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 FEBRUARY 28,AUGUST 31, 2022

ORor

 

[ ] 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

(State or other jurisdiction of

Incorporation of organization)

Delaware                                                                                                                                                  95-2645573

(I.R.S. Employer
Identification No.)



17571 Von Karman Avenue, Irvine, CA

(Address of principal executive offices)

92614

(Zip Code)

--------------------------------------------------------------------------------------------------------------------------------------------------------------------REGISTRANT'S TELEPHONE NUMBER:

(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)949) 645-2111

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

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

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

 

Securities registered pursuant tounder Section 12(b) of the Exchange Act:

 

(TITLE OF EACH CLASS)

(Title of each class)

COMMON STOCK, PAR VALUE $0.08

(Name of each exchange on which registered)

NASDAQ Capital Market

(Trading symbol)

 (TICKER SYMBOL)

(NAME OF EACH EXCHANGE ON WHICH REGISTERED)

 -----------------------------------

 ----------------------------------- 

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

Common, par value $.08

BMRA

NASDAQ Capital Market

 

Indicate by check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

         Yes [X] No [_]

 

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (paragraph 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

 

         Yes [X] No [_]

 

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

 

Large accelerated filer [  ]

 

Accelerated filer   [  ]

Non-accelerated filer   [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]

 

The number of shares of the registrant's common stock outstanding as of April 14,October 11, 2022was 12,851,924.13,427,651.

 


 

BIOMERICA, INC.

 

INDEX

 

 


Table of Contents


PART I - FINANCIAL INFORMATION

SUMMARIZED FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

 

BIOMERICA, INC. AND SUBSIDIARIES

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  

February 28,

2022

(Unaudited)

   
   

May 31,

2021

   

Assets

 

 

 

 

 

 

       

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

10,173,808

 

$

4,199,311

Accounts receivable, less allowance for doubtful accounts
      of $20,293 and $837,415 as of February 28, 2022 and  May 31, 2021, respectively

 

 

1,158,738

 

 

1,455,051

Inventories, net

  

3,231,430

  

3,206,255

Prepaid expenses and other

 

 

667,129

 

 

370,290

Total current assets

  

15,231,105

  

9,230,907

 

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation and amortization 
      of $2,046,612 and $1,972,357 as of February 28, 2022 and  May 31, 2021, respectively

  

263,048

  

310,520

 

 

 

 

 

 

 

Right of use assets, net of accumulated amortization
      of $658,773 and $469,077 as of February 28, 2022 and  May 31, 2021, respectively

  

1,367,863

  

1,553,081

 

 

 

 

 

 

 

Investments

  

165,324

  

165,324

 

 

 

 

 

 

 

Intangible assets, net of accumulated amortization
      of $49,253 and $126,769 as of February 28, 2022 and  May 31, 2021, respectively

  

386,013

  

294,830

 

 

 

 

 

 

 

Other assets

 

 

146,980

 

 

264,151

Total Assets

 

$

17,560,333

 

$

11,818,813

       

Liabilities and Shareholders' Equity

 

 

 

 

 

 

       

Current Liabilities:

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

2,608,840

 

$

583,380

Accrued compensation

 

 

537,284

 

 

388,896

Advances from customers

  

3,213,052

  

  -

Lease liability, current portion

 

 

338,744

 

 

327,944

Total current liabilities

  

6,697,920

  

1,300,220

Lease liability, net of current portion

 

 

1,104,611

 

 

1,291,570

Total Liabilities

 

 

7,802,531

 

 

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 February 28, 2022 and 
May 31, 2021

 

 

 -

 

 

 -

Preferred stock, undesignated, 0 par value,
4,428,571 shares authorized, NaN issued and outstanding as of February 28, 2022 and
May 31, 2021

  

 -

  

 -

Common stock, $0.08 par value,
25,000,000 shares authorized, 12,851,924 and 12,307,157 issued and outstanding at
February 28, 2022 and May 31, 2021, respectively

 

 

1,028,152

 

 

984,571

Additional paid-in-capital

  

42,108,865

  

38,836,743

Accumulated other comprehensive loss

 

 

(60,857)

 

 

(47,956)

Accumulated deficit

 

 

(33,318,358)

 

 

(30,546,335)

Total Shareholders' Equity

 

 

9,757,802

 

 

9,227,023

Total Liabilities and Shareholders' Equity

 

$

17,560,333

 

$

11,818,813

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)


The accompanying notes are an integral part of these statements.

August 31, 2022

 

May 31, 2022

Assets

 

 

 

 

 

Current Assets:

 

 

 

 

 

Cash and cash equivalents

$

6,075,037

$

5,916,983

Accounts receivable, less allowance for doubtful accounts

        of $383,106 and $153,231 as of August 31, 2022 and May 31, 2022, respectively

 

932,273

 

 

773,818

Inventories, net of inventory reserves
        of $981,814 and $845,549 as of August 31, 2022 and May 31, 2022, respectively

1,921,734

2,416,447

Prepaid expenses and other

 

238,762

 

 

320,283

Total current assets

9,167,806

9,427,531

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation and amortization

        of $1,325,561 and $1,305,360 as of August 31, 2022 and May 31, 2022, respectively

227,908

214,487

 

 

 

 

 

 

Right of use assets, net of accumulated amortization

         of $791,859 and $724,802 as of August 31, 2022 and May 31, 2022, respectively

1,234,777

1,301,834

 

 

 

 

 

 

Investments

165,324

165,324

 

 

 

 

 

 

Intangible assets, net of accumulated amortization

         of $21,271 and $18,994 as of August 31, 2022 and May 31, 2022, respectively

160,750

169,516

 

 

 

 

 

 

Other assets

 

93,509

 

95,588

Total Assets

$

11,050,074

 

$

11,374,280

Liabilities and Shareholders' Equity

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

$

671,240

$

972,372

Accrued compensation

 

591,948

 

 

646,944

Advance from customers

150,523

50,670

Lease liability, current portion

 

343,889

 

 

341,296

Total current liabilities

1,757,600

2,011,282

Lease liability, net of current portion

 

970,890

 

 

1,038,284

Total Liabilities

 

2,728,490

 

3,049,566

 

 

 

 

 

 

Commitments and contingencies (Notes 5 and 6)

 

 

 

 

 

 

Shareholders' Equity:

 

 

 

 

 

 

Common stock, $0.08 par value,

25,000,000 shares authorized, 13,406,901 and 12,867,924 issued and outstanding at

August 31, 2022 and May 31, 2022,  respectively

1,072,550

1,029,432

Additional paid-in-capital

 

44,484,752

 

 

42,446,597

Accumulated other comprehensive loss

(86,463)

(73,936)

Accumulated deficit

 

(37,149,255)

 

 

(35,077,379)

Total Shareholders' Equity

 

8,321,584

 

8,324,714

Total Liabilities and Shareholders' Equity

$

11,050,074

 

$

11,374,280

The accompanying notes are an integral part of these statements.

 

1


Table of Contents

 

BIOMERICA, INC. AND SUBSIDIARIES

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS (UNAUDITED)

 

Three Months Ended

February 28,

Nine Months Ended

February 28,

2022

2021
(As Restated)

2022

2021
(As Restated)

Net sales

 

$

7,660,501

 

$

3,628,638

 

$

13,569,188

 

$

6,144,970

Cost of sales

 

(5,987,277)

 

(3,702,069)

 

(11,213,175)

 

(5,791,593)

Gross profit (loss)

 

 

1,673,224

 

 

(73,431)

 

 

2,356,013

 

 

353,377

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

1,323,725

1,527,947

3,618,258

4,238,737

Research and development

 

 

456,998

 

 

563,967

 

 

1,515,384

 

 

1,892,033

Total operating expense

 

1,780,723

 

2,091,914

 

5,133,642

 

6,130,770

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(107,499)

 

(2,165,345)

 

(2,777,629)

 

(5,777,393)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

Dividend and interest income

 

 

6,019

 

 

37,687

 

 

19,740

 

 

53,761

Loss before income taxes

 

 

(101,480)

 

 

(2,127,658)

 

 

(2,757,889)

 

 

(5,723,632)

(Provision) benefit for income taxes

 

 

(2,688)

 

 

3,117

 

 

(14,134)

 

 

(11,401)

Net loss

 

$

(104,168)

 

$

(2,124,541)

 

$

(2,772,023)

 

$

(5,735,033)

Basic net loss per common share

 

$

(0.01)

 

$

(0.18)

 

$

(0.22)

 

$

(0.49)

Diluted net loss per common share

 

$

(0.01)

 

$

(0.18)

 

$

(0.22)

 

$

(0.49)

Weighted average number of common and
common equivalent shares:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

12,820,481

 

11,905,492

 

12,611,760

 

11,802,803

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

12,820,481

 

11,905,492

 

12,611,760

 

11,802,803

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(104,168)

$

(2,124,541)

$

(2,772,023)

$

(5,735,033)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss, net of tax:

Foreign currency translation

 

 

(2,538)

 

 

(5,437)

 

 

(12,901)

 

 

(8,687)

Comprehensive loss

$

(106,706)

$

(2,129,978)

$

(2,784,924)

$

(5,743,720)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS (UNAUDITED)

 

Three Months Ended

 

August 31, 2022

 

August 31, 2021

Net sales

$

1,637,435

 

$

1,261,787

Cost of sales

 

