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 June 30, 2021March 31, 2022

 

or

 

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

 

For the transition period from ________ to ________.

 

Commission File Number: 0-12305

 

REPRO MED SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

 

New York13-3044880
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
  
24 Carpenter Road, Chester, New York10918
(Address of principal executive offices)(Zip Code)

 

(845(845)) 469-2042

(Registrant’s telephone number, including area code)

 

N/A

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

 

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

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common stock, $0.01 par valueKRMDThe Nasdaq Stock Market

 

Indicate by check mark whether the registrant (1) has 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.  [X] Yes  [_] No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  [X] Yes  [_] No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the 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 Exchange Act).  [_] Yes  [X] No

 

As of August 11, 2021,May 4, 2022, 44,511,16244,868,605 shares of common stock, $0.01 par value per share, were outstanding, which excludes 3,420,502 shares of treasury stock.

 


 

REPRO MED SYSTEMS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2021MARCH 31, 2022

TABLE OF CONTENTS

 

  PAGE
   
PART I. FINANCIAL INFORMATION
   
ITEM 1.Financial Statements (Unaudited)3
   
 Balance Sheets (Unaudited) as of June 30, 2021 (Unaudited)March 31, 2022 and December 31, 202020213
   
 Statements of Operations (Unaudited) for the three and six months ended June 30,March 31, 2022 and 2021 and 20204
   
 Statements of Cash Flows (Unaudited) for the sixthree months ended June 30,March 31, 2022 and 2021 and 20205
   
 Statements of Stockholders’ Equity (Unaudited) for the three and six months ended June 30,March 31, 2022 and 2021 and 20206
   
 Notes to Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations16
   
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk2119
   
ITEM 4.Controls and Procedures2120
   
PART II. OTHER INFORMATION
   
ITEM 1.Legal Proceedings2120
   
ITEM 1A.Risk Factors2120
   
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2120
   
ITEM 6.Exhibits2221
   
 Signatures2322

 

- 2 -


 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements (Unaudited)

 

REPRO MED SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

 

  June 30, December 31, 
  2021 2020 
        
ASSETS       
        
CURRENT ASSETS       
Cash and cash equivalents $26,538,478 $27,315,286 
Accounts receivable less allowance for doubtful accounts of $24,469 for June 30, 2021, and December 31, 2020  2,577,400  2,572,954 
Inventory  7,562,750  6,829,772 
Prepaid expenses  461,553  807,780 
TOTAL CURRENT ASSETS  37,140,181  37,525,792 
Property and equipment, net  1,110,550  1,167,623 
Intangible assets, net of accumulated amortization of $232,820 and $199,899 at June 30, 2021 and December 31, 2020, respectively  834,644  843,587 
Operating lease right-of-use assets  166,483  236,846 
Deferred income tax assets, net  1,327,230  125,274 
Other assets  19,812  19,812 
TOTAL ASSETS $40,598,900 $39,918,934 
        
LIABILITIES AND STOCKHOLDERS’ EQUITY       
        
CURRENT LIABILITIES       
Accounts payable $1,005,653 $624,920 
Accrued expenses  1,771,666  2,610,413 
Accrued payroll and related taxes  390,326  287,130 
Finance lease liability – current  1,030  2,646 
Operating lease liability – current  142,450  141,293 
TOTAL CURRENT LIABILITIES  3,311,125  3,666,402 
Operating lease liability, net of current portion  24,033  95,553 
TOTAL LIABILITIES  3,335,158  3,761,955 
Commitments and contingencies (Refer to Note 3)       
STOCKHOLDERS’ EQUITY       
Common stock, $0.01 par value, 75,000,000 shares authorized, 47,910,676 and 46,680,119 shares issued 44,490,174 and 43,259,617 shares outstanding at June 30, 2021, and December 31, 2020, respectively  479,106  466,801 
Additional paid-in capital  39,376,131  35,880,986 
Treasury stock, 3,420,502 shares at June 30, 2021 and December 31, 2020, respectively, at cost  (3,843,562) (3,843,562)
Retained earnings  1,252,067  3,652,754 
TOTAL STOCKHOLDERS’ EQUITY  37,263,742  36,156,979 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $40,598,900 $39,918,934 

   March 31,  December 31, 
  2022 2021 
        
ASSETS       
        
CURRENT ASSETS       
Cash and cash equivalents $22,577,247 $25,334,889 
Accounts receivable less allowance for doubtful accounts of $24,271 for March 31, 2022 and December 31, 2021  3,145,397  3,592,886 
Inventory  6,017,737  6,106,338 
Other Receivables  680,075  718,220 
Prepaid expenses  1,510,851  1,568,821 
TOTAL CURRENT ASSETS  33,931,307  37,321,154 
Property and equipment, net  1,763,269  1,106,445 
Intangible assets, net of accumulated amortization of $278,897 and $263,729 at March 31, 2022 and December 31, 2021, respectively  795,339  808,813 
Operating lease right-of-use assets  4,309,282  95,553 
Deferred income tax assets, net  2,538,853  1,941,254 
Other assets  89,587  19,812 
TOTAL ASSETS $43,427,637 $41,293,031 
        
LIABILITIES AND STOCKHOLDERS’ EQUITY       
        
CURRENT LIABILITIES       
Accounts payable $1,267,980 $1,227,533 
Accrued expenses  2,171,724  2,709,704 
Note Payable  255,614  508,583 
Other Liabilities  115,625  90,000 
Accrued payroll and related taxes  506,315  160,603 
Operating lease liability - current  395,359  95,553 
TOTAL CURRENT LIABILITIES  4,712,617  4,791,976 
Operating lease liability, net of current portion  3,913,923   
TOTAL LIABILITIES  8,626,540  4,791,976 
Commitments and contingencies (Refer to Note 3)       
STOCKHOLDERS’ EQUITY       
Common stock, $0.01 par value, 75,000,000 shares authorized, 48,121,289 and 48,044,162 shares issued, 44,700,787 and 44,623,660 shares outstanding at March 31, 2022 and December 31, 2021, respectively  481,212  480,441 
Additional paid-in capital  41,611,030  40,774,245 
Treasury stock, 3,420,502 shares at March 31, 2022 and December 31, 2021, at cost  (3,843,562) (3,843,562)
Retained deficit  (3,447,583) (910,069)
TOTAL STOCKHOLDERS’ EQUITY  34,801,097  36,501,055 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $43,427,637 $41,293,031 

 

The accompanying notes are an integral part of these financial statements.

 

- 3 -


 

REPRO MED SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

            
  Three Months Ended Six Months Ended 
  June 30, June 30, 
  2021 2020 2021 2020 
              
NET SALES $5,528,174 $7,708,904 $10,959,125 $14,038,913 
Cost of goods sold  2,317,990  2,799,024  4,517,087  5,340,823 
Gross Profit  3,210,184  4,909,880  6,442,038  8,698,090 
              
OPERATING EXPENSES             
Selling, general and administrative  4,085,945  3,201,831  9,078,774  5,964,811 
Litigation    2,346,914    2,446,072 
Research and development  386,878  298,196  723,719  554,221 
Depreciation and amortization  118,415  94,940  233,888  182,164 
Total Operating Expenses  4,591,238  5,941,881  10,036,381  9,147,268 
              
Net Operating Loss  (1,381,054) (1,032,001) (3,594,343) (449,178)
              
Non-Operating Income/(Expense)             
Gain/(Loss) on currency exchange  1,239  (2,594) (14,478) (13,091)
(Loss)/Gain on disposal of fixed assets, net    (5,522) 736  (5,522)
Interest income, net  9,950  (5,002) 19,721  14,028 
TOTAL OTHER INCOME/(EXPENSE)  11,189  (13,118) 5,979  (4,585)
              
LOSS BEFORE INCOME TAXES  (1,369,865) (1,045,119) (3,588,364) (453,763)
              
Income Tax Benefit/(Expense)  245,316  (30,919) 1,187,677  (172,847)
              
NET LOSS $(1,124,549)$(1,076,038)$(2,400,687)$(626,610)
              
NET LOSS PER SHARE             
              
Basic $(0.03)$(0.03)$(0.05)$(0.02)
Diluted $(0.03)$(0.03)$(0.05)$(0.02)
              
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING             
              
Basic  44,489,853  40,361,924  44,226,936  40,018,559 
Diluted  44,489,853  40,361,924  44,226,936  40,018,559 

        
  Three Months Ended 
  March 31, 
  2022 2021 
        
NET SALES $6,244,330 $5,430,951 
Cost of goods sold  2,622,025  2,199,097 
Gross Profit  3,622,305  3,231,854 
        
OPERATING EXPENSES       
Selling, general and administrative  5,491,213  4,992,829 
Research and development  1,148,355  336,841 
Depreciation and amortization  109,252  115,473 
Total Operating Expenses  6,748,820  5,445,143 
        
Net Operating Loss  (3,126,515) (2,213,289)
        
Non-Operating Expense       
Loss on currency exchange  (7,135) (15,717)
Gain on disposal of fixed assets, net    736 
Interest (Expense)/Income, net  (1,463) 9,771 
TOTAL OTHER EXPENSE  (8,598) (5,210)
        
LOSS BEFORE INCOME TAXES  (3,135,113) (2,218,499)
        
Income Tax Benefit  597,599  942,361 
        
NET LOSS $(2,537,514)$(1,276,138)
        
NET LOSS PER SHARE       
        
Basic $(0.06)$(0.03)
Diluted $(0.06)$(0.03)
        
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING       
        
Basic  44,667,977  43,960,936 
Diluted  44,667,977  43,960,936 

 

The accompanying notes are an integral part of these financial statements.

