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 September 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) 469-2042

(Registrant’s telephone number, including area code)

N/A

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

 

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

 

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

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  [X] Yes  [_] No

 

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

 

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

 

 Large accelerated filer [_]Accelerated filer [_]
 Non-accelerated filer   [X]Smaller reporting company [X]
  Emerging growth company [_]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [_]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  [_] Yes  [X] No

 

As of November 10, 2021,9, 2022, 44,561,16045,279,948 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 SEPTEMBER 30, 20212022

TABLE OF CONTENTS

 

  PAGE
   
PART I. FINANCIAL INFORMATION
   
ITEM 1.Financial Statements (Unaudited)3
   
 Balance Sheets as of September 30, 20212022 (Unaudited) and December 31, 202020213
   
 Statements of Operations (Unaudited) for the three and nine months ended September 30, 20212022 and 202020214
   
 Statements of Cash Flows (Unaudited) for the nine months ended September 30, 20212022 and 202020215
   
 Statements of Stockholders’ Equity (Unaudited) for the three and nine months ended September 30, 20212022 and 2020202166-7
   
 Notes to Financial Statements8
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations18
   
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk2223
   
ITEM 4.Controls and Procedures23
   
PART II. OTHER INFORMATION
   
ITEM 1.Legal Proceedings23
ITEM 1A.Risk Factors23
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2324
   
ITEM 6.Exhibits24
   
 Signatures25

 

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Table of Contents

 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements (Unaudited)

 

REPRO MEDKORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

 

     
  September 30,  December 31,  September 30, December 31, 
 2021 2020  2022 2021 
             
ASSETS          
          
CURRENT ASSETS          
Cash and cash equivalents $26,233,411 $27,315,286  $16,441,268 $25,334,889 
Accounts receivable less allowance for doubtful accounts of $24,469 for September 30, 2021 and December 31, 2020 3,122,665 2,572,954 
Accounts receivable less allowance for doubtful accounts of $24,471 for September 30, 2022, and December 31, 2021 5,070,077 3,592,886 
Inventory 6,967,932 6,829,772  6,884,156 6,106,338 
Other Receivables 686,108 718,220 
Prepaid expenses  1,336,819  807,780   1,660,655  1,568,821 
TOTAL CURRENT ASSETS 37,660,827 37,525,792  30,742,264 37,321,154 
Property and equipment, net 1,159,819 1,167,623  3,318,612 1,106,445 
Intangible assets, net of accumulated amortization of $248,252 and $199,899 at September 30, 2021 and December 31, 2020, respectively 821,071 843,587 
Intangible assets, net of accumulated amortization of $310,011 and $263,729 at September 30, 2022 and December 31, 2021, respectively 798,534 808,813 
Operating lease right-of-use assets 131,228 236,846  3,865,370 95,553 
Finance lease right -of-use, net accumulated depreciation of $23,671 at September 30, 2022 331,400  
Deferred income tax assets, net 1,565,334 125,274  3,520,823 1,941,254 
Other assets  19,812  19,812   88,772  19,812 
TOTAL ASSETS $41,358,091 $39,918,934  $42,665,775 $41,293,031 
          
LIABILITIES AND STOCKHOLDERS’ EQUITY          
          
CURRENT LIABILITIES          
Accounts payable $1,385,413 $624,920  $1,365,610 $1,227,533 
Accrued expenses 2,036,848 2,610,413  2,568,746 2,709,704 
Note Payable 644,733 508,583 
Other Liabilities 357,491 90,000 
Accrued payroll and related taxes 332,814 287,130  824,047 160,603 
Finance lease liability – current 414 2,646 
Financing lease liability – current 64,467  
Operating lease liability – current 131,228 141,293   342,399  95,553 
Note Payable  673,133   
TOTAL CURRENT LIABILITIES 4,559,850 3,666,402  6,167,493 4,791,976 
Financing lease liability, net of current portion 265,542  
Operating lease liability, net of current portion    95,553   3,741,015   
TOTAL LIABILITIES  4,559,850  3,761,955   10,174,050  4,791,976 
Commitments and contingencies (Refer to Note 3)     
     
