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, 20212022

 

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 MEDKORU MEDICAL 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 Road100 Corporate Drive, ChesterMahwah, New YorkJersey1091807430
(Address of principal executive offices)(Zip Code)

 

(845(845)) 469-2042

(Registrant’s telephone number, including area code)

 

N/ARepro Med Systems, Inc., 24 Carpenter Drive, ChesterNY, 10918

((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, 2021,3, 2022, 44,511,16245,033,053 shares of common stock, $0.01 par value per share, were outstanding, which excludes 3,420,502 shares of treasury stock.


 

REPRO MEDKORU MEDICAL SYSTEMS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 20212022

TABLE OF CONTENTS

 

  PAGE
   
PART I. FINANCIAL INFORMATION
   
ITEM 1.Financial Statements (Unaudited)3
   
 Balance Sheets as of June 30, 20212022 (Unaudited) and December 31, 202020213
   
 Statements of Operations (Unaudited) for the three and six months ended June 30, 20212022 and 202020214
   
 Statements of Cash Flows (Unaudited) for the six months ended June 30, 20212022 and 202020215
   
 Statements of Stockholders’ Equity (Unaudited) for the three and six months ended June 30, 20212022 and 202020216
   
 Notes to Financial Statements7
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1617
   
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk2122
   
ITEM 4.Controls and Procedures2122
   
PART II. OTHER INFORMATION
   
ITEM 1.1A.Legal ProceedingsRisk Factors2122
   
ITEM 1A.5.Risk FactorsOther Information21
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2123
   
ITEM 6.Exhibits2224
   
 Signatures2325

 

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Table of Contents

 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements (Unaudited)

 

REPRO MEDKORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

 

 June 30, December 31,  June 30, December 31, 
 2021 2020  2022 2021 
             
ASSETS          
          
CURRENT ASSETS          
Cash and cash equivalents $26,538,478 $27,315,286  $18,265,552 $25,334,889 
Accounts receivable less allowance for doubtful accounts of $24,469 for June 30, 2021, and December 31, 2020 2,577,400 2,572,954 
Accounts receivable less allowance for doubtful accounts of $24,471 for June 30, 2022, and December 31, 2021 4,084,762 3,592,886 
Inventory 7,562,750 6,829,772  6,771,514 6,106,338 
Other Receivables 680,796 718,220 
Prepaid expenses  461,553  807,780   1,165,668  1,568,821 
TOTAL CURRENT ASSETS 37,140,181 37,525,792  30,968,292 37,321,154 
Property and equipment, net 1,110,550 1,167,623  2,823,090 1,106,445 
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 
Intangible assets, net of accumulated amortization of $294,301 and $263,729 at June 30, 2022 and December 31, 2021, respectively 791,781 808,813 
Operating lease right-of-use assets 166,483 236,846  4,190,931 95,553 
Finance lease right -of-use, net accumulated depreciation of $5,918 at June 30, 2022 349,153  
Deferred income tax assets, net 1,327,230 125,274  3,249,323 1,941,254 
Other assets  19,812  19,812   88,772  19,812 
TOTAL ASSETS $40,598,900 $39,918,934  $42,461,342 $41,293,031 
          
LIABILITIES AND STOCKHOLDERS’ EQUITY          
          
CURRENT LIABILITIES          
Accounts payable $1,005,653 $624,920  $2,389,862 $1,227,533 
Accrued expenses 1,771,666 2,610,413  1,974,196 2,709,704 
Note Payable  508,583 
Other Liabilities 240,501 90,000 
Accrued payroll and related taxes 390,326 287,130  696,042 160,603 
Finance lease liability – current 1,030 2,646 
Financing lease liability – current 66,503  
Operating lease liability – current  142,450  141,293   363,030  95,553 
TOTAL CURRENT LIABILITIES 3,311,125 3,666,402  5,730,134 4,791,976 
Financing lease liability, net of current portion 281,958  
Operating lease liability, net of current portion  24,033  95,553   3,827,900   
TOTAL LIABILITIES  3,335,158  3,761,955   9,839,992  4,791,976 
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 
Common stock, $0.01 par value, 75,000,000 shares authorized, 48,407,619 and 48,044,162 shares issued 44,987,117 and 44,623,660 shares outstanding at June 30, 2022, and December 31, 2021, respectively 484,076 480,441 
Additional paid-in capital 39,376,131 35,880,986  42,349,760 40,774,245 
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 
Treasury stock, 3,420,502 shares at June 30, 2022 and December 31, 2021, respectively, at cost (3,843,562) (3,843,562)
Retained deficit  (6,368,924) (910,069)
TOTAL STOCKHOLDERS’ EQUITY  37,263,742 36,156,979   32,621,350 36,501,055 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $40,598,900 $39,918,934  $42,461,342 $41,293,031 

 

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

 

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REPRO MED

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

                      
 Three Months Ended Six Months Ended  Three Months Ended Six Months Ended 
 June 30, June 30,  June 30, June 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
                         
NET SALES $5,528,174 $7,708,904 $10,959,125 $14,038,913  $6,546,628 $5,528,174 $12,790,958 $10,959,125 
Cost of goods sold  2,317,990  2,799,024  4,517,087  5,340,823   3,200,455  2,317,990  5,822,480  4,517,087 
Gross Profit 3,210,184 4,909,880 6,442,038 8,698,090  3,346,173 3,210,184 6,968,478 6,442,038 
                  
OPERATING EXPENSES                  
Selling, general and administrative 4,085,945 3,201,831 9,078,774 5,964,811  5,530,022 4,085,945 11,021,235 9,078,774 
Litigation  2,346,914  2,446,072 
Research and development 386,878 298,196 723,719 554,221  1,303,731 386,878 2,452,086 723,719 
Depreciation and amortization  118,415  94,940  233,888  182,164   125,882  118,415  235,134  233,888 
Total Operating Expenses  4,591,238  5,941,881  10,036,381  9,147,268   6,959,635  4,591,238  13,708,455  10,036,381 
                  
Net Operating Loss (1,381,054) (1,032,001) (3,594,343) (449,178) (3,613,462) (1,381,054) (6,739,977) (3,594,343)
                  
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)
(Loss)/Gain on currency exchange (21,705) 1,239 (28,840) (14,478)
Gain on disposal of fixed assets, net    736 
Interest income, net  9,950  (5,002) 19,721  14,028   3,566  9,950  2,103  19,721 
TOTAL OTHER INCOME/(EXPENSE)  11,189  (13,118) 5,979  (4,585)  (18,139) 11,189  (26,737) 5,979 
                  
LOSS BEFORE INCOME TAXES (1,369,865) (1,045,119) (3,588,364) (453,763) (3,631,601) (1,369,865) (6,766,714) (3,588,364)
                  
