation allowance is recorded to reduce deferred tax assets to the extent that management considers it is more likely than not that
a deferred tax asset will not be realized. In determining the valuation allowance, the Company considers factors such as the reversal
of deferred income tax assets, projected taxable income, and the character of income tax assets and tax planning strategies. A change
to these factors could impact the estimated valuation allowance and income tax expense. As of May 31, 2024 and 2023, in accordance with
ASC 740, the Company has a valuation allowance for all of its net deferred tax assets. During the year ended May 31, 2024,
this valuation allowance was increased to $ 10,369,000 , which fully covers the net deferred tax asset of $ 10,369,000 .
The
Company accounts for its uncertain tax provisions by using a two-step approach to recognizing and measuring uncertain tax positions.
The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates it is more
likely than not, based solely on the technical merits, that the position will be sustained in an audit, including resolution of related
appeals or litigation processes, if any. The second step is to measure the appropriate amount of the benefit to recognize. The amount
of benefit to recognize is measured as the maximum amount which is more likely than not to be realized. The tax position is derecognized
when it is no longer more likely than not capable of being sustained. On subsequent recognition and measurement, the maximum amount which
is more likely than not to be recognized at each reporting date will represent the Company’s best estimate, given the information
available at the reporting date, although the outcome of the tax position is not absolute or final. The Company elected to follow an
accounting policy to classify accrued interest related to liabilities for income taxes within the “Interest expense” line
and penalties related to liabilities for income taxes within the “Other expense” line of the consolidated statements of operations
and comprehensive loss.
ADVERTISING
COSTS
The
Company reports the cost of all advertising as expense in the period in which those costs are incurred. Advertising costs were approximately
$ 101,000 and $ 156,000 for the years ended May
31, 2024 and 2023, respectively.
FOREIGN
CURRENCY TRANSLATION
The
subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using
the U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these
subsidiaries are translated using exchange rates in effect at the end of the year, and revenues and costs are translated using
average exchange rates for the year. The resulting adjustments to assets and liabilities are presented as a separate component of
accumulated other comprehensive loss. There are no foreign currency transaction gains or losses that are included in the
consolidated statements of operations for the years ended May 31, 2024 and 2023.
FS- 13
RIGHT-OF-USE
ASSETS AND LEASE LIABILITIES
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued an accounting standard update which requires lessees
to recognize most leases on the balance sheet with a corresponding right-of-use asset. Right-of-use assets represent the Company’s
right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from
the lease. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value
of fixed lease payments over the lease term. Leases are classified as financing or operating which will drive the expense recognition
pattern. The Company has elected to exclude short-term leases. The Company leases office space and copy machines, all of which are operating
leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options
to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The
leases do not include the options to purchase the leased property. The depreciable life of assets and leasehold improvements are limited
by the expected lease term. For additional information, see Note 9-Commitments and Contingencies.
NET
LOSS PER SHARE
Basic
loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss
per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible
securities using the treasury stock method. The total amounts of anti-dilutive stock options not included in the loss per share calculation
for the years ended May 31, 2024 and 2023 were 3,479,616 and 2,342,616 , respectively.
SEGMENT
REPORTING
ASC
280, Segment Reporting (“ASC 280”), establishes standards for reporting, by public business enterprises, information about
operating segments, products and services, geographic areas, and major customers. The Company’s operations are analyzed by management
and its chief operating decision maker as being part of a single industry segment: the design, development, marketing, and sales of diagnostic
kits.
REPORTING
COMPREHENSIVE LOSS
Comprehensive
loss represents net loss and any revenues, expenses, gains and losses that, under GAAP, are excluded from net loss and recognized directly
as a component of shareholders’ equity. Items of other comprehensive loss consist solely of foreign currency translation adjustments
for the years ended May 31, 2024 and 2023.
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 consolidated financial statements.
In
November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-07, “Improvements to Reportable Segment
Disclosures.” The ASU includes enhanced disclosure requirements, primarily related to significant segment expenses that are regularly
provided to and used by the chief operating decision maker (“CODM”). The amendments are to be applied retrospectively to all prior periods
presented in the financial statements. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, with early adoption
permitted. We are currently evaluating the effect of adopting this pronouncement on our financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. The ASU includes
enhanced disclosure requirements, primarily related to the rate reconciliation and income taxes paid information. The amendments are
to be applied prospectively in the financial statements. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024,
with early adoption permitted. We are currently evaluating the effect of adopting this pronouncement on our financial statements and
disclosures.