(1,692,390)

 

 

(1,350,757)

Gross loss

 

(54,955)

 

 

(88,970)

      

Operating expenses:

 

 

 

 

 

Selling, general and administrative

 

1,653,821

  

1,069,855

Research and development

 

361,171

 

 

381,544

Total operating expenses

 

2,014,992

 

 

1,451,399

 

 

 

 

 

 

Loss from operations

 

(2,069,947)

 

 

(1,540,369)

 

 

 

 

 

 

Other income:

     

Dividend and interest income

 

28

 

 

6,805

Interest expense

 

-

  

-

Total other income

 

28

 

 

6,805

 

 

 

 

 

 

Loss before income taxes

 

(2,069,919)

 

 

(1,533,564)

      

Provision for income taxes

 

(1,957)

 

 

(9,017)

      

Net loss

$

(2,071,876)

 

$

(1,542,581)

      

Basic net loss per common share

$

(0.16)

 

$

(0.12)

      

Diluted net loss per common share

$

(0.16)

 

$

(0.12)

      

Weighted average number of common and
common equivalent shares:

 

 

 

 

 

Basic

 

13,100,407

 

 

12,426,784

      

Diluted

 

13,100,407

 

 

12,426,784

      

Net loss

$

(2,071,876)

 

$

(1,542,581)

      

Other comprehensive loss, net of tax:

 

 

 

 

 

Foreign currency translation

 

(12,527)

 

 

(5,613)

 

 

 

 

 

 

Comprehensive loss

$

(2,084,403)

 

$

(1,548,194)

 

The accompanying notes are an integral part of these statements.


The accompanying notes are an integral part of these statements.

 

2


Table of Contents

 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (UNAUDITED)

 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (Unaudited)

 

For the Nine Months Ended February 28, 2021 (As Restated)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Series A 5% Convertible

Preferred Stock

 

Additional

 

Accumulated

Other
Comprehensive

 

Accumulated

 

 

 

 

Shares

Amount

 

Shares

 

Amount

 

  Paid-in Capital

 

 Loss

 

 Deficit

 

 

Total

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

81,750

 

6,540

 

 -

 

 -

 

 

89,915

 

 

 -

 

 

 -

 

 

96,455

Net proceeds from ATM

158,889

 

12,711

 

 -

 

 -

 

 

998,764

 

 

 -

 

 

 -

 

 

1,011,475

Foreign currency translation

 -

 

 -

 

 -

 

 -

 

 

 -

 

 

(8,687)

 

 

 -

 

 

(8,687)

Conversion of preferred to common stock

321,429

 

25,714

 

(321,429)

 

(25,714)

 

 

 -

 

 

 -

 

 

 -

 

 

 -

Compensation expense in connection with options granted

 -

 

 -

 

 -

 

 -

 

 

1,022,320

 

 

 -

 

 

 -

 

 

1,022,320

Net loss

 -

 

 -

 

 -

 

 -

 

 

 -

 

 

 -

 

 

(5,735,033)

 

 

(5,735,033)

 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances, February 28, 2021, restated

12,302,157

$

984,170

 

 -

    $

 -

 

$

38,499,055

 

$

(48,528)

 

$

(28,835,114)

 

$

  10,599,583

 

For the Nine Months Ended February 28, 2022

 

 

Common Stock

 

Series A 5% Convertible

Preferred Stock

 

 

Additional

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

 

 

Shares

Amount

 

Shares

 

Amount

 

Paid-in Capital

 

Loss

 

Deficit

 

Total

Balances, May 31, 2021

12,307,157

$

984,571

 

 -

 $

 -   

 

$

 38,836,743

 

$

(47,956)

 

$

  (30,546,335)

 

$

9,227,023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options

23,500

 

1,880

 

 -

 

 -

 

 

37,295

 

 

 -

 

 

 -

 

 

39,175

Net proceeds from ATM

521,267

 

41,701

 

 -

 

 -

 

 

2,275,459

 

 

 -

 

 

 -

 

 

2,317,160

Foreign currency translation

 -

 

 -

 

 -

 

 -

 

 

 -

 

 

(12,901)

 

 

 -

 

 

(12,901)

Compensation expense in connection with options granted

 -

 

 -

 

 -

 

 -

 

 

959,368

 

 

 -

 

 

 -

 

 

959,368

Net loss

 -

 

 -

 

 -

 

 -

 

 

 -

 

 

 -

 

 

(2,772,023)

 

 

(2,772,023)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances, February 28, 2022

12,851,924

$

 1,028,152

 

 -

 $

 -

 

$

  42,108,865

 

$

(60,857)

 

$

(33,318,358)

 

$

9,757,802


The accompanying notes are an integral part of these statements.

For the Three Months Ended August 31, 2021

 

 

 

 

 

 

 

 

 

 

 

Accumulated Other

Comprehensive

Loss

 

 

 

 

 

 

Common Stock  

 

Additional

 Paid-in Capital

 

 

Accumulated

Deficit

 

 

 

 

Shares

 

Amount

 

 

 

 

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)

Stock option expense

-

 

 

-

 

 

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

For the Three Months Ended August 31, 2022

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated Other

Comprehensive

Loss

 

 

 

 

Common Stock  

 

Additional

 Paid-in Capital

 

Accumulated

Deficit

 

 

 

 

Shares

 

Amount

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances, May 31, 2022

12,867,924

 

 $

1,029,432

 

 $

42,446,597

 

 $

(73,936)

 $

(35,077,379)

 $

8,324,714

Exercise of stock options

15,000

1,200

12,750

-

-

13,950

Net proceeds from ATM

523,977

 

 

41,918

 

 

1,721,650

 

 

-

 

-

 

1,763,568

Foreign currency translation

-

-

-

(12,527)

-

(12,527)

Stock option expense

-

 

 

-

 

 

303,755

 

 

-

 

-

 

303,755

Net loss

-

 

 

-

 

-

 

-

 

(2,071,876)

 

(2,071,876)

Balances, August 31, 2022

13,406,901

 

 $

1,072,550

 

 $

44,484,752

 

 $

(86,463)

 $

(37,149,255)

 $

8,321,584

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)

 

BIOMERICA, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

  

Nine Months Ended

February 28,

  
     

2021

(As Restated)

  

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

       

Net loss

 

$

(2,772,023)

 

$

(5,735,033)

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

      

Depreciation and amortization

 

 

102,272

 

 

94,550

Change in allowance on accounts receivable

  

(817,122)

  

578,438

Inventory reserve

 

 

270,805

 

 

1,437,547

Stock option expense

  

959,368

  

1,022,320

Amortization of right-of-use asset

 

 

189,696

 

 

173,919

Changes in assets and liabilities:

      

Accounts receivable

 

 

1,113,435

 

 

(690,691)

Inventories

  

(295,980)

  

(1,446,766)

Prepaid expenses and other

 

 

(296,839)

 

 

734,966

Reduction in lease liability

  

(180,637)

  

(156,384)

Other assets

 

 

117,171

 

 

(114,664)

Accounts payable and accrued expenses

  

2,025,460

  

(230,575)

Accrued compensation

 

 

148,388

 

 

88,309

Advances from customers

 

 

3,213,052

 

 

 -

Net cash provided by (used in) operating activities

 

 

3,777,046

 

 

(4,244,064)

       

Cash flows from investing activities:

 

 

 

 

 

 

Increase in intangibles

  

(113,436)

  

(116,881)

Purchases of property and equipment

 

 

(32,547)

 

 

(106,760)

Net cash used in investing activities

 

 

(145,983)

 

 

(223,641)

 

 

 

 

 

 

 

Cash flows from financing activities:

      

Proceeds from sale of common stock, net

 

 

2,317,160

 

 

1,011,475

Proceeds from exercise of stock options

 

 

39,175

 

 

96,455

Net cash provided by financing activities

 

 

2,356,335

 

 

1,107,930

       

Effect of exchange rate changes in cash

 

 

(12,901)

 

 

(8,687)

Net increase (decrease) in cash and cash equivalents

  

5,974,497

  

(3,368,462)

 

 

 

 

 

 

 

Cash and cash equivalents at beginning of period

 

 

4,199,311

 

 

8,641,027

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

10,173,808

 

$

5,272,565

 

 

 

 

 

 

 

Supplemental Disclosure of Cash Flow Information:

      

Cash paid during the period for:

 

 

 

 

 

 

Income taxes

 

$

13,334

 

$

13,730

 

 

 

 

 

 

 

Non-cash investing and financing activities:

      

Increase in right-of-use asset due to lease extension or establishment

 

$

4,478

 

$

 -

Increase in lease liability due to lease extension or establishment

 

$

4,478

 

$

 -


The accompanying notes are an integral part of these statements.