Income Tax Benefit/(Expense)  245,316  (30,919) 1,187,677  (172,847)
Income Tax Benefit  710,260  245,316  1,307,859  1,187,677 
                  
NET LOSS $(1,124,549)$(1,076,038)$(2,400,687)$(626,610) $(2,921,341)$(1,124,549)$(5,458,855)$(2,400,687)
                  
NET LOSS PER SHARE                  
                  
Basic $(0.03)$(0.03)$(0.05)$(0.02) $(0.07)$(0.03)$(0.12)$(0.05)
Diluted $(0.03)$(0.03)$(0.05)$(0.02) $(0.07)$(0.03)$(0.12)$(0.05)
                  
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING                  
                  
Basic  44,489,853  40,361,924  44,226,936  40,018,559   44,921,870  44,489,853  44,795,625  44,226,936 
Diluted  44,489,853  40,361,924  44,226,936  40,018,559   44,921,870  44,489,853  44,795,625  44,226,936 

 

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

 

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REPRO MED

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

            
 For the
Six Months Ended
  For the
Six Months Ended
 
 June 30,  June 30, 
 2021 2020  2022 2021 
              
CASH FLOWS FROM OPERATING ACTIVITIES          
Net Loss $(2,400,687)$(626,610) $(5,458,855)$(2,400,687)
Adjustments to reconcile net loss to net cash (used in)/provided by operating activities:     
Adjustments to reconcile net loss to net cash used in operating activities:     
Stock-based compensation expense 1,339,356 784,821  1,579,151 1,339,356 
Stock-based litigation settlement expense  1,285,102 
Depreciation and amortization 233,888 182,164  235,134 233,888 
Deferred income taxes (1,201,956) (145,770) (1,308,069) (1,201,956)
(Gain)/Loss on disposal of fixed assets (736) 5,522 
Gain on disposal of fixed assets  (736)
Changes in operating assets and liabilities:          
(Increase)/Decrease in accounts receivable (4,446) 268,619 
Increase in accounts receivable (454,452) (4,446)
Increase in inventory (732,978) (1,278,811) (665,176) (732,978)
Decrease/(Increase) in prepaid expenses and other assets 346,227 (156,316)
Decrease in prepaid expenses and other assets 334,193 346,227 
Increase in other Liabilities 150,501  
Increase in accounts payable 380,733 347,350  1,162,329 380,733 
Increase in accrued payroll and related taxes 103,196 333,272  535,438 103,196 
(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 
Decrease in accrued expenses (735,508) (838,747)
     
NET CASH USED IN OPERATING ACTIVITIES  (4,625,314) (2,776,150)
          
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchases of property and equipment (152,223) (363,750) (1,915,289) (152,223)
Proceeds from disposal of property and equipment 9,065    9,065 
Purchases of intangible assets  (23,978) (149,523)  (13,540) (23,978)
NET CASH USED IN INVESTING ACTIVITIES  (167,136) (513,273)  (1,928,829) (167,136)
          
CASH FLOWS FROM FINANCING ACTIVITIES          
Borrowings from indebtedness  3,500,000 
Payments on indebtedness (508,583)  
Proceeds from issuance of equity 1,230,000 26,567,861   1,230,000 
Common stock issuance as settlement for litigation 938,094    938,094 
Payments on finance lease liability  (1,616) (3,717)  (6,611) (1,616)
NET CASH PROVIDED BY FINANCING ACTIVITIES  2,166,478  30,064,144 
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES  (515,194) 2,166,478 
          
NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS (776,808) 32,258,420 
NET DECREASE IN CASH AND CASH EQUIVALENTS (7,069,337) (776,808)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  27,315,286  5,870,929   25,334,889  27,315,286 
CASH AND CASH EQUIVALENTS, END OF PERIOD $26,538,478 $38,129,349  $18,265,552 $26,538,478 
          
Supplemental Information          
Cash paid during the periods for:          
Interest $47 $13,554  $6,204 $47 
Income Taxes $850 $  $ $850 
          
Schedule of Non-Cash Operating, Investing and Financing Activities:          
Issuance of common stock as compensation $153,446 $120,004  $258,005 $153,446 
Issuance of common stock as settlement for litigation $938,094 $938,094  $ $938,094 

 

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

 

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REPRO MED

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

                      
   Additional     Total    Additional Retained   Total 
 Common Stock Paid-in Retained Treasury Stockholders’  Common Stock Paid-in Earnings Treasury Stockholders’ 
 Shares Amount Capital Earnings Stock Equity  Shares Amount Capital (Deficit) Stock Equity 
                               
Three and Six Months Ended
June 30, 2021
             
Three and Six Months Ended
June 30, 2022
             
                          
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 
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 14,615 146 97,050   97,196  47,500 475 142,025   142,500 
Compensation expense related to stock options   441,841   441,841    524,670   524,670 
Compensation expense related to restricted stock awards   66,135   66,135    170,386   170,386 
Issuance upon options exercised        29,627 296 (296)    
Net loss       (1,124,549)   (1,124,549)       (2,537,514)   (2,537,514)
BALANCE, JUNE 30, 2021 47,910,676 $479,106 $39,376,131 $1,252,067 $(3,843,562)$37,263,742 
BALANCE, MARCH 31, 2022 48,121,289 $481,212 $41,611,030 $(3,447,583)$(3,843,562)$34,801,097 
             
Issuance of stock-based compensation 69,707 697 114,808   115,505 
Compensation expense related to stock options   527,736   527,736 
Compensation expense related to restricted stock awards 50,000 500 231,011   231,511 
Issuance upon options exercised 166,623 1,667 (134,825)   (133,158)
Net loss       (2,921,341)   (2,921,341)
BALANCE, JUNE 30, 2022 48,407,619 $484,076 $42,349,760 $(6,368,924)$(3,843,562)$32,621,350 

 

                      
   Additional     Total    Additional Retained   Total 
 Common Stock Paid-in Retained Treasury Stockholders’  Common Stock Paid-in Earnings Treasury Stockholders’ 
 Shares Amount Capital Earnings Stock Equity  Shares Amount Capital (Deficit) Stock Equity 
                             
Three and Six Months Ended
June 30, 2020
 
Three and Six Months Ended
June 30, 2021
 
  
BALANCE, DECEMBER 31, 2019 42,239,788 $422,398 $6,293,069 $4,864,817 $(344,204)$11,236,080 
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 9,189 92 59,910   60,002  10,124 101 56,149   56,250 
Compensation expense related to stock options   300,966   300,966    677,934   677,934 
Litigation settlement share issuance 95,238 952 937,142   938,094 
Issuance upon options exercised 175,000 1,750 83,750   85,500  1,110,580 11,106 1,218,894   1,230,000 
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 
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 
  
Issuance of stock-based compensation 7,999 80 59,922   60,002  14,615 146 97,050   97,196 
Compensation expense related to stock options   363,851   363,851    441,841   441,841 
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 
Compensation expense related to restricted stock awards   66,135   66,135 
Net loss       (1,076,038)   (1,076,038)       (1,124,549)   (1,124,549)
BALANCE, JUNE 30, 2020 46,640,120 $466,401 $34,886,850 $4,238,207 $(344,204)$39,247,254 
BALANCE, JUNE 30, 2021 47,910,676 $479,106 $39,376,131 $1,252,067 $(3,843,562)$37,263,742 

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

 

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REPRO MED

KORU MEDICAL SYSTEMS, INC.