FS- 14
NOTE
3: PROPERTY AND EQUIPMENT, NET
The
following is an approximate breakdown of property and equipment, net of accumulated depreciation:
SCHEDULE OF PROPERTY AND EQUIPMENT, NET
2024
2023
May 31,
2024
2023
Equipment
$ 1,384,000
$ 1,333,000
Furniture, fixtures and leasehold improvements
211,000
211,000
Less accumulated depreciation
( 1,394,000 )
( 1,331,000 )
Net property and equipment
$ 201,000
$ 213,000
NOTE
4: INTANGIBLE ASSETS, NET
The
following is an approximate breakdown of intangible assets, net of accumulated amortization:
SCHEDULE OF INTANGIBLE ASSETS, NET
2024
2023
May 31,
2024
2023
Patents
$ 260,000
$ 196,000
Less accumulated amortization-patents
( 48,000 )
( 31,000 )
Intangible assets, net
$ 212,000
$ 165,000
Expected
amortization of intangible assets for the years ending May 31:
SCHEDULE OF EXPECTED AMORTIZATION OF INTANGIBLE ASSETS
2025
$ 18,000
2026
18,000
2027
18,000
2028
18,000
2029
18,000
Thereafter
122,000
Total
$ 212,000
NOTE
5: ACCOUNTS PAYABLE AND ACCRUED EXPENSES
The
following is an approximate breakdown of accounts payable and accrued expenses balances:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2024
2023
May 31,
2024
2023
Accounts payable
$ 288,000
$ 344,000
Accrued expenses
850,000
548,000
Total
$ 1,138,000
$ 892,000
As
of May 31, 2024, the Company had two vendors that accounted for 69 % of accounts payable. As of May 31, 2023, the Company had one vendor
that accounted for 23 % of accounts payable.
FS- 15
NOTE
6: SHAREHOLDERS’ EQUITY
STOCK
OPTION AND RESTRICTED STOCK PLANS
In
December 2014, the Company adopted and shareholders approved a stock option and restricted stock plan (the “2014 Plan”).
Subsequently, in December 2017, the Company adopted and shareholders approved a stock option and restricted stock plan (the “2017
Plan”). In February 2020, the Board approved the 2020 Stock Incentive Plan (the “2020 Plan”, and collectively with
the 2014 Plan and 2017 Plan, the “Equity Incentive Plans”) and on December 11, 2020, the shareholders of the Company approved
the 2020 Plan. In April 20, 2023, the Board approved the Company’s 2023 Stock Incentive Plan and on December 7, 2023, the shareholders
of the Company approved the 2023 Plan.
The
Equity Incentive Plans provide that non-qualified options and incentive stock options and restricted stock may be granted to directors,
affiliates, employees, or consultants of the Company. The Equity Incentive Plans authorize awards representing up to 850,000 , 900,000 ,
900,000 , and 1,200,000 shares of the Company’s common stock to be issued under the 2014 Plan, 2017 Plan, 2020 Plan, and 2023 Plan,
respectively. Awards granted under the Equity Incentive Plans typically vest over 4 years. Options granted under the Equity Incentive
Plans will be granted at prices not less than 80 % of the then fair market value of the common stock and will expire not more than 10
years after the date of grant. The 2014 Plan expires in December 2024, the 2017 Plan expires in December 2027, the 2020 Plan expires
in December 2030, and 2023 Plan expires on April 20, 2033.
Stock-based
compensation expense for the years ended May 31, 2024 and 2023 is as follows:
SCHEDULE OF STOCK BASED COMPENSATION EXPENSE
2024
2023
For the Year Ended May 31,
2024
2023
Cost of sales
$ 70,000
$ 143,000
Selling, general and administrative
742,000
971,000
Research and development
25,000
71,000
Total stock option expense
$ 837,000
$ 1,185,000
Activity
as to aggregate stock options outstanding is as follows:
SCHEDULE OF ACTIVITY TO AGGREGATE STOCK OPTIONS
Number of Stock Options
Weighted Average Exercise
Price
Aggregate Intrinsic Value
Options Outstanding at May 31, 2022
2,321,616
$ 3.72
$ 1,838,000
Options granted
243,000
$ 2.70
$ -
Options exercised
( 46,500 )
$ 1.73
$ 90,000
Options canceled or expired
( 175,500 )
$ 5.56
$ -
Options Outstanding at May 31, 2023
2,342,616
$ 3.52
$ 146,000
Options granted
1,338,500
$ 1.13
$ -
Options canceled or expired
( 201,500 )
$ 4.64
$ -
Options Outstanding at May 31, 2024
3,479,616
$ 2.53
$ -
Options vested and exercisable
at May 31, 2024
2,047,712
$ 3.23
$ -
The
weighted average grant date fair value of options granted during 2024 and 2023 were $ 0.80 and $ 2.19 , respectively.