 

- 4 -


 

REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

       
  For the
Six Months Ended
 
  June 30, 
  2021 2020 
        
CASH FLOWS FROM OPERATING ACTIVITIES       
Net Loss $(2,400,687)$(626,610)
Adjustments to reconcile net loss to net cash (used in)/provided by operating activities:       
Stock-based compensation expense  1,339,356  784,821 
Stock-based litigation settlement expense    1,285,102 
Depreciation and amortization  233,888  182,164 
Deferred income taxes  (1,201,956) (145,770)
(Gain)/Loss on disposal of fixed assets  (736) 5,522 
Changes in operating assets and liabilities:       
(Increase)/Decrease in accounts receivable  (4,446) 268,619 
Increase in inventory  (732,978) (1,278,811)
Decrease/(Increase) in prepaid expenses and other assets  346,227  (156,316)
Increase in accounts payable  380,733  347,350 
Increase in accrued payroll and related taxes  103,196  333,272 
(Decrease)/Increase in accrued expenses  (838,747) 1,389,588 
Increase in accrued tax liability    318,618 
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES  (2,776,150) 2,707,549 
        
CASH FLOWS FROM INVESTING ACTIVITIES       
Purchases of property and equipment  (152,223) (363,750)
Proceeds from disposal of property and equipment  9,065   
Purchases of intangible assets  (23,978) (149,523)
NET CASH USED IN INVESTING ACTIVITIES  (167,136) (513,273)
        
CASH FLOWS FROM FINANCING ACTIVITIES       
Borrowings from indebtedness    3,500,000 
Proceeds from issuance of equity  1,230,000  26,567,861 
Common stock issuance as settlement for litigation  938,094   
Payments on finance lease liability  (1,616) (3,717)
NET CASH PROVIDED BY FINANCING ACTIVITIES  2,166,478  30,064,144 
        
NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS  (776,808) 32,258,420 
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  27,315,286  5,870,929 
CASH AND CASH EQUIVALENTS, END OF PERIOD $26,538,478 $38,129,349 
        
Supplemental Information       
Cash paid during the periods for:       
Interest $47 $13,554 
Income Taxes $850 $ 
        
Schedule of Non-Cash Operating, Investing and Financing Activities:       
Issuance of common stock as compensation $153,446 $120,004 
Issuance of common stock as settlement for litigation $938,094 $938,094 

        
  For the
Three Months Ended
 
  March 31, 
  2022 2021 
        
CASH FLOWS FROM OPERATING ACTIVITIES       
Net Loss $(2,537,514)$(1,276,138)
Adjustments to reconcile net loss to net cash used in operating activities:       
Stock-based compensation expense  837,556  734,184 
Depreciation and amortization  109,252  115,473 
Deferred income taxes  (597,599) (943,211)
Gain on disposal of fixed assets    (736)
        
Changes in operating assets and liabilities:       
Decrease/(Increase) in accounts receivable  447,489  (988,387)
Decrease in other receivables  38,145   
Decrease/(Increase) in inventory  88,601  (1,229,052)
(Increase)/Decrease in prepaid expenses and other assets  (11,805) 117,455 
Increase in accounts payable  40,447  1,290,603 
Increase in accrued payroll and related taxes  345,712  428,769 
Decrease in accrued expenses  (537,981) (854,613)
Increase in other liabilities  25,625   
NET CASH USED IN OPERATING ACTIVITIES  (1,752,072) (2,605,653)
        
CASH FLOWS FROM INVESTING ACTIVITIES       
Purchases of property and equipment  (750,908) (95,477)
Proceeds from disposal of property and equipment    9,065 
Purchases of intangible assets  (1,694) (15,792)
NET CASH USED IN INVESTING ACTIVITIES  (752,602) (102,204)
        
CASH FLOWS FROM FINANCING ACTIVITIES       
      Payments on indebtedness  (252,968)   
Proceeds from issuance of equity    1,230,000 
Common stock issuance as settlement for litigation    938,094 
Payments on finance lease liability    (803)
NET CASH (USED IN)/PROVIDED BY FINANCING ACTIVITIES  (252,968) 2,167,291 
        
NET DECREASE IN CASH AND CASH EQUIVALENTS  (2,757,642) (540,566)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  25,334,889  27,315,286 
CASH AND CASH EQUIVALENTS, END OF PERIOD $22,577,247 $26,774,720 
        
Supplemental Information       
Cash paid during the periods for:       
Interest $4,425 $28 
Income Taxes $ $850 
        
Schedule of Non-Cash Operating, Investing and Financing Activities:       
Issuance of common stock as compensation $142,500 $56,250 
Issuance of common stock as settlement for litigation $ $938,094 

 

The accompanying notes are an integral part of these financial statements.

 

- 5 -


 

REPRO MED SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

               
    Additional     Total 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Earnings Stock Equity 
                   
Three and Six Months Ended
June 30, 2021
                  
                   
BALANCE, DECEMBER 31, 2020 46,680,119 $466,801 $35,880,986 $3,652,754 $(3,843,562)$36,156,979 
                   
Issuance of stock-based compensation 10,124  101  56,149      56,250 
Compensation expense related to stock options     677,934      677,934 
Litigation settlement share issuance 95,238  952  937,142      938,094 
Issuance upon options exercised 1,110,580  11,106  1,218,894      1,230,000 
Net income       (1,276,138)   (1,276,138)
BALANCE, MARCH 31, 2021 47,896,061 $478,960 $38,771,105 $2,376,616 $(3,843,562)$37,783,119 
                   
Issuance of stock-based compensation 14,615  146  97,050      97,196 
Compensation expense related to stock options     441,841      441,841 
Compensation expense related to restricted stock awards     66,135      66,135 
Issuance upon options exercised            
Net loss       (1,124,549)   (1,124,549)
BALANCE, JUNE 30, 2021 47,910,676 $479,106 $39,376,131 $1,252,067 $(3,843,562)$37,263,742 

 

              
    Additional     Total 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Earnings Stock Equity 
                   
Three and Six Months Ended
June 30, 2020
                  
                   
BALANCE, DECEMBER 31, 2019 42,239,788 $422,398 $6,293,069 $4,864,817 $(344,204)$11,236,080 
                   
Issuance of stock-based compensation 9,189  92  59,910      60,002 
Compensation expense related to stock options     300,966      300,966 
Issuance upon options exercised 175,000  1,750  83,750      85,500 
Net income       449,428    449,428 
BALANCE, MARCH 31, 2020 42,423,977 $424,240 $6,737,695 $5,314,245 $(344,204)$12,131,976 
                   
Issuance of stock-based compensation 7,999  80  59,922      60,002 
Compensation expense related to stock options     363,851      363,851 
Litigation settlement options     347,008      347,008 
Litigation settlement share issuance 95,238  952  937,142      938,094 
Issuance upon options exercised 519,156  5,192  5,189      10,381 
Capital raise 3,593,750  35,937  26,436,043      26,471,980 
Net loss       (1,076,038)   (1,076,038)
BALANCE, JUNE 30, 2020 46,640,120 $466,401 $34,886,850 $4,238,207 $(344,204)$39,247,254 

Three Months Ended March 31, 2022

                   
    Additional     Total 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Deficit Stock Equity 
                   
BALANCE, DECEMBER 31, 2021 48,044,162 $480,441 $40,774,245 $(910,069)$(3,843,562)$36,501,055 
Issuance of stock-based compensation 47,500  475  142,025      142,500 
Compensation expense related to stock options     524,670      524,670 
Compensation related to Restricted Stock     170,386      170,386 
Issuance upon options exercised 29,627  296  (296)      
Net loss       (2,537,514)   (2,537,514)
BALANCE, MARCH 31, 2022 48,121,289 $481,212 $41,611,030 $(3,447,583)$(3,843,562)$34,801,097 

Three Months Ended March 31, 2021

                   
    Additional     Total 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Earnings Stock Equity 
                   
BALANCE, DECEMBER 31, 2020 46,680,119 $466,801 $35,880,986 $3,652,754 $(3,843,562)$36,156,979 
Issuance of stock-based compensation 10,124  101  56,149      56,250 
Compensation expense related to stock options     677,934      677,934 
Litigation settlement share issuance 95,238  952  937,142      938,094 
Issuance upon options exercised 1,110,580  11,106  1,218,894      1,230,000 
Net loss       (1,276,138)   (1,276,138)
BALANCE, MARCH 31, 2021 47,896,061 $478,960 $38,771,105 $2,376,616 $(3,843,562)$37,783,119 

The accompanying notes are an integral part of these financial statements.

 

- 6 -


 

REPRO MED SYSTEMS, INC.

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS

 

NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

NATURE OF OPERATIONS

 

REPRO MED SYSTEMS, INC. d/b/a KORU Medical Systems (the “Company,” “KORU Medical,” “we,” “us” or “our”) designs, manufactures and markets proprietary portable and innovative medical devices primarily for the ambulatory infusion market as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality system management. The Company operates as one segment.

 

BASIS OF PRESENTATION

 

The accompanying financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 20202021 (“Annual Report”).  Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (“GAAP”) have been condensed or omitted from the accompanying financial statements.  The accompanying year-end balance sheet was derived from the audited financial statements included in the Annual Report.  The accompanying interim financial statements are unaudited and reflect all adjustments which are in the opinion of management necessary for a fair statement of the Company’s financial position, results of operations, and cash flows for the periods presented.  All such adjustments are of a normal, recurring nature.  The Company’s results of operations and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods.

 

CASH AND CASH EQUIVALENTS

 

For purposes of the statement of cash flows, the Company considers all short-term investments with an original maturity of three months or less to be cash equivalents.  The Company holds cash in excess of $250,000 at its depository, which exceeds the FDIC insurance limits and is, therefore, uninsured.