 

 

Three Months Ended

 

 

August 31, 2022

 

August 31, 2021

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(2,071,876)

 

$

(1,542,581)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

28,971

 

 

34,722

Provision for allowance on accounts receivable

 

 

229,875

 

 

(94,891)

Inventory reserve

 

 

136,265

 

 

179,744

Stock option expense

 

 

303,755

 

 

319,622

Amortization of right-of-use asset

 

 

67,057

 

 

62,897

Changes in assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(388,330)

 

 

777,752

Inventories

 

 

358,448

 

 

164,732

Prepaid expenses and other

 

 

81,521

 

 

55,069

Reduction in lease liability

 

 

(64,801)

 

 

(55,649)

Other assets

 

 

2,076

 

 

(2,431)

Accounts payable and accrued expenses

 

 

(301,132)

 

 

58,024

Accrued compensation

 

 

(54,996)

 

 

118,826

Advance from customers

 

 

99,853

 

 

-

Net cash (used in) provided by operating activities

 

 

(1,573,314)

 

 

75,836

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

Expenditures related to intangibles

 

 

-

 

 

(72,375)

Purchases of property and equipment

 

 

(33,623)

 

 

(5,141)

Net cash used in investing activities

 

 

(33,623)

 

 

(77,516)

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

Gross proceeds from sale of common stock

 

 

1,810,927

 

 

838,333

Costs from sale of common stock

 

 

(47,359)

 

 

(37,622)

Proceeds from exercise of stock options

 

 

13,950

 

 

3,895

Net cash provided by financing activities

 

 

1,777,518

 

 

804,606

 

 

 

 

 

 

 

Effect of exchange rate changes in cash

 

 

(12,527)

 

 

(5,613)

Net increase in cash and cash equivalents

 

 

158,054

 

 

797,313

 

 

 

 

 

 

 

Cash and cash equivalents at beginning of year

 

 

5,916,983

 

 

4,199,311

 

 

 

 

 

 

 

Cash and cash equivalents at end of the period

 

$

6,075,037

 

$

4,996,624

 

 

 

 

 

 

 

Supplemental Disclosure of Cash Flow Information:

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

Income taxes

 

$

1,957

 

$

9,017

 

 

 

 

 

 

 

Non-cash investing and financing activities:

 

 

 

 

 

 

Write off of intangible assets, cost

 

$

6,489

 

$

-

Write off of intangible assets, accumulated amortization

 

$

850

 

$

-

 

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 its subsidiaries (collectively the “Company”, “Biomerica”, “we”, “us”, or “our”)(which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH) is a biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in homephysicians' offices and physicians' offices) over-the-counter through drugstores and online)and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. diseases. Our diagnostic test kits are used to analyze blood, urine, nasal or fecal material from patients in the diagnosis of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens or other substances, which may exist in the human body in extremely small concentrations. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs.

 

Our primary focus is the research, development, commercialization and in certain cases regulatory approval, of patented, diagnostic-guided therapy (“DGT”) products tobased on our InFoods® Technology platform that treat gastrointestinal diseases, such as irritable bowel syndrome (“IBS”), and other inflammatory diseases. These InFoods® based products are directed at chronic inflammatory illnesses that are widespread and common, and as such address very large markets. The first product we are launching using this patented InFoods Technology is our InFoods® IBS product which uses a simple blood sample and is designed to identify patient-specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, cramping and constipation. Instead of broad and difficult to manage dietary restrictions, the InFoods® IBS product works by identifying a patient’s above normal immunoreactivity to specific foods.  A food identified as positive and causing an abnormal immune response in the patient is simply removed from the diet to help alleviate IBS symptoms. We are currently in discussions with key gastroenterology (GI) physician groups who are interested in offering this product to their patients. As such, we are expecting to begin generating revenues from the launch of our InFoods® IBS product during our fiscal third quarter.   

 

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

 

Due to the global 2019 SARS-CoV-2 novel coronavirus pandemic, in March 2020 we began developing COVID-19 products to indicate if a person has been infected by COVID-19 or is currently infected. While the Company does offerwe initially offered a COVID-19 antibody diagnostic test to determine if a person has previously been infected by the COVID-19 virus, all of our COVID-19 revenues in fiscal 2022 and 2023 have come from international sales of our COVID-19 antigen tests that use a patient’s nasal fluid sample to detect if the patient is currently infected with the virus. Due to falling demand, less than 12% of our revenues during the three months ended August 31, 2022 were from sales of our COVID-19 related products.

 

The otherOur non-COVID-19 products we sellthat accounted for over 88% of our revenues during the three months ended August 31, 2022, are primarily focused on gastrointestinal diseases, food intolerances, 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.United States by the FDA.

 

The information set forth in these condensedunaudited consolidated financial statements isherein have been prepared by management pursuant to the rules and regulations of the United States Securities and Exchange Commission ("SEC"). The accompanying interim unaudited consolidated financial statements have been prepared under the presumption that users of the interim financial information have either read or have access to the audited consolidated financial statements for the latest fiscal year ended May 31, 2022. Accordingly, certain information and reflects all adjustments which,note disclosures normally included in financial statements prepared in accordance with United States generally accepted accounting principles ("GAAP") have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, 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 footnotesadjustments considered necessary for a fair presentation have been included. Operating results for the three months ended August 31, 2022 are not necessarily indicative of financial position,the results of operations, and cash flows in conformity with accounting principles generally accepted inthat may be expected for the United States of America. All adjustments that were made are of a normal recurring nature.

The unaudited, condensedfiscal year ending May 31, 2023. For further information, refer to the audited consolidated financial statements and notes are presented as permitted bythereto for the requirements for Form 10-Q and do not contain certain informationfiscal year ended May 31, 2022 included in the annual financial statements and notes. The condensed consolidated balance sheet data as of May 31, 2021 was derived from restated, audited financial statements. The accompanying interim condensed consolidated financial statements should be read in conjunction with the financial statements and related notes included in theCompany's Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”)SEC on August 27, 2021 for29, 2022. Management has evaluated all subsequent events and transactions through the fiscal year ended May 31, 2021, which have been restated as described in our Form 10-K/A as filed on October 14, 2021. The resultsdate of operations for the interim periods are not necessarily indicative of results to be achieved for the full fiscal year.filing this report.

 

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 periods ended February 28, 2021, were materially misstated; accordingly, we have restated the prior period financial statements. See Note 8 to these 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 is based on projected and historical usage of materials; and lease liability and right-of-use assets, which are calculated based on certain assumptions such as borrowing rate, the likelihood of lease extensions to occur, asset valuation, among other things; and other items that may be necessary to estimate using current, historical and judgment based information. Actual results could materially differ from those estimates.

 

MARKETS AND METHODS OF DISTRIBUTION

 

Due to the Coronavirus global pandemic, and the economic disruptions that have followed, 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, cost inflation, 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 have materially negatively impacted 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 $33.3$37.1 million as of February 28,August 31, 2022. Management expects to continue to incur significant costs as it advances its clinical trials and product development activities. As of August 31, 2022, the Company had cash and cash equivalents of approximately $6,075,000 and working capital of approximately $7,410,000.

 

On July 21, 2020, the Company filed with the SEC a “shelf” registration statement on Form S-3. The registration statement registers common shares that may be issued by the Company in a maximum aggregate amount of up to $90,000,000.  Shares of the Company’s common stock may be sold from time to time under this registration statement for up to three years from the filing date. On January 22, 2021, the Company filed a prospectus supplement for purposesthe sale of raising up to $15,000,000 toof shares of our common stock in an at-the-market offering (“ATM Offering”) under the base prospectus filed with the SEC on July 21, 2020 and included in theshelf registration statement, on Form S-3 (File No. 333-239980) that was declared effective by the SEC on September 30, 2020. The shares included inof which approximately $9,600,000, remains available for sale under the prospectus supplement may be sold pursuant to the terms of an At-The- Market Issuance Sales Agreement between the Company and B. Riley Securities, Inc., as sales agent, the ATM Agreement.supplement.

 

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 sold “at the market offerings” as defined in Rule 415 promulgated under the Securities Act. The sales agent under the ATM AgreementOffering 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,Offering, and may at any time suspend offers under, or terminate the ATM Agreement.Offering.

During the quarter ended August 31, 2022, the Company sold 523,977 shares of its common stock at prices ranging from $3.15 to $3.55 under its ATM Offering which resulted in gross proceeds of approximately $1,811,000 and net proceeds to the Company approximately of $1,764,000 after deducting commissions for each sale and legal, accounting, and other fees related to the ATM Offering.

As a result of cash and cash equivalents on hand at February 28,August 31, 2022, and the ability to raise additional funds, including through the ATM AgreementOffering noted above,management believes the Company has sufficient funds to operate through Mayat least November 2023.

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CONCENTRATION OF CREDIT RISK

 

The Company maintains cash balances at certain financial institutions in excess of amounts insured by federal agencies. As of February 28,August 31, 2022, the Company had approximately $9,765,000$5,834,000 of uninsured cash. The Company does not believe it is exposed to any significant credit risks.

 

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Consolidated net sales were approximately $1,637,000 for the three months ended August 31, 2022, as compared to $1,262,000 for the three months ended August 31, 2021. For the ninethree months ended February 28,August 31, 2022 and 2021, the Company had three and two key customers who are located in foreign countries which accounted for 75%64% and 66%60% of net consolidated sales, respectively.

At February 28,Total gross receivables on August 31, 2022 and May 31, 2022 were approximately $1,315,000 and $927,000, respectively. On August 31, 2022 and May 31, 2021,2022, the Company had onetwo and twoone key customers who are located in foreign countries which accounted for a total of 67% and 73%50%, respectively, of gross accounts receivable.

 

For the ninethree months ended February 28,August 31, 2022 and 2021, the Company had one key vendor which accounted for 85%9% and 62%17% of the purchases of raw materials, respectively. As of February 28,August 31, 2022 and May 31, 2021,2022, the Company had one and two key vendorvendors which accounted for 80%11% and 17%69%, respectively, of accounts payable.