STOCKHOLDERS’ EQUITY          
Common stock, $0.01 par value, 75,000,000 shares authorized, 47,931,664 and 46,680,119 shares issued 44,511,162 and 43,259,617 shares outstanding at September 30, 2021 and December 31, 2020, respectively 479,317 466,801 
Common stock, $0.01 par value, 75,000,000 shares authorized, 48,657,023 and 48,044,162 shares issued 45,236,521 and 44,623,660 shares outstanding at September 30, 2022, and December 31, 2021, respectively 486,570 480,441 
Additional paid-in capital 40,004,197 35,880,986  43,443,201 40,774,245 
Treasury stock, 3,420,502 shares at September 30, 2021 and December 31, 2020, at cost (3,843,562) (3,843,562)
Retained earnings  158,289  3,652,754 
Treasury stock, 3,420,502 shares at September 30, 2022 and December 31, 2021, respectively, at cost (3,843,562) (3,843,562)
Retained deficit  (7,594,484) (910,069)
TOTAL STOCKHOLDERS’ EQUITY  36,798,241  36,156,979   32,491,725 36,501,055 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $41,358,091 $39,918,934  $42,665,775 $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 Nine Months Ended  Three Months Ended Nine Months Ended 
 September 30, September 30,  September 30, September 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
                         
NET SALES $6,040,544 $6,080,315 $16,999,669 $20,119,228  $7,760,398 $6,040,544 $20,551,356 $16,999,669 
Cost of goods sold  2,544,794  2,139,592  7,061,881  7,480,415   3,438,036  2,544,794  9,260,516  7,061,881 
Gross Profit 3,495,750 3,940,723 9,937,788 12,638,813  4,322,362 3,495,750 11,290,840 9,937,788 
                  
OPERATING EXPENSES                  
Selling, general and administrative 3,901,830 3,075,169 12,980,604 9,039,980  4,825,349 3,901,830 15,846,584 12,980,604 
Litigation  675  2,446,747 
Research and development 800,020 390,416 1,523,739 944,637  862,148 800,020 3,314,233 1,523,739 
Depreciation and amortization  115,934  115,637  349,822  297,801   164,344  115,934  399,479  349,822 
Total Operating Expenses  4,817,784  3,581,897  14,854,165  12,729,165   5,851,841  4,817,784  19,560,296  14,854,165 
                  
Net Operating (Loss)/Profit (1,322,034) 358,826 (4,916,377) (90,352)
Net Operating Loss (1,529,479) (1,322,034) (8,269,456) (4,916,377)
                  
Non-Operating (Expense)/Income         
(Loss)/Gain on currency exchange (7,283) 1,927 (21,761) (11,164)
Non-Operating Income/(Expense)         
Loss on currency exchange (10,057) (7,283) (38,897) (21,761)
Gain on disposal of fixed assets, net 273 22,113 1,009 16,591   273  1,009 
Interest (expense)/income, net  (2,838) 9,662  16,883  23,690 
TOTAL OTHER (EXPENSE)/INCOME  (9,848) 33,702  (3,869) 29,117 
Interest income (expense), net  42,476  (2,838) 44,579  16,883 
TOTAL OTHER INCOME/(EXPENSE)  32,419  (9,848) 5,682  (3,869)
                  
(LOSS)/INCOME BEFORE INCOME TAXES (1,331,882) 392,528 (4,920,246) (61,235)
LOSS BEFORE INCOME TAXES (1,497,060) (1,331,882) (8,263,774) (4,920,246)
                  
Income Tax Benefit/(Expense)  238,104  (143,353) 1,425,781  (316,200)
Income Tax Benefit  271,500  238,104  1,579,359  1,425,781 
                  
NET (LOSS)/INCOME $(1,093,778)$249,175 $(3,494,465)$(377,435)
NET LOSS $(1,225,560)$(1,093,778)$(6,684,415)$(3,494,465)
                  