 

INVENTORY

 

Inventories of raw materials are stated at the lower of standard cost, which approximates average cost, or market value including allocable overhead.  Work-in-process and finished goods are stated at the lower of standard cost or market value and include direct labor and allocable overhead.

 

PATENTS

 

Costs incurred in obtaining patents have been capitalized and are being amortized over the legal life of the patents.

 

INCOME TAXES

 

Deferred income taxes are provided using the liability method whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences.

 

The Company believes that it has no uncertain tax positions requiring disclosure or adjustment.  Generally, tax years starting with 20182019 are subject to examination by income tax authorities.

 

PROPERTY, EQUIPMENT, AND DEPRECIATION

 

Property and equipment is stated at cost and is depreciated using the straight-line method over the estimated useful lives of the respective assets.

- 7 -


 

STOCK-BASED COMPENSATION

 

The Company maintains a stock option plan under which it grants stock options to certain executives, key employees and consultants. The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model.  All options are charged against income at their fair value.  The entire compensation expense of the award is recognized over the vesting period. Shares of stock granted for director fees are recorded at the fair value of the shares at the grant date.

 

- 7 -


The Company also maintains an omnibus equity incentive plan. There have been no awards made pursuant toTo date the Company has only granted shares of stock for director fees under this plan.plan and those shares of stock granted are recorded at the fair value of the shares at the grant date.

 

The Company issues restricted stock awards. Restricted stock awards are equity classified and measured at the fair market value of the underlying stock at the grant date. The fair value of restricted stock awards vesting at certain market capitalization thresholds were estimated on the date of grant using the Brownian Motion Monte Carlo lattice model. The fair value of restricted stock awards with time-based vesting were estimated on the date of grant at the current stock price. We recognize restricted stock expense using the straight-line attribution method over the requisite service period and account for forfeitures as they occur.

 

NET INCOMELOSS PER COMMON SHARE

 

Basic earnings per share are computed on the weighted average of common shares outstanding during each year.  Diluted earnings per share include only an increase in the weighted average shares by the common shares issuable upon exercise of employee and consultant stock options.  See “NOTE 4 — STOCK-BASED COMPENSATION” for further detail.

            
  Three Months Ended Six Months Ended 
  June 30, June 30, 
  2021 2020 2021 2020 
              
Net loss $(1,124,549)$(1,076,038)$(2,400,687)$(626,610)
              
Weighted Average Outstanding Shares:             
Outstanding shares  44,489,853  40,361,924  44,226,936  40,018,559 
Option shares includable  (a) (a) (a) (a)
   44,489,853  40,361,924  44,226,936  40,018,559 
              
Net loss per share             
Basic $(0.03)$(0.03)$(0.05)$(0.02)
Diluted $(0.03)$(0.03)$(0.05)$(0.02)

Schedule of net income per common share

       
  Three Months Ended 
  March 31, 
  2022 2021 
        
Net loss $(2,537,514)$(1,276,138)
        
Weighted Average Outstanding Shares:       
Outstanding shares  44,667,977  43,960,936 
Option shares includable  0(a) 0(a)
 Total  44,667,977  43,960,936 
        
Net loss per share       
Basic $(0.06)$(0.03)
Diluted $(0.06)$(0.03)

__________

(a)For the three months ended June 30,March 31, 2022 and March 31, 2021, and 2020, option shares of 224,336346,020 and 162,831183,681 respectively, were not included as the impact is anti-dilutive.  For the six months ended June 30, 2021, and 2020, option shares of 214,132 and 182,575 respectively, were not included as the impact is anti-dilutive.  For the three and six months ended June 30,March 31, 2022 and March 31, 2021, and 2020, restricted shares of 1,000,000 and zero respectively, were not included as the impact is anti-dilutive.

 

USE OF ESTIMATES IN THE FINANCIAL STATEMENTS

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.  Actual results could differ from those estimates. Important estimates include but are not limited to asset lives, valuation allowances, inventory valuation, and accruals.

 

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REVENUE RECOGNITION

 

The Financial Accounting Standards BoardOur revenues derive from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies.  Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“FASB”Product Revenue”) issued Accounting Standards Updatefor the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“ASU”NRE”) No. 2014-09, Revenuereceived from Contracts with Customers, which provides a single comprehensive modelbiopharmaceutical companies to ready or customize the FREEDOM System for entities to use in accounting for revenue arising from contracts with customers.  We adopted this ASU effective January 1, 2018, on a full retrospective basis.  Adoption of this standard did not result in significant changes to our accounting policies, business processes, systems or controls, or have a material impact on our financial position, results of operationsclinical and cash flows or related disclosures.  As such, prior period financial statements were not recast.commercial use.

 

The Company’s revenues result from the sale of assembled products.  WeFor Product Revenues, we recognize revenues when shipment occurs, and at which point the customer obtains control and ownership of the goods.  Shipping costs generally are billed to customers and are included in sales.

 

The Company generally does not accept return of goods shipped unless it is a Company error.  The only credits provided to customers are for defective merchandise.  The Company warrants the syringe driver from defects in materials and workmanship under normal use and the warranty does not include a performance obligation.  The costs under the warranty are expensed as incurred.

 

- 8 -


Provisions for distributor pricing and annual customer growth rebates are variable consideration and are recorded as a reduction of revenue in the same period the related sales are recorded or when it is probable the annual growth target will be achieved. Rebates are provided to distributors for the difference in selling price to distributor and pricing specified to select customers.

 

Our NRE revenue will be complimentary to our existing product line offering. This revenue stream can fluctuate and may not be consistent from period to period, as the main area of opportunity is in relation to clinical trial support. Engineering work performed on our product may be specialized and tailored to the specific needs of each independent clinical trial and not uniform in nature. The clinical trial size and scope of protocols may also range greatly from customer to customer, and there is no expectation of repeat customers on a consistent basis compared to our normal course of business. We recognize NRE revenue under an input method, which recognizes revenue on the basis of our efforts or inputs to the satisfaction of a performance obligation (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation. The input method that we use is based on costs incurred.

The following table summarizes net sales by geography for the three and six months ended June 30, 2021,March 31, 2022, and 2020:2021:

 

  Three Months Ended June 30, Six Months Ended June 30, 
  2021 2020 2021 2020 
Sales             
Domestic $4,645,770 $6,745,810 $9,092,559 $12,086,676 
International  882,404  963,094  1,866,566  1,952,237 
Total $5,528,174 $7,708,904 $10,959,125 $14,038,913 

Schedule of net sales by geography

  Three Months Ended March 31, % of Total Net Sales 
  2022 2021 2022 2021 
Net Sales            
Domestic $5,301,388 $4,446,789  84.9% 81.9% 
International  942,942  984,162  15.1% 18.1% 
Total Net Sales $6,244,330 $5,430,951      

 

LEASES

 

In February 2016, the FASB issued a standard related to leases to increase transparency and comparability among organizations by requiring the recognition of right-of-use (“ROU”) assets and lease liabilities on the balance sheet.  Most prominent among the changes in the standard is the recognition of ROU assets and lease liabilities by the Company for those leases classified as operating leases under current GAAP, while our accounting for capital leases remains substantially unchanged.  Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty of cash flows arising from leases.  The standard became effective for us on January 1, 2019.  The standard had a material impact on our balance sheets but did not have a material impact on our statements of operations.  See “NOTE 6 LEASES” for further detail.

 

ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED

 

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740):  Simplifying the Accounting for Income Taxes. The amendments in this ASU simplify the accounting for income taxes by removing several exceptions including the exception to the general methodology for calculating income taxes in an interim period when a year-to-date loss exceeds the anticipated loss for the year.  The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance.  The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020.  The Company adopted this standard on January 1, 2021, and it had no impact on our financial statement disclosures.

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ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities.  For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses.  The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected.  For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down.  This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income.  The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash.  The amendments in this update are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years.  The Company is assessing the impact of the adoption of the ASU on its financial statements, disclosure requirements and methods of adoption.

 

In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provided elective amendments for entities that have contracts, hedging relationships and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform.  The amendments may be applied to impacted contracts and hedges prospectively through December 31, 2022.  The Company is currently evaluating the impact this guidance will have on its financial statements.

 

The Company considers the applicability and impact of all recently issued accounting pronouncements.  Recent accounting pronouncements not specifically identified in our disclosures are either not applicable to the Company or are not expected to have a material effect on our financial condition or results of operations.

 

- 9 -


FAIR VALUE MEASUREMENTS

 

Fair value is the exit price that would be received to sell an asset or paid to transfer a liability.  Fair value is a market-based measurement that should be determined using assumptions that market participants would use in pricing an asset or liability. Valuation techniques used to measure fair value should maximize the use of observable inputs and minimize the use of unobservable inputs.  To measure fair value, the Company uses the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable:

 

Level 1 – Quoted prices in active markets for identical assets or liabilities.
  
Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means.
  
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.  Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and includes instruments for which the determination of fair value requires significant judgment or estimation.

 

The carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses are considered to be representative of their fair values because of the short-term nature of those instruments.  There were no transfers between levels in the fair value hierarchy during the sixthree months ended June 30, 2021.March 31, 2022.

 

IMPAIRMENT OF LONG-LIVED ASSETS

 

The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable.  An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount.  The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value.  No impairment losses have been recorded through June 30, 2021.March 31, 2022.

 

RECLASSIFICATION

 

Certain reclassifications have been made to conform prior period data to the current presentation.  These reclassifications had no effect on reported net income.