 

CASH AND CASH EQUIVALENTS

 

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

 

ACCOUNTS RECEIVABLE

 

The Company extends unsecured credit to its customers on a regular basis. International accounts are usually required to prepay until they establish a history with the Company and at that time, they are extended credit at levels based on a number of criteria. Based on various criteria, initial credit levels for individual distributors are approved by designated officers and managers of the Company. All increases in credit limits are also approved by designated upper-level management. Management evaluates receivables on a quarterly basis and adjusts the allowance for doubtful accounts accordingly. Balances over ninety days old are 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.

 

TheAs of August 31, 2022 and May 31, 2022, the Company has established a reserve of approximately $20,000$383,000 and $153,000, respectively, for doubtful accounts as of February 28, 2022.accounts.

 

PREPAID EXPENSES AND OTHER

 

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

 

As of February 28,August 31, 2022 and May 31, 2021,2022, theprepaid expenses and other were approximately $667,000$239,000 and $370,000,320,000, respectively. The prepaid expenses and other balance were, composed of prepayments to raw materials suppliers, insurance and various other suppliers.

 

INVENTORIES, NET

 

The Company values inventory at the lower of cost (determined using a combination of specific lot identification and the first-in, first-out methods) or net realizable value. Management periodically reviews inventory for excess quantities and obsolescence. Management evaluates quantities on hand, physical condition, and technical functionality as these characteristics may be impacted by anticipated customer demand for current products and new product introductions. The inventory reserve (as described below) 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.

 

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Net inventories are approximately the following:

 

February 28,
2022

May 31,
2021

August 31, 2022

 

May 31, 2022

Raw materials

 

$

1,360,000

 

$

1,583,000

$

1,732,000

 

$

1,717,000

Work in progress

714,000

1,006,000

723,000

763,000

Finished products

 

 

1,157,000

 

 

617,000

 

449,000

 

 

782,000

Total

$

3,231,000

$

3,206,000

Total gross inventory

$

2,904,000

$

3,262,000

Inventory reserves

 

(982,000)

 

 

(846,000)

Net inventory

$

1,922,000

$

2,416,000

 

Reserves for inventory obsolescence are recorded as necessary to reduce obsolete inventory carrying value to estimated net realizable value or to specifically reserve for obsolete inventory that the Company intends to dispose of.inventory. As of February 28,August 31, 2022, and May 31, 2021,2022, inventory reserves were approximately $1,888,000$982,000 and $1,617,000,$846,000, respectively. Of the inventory reserve as of February 28, 2022, approximately $1,686,000 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.

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PROPERTY AND EQUIPMENT, NET

 

Property and equipment are stated at cost. Expenditures for additions and major improvements are capitalized. Repairs and maintenance costs are charged to operations as incurred. When property and equipment are sold, retired or otherwise disposed of, the related cost and accumulated depreciation or amortization are removed from the accounts, and gains or losses from sales, retirements and dispositions are credited or charged to income.

 

Depreciation and amortization are provided over the estimated useful lives of the related assets, ranging from 5 to 10 years, using the straight-line method. Leasehold improvements are amortized over the lesser of the estimated useful life of the asset or the term of the lease. Depreciation and amortization expense on property and equipment were approximately $26,000$20,000 and $28,000 for the three months ended February 28,August 31, 2022 and 2021, and approximately $80,000 and $78,000 for the nine months ended February 28, 2022 and 2021,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.Other (“ASC 350”). In that regard, intangible assets that have indefinite useful lives are not amortized but are tested at least annually for impairment or more frequently if events or changes in circumstances indicate that the asset might be impaired.

 

Intangible assets are being amortized using the straight-line method over the useful life, not to exceed 18 years for marketing and distribution rights, 10 years for purchased technology use rights, and 20 years for patents. Amortization expense was approximately $8,000$9,000 and $4,000$7,000 for the three months ended February 28, 2022 and 2021 and approximately $22,000 and $16,000 for the nine months ended February 28,August 31, 2022 and 2021, 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. NoAs of August 31, 2022 and 2021, an impairment adjustment was required asmade of February 28, 2022 or 2021.$6,000 and $0, respectively.

 

INVESTMENTS

 

From time-to-time, the Company makes investments in privately-heldprivately 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 equity investment in a Polish-based distribution companyPolish distributor, which is primarily engaged in distributing medical products and devices, including those manufactured by the Company, and in certain cases, manufacturing the products they sell.  The Company currently has not written down the investment and has no information that would indicate the carrying value is greater than the fair value.devices. The Company owns approximately 6% of the investee and invested approximately $165,000 into the Polish distribution company, and accordingly, appliesdistributor.

Equity holdings in nonmarketable unconsolidated entities in which the Company is not able to exercise significant influence ("Cost Method Holdings") are accounted for at the Company's initial cost, method to accountminus any impairment (if any), plus or minus changes resulting from observable price changes in orderly transactions for the investment.  Underidentical or a similar holding or security of the cost method, investmentssame issuer. Dividends received are recorded at cost, with gains and losses recognizedas other income.

The Company assesses its equity holdings for impairment whenever events or changes in circumstances indicate that the carrying value of an equity holding may not be recoverable. Management reviewed the underlying net assets of the Company's equity method holding as of August 31, 2022 and determined that the sale date, and income recorded when received.Company's proportionate economic interest in the entity indicates that the equity holding was not impaired. There were no observable price changes in orderly transactions for identical or a similar holding or security of the Company’s Cost Method Holding during the period ended August 31, 2022.

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SHARE-BASED COMPENSATION

 

The Company follows the guidance of the accounting provisions of Accounting Standards CodificationASC 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 directors and others are grantedreceive shares of the Company’s common stock or equity instruments (stock options)(options). The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricingoptions-pricing model that uses assumptions for expected volatility, expected dividends, expected forfeiture rate, expected term, and the risk-free interest rate. The Company has not paid dividends historically and does not expect to pay them in the foreseeable future. Expected volatilities are based on weighted averages of the historical volatility of the Company’s common stock estimated over the expected term of the options. The expected forfeiture rate is based on historical forfeitures experienced. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term as historically the Company had limited exercise activity surrounding its options. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period ofthe expected term. The grant date fair value of the award is recognized under the straight-line attribution method.

 

8


TableThe Company expensed approximately $304,000 and $320,000 of Contentsstock-based compensation during the three months ended August 31, 2022 and 2021, respectively.

 

The following summary presents the options and warrants granted, exercised, expired, canceled and outstanding for the ninethree months ended February 28,August 31, 2022:

 

Option Shares

Exercise Price Weighted Average

Option Shares

Exercise Price

Weighted Average

Outstanding May 31, 2021

 

2,081,366

 

$

3.59

Outstanding May 31, 2022

2,321,616

 

$

3.72

Granted

307,000

4.44

146,000

3.37

Exercised

 

(23,500)

 

1.71

(15,000)

 

0.95

Cancelled or expired

(28,750)

3.49

(64,000)

 

4.78

Outstanding February 28, 2022

 

2,336,116

 

$

3.72

Outstanding August 31, 2022

2,388,616

 

$

3.69

                                                                                                                                                       

During the ninethree months ended February 28,August 31, 2022, options to purchase 23,50015,000 shares of common stock were exercised at prices ranging from $1.20$0.82 to $3.62.$1.20. Total net proceeds to the Company were $39,175.approximately $14,000.

 

During the ninethree months ended February 28,August 31, 2022, the Company granted 307,000146,000 options to purchase common stock at an average purchase price of $4.44.$3.37, with the majority of those options issued to the Company’s new Chief Commercial Officer, who is managing the commercialization and roll-out of the InFoods IBS test.

 

REVENUE RECOGNITION

 

The Company has various contracts with customers.  All of the contracts specify that revenues from product sales are recognized at the time the product is shipped, customarily FOB shipping point, which is when the transfer of control of goods has occurred and at which point title passes.

 

The Company does not typically allow for returns from international customers except in the event of defective merchandise and therefore does not establish an allowance for returns. The Company does allow for a return merchandise allowance of approximately one percent of sales to certain domestic retailers. This allowance reduces revenue recognition by approximately one percent, and is included in sales discounts. 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 February 28,during the three months ended August 31, 2022 and 2021, and does not believe that any additional discounts will be given through the end of the contract periods.

 

Services for contract workswork performed by the Company for others are invoiced and recognized as that work that has been performed and as the project progresses. The Company sells clinical lab products to domestic and international distributors, including hospitals and clinical laboratories, medical research institutions, medical schools and pharmaceutical companies. OTC products are sold directly to drug stores and e-commerce customers as well as to distributors.  Physicians’ office products are sold to physicians and distributors, all of whom are categorized below according to the type of products sold to them. We also manufacture certain components on a contract basis for domestic and international manufacturers.

 

During the quarter ended February 28,As of August 31, 2022, the Company had approximately $3,213,000$151,000 of advances from certain foreign customers. The majority of these advances are prepayments on orders that are expected to ship during our fourthsecond quarter ended May 31,November 30, 2022.