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS

 

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

 

NATURE OF OPERATIONS

 

REPRO MEDKORU MEDICAL 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.

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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.

 

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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

 

Schedule of loss income 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 loss per common share

            
  Three Months Ended Six Months Ended

 

  June 30, June 30, 
  2022 2021 2022 2021 
              
Net loss $(2,921,341)$(1,124,549)$(5,458,855)$(2,400,687)
              
Weighted Average Outstanding Shares:             
Outstanding shares  44,921,870  44,489,853  44,795,625  44,226,936 
Option shares includable  0(a) 0(a) 0(a) 0(a)
   44,921,870  44,489,853  44,795,625  44,226,936 
              
Net loss per share             
Basic $(0.07)$(0.03)$(0.12)$(0.05)
Diluted $(0.07)$(0.03)$(0.12)$(0.05)

__________

(a)

For the three months ended June 30, 2021,2022, and 2020,2021, option shares of 224,336137,539 and 162,831224,336 respectively, were not included as the impact is anti-dilutive.  For the six months ended June 30, 2021,2022, and 2020,2021, option shares of 214,132166,441 and 182,575214,132 respectively, were not included as the impact is anti-dilutive.

For the three months ended June 30, 2022 and 2021, restricted shares of 950,000 and 1,000,000 respectively, were not included as the impact is anti-dilutive. For the three and six months ended June 30, 20212022, and 2020,2021, restricted shares of 1,000,000950,000 and zero1,000,000 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 are derived 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 (“ASU”NRE”) No. 2014-09, Revenuerevenues received 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.

 

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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 novel therapies revenues can fluctuate and may not be consistent from period to period. 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 (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the satisfaction of a performance obligation relative to the total expected inputs to the satisfaction of that performance obligation (ie completion milestone). 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, 2021,2022, 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 June 30, Six Months Ended June 30, 
  2022 2021 2022 2021 
Sales             
Domestic $5,512,173 $4,645,770 $10,813,561 $9,092,559 
International  1,034,455  882,404  1,977,397  1,866,566 
Total $6,546,628 $5,528,174 $12,790,958 $10,959,125 

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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Table of Contents

 

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.

 

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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 six months ended June 30, 2021.2022.

 

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, 2021.2022.

 

RECLASSIFICATION

 

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

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NOTE 2 — PROPERTY AND EQUIPMENT

 

Property and equipment consists of the following at:

Schedule of property and equipment

  June 30, 2021 December 31, 2020 
        
Furniture and office equipment $787,694 $753,536 
Leasehold improvements  556,907  542,796 
Manufacturing equipment and tooling  1,922,196  1,856,909 
   Total property and equipment  3,266,797  3,153,241 
Less: accumulated depreciation and amortization  (2,156,247) (1,985,618)
Property and equipment, net $1,110,550 $1,167,623 

  June 30, 2022 December 31, 2021 
        
Furniture and office equipment $867,559 $818,897 
Construction in progress  625,296   
Leasehold improvements  1,590,417  556,907 
Manufacturing equipment and tooling  2,237,772  2,042,675 
   Total property and equipment  5,321,044  3,418,479 
Less: accumulated depreciation and amortization  (2,497,954) (2,312,034)
Property and equipment, net $2,823,090 $1,106,445 

Construction in progress and leasehold improvement increases of $0.6 million and $1.0 million, respectively are due to the new corporate headquarters and manufacturing facility buildout.

 

Depreciation expense was $100,564104,560 and $79,245100,564 for the three months ended June 30, 20212022 and 2020,2021, respectively, and $200,967198,644 and $152,013200,967 for the six months ended June 30, 20212022 and 2020,2021, 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.

 

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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 three equity incentive plans: the Board of Directors amended the Company’s 2015 Stock Option Plan, (asas amended (the “2015 Plan”) , the “Plan”2021 Omnibus Equity Incentive Plan (the “2021 Plan”) authorizing, and the Non-Employee Director Compensation Plan. The Company to granthas also issued restricted stock as employment inducement awards to certain executives, key employees, and consultants under the Plan, which was approved by shareholders at the Annual Meeting of Shareholders held on September 6, 2016.  The total number of shares of Common Stock, with respect to which awards 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.its Chief Executive Officer.

 

On February 15, 2021, under the Plan, the Company issued to James M. Beck, its Interim Chief Executive Officer, a non-qualified optionAs of June 30, 2022, there were options to purchase up to 150,0002,937,500 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, under the Plan, the Company issued to Linda Tharby, its incoming President and Chief Executive Officer, a non-qualified stock option to purchase up to 1,000,000 shares of the Company’s common stock at an exercise price of $3.875 per share, subject to vesting as follows: 25% on March 15, 2022 and 25% each twelve months thereafter.

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 2015 Plan, of which 1,150,000160,000 were issued during the three months ended June 30, 2022 and 295,000 were issued during the six months ended June 30, 2021.2022. Additional options may be issued under the 2015 Plan as outstanding options are forfeited, subject to a maximum 6,000,000 available for issuance under the 2015 Plan.

 

PriorThe 2021 Plan provides for the grant of up to January 1,1,000,000 incentive stock options, nonqualified stock options, stock awards, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, consultants and directors. During the three and six months ended June 30, 2022, there were issued 49,600 and 97,100 shares of common stock, respectively, as director compensation and 475,000 options to purchase shares of common stock as executive compensation under the 2021 each non-employee director of the Company was eligible to receive $50,000 annually (effective January 1, 2019), plus $10,000 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.Plan.

 

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor arewere eligible to receive of $75,000 annually, to be paid quarterly $12,500 in cash and $6,250 in common stock.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.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 $110,000annually, to be paid quarterly $12,500 in cash and $15,000 in common stock.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. From May 18, 2021 to May 6, 2022, non-employee director compensation was paid pursuant to the 2021 Plan. Since May 6, 2022, non-employee director compensation has been paid pursuant to the Non-Employee Director Compensation Plan. All payments were and are pro-rated for partial service.