- 10 -


 

NOTE 2 —PROPERTY AND EQUIPMENT

 

Property and equipment consists of the following at:

 

 June 30, 2021 December 31, 2020  March 31, 2022 December 31, 2021 
             
Furniture and office equipment $787,694 $753,536  $826,503 $818,897 
Construction in progress 638,489  
Leasehold improvements 556,907 542,796  556,907 556,907 
Manufacturing equipment and tooling  1,922,196  1,856,909   2,134,764  2,042,675 
Total property and equipment 3,266,797 3,153,241  4,156,663 3,418,479 
Less: accumulated depreciation and amortization  (2,156,247) (1,985,618)  (2,393,394) (2,312,034)
Property and equipment, net $1,110,550 $1,167,623  $1,763,269 $1,106,445 

 

Depreciation expense was $100,56494,085 and $79,245100,403 for the three months ended June 30,March 31, 2022, and 2021, and 2020, respectively, and $200,967 and $152,013 for the six months ended June 30, 2021 and 2020, respectively.

 

NOTE 3 — COMMITMENTS AND CONTINGENCIES

 

LEGAL PROCEEDINGS

 

The Company has been and may again become involved in legal proceedings, claims and litigation arising in the ordinary course of business.  KORU Medical is not presently a party to any litigation or other legal proceeding that is believed to be material to its financial condition.

 

- 10 -


On July 12, 2021, the lead plaintiff filed a notice of voluntary dismissal without prejudice of the claims in the previously disclosed putative class action lawsuit filed in the United States District Court for the Southern District of New York against the Company and its Chief Financial Officer and former Chief Executive Officer, alleging they made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations and prospects, in the Company’s earnings communications and Form 10-Q filed during the period August 4, 2020 and January 25, 2021.

OTHER

On November 11, 2020, the Company entered into a Manufacturing and Supply Agreement with Command Medical Products, Inc. (“Command”), pursuant to which Command has agreed to manufacture and supply the Company’s subassemblies, needle sets and tubing products pursuant to the Company’s specifications and purchase orders.  The first binding purchase order pursuant to the Manufacturing and Supply Agreement was made on November 17, 2020 (the “Effective Date”).

The Manufacturing and Supply Agreement provides for a term of five years from the Effective Date.  Either party may terminate the Manufacturing and Supply Agreement upon a material breach by the other Party that has not been cured within 90 days, upon the bankruptcy or insolvency of the other Party or as expressly set forth elsewhere in the Agreement.  If the Company terminates the Manufacturing and Supply Agreement other than for those reasons within the first three years from the Effective Date, the Company is obligated to pay an early termination fee to Command.

The Manufacturing and Supply Agreement also includes customary provisions relating to, among other things, delivery, inspection procedures, warranties, quality management, business continuity plans, handling and transport, intellectual property, confidentiality and indemnification.

NOTE 4 — STOCK-BASED COMPENSATION

 

On June 29, 2016,The Company has two equity incentive plans: the Board of Directors amended the Company’s 2015 Stock Option Plan, (asas amended (the “2015 Plan”) and the “Plan”2021 Omnibus Equity Incentive Plan (the “2021 Plan”) authorizing. As of March 31, 2022, there were options to purchase 3,638,750 shares of the Company to grant awardsCompany’s common stock outstanding to certain executives, key employees and consultants under the 2015 Plan, of which was approved by shareholders at135,000 were issued during the Annual Meeting of Shareholders held on September 6, 2016.  The total number of shares of Common Stock, with respect to which awardsthree months ended March 31, 2022. Additional options may be granted pursuant to the Plan, may not exceed 6,000,000 pursuant to an amendment to the Plan approved by shareholders at their annual meeting on April 23, 2019.

On February 15, 2021,issued under the 2015 Plan the Company issuedas outstanding options are forfeited, subject to James M. Beck, its Interim Chief Executive Officer, a non-qualified option to purchase up tomaximum 150,0006,000,000 shares of the Company’s common stock at an exercise price of $4.37 per share, of which 100,000 vested on February 15, 2021 and 50,000 vested on March 22, 2021.

On March 15, 2021,available for issuance under the 2015 Plan. The 2021 Plan provides for the Company issued to Linda Tharby, its incoming President and Chief Executive Officer, a non-qualified stock option to purchasegrant of up to 1,000,000 incentive stock options, nonqualified stock options, stock awards, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, consultants and directors. For the quarter ended March 31, 2022, there had been issued 47,500shares of the Company’s common stock at an exercise priceas directors fees under the 2021 Plan.

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor were eligible to receive of $3.87575,000 per share, subject annually, to vesting as follows: 25% on March 15, 2022be paid quarterly $12,500 in cash and 25%$6,250 in common stock.  The Chairman of the Board is eligible to receive $100,000 annually, to be paid quarterly $12,500 in cash and $12,500 in common stock.   Effective May 18, 2021, each twelve months thereafter.non-employee director of the Company (other than the Chairman of the Board) and Board advisor are eligible to receive of $110,000 annually, to be paid quarterly $12,500 in cash and $15,000 in common stock.  The Chairman of the Board is eligible to receive $140,000 annually, to be paid quarterly $12,500 in cash and $22,500 in common stock. All payments were and are pro-rated for partial service.

 

On April 12, 2021, pursuant to an employment agreement entered into on March 15, 2021, with Linda Tharby, the Company’s President and Chief Executive Officer, the Company issued three restricted stock awards for an aggregate 1,000,000 shares of common stock for an aggregate stock price of $3,310,000 and each vesting subject to employment on the respective vesting date.

As of June 30, 2021, the Company had options to purchase 3,072,494 shares of Common Stock outstanding to certain executives, key employees and consultants under the Plan, of which 1,150,000 These awards were issued during the six months ended June 30, 2021.

Prior to January 1, 2021, each non-employee director of the Company was eligible to receive $50,000 annually (effective January 1, 2019), plus $10,000as an inducement for chairing a Board committee (effective February 20, 2019), all to be paid quarterly half in cash and half in common stock.  The Chairman of the Board was eligible to receive an additional $50,000 annually (effective October 1, 2019), all to be paid in common stock.

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor are eligible to receive of $75,000 annually, to be paid quarterly $12,500 in cash and $6,250 in common stock.  The Chairman of the Board is eligible to receive $100,000 annually, to be paid quarterly $12,500 in cash and $12,500 in common stock.   Effective May 18, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor are eligible to receive of $110,000 annually, to be paid quarterly $12,500 in cash and $15,000 in common stock.  The Chairman of the Board is eligible to receive $140,000 annually, to be paid quarterly $12,500 in cash and $22,500 in common stock. All payments were and are pro-rated for partial service.

- 11 -


On May 20, 2020, the Company entered into a Settlement Agreement with EMED Technologies Corporation (“EMED”) to settle all claims in connection with all pending litigation matters between them.  Pursuant to the Settlement Agreement, the Company issued to EMED (i) 95,238 restricted stock units, which vested on May 21, 2020, and 95,238 restricted stock units, which vested on January 1, 2021, and (ii) an option to purchase up to 400,000 shares of the Company’s common stock at an exercise price of $11.21 per share prior to February 1, 2021, which was not exercised.

On February 16, 2021, Donald Pettigrew, the Company’s former Chief Executive Officer, exercised options held by him for an aggregate 1,000,000 shares of common stock for an aggregate exercise price of $1,230,000.

On March 18, 2021, our shareholders approved the Company’s 2021 Omnibus Equity Incentive Plan (the “2021 Equity Plan”). There have been no awards made pursuant to the 2021 Equity Plan to date.her employment.

 

2015 STOCK OPTION PLAN, as amended

 

Time Based Stock Options

 

The per share weighted average fair value of stock options granted during the sixthree months ended June 30,March 31, 2022 and March 31, 2021 and June 30, 2020 was $3.062.45 and $6.683.06, respectively.  The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the sixthree months ended June 30, 2021March 31, 2022 and June 30, 2020.March 31, 2021. Historical information was the primary basis for the selection of the expected volatility, expected dividend yield and the expected lives of the options.  The risk-free interest rate was selected based upon yields of the U.S. Treasury issues with a term equal to the expected life of the option being valued. We have recognized tax benefits associated with stock-based compensation of $9,81749,406 and $31,19643,067 for the sixthree months ended June 30,March 31, 2022 and 2021, and 2020, respectively.

 

  June 30, 
  2021 2020 
        
Dividend yield  0.00%  0.00% 
Expected Volatility  74.01%-74.28%  62.1% 
Weighted-average volatility  0  0 
Expected dividends  0  0 
Expected term (in years)  10  10 
Risk-free rate  1.20%-1.62%  0.63% 

- 11 -


Schedule of time based stock option

  March 31, 
  2022 2021 
        
Dividend yield  0.00%  0.00% 
Expected Volatility  76.177.5%  74.0174.28% 
Weighted-average volatility  0  0 
Expected dividends  0  0 
Expected term (in years)  10  10 
Risk-free rate  1.811.87%  1.201.62% 

 

The following table summarizes the status of the 2015 Plan with respect to time based stock options:

 

  Six Months Ended June 30, 
  2021 2020 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 2,922,494 $2.46  3,647,000 $1.32 
Granted 1,250,000 $3.94  60,000 $9.76 
Exercised 1,000,000 $1.23  722,000 $0.58 
Forfeited 100,000 $3.94  200,000 $2.09 
Outstanding at June 30 3,072,494 $3.41  2,785,000 $1.64 
Options exercisable at June 30 871,244 $2.18  812,760 $1.37 
Weighted average fair value of options granted during the period  $3.06   $6.68 
Stock-based compensation expense  $1,528,522   $290,991 

Schedule of stock option plan

  Three Months Ended March 31, 
  2022 2021 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 3,672,500 $3.42 2,922,494 $2.46 
Granted 135,000 $3.07 1,250,000 $3.94 
Exercised 75,000 $1.60 1,000,000 $1.23 
Forfeited 93,750 $1.57 0 $0 
Outstanding at March 31 3,638,750 $3.49 3,172,494 $3.43 
Options exercisable at March 31 1,358,750 $2.83 803,119 $2.09 
Weighted average fair value of options granted during the period  $2.45  $3.06 
Stock-based compensation expense  $524,670  $1,086,681 

 

Total stock-based compensation expense was $1,528,522$524,670 and $290,991$1,086,681 for the sixthree months ended June 30,March 31, 2022, and 2021, and 2020, respectively. Cash received from option exercises for the sixthree months ended June 30,March 31, 2022, and 2021 and 2020 was $1,230,0000 and $95,8801,230,000, respectively.