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Disaggregation of revenue:

 

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

               

Three Months Ended
February 28,

Nine Months Ended
February 28,

 

Three Months Ended August 31,

2022 

 

2021

 

2022 

 

2021

 

2022

2021

Physician's office

 

$

6,518,000

 

$

2,384,000

 

$

10,134,000

 

$

2,735,000

Clinical lab

731,000

967,000

2,259,000

2,441,000

 

 $

1,146,000

 

 $

886,000

Over-the-counter

 

244,000

 

 

148,000

 

 

857,000

 

 

605,000

 

213,000

 

79,000

Physician's office

 

183,000

 

257,000

Contract manufacturing

 

 

167,000

 

 

130,000

 

 

319,000

 

 

364,000

 

 

95,000

 

 

40,000

Total

$

7,660,000

$

3,629,000

$

13,569,000

$

6,145,000

 

 $

1,637,000

 

 $

1,262,000

 

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.

 

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RESEARCH AND DEVELOPMENT

 

Research and development costs are expensed as incurred. The Company expensed approximately $457,000$361,000 and $564,000382,000 of research and development costs during the three months ended February 28, 2022 and 2021 and approximately $1,515,000 and $1,892,000 during the nine months ended February 28,August 31, 2022 and 2021, respectively.

 

INCOME TAXES

 

The Company has provided a full valuation allowance on deferred income tax assets of approximately $6,479,000$7,402,000 and $5,904,000$6,967,000 as of February 28,August 31, 2022 and May 31, 2022, respectively.  

ADVERTISING COSTS

The Company reports the cost of advertising as expense in the period in which those costs are incurred. Advertising costs were approximately $18,000 and $8,000 for the three months ended August 31, 2022 and 2021, respectively.

 

FOREIGN CURRENCY TRANSLATION

 

The subsidiary located in Mexico operates primarily using the Mexican peso. The subsidiary located in Germany operates primarily using the U.S. dollar, with an immaterial amount of transactions occurring using the Euro. Accordingly, assets and liabilities of these subsidiaries are translated using exchange rates in effect at the end of the period, and revenues and costs are translated using average exchange rates for the period. The resulting translation adjustments to assets and liabilities are presented as a separate component of accumulated other comprehensive loss. There are no adjustments to foreign currency losstransactions that are included in the consolidated statements of operations for the three and nine months ended February 28,August 31, 2022 and 2021.

 

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 theour obligation to make lease payments arising from the lease.  Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term.  Leases are classified as financing or operating which will drive the expense recognition pattern. The Company has elected to exclude short-term leases.  The Company leases office space and copy machines, all of which are operating leases. 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.

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NET LOSS PER SHARE

 

Basic loss per share is computed as net loss divided by the weighted average number of common shares outstanding for the period. Diluted loss per share reflects the potential dilution that could occur from common shares issuable through stock options, warrants and other convertible securities using the treasury stock method. The total amount of anti-dilutive stock options not included in the loss per share calculation at February 28,August 31, 2022 and 2021 was 2,336,1162,388,616 and 1,360,192,2,081,116, respectively.

 

RECENT ACCOUNTING PRONOUNCEMENTS

 

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

In June 2016, the FASB issued ASU 2016-13, "Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments." This ASU will require the measurement of all expected credit losses for financial assets, including trade receivables, held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. The guidance was initially effective for the Company for annual reporting periods beginning after December 15, 2019, and interim periods within those fiscal years. In November 2019, the FASB issued ASU 201·9- 10, "Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates," which, among other things, defers the effective date of ASU 2016-13 for public filers that are considered smaller reporting companies as defined by the Securities and Exchange Commission to fiscal years beginning after December 15, 2022, including interim periods within those years. Early adoption is permitted. The Company is currently reviewing the requirements of this ASU to determine its impact on the Company’s consolidated results of operations and financial position.

RECLASSIFICATIONS

Certain comparative figures in the August 31, 2021 condensed consolidated statement of operations have been reclassified to conform to the current period presentation.

 

NOTE 3:  SHAREHOLDERS’ EQUITY

 

Stock option expense during the ninethree months ended February 28,August 31, 2022 and 2021 was approximately $959,000$304,000 and $1,022,000 (as restated, see Note 8 to these Financial Statements),$320,000, respectively.

During the ninethree months ended February 28,August 31, 2022, the Company sold 521,267523,977 shares of its common stock at prices ranging from $4.02$3.15 to $5.63$3.55 under its January 22, 2021 prospectus supplementForm S-3 Registration Statement and the ATM Agreement (see Note 2 to these Financial Statements)Offering which resulted in gross proceeds of approximately $2,402,000$1,811,000 and net proceeds to the Company of approximately $2,317,000$1,764,000 after deducting commissions for each sale and legal, accounting, and other fees related to the filing of the Form S-3.ATM Offering.

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NOTE 4:  GEOGRAPHIC INFORMATION

 

The Company operates as 1one segment. Geographic information regarding net sales is approximately as follows:

 

 

Three Months Ended
February 28,

 

Nine Months Ended
February 28,

Three Months Ended August 31,

 

2022

 

2021

 

2022

 

2021

2022

2021

Revenues from sales to unaffiliated customers:

  

 

  

 

  

 

  

Asia

 

$

4,877,000

 

$

756,000

 

$

8,925,000

 

$

1,653,000

$

814,000

 

$

675,000

Europe

 

2,416,000

 

 

2,611,000

 

 

3,683,000

 

 

3,781,000

552,000

471,000

North America

 

286,000

 

133,000

 

820,000

 

374,000

 

268,000

 

105,000

South America

 

81,000

 

 

64,000

 

 

87,000

 

 

146,000

3,000

3,000

Middle East

 

 

-

 

 

65,000

 

 

54,000

 

 

191,000

 

-

 

 

8,000

 

$

7,660,000

 

$

3,629,000

 

$

13,569,000

 

$

6,145,000

$

1,637,000

$

1,262,000

 

As of February 28,August 31, 2022, and May 31, 2021,2022, approximately $142,000$725,000 and $803,000$621,000 of Biomerica’s gross inventory was located in Mexicali, Mexico, respectively.

As of February 28,August 31, 2022, and May 31, 2021,2022, approximately $19,000$20,000 and $25,000$17,000 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

 

The Company leases its facilities. On June 18, 2009,August 31, 2022, the Company entered into an agreement to lease a buildinghad approximately 22,000 square feet of floor space at its corporate headquarters at 17571 Von Karman Avenue in Irvine, California.California, which it has been leasing since 2009. The lease commenced September 1, 2009 and endedfor its headquarters expired on August 31, 2016.  The Company had an option to extend the term of its lease for two additional sixty-month periods. On November 30, 2015, the Company exercised its option to extend its lease for an additional sixty-month period and entered into the First Amendment to Lease wherein it exercised its option to extendextended its lease until August 31, 2021. The 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.  Theyears.  When the Company extended its lease in April 2021, it was also granted an additional five yearsfive-year lease extension option through August 2031.option. The current rent is currently $25,588approximately $26,000 per month. The security deposit of $22,078 remains the same. is approximately $22,000.

 

In November 2016, the Company’s Mexican subsidiary, Biomerica de Mexico, entered into a ten-year10-year lease for approximately 8,1048,100 square feet at a monthly rent of $2,926.manufacturing space. The Company has one 10-year option to renew at the end of the initial lease period. The yearly ratecurrent rent 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 $3,438.  Biomerica, Inc. is not a guarantor of such lease.approximately $3,400 per month. Biomerica de Mexico also leases a smaller unit on a month-to-month basis for use in one manufacturing process.

 

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

 

RentTotal gross rent expense in the U.S.United States for the ninethree months ended February 28,August 31, 2022 and 2021 was approximately $230,000$78,000 and $227,000,$78,000, respectively.  Rent expense for the Mexico facility for the ninethree months ended February 28,August 31, 2022 and 2021 was approximately $31,000.$11,000 and $10,000, 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 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 Consolidated Statements of Operations and Comprehensive Loss when they are incurred.

 

Supplemental cash flow information related to leases for the ninethree months ended February 28,August 31, 2022:  

 

Operating cash flows from operating leases     

 

$

252,252

 

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

 

$

-

 

Weighted average remaining lease term (in years)

 

 

4.53

 

Weighted average discount rate

  

6.50

%

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Operating cash flows from operating leases     

 $

86,000

Right-of-use assets obtained in exchange for

   new operating lease liabilities

$

-

Weighted average remaining lease term (in years)

4.02

Weighted average discount rate

6.50%

 

The approximate maturity of lease liabilities as of February 28,August 31, 2022 are as follows:

 

Less than 1 year

 

$

349,000

1 to 2 years

359,000

2 to 3 years

 

 

370,000

3 to 4 years

381,000

4 to 5 years

 

 

201,000

Total undiscounted lease payments

 

 

1,660,000

Less imputed interest

217,000

Total operating lease liabilities

 

$

1,443,000

Less than 1 year

 $

354,000

1 to 2 years

364,000

2 to 3 years

375,000

3 to 4 years

387,000

4 to 5 years

8,000

Total undiscounted lease payments

1,488,000

Less imputed interest

173,000

Total operating lease liabilities

 $

1,315,000

 

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

 

LITIGATION

 

The Company is, from time to time, involved in legal proceedings, claims and litigation arising in the ordinary course of business. While the amounts claimed may be substantial, the ultimate liability cannot presently be determined because of considerable uncertainties that exist. Therefore, it is possible the outcome of such legal proceedings, claims and litigation could have a material effect on quarterly or annual operating results or cash flows when resolved in a future period. However, based on facts currently available, management believes such matters will not have a material adverse effect on the Company's consolidated financial position, results of operations or cash flows.