On
May 31, 2024, total compensation cost related to non-vested stock option awards not yet recognized totaled approximately $ 1,265,000 .
The weighted-average period over which this amount is expected to be recognized is 2.37 years. The weighted average remaining contractual
term of options that were exercisable on May 31, 2024 was 4.97 years. The weighted average remaining contractual term of options that
were vested, exercisable, or expected to vest on May 31, 2024 was 6.62 years.
COMMON
STOCK ACTIVITY
On
January 22, 2021, the Company filed a prospectus supplement to the base prospectus included in a registration statement filed with
the SEC on July 21, 2020, and declared effective by the SEC on September 30, 2020, for purposes of selling up to $ 15,000,000
in the ATM Offering, as defined in Rule 415 promulgated under the Securities Act.
FS- 16
On
May 21, 2021, in conjunction with the Company’s 2020 Stock Incentive Plan, that was approved by shareholders at the Company’s
annual meeting in December 2020, the Company filed an S-8 Registration Statement to register up to 900,000 shares of the Company’s
common stock that could be issued under this Plan.
Under
the ATM Offering, the sales agent uses commercially reasonable efforts to sell on the Company’s behalf all of the shares requested
to be sold from time to time by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between
the agent and the Company. The Company has no obligation to sell any of the shares under the ATM Offering, and may at any time suspend
offers under, or terminate the ATM Offering.
During
the year ended May 31, 2023 the Company sold 573,889
shares of its common
stock at prices ranging from $ 3.15
to $ 4.26
pursuant to the ATM
Offering, which resulted in gross proceeds of approximately $ 2,014,000
and net proceeds to
the Company of $ 1,961,000 ,
after deducting commissions for each sale and legal, accounting, and other fees related to the offering in the amount of $ 53,000 .
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 .
As a result of this public offering, the Company terminated the ATM offering agreement.
On
September 28, 2023, the Company filed a “shelf” registration statement on Form S-3 with the SEC, allowing the Company to
issue up to $ 20,000,000 in common shares. Under this registration statement, shares of our common stock may be sold from time to time
for up to three years from the filing date. On May 10, 2024, the Company filed a prospectus supplement with the SEC, as part of the registration
statement filed on September 28, 2023, which was declared effective on September 29, 2023. This supplement was intended to facilitate
the sale of up to $ 5,500,000 in common stock through ATM offerings, as defined in Rule 415 under the Securities Act.
During the year ended May 31, 2024, the Company has not sold any shares of its common stock through the ATM Offering.
PREFERRED
STOCK ACTIVITY
On
February 24, 2020, the Company entered into and closed on a Stock Purchase Agreement (the “Stock Purchase Agreement”) with
Palm Global Small Cap Master Fund LP (“Palm”) pursuant to which the Company agreed to sell and issue to Palm, and Palm agreed
to purchase from the Company, 571,429 shares of the Company’s Series A 5% Convertible Preferred Stock, $ 0.08 par value per share
for a purchase price of approximately $ 2 million, or $ 3.50 per Series A Convertible Preferred Stock. Under the terms of the Stock Purchase
Agreement, each share of issued Convertible Preferred Stock can be converted at any time by Palm into one share of the Company’s
common stock, subject to certain adjustments.
The
Series A 5% Convertible Preferred Stock accrued annual preferred dividends at a rate of $ 0.175 per Series A 5% Convertible Preferred
Share. However, accruing dividends were payable only when, as, and if declared by the Board and the Company had no obligation to pay
such accruing dividends.
On
March 24, 2020, Palm converted 250,000 shares of Convertible Preferred Stock into 250,000 shares of unregistered common stock. On July
21, 2020, the Company filed with the SEC a registration statement on Form S-3, that among other things, registered 571,429 common shares
issued, or to be issued, to Palm upon conversion of the Convertible Preferred Stock into common shares. On September 30, 2020, the Company
received a Notice of Effectiveness from the Securities and Exchange Commission for registration of these shares. On January 21, 2021,
Palm converted their remaining 321,429 Convertible Preferred Shares into registered common shares. On May 30, 2021, the Company had no
shares of Preferred Stock outstanding. Under the terms of the Preferred Stock Purchase Agreement, none of the cumulative dividends were
paid to Palm during the period they owned the Preferred Stock. Once converted to common shares, Palm lost all rights to receive any past
cumulative dividends.
