UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED NOVEMBER 30, 2020AUGUST 31, 2021

 

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                                                                                                (I.R.S. Employer

incorporation or organization)                                                                                               Identification No.)

 

17571 Von Karman Avenue, Irvine, CA                                                                               92614

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Address of principal executive offices)                                                                          (Zip Code)

 

Registrant's telephone number including area code:  (949) 645-2111

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(Former name, former address and former fiscal year, if changed since last report.)


(TITLE OF EACH CLASS)                    (NAME OF EACH EXCHANGE ON WHICH REGISTERED)

---------------------                     -------------------------------------------

Common, par value $.08                                    NASDAQ Capital Market

 

Securities registered pursuant to Section 12(g)12(b) of the Act:

 

(TITLE OF EACH CLASS)

(TITLE OF EACH CLASS)

 (TICKER SYMBOL)

(NAME OF EACH EXCHANGE ON WHICH REGISTERED)

 -----------------------------------

 ----------------------------------- 

 -------------------------------------------------------------------------------

Common, par value $.08

BMRA

NASDAQ Capital Market

COMMON STOCK, PAR VALUE $0.08

 

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 [X]  No [_][]

 

Indicate by check mark whether the registrant has submitted electronically, and posted on its corporate Website, if any, every Interactive DateData File required to be submitted and posted 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 [X]  No [_][]

 

Indicate by check mark whether the registrant is a large accelerated, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See definitions of "large accelerated filer"filer,", "accelerated filer"filer,", and "smaller reporting company", and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 Large Accelerated Filer [_]           Accelerated Filer [_]

           Non-Accelerated Filer   [_]          

Large Accelerated Filer [  ]

Accelerated Filer   []

Non-Accelerated Filer   [X]

Smaller Reporting Company [X]

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 [X]

 

         Yes [_] No [X]

Indicate theThe number of shares outstanding of each of the registrant's common stock outstanding as of the latest practicable date 11,780,089 shares of common stock, par value $0.08, as of JanuaryOctober 14, 2021.2021 was 12,511,210.


 


BIOMERICA, INC.

INDEX

PART I

Financial Information

Item 1.

Financial Statements:

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
– Three and Six Months Ended November 30,August 31, 2021 and 2020 and 2019(restated)

1

Condensed Consolidated Balance Sheets (unaudited) November 30, 2020August 31, 2021 and (audited) May 31, 20202021 (restated)

2

Condensed Consolidated StatementStatements of Shareholders’ Equity – (unaudited) SixThree Months Ended November 30,August 31, 2021 and 2020 (restated)

3

Condensed Consolidated Statements of Cash Flows (unaudited) - SixThree Months Ended November 30,August 31, 2021 and 2020 and 2019(restated)

4

Notes to Condensed Consolidated Financial Statements (unaudited)

5-115 - 14

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

11-1514 - 16

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

1516

Item 4.

Controls and Procedures

1516 - 17

PART II

Other Information

Item 1.

Legal Proceedings

1617

Item 1A.

Risk and Uncertainties

16-1817 - 18

Item 2.5.

Unregistered Sales of Equity Securities & Use of ProceedsOther Information

18

Item 3.6.

Defaults upon Senior SecuritiesExhibits

18

Item 4.Signatures

Mine Safety Disclosures

18

Item 5.

Other Information

18

Item 6.

Exhibits

18

Signatures

19


 



Table of Contents

PART I - FINANCIAL INFORMATION

SUMMARIZED FINANCIAL INFORMATION

ITEM 1.1. FINANCIAL STATEMENTS

 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS(UNAUDITED)LOSS (UNAUDITED)

 

Six Months Ended

Three Months Ended

Three Months Ended

November 30, 2020

November 30, 2019

November 30, 2020

November 30, 2019

  

August 31, 2020

    

 

August 31, 2021

 

( As Restated)

Net sales

$

2,516,332

 

$

2,790,823

 

$

1,372,526

 

$

1,596,408

$

1,261,787

 

$

1,143,806

Cost of sales

 

(1,971,960)

 

(1,954,647)

 

(1,011,030)

 

(1,127,536)

 

(1,350,757)

 

 

(1,025,717)

Gross Profit

 

544,372

 

 

836,176

 

 

361,496

 

 

468,872

Gross (Loss) Profit

 

(88,970)

 

118,089

    

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

2,419,411

1,060,958

1,254,847

553,761

 

1,011,535

 

1,305,944

Research and development

 

1,261,096

 

 

775,320

 

 

586,403

 

 

404,854

 

439,864

 

 

711,505

Total operating expense

 

3,680,507

 

1,836,278

 

1,841,250

 

958,615

 

1,451,399

 

 

2,017,449

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(3,136,135)

 

(1,000,102)

 

(1,479,754)

 

(489,743)

 

(1,540,369)

 

 

(1,899,360)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income:

    

Dividend and interest income

 

16,074

 

 

8,551

 

 

7,983

 

 

4,488

 

6,805

 

 

8,091

Interest expense

 

-

 

(5)

 

-

 

(5)

Total other income

 

16,074

 

 

8,546

 

 

7,983

 

 

4,483

    

Loss before income taxes

 

(3,120,061)

 

 

(991,556)

 

 

(1,471,771)

 

 

(485,260)

 

(1,533,564)

 

(1,891,269)

    

Provision for income taxes

 

14,518

 

 

-

 

 

13,393

 

 

-

 

(9,017)

 

 

(1,125)

    

Net loss

$

(3,134,579)

 

$

(991,556)

 

$

(1,485,164)

 

$

(485,260)

$

(1,542,581)

 

$

(1,892,394)

    

Basic net loss per common share

$

(0.27)

 

$

(0.10)

 

$

(0.13)

 

$

(0.05)

$

(0.12)

 

$

(0.16)

    

Diluted net loss per common share

$

(0.27)

 

$

(0.10)

 

$

(0.13)

 

$

(0.05)

$

(0.12)

 

$

(0.16)

    

Weighted average number of common and
common equivalent shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

11,752,299

 

9,780,813

 

11,756,265

 

9,817,363

 

12,426,784

 

 

11,748,377

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

11,752,299

 

9,780,813

 

11,756,265

 

9,817,363

 

12,426,784

 

 

11,748,377

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(3,134,579)

$

(991,556)

$

(1,485,164)

$

(485,260)

$

(1,542,581)

 

$

(1,892,394)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss, net of tax:

    

Foreign currency translation

 

(3,250)

 

 

(5,085)

 

 

(1,530)

 

 

(1,643)

 

(5,613)

 

 

(1,721)

    

Comprehensive loss

$

(3,137,829)

 

$

(996,641)

 

$

(1,486,694)

 

$

(486,903)

$

(1,548,194)

 

$

(1,894,115)

The accompanying notes are an integral part of these statements.

                                                                           The accompanying notes are an integral part of these statements.

1


Table of Contents

 

1


Table of Contents

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

November 30, 2020

(unaudited)

May 31, 2020

(audited)

Assets

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

$

5,683,787

$

8,641,027

Accounts receivable, less allowance for doubtful accounts
    of $481,142 and $70,981 as of November 30, 2020 and May 31, 2020,
    respectively

 

1,611,769

 

 

1,765,871

Inventories, net

4,198,213

2,850,836

Prepaid expenses and other

 

453,137

 

 

1,509,083

Total current assets

11,946,906

14,766,817

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation and amortization 
    of $1,920,217 and $1,867,643 as of November 30, 2020 and May 31, 2020,
    respectively

288,370

279,379

 

 

 

 

 

 

Right of use assets, net of accumulated amortization of $346,514 and $231,489
    as of November 30, 2020 and May 31, 2020, respectively

1,596,485

1,711,510

 

 

 

 

 

 

Investments

165,324

165,324

 

 

 

 

 

 

Intangible assets, net of accumulated amortization of $513,367 and $496,124  as
    of November 30, 2020 and May 31, 2020, respectively

218,331

168,655

 

 

 

 

 

 

Other assets

 

262,278

 

168,193

Total Assets

$

14,477,694

 

$

17,259,878

Liabilities and Shareholders' Equity

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

$

1,258,097

$

986,711

Accrued compensation

 

392,006

 

 

278,627

Lease liability, current portion

 

223,920

 

211,809

Total current liabilities

 

1,874,023

 

 

1,477,147

Lease liability, net of current portion

 

1,454,890

 

1,569,678

Total Liabilities

 

3,328,913

 

 

3,046,825

Commitments and contingencies (Notes 5 and 6)

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

Preferred stock, Series A 5% convertible, $0.08 par value,
    571,429 shares authorized, 321,429 issued and outstanding at November
    30, 2020 and May 31, 2020

 

25,714

 

 

25,714

Preferred stock, undesignated, no par value,
    4,428,571 shares authorized, none issued and outstanding at November
    30, 2020 and May 31, 2020

-

-

Common stock, $0.08 par value,
    25,000,000 shares authorized, 11,770,089 and 11,740,089 issued and
    outstanding at November 30, 2020 and May 31, 2020, respectively

 

941,605

 

 

939,205

Additional paid-in-capital

35,284,864

35,213,707

Accumulated other comprehensive loss

 

(43,091)

 

 

(39,841)

Accumulated deficit

 

(25,060,311)

 

(21,925,732)

Total Shareholders' Equity

 

11,148,781

 

 

14,213,053

Total Liabilities and Shareholders' Equity

$

14,477,694

$

17,259,878

The accompanying notes are an integral part of these statements.