 

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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 sharesTable 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.Contents

 

2015 STOCK OPTION PLAN, as amended

 

Time Based Stock Options

 

The per share weighted average fair value of stock options granted during the six months ended June 30, 20212022 and June 30, 20202021 was $3.06$2.10 and $6.68,$3.06, 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 six months ended June 30, 20212022 and June 30, 2020.2021. 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 $9,817$99,584 and $31,196$9,817 for the six months ended June 30, 20212022 and 2020,2021, 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% 

Schedule of time based stock options

  June 30, 
  2022 2021 
        
Dividend yield  0.00%  0.00% 
Expected Volatility  65.9% - 77.5%  74.01% - 74.28% 
Weighted-average volatility     
Expected dividends     
Expected term (in years)  10  10 
Risk-free rate  1.81% - 2.99%  1.20% - 1.62% 

 

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 status of time based stock options

  Six Months Ended June 30, 
  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 295,000 $2.70  1,250,000 $3.94 
Exercised 618,750 $1.57  1,000,000 $1.23 
Forfeited 411,250 $2.94  100,000 $3.94 
Outstanding at June 30 2,937,500 $3.80  3,072,494 $3.41 
Options exercisable at June 30 837,500 $3.47  871,244 $2.18 
Weighted average fair value of options granted during the period  $2.10   $3.06 
Stock-based compensation expense  $1,013,021   $1,528,522 

 

Total stock-based compensation expense was $1,528,522$1,013,021 and $290,991$1,528,522 for the six months ended June 30, 2021,2022, and 2020,2021, respectively. Cash received from option exercises for the six months ended June 30, 2021,2022, and 20202021 was $1,230,0000 and $95,8801,230,000, respectively.

 

The weighted-average grant-date fair value of options granted during the six months ended June 30, 2021,2022, and 20202021 was $3.80.6 million million and $0.43.8 million million,, respectively.  There were 1.0 million618,750 options exercised during the six months ended June 30, 2021,2022, and 722,0001.0 million during the six months ended June 30, 2020.2021.

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

 

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-$9.49 2,937,500 8.4 years $3.80 837,500 $3.47 

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Table of Contents

 

As of June 30, 2021,2022, there was $5.4$5,117,429 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 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, 2021,2022, and June 30, 2020,2021, was $1,378,220$2,149,858 and $1,110,068,$1,378,220, respectively.

 

Performance Based Stock Options

 

There were no performance based stock options granted during the six months ended June 30, 2021,2022, and 2020.2021.

 

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

  Six Months Ended June 30, 
  2022 2021 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1  $ 1,000,000 $1.70 
Granted  $  $ 
Exercised  $  $ 
Forfeited  $  $ 
Outstanding at June 30  $ 1,000,000 $1.70 
Options exercisable at June 30  $  $ 
Weighted average fair value of options granted during the period  $  $ 
Stock-based compensation expense  $  $(408,747)

 

Total performance stock-based compensation expense totaled ($408,747)zero and $373,826($408,747) for the six months ended June 30, 2021,2022, and 2020,2021, respectively. All performance-basedperformance based stock options were forfeited as of June 30, 2021, and there was 0no unrecognized compensation cost remaining.

 

Restricted2021 STOCK OPTION PLAN, as amended

Time Based Stock AwardsOptions

The per share weighted average fair value of stock options granted during the six months ended June 30, 2022 and June 30, 2021 was $1.99 and $0 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 six months ended June 30, 2022 and June 30, 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 $8,271 and $0 for the six months ended June 30, 2022 and 2021, respectively.

Schedule of time based stock options

  June 30, 
  2022 2021 
        
Dividend yield  0.00%  0.00% 
Expected Volatility  65.9%  0% - 0% 
Weighted-average volatility     
Expected dividends     
Expected term (in years)  10  0 
Risk-free rate  2.99%  0% - 0% 

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Table of Contents

The following table summarizes the status of the 2021 Plan with respect to time based stock options:

Schedule of status of time based stock options

  Six Months Ended June 30, 
  2022 2021 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 0 $0   $ 
Granted 475,000 $2.67   $ 
Exercised 0 $   $ 
Forfeited 0 $   $ 
Outstanding at June 30 475,000 $2.67   $ 
Options exercisable at June 30 0 $   $ 
Weighted average fair value of options granted during the period  $1.99   $ 
Stock-based compensation expense  $39,384   $ 

Total stock-based compensation expense was $39,384 and $0 for the six months ended June 30, 2022, and 2021, respectively. There were no options exercised during the six months ended June 30, 2022 and June 30, 2021.

The weighted-average grant-date fair value of options granted during the six months ended June 30, 2022, and 2021 was $0.95 million and $0 million, respectively.  There were zero options exercised during the six months ended June 30, 2022, and zero during the six months ended June 30, 2021.

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

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
 
              
$2.67 475,000 9.8 years $2.67 0 $0 

As of June 30, 2022, there was $905,831 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2021 Plan.  That cost is expected to be recognized over a weighted-average period of 48 months.  The total fair value of shares vested as of June 30, 2022, and June 30, 2021, was zero and zero, respectively.

RESTRICTED STOCK AWARDS

 

The following table summarizes the activities for our unvested restricted stock awards for the six months ended June 30, 2021,2022, 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 restricted stock awards

  Six Months Ended June 30, 
  2022 2021 
  Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
 
          
Unvested at January 1  $  $ 
Granted 1,000,000 $3.01 1,000,000 $3.01 
Vested 50,000 $3.31  $ 
Forfeited/canceled  $  $ 
Unvested at June 30 950,000 $2.99 1,000,000 $3.01 

 

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Table of Contents

 

As of June 30, 2022, and 2021, there was $1,958,952 and $2,458,451 of unrecognized compensation cost related to unvested employee restricted shares. This amount is expected to be recognized over a weighted-average period of 21 months. We have recognized tax benefits associated with restricted stock award compensation of $13,88871,563 and $013,888 for the six months ended June 30, 20212022 and 2020,2021, respectively.

 

NOTE 5 — DEBT OBLIGATIONS

 

On April 14, 2020,June 29, 2022, the Company issuedentered into a promissory noteLoan Modification Extension Agreement (the “Modification Agreement”) with Keybank National Association (“Lender”) to KeyBank in the aggregate principal amount of $3.5 million (the “Note”) as an extension ofmodify 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 rateLender in the amount of Prime Rate announced by the Bank minus 0.75%$3,500,000.  The Note (the “Loan”) that was originally made available on April 14, 2020 and renewed on June 24, 2021, in2021. Among other things, the same form with anModification Agreement: (i) extends the maturity date of the Loan from June 1, 2022 to June 1, 2023; (ii) changes the interest rate of applicable to the Loan from 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.  The $3.5 million Note contains events of default and other provisions customary for a loan of this type.