FS- 17
NOTE
7: INCOME TAXES
Provision
for income taxes for the years ended May 31 consists of the following:
SCHEDULE OF PROVISION FOR INCOME TAXES
2024
2023
For the Year Ended May 31,
2024
2023
Current:
U.S. Federal
$ -
$ -
Foreign Taxes Subsidiaries
( 41,000 )
( 50,000 )
State and local
( 1,000 )
( 1,000 )
Total current
( 42,000 )
( 51,000 )
Deferred:
U.S. Federal
-
-
State and local
-
-
Total deferred
-
-
Income tax expense
$ ( 42,000 )
$ ( 51,000 )
Provision
for income taxes differs from the amounts computed by applying the U.S. Federal income tax rate applicable for each year ( 21 % for 2024
and 2023) to pretax income as a result of the following:
SCHEDULE OF EFFECTIVE INCOME TAX RECONCILIATION
2024
2023
For the Year Ended May 31,
2024
2023
Computed “expected” tax benefit
$ 1,247,000
1,490,000
Increase (reduction) in income taxes resulting from:
Change in valuation allowance
( 1,428,000 )
( 1,973,000 )
State income taxes, net of federal benefit
459,000
583,000
Permanent tax differences and other
( 148,000 )
( 17,000 )
Stock based compensation benefit
-
( 5,000 )
Foreign taxes of subsidiaries
( 172,000 )
( 129,000 )
Income tax expense
$ ( 42,000 )
$ ( 51,000 )
The
tax effect of significant temporary differences is presented below:
SCHEDULE OF DEFERRED TAX ASSETS
2024
2023
May 31,
2024
2023
Deferred tax assets:
Accounts receivable, principally due to allowance for credit losses
$ 5,000
$ 8,000
Inventory valuation
131,000
188,000
Compensated absences
144,000
118,000
Net operating loss carryforwards
6,658,000
5,817,000
Tax credit carryforwards
1,380,000
1,239,000
Deferred rent expense/capitalized leases
11,000
11,000
Stock options
1,561,000
1,296,000
Sec 174 capitalized costs
501,000
284,000
Losses of foreign subsidiaries and other, net
2,000
-
Accumulated depreciation and amortization
( 24,000 )
( 21,000 )
Total deferred tax assets
10,369,000
8,940,000
Less valuation allowance
( 10,369,000 )
( 8,940,000 )
Net deferred tax asset
$ -
$ -
The
Company has provided a valuation allowance of approximately $ 10,369,000
and $ 8,940,000
as of May 31, 2024 and 2023, respectively. The net change in the valuation allowance for the years ended May 31, 2024 and 2023 was
an increase of $ 1,429,000
and $ 1,973,000 ,
respectively. The Company has recorded a full valuation allowance against its United States and foreign deferred tax assets in
each of the years ended May 31, 2024 and 2023 because the Company’s management believes that it is more likely than not that these
assets will not be realized.
On
May 31, 2024, the Company has Federal income tax net operating loss carryforwards of approximately $ 24,384,000 . On May 31, 2024, the
Company has California state income tax net operating loss carryforwards of approximately $ 22,014,000 . For tax reporting purposes, operating
loss carryforwards are available to offset future taxable income; such carryforwards expire in varying amounts beginning in 2024 and
2038 for federal and state purposes, respectively. Federal net operating losses beginning in 2018 have no expiration date.
FS- 18
On
May 31, 2024, the Company has Federal research and development tax credit carryforward of approximately $ 888,000 . The Federal credits
begin to expire in 2028. The Company also had similar credit carryforwards for state purposes of $ 623,000 on May 31, 2024, which do not
expire.
Pursuant
to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss (“NOL”)
and credit carryforwards may be limited by statute because of a cumulative change in ownership of more than 50%. Pursuant to Sections
382 and 383 of the IRC, the annual use of the Company’s NOLs and credit carryforwards would be limited if there is a cumulative
change of ownership (as that term is defined in Section 382(g) of the IRC of greater than 50% in a three-year period). Management has
not performed an analysis to determine if the Company has had a cumulative change in ownership of greater than 50%.
For
the year ended May 31, 2024, the Company performed an analysis and has not identified any uncertain tax positions as defined under ASC
740. Should such position be identified in the future, and should the Company owe interest and penalties as a result of this, these would
be recognized as interest expense and other expense, respectively, in the consolidated financial statements. The Company is no longer
subject to any significant U.S. federal tax examinations by tax authorities for years before fiscal 2018.
NOTE
8: GEOGRAPHIC INFORMATION
The
Company operates as one segment. Geographic information regarding net sales is approximately as follows:
SCHEDULE OF GEOGRAPHIC INFORMATION
2024
2023
For the Year Ended May 31,
2024
2023
Revenues from sales to unaffiliated customers:
Asia
$ 1,881,000
$ 2,021,000
Europe
1,438,000
1,798,000
North America
1,285,000
1,470,000
Middle East
800,000
39,000
South America
11,000
11,000
Total
$ 5,415,000
$ 5,339,000
NOTE
9: COMMITMENTS AND CONTINGENCIES
OPERATING
LEASES
The
Company leases facilities in Irvine, California and Mexicali, Mexico.