 

August 31, 2021

 

May 31, 2021

 

(Unaudited)

 

(As Restated)

Assets

 

 

 

 

 

      

Current Assets:

 

 

 

 

 

Cash and cash equivalents

$

4,996,623

 

$

4,199,311

Accounts receivable, less allowance for doubtful accounts
       of $742,524 and $837,415 as of August 31, 2021 and  May 31, 2021, respectively

 

772,190

 

 

1,455,051

Inventories, net

 

2,861,779

  

3,206,255

Prepaid expenses and other

 

315,221

 

 

370,290

Total current assets

 

8,945,813

  

9,230,907

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation and amortization 
       of $2,000,167 and $1,972,357 as of August 31, 2021 and May 31, 2021, respectively

 287,852  310,520

 

 

 

 

 

 

Right of use assets, net of accumulated amortization of $531,974 and $469,077
       as of August 31, 2021 and May 31, 2021, respectively

 1,490,184  1,553,081

 

 

 

 

 

 

Investments

 

165,324

  

165,324

 

 

 

 

 

 

Intangible assets, net of accumulated amortization of $83,683 and $126,769 as
       of August 31, 2021 and May 31, 2021, respectively

 

360,292

  

294,830

 

 

 

 

 

 

Other assets

 

266,582

 

 

264,151

Total Assets

$

11,516,047

 

$

11,818,813

      

Liabilities and Shareholders' Equity

 

 

 

 

 

      

Current Liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

$

641,404

 

$

583,380

Accrued compensation

 

507,722

 

 

388,896

Lease liability, current portion

 

332,967

 

 

327,944

Total current liabilities

 

1,482,093

 

 

1,300,220

Lease liability, net of current portion

 

1,230,898

 

 

1,291,570

Total Liabilities

 

2,712,991

 

 

2,591,790

      

Commitments and contingencies (Notes 1 and 6)

 

 

 

 

 

      

Shareholders' Equity:

 

 

 

 

 

      

Preferred stock, Series A 5% convertible, $0.08 par value,
       571,429 shares authorized, NaN issued and outstanding as of August 31, 2021 and May 31, 2021

 

-

 

 

-

Preferred stock, undesignated, 0 par value,
       4,428,571 shares authorized, NaN issued and outstanding as of August 31, 2021 and May 31, 2021

 -  -

Common stock, $0.08 par value,
        25,000,000 shares authorized, 12,510,210 and 12,307,157 issued and outstanding at
        August 31, 2021 and May 31, 2021, respectively

 

1,000,815

 

 

984,571

Additional paid-in-capital

 

39,944,726

  

38,836,743

Accumulated other comprehensive loss

 

(53,569)

 

 

(47,956)

Accumulated deficit

 

(32,088,916)

 

 

(30,546,335)

Total Shareholders' Equity

 

8,803,056

 

 

9,227,023

Total Liabilities and Shareholders' Equity

$

11,516,047

 

$

11,818,813

 

                                                                           The accompanying notes are an integral part of these statements.

2



Table of Contents

 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF SHAREHOLDERS'SHAREHOLDERS' EQUITY (Unaudited)

Six

For the Three Months Ended November 30,August 31, 2020 (As Restated)

 

Common Stock

 

Series A 5% Convertible Preferred Stock

 

Additional

 Paid-in Capital

 

Accumulated
Other Comprehensive

Loss

 

Accumulated

Deficit

 

 

     

Series A 5% Convertible

    

Accumulated Other

      

Shares

 

Amount

 

Shares

 

Amount

 

 

 

Total

Common Stock

 

Preferred Stock

 

Additional

 

Comprehensive

 

Accumulated

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Shares

 

Amount

 

 Paid-in Capital

 

Loss

 

Deficit

 

Total

Balances, May 31, 2020

11,740,089

 

$

939,205

 

321,429

 

$

25,714

 

$

35,213,707

 

$

(39,841)

 

$

(21,925,732)

 

$

14,213,053

Balances, May 31, 2020. restated

11,740,089

 

$

939,205

 

321,429

 

$

25,714

 

$

36,388,056

 

$

(39,841)

 

$

(23,100,081)

 

$

14,213,053

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                     

Exercise of stock options

30,000

 

 

 2,400

 

-

 

-

 

46,930

 

 

-

 

 

-

 

49,330

12,500

 

 

1,000

 

 -

 

 

 -

 

 

13,900

 

 

-

 

 

-

 

 

14,900

                     

Foreign currency translation

-

 

 

-

 

-

 

-

 

-

 

 

(3,250)

 

 

-

 

(3,250)

 -

 

 

 -

 

 -

 

 

 -

 

 

 -

 

 

(1,721)

 

 

-

 

 

(1,721)

                     

Compensation expense in connection with options granted

-

 

 

-

 

-

 

-

 

24,227

 

 

-

 

 

-

 

24,227

 -

 

 

 -

 

 -

 

 

 -

 

 

246,787

 

 

-

 

 

-

 

 

246,787

                     

Net loss

-

 

 

-

 

-

 

-

 

 

-

 

 

-

 

 

(3,134,579)

 

 

(3,134,579)

 -

 

 

 -

 

 -

 

 

 -

 

 

 -

 

 

-

 

 

(1,892,394)

 

 

(1,892,394)

Balances, November 30, 2020

 11,770,089

 

$

 941,605

321,429

 

$

25,714

$

35,284,864

$

(43,091)

$

(25,060,311)

$

11,148,781

                     

The accompanying notes are an integral part of these statements.

Balances, August 31, 2020, restated

11,752,589

 

940,205 

 

321,429

 

25,714

 

36,648,743

 

(41,562)

 

(24,992,475)

 

12,580,625

 

3

For the Three Months Ended August 31, 2021


      

Series A 5% Convertible

    

Accumulated Other

      
 

Common Stock

 

Preferred Stock

 

Additional

 

Comprehensive

 

Accumulated

   
 

Shares

 

Amount

 

Shares

 

Amount

 

 Paid-in Capital

 

Loss

 

Deficit

 

Total

Balances, May 31, 2021, restated

12,307,157

 

$

984,571

 

 -

 

$

 -

 

$

38,836,743

 

$

(47,956)

 

$

(30,546,335)

 

$

9,227,023

                      

Exercise of stock options

1,500

 

 

120

 

 -

 

 

 -

 

 

3,775

 

 

-

 

 

-

 

 

3,895

                      

Net proceeds from ATM

201,553

 

 

16,124

 

 -

 

 

 -

 

 

784,586

 

 

-

 

 

-

 

 

800,710

                      

Foreign currency translation

 -

 

 

 -

 

 -

 

 

 -

 

 

 -

 

 

(5,613)

 

 

-

 

 

(5,613)

                      

Compensation expense in connection with options granted

 -

 

 

 -

 

 -

 

 

 -

 

 

319,622

 

 

-

 

 

-

 

 

319,622

                      

Net loss

 -

 

 

 -

 

 -

 

 

 -

 

 

 -

 

 

-

 

 

(1,542,581)

 

 

(1,542,581)

                      

Balances, August 31, 2021

12,510,210

 

$

1,000,815

 

 -

 

$

 -

 

$

39,944,726

 

$

(53,569)

 

$

(32,088,916)

 

$

8,803,056

                                                                           The accompanying notes are an integral part of these statements.

3


Table of Contents


 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

Six Months Ended

November 30, 2020

November 30, 2019

August 31, 2021

 

August 31, 2020
(As Restated)

Cash flows from operating activities:

 

 

 

 

 

 

 

 

    

Net loss

$

(3,134,579)

 

$

(991,556)

$

(1,542,581)

 

$

(1,892,394)

Adjustments to reconcile net loss to net cash used in operating activities:

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

    

Depreciation and amortization

 

64,435

 

65,545

 

34,722

 

32,570

Change in allowance on accounts receivable

410,161

3,571

 

(94,891)

 

201,375

Inventory reserve

 

11,943

 

6,873

 

179,744

 

5,005

Stock option expense

24,227

34,978

 

319,622

 

246,787

Reduction in deferred rent liability

 

-

 

(37,971)

Amortization of right-of-use asset

115,025

157,356

 

62,897

 

57,257

Changes in assets and liabilities:

 

 

 

 

    

Accounts receivable

(256,059)

168,133

 

777,752

 

(18,924)

Inventories

 

(1,359,320)

 

(46,675)

 

164,732

 

(1,255,573)

Prepaid expenses

1,055,946

18,431

Prepaid expenses and other

 

55,069

 

1,038,149

Reduction in lease liability

 

(102,677)

 

(102,133)

 

(55,649)

 

(49,880)

Other assets

(94,085)

-

 

(2,431)

 

(276,438)

Accounts payable and accrued expenses

 

271,386

 

345,211

 

58,024

 

284,202

Accrued compensation

 

113,379

 

12,243

 

118,826

 

 

30,718

Net cash used in operating activities

 

(2,880,218)

 

 

(365,994)

Net cash provided by (used in) operating activities

 

75,836

 

 

(1,597,146)

 

 

 

 

Cash flows from investing activities:

 

 

 

 

    

Increase in intangibles

(61,536)

(15,008)

 

(72,375)

 

(53,158)

Purchases of property and equipment

 

(61,566)

 

 

(6,323)

 

(5,141)

 

 

(39,588)

Net cash used in investing activities

 

(123,102)

 

(21,331)

 

(77,516)

 

 

(92,746)

 

 

 

 

    

Cash flows from financing activities:

 

 

 

 

Proceeds from sale of common stock, net

 

-

 

307,686

 

800,710

 -

Proceeds from exercise of stock options

49,330

48,928

 

3,895

 

 

14,900

Proceeds from equity financing-officer

 

-

 

 

200,000

Net cash provided by financing activities

49,330

556,614

 

804,605

 

14,900

 

 

 

 

 

 

 

 

Effect of exchange rate changes in cash

 

(3,250)

 

(5,085)

 

(5,613)

 

 

(1,721)

Net (decrease) increase in cash and cash equivalents

 

(2,957,240)

 

164,204

Net increase (decrease) in cash and cash equivalents

 

797,312

 

(1,676,713)

    

Cash and cash equivalents at beginning of period

 

8,641,027

 

 

686,785

 

4,199,311

 

 

8,641,027

    

Cash and cash equivalents at end of period

$

5,683,787

 

$

850,989

$

4,996,623

 

$

6,964,314

    

Supplemental Disclosure of Cash-Flow Information:

 

 

 

 

 

 

 

 

Cash paid during the period for:

    

Interest

$

-

 

$

5

Income taxes

$

11,735

$

7,844

$

9,017

 

$

1,125

Non-cash investing and financing activities:

 

 

 

 

Establishment of Right-Of-Use Asset per ASC 842

$

-

$

1,942,999

Establishment of Lease Liability per ASC 842

$

-

 

$

1,980,970

The accompanying notes are an integral part of these statements.

 

                                                                           The accompanying notes are an integral part of these statements.

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BIOMERICA, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 1:  BASIS OF PRESENTATION

 

Biomerica Inc. and Subsidiariessubsidiaries (collectively "the Company"the “Company”, “Biomerica”, “we”, “us”, or “our”) are primarily engaged in the development, manufacturing and marketing of medical diagnostic products.

The Company develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs.

Our primary focus is the research and development of revolutionary, patented, diagnostic-guided therapy (“DGT”) products to treat gastrointestinal diseases, such as irritable bowel syndrome, 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 existing medical diagnostic products designed forthat are in the early detection and monitoring of chronic diseases and other medical conditions. The Company’s medical diagnostic productsmarket are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point of carepoint-of-care (physicians' offices and over-the-counter drugstores)drugstores like Walmart and Walgreens). TheOur diagnostic test kits are used to analyze blood, urine, nasal or fecal samplesspecimens 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 redirecting and focusing a majority of our resources to develop, test, validate, seek regulatory approval for, and sell diagnostic products that indicate if a person has been infected by COVID-19. During fiscal 2021, we sold 2 primary types of COVID-19 tests; 1) antibody diagnostic tests that use a patient’s blood sample to detect if the patient has certain antibodies to COVID-19 that were created as part of their body’s immune response to a COVID-19 infection, even if the infection was asymptomatic, and 2) antigen tests that use a patient’s nasal fluid sample to detect if the patient is currently infected with the virus.