In connection with the Note,Prime + 0%; (iii) releases the Company entered intofrom its obligations under a Commercial Security Agreement with the Bankcertain security agreement dated April 14, 2020 (the “Security Agreement”),June 24, 2021 pursuant to which the Company had previously granted the Lender a first priority security interest in substantially all assetsequipment, inventory, accounts, instruments, chattel paper and general intangibles of the Company to secure(the “Security Agreement”); and (iv) replaces the obligationsSecurity Agreement with a new pledge security agreement dated June 29, 2022 by and between the Company and Lender (the “Pledge Agreement”), which Pledge Agreement grants Lender a first priority security interest in certain of the Company under the Note.  The Security Agreement contains terms and conditions typicalCompany’s bank accounts as collateral security for the granting of security interests of this kind.

Loan. The Company had no amount outstanding against the line of credit as of June 30, 2021.2022.

 

On April 27, 2020,July 26, 2021, the Company entered into a Progress Payment Loancommercial insurance premium finance and Security Agreement (“PPLSA”) and a Master Security Agreement (the “MSA”), each dated assecurity agreement with AON Premium Finance, LLC in the aggregate principal amount of April 20, 2020, with Key Equipment Finance, a division$0.9 million bearing an annual percentage rate of the Bank (“KEF”)4.17%, to provide up to $finance its insurance premiums. 2.5 million in financing for equipment purchases from third party vendors.  The PPLSA allowsMonthly payments were due on 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 endfirst of each calendar quarter or year,month beginning August 1, 2021 through June 1, 2022. The Company is in the advances made underprocess of renewing the PPLSA will be convertedcommercial insurance 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 a fixed 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.  Each fixed rate installment promissory note may be prepaid, subject to a penalty if prepaid before the fifth anniversary of its issuance.  As ofbegin August 1, 2022 through June 30, 2021, the Company had no amount outstanding against the PPLSA.1, 2023.

 

NOTE 6 — LEASES

 

We have finance and operating leases for our corporate office and certain office and computer equipment.  Our two operating leases have remaining lease terms of one year, someten years and 6 months, respectively. Our finance lease, which was entered into in June 2022 has a remaining lease term of which include options to extend the leases monthly and annually and some with options to terminate the leases within 15 year.years.

 

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

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  Three Months Ended Six Months Ended 
  June 30, June 30, 
  2022 2021 2022 2021 
              
Operating lease cost $161,140 $37,369 $239,582 $75,290 
Short-term lease cost  28,579  33,548  78,288  68,437 
Total lease cost $189,719 $70,917 $317,870 $143,727 
              
Finance lease cost:             
Amortization of right-of-use assets $5,918 $794 $5,918 $1,589 
Interest on lease liabilities  0  19  0  47 
Total finance lease cost $5,918 $813 $5,918 $1,636 

 

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

       
  Six Months Ended 
  June 30, 
  2022 2021 
Cash paid for amounts included in the measurement of lease liabilities:       
Operating cash flows from operating leases $181,544 $70,363 
Financing cash flows from finance leases  6,611  1,616 

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Table of Contents

 

Supplemental balance sheet information related to leases was as follows:

 

  June 30,
2021
 December 31,
2020
 
        
Operating Leases       
Operating lease right-of-use assets $166,483 $236,846 
        
Operating lease current liabilities  142,450  141,293 
Operating lease long term liabilities  24,033  95,553 
Total operating lease liabilities $166,483 $236,846 
        
Finance Leases       
Property and equipment, at cost $12,725 $12,725 
Accumulated depreciation  (11,729) (10,139)
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 

Schedule of balance sheet information related to leases

  June 30,
2022
 December 31,
2021
 
        
Operating Leases       
Operating lease right-of-use assets $4,190,931 $95,553 
        
Operating lease current liabilities  363,030  95,553 
Operating lease long term liabilities  3,827,900   
Total operating lease liabilities $4,190,930 $95,553 
        
Finance Leases       
Property and equipment, at cost $355,071 $12,725 
Accumulated depreciation  5,918  (12,725)
Property and equipment, net $349,153 $ 
        
Finance lease current liabilities  66,503   
Finance lease long term liabilities  281,958   
Total finance lease liabilities $348,461 $ 

 

 June 30,
2021
 December 31,
2020
  June 30,
2022
 December 31,
2021
 
    
Weighted Average Remaining Lease Term        
Operating leases 0.9 Years 1.4 Years  10.2 Years 0.6 Years 
Finance leases 0.4 Years 0.7 Years  5 Years 0 Years 
        
Weighted Average Discount Rate        
Operating leases 4.75% 4.75%  4.04% 4.75% 
Finance leases 4.75% 4.75%  4.25% 4.75% 

 

Maturities of lease liabilities are as follows:

Schedule of maturities of lease liabilities

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 

Year Ending December 31, Operating Leases Finance Leases 
2022 (excluding the six months ended June 30, 2022)  273,928  39,664 
2023  499,503  79,329 
2024  499,503  79,329 
2025  499,503  79,329 
2026  499,503  79,329 
Thereafter  2,830,518  33,052 
Total undiscounted lease payments  5,102,458  390,032 
Less: imputed interest  (911,528) (41,571)
Total lease liabilities $4,190,930 $348,461 

 

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NOTE 7 — EQUITYTable of Contents

 

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, and our officers and representatives may from time to time make, 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. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

 

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, inflation, war and other geopolitical conflicts, 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.pronouncements, as well as those risks and uncertainties described in Part II.— Item IA. “Risk Factors” in this report and from time to time in our past and future reports filed with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2021 in addition to others. 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.statements, which include, without limitation, statements regarding transition to our secondary manufacturing source, clearing second quarter 2022 backorders, non-recurrence of the impact from inventory accounting, move of our manufacturing facility, need for additional financing, and 2022 expenses and capital expenditures.  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 MedKORU Medical 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.

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Our revenues derive from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies.  Our domestic core and international core 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 use being for the 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.

 

TotalWe have experienced and continue to experience supply chain issues and inflationary impacts on raw materials and labor resulting from the COVID-19 pandemic. We cannot predict whether current trends will continue and what impact they may have on our business, our customers or our financial results.

The Company continued its implementation of finished goods manufacturing of our needle and tubing sets to Command Medical Products, a third party contract manufacturing organization, which began in 2021 and expects to complete the implementation before the end of first quarter 2023. This move is intended to create a dual source of manufacturing and improve costs.

The Company entered into a lease commencing March 1, 2022 for a new corporate headquarters and manufacturing facility located in Mahwah, NJ. During the quarter ended June 30, 2022, the Company completed the first phase of the move, the headquarters and office staff to the new location, and expects to complete the move of manufacturing before the end of the year.