There were no legal proceedings pending as of February 28,August 31, 2022.

CONTRACTS AND LICENSING AGREEMENTS

None

 

NOTE 7:  SUBSEQUENT EVENTS

 

None.

NOTE 8:  RESTATEMENT OF PREVIOUSLY ISSUED FINANCIAL STATEMENTS

DuringOn September 2021,29, 2022, the Company determinedannounced that errors were included in the previously issued financial statements as described below. As a result, we restated our financial statements for the periods ended February 28, 2021.its Aware® Breast Self Exam device and EZ Detect Colon Disease test are being sold on Amazon and fulfilled by Amazon.   

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 and vesting had occurred, which resulted in an understatement of stock compensation expense. Additionally, our calculation expensed all issued options 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 cash, revenues or other aspects of ongoing operations.

The restatement for the quarter ended February 28, 2021 resulted in no changes in the provision for income taxes.

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The effect of the restatement on the consolidated statement of operations for the three months ended February 28, 2021 is as follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Cost of sales

$

3,667,143

 

$

34,926

 

$

3,702,069

Gross Profit

 

(38,505)

 

 

(34,926)

 

 

(73,431)

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

Selling, general and administrative

 

1,278,393

 

 

249,554

 

 

1,527,947

Research and development

 

563,216

 

 

751

 

 

563,967

Total operating expense

 

1,841,609

 

 

250,305

 

 

2,091,914

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,880,114)

 

 

(285,231)

 

 

(2,165,345)

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

(1,842,427)

 

 

(285,231)

 

 

(2,127,658)

 

 

 

 

 

 

 

 

 

Net loss

$

(1,839,310)

 

$

(285,231)

 

$

(2,124,541)

 

 

 

 

 

 

 

 

 

Basic net loss per common share

$

(0.15)

 

$

(0.03)

 

$

(0.18)

 

 

 

 

 

 

 

 

 

Diluted net loss per common share

$

(0.15)

 

$

(0.03)

 

$

(0.18)

 

 

 

 

 

 

 

 

 

Comprehensive loss

$

(1,844,747)

 

$

(285,231)

 

$

(2,129,978)

The effect of the restatement on the consolidated statement of operations for the nine months ended February 28, 2021 is as follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Cost of sales

$

5,639,103

 

$

152,490

 

$

5,791,593

Gross Profit

 

505,867

 

 

(152,490)

 

 

353,377

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

Selling, general and administrative

 

3,697,804

 

 

540,933

 

 

4,238,737

Research and development

 

1,824,312

 

 

67,721

 

 

1,892,033

Total operating expense

 

5,522,116

 

 

608,654

 

 

6,130,770

 

 

 

 

 

 

 

 

 

Loss from operations

 

(5,016,249)

 

 

(761,144)

 

 

(5,777,393)

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

(4,962,488)

 

 

(761,144)

 

 

(5,723,632)

 

 

 

 

 

 

 

 

 

Net loss

$

(4,973,889)

 

$

(761,144)

 

$

(5,735,033)

 

 

 

 

 

 

 

 

 

Basic net loss per common share

$

(0.42)

 

$

(0.07)

 

$

(0.49)

 

 

 

 

 

 

 

 

 

Diluted net loss per common share

$

(0.42)

 

$

(0.07)

 

$

(0.49)

 

 

 

 

 

 

 

 

 

Comprehensive loss

$

(4,982,576)

 

$

(761,144)

 

$

(5,743,720)

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The effect of the restatement on the consolidated statement of cash flows for the period ended February 28, 2021 is as follows:

 

As Previously Reported

 

Adjustments

 

As Restated

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(4,973,889)

 

$

(761,144)

 

$

(5,735,033)

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

 

 

 

 

 

 

 

 

Stock option expense

 

261,176

 

 

761,144

 

 

1,022,320

Net cash used in operating activities

 

(4,244,064)

 

 

 -

 

 

(4,244,064)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

$

5,272,565

 

$

 -

 

$

5,272,565

 

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

 

You should read the following discussion and analysis in conjunction with our unaudited condensed consolidated financial statements and the accompanying notes thereto included in Part II,I, Item 81 of this Report.Report and the audited consolidated financial statements in our Annual Report on Form 10-K for the fiscal year ended May 31, 2022 (our 2022 Annual Report). This discussion and analysis contains forward-looking statements that are based on our management’s current beliefs and assumptions, which statements are subject to substantial risks and uncertainties. Our actual results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including those discussed in “Risk Factors” included in Part I, Item 1A of thisour 2022 Annual Report. 

 

OVERVIEW

 

Biomerica, Inc. and its subsidiaries (which includes wholly-owned subsidiaries, Biomerica de Mexico and BioEurope GmbH), is a biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in homephysicians' offices and physicians' offices)over-the-counter through drugstores and online) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. Our diagnostic test kits are used to analyze blood, urine, nasal or fecal material from patients in the diagnosis of various diseases, food intolerances and other medical complications, or to measure the level of specific hormones, antibodies, antigens or other substances, which may exist in the human body in extremely small concentrations. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs.

 

Our primary focus is the research, development, commercialization and developmentin certain cases regulatory approval, of revolutionary, patented, diagnostic-guided therapy or DGT,(“DGT”) products tobased on our InFoods® Technology platform that treat gastrointestinal diseases, such as irritable bowel syndrome, and other inflammatory diseases. These InFoods® based products are directed at chronic inflammatory illnesses that are widespread and common, and as such address very large markets. If these DGT products prove effectiveThe first product we are launching using this patented InFoods Technology is our InFoods® IBS product which uses a simple blood sample and is designed to identify patient-specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea, cramping and constipation. Instead of broad and difficult to manage dietary restrictions, the InFoods® IBS product works by identifying a patient’s above normal immunoreactivity to specific foods.  A food identified as positive and causing an abnormal immune response in the patient is simply removed from the diet to help alleviate IBS symptoms. We are currently in discussions with key gastroenterology (GI) physician groups who are interested in offering this product to their clinical trials, andpatients. As such, we are ultimately cleared for sale byexpecting to begin generating revenues from the U.S. Food and Drug Administration, we believe the revenue potential to the Company is significant.launch of our InFoods® IBS product during our fiscal third quarter.  

 

We recentlyDuring fiscal 2022, we completed an endpoint determination clinical trial on our InFoods® IBS product. This trial was conducted at the Mayo ClinicsClinic centers 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 monitored IBS patients over an 8-week period to determine the efficacy of our InFoods® IBS product to improve the patients’ IBS symptoms.symptoms or endpoints. The top-line trial results were reported in February 2022. Multiple endpoints demonstrated statistically significant improvements, indicating that the elimination of specific foods may meaningfully reduce the symptoms of IBS in all patient subtypes (including patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed). The greatest clinical improvements, including but not limited to abdominal pain and bloating, were seen in patients diagnosed with IBS-Mixed and IBS-Constipation, in the top line data. The purpose of the endpoint study was to validate efficacy, and determine the primary symptom endpoint, or endpoints to be used in a final pivotal trial that will be conducted to attain the validation data needed to apply for FDAU.S. Food and Drug Administration (“FDA”) clearance for the product. We are now in the process of reviewing the complete data-setdataset and selecting the target endpoint(s) to be used in the pivotal trial. We are also writingpreparing the protocols for this trial and expect to present these protocols to the FDA over the next several months,during fiscal 2023, with the intention of beginning the trial in calendar year 2022.by June 30, 2023. The trial is expected to include the large medical institution participants that conducted the endpoint trial, in addition to other new institutions and a Clinical Research Organization. clinical research organization.

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Following the successful completion and positive results from the Company’s InFoods® IBS clinical trial, we’ve seen significant interest from Gastroenterology (GI) physicians who would like to provide the InFoods® IBS Product to their patients immediately.  Therefore, while we are proceeding with the work needed to seek FDA clearance for this product, we also are currently preparing to launch the InFoods® IBS product through a CLIA-certified, high-complexity laboratory facility that will be offering the product as a laboratory developed test (LDT). Our expectation is that we will begin to generate revenues from this product during our fiscal third quarter. In preparation for the launch of this LDT, we are in negotiations with large physician groups that would like to offer the LDT to their IBS patients.

We are also beginning the work of selecting and validating at least one new disease (such as ulcerative colitis or migraines), where there is evidence that certain foods can trigger or contribute to the symptoms found in these indications. We expect any new disease we target will follow a similar development pathway as InFoods IBS in simultaneously seeking FDA clearance of the diagnostic guided therapy.product while also initially launching the product as an LDT.

 

We will also continue to evaluate partnership/licensing opportunities, as they arise, with U.SU.S. and multinational companies that could help us commercialize the InFoods products in the U.S and overseas.

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Our existing medical diagnostic products are sold worldwide primarily in two markets: 1) clinical laboratories and 2) point-of-care (physicians' offices and over-the-counter drugstores like Walmart and 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.

 

During fiscal 2022, we finalized development of our H. Pylori diagnostic test that indicates if a patient is infected with the H. Pylori bacteria. H. Pylori infection is extremely common, and if left untreated, can lead to ulcers and possibly stomach cancers. During our fourth quarter of fiscal 2022, we applied for FDA clearance of this product though a 510(k) premarket submission. We have been in communications with the FDA answering certain follow-up questions and providing additional data as requested. We are currently awaiting FDA clearance of the product. Once cleared, we will begin marketing the product in the U.S. market.