Aside from the COVID-19 products we offer, the other products we sell are primarily focused on gastrointestinal diseases, food intolerances, cancer screening and awareness and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our commercial 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 U.S. by the FDA.

The information set forth in these condensed consolidated financial statements is unaudited and reflects all adjustments which, in the opinion of management, are necessary to present a fair statement of the consolidated results of operations of Biomerica, Inc. and subsidiaries, for the periods indicated. It does not include all information and footnotes necessary for a fair presentation of financial position, results of operations, and cash flows in conformity with accounting principles generally accepted in the United States of America. All adjustments that were made are of a normal recurring nature.

 

The unaudited, Condensed Consolidated Financial Statementscondensed consolidated financial statements and notes are presented as permitted by the requirements for Form 10-Q and do not contain certain information included in the annual financial statements and notes. The condensed consolidated balance sheet data as of May 31, 20202021 was derived from audited financial statements. The accompanying interim condensed consolidated financial statements should be read in conjunction with the financial statements and related notes included in the Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on August 31, 202027, 2021 for the fiscal year ended May 31, 2020.2021, which have been restated as described in our Form 10-K/A as filed on October 14, 2021. The results of operations for the interim periods are not necessarily indicative of results to be achieved for the full fiscal year.

CORRECTION OF AN ERROR

As disclosed in our Form 10-K/A for the year ended May 31, 2021, filed on October 14, 2021, during the process of preparing our financial statements for the quarter ended August 31, 2021, we determined that our calculation of non-cash stock-based compensation expense related to issued stock options in previously issued financial statements was incorrect. Our calculation applied forfeiture adjustments to both vested and unvested outstanding options, including those for which the employee had provided the requisite service, which resulted in an understatement of stock compensation expense. Additionally, our calculation expensed the option at vesting dates versus pro rata over the period the requisite service was provided. As a result of these errors, certain previously reported amounts in the condensed consolidated statement of operations, condensed consolidated statement of stockholders’ equity and condensed consolidated statement of cash flows for the quarter ended August 31, 2020, were materially misstated; accordingly, we have restated the prior period financial statements. See Note 8 to the Financial Statements.

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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 past practices with a customer; stock option forfeiture rates, which are calculated based on historical data; inventory obsolescence, which areis 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

Due to the Coronavirus global pandemic, the Company’s operations have been negatively impacted. The Company has faced disruptions in certain of the following areas, and may face further challenges from supply chain disruptions, loss of contracts and/or customers, closure of the Company’s manufacturing or distribution facilities or of the facilities of the Company’s suppliers, partners and customers, travel, shipping and logistical disruptions, government responses of all types, international business risks in countries where the Company makes and/or sells its products, loss of human capital or personnel at the Company, its partners and its customers, interruptions of production, customer credit risk, and general economic calamities. These ongoing pandemic related disruptions can materially negatively impact the Company’s operations and financial performance and may continue to have significant material negative impacts on the Company.  

LIQUIDITY

The Company has incurred net losses and negative cash flows from operations and has an accumulated deficit of approximately $32.1 million as of August 31, 2021.  Management expects to continue to incur significant costs as it advances its trials and development activities.

On January 22, 2021, the Company filed a prospectus supplement for purposes of raising up to $15,000,000 to the base prospectus filed with the SEC on July 21, 2020 and included in the registration statement on Form S-3 (File No. 333-239980) that was declared effective by the SEC on September 30, 2020. The shares included in the prospectus supplement may be sold pursuant to the terms of an At Market Issuance Sales Agreement between the Company and B. Riley Securities, Inc., as sales agent, the ATM Agreement.

The Company intends to use the net proceeds from such offering for general corporate purposes, including, without limitation, sales and marketing activities, clinical studies and product development, making acquisitions of assets, businesses, companies or securities, capital expenditures, and for working capital needs.

Under an ATM Agreement, sales of shares are deemed to be “at the market offerings” as defined in Rule 415 promulgated under the Securities Act.  The sales agent under the ATM Agreement agrees to use 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 sales agent and the Company. The Company has no obligation to sell any of the shares under the ATM Agreement, and may at any time suspend offers under, or terminate the ATM Agreement. 

As a result of cash and cash equivalents on hand at August 31, 2021, management believes the Company has sufficient funds to operate through November 2022 and the ability to raise additional funds through the ATM Agreement noted above.

CONCENTRATION OF CREDIT RISK

 

The Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. As of November 30, 2020,August 31, 2021, the Company had approximately $5,417,958$4,790,000 of uninsured cash.  The Company does not believe it is exposed to any significant credit risks.

 

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For the sixthree months ended November 30,August 31, 2021 and 2020, and November 30, 2019, the Company had one distributortwo key distributors which accounted for 35.1%60% and 50.3%40% of net consolidated sales, respectively.  At November 30, 2020August 31, 2021 and May 31, 2020,2021, the Company had two distributors and threekey distributors which accounted for a total of 61.9%77% and 80.0%73%, respectively, of gross accounts receivable. Of the 61.9% as of November 30, 2020, 37.1% was owed by a distributor in South America. 

 

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For the sixthree months ended November 30,August 31, 2021 and 2020, one key vendor accounted for 17% and 2019, two key vendors accounted for 56.0% and three vendors which accounted for 51.4%64% of the purchases of raw materials, respectively. As of November 30, 2020August 31, 2021 and May 31, 2020,2021, the Company had one key vendor and two vendors which accounted for 26.5%25% and 26.9%17%, respectively, of accounts payable.

 

CASH AND CASH EQUIVALENTS

 

Cash and cash equivalents consist of demand deposits and money market accounts with original maturities of less than three months.

 

ACCOUNTS RECEIVABLE

 

The Company extends unsecured credit to its customers located throughout the United States and the world.on a regular basis.  International accounts are normallyusually 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.  Management evaluates receivables on a quarterly basis and adjusts the allowance for doubtful accounts accordingly.  For receivablesBalances over ninety days old the Company begins to reserve a portion of the balanceare usually reserved for unless collection is reasonably assured.

 

Occasionally certain long-standing customers, who routinely place large orders, will have unusually large receivables balances relative to the total gross receivables.   Management monitors the payments for these large balances closely and very often requires payment of existing invoices before shipping new sales orders.

 

The Company has established a reserve of $481,142approximately $743,000 for doubtful accounts.accounts as of August 31, 2021. The majority of this reserve has been established to cover 40%100% of outstanding accounts receivable from an international distributor.  The distributor continues to make small payments and the Company is continuining to work on collection of this account.

 

PREPAIDSPREPAID EXPENSES AND OTHER

 

The Company occasionally prepays for items such as inventory, insurance and other items.  These items are reported as prepaids,prepaid expenses and other, until either the inventory is physically received or the insurance and other items are expensed.

 

As of August 31, 2021 and May 31, 2020,2021, the prepaid expenses and other were approximately $1 million$315,000 and $370,000, respectively. The prepaid expenses and other balance were composed of the prepaids was an advance paymentprepayments to one of ourinsurance and various other suppliers.   This prepayment was subsequently refunded by the supplier.

 

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.

 

Inventories approximate the following at:

 

November 30,
2020

May 31,
2020

 

August 31, 2021

 

May 31, 2021

Raw materials

 

$

1,748,000

 

$

1,635,000

 

$

1,493,000

 

$

1,583,000

Work in progress

1,516,000

988,000

 

926,000

 

1,006,000

Finished products

 

 

934,000

 

 

228,000

 

 

443,000

 

 

617,000

Total

$

4,198,000

$

2,851,000

 

$

2,862,000

 

$

3,206,000

 

During the first fiscal quarter ended August 31, 2021, the Company wrote-down the carrying value of certain inventory by approximately $179,000 to assign a new carrying value for this inventory of $211,000.  As part of a large international order for this product that was to ship in the second quarter of 2022, the Company agreed to sell this product as a small portion of that order at a price below its carrying value, which required a write down. 

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Reserves for inventory obsolescence are recorded as necessary to reduce obsolete inventory carrying value to estimated realizable value or to specifically reserve for obsolete inventory that the Company intends to dispose of. As of November 30, 2020August 31, 2021 and May 31, 2020,2021, inventory reserves were approximately $78,000$1,797,000 and $67,000,$1,617,000, respectively.

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Table of Contents Of the inventory reserve, approximately $1,683,000 was related to a market downturn in our COVID-19 antibody test and materials, as the market shifted to COVID-19 PCR viral tests and antigen tests.

 

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 $25,843$27,809 and $24,321$26,732 for the three months ended November 30,August 31, 2021 and 2020, and 2019, and $52,575 and $53,819 for the six months ended November 30, 2020 and 2019, 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”).Other. 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 amounted to $6,022$6,913 and $5,946$5,838 for the three months ended November 30,August 31, 2021 and 2020, and 2019 and $11,860 and $11,726 for the six months ended November 30, 2020 and 2019, 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. No impairment adjustment was required as of November 30, 2020August 31, 2021 or 2019.2020.

 

INVESTMENTS

 

From time-to-time, the Company makes investments in privately-held companies.  The Company determines whether the fair values of any investments in privately-held entities have declined below their carrying value whenever adverse events or changes in circumstances indicate that recorded values may not be recoverable.  If the Company considers any such decline to be other than temporary (based on various factors, including historical financial results, and the overall health of the investee’s industry), a write-down to estimated fair value is recorded. Investments represent the Company’s investment in a Polish based distributor which is primarily engaged in distributing medical products and devices.devices, including those manufactured by the Company, and in certain cases, manufacturing the certain of the products sold.  The Company currently has not written down the investment and has no events have occurred which couldinformation that would indicate the carrying value to beis greater than the fair value.  The Company owns approximately 6% of the investee, and accordingly, applies the cost method to account for the investment.  Under the cost method, investments are recorded at cost, with gains and losses recognized as of the sale date, and income recorded when received.

 

SHARE-BASED COMPENSATION

 

The Company follows the guidance of the accounting provisions of ASC 718, Share-based Compensation, (“ASC 718”), which requires the use of the fair-value based method to determine compensation expense 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 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 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.