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Table of Contents

The Company ended the 2022 second fiscal quarter with $6.5 million in net sales, werea 18.4% increase, compared with $5.5 million or 28% lowerin the same period last year driven by growth in all three of our business sources.

Gross profit, stated as a percentage of net sales, for the three months ended June 30, 2021, as compared to2022, was 51.1%, a decline from 58.1% in 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 fromperiod.

Operating expenses for the three months ended March 31, 2021, grew 2%,June 30, 2022, were $7.0 million, up from $4.6 million for the same period last year, driven primarily by domestic core growth of 4%. Both the overall domestic marketresearch and our end-user salesdevelopment, and for selling, general and administrative for new hires 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.

Our inventory position increased $0.7 million from December 31, 2020, as we transition manufacturing to our secondary source.support commercialization, business development, quality, and regulatory capabilities.

 

RESULTS OF OPERATIONS

 

Three months ended June 30, 2021,2022, compared to June 30, 20202021

 

Net Sales

 

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

 

 Three Months Ended June 30, Change from Prior Year % of Net Sales  Three Months Ended June 30, Change from Prior Year % of 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%  $4,996,791 $4,597,797 $398,994 8.7% 76.3% 83.2% 
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%  951,485 859,694 91,791 10.7% 14.5% 15.5% 
Novel Therapies  22,710  110,051  (87,341)(79.4%)0.4% 1.4%   598,352  70,683  527,669 746.6% 9.2% 1.3% 
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%)  $6,546,628 $5,528,174 $1,018,454 18.4% 

 

Total net sales decreased $2.2increased $1.0 million, or 28.3%18.4%, for the three months ended June 30, 2021,2022, as compared with the same period last year, driven primarily by lowerhigher novel therapies sales of $1.2 million compared with last year due tofor a non-recurringmilestone completion on an NRE innovation development agreement for a large pharmaceutical customer, clinical trial last year,product sales for an expanded pipeline and lowerincreases in average selling prices for our products. Our domestic core business grew by 8.7%, and was impacted by supply chain issues and labor shortages which created backorders estimated to be $0.3 million that are not included in the reported net sales number. The increase in domestic core demand inclusive of backorders was attributed to our largest distributor, where we believe pandemic related stocking occurred last year.volume growth driven by SCIg market growth and label expansions. We define backorders as any non-cancellable open order not shipped before promised delivery date net of rebates, discounts, and other fees. Backorders are expected to be cleared in the third quarter of 2022. International core net sales were $0.9$1.0 million for the three months ended June 30, 2022, up 1%10.7% compared with the same period last year.year due to volume growth in several European markets driven by key tender wins.

 

Gross Profit

 

Our gross profit for the three months ended June 30, 20212022 and 20202021 is as follows:

 

 Three Months Ended June 30, Change from Prior Year  Three Months Ended June 30, Change from Prior Year 
 2021 2020 $  %  2022 2021 $  % 
Gross Profit $3,210,184 $4,909,880 $(1,699,696) (34.6%) $3,346,173 $3,210,184 $135,989  4.2% 
Stated as a Percentage of Net Sales 58.1% 63.7%    51.1% 58.1%   

 

Gross profit decreased $1.7increased $0.14 million or 34.6%4.2% in the three months ended June 30, 2021,2022, compared to the same period in 2020.2021.  This decreaseincrease in the 2022 second quarter was mostly driven by the decreaseincrease in net sales of $2.2$1.0 million as described above.  Gross marginprofit as a percent of sales decreased to 51.1% compared to 58.1% from the second quarter of 2021.  The decline in the gross profit percent was negativelyprimarily caused by the accelerated amortization of manufacturing variances in the quarter, due to lower levels of finished goods inventory.  This accounting treatment contributed 3.8 percentage points to the reduction and we believe is a non-recurring event.  In addition, the gross profit percent was impacted by lower volumes, resulting in unfavorable absorptionmanufacturing variances due to supply chain issues in the quarter.

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first quarter of 2022, amortized in the current period. Further contributing was lower gross profit from NRE revenues.  Partially offsetting these unfavorable impacts to the gross profit percent was a nominal impact from an increase in average selling prices.

 

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, 20212022 and 20202021 are as follows:

 

  Three Months Ended June 30, Change from Prior Year 
  2021 2020 $ % 
Selling, general and administrative $4,085,945 $3,201,831 $884,114 27.6% 
Litigation    2,346,914  (2,346,914)(100.0%)
Research and development  386,878  298,196  88,682 29.7% 
  $4,472,823 $5,846,941 $(1,374,118)(23.5%)
Stated as a Percentage of Net Sales  80.9%  75.9%      

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Table of Contents

  Three Months Ended June 30, Change from Prior Year 
  2022 2021 $ % 
Selling, general and administrative $5,530,022 $4,085,945 $1,444,077 35.3% 
Research and development  1,303,731  386,878  916,853 237% 
  $6,833,753 $4,472,823 $2,360,930 52.8% 
Stated as a Percentage of Net Sales  104.4%  80.9%      

 

Selling, general and administrative expenses increased $0.9$1.4 million, or 27.6%35.3%, during the three months ended June 30, 20212022 compared to the same period last year, mostlyprimarily due to $0.5$1.2 million in market research, testingcompensation and consulting fees all to support commercialization, regulatory and strategic initiatives, $0.2benefits associated with new hires, $0.15 million in costs associated with the departurestock compensation, and replacement of the former chief executive officer, as well as higher board of director$0.3 million in recruitment fees, and directors and officers liability insurancepartially offset by lower restructuring costs 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$0.9 million during the three months ended June 30, 20212022 compared with the same period last year, mostlyprimarily due to $0.3 million in compensation and benefits, and $0.5 million in higher consulting fees to support product development for novel therapies.

 

Depreciation and amortization

 

Depreciation and amortization expense increased by 24.76.3 % to $125,882 in the three months ended June 30, 2022 compared with $118,415 in the three months ended June 30, 2021 compared with $94,940 in the three months ended June 30, 2020.2021.  We continue to invest in capital assets, mostly related to leasehold improvements, manufacturing, and computer equipment.

 

Net IncomeLoss

 

 Three Months Ended June 30, Change from Prior Year  Three Months Ended June 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Net Loss $(1,124,549$(1,076,038$(48,511)(4.5%) $(2,921,341$(1,124,549$(1,796,792)159.8% 
Stated as a Percentage of Net Sales (20.3% (14.0%)  (44.6% (20.3%) 

 

Our net loss increased $48,511$1.8 million in the three months ended June 30, 20212022 compared with the same period last year mostly driven by lower gross profit andhigher operating expenses due to higher selling, general and administrative expenses, offset by lower litigation costs all as described above.and research and development expenses. A tax benefit of $0.7 million resulting from the loss was also recorded during the period.