Due to the global 2019 SARS-CoV-2 novel coronavirus pandemic, in March 2020 we began developing COVID-19 products to indicate if a person has been infected by COVID-19 or is currently infected. While the Company does offerwe initially offered a COVID-19 antibody diagnostic test to determine if a person has previously been infected by the COVID-19 virus, all of our COVID-19 revenues in fiscal 2022 and 2023 have come from international sales of our COVID-19 antigen tests that use a patient’s nasal fluid sample to detect if the patient is currently infected with the virus. Due to falling demand, less than 12% of our revenues during the three months ended August 31, 2022 were from sales of our COVID-19 related products.

 

The otherWhile limited sales continue to occur in our COVID-19 products, we sellvirtually all our research and development efforts are focused on development and commercialization of non-COVID-19 related products such as our H. Pylori product, and our InFoods® IBS product.

Our non-COVID-19 products that accounted for over 88% of our revenues during the three months ended August 31, 2022, are primarily focused on gastrointestinal diseases, food intolerances, and certain esoteric tests. These diagnostic test products utilize immunoassay technology. Most of our products are CE marked and/or sold for diagnostic use where they are registered by each country’s regulatory agency. In addition, some products are cleared for sale in the U.S.United States by the FDA.

 

While sales continue to occur in our COVID-19 products, 14


the majorityTable of our research and development efforts are focused on development and commercialization of non-COVID related products such as our H. Pylori product, and our InFoods® IBS product.Contents

 

We also recently added several new employees in our sales and marketing department in order to increase sales of existing 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 screening programs in other countries.

RESULTS OF OPERATIONS

 

As disclosed in Note 8 of Item 1 to these unaudited condensed consolidated financial statements, during the fiscal quarter ended November 30, 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 nine months ended February 28, 2021, 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 nine months ended February 28, 2021 have been restated.

Three months ended February 28,August 31, 2022

 

Net Sales and Cost of Sales

 

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

 

Three Months Ended
February 28,,

Increase (Decrease)

Three Months Ended August 31,

 

Increase (Decrease)

2022

 

2021

 

 

%

2022

 

2021

 

$

 

%

Physician's office

 

$

6,518,000

 

$

2,384,000

 

$

4,134,000

 

173%

Clinical lab

731,000

967,000

(236,000)

-24%

$

1,146,000

 

$

886,000

 

$

    260,000

 

      29%

Over-the-counter

 

 

244,000

 

 

148,000

 

 

96,000

 

 

65%

 

213,000

  

79,000

  

134,000

 

170%

Contract manufacturing

 

 

167,000

 

 

130,000

 

 

37,000

 

 

28%

Physician's office

 

183,000

 

 

257,000

 

 

(74,000)

 

-29%

Contract Manufacturing

 

95,000

 

 

40,000

 

 

55,000

 

 

138%

Total

$

7,660,000

$

3,629,000

$

4,031,000

111%

$

1,637,000

 

$

1,262,000

 

$

375,000

 

 

30%

 

Consolidated net sales were approximately $7,660,000$1,637,000 for the three months ended February 28,August 31, 2022, as compared to $3,629,000$1,262,000 for the three months ended February 28, 2021.August 31, 2021, This represents an increase of approximately $4,031,000$375,000, or 111%30%. TheThis increase for the three months ended February 28,August 31, 2022, as compared to the three months ended February 28, 2021, was driven primarily due to the sale ofby demand for our COVID-19 product to distributorsclinical lab products in Asia and Europe.OTC products in the United States. Periodic and infrequent orders may cause volatility in quarterly sales.

               

Consolidated cost of sales waswere approximately $5,987,000$1,692,000, or 78% of net sales, for the three months ended February 28, 2022, as compared to $3,702,000 or 102%103% of net sales, for the three months ended February 28, 2021. This representsAugust 31, 2022, as compared to $1,351,000, or 107% of net sales, for the three months ended August 31, 2021, an increase of approximately $2,285,000$342,000, or 62%25%. The increase for the three months ended February 28,August 31, 2022, as compared to the three months ended February 28, 2021, was driven primarily due to the saleby an increase in volume of our COVID-19food intolerance product to distributors in Asia and Europe.

15


Table of Contentsproduct cost inflation.

 

Operating Expenses

 

The following is a summary of operating expenses:

 

 

Three Months Ended

February 28,

 

Three Months Ended August 31,

 

 2022

2021

Increase (Decrease)

2023

2022

 

Increase (Decrease)

 

Operating Expense

 

As a % of
Total Revenues

 

 

Operating Expense

As a % of
Total Revenues

$

%

Operating Expense

As a % of Total Revenues

Operating Expense

As a % of Total Revenues

$

%

Selling, General and
Administrative Expenses

$

1,324,000

 

17%

 

$

1,528,000

 

42%

 

$

 (204,000)

 

-13%

$

1,654,000

 

101%

 

$

1,070,000

 

85%

 

$

584,000

 

      55%

Research and Development

$

457,000

 

6%

 

$

564,000

 

16%

 

$

 (107,000)

 

-19%

$

361,000

 

22%

 

$

381,000

 

30%

 

$

(20,000)

 

-5%

 

Selling, General and Administrative Expenses

 

Consolidated selling, general and administrative expenses were approximately $1,324,000$1,654,000 for the three months ended February 28,August 31, 2022, as compared to $1,528,000$1,070,000 for the three months ended February 28, 2021. This represents a decreaseAugust 31, 2021, an increase of approximately $204,000$584,000, or 13%55%.The decreaseincrease in the three months ended February 28,August 31, 2022, was primarily due to a reduction ofapproximate increases in bad debt expense partially offset by increases inof $300,000, compensation of $73,000, and outside services expense.legal expense of $65,000.

 

Research and Development

 

Consolidated research and development expenses were approximately $457,000$361,000 for the three months ended February 28,August 31, 2022, as compared to $564,000$381,000 for the three months ended February 28, 2021.August 31, 2021, This represents a decrease of approximately $107,00020,000, or 19%5%. The decrease in the three months ended February 28,August 31, 2022, was primarily due to a result of decreasesreduction in costs related to the research, development, and validation of COVID-19 tests.research.

 

Interest and Dividend Income

 

Interest and dividend income were approximately $6,000$0 for the three months ended February 28,August 31, 2022, as compared to $38,000$7,000 for the three months ended February 28, 2021.August 31, 2021, This represents a decrease of $32,000$7,000, or 84%100%.

Nine months ended February 28, 2022

Net Sales and Cost of Sales

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

Nine Months Ended
February 28,

Increase (Decrease)

2022

 

2021

 

 

%

Physician's office

 

$

10,134,000

 

$

2,735,000

 

$

7,399,000

 

271%

Clinical lab

2,259,000

2,441,000

(182,000)

-7%

Over-the-counter

 

 

857,000

 

 

605,000

 

 

252,000

 

 

42%

Contract manufacturing

 

 

319,000

 

 

364,000

 

 

(45,000)

 

 

-12%

Total

$

13,569,000

$

6,145,000

$

7,424,000

121%

Consolidated net sales were approximately $13,569,000 for the nine months ended February 28, 2022, as compared to $6,145,000 for the nine months ended February 28, 2021. This represents an increase of approximately $7,424,000 or 121%. The increase for the nine months ended February 28, 2022, as compared to the nine months ended February 28, 2021,$7,000 decrease was primarily due to the sale oflower dividend payment from our COVID-19 product to distributors in Asia and Europe.investment.

Consolidated cost of sales was approximately $11,213,000 or 83% of net sales, for the nine months ended February 28, 2022, as compared to $5,792,000 or 94% of net sales, for the nine months ended February 28, 2021. This represents an increase of approximately $5,421,000 or 94%. The increase for the nine months ended February 28, 2022, as compared to the nine months ended February 28, 2021, was primarily due to the sale of our COVID-19 product to distributors in Asia and Europe.

16


Table of Contents

Operating Expenses

The following is a summary of operating expenses:

 

 

Nine Months Ended

February 28,

 

 

 

 2022

2021

Increase (Decrease)

 

 

Operating Expense

 

As a % of
Total Revenues

 

 

Operating Expense

As a % of
Total Revenues

$

%

Selling, General and
Administrative Expenses

$

3,618,000

 

27%

 

$

4,239,000

 

69%

 

$

 (621,000)

 

-15%

Research and Development

$

1,515,000

 

11%

 

$

1,892,000

 

31%

 

$

 (377,000)

 

-20%

Selling, General and Administrative Expenses

Consolidated selling, general and administrative expenses were approximately $3,618,000 for the nine months ended February 28, 2022, as compared to $4,239,000 for the nine months ended February 28, 2021. This represents a decrease of approximately $621,000 or 15%. The decrease in the nine months ended February 28, 2022, was primarily due to a reduction of bad debt expense, partially offset by increases in compensation and outside services expense.

Research and Development

Consolidated research and development expenses were approximately $1,515,000 for the nine months ended February 28, 2022, as compared to $1,892,000 for the nine months ended February 28, 2021. This represents a decrease of approximately $377,000 or 20%. The decrease in the nine months ended February 28, 2022, was primarily a result of decreases in costs related to the research, development, and validation of COVID-19 tests.