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The following summary presents the options and warrants granted, exercised, expired, cancelledcanceled and outstanding for the sixthree months ended November 30, 2020:August 31, 2021:

  

Option Shares

 

Exercise Price Weighted Average

Outstanding May 31, 2021

 

2,081,366

 

$

3.59

Granted

 

24,000

  

4.25

Exercised

 

(1,500)

 

 

2.68

Cancelled or expired

 

(22,750)

 

 

3.02

Outstanding August 31, 2021

 

2,081,116

 

$

3.60

                                                                                     ��                                                                    

Option Shares

Exercise Price Weighted Average

Outstanding May 31, 2020

 

1,789,251

 

$

2.75

Granted

171,000

7.46

Exercised

 

(30,000)

 

 

1.67

Cancelled or expired

(22,001)

3.43

Outstanding November 30, 2020

 

1,908,250

 

$

3.18

During the sixthree months ended November 30, 2020,August 31, 2021, options to purchase 30,0001,500 shares of common stock were exercised at prices ranging from $1.04 to $3.62.price of $2.68. Total net proceeds to the Company were $49,330.$3,895.

 

During the sixthree months ended November 30, 2020,August 31, 2021, the Company granted 171,00024,000 options to purchase common stock at an average purchase price of $7.46.$4.25. Total net proceeds to the Company were $14,900.

 

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 allow for returns except in the event of defective merchandise and therefore does not establish an allowance for returns. In addition, the Company has contracts with customers wherein they receive purchase discounts for achieving specified sales volumes. The Company evaluated the status of these contracts as of November 30,August 31, 2021 and 2020, and does not believe that any additional discounts will be given through the end of the contract periods. Services for some contract workworks are invoiced and recognized for work that has been performed as the project progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories, medical research institutions, medical schools and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce customers as well as to distributors.  Physician’sPhysicians’ office products are sold to physicians and distributors, all of whom are categorized below according to the type of productproducts sold to them. The CompanyWe also manufacturesmanufacture certain components on a contract basis for domestic and international manufacturers.

 

Disaggregation of revenue:

 

The following is a breakdown of revenues according to markets to which the products are sold:

 

Six Months Ended

Three Months Ended

 

Three Months Ended

November 30, 2020

 

November 30, 2019

 

November 30, 2020

 

November 30, 2019

 

August 31, 2021

 

August 31, 2020

Clinical lab

 

$

1,474,512

 

$

2,034,228

 

$

892,804

 

$

1,144,172

 

$

886,000

 

$

582,000

Lab Supplies

2,884

 -

2,884

 -

OTC

 

457,131

 

 

520,109

 

 

272,223

 

 

320,785

Physician's office

350,604

124,493

153,273

79,226

 

257,000

 

197,000

Over-the-counter

 

79,000

 

185,000

Contract Manufacturing

 

 

231,201

 

 

111,993

 

 

51,342

 

 

52,225

 

40,000

 

180,000

Total

$

2,516,332

$

2,790,823

$

1,372,526

$

1,596,408

 

$

1,262,000

 

$

1,144,000

 

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 $586,403approximately $440,000 and $404,854$712,000 of research and development costs during the three months ended November 30,August 31, 2021 and 2020, and 2019 and $1,261,096 and $775,320 during the six months ended November 30, 2020 and 2019, respectively.

 

INCOME TAXES

 

The Company has provided a valuation allowance on deferred income tax assets of approximately $3,832,000$6,226,000 and $3,175,000$5,904,000 as of November 30, 2020August 31, 2021 and May 31, 2020,2021, respectively.  

 

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FOREIGN CURRENCY TRANSLATION

 

FOREIGN CURRENCY TRANSLATION

The subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries are translated using exchange rates in effect at the end of the period, and revenues and costs are translated using average exchange rates for the period. The resulting adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive loss. There are no adjustments to foreign currency loss that are included in the consolidated statements of operations for the three months ended November 30, 2020August 31, 2021 and 2019 and six months ended November 30, 2020 and 2019.2020.

 

RIGHT-OF-USE ASSETS AND LEASE LIABILITY

 

The Company follows the guidance of ASC 842, Leases, 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 the obligation to make lease payments arising from the lease. The Company leases office space and copy machines, all of which are operating leases. The Company has elected to exclude short-term leases. Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise.  The leases do not include the options to purchase the leased property.  The depreciable life of assets and leasehold improvements are limited by the expected lease term.

 

NET LOSS PER SHARE

 

Basic loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible securities using the treasury stock method. The total amount of anti-dilutive stock options not included in the loss per share calculation for the three months ended November 30,August 31, 2021 and 2020 was 2,081,116 and 2019 was 1,326,489 and 521,782,1,925,750, respectively. The total amount of anti-dilutive stock options not included in the loss per share calculation for the six months ended November 30, 2020 and 2019 was 1,399,763 and 498,040, respectively. The Company also has outstanding 321,429 of series A 5% convertible preferred stock, which may be converted at any time to common stock.

 

RECENT ACCOUNTING PRONOUNCEMENTS

 

Recent ASU'sASUs issued by the FASB and guidance issued by the Securities and Exchange Commission (“SEC”) did not, or are not believed by management to, have a material effect on the Company’s present or future consolidated financial statements.

 

NOTE 3:  SHAREHOLDERS’ EQUITY

 

On July 20,Stock option expense during the three months ended August 31, 2021 and 2020 were $319,622 and $246,787 (as restated, see Note 8 to the Company’s outstanding SEC Form S-3 “Shelf” registration statement dated July 20, 2017 expired. This prior registration statement registered an indeterminant number of shares equating to a maximum aggregate offering amount of $45,000,000 of shares.Financial Statements), respectively.

On July 21, 2020,During the three months ended August 31, 2021, the Company filed withsold 201,553 shares of its common stock at prices ranging from $4.02 to $4.47 under its January 22, 2021 prospectus supplement and the SEC a new Form S-3 “Shelf” registration statementATM Agreement (see Note 2 to replaceFinancial Statements) which resulted in gross proceeds of $838,332 and net proceeds to the registration statement that expired on July 20, 2020. The new registration statement registers common sharesCompany of $800,710 after deducting commissions for each sale and legal, accounting and other fees related to be issued in a maximum aggregate amount of $90,000,000. Included in this registration statement was the registration of allfiling of the common shares issued, or to be issued, to Palm Global Small Cap Master Fund LP upon conversion of their Series A 5% Convertible Preferred Stock into common shares. This S-3 registration statement became effective September 30, 2020.Form S-3.

 

NOTE 4:  GEOGRAPHIC INFORMATION

 

FinancialThe Company operates as 1 segment. Geographic information about foreign and domestic operations and exportregarding net sales is approximately as follows:

 

Six Months Ended

Three Months Ended

Three Months Ended

November 30, 2020

November 30, 2019

November 30, 2020

November 30, 2019

August 31, 2021

August 31, 2020

Revenues from sales to unaffiliated customers:

   

United States

 

$

241,000

 

$

224,000

 

$

107,000

 

$

109,000

Asia

897,000

1,460,000

550,000

797,000

 

$

675,000

 

$

347,000

Europe

 

1,170,000

 

 

717,000

 

 

580,000

 

 

416,000

471,000

591,000

North America

 

105,000

 

134,000

Middle East

8,000

29,000

South America

82,000

71,000

39,000

24,000

 

 

3,000

 

 

43,000

Middle East

 

125,000

 

 

309,000

 

 

96,000

 

 

241,000

Other

 

1,000

 

10,000

 

1,000

 

10,000

$

2,516,000

$

2,791,000

$

1,373,000

$

1,597,000

$

1,262,000

$

1,144,000

 

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As of November 30, 2020August 31, 2021 and May 31, 2020,2021, approximately $555,000$665,000 and $613,000$803,000 of Biomerica’s gross inventory and approximately $28,000$24,000 and $31,000,$25,000, of Biomerica’s property and equipment, net of accumulated depreciation and amortization, was located in Mexicali, Mexico, respectively.

 

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NOTE 5:  LEASES

 

On June 18, 2009, the Company entered into an agreement to lease a building in Irvine, California. The lease commenced September 1, 2009 and ended August 31, 2016. In On November 30, 2015, the Company signedentered into the First Amendment to Lease wherein it exercised its option to extend theits lease until August 31, 2021. As ofThe initial base rent for the lease extension was $21,000 per month, increasing to $23,637 through August 31, 2021. On April 9, 2021, the Company exercised its second option to extend its lease for an additional five years through August 2026.  The Company was also granted an additional five years lease extension option through August 2031. The rent is currently $23,637 per month and will increase on September 1, 2020,2021 to $25,970 per month and be increased 3% each year thereafter. The security deposit of $22,080 remains the rent was $23,637 per month. The Company has an option to renew this lease for another 5 years and intends to pursue this renewal.same.

 

In November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a 10-yearten-year lease for approximately 8,1008,104 square feet at a monthly rent of manufacturing space. The rent is currently $3,383 per month.$2,926. The Company has one 10-year option to renew at the end of the initial lease period. The yearly rate is subject to an annual adjustment for inflation according to the United States Bureau of Labor Statistics Consumer Price Index for All Urban Consumers. The monthly rate is currently $3,262.  Biomerica, Inc. is not a guarantor of such lease.  Biomerica de Mexico also leases a smaller unit on a month-to-month basis for use in one manufacturing process.

In addition, the Company leases a small office in Lindau, Germany on a month-to-month basis, in Lindau, Germany, as headquarters for BioEurope GmbH, its Germany subsidiary.

 

Components of leaseRent expense include fixed lease expense of $171,769in the U.S. for the sixthree months ended November 30, 2020.  August 31, 2021 and 2020 was $78,166 and $75,764, respectively.  Rent expense for the Mexico facility for the three months ended August 31, 2021 and 2020 was $10,421 and $10,870, respectively.

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 optionoptions 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 which are included in the measurement of the right-of-use asset and related lease liability.  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 liability but are instead recognized as variable lease expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss when they are incurred.

Supplemental cash flow information related to leases for the three months ended August 31, 2021: 

 

Supplemental cash flow information related to leases for

the six months ended November 30, 2020:

Operating cash flows from operating leases

 

$

159,212

 

 

$

80,697

Right-of-use assets obtained in exchange for
new operating lease liabilities

--

Right-of-use assets obtained in exchange for

  

new operating lease liabilities

 

$

 -

Weighted average remaining lease term (in years)

 

 

5.77

 

 

5.02

Weighted average discount rate

6.5

%

 

6.50%

 

The maturity of lease liabilities as of November 30, 2020August 31, 2021 are as follows:

 

2021

 

$

108,290

2022

235,569

2023

 

 

262,698

2024

291,210

2025

 

 

321,971

Thereafter

459,072

Total

 

$

1,678,810

Less than 1 year

 

$

342,640

1 to 2 years

  

352,869

2 to 3 years

 

 

363,404

3 to 4 years

  

374,253

4 to 5 years

 

 

385,426

5 to 10 years

 

 

7,517

Total undiscounted lease payments

 

 

1,826,109

Less imputed interest

 

 

262,244

Total operating lease liabilities

 

$

1,563,865

According to the terms of the lease in Irvine, the Company is also responsible for routine repairs of the building and for certain increases in property tax.