As
of May 31, 2024, the Company had approximately 22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue
in Irvine, California. The lease for its headquarters expires in August 2026. The Company has the option to extend the lease for an additional
five-year term. The Company made a security deposit of approximately $ 22,000 .
In
November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10 -year lease for approximately 8,100 square
feet of manufacturing space. The Company has one 10 -year option to renew at the end of the initial lease period. Biomerica de Mexico
also leases a smaller unit on a month-to-month basis for use in the Company’s manufacturing process .
In
addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, as headquarters for BioEurope GmbH, its Germany
subsidiary.
For
purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of
the facility, including any periods of free rent and any renewal options periods that the Company is reasonably certain of exercising.
The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases are included
in the measurement of the right-of-use asset and related lease liabilities. Additionally, under these lease arrangements, the Company
may be required to pay directly, or reimburse the lessors, for some maintenance and operating costs. Such amounts are generally variable
and therefore not included in the measurement of the right-of-use asset and related lease liabilities but are instead recognized as variable
lease expense in the consolidated statements of operations and comprehensive loss when they are incurred.
FS- 19
The
following table presents information on our operating leases for the years ended May 31, 2024 and 2023:
SCHEDULE OF OPERATING LEASES
For the Year Ended May 31,
2024
2023
Operating lease cost
$ 353,000
$ 353,000
Variable lease cost
11,000
-
Short-term lease cost
14,000
5,000
Total lease cost
$ 378,000
$ 358,000
The
future minimum lease payments of the Company’s operating lease liabilities by fiscal year are as follows:
SCHEDULE OF FUTURE MINIMUM LEASE PAYMENTS
Year Ending May 31,
Operating Leases
2025
$ 365,000
2026
376,000
2027
101,000
Total minimum future lease payments
842,000
Less: imputed interest
57,000
Total operating lease liabilities
$ 785,000
The
following table summarizes the Company’s other supplemental lease information for the years ended May 31, 2024 and 2023:
SCHEDULE OF OTHER SUPPLEMENTAL LEASE INFORMATION
For the Year Ended May 31,
2024
2023
Cash paid for operating lease liabilities
$ 356,000
$ 347,000
Weighted-average remaining lease term (years)
2.27
3.27
Weighted-average discount rate
6.50 %
6.50 %
The
Company also has various insignificant leases for office equipment.
RETIREMENT
SAVINGS PLAN
Effective
September 1, 1986, the Company established a 401(k) plan for the benefit of its employees. The plan permits eligible employees to contribute
to the plan up to the maximum percentage of total annual compensation allowable under the limits of IRC Sections 415, 401(k) and 404.
The Company, at the discretion of its Board of Directors, may make contributions to the plan in amounts determined by the Board each
year. No contributions by the Company have been made since the plan’s inception.
LITIGATION
The
Company is, from time to time, involved in legal proceedings, claims, and litigation arising in the ordinary course of business. While
the amounts claimed may be substantial, the ultimate liability cannot presently be determined because of considerable uncertainties that
exist. Therefore, it is possible the outcome of such legal proceedings, claims, and litigation could have a material effect on quarterly
or annual operating results or cash flows when resolved in a future period. However, based on facts currently available, management believes
such matters will not have a material adverse effect on the Company’s consolidated financial position, results of operations or
cash flows.
There
were no legal proceedings pending as of May 31, 2024.
CONTRACTS
Contracts
and Licensing Agreements
The
Company has one royalty agreement in which it has obtained rights to manufacture and market certain products for the life of the products.
Royalty expenses of approximately $ 10,000 and $ 13,000 is included in cost of sales for the agreement for each of the years ended May
31, 2024 and 2023, respectively. Sales of products manufactured under these agreements comprise approximately 1 % and 2 % of total sales
for the years ended May 31, 2024 and 2023, respectively. The Company may license other products or technology in the future as it deems
necessary for conducting business. The Company has other royalty agreements; however, they are not considered material.
Clinical
Trial Agreements
There
are no Clinical Trial Agreements for each of the years ended May 31, 2024 and 2023.
NOTE
10: SUBSEQUENT EVENTS
As
part of our ongoing efforts to reduce costs, we have implemented significant cost-cutting measures, including a workforce reduction of
nearly 15% in July 2024.
FS- 20
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.