Interest and Dividend Income

Interest and dividend income were approximately $20,000 for the nine months ended February 28, 2022, as compared to $54,000 for the nine months ended February 28, 2021. This represents a decrease of $34,000 or 63%.

 

LIQUIDITY AND CAPITAL RESOURCES

 

The following are the principal sources of liquidity:

 

 

February 28,
2022

 

May 31,

2021

 

 

 

August 31, 2022

May 31, 2022

Cash and cash equivalents

 

$

10,174,000

 

 $

4,199,000

 

$

6,075,000

 

 $

5,917,000

Working capital including cash and cash equivalents

 

$

8,533,000

 

 $

7,931,000

 

$

7,410,000

 

 $

7,416,000

15


Table of Contents

 

As of February 28,August 31, 2022 and May 31, 2021, we2022, the Company had cash and cash equivalents of approximately$10,174,000 $6,075,000 and $4,199,000,5,917,000, respectively,respectively.  As of August 31, 2022 and May 31, 2022, the Company had working capital of approximately $8,533,000$7,410,000 and $7,931,000,$7,416,000, respectively. As a resultWe believe that the aggregate of our existing cash and cash equivalents on hand is sufficient to meet our operating cash requirements and strategic objectives for growth for at February 28, 2022, andleast the next year. To satisfy our abilitycapital requirements beyond the next year, including ongoing future operations, we may seek to raise additional fundsfinancing through debt and equity financings, including use of our ATM Agreement, management believes we have sufficient funds to operate through the next twelve months or more.offering.

 

Operating Activities

 

CashDuring the three months ended August 31, 2022, cash used in operating activities was approximately $1,573,000. The primary factors that contributed to this was a loss of approximately $2,072,000, non-cash expenses of $766,000, primarily associated with stock-based compensation, account receivables provision, and inventory reserves. This was partially offset by changes in asset and liability accounts of $(267,000).

During the three months ended August 31, 2021, cash provided by operating activities ofwas approximately $3,777,000 during the nine months ended February 28, 2022, reflects$76,000. The primary factors that contributed to this was a net loss of approximately $2,772,000 and$1,543,000, non-cash adjustmentsexpenses of $705,000 $502,000, primarily associated with depreciation, amortization, stock-based compensation, adjustments to allowance for doubtful accounts, and inventory reserves. In addition, we realized an increase in net working capital of approximately $5,844,000 primarily driven by an increase in advances from customers and accounts payable. For the nine months ended February 28, 2021, cash used by operating activities of approximately $4,244,000 reflects a net loss of $5,735,000 and non-cash adjustments of $3,307,000 primarily associated with depreciation, amortization, stock-based compensation and inventory reserves. The non-cash adjustments were partially offset byreserves. In addition, we benefited from a declinedecrease in net working capitalaccounts receivable of approximately $1,816,000 primarily driven by an increase$778,000, and changes in inventory.other asset and liability accounts of $339,000.

 

Investing Activities

 

CashDuring the three months ended August 31, 2022, cash used in investing activities was approximately $34,000 for purchases of property and equipment.

During the ninethree months ended February 28, 2022,August 31, 2021, cash used in investing activities was approximately $33,000$78,000 for purchases of property and equipment, and $113,000 for increased intangibles. Cash used in investing activities for the nine months ended February 28, 2021, was approximately $107,000 for purchases of property and equipment and $117,000 for increased intangibles.

17


Table of Contentsexpenditures related to patents.

 

Financing Activities

 

CashDuring the three months ended August 31, 2022, cash provided by financing activities for the nine months ended February 28, 2022,was approximately $2,356,000$1,778,000 which was a result of stock option exercises of $39,000 and net proceeds from the sale of common stock of $2,317,000. Cash$1,764,000, and stock option exercises of $14,000.

During the three months ended August 31, 2021, cash provided by financing activities for the nine months ended February 28, 2021, was approximately $1,108,000$805,000 which was a result of stock option exercises of $96,000 andnet proceeds from the sale of commentcommon stock of $1,011,000.$801,000, and stock option exercises of $4,000.

 

OFF BALANCE SHEET ARRANGEMENTS

 

There were no off-balance sheet arrangements as of February 28,August 31, 2022.

 

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 under the current conditions; however, actual results may differ from these estimates under different future conditions.

 

We believe that the estimates and assumptions that are most important to the portrayal of our financial condition and results of operations, in that they require subjective or complex judgments, form the basis for the accounting policies deemed to be most critical to us. These relate to revenue recognition, accounts receivablebad debts, inventory overhead application, inventory reserves, inventory valuation, lease liabilities and right-of-use assets, and stock- based compensation.assets. We believe estimates and assumptions related to these critical accounting policies are appropriate under the circumstances; however, should future events or occurrences result in unanticipated consequences, there could be a material impact on our future financial conditions or results of operations. We suggest that our significant accounting policies be read in conjunction with this Management’s Discussion and Analysis of Financial Condition and Results of Operations. SeePlease refer to Note 2 to these Financial Statements for information on Significant Accounting Policies. Our critical accounting policies are discussed in our Annual Report on Form 10-K for the fiscal year ended May 31, 2022.

16


Table of Contents

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to provide the information under this item.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Our management evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of the end of the period covered by this report. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. The disclosure controls and procedures have been designed to provide reasonable assurance of achieving their objectives and the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective at the "reasonable assurance" level. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures were effective to ensure that information required to be disclosed in the reports that we file and submit under the Exchange Act is (1) recorded, processed, summarized and reported within the time periods specified in the Commission's rules and forms; and (2) accumulated and communicated to the Company's management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

There have been no changes in our internal control over financial reporting identified in connection with the evaluation that occurred during our last fiscal quarter that has materially affected, or that is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II.  OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

The Company is, from time to time, involved in legal proceedings, claims and litigation arising in the ordinary course of business. 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 February 28,August 31, 2022.

18


Table of Contents

 

ITEM 1A.  RISKS AND UNCERTAINTIES.

 

An investment in our common stock involves risks. Before making an investment decision, you should carefully consider all the information within this Quarterly Report, including the information contained in Part I, Item 2, "Management's Discussion and Analysis of Financial Condition and Results of Operations," as well as in our condensed consolidated financial statements and the related notes contained in Part I, Item 1 within this Quarterly Report. In addition, you should carefully consider the risks and uncertainties described in Part I, Item 1A, “Risk Factors,” of our 20212022 Annual Report on Form 10-K/A,10-K, as well as in our other public filings with the SEC. If any of the identified risks are realized, our business, results of operations, financial condition, liquidity, and prospects could be materially and adversely affected. In that case, the trading price of our common stock may decline, and you could lose all or part of your investment. In addition, other risks of which we are currently unaware, or which we do not currently view as material, could have a material adverse effect on our business, results of operations, financial condition, and prospects.

 

During the ninethree months ended February 28,August 31, 2022, there were no material changes to the risks and uncertainties described in Part I, Item 1A, “Risk Factors,” of our 20212022 Annual Report on Form 10-K/A.10-K.

 

ITEM 5.  OTHER INFORMATION

 

See Note 8On October 11, 2022, the board of directors of the Company approved and adopted the Amended and Restated Bylaws of the Company, which became effective the same day, in order to, among other things (i) update the Financial Statementsname of the Company from “Nuclear Medical Systems, Inc.” to “Biomerica, Inc.”, (ii) change the annual meeting date from October 15 to any such date that the Board shall fix each year, (iii) change the voting standard for discussionall matters other than election of our prior period financial restatements.directors from a plurality vote to a majority vote, (iv) update the requirements for the list of stockholders, (v) revise the indemnification provisions, and (vi) add new forum selection provisions.

 

19The preceding summary of the Amended and Restated Bylaws is qualified in its entirety by reference to, and should be read in connection with, the complete copy of the Amended and Restated Bylaws filed herewith as Exhibit 3.1.

17


Table of Contents

 

ITEM 6.  EXHIBITS.

 

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

 

Exhibit No.

 

Description

 

 

 

 

 

 

3.1

*

Amended and Restated Bylaws of the Company

31.1

**

 

Certification Pursuant to Section 302 of the Sarbanes-Oxley Act — Zackary S. Irani

 

 

 

 

 

 

31.2

**

 

Certification Pursuant to Section 302 of the Sarbanes-Oxley Act — 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.INS-XBRL Instance Document

 

          101.SCH-XBRL Taxonomy Extension Schema Document

          101.CAL-XBRL Taxonomy Extension Calculation Linkbase Document

          101.DEF–XBRL Taxonomy Extension Definition Linkbase Document

          101.LAB-XBRL Taxonomy Extension Label Linkbase Document

          101.PRE-XBRL Taxonomy Extension Presentation Linkbase Document

          104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibits 101)

                  * Filed herein.

 

    *Filed** Filed herewith.

 

2018


Table of Contents

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:  April 14,October 13, 2022

 

 

                                        

By: 

/S/ Zackary S. Irani

 

 

Zackary S. Irani

                                           

Chief Executive Officer

                                           

(Principal Executive Officer)

 

 

 

Date:  April 14,October 13, 2022

 

 

 

By: 

/S/ Steve Sloan

 

 

Steve Sloan

 

 

Chief Financial Officer

 

 

(Principal Financial Officer)

 

2119

iso4217:USD xbrli:shares