 

The weighted-average grant-date fair value of options granted during the sixthree months ended June 30,March 31, 2022, and 2021 and 2020 was $3.80.3 million million and $0.43.8 million million,, respectively.  There were 1.0 million75,000 options exercised during the sixthree months ended June 30, 2021,March 31, 2022, and 722,0001.0 million during the sixthree months ended June 30, 2020.March 31, 2021.

- 12 -


 

The following table presents information pertaining to options outstanding at June 30, 2021:March 31, 2022:

 

Range of Exercise Price Number
Outstanding
 Weighted
Average
Remaining
Contractual
Life
 Weighted
Average
Exercise
Price
 Number
Exercisable
 Weighted
Average
Exercise
Price
 
              
$0.50-$9.76 3,072,494 7.7 years $3.41 871,244 $2.18 

Schedule of information pertaining to options outstanding

Range of Exercise Price Number
Outstanding
 Weighted
Average
Remaining
Contractual
Life
 Weighted
Average
Exercise
Price
 Number
Exercisable
 Weighted
Average
Exercise
Price
 
              
$1.57-$9.76 3,638,750 8.5 years $3.49 1,358,750 $2.83 

 

As of June 30, 2021,March 31, 2022, there was $5.45,861,444 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2015 Plan.  That cost is expected to be recognized over a weighted-average period of 46 months.  The total fair value of shares vested as of June 30,March 31, 2022, and March 31, 2021, and June 30, 2020, was $1,378,2202,815,943 and $1,110,0681,230,434, respectively.

 

Performance Based Stock Options

 

There were no stock options granted during the sixthree months ended June 30, 2021,March 31, 2022, and 2020.2021.

- 12 -


 

The following table summarizes the status of the 2015 Plan with respect to performance-based stock options:

 

  Six Months Ended June 30, 
  2021 2020 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 1,000,000 $1.70 1,000,000 $1.70 
Granted 0 $0 0 $0 
Exercised 0 $0 0 $0 
Forfeited 1,000,000 $1.70 0 $0 
Outstanding at June 30 0 $ 1,000,000 $1.70 
Options exercisable at June 30 0 $0 0 $ 
Weighted average fair value of options granted during the period  $  $ 
Stock-based compensation expense  $(408,747) $373,826 

Schedule of performance base options outstanding

  Three Months Ended March 31, 
  2022 2021 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1  $ 1,000,000 $1.70 
Granted 0 $0 0 $ 
Exercised 0 $0 0 $ 
Forfeited  $ 1,000,000 $1.70 
Outstanding at March 31 0 $0  $ 
Options exercisable at March 31 0 $0 0 $0 
Weighted average fair value of options granted during the period 0 $0  $ 
Stock-based compensation expense  $  $(408,747)

 

Total performance stock-based compensation expense totaled ($408,747)zero and $373,826($408,747) for the sixthree months ended June 30,March 31, 2022, and 2021, and 2020, respectively. All performance-based stock options were forfeited as of June 30, 2021, and there was0 no unrecognized compensation cost remaining.

 

Restricted Stock AwardsRESTRICTED STOCK AWARDS

 

On April 12, 2021, pursuant to an employment agreement entered into on March 15, 2021, with Linda Tharby, the Company’s President and Chief Executive Officer and as an inducement to her employment, the Company issued three restricted stock awards for an aggregate 1,000,000 shares of common stock for an aggregate stock price of $3,310,000 and each vesting subject to employment on the respective vesting date. The following table summarizes the activities for our unvested restricted stock awards for the sixthree months ended June 30, 2021,March 31, 2022, and 2020.2021.

 

  Six Months Ended June 30, 
  2021 2020 
  Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
 
          
Unvested at January 1 0 $0 0 $0 
Granted 1,000,000 $3.01 0 $0 
Vested 0 $0 0 $0 
Forfeited/canceled 0 $0 0 $0 
Unvested at June 30 1,000,000 $3.01 0 $ 

Schedule of activities for our unvested restricted stock awards

- 13 -


  Three Months Ended March 31, 
  2022 2021 
  Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
 
          
Unvested at January 1 1,000,000 $3.01 0 $0 
Granted 0 $0 0 $0 
Vested 0 $0 0 $0 
Forfeited/canceled 0 $0 0 $0 
Unvested at March 31 1,000,000 $3.01 0 $0 

 

As of June 30, 2021,March 31, 2022, there was $2,458,4512,129,339 of unrecognized compensation cost related to unvested employee restricted shares. This amount is expected to be recognized over a weighted-average period of 2139 months. We have recognized tax benefits associated with restricted stock award compensation of $13,88835,781 and0zero for the sixthree months ended June 30,March 31, 2022 and 2021 and 2020, respectively.

Schedule of restricted stock units

Range of Exercise Price Number
Outstanding
 Weighted
Average
Remaining
Contractual
Life
 Weighted
Average
Exercise
Price
 Number
Exercisable
 Weighted
Average
Exercise
Price
 
              
$3.31 1,000,000 3.20 years $3.01  $3.01 

- 13 -


 

NOTE 5 — DEBT OBLIGATIONS

On July 26, 2021, the Company entered into a commercial insurance premium finance and security agreement with AON Premium Finance, LLC in the aggregate principal amount of $0.9 million bearing an annual percentage rate of 4.17%, to finance its insurance premiums. Monthly payments are due on the first of each month beginning August 1, 2021 through June 1, 2022.

 

On April 14, 2020, the Company issued a promissory note to KeyBank in the aggregate principal amount of $3.5 million (the “Note”) as an extension of its line of credit, replacing its then current line of credit agreement.  The $3.5 million Note is in the form of a variable rate non-disclosable revolving line of credit with an interest rate of Prime Rate announced by the Bank minus 0.75%.  The Note was renewed on June 24, 2021, in the same form with an interest rate of Prime Rate announced by the Bank minus 1.50%. Interest is due monthly, and all principal and unpaid interest is due on June 1, 2022.  The $3.5 million Note may be prepaid at any time prior to maturity with no prepayment penalties.penalties.  The $3.5 million Note contains events of default and other provisions customary for a loan of this type.

 

In connection with the Note, the Company entered into a Commercial Security Agreement with the Bank dated April 14, 2020 (the “Security Agreement”), pursuant to which the Company granted a security interest in substantially all assets of the Company to secure the obligations of the Company under the Note.  The Security Agreement contains terms and conditions typical for the granting of security interests of this kind.

 

The Company had no amount outstanding against the line of credit as of June 30, 2021.March 31, 2022.

 

On April 27, 2020, the Company entered into a Progress Payment Loan and Security Agreement (“PPLSA”) and a Master Security Agreement (the “MSA”), each dated as of April 20, 2020, with Key Equipment Finance, a division of the Bank (“KEF”), to provide up to $2.5 million in financing for equipment purchases from third party vendors.  The PPLSA allows the Company to make draws with KEF to make certain payments to the equipment suppliers prior to the commencement of periodic payments under a term loan. Each draw under the PPLSA will bear interest at a variable rate equal to the then-current Prime Rate and will be secured by the financed equipment under the MSA.  At the end of each calendar quarter or year, the advances made under the PPLSA will be converted to term loans, subject to KEF’s approval of the equipment and certain other closing conditions being met.  Once the draws under the PPLSA are converted into a term loan, each promissory note will bear interest at afixed rate of 4.07% per annum, subject to adjustment based on KEF’s cost of funds, with principal and interest payable in 84 equal consecutive monthly installments.installments.  Each fixed rate installment promissory note may be prepaid, subject to a penalty if prepaid before the fifth anniversary of its issuance.  As of June 30, 2021,March 31, 2022, the Company had no amount outstanding against the PPLSA.

 

NOTE 6 —LEASES

 

We have finance and operating leases for our new corporate office location and certain office and computer equipment.  Ourour existing corporate offices.  These two leases have remaining lease terms of one year, some of which include options to extend the leases monthly10.5 years and annually and some with options to terminate the leases within 19 year.months, respectively.