The Company also has various insignificant leases for office equipment.

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NOTE 6:  COMMITMENTS AND CONTINGENCIES

 

Contracts and Licensing AgreementsLITIGATION

 

On May 25, 2016, theThe Company entered into an Exclusive Marketing License Agreement (“Telcon Agreement”) with Celtis Pharm Co., Ltd., who subsequently changed their nameis, from time to Telcon Pharmaceutical Co., LTD (“Telcon”), a medical companytime, involved in legal proceedings, claims and litigation arising in the South Korea. The Telcon Agreement grants to Telcon an exclusive license to market and sell Biomerica’s new InFoods® IBS products (“IBS Products”) in South Korea. The termordinary course of business. While the agreement is for a period of five years following Korean FDA clearance of the product and provides an additional two years for Telcon to attain such Korean FDA clearance. The sequential two-year and five-year terms do not begin until after Biomerica first receives final clearance for sale of the IBS Products in the United States from the US FDA. Telcon, at its sole cost and expense, must use its commercially reasonably good faith efforts to obtain Korean FDA for the IBS Product to be sold in South Korea. The agreementamounts claimed may be cancelled if Biomerica hassubstantial, 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 obtained final US FDA clearance for salehave a material adverse effect on the Company's consolidated financial position, results of the IBS Products onoperations or before Decembercash flows. There were no legal proceedings pending as of August 31, 2019. Biomerica is also obligated to maintain a full quality assurance system for the IBS Products following the harmonized standards according to Annex IV of Directive 98/79/EC.2021.

 

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The terms of the Telcon Agreement provide up to $1.25 million in exclusivity fees based on certain milestones including Biomerica’s starting clinical trials in the United States, receipt of US FDA clearance and Telcon’s first sales of IBS Products in Korea. If Biomerica commences FDA Trials and Telcon pays the initial $250,000 milestone-based exclusivity fees, and the Agreement is subsequently terminated by either party for lack of performance, then Biomerica shall issue to Telcon 83,333 shares of Biomerica common in consideration for the $250,000 of paid exclusivity fee. No exclusivity fees have yet been paid.

Additionally, the Telcon Agreement provides for a royalty of 15% paid to Biomerica on all sales in Korea of the IBS Product, and further sets the pricing of IBS Products sold to Telcon.  In order to retain the exclusivity within South Korean, Telcon must meet certain annual minimum royalty payments to Biomerica following Telcon’s receipt of Korean FDA approval or clearance for the IBS Product to be sold in Korea, which in no case will be later than May 31, 2019.In September 2017, the Telcon Agreement was amended to extend the date by which Telcon must attain Korean FDA approval until April 30, 2020. During the quarter ended August 31, 2020, a second amendment was signed extending the required FDA approval date to December 31, 2021.

On June 25, 2020, the Company entered into a Clinical Trial Agreement with the University of Texas Health Science Center for the purpose of conducting a clinical trial of the Biomerica InFoods product. The term of the agreement shall be until completion of the work outlined and the charges will be invoiced monthly for work performed in the previous month. The maximum budgeted costs will be $139,850.

On September 15, 2020, the Company entered into an agreement with Public Health England research institution for the purpose of evaluating the Company’s COVID-19 Rapid Test.

As disclosed in the Form 10K filed with the SEC on August 31, 2020, on July 2, 2020, the Companywe received a notice of investigation and subpoena to produce information and documents from the Division of Enforcement of the SEC. The subpoena seeksrequested information and documents related to events and circumstances leading up to theour March 17, 2020 announcement that the Companywe had commenced shipping samples of the Company’sour COVID-19 IgG/IgM Rapid Test to countries outside of the United States, and had initiated the application process with the United States Food and Drug Administration under the COVID-19 Emergency Use Authorization for approval to market and sell the test in the United States. The subpoena also seeksrequested information and documents about the identity of any persons who were aware of the substance of the March 17, 2020 announcement prior to that date. In addition, on December 15, 2020, the SEC sent a second subpoena related to this investigation to Zack Irani, the Company’s CEO, requesting documents held by Mr. Irani concerning his past purchases of Company stock, anyhis past communications with certain persons and entities, and other personal and Company documents. The Company and Mr. Irani are continuing to cooperatehave cooperated fully with the SEC’s investigation and provideprovided information as requested. At this time, the Company is unable to predict the duration, scope or outcome of these investigations.

Contracts and Licensing Agreements

On June 21, 2021, the Company signed an exclusive distribution and marketing agreement in Canada for its Helicobacter Pylori (H. Pylori) test.

 

NOTE 7:  SUBSEQUENT EVENTS

At the December 10, 2020 board meeting, the Board of Directors approved the grant of 213,616 options to purchase shares of the Company’s common stock to officers, directors and certain employees.  The options are exercisable by outside board members one year from date of grant and for officers and employees one-quarter per year with the first quarter vesting one year from date of grant. The options will be at the exercise price of $6.36 per share and expire ten years from date of grant.

 

During DecemberNone

NOTE 8:  RESTATEMENT OF PREVIOUSLY ISSUED FINANCIAL STATEMENTS

Subsequent to the issuance of our financial statements for the quarter ended August 31, 2020, the Company filed the necessary paperwork with Medical Device Safety Service who then notified the competent authority in Germany to attain CE Markdetermined that errors were included in the EUpreviously issued financial statements as described below. As a result, we restated our financial statements for the quarter ended August 31, 2020.

The Company discovered the errors listed below. The restatement corrects these errors.

Our non-cash stock based compensation expenses calculation applied forfeiture adjustments to both vested and unvested outstanding options, including those for which the employee had provided the requisite service, which resulted in an understatement of stock compensation expense. Additionally, our calculation expensed the option at vesting dates versus pro rata over the period the requisite service was provided.

Stock-based compensation expense shown on the statement of operations is a non-cash expense, and impacts accumulated deficit and additional paid-in capital on the balance sheet. However, this does not impact the Company’s COVID-19 antigen test that uses a nasal swab to collect a person’s nasal fluid sample to detect ifcash, revenues or other aspects of ongoing operations.

The restatement for the person has COVID-19 antigenquarter ended August 31, 2020 resulted in their system, which can indicate that the person has recently been infected with the COVID-19 virus and may still be infectious to others.  This nasal swab antigen test received CE clearance on January 8, 2021, and is now available for saleno changes in the EU.  provision for income taxes.

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The Company has received an initial ordereffect of the restatement on the consolidated statement of operations for over $1 millionthe three months ended August 31, 2020 is as follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Cost of sales

$

960,930

 

$

64,787

 

$

1,025,717

Gross Profit

 

182,876

  

(64,787)

  

118,089

 

 

 

 

 

 

 

 

 

Operating Expenses:

        

Selling, general and administrative

 

1,164,564

 

 

141,380

 

 

1,305,944

Research and development

 

674,693

 

 

36,812

 

 

711,505

Total operating expense

 

1,839,257

 

 

178,192

 

 

2,017,449

         
Loss from operations (1,656,381)  (242,979)  (1,899,360)
         
Loss before income taxes (1,648,290)  (242,979)  (1,891,269)
         

Net loss

$

(1,649,415)

 

$

(242,979)

 

$

(1,892,394)

 

 

 

      

Basic net loss per common share

$

(0.14)

 

$

(0.02)

 

$

(0.16)

         

Diluted net loss per common share

$

(0.14)

 

$

(0.02)

 

$

(0.16)

         

Comprehensive loss

$

(1,651,136)

 

$

(242,979)

 

$

(1,894,115)

The effect of these tests andthe restatement on the consolidated balance sheet at May 31, 2021 is inas follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Shareholders' Equity:

 

 

 

 

 

 

 

 

         

Additional paid-in-capital

$

36,685,176

 

$

2,151,567

 

$

38,836,743

Accumulated deficit

 

(28,394,768)

  

(2,151,567)

  

(30,546,335)

Other Equity accounts

 

936,615

 

 

 -

 

 

936,615

Total Shareholders' Equity

$

9,227,023

 

$

 -

 

$

9,227,023

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The effect of the processrestatement on the consolidated statement of filling this order.cash flows for the period ended August 31, 2020 is as follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Cash flows from operating activities:

 

 

 

 

 

 

 

 

         

Net loss

$

(1,649,415)

 

$

(242,979)

 

$

(1,892,394)

Adjustments to reconcile net loss to net cash used in operating activities:

        

Stock option expense

 

3,808

 

 

242,979

 

 

246,787

Net cash used in operating activities

 

(1,597,146)

  

 -

  

(1,597,146)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

$

6,964,314

 $

 -

 

$

6,964,314

 

ITEM 2. 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

EXCEPT FOR HISTORICAL INFORMATION CONTAINED HEREIN, THE STATEMENTS IN THIS QUARTERLY REPORT ON FORM 10-Q MAY BE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934 AND SECTION 27A OF THE SECURITIES ACT OF 1933. FORWARD-LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES WHICH MAY CAUSE BIOMERICA'S RESULTS IN FUTURE PERIODS TO DIFFER MATERIALLY FROM FORECASTED RESULTS.

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Like other businesses, THE COMPANY IS susceptible to macroeconomic downturnsYou should read the following discussion and analysis in the United States or abroad, as were experienced recently AND AS CURRENTLY CONTINUE, that may affect the general economic climate and OUR performance or OUR customers. Aside from general macroeconomic downturns, the additional material factors, RISKS AND UNCERTAINTIES that could affect futureconjunction with our consolidated financial results include, but are not limited to: THE CONTINUED DEMAND FOR THE COMPANY'S PRODUCTS; AVAILABILITY OF RAW MATERIALS; RESULTS OF RESEARCH AND DEVELOPMENT ACTIVITIES; THE ABILITY TO RETAIN KEY EMPLOYEES AND CUSTOMERS; THE ABILITY TO COLLECT RECEIVABLES FROM CUSTOMERS; THE CONTINUED ABILITY OF THE COMPANY TO ATTAIN AND MAINTAIN THE LICENSES AND APPROVALS REQUIRED, INCLUDING EUA CLEARANCE FROM THE FDA FOR THE COMPANY’S COVID-10 PRODUCTS;Regional or global pandemics, GOVERNMENT RESPONSES TO SUCH PANDEMICS,statements and the economicaccompanying notes thereto included in Part II, Item 8 of this Report. This discussion and social disruptionsanalysis 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 cause ESPECIALLY IN THE HEALTHCARE INDUSTRY IN WHICH WE OPERATE; SHUTDOWNS OR DISRUPTIONS IN OUR MANUFACTURING DUE TO WIDESPRED ILLNESS, OR OTHER ISSUES; terrorist attacks and the impactforward-looking statements as a result of such events; existing and potential increase in trade tariffs, especially with China; diminished or no access to raw materials that directly enter into our manufacturing process; shipping labor disruption or other major degradation of the ability to ship out products to end users; inability to successfully control our margins which are affected by many factors, including RAW MATERIALS, competition and product mix; protracted shutdownthose discussed in “Risk Factors” included in Part I, Item 1A of the U.S. border due to an escalation of terrorist or counter terrorist activity; any changes in our business relationships with international distributors or the economic climate they operate in; any event that has a material adverse impact on our foreign manufacturing operations may adversely affect our operations as a whole; failure to manage the future expansion of our business could have a material adverse effect on our revenues and profitability; possible costs in complying with government regulations and the delays in receiving required regulatory approvals or the enactment of new adverse regulations or regulatory requirements; numerous competitors, some of which have substantially greater financial and other resources than we do; potential claims and litigation brought by patients or medical professionals alleging harm caused by the use of or exposure to our products; recalls of products; inability to obtain FDA clearance on products or excessive costs incurred in order to obtain such approvals; regulatory actions taken by government agencies such as the FDA, SEC, USDA and other regulators; quarterly variations in operating results caused by a number of factors, including business and industry conditions; and other factors beyond our control. All these factors make it difficult to predict operating results for any particular period.