 

Six months ended June 30, 20212022 compared to June 30, 20202021

 

Net Sales

 

The following table summarizes our net sales for the six months ended June 30, 20212022 and 2020:2021:

 

  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%)    

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  Six Months Ended June 30, Change from Prior Year % of Net Sales 
  2022 2021 $ % 2022 2021 
Net Sales                
Domestic Core $9,990,327 $9,010,214 $980,113 10.9% 78.1% 82.2% 
International Core  1,846,427  1,838,600  7,827 0.4% 14.4% 16.8% 
Novel Therapies  954,204  110,311  843,893 765.0% 7.5% 1.0% 
Total $12,790,958 $10,959,125 $1,831,833 16.7%     

 

Total net sales decreased $3.1increased $1.8 million or 21.9%16.7% for the six months ended June 30, 2021,2022, as compared to the prior year period, driven primarily by lowerhigher domestic core net sales of $1.0 million driven by increases in price and volume of pumps and consumables. Further contributing were higher novel therapies sales of $1.7$0.8 million compared with last year due to a non-recurring clinical trial lastpayment upon completion of two interim NRE milestones this year and lower domesticclinical product sales for an expanded pipeline. Domestic core net sales drivenwere impacted by what we believesupply chain issues and labor shortages which created backorders estimated to be pandemic related stocking last year at our largest distributor.$0.3 million that are not included in reported net sales. We define backorders as any non-cancellable open order not shipped before promised delivery date net of rebates, discounts, and other fees. Backorders are expected to be cleared in the third quarter of 2022. International core net sales were $1.8 million tracking even within the 2022 first six months, relatively flat from the same period last year.

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Gross Profit

 

Our gross profit for the six months ended June 30, 20212022 and 20202021 is as follows:

 

 Six Months Ended June 30, Change from Prior Year  Six Months Ended June 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Gross Profit $6,442,038 $8,698,090 $(2,256,052)(25.9%) $6,968,478 $6,442,038 $526,440 8.2% 
Stated as a Percentage of Net Sales 58.8% 62.0%  54.5% 58.8% 

 

Gross profit decreased $2.3increased $0.53 million or 25.9%8.2% in the six months ended June 30, 2021,2022, compared to the same period last year. This increase in the first half of 2022 was mostly driven by the increase in net sales of $1.8 million as described above.  Gross margin decreased primarilyprofit, stated as a percentage of net sales, was impacted by unfavorable manufacturing variances due to under absorption due tosupply chain issues, labor shortages, and higher NRE revenue at lower volume.margins recorded in the first half of 2022, partially offset by increased average selling prices.

 

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, 20212022 and 20202021 are as follows:

 

 Six Months Ended June 30, Change from Prior Year  Six Months Ended June 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Selling, general and administrative $9,078,774 $5,964,811 $3,113,963 52.2%  $11,021,235 $9,078,774 $1,942,461 21.4% 
Litigation  2,446,072 (2,446,072)(100.0%)
Research and development  723,719  554,221  169,498 30.6%   2,452,086  723,719  1,728,367 238.8% 
 $9,802,493 $8,965,104 $837,389 9.3%  $13,473,321 $9,802,493 $3,670,828 37.4% 
Stated as a Percentage of Net Sales 89.4% 63.9%  105.3% 89.4% 

 

Selling, general and administrative expenses increased $3.1$1.94 million, or 52.2%21.4%, during the six months ended June 30, 20212022 compared to the same period last year, mostlyprimarily due to $1.6$2 million in costs associated with the departurecompensation 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 contributingbenefits related mostly to the increase was the rollout impact of higher salary and related benefits of $0.9 million from new hires in the second half of last yearSales, Quality and Regulatory to support commercialization, business development and medical affairs for our novel therapiesstrategic growth initiatives, as well as infrastructure. Market research, testing and consulting$0.5 million in recruitment fees, to support commercialization and regulatory filings also contributed $0.6$0.2 million as well as higher director fees and director and officerin stock compensation, $0.2 million in liability insurance, $0.2 million in travel related costs, and $0.1 million in consulting costs, partially offset by lower restructuring costs of $0.4$1.2 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.

 

Research and development expenses increased $0.2$1.73 million during the six months ended June 30, 20212022 compared with the same period last year mostlyprimarily due to increases$0.5 million in compensation and benefits, $0.1 million in recruitment fees, and $1.0 million in higher consulting fees to support product development for novel therapies.

 

Depreciation and amortization

 

Depreciation and amortization expense increased by 28.4%0.5% to $235,134 the six months ended June 30, 2022 compared with $233,888 in the six months ended June 30, 2021 compared with $182,164 in the six months ended June 30, 2020.2021.  We continue to invest in capital assets, mostly related to leasehold improvements, manufacturing and computer equipment.

 

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%)     

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  Six Months Ended June 30, Change from Prior Year 
  2022 2021 $ % 
Net Loss $(5,458,855)$(2,400,687)$(3,058,168)127.4% 
Stated as a Percentage of Net Sales  (42.7%) (21.9%)     

 

Our net loss for the six months ended June 30, 20212022 was $2.4$5.5 million compared to net loss of $0.6$2.4 million for the six months ended June 30, 2020,2021, driven by lower gross profit and higher selling, general and administrative expenses, offset by litigation expenses incurred last year, all as described above. Offsetting the loss was a tax benefitand research and development expenses.

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Table of $0.5 million resulting from book to tax differences related to stock option expense.Contents

 

LIQUIDITY AND CAPITAL RESOURCES

 

Our principal source of liquidity is our cash on hand of $26.5$18.3 million as of June 30, 2021.2022.  Our principal source of operating cash inflows is from sales of our products and NRE services to customers. Our principal cash outflows relate to the purchase and production of inventory and related costs, and selling, general and administrative expenses. Our cash outflows during the six months ended June 30, 2022 include expenses related to our facility move, which we do not expect to recur in future periods. We expect that equipment financing, the Employee Retention Credit (“ERC”), leasehold improvement credits, and inventory reduction by the end of fiscal year 2022 will reduce the current rate of our cash outflows.

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 $0.9 million, which are expected to be fully executed in the third quarter of 2022.

Our inventory position was $6.8 million at June 30, 2022, which reflects an excess of work in process inventory when compared to prior periods that could not be converted to finished goods as a result of supply chain issues and labor shortages. We expect to reduce this excess inventory and convert it to a source of cash by the end of 2022. We further expect to reduce our inventory position when the transition to our secondary manufacturing source is completed, which we expect by March 31, 2023.

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 June 30, 2022, the credit has not been received.

We expect that our cash on hand and cash flows from operations 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 inflation and 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 its operations or planned expansion.