 

The components of lease expense were as follows:

            
  Three Months Ended Six Months Ended 
  June 30, June 30, 
  2021 2020 2021 2020 
              
Operating lease cost $37,369 $37,921 $75,290 $75,843 
Short-term lease cost  33,548  8,231  68,437  13,688 
Total lease cost $70,917 $46,152 $143,727 $89,531 
              
Finance lease cost:             
Amortization of right-of-use assets $794 $1,855 $1,589 $3,711 
Interest on lease liabilities  19  65  47  152 
Total finance lease cost $813 $1,920 $1,636 $3,863 

Schedule of components of lease expense

        
  Three Months Ended 
  March 31, 
  2022 2021 
        
Operating lease cost $78,442 $37,921 
Short-term lease cost  49,709  34,889 
Total lease cost $128,151 $72,810 
        
Finance lease cost:       
Amortization of right-of-use assets $ $795 
Interest on lease liabilities    28 
Total finance lease cost $ $823 

 

- 14 -


 

Supplemental cash flow information related to leases was as follows:

       
  Six Months Ended 
  June 30, 
  2021 2020 
Cash paid for amounts included in the measurement of lease liabilities:       
Operating cash flows from operating leases $70,363 $67,633 
Financing cash flows from finance leases  1,616  3,717 

Schedule of cash flow information related to leases

        
  Three Months Ended 
  March 31, 
  2022 2021 
Cash paid for amounts included in the measurement of lease liabilities:       
Operating cash flows from operating leases $63,193 $35,248 
Financing cash flows from finance leases    803 

 

Supplemental balance sheet information related to leases was as follows:

 Schdeule of balance sheet information related to leases

 June 30,
2021
 December 31,
2020
  March 31,
2022
 December 31,
2021
 
            
Operating Leases  
Operating lease right-of-use assets $166,483 $236,846  $4,309,282 $95,553 
  
Operating lease current liabilities 142,450 141,293  395,359 95,553 
Operating lease long term liabilities  24,033  95,553   3,913,923   
Total operating lease liabilities $166,483 $236,846  $4,309,282 $95,553 
  
Finance Leases  
Property and equipment, at cost $12,725 $12,725  $ $12,725 
Accumulated depreciation  (11,729) (10,139)    (12,725)
Property and equipment, net $996 $2,586  $ $ 
  
Finance lease current liabilities 1,030 2,646    
Finance lease long term liabilities          
Total finance lease liabilities $1,030 $2,646  $ $ 

 

  June 30,
2021
 December 31,
2020
 
      
Weighted Average Remaining Lease Term     
Operating leases 0.9 Years 1.4 Years 
Finance leases 0.4 Years 0.7 Years 
      
Weighted Average Discount Rate     
Operating leases 4.75% 4.75% 
Finance leases 4.75% 4.75% 

  March 31,
2022
 December 31,
2021
 
      
Weighted Average Remaining Lease Term     
Operating leases 10.4 Years 0.6 Years 
Finance leases 0 Years 0 Years 
      
Weighted Average Discount Rate     
Operating leases 4.05% 4.75% 
Finance leases 0 4.75% 

 

Maturities of lease liabilities are as follows:

 

Year Ending December 31, Operating Leases Finance Leases 
2021 (excluding the six months ended June 30, 2021)  74,185  1,042 
2022  97,257  0 
2023  0  0 
2024  0  0 
2025  0  0 
Thereafter  0  0 
Total undiscounted lease payments  171,442  1,042 
Less: imputed interest  (4,959) (12)
Total lease liabilities $166,483 $1,030 

Schedule of maturities of lease liabilities

Year Ending December 31, Operating Leases Finance Leases 
2022 (excluding the three months ended March 31, 2022) $435,067 $0 
2023  499,503  0 
2024  499,503  0 
2025  499,503  0 
2026  499,503  0 
Thereafter  2,830,518  0 
Total undiscounted lease payments  5,263,597  0 
Less: imputed interest  (954,315) 0 
Total lease liabilities $4,309,282 $ 

 

- 15 -


 

NOTE 7 — EQUITY

On June 18, 2020, the Company entered into a Purchase Agreement with Piper Sandler & Co. and Canaccord Genuity LLC, as representatives of the several underwriters named therein (the “Underwriters”), pursuant to which the Company agreed to issue and sell 3,125,000 shares of its common stock.  Under the terms of the Purchase Agreement, the Company granted to the Underwriters an option, exercisable for a period of 30 days, to purchase up to an additional 468,750 shares of the Company’s common stock, which the Underwriters exercised in full on June 19, 2020.  The Underwriters purchased the shares pursuant to the Purchase Agreement, including the shares subject to the option, at a price of $7.52 per share.  Proceeds to the Company, net of discounts, commissions, fees and expenses, were $26.6 million.

On November 16, 2020, the Company announced that its Board of Directors had authorized a stock repurchase program under which the Company may purchase up to $10.0 million of its outstanding common stock through December 31, 2021.  As of June 30, 2021, the Company had purchased 683,271 shares for an aggregate $3,499,358 pursuant to this program.

NOTE 8 — SUBSEQUENT EVENTS

On July 12, 2021, the lead plaintiff filed a notice of voluntary dismissal without prejudice of the claims in the previously disclosed putative class action lawsuit filed in the United States District Court for the Southern District of New York against the Company and its Chief Financial Officer and former Chief Executive Officer, alleging they made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations and prospects, in the Company’s earnings communications and Form 10-Q filed during the period August 4, 2020 and January 25, 2021.

PART I — ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Quarterly Report on Form 10-Q contains certain “forward-looking” statements (as such term is defined in the Private Securities Litigation Reform Act of 1995) and information relating to us that are based on the beliefs of the management, as well as assumptions made and information currently available.

 

Our actual results may vary materially from the forward-looking statements made in this report due to important factors such as uncertainties associated with COVID-19, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, our ability to convert inventory to a source of cash, future operating results, growth of new patient starts, Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of FREEDOM60® demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, and the impact of recent accounting pronouncements. When used in this report, the words “estimate,” “project,” “believe,” “may,” “will,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements. Such statements reflect current views with respect to future events based on currently available information and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The Company does not undertake any obligation to release publicly any revision to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

Throughout this report, the “Company,” “KORU Medical,” “we,” “us” or “our” refers to Repro Med Systems, Inc.

 

OVERVIEW

 

The Company designs, manufactures and markets proprietary portable and innovative medical devices primarily for the ambulatory infusion market as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality system management.

 

KORU Medical continues to monitor its operations and government recommendations as they relate to the COVID-19 pandemic. We cannot predict the effects the pandemic may have on our business, in particular with respect to demand for our products, our strategy, and our prospects, the effects on our customers, or the impact on our financial results.  For example, our future net sales growth may continue to be impacted due to fewer new prescriptions for individuals with Primary Immune Deficiency Disease (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) as a result of patients not seeking care during the pandemic. We believe that the pandemic has precipitated limited availability and rising costs of raw materials and labor, which may impact our financial results if current trends continue.

 

- 16 -


Our revenues derive from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies.  Our core domestic and international revenues consist of sales of our products for the delivery of SCIg to treat PIDD, CIDP, and other disease statessubcutaneous drugs that are FDA cleared for use with the KORU syringe driver.Medical infusion system, with the primary delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of product revenues from clinical trials, which consist of sales of syringeour infusion system (syringe drivers, tubing and needles,needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services.services revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use.

 

TotalThe Company began its implementation of secondary sourcing of our needle and tubing sets to Command at the beginning of 2021 and is expected to complete the implementation by the second half of 2022. The Company has entered into a lease commencing March 1, 2022 for a new manufacturing facility and corporate headquarters, into which the Company expects to move in June 2022.

The Company ended the quarter with $6.2 million in net revenues, or a 15.0% increase, compared with $5.4 million in the same period last year driven by growth in domestic core, both pumps and consumables, and novel therapies.

Our gross margin, which is our gross profit stated as a percentage of net sales, were $5.5 million, or 28% lower for the three months ended June 30, 2021, as compared to the prior year period, where we saw stocking orders of approximately $1.1 million that we believe were due to the uncertainty of the pandemic, as well as higher novel therapies sales of $1.2 million from non-recurring clinical trials. Sequential quarter net sales from the three months ended March 31, 2021, grew 2%2022, was 58.0%, a decline from prior year period of 59.5%. The majority of the decline was driven by domesticmore lower margin NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer in the 2022 period and year over year higher manufacturing costs in our core growth of 4%. Both the overall domestic marketbusiness due to increasing raw material and our end-user sales to the specialty pharmacy channel grew mid-single digits through the second quarter of 2021, we believe indicating market recovery in new patient starts for SCIg therapy.labor costs, partially offset by increased price and mix.

 

Our inventory position increased $0.7- 16 -


Operating expenses for the three months ended March 31, 2022, were $6.7 million, up from December 31, 2020, as we transition manufacturing$5.4 million for the same period last year, driven primarily by research and development efforts to support our secondary source.core and novel therapies business, and by new hires to support commercialization and business development, and quality and regulatory consulting, partially offset by reorganization costs of $1.0 million last year.

 

RESULTS OF OPERATIONS

 

Three months ended June 30, 2021,March 31, 2022, compared to June 30, 2020March 31, 2021

 

Net Sales

 

The following table summarizes our net sales for the three months ended June 30, 2021,March 31, 2022, and 2020:2021:

 

 Three Months Ended June 30, Change from Prior Year % of Net Sales  Three Months Ended March 31, Change from Prior Year % of Total Net Sales 
 2021 2020 $ % 2021 2020  2022 2021 $ % 2022 2021 
Net Sales                                
Domestic Core $4,597,797 $5,557,577 $(959,780)(17.3%)83.2% 72.1%  $4,993,536 $4,412,417 $581,119 13.2% 80.0% 81.2% 
Novel Therapies  47,973  1,188,233  (1,140,260)(96.0%)0.9% 15.4% 
Total Domestic 4,645,770 6,745,810 (2,100,040)(31.1%)84.1% 87.5% 
 
International Core 859,694 853,043 6,651 0.8% 15.5% 11.1%  894,942 978,906 (83,964)(8.6%)14.3% 18.0% 
Novel Therapies  22,710  110,051  (87,341)(79.4%)0.4% 1.4%   355,852  39,628  316,224 798.0% 5.7% 0.8% 
Total International  882,404  963,094  (80,690)(8.4%)15.9% 12.5% 
Total $5,528,174 $7,708,904 $(2,180,730)(28.3%)  $6,244,330 $5,430,951 $813,379 15.0% 

 

Total net sales decreased $2.2were $6.2 million or 28.3%, for the three months ended June 30, 2021, as compared withMarch 31, 2022, a 15.0% increase from $5.4 million in the same period lastof 2021, with strong year over year growth driven primarily by lowerdomestic core, up 13.2%, due to growth in pumps and consumables driven by an overall increase in the subcutaneous immunoglobulin market, as well as our key growth initiatives including prefills and label expansions. Total novel therapies sales were $0.4 million for the three months ended March 31, 2022, a $0.3 million increase from the same period of $1.2 million compared with last2021 primarily due to recognition of initial NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer. International core was down 8.6% year over year, due to quarterly buying pattern changes of a non-recurring clinical trial last year, and lower domestic core sales to our largest distributor, where we believe pandemic related stocking occurred last year. International core net sales were $0.9 million, up 1% compared with the same period last year.few smaller customers.