EXCEPT AS MAY BE REQUIRED BY APPLICABLE LAW, WE MAY NOT UPDATE OR REVISE OUR FORWARD-LOOKING STATEMENTS AND THE LACK OF SUCH UPDATE DOES NOT IMPLY THAT ACTUAL EVENTS ARE AS ORIGINALLY EXPRESSED BY SUCH FORWARD-LOOKING STATEMENTS. YOU SHOULD READ THE DISCLOSURES IN THIS REPORT AND OTHER REPORTS, WHICH WE FILE WITH THE SECURITIES AND EXCHANGE COMMISSION, INCLUDING THE RISK FACTORS CONTAINED THEREIN.this Report. 

 

OVERVIEW

 

Biomerica, Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH), (the “Company”, “we”, “our”) isa biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and physicians' offices and over-the-counter through drugstores and online)offices) 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 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 and development of disruptive,revolutionary, patented, diagnostic-guided therapy, (“DGT”)or 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. If these DGT products prove effective in their clinical trials, and are ultimately cleared for sale by the U.S. FDA, management believesFood and Drug Administration, we believe the revenuerevenues potential to the Company is significant. 

 

We are currently finalizing an endpoint determination clinical trial on our InFoods® IBS product. This trial is and has been conducted at Mayo Clinics in Florida and Arizona, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, University of Texas Health Science Center at Houston, Houston Methodist, the University of Michigan and other institutions. This trial monitors IBS patients over an 8-week period to determine the efficacy of our InFoods® IBS product to improve the patients’ IBS symptoms. We expect our final enrolled patients to complete the trial, and for top-line trial results to be reported at or around the end of December 2021. During the next six months, we also expect to be entertaining partnership/licensing discussions with pharmaceutical and technology companies that could help us commercialize the product, including obtaining final FDA clearance.

Our medical diagnostic products are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point-of-care (physicians' offices and over-the-counter drugstores like Walmart and Walgreens). The diagnostic test kits are used to analyze blood, urine, nasal or fecal specimens from patients in the diagnosis of various diseases, food intolerances and other medical complications, by measuring or detecting the existence and/or level of specific bacteria, hormones, antibodies, antigens or other substances, which may exist in a patient’s body, stools, or blood, often in extremely small concentrations.

Due to the global 2019 SARS-CoV-2 novel coronavirus (“COVID-19”) pandemic, in March 2020 we began redirecting and focusing a majoritymuch of our resources to develop, test, validate, seek regulatory approval for and sellCOVID-19 tests. During fiscal 2021, we sold 2 primary types of COVID-19 tests: 1) antibody diagnostic productstests that indicate if a person has been infected by COVID-19. These diagnostic tests use a patient’s blood sample to detect if the patient has certain antibodies to COVID-19 that were created as part of their body’s immune response to a COVID-19 infection, even if the infection was asymptomatic. The Companyasymptomatic, and 2) antigen tests that use a patient’s nasal fluid sample to detect if a patient is marketing and selling outside ofcurrently infected with the U.S. a disposable rapid finger-prick blood test, which detects COVID-19 IgG/IgM antibodies within 10 minutes.  

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Followingvirus.  During the fiscal 2020 year-end,year, we submitted to the FDA an application under an Emergency Use Authorization (“EUA”) to sell in the U.S. a lab-scale, high throughput ELISA COVID-19 antibody test kit that would be sold to labs and hospitals to perform COVID-19 antibody testing. The Company also anticipates selling this test kitthese products outside of the U.S. under a CE Mark (European Conformity). This ELISA lab test can be run using blood drawn by a medical professional, or can be run using a finger prick blood sample that can be collected by a patientBecause individual orders for these tests have been large in their own home, usingsize, this has created volatility and material fluctuations in our proprietary “at-home” blood collection kit, that the patient sends to a lab for processing on our ELISA test. Our EUA application/submission for the ELISA COVID-19 antibody test includes the at-home blood collection kit.  Initial sales for the ELISA test kitmonthly and the at-home blood collection kits are expected following EUA clearance from the FDA for the products to be sold in the US. The FDA has now assigned an examiner to review this submission and the Company is actively working with the FDA to attain EUA clearance. The Company manufactures this COVID-19 ELISA test on its automated equipment at the Company’s California facility that is also used to produce serology antibody tests for other diseases. Since we did not receive FDA clearance for this product during our second quarter of fiscal year 2021, we did not record anyquarterly revenues. Although sales in the U.S.these products have slowed, we continue to receive and fill orders for our COVID-19 ELISAtest products. Further,During our fiscal first quarter of 2022, we recorded approximately $226,000 in sales of our disposable rapid finger prick blood test, which is only authorized for sale outside of the U.S., were slower in the second quarter as we are told by customers that most government health agencies are focused on viral testing (determining who is currently infected) while the infection rates in the territories we serve showed lower overall cases. However, the Company believes even with vaccines beginning to become available in the market, demand for serology (antibody) tests, like those we produce, could increase. In addition, the infection rates in the territories we serve have increased, which we believe will result in a higher demand for both antibody and viral testing, as long as pandemic continues. Vaccines are designed to create antibodies in individuals that will enable them to avoid serious illness when exposed to the COVID-19 virus. Therefore, following vaccination, the Company believes many patients will want to know if the vaccination worked and they have produced antibodies to the COVID-19 virus.  Further, at various points following vaccination (e.g., 3 months, 6 months, etc.), we anticipate people will want to receive an antibody test to determine if the level of antibodies produced from the vaccine are still adequate to fight off a serious infection. Therefore, we believe demand for COVID-19 antibody testing will begin to strengthen near term, and could remain strong into the foreseeable future, even after demand for actual virus testing begins to fall.antigen test.

 

During the first and second fiscal quarters14


Table of 2021, we also focused resources on developing and validating a COVID-19 antigen test that uses nasal (via a nasal swab) or saliva human samples to detect if the COVID-19 antigen is present in a person’s nasal and oral fluids, indicating that the person has been infected with the COVID-19 virus, and may still be actively infected and infectious to others.Contents

 

Aside from the current focus on COVID-19 products in research, development and clinical trials,we offer, the other products we continue to sell are primarily focused on gastrointestinal diseases, food intolerances, diabetescancer screening and awareness and certain esoteric tests. These diagnostic test products utilize immunoassay technology. OurMost 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 U.S. by the FDA.

 

Finally, While sales continue to occur in our COVID-19 products, the Company continues to see progress in completing the testing required to attain FDA clearance formajority of our patented 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 DGT product that is designed to diagnose and treat sufferers of IBS. Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School teaching hospital, University of Texas Health Science Center at Houston, Houston Methodist and the University of Michigan are participating in our clinical trials for this product.

InFoods® IBS is a unique, patented product that can allow physicians to identify specific foods (e.g., pork, milk, onions, sugar, chickpeas, etc.) for each IBS patient, that when removed from that patient’s diet, may alleviate or improve their IBS symptoms and suffering.

 

Upon demonstrating efficacyWe also recently added several new employees in its sales and obtaining FDA approval, we believe the long-term opportunities for the InFoods IBS product could be comparablemarketing department in order to anyincrease sales of the major drugs currently used to treat IBS.existing non-COVID products during fiscal 2022.  Through these efforts, our EZ Detect colon disease home screening test is seeing a significant increased interest from retailers such as Walmart, distributors, and ministries of health in many countries.

 

Further, the United States Patent and Trademark Office (“USPTO”) has issued the Company two patents with broad claims that protect the InFoods® IBS product. Patents have also been issued in the countries of Japan, Korea and recently Singapore with many other patents still pending globally. Additional patents have also been filed for other diseases that utilize the InFoods® DGT technology platform which include:  functional dyspepsia, Crohn’s Disease, ulcerative colitis, gastroesophageal reflux disease (“GERD”), migraine headaches, and osteoarthritis.

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RESULTS OF OPERATIONS

 

Consolidated net salesAs disclosed in Note 8 to the unaudited condensed consolidated financial statements in Item 1, during the process of preparing our financial statements for Biomerica were $1,372,526the quarter ended August 31, 2021, we determined that our calculation of non-cash stock-based compensation expense related to issued stock options in previously issued financial statements was incorrect. Our calculation applied forfeiture adjustments to both vested and unvested outstanding options, including those for which the employee had provided the requisite service, which resulted in an understatement of stock compensation expense. Additionally, our calculation expensed the option at vesting dates versus pro rata over the period the requisite service was provided. These errors resulted in an understatement of stock compensation expense during the three months ended August 31, 2020, and periods prior to May 31, 2020, resulting in a cumulative adjustment to equity accounts. As a result, our previously issued financial statements for the three months ended November 30,August 31, 2020 as compared to $1,596,408 for the same period in the previous year. This represents a decreasehave been restated.

Net Sales and Cost of $223,882, or 14%. Sales

Consolidated net sales for Biomerica were $2,516,332 for the six months ended November 30, 2020 as compared to $2,790,823 for the same period in the previous year. This represents a decrease of $274,491, or 10%. The decrease$1,261,787 for the three months ended November 30, 2020August 31, 2021, as compared to the same period in the previous year was primarily due to softness in demand for our non-COVID products in certain markets due to the pandemic. However, the Company believes demand to be returning for certain regions as orders for non-COVID products received from Asian customers during the first six weeks of fiscal third quarter 2021 were over $700,000. Nevertheless, the Company still believes that total sales of non-COVID-19 products could continue to be negatively impacted by the world-wide pandemic. Because the Company sells both COVID-19 and Non-COVID-19 products, the impact COVID-19 will have on future revenues is difficult to predict.