 

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 
  Six Months Ended
June 30, 2022
 Six Months Ended
June 30, 2021
 
Net cash used in operating activities $(4,625,314)$(2,776,150
Net cash used in investing activities $(1,928,829)$(167,136)
Net cash (used in)/provided by financing activities $(515,194)$2,166,478 

 

Operating Activities

Net cash used in operating activities of $4.6 million for the six months ended June 30, 2022 was primarily due to the net loss of $5.5 million, working capital changes which included an increase in inventory of $0.7 million, an increase in accounts receivable of $0.5 million, and a decrease in accrued expenses of $0.7 million, offset by an increase in accounts payable of $1.2 million, an increase in accrued payroll of $0.5 million, and a decrease in prepaids of $0.3 million related to insurance payments.  Further contributing were deferred tax assets of $1.3 million increased for book to tax differences related to stock option expense.  Offsetting these were primarily non-cash charges for stock-based compensation of $1.6 million, and depreciation and amortization of $0.2 million.

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Net cash used in operating activities of $2.8 million for the six months ended June 30, 2021 was primarily due to the net loss of $2.4 million, working capital changes which included an increase in inventory of $0.7 million related to the transition of manufacturing to our secondary source, and a decrease in accrued expenses of $0.8 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.  Further contributing were deferred tax assets of $1.2 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.

 

Investing Activities

Net cash provided by operatingused in investing activities of $2.7$1.9 million for the six months endedending June 30, 2020,2022, was mostly attributable to non-cash charges for stock-based compensationcapital expenditures for manufacturing and litigation settlement expense of $2.1 million, an increase in accounts payable, accrued expensesoffice equipment for our corporate office and accrued payroll of $2.1 million, driven by the litigation settlement with EMED, the capital raise and customer rebates. Further adding 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 pace with sales growth and to insure timely order fulfillment.

Investing Activitiesmanufacturing facilities move.

 

Net cash used in investing activities of $0.2 million for the six months ending June 30, 2021, was for capital expenditures for manufacturing and office equipment.

 

Net cashFinancing Activities

The $0.5 million used in investingfinancing activities of $0.5 million for the six months endingended June 30, 2020, was2022, is from payments on our indebtedness for capital expendituresa note payable for research and development and strategic initiatives as well as for patent and trademark applications.

Financing Activitiesinsurance premium financing.

 

The $2.2 million provided by financing activities for the six months ended June 30, 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.

 

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, 2021,2022, 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 and below in this Quarterly Report on Form 10-Q, 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

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Rising inflation may materially impact our financial operations or results of operations.

Inflation has increased in the first half of 2022 and is expected to our risk factors since our Annual Report on Form 10-Kcontinue to increase for the year ended December 31, 2020.near future. Inflationary factors, such as increases in the cost of our raw materials, manufacturing, interest rates, labor and overhead costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we expect to experience effects beginning in the second half of 2022, which could have a material impact on our financial condition or results of operations.

 

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

The Company issued an aggregate 14,615 shares of common stock to its non-employee directors during the three months ended June 30, 2021 in accordance with its non-employee director compensation program.

All of the securities issued by the Company as described in this Item 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 Securities5.  OTHER INFORMATION

 

On November 16,August 1, 2022, the Company amended and restated its annual cash bonus incentive plan for executives that was adopted in 2020, the Company announced that itsManagement Incentive Compensation Plan, to serve as an annual cash bonus incentive plan applicable to all full-time, salaried employees and such other employees designated by the Chief Executive Officer, now known as the Annual Incentive Compensation Plan.

On August 1, 2022, the Company’s Board of Directors had authorized a stock repurchase program under whicheliminated the position of Chief Operating Officer and, therefore, removed Manuel Marques as an officer of the Company. Also on August 1, 2022, the Company may choosegave Mr. Marques notice pursuant to his employment agreement that his employment with the Company would terminate, as a result of the position elimination, effective September 30, 2022 post an orderly transition.

On August 2, 2022, the Company appointed Christopher Pazdan, previously Vice President of Quality Assurance and Regulatory Affairs, to the newly created position of Senior Vice President, Operations. Mr. Pazdan will continue accountability for Quality Assurance and Regulatory Affairs, in addition to his new responsibility for Operations. In connection with such appointment, Mr. Pazdan entered into an amended employment agreement to increase his annual bonus potential from 35% to 40% of his base salary and, subject to approval of the Compensation Committee of the Company’s Board of Directors (the “Committee”), will receive options to purchase up to $10.0 million100,000 shares of its outstandingthe Company’s common stock through December 31,at an exercise price on the date of issuance (which will be the 1st or 15th day of the month following the Committee’s approval). The options will be subject to vesting conditions based on certain performance criteria to be determined by the Committee.

Mr. Pazdan has served as the Company’s Vice President of Quality Assurance and Regulatory Affairs since September 2021. As of December 31, 2020,From February 2019 to the time he joined the Company, had purchased 683,271 shares for an aggregate $3,499,358 pursuantMr. Pazdan served first as Vice President, QA/RA and then Vice President, Quality Assurance at Hillrom, a global medical technology company. Prior to this program. No purchases have been made since that time, from January 2017 to May 2018, he served as we continueSr. Director, Corporate QA/RA at Hillrom. From May 2018 to evaluate our cash needsFebruary 2019, Mr. Pazdan held the position of Director, Operations Quality at Abbott Laboratories. Mr. Pazdan previously worked at Becton Dickinson, Wockhardt and Rexam Pharma. Mr. Pazdan received his bachelor’s degree in connection with strategic planning underengineering from the leadershipUniversity of our new Chief Executive Officer.Illinois at Urbana-Champaign.

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PART II – ITEM 6.  EXHIBITS.

 

Exhibit No.Description
10.1SummaryEmployment Agreement dated as of Non-Employee Director Compensation (effective May 18, 2021)October 20, 2021 between KORU Medical Systems, Inc. and Thomas Adams
  
10.2Repro MedEmployment Agreement dated as of August 4, 2021 between KORU Medical Systems, Inc. 2021 Omnibus Equity Incentive Planand Christopher Pazdan
  
10.3FormAmendment to Employment and Option Agreements dated as of non-qualified/incentive stock option award agreement pursuant to the 2021 Omnibus Equity Inventive Plan
10.4Form of Indemnification AgreementAugust 2, 2022 between Repro MedKORU Medical Systems, Inc. and each of its directors and executive officersChristopher Pazdan
  
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 MEDKORU MEDICAL SYSTEMS, INC.
  
August 11, 20213, 2022/s/ Linda Tharby
 Linda Tharby, President and Chief Executive Officer
(Principal Executive Officer)
  
August 11, 20213, 2022/s/ Karen FisherThomas Adams
 Karen Fisher,Thomas Adams, Interim Chief Financial Officer and Treasurer
(Principal Financial Officer)

 

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