 

Gross Profit

 

Our gross profit for the three months ended June 30,March 31, 2022, and 2021 and 2020 is as follows:

 

 Three Months Ended June 30, Change from Prior Year  Three Months Ended March 31, Change from Prior Year 
 2021 2020 $  %  2022 2021 $  % 
Gross Profit $3,210,184 $4,909,880 $(1,699,696) (34.6%) $3,622,305 $3,231,854 $390,451  12.1% 
Stated as a Percentage of Net Sales 58.1% 63.7%    58.0% 59.5%   

 

Gross profit decreased $1.7increased by $0.4 million or 34.6%12.1% in the three months ended June 30, 2021, comparedfirst quarter of 2022, while gross margin decreased by 1.5 margin points to the same period in 2020.  This decrease in the quarter was mostly58.0% primarily driven by the decreaseincreased lower margin NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer and year over year higher manufacturing costs in net sales of $2.2 million as described above.  Gross margin was negatively impactedour core business due to increasing raw material and labor costs, partially offset by lower volumes, resulting in unfavorable absorption in the quarter.

- 17 -


increased price and mix.

 

Selling, general and administrative, Litigation and Research and development

 

Our selling, general and administrative, litigation and research and development costs for the three months ended June 30,March 31, 2022, and 2021 and 2020 are as follows:

 

 Three Months Ended June 30, Change from Prior Year  Three Months Ended March 31, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Selling, general and administrative $4,085,945 $3,201,831 $884,114 27.6%  $5,491,213 $4,992,829 $498,384 10.0% 
Litigation  2,346,914 (2,346,914)(100.0%)
Research and development  386,878  298,196  88,682 29.7%   1,148,355  336,841  811,514 240.9% 
 $4,472,823 $5,846,941 $(1,374,118)(23.5%) $6,639,568 $5,329,670 $1,309,898 24.6% 
Stated as a Percentage of Net Sales 80.9% 75.9%  106.3% 98.1% 

 

Selling, general and administrative expenses increased $0.9$0.5 million, or 27.6%10.0%, during the three months ended June 30, 2021March 31, 2022, compared to the same period last year, mostly due to $0.5 million in market research, testing and consulting fees all to support commercialization, regulatory and strategic initiatives, $0.2driven by $1.5 million in costs associated with new hires in the departure and replacementsecond half of the former chief executive officer, as well as higher board of director fees and directors and officers liability insurance of $0.2 million.

Litigation fees were zero for the three months ended June 30, 2021 compared to the same period last year as a result of the settlement reached with our competitor last year.

Research and development expenses increased $0.1 million during the three months ended June 30, 2021 compared with the same period last year mostly due to higher consulting fees to support productcommercialization and business development, for novel therapies.

Depreciation and amortization

Depreciationquality and amortization expense increased by 24.7 % to $118,415 in the three months ended June 30, 2021 compared with $94,940 in the three months ended June 30, 2020.  We continue to invest in capital assets, mostly related to manufacturing and computer equipment.

Net Income

  Three Months Ended June 30, Change from Prior Year 
  2021 2020 $ % 
Net Loss $(1,124,549$(1,076,038$(48,511)(4.5%)
Stated as a Percentage of Net Sales  (20.3% (14.0%)     

Our net loss increased $48,511 in the three months ended June 30, 2021 compared with the same period last year mostly driven by lower gross profit and higher selling, general and administrative expenses,regulatory consulting, partially offset by lower litigation costs all as described above.

Six months ended June 30, 2021 compared to June 30, 2020

Net Sales

The following table summarizes our net sales for the six months ended June 30, 2021 and 2020:

  Six Months Ended June 30, Change from Prior Year % of Net Sales 
  2021 2020 $ % 2021 2020 
Net Sales                
Domestic Core $9,010,214 $10,430,343 $(1,420,129)(13.6%)82.2% 74.3% 
Novel Therapies  82,345  1,656,333  (1,573,988)(95.0%)0.8% 11.8% 
Total Domestic  9,092,559  12,086,676  (2,994,117)(24.8%)83.0% 86.1% 
                 
International Core  1,838,600  1,837,910  690 0.0% 16.8% 13.1% 
Novel Therapies  27,966  114,327  (86,361(75.5%)0.2% 0.8% 
Total International  1,866,566  1,952,237  (85,671)(4.4%)17.0% 13.9% 
Total $10,959,125 $14,038,913 $(3,079,788)(21.9%)    

- 18 -


Total net sales decreased $3.1 million or 21.9% for the six months ended June 30, 2021, as compared to the prior year period, driven primarily by lower novel therapies sales of $1.7 million compared with last year due to a non-recurring clinical trial last year and lower domestic core net sales driven by what we believe to be pandemic related stocking last year at our largest distributor. International core net sales were $1.8 million tracking even with the same period last year.

Gross Profit

Our gross profit for the six months ended June 30, 2021 and 2020 is as follows:

  Six Months Ended June 30, Change from Prior Year 
  2021 2020 $ % 
Gross Profit $6,442,038 $8,698,090 $(2,256,052)(25.9%)
Stated as a Percentage of Net Sales  58.8%  62.0%      

Gross profit decreased $2.3 million or 25.9% in the six months ended June 30, 2021, compared to the same period last year. Gross margin decreased primarily due to under absorption due to lower volume.

Selling, general and administrative, Litigation and Research and development

Our selling, general and administrative expenses, litigation and research and development costs for the six months ended June 30, 2021 and 2020 are as follows:

  Six Months Ended June 30, Change from Prior Year 
  2021 2020 $ % 
Selling, general and administrative $9,078,774 $5,964,811 $3,113,963 52.2% 
Litigation    2,446,072  (2,446,072)(100.0%)
Research and development  723,719  554,221  169,498 30.6% 
  $9,802,493 $8,965,104 $837,389 9.3% 
Stated as a Percentage of Net Sales  89.4%  63.9%      

Selling, general and administrative expenses increased $3.1 million, or 52.2%, during the six months ended June 30, 2021 compared to the same period last year, mostly due to $1.6 million in costs associated with the departure and replacement of the former chief executive officer and the recruitment of two new Board members which includes non-cash equity expense of $0.4 million.  Further contributing to the increase was the rollout impact of higher salary and related benefits of $0.9$1.0 million from new hires in the second half of last year to support commercialization, business development and medical affairs for our novel therapies initiatives, as well as infrastructure. Market research, testing and consulting fees to support commercialization and regulatory filings also contributed $0.6 million, as well as higher director fees and director and officer liability insurance of $0.4 million. Offsetting these expenses were lower professional fees, the Covid-related heroes bonus paid last year and other miscellaneous expenses in aggregate $0.4 million. Litigation expense was lower by $2.4 million as a result of the settlement agreement entered into last year.

- 17 -


 

Research and development expenses increased $0.2$0.8 million, or 240.9%, during the sixthree months ended June 30, 2021March 31, 2022, compared with the same period last year mostly due to increaseshigher salary and related expenses to build our internal capability and consulting fees to support product development for novel therapies.development.

 

Depreciation and amortization

 

Depreciation and amortization expense increaseddecreased by 28.4%5.4% to $233,888$109,252 in the sixthree months ended June 30, 2021March 31, 2022, compared with $182,164$115,473 in the sixthree months ended June 30, 2020.March 31, 2021.  We continue to invest in capital assets, mostly related to manufacturing and computer equipment.equipment, offset by assets reaching their remaining useful life.

 

Net (Loss)/IncomeLoss

 

  Six Months Ended June 30, Change from Prior Year 
  2021 2020 $ % 
Net Loss $(2,400,687)$(626,610)$(1,774,077)(283.1%)
Stated as a Percentage of Net Sales  (21.9%) (4.5%)     

- 19 -


  Three Months Ended March 31, Change from Prior Year 
  2022 2021 $ % 
Net Loss $(2,537,514)$(1,276,138)$(1,261,376)(98.8%)
Stated as a Percentage of Net Sales  (40.6%) (23.5%)     

 

Our net loss forwas $2.5 million in the sixthree months ended June 30, 2021 was $2.4 millionMarch 31, 2022, compared towith net loss of $0.6$1.3 million for the six months ended June 30, 2020,in same period last year mostly driven by lower gross profit and higher selling, general and administrative expenses and higher research and development expenses, partially offset by litigation expenses incurred last year,higher gross profit, all as described above. OffsettingA tax benefit of $0.6 million resulting from the loss was a tax benefit of $0.5 million resulting from book to tax differences related to stock option expense.also recorded during the three months ended March 31, 2022.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Our principal source of liquidity is our cash on hand of $26.5$22.6 million as of June 30, 2021.March 31, 2022.  Our principal source of operating cash inflows is from sales of our products to customers. Our principal cash outflows relate to the purchase and production of inventory and related costs, research and development expenses and selling, general and administrative expenses.

To develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in manufacturing technologies, facilities and equipment, and research and development. We estimate expenses to be between $27.0 million and $28.0 million in 2022. We expect our 2022 capital investments for manufacturing and leasehold improvements for our new facility to be in aggregate between $1.5 million and $2.0 million, net of pre-approved financing arrangements totaling approximately $1.0 million, which are expected to be executed in the second quarter of 2022.

Our inventory position was $6.0 million at March 31, 2022. We expect these levels to rise in the short term as we build to ensure timely order fulfillment as we complete the transition of the manufacturing of our needle sets and tubing products to our secondary source and for supply continuity as we move our manufacturing facility to our new location in 2022. As the relocation and transition to our secondary source are completed, which we expect by the end of 2022, this inventory is expected to convert to a source of cash.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law. The CARES Act contains a provision known as the Employee Retention Credit (“ERC”), a refundable payroll tax credit for qualified wages paid to retained full-time employees between March 13, 2020, and December 31, 2020. The Consolidations Appropriations Act (CAA), signed into law on December 27, 2020, significantly modified and expanded the provisions of the ERC to include wages paid in 2021. For 2021, the ERC provides employers a refundable federal tax credit equal to 70% of the first $10,000 of qualified wages and benefits paid to retained employees between January 1, 2021, and December 31, 2021. Credits may be claimed immediately by reducing payroll taxes sent to the Internal Revenue Service. To the extent that the credit exceeds employment withholdings, the employer may request a refund of prior taxes paid. The Company determined that it qualified for this credit and anticipated utilizing benefits under this act to aid its liquidity position and as a result recorded a receivable of $0.7 million as of December 31, 2021. As of March 31, 2022, the credit has not been received.

We expect that our cash on hand, cash flows from operations, and our available credit facility will be sufficient to meet our requirements at least through the next 12 months. Continued execution on our longer-term strategic plan may require the Company to take on additional debt or raise capital through issuance of equity, or a combination of both in the periods post 12/31/2023. Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including the potential impact of global supply imbalances and COVID-19 on the global financial markets. To the extent that current and anticipated future sources of liquidity are insufficient to fund our future business activities and requirements, we may be required to seek additional equity or debt financing sooner. There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund planned expansion.

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Cash Flows

 

The following table summarizes our cash flows:

 

  Six Months Ended
June 30, 2021
 Six Months Ended
June 30, 2020
 
Net cash (used in)/provided by operating activities $(2,776,150)$2,707,549 
Net cash used in investing activities $(167,136)$(513,273)
Net cash provided by financing activities $2,166,478 $30,064,144 
  Three Months Ended
March 31, 2022
 Three Months Ended
March 31, 2021
 
Net cash used in operating activities $(1,752,072)$(2,605,653)
Net cash used in investing activities $(752,602)$(102,204)
Net cash (used in)/provided by financing activities $(252,968)$2,167,291 

 

Operating Activities

 

Net cash used in operating activities of $2.8$1.8 million for the sixthree months ended June 30,March 31, 2022, was primarily due to the net loss of $2.5 million and the deferred tax asset of $0.6 million, offset by favorable net working capital of $0.4 million driven by accounts receivable collections and non-cash charges for stock-based compensation of $0.8 million, and depreciation and amortization of $0.1 million.

Net cash used in operating activities of $2.6 million for the three months ended March 31, 2021 was primarily due to the net loss of $2.4$1.3 million, working capital changes which includedinclude an increase in inventory of $0.7$1.2 million related to the transition of manufacturing to our secondary source, andan increase in accounts receivable of $1.0 million due to delayed payments at our largest distributor, as well as a decrease in accrued expenses of $0.8$0.9 million most of which was non-cash activity related to the issuance of common stock in settlement of litigation, offset by an increase in accounts payable of $0.4 million and a decrease in prepaids of $0.3 million related to insurance payments.litigation.  Further contributing were deferred tax assets of $1.2$0.9 million increased for book to tax differences related to stock option expense.  Offsetting these were primarily non-cash charges for stock-based compensation of $1.3 million, and depreciation and amortization of $0.2 million.

Net cash provided by operating activities of $2.7 million for the six months ended June 30, 2020, was mostly attributable to non-cash charges for stock-based compensation and litigation settlement expense of $2.1$0.7 million, an increase in accounts payable accrued expensesof $1.3 million due to timing of payments and an increase in accrued payroll of $2.1$0.4 million driven by the litigation settlement with EMED, the capital raise and customer rebates. Further addingrelated to the cash provided by operating activities was an increase in tax liability of $0.3 million, resulting from book tax differences related to option expense.  Collection against accounts receivable also contributed $0.3 million.  Offsetting these were an increase in inventory of $1.3 million as we built inventory to keep paceseparation agreement with sales growth and to insure timely order fulfillment.our former chief executive officer.

 

Investing Activities

 

Net cash used in investing activities of $0.2$0.8 million for the sixthree months ending June 30, 2021,ended March 31, 2022, was for capital improvement expenditures for our new location and manufacturing and office equipment.

 

Net cash used in investing activities of $0.5$0.1 million for the sixthree months ending June 30, 2020,ended March 31, 2021 was for capital expenditures for researchmanufacturing and development and strategic initiatives as well as for patent and trademark applications.office equipment.

 

Financing Activities

The $0.3 million used by financing activities for the three months ended March 31, 2022, was for financed director and officer liability insurance.

 

The $2.2 million provided by financing activities for the sixthree months ended June 30,March 31, 2021 is from options exercised and the non-cash activity related to the issuance of common stock in settlement of litigation.

The $30.1 million provided by financing activities for the six months ended June 30, 2020, is from the $26.5 million capital raise, net of expenses, a $3.5 million draw on the line of credit and $0.1 million from options exercised.

 

ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED

 

Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the accompanying financial statements, which is incorporated herein by reference.

 

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ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

 

Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the accompanying financial statements, which is incorporated herein by reference.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

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ITEM 4.  CONTROLS AND PROCEDURES

 

The Company’s management, including the Company’s Principal Executive Officer and Principal Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures as such is defined in Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Based upon their evaluations, the Principal Executive Officer and Principal Financial Officer concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective for the purpose of ensuring that the information required to be disclosed in the reports that the Company files or submits under the Exchange Act with the Securities and Exchange Commission (the “SEC”) (1) is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (2) is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.

 

There have been no changes in the Company’s internal control over financial reporting during the three months ended June 30, 2021,March 31, 2022, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

PART II – OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

The Company has been and may again become involved in legal proceedings, claims and litigation arising in the ordinary course of business.  KORU Medical is not presently a party to any litigation or other legal proceeding that is believed to be material to its financial condition.

On July 12, 2021, the lead plaintiff filed a notice of voluntary dismissal without prejudice of the claims in the previously disclosed putative class action lawsuit filed in the United States District Court for the Southern District of New York against the Company and its Chief Financial Officer and former Chief Executive Officer, alleging they made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations and prospects, in the Company’s earnings communications and Form 10-Q filed during the period August 4, 2020 and January 25, 2021.

 

ITEM 1A.  RISK FACTORS

 

Our operations and financial results are subject to various risks and uncertainties, including those described in “PART 1, ITEM 1A. RISK FACTORS” in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, which could adversely affect our business, financial condition, results of operations, cash flows, and the trading price of our common stock.  There have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2020.2021.

 

ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

The CompanyOn March 4, 2022, we issued an aggregate 14,61520,107 shares of our common stock to its non-employee directors during the three months ended June 30,our Chief Executive Officer as a portion of her 2021 annual bonus in accordance with its non-employee director compensation program.

Allthe terms of the securities issued by the Company as described in this Itemher employment agreement. These shares were issued in reliance on the exemption from registration under Section 4(2) under the Securities Act of 1933, as amended.

 

Issuer Purchases of Equity Securities

On November 16, 2020, the Company announced that its Board of Directors had authorized a stock repurchase program under which the Company may choose to purchase up to $10.0 million of its outstanding common stock through December 31, 2021.  As of December 31, 2020, the Company had purchased 683,271 shares for an aggregate $3,499,358 pursuant to this program. No purchases have been made since that time, as we continue to evaluate our cash needs in connection with strategic planning under the leadership of our new Chief Executive Officer.

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PART II – ITEM 6.  EXHIBITS.

 

10.1Exhibit No.Summary of Non-Employee Director Compensation (effective May 18, 2021)
10.2Repro Med Systems, Inc. 2021 Omnibus Equity Incentive Plan
10.3Form of non-qualified/incentive stock option award agreement pursuant to the 2021 Omnibus Equity Inventive Plan
10.4Form of Indemnification Agreement between Repro Med Systems, Inc. and each of its directors and executive officersDescription
  
31.1Certification of Principal Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002
  
31.2Certification of Principal Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002
  
32.1Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002
  
32.2Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002
  
101.INSInline XBRL Instance Document - the XBRL Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
  
101.SCHInline XBRL Taxonomy Extension Schema Document
  
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document
  
101.DEFInline XBRL Taxonomy Definition Linkbase Document
  
101.LABInline XBRL Taxonomy Extension Label Linkbase Document
  
101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document
  
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 REPRO MED SYSTEMS, INC.
  
August 11, 2021May 4, 2022/s/ Linda Tharby
 Linda Tharby, President and Chief Executive Officer
(Principal Executive Officer)
  
August 11, 2021May 4, 2022/s/ Karen Fisher
 Karen Fisher, Chief Financial Officer and Treasurer
(Principal Financial Officer)

 

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