Consolidated cost of sales for Biomerica were $1,011,030$1,143,806 for the three months ended November 30, 2020 as compared to $1,127,536 for the same period in the previous year. This represents a decrease of $116,506, or 10%. Consolidated cost of sales for Biomerica were $1,971,960 for the six months ended November 30, 2020 as compared to $1,954,647 for the same period in the previous year.August 31, 2020. This represents an increase of $17,313,$117,981 or 1%10%. The percentageincrease for the three months ended August 31, 2021, as compared to the three months ended August 31, 2020, was primarily due to the sale of our food intolerance products to a distributor in Asia.

Consolidated cost of sales relative towas $1,350,757, or 107% of net sales, for the three months ended November 30, 2020 increased from 71%August 31, 2021, as compared to 74%$1,025,717, or 90% of net sales, for the three months ended August 31, 2020. This represents an increase of $325,040 or 32%. The percentage ofOur cost of sales relative to sales for the sixthree months ended November 30, 2020 increased from 70%August 31, 2021, were impacted by an adjustment to 78%. The Company’s standard margin on products sold was similar to previous periods. However, during the three and six months ended November 30, 2020 the manufacturing facilities were not running at 100% capacity due to the negative impactmarket or net realizable value for COVID-19 had on salesantigen tests of the Company’s non-COVID-19 products.  This generated unfavorable manufacturing variances within our reported cost of sales. Because the Company sells both COVID-19 and Non-COVID-19 products, the impact COVID-19 will have on future cost of sales is difficult to determine.approximately $179,000.

 

Selling, General and Administrative Expenses

Consolidated selling, general and administrative expenses for Biomerica were $1,254,847$1,011,535 for the three months ended November 30, 2020August 31, 2021, as compared to $553,761$1,305,944 for the same period in the previous year.three months ended August 31, 2020. This represents an increasea decrease of $701,086,$294,409 or 127%23%. Consolidated selling, general and administrative expense for Biomerica were $2,419,411 for the six months ended November 30, 2020 as compared to $1,060,958 for the same period in the previous year. This represents an increase of $1,358,453, or 128%. The increasedecrease in the three and six month periodsmonths ended August 31, 2021, was primarily due to a reduction of legal expenses related to responding to the SEC inquiry discussed in Part II, as well as an increase in the allowance for doubtful accounts, additional consulting fees, and increased personnel costs as the Company is expanding and strengthening its management team in sales, marketing, and administration.expenses.

 

Research and Development

Consolidated research and development expenses for Biomerica were $586,403$439,864 for the three months ended November 30, 2020August 31, 2021, as compared to $404,854$711,505 for the same period in the previous year.three months ended August 31, 2020. This represents an increasea decrease of $181,549,$271,641, or 45%38%. Consolidated research and development expense for Biomerica were $1,261,096 for the six months ended November 30, 2020 as compared to $775,320 for the same period in the previous year. This represents an increase of $485,776, or 63%. The increasedecrease in the three and six month periodsmonths ended August 31, 2021, was primarily a result of increasesdecreases in costs related to the research, development, and validation of COVID-19 tests, and the initiation costs at Mayo Clinic, University of Houston Texas, and Methodist Hospital in Texas for clinical trials for our InFoods® IBS product.tests.

 

Interest Expense

Interest and dividend income were $7,983$6,805 for the three months ended November 30, 2020August 31, 2021, as compared to $4,488$8,091 for the same period in the previous year.three months ended August 31, 2020. This represents an increasea decrease of $3,495,$1,286, or 78%16%. Interest and dividend income were $16,074 for the six months ended November 30, 2020 as compared to $8,551 for the same period in the previous year. This represents an increase of $7,523, or 88%.

 

LIQUIDITY AND CAPITAL RESOURCES

 

As of November 30, 2020August 31, 2021 and May 31, 2020, the Company2021, we had cash and cash equivalents in the amount of $5,683,787approximately $4,997,000 and $8,641,027$4,199,000, respectively, and working capital of $10,072,883approximately $7,464,000 and $13,289,670,$7,931,000, respectively. As a result of cash and cash equivalents on hand at August 31, 2021, and our ability to raise additional funds through our ATM Agreement, management believes we have sufficient funds to operate through the next twelve months or more.

 

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Operating Activities

Cash provided by operating activities of $75,836 during the sixthree months ended November 30, 2020, the Company’s operations used cashAugust 31, 2021, reflects a net loss of $2,880,218 compared to cash used in operations$1,542,581 and non-cash adjustments of $365,994 in the same period of the prior fiscal year. Cash used by operations increased year to date in fiscal 2021 compared to year-to-date fiscal 2020$502,094 primarily due to operating losses of $3,134,579, growth inassociated with depreciation, amortization, stock-based compensation, and inventory of $1,359,320 driven byreserves. In addition, we realized an increase in COVID-19net working capital of $1,116,322 primarily driven by a decrease in accounts receivable and inventory. For the three months ended August 31, 2020, cash used by operating activities of $1,597,146 reflects a net loss of $1,892,394 and non-cash adjustments of $542,994 primarily associated with depreciation, amortization, stock-based compensation, and inventory of approximately $1,519,000reserves. This was partially offset by a reductiondecline in prepaidsnet working capital of $1,055,946$247,746 driven by increases in inventory, which was primarily drivenpartially offset by a repayment of an advance the Company had with one of our suppliers. decrease in prepaid expenses.

Investing Activities

Cash used in investing activities year to date in fiscalfor the three months ended August 31, 2021, was $61,566$5,141 for purchases of fixed assetsproperty and $61,536equipment and $72,375 for increased intangibles. Cash used in investing activities for the three months ended August 31, 2020, was $39,588 for purchases of property and equipment and $53,158 for increased intangibles.

Financing Activities

Cash provided by financing activities in fiscal yearfor the three months ended August 31, 2021, to date was $49,330$804,605 which was a result of stock option exercises.

We have been working on new products that address large markets for the gastroenterology sector.  Patent applications for these new products have been filedexercises of $3,895 and six patents have been issued (two in the USA, two in Korea, and one each in Japan, and Singapore). The Company has been working on obtaining additional patents and U.S. regulatory approvals for these products. Due to the significant revenue opportunities these products represent, the Company has been spending significant funds on research, development, patents and related costs, and expects this will continue in order to strengthen and expand our patent protection, and attain regulatory approvals of these products.

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On July 21, 2020, the Company filed with the SEC a new Form S-3 “Shelf” registration statement to replace the registration statement that expired on July 20, 2020. The new registration statement registers common shares to be issued in a maximum aggregate amount of $90,000,000. Included in this registration statement was the registration of all of the common shares issued, or to be issued, to Palm Global Small Cap Master Fund LP upon conversion of their convertible Preferred stock into common shares. This S-3 registration statement became effective September 30, 2020. The Company intended to use the net proceeds from this offeringthe sale of common stock of $800,710. Cash provided by financing activities for general corporate purposes, including, without limitation, sales and marketing activities, clinical studies and product development, making acquisitionsthe three months ended August 31, 2020, was $14,900 which was a result of assets, businesses, companies or securities, capital expenditures, and for working capital needs.stock option exercises of $14,900.

 

OFF BALANCE SHEET ARRANGEMENTS

 

There were no off-balance sheet arrangements as of November 30, 2020.August 31, 2021.

 

CRITICAL ACCOUNTING POLICIES

 

The preparation of condensed 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 inunder the circumstances;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,accounts receivable reserves, inventory overhead application, inventory reserve,valuation, lease liabilities, right-of-use assets, and right-of-use assets.stock based compensation. 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 referSee Note 2 to Note 2the Financial Statements for information on Significant Accounting Policies.

 

ITEM 3.3.  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 4.4.  CONTROLS AND PROCEDURES

 

Our management, evaluatedincluding our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures as(as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities and Exchange Act of 1934 as of August 31, 2021. Our evaluation tested controls and other procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities and 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'sSEC’s rules and forms;forms. Disclosure controls and (2)procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Act is accumulated and communicated to the Company'sissuer’s management, including its Chief Executive Officerprincipal executive and Chief Financial Officer,principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

There have been no changes Based on our evaluation, as of August 31, 2021, our management, including our principal executive officer and principal financial officer, concluded that our disclosure controls and procedures were not effective due to a material weakness in our internal control over financial reporting identifiedrelated to the financial reporting described below in connection with the evaluation that occurred during our last fiscalarea of accounting for non-cash stock-based compensation.


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Changes in Internal Control over Financial Reporting

Other than as described below, there were no changes to internal controls in the first quarter that hashave materially affected, or that isare reasonably likely to materially affect, our internal control over financial reporting.

During the second quarter ending November 30, 2021 and prior to filing this Quarterly Report, we completed the following steps to address the non-cash stock-based compensation deficiency identified in our Form 10-K/A filed on October 14, 2021:

 

15•   implemented a leading industry standard equity and disclosure management software system to calculate non-cash stock-based compensation expense;


Table•   engaged an outside accounting advisory firm to review our revised stock-based compensation amounts and our methods for calculating non-cash stock-based compensation expenses going forward;

•   developed and implemented additional procedures to increase the level of Contentsreview, evaluation and validation of the Company’s stock-based compensation expense;

•   increased the level of knowledge among our executives and accounting staff in the area of stock-based compensation; and

•   independently tested the calculations produced by our new equity and disclosure management software system

 

PART II.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. 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 November 30, 2020.August 31, 2021.

 

As disclosed in the Form 10K filed with the SEC on August 31, 2020, onOn July 2, 2020, the Companywe received a notice of investigation and subpoena to produce information and documents from the Division of Enforcement of the SEC. The subpoena seeksrequested information and documents related to events and circumstances leading up to theour March 17, 2020 announcement that the Companywe had commenced shipping samples of the Company’sour COVID-19 IgG/IgM Rapid Test to countries outside of the United States, and had initiated the application process with the United States Food and Drug Administration under the COVID-19 Emergency Use Authorization for approval to market and sell the test in the United States. The subpoena also seeksrequested information and documents about the identity of any persons who were aware of the substance of the March 17, 2020 announcement prior to that date. In addition, on December 15, 2020, the SEC sent a second subpoena related to this investigation to Zack Irani, the Company’s CEO, requesting documents held by Mr. Irani concerning his past purchases of Company stock, anyhis past communications with certain persons and entities, and other personal and Company documents. The Company and Mr. Irani are continuing to cooperatehave cooperated fully with the SEC’s investigation and provideprovided information as requested. At this time, the Company is unable to predict the duration, scope or outcome of these investigations.

 

ITEM 1A.  RISKS AND UNCERTAINTIES.UNCERTAINTIES.

 

YouAn investment in our common stock involves risks. Before making an investment decision, you should readcarefully consider all the following factorsinformation within this Quarterly Report, including the information contained in conjunction withPart 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 factors discussed elsewhererelated 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 2021 Annual Report on Form 10-K, as well as in our other public filings with the Securities and Exchange Commission and in materials incorporated by reference in these filings such asSEC. If any of the Form S-3 and Prospectus Supplement filed on July 21, 2020. The following is intended to highlight certain factors that may affect the financial condition andidentified risks are realized, our business, results of operations, of Biomerica, Inc.financial condition, liquidity, and are not meant toprospects could be an exhaustive discussion of risksmaterially and adversely affected. In that apply to companies such as Biomerica, Inc. Like other businesses, Biomerica, Inc. is susceptible to macroeconomic downturns incase, the United States or abroad, as were experienced in recent history that may affect the general economic climate and performance of Biomerica, Inc. or its customers. Our results may fluctuate adversely as a result of many factors that are outside our control, which may negatively impact our stock price. Salestrading price of our common stock in the public marketmay decline, and you could lower the market price for our common stock and the pricelose all or part of our stock could fluctuate unpredictably in response to various factors.  The Company does not anticipate paying dividends in the foreseeable future, which could affect the market price of the stock.

Our business could be adversely affected by the effects of widespread public health epidemics.

We are susceptible to a widespread outbreak of an illness or other health issue, such as the recent COVID-19 Coronavirus outbreak first reported in Wuhan, Hubei Province, China in December 2019 and subsequently spreading throughout the world resulting in tens of millions of confirmed cases worldwide and hundreds of thousands of deaths. The outbreak of the COVID-19 virus has caused virtually all governments, including the U.S., to implement quarantines, various restrictions on travel causing airlines to suspend international and certain domestic flights, shelter in place orders and other restrictions. Governments have also implemented work restrictions that prohibit many employees from going to work, and for businesses that are allowed to remain open, many employees are electing to remain at home to avoid spread of the disease.your investment. In addition, infections among employees at Company’s like ours is causing significant work disruptions. As a result of this COVID-19 virus outbreak and potential future pandemic outbreaks, the Company faces significantother risks including, but not limited to: a) supply chain disruptions making it difficult for the Company to contract and receive materials needed for production of its products, and needed to ship finished products to our end customers, b) loss of contracts and customers from the financial strains or other disruptions they are experiencing as a result of the pandemic, c) financial risks pertaining to receivables due from customers that may fall into insolvency or otherwise be unable to pay their bills, d) government responses including orders that make it difficult to remain open for business, restrict imports of raw materials or exports of finished goods, refusal to allow the Company’s product to be licensed for sale in their countries, and other foreseeable or unforeseen actions taken by government agencies, e) absenteeism or loss of employees at the Company, or at our partner’s companies due to COVID-19 infection or infection of employee family members or do to other health reasons, f) government restrictions, that are needed to develop, validate, manufacture and perform other necessary functions for our operations, g) equipment failures, loss of utilities and other disruptions that could impact our operations or render them inoperable, h) litigation or government actions against the Company pertaining to existing products or new products sold by the Company that are designed to detect if a person has been infected by the COVID-19 virus or designed to help limit the spread of the pandemic outbreak, i) a local or global recession or depression that could harm the international banking system, limit demand for all products including those made by the Company,  j) a drop in demand for our products, that are all medical related, due to patients’ reluctance or refusal to visit hospitals, labs, and doctors’ offices where our products are used, due to their fear of contracting a disease, and many other seen and unforeseen events and circumstances, all of which could negatively impact the Company.

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If our COVID-19 testswe are unable to gain acceptance in the market, prove to be ineffectivecurrently unaware, or less effective than expected, and/orwhich we do not receive regulatory approvals for our COVID-19 tests to be sold, our results of operation could be materially harmed.

Although we believe that our COVID-19 tests represent promising tests to detect prior COVID-19 virus exposure, the tests may never gain significant acceptance in the marketplace and therefore may never generate substantial revenue or profits for us. We will need to establish a market for our COVID-19 antibody and antigen tests. Gaining acceptance in medical communities requires increasing awareness of our COVID-19 tests and their benefits.  Also, there are a large number of companies around the world now making and selling COVID-19 tests that compete with our COVID-19 tests. Many of these competitor products are made in China and other parts of Asia where manufacturing costs are low. As such, we are seeing supply and price competition which could make it difficult for the Company to compete.  Other risks pertaining to these products include: 

•          our ability to demonstrate the efficacy, speed and cost competitiveness of our COVID-19 tests;

•          whether healthcare providers and governmental agencies believe our COVID-19 tests are sufficiently safe, effective, and accurate;

•          our ability to transfer, further develop, integrate and use third-party licensed technology;

•          our ability to manufacture and scale commercial products;

•          our ability to source required raw materials in a cost effective and timely manner;

•          manufacturing capabilities of our materials partners and their ability to meet our quality and delivery requirements;

•          mutations in the COVID-19 virus that render our tests ineffective;

•          receipt of regulatory approvals necessary prior to commercialization of our products;

•          the FDA or other regulatory agencies retracting their prior approval for our products to be sold in their market or changing regulations
      for approval; and

•          whether the medical community accepts our COVID-19 testscurrently view as a supplement to, alternative to, or complementary to, current PCR or other
      tests for COVID-19 infection.

In addition, each country in which we wish to sell these tests has its own regulatory approval requirements.  We will need to comply with the regulatory requirements of each country before we are permitted to sell in that country.  There can be no assurance that governmental agencies, including the FDA, will provide clearance of our COVID-19 tests to be sold in their markets.   Failure to achieve widespread market acceptance of our COVID-19 tests, or failure to achieve regulatory clearance of our COVID-19 tests, could materially harm our business, financial condition, and results of operations.  Our COVID-19 tests are new tests that only generated revenue during the last two months of our prior fiscal year and for the current fiscal year. It is uncertain how long we will be able to generate revenues from these tests, and what level of sales, if any, we will attain in the future.

There is no assurance that we will be able to remain competitive and develop new products and markets for these products. Raising funds to support this development may be difficult and the inability to do so may impact our ability to develop these new products.  Acceptance of these new products by health care providers and physicians could have a negative impact on future sales.

Our business is subject to regulation by various governmental agencies. Our results of operations could be negatively impacted by failures or delays in approvals or the loss of previously received approvals or changes to existing laws and regulations. Possible costs or difficulty in complying with government regulations and the delays in receiving required regulatory approvals or the enactment of new adverse regulations or regulatory requirements could affect results adversely.

Interruptions in the supply of raw materials could adversely affect our operations and results. Inability to successfully control our margins is affected by many factors including competition and product mix.

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The loss of key personnel and the inability to hire key personnel could affect the business. Aside from general macroeconomic downturns, the additional material, factors that could affect future financial results include, but are not limited to: Terrorist attacks and the impact of such events; shipping labor disruption or other major degradation of the ability to ship out products to end users; inability to successfully control our margins which are affected by many factors including competition and product mix; protracted shutdown of the U.S. border due to an escalation of terrorist or counter terrorist activity; additional governmental tariffs or other fees imposed by the U.S. government for the export of goods to China or other countries; tariffs or restrictions implemented by the Chinese government on shipments of raw materials to us from our suppliers in China; any changes in our business relationships with international distributors or the economic climate they operate in; any event that has a material adverse impact on our foreign manufacturing operations may adversely affect our operations as a whole; failure to manage the future expansion of our business could have a material adverse effect on our revenues and profitability; numerous competitors, some of which have substantially greater financial and other resources than we do; potential claims and litigation brought by patients or medical professionals alleging harm caused by the use of or exposure to our products; quarterly variations in operating results caused by a number of factors, including business, and industry conditions; concentrations of sales with certain distributors-the loss of certain of these distributors could lead to significantly reduced sales, which have been increasing. This could adversely affect the results of the Company if the Company were to lose the sales of that distributoroperations, financial condition, and other factors beyond our control; high balances carried on accounts receivables from concentrated customers could result in write-offs of accounts receivable; and the costs of recalls, should such occasion arise.  All these factors make it difficult to predict operating results for any particular period.prospects.

 

ITEM 2.  17


UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDSTable of Contents - None.

 

ITEM 3.  During the three months ended August 31, 2021, there were no material changes to the risks and uncertainties described in Part I, Item 1A, “Risk Factors,” of our 2021 Annual Report on Form 10-K/A.

DEFAULTS UPON SENIOR SECURITIES - None.

ITEM 4.  MINE SAFETY DISCLOSURES - None.

 

ITEM 5.  OTHER INFORMATION

 

The Company held its Annual Meeting of Stockholders on December 10, 2020, to consider and vote on the proposals set forth in our proxy statement filed with the Securities and Exchange Commission on September 25, 2020. Please referSee Note 8 to the Form 8-K filed on December 11, 2020Financial Statements for a descriptiondiscussion of the results of the meeting.our prior period financial restatements.

 

ITEM 6.  EXHIBITS.EXHIBITS.

 

The following exhibits are filed or furnished as part of this quarterly report on Form 10-Q:

 

 

 

 

 

Exhibit No.

 

Description

 

 

 

 

 

 

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 — Steve Sloan

 

 

 

 

 

 

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 — Steve Sloan

101

Interactive data files pursuant to Rule 405 Regulation S-T, as follows:

 

 

 

 

 

101       Interactive data files pursuant to Rule 405 Regulation S-T, as follows:

101. INS-XBRL Instance Document

 101.INS-XBRL Instance Document

 

          101.SCH-XBRL101. SCH-XBRL Taxonomy Extension Schema Document

 101.CAL-XBRL

101. CAL-XBRL Taxonomy Extension Calculation Linkbase Document

 101.DEF–

101. DEF–XBRL Taxonomy Extension Definition Linkbase Document

 101.LAB-XBRL

101. LAB-XBRL Taxonomy Extension Label Linkbase Document

 

101.PRE-XBRL Taxonomy Extension Presentation Linkbase Document

   *Filed herewith.

 

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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:  JanuaryOctober 14, 2021

By: 

/S/ Zackary S. Irani

Zackary S. Irani

Chief Executive Officer

(Principal Executive Officer)

 

By: 

/S/ Zackary S. Irani

Date:  October 14, 2021

Zackary S. Irani

 

Chief Executive OfficerBy: 

/S/ Steve Sloan

 

(Principal Executive Officer)

Date:  January 14, 2021

 

By:

/S/ Steve Sloan

Steve Sloan

 

Chief Financial Officer

 

(Principal Financial Officer)


19

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