NET (LOSS)/INCOME PER SHARE         
NET LOSS PER SHARE         
                  
Basic $(0.02)$0.01 $(0.08)$(0.01) $(0.03)$(0.02)$(0.15)$(0.08)
Diluted $(0.02)$0.01 $(0.08)$(0.01) $(0.03)$(0.02)$(0.15)$(0.08)
                  
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING                  
                  
Basic  44,322,335  43,914,542  44,510,021  41,326,815   45,038,181  44,322,335  44,877,366  44,510,021 
Diluted  44,322,335  44,119,511  44,510,021  41,326,815   45,038,181  44,322,335  44,877,366  44,510,021 

 

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
Nine Months Ended
  For the
Nine Months Ended
 
 September 30,  September 30, 
 2021 2020  2022 2021 
            
CASH FLOWS FROM OPERATING ACTIVITIES          
Net Loss $(3,494,465)$(377,435) $(6,684,415)$(3,494,465)
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 1,967,632 1,191,146  2,361,085 1,967,632 
Stock-based litigation settlement expense  1,285,102 
Depreciation and amortization 349,822 297,801  399,479 349,822 
Deferred income taxes (1,440,060) (161,368) (1,579,569) (1,440,060)
Gain on disposal of fixed assets (1,009) (16,591)
     
Loss on disposal of fixed assets  (1,009)
ROU landlord credit 218,044  
Changes in operating assets and liabilities:          
Increase in accounts receivable (549,711) (502,075) (1,445,079) (549,711)
Increase in inventory (138,160) (3,244,662) (777,818) (138,160)
Increase in prepaid expenses and other assets (529,039) (457,330) (160,794) (529,039)
Increase in other Liabilities 267,491  
Increase in accounts payable 760,493 790,414  138,077 760,493 
Increase in accrued payroll and related taxes 45,684 249,879  663,444 45,684 
(Decrease)/Increase in accrued expenses (573,565) 1,754,970 
Increase in accrued tax liability    158,586 
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES  (3,602,378) 968,437 
Decrease in accrued expenses (140,958) (573,565)
     
NET CASH USED IN OPERATING ACTIVITIES  (6,741,013) (3,602,378)
          
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchases of property and equipment (301,720) (908,323) (2,541,693) (301,720)
Proceeds from disposal of property and equipment 9,065 25,000   9,065 
Purchases of intangible assets  (25,838) (124,216)  (36,003) (25,838)
NET CASH USED IN INVESTING ACTIVITIES  (318,493) (1,007,539)  (2,577,696) (318,493)
          
CASH FLOWS FROM FINANCING ACTIVITIES          
Borrowings from indebtedness 924,389 4,976,508  644,733 924,389 
Payments on indebtedness (251,255) (4,976,508) (508,583) (251,255)
Proceeds from issuance of equity 1,230,000 26,606,486  314,000 1,230,000 
Common stock issuance as settlement for litigation 938,094    938,094 
Payments on finance lease liability  (2,232) (4,502)  (25,062) (2,232)
NET CASH PROVIDED BY FINANCING ACTIVITIES  2,838,996  26,601,984   425,088  2,838,996 
          
NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS (1,081,875) 26,562,882 
NET DECREASE IN CASH AND CASH EQUIVALENTS (8,893,621) (1,081,875)
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 $26,233,411 $32,433,811  $16,441,268 $26,233,411 
          
Supplemental Information          
Cash paid during the periods for:          
Interest $6,194 $27,698  $15,700 $6,194 
Income Taxes $850 $318,983  $ $850 
          
Schedule of Non-Cash Operating, Investing and Financing Activities:          
Issuance of common stock as compensation $295,947 $180,006  $355,505 $295,947 
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 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Earnings Stock Equity 
                   
Three and Nine Months Ended September 30, 2021                  
                   
BALANCE, DECEMBER 31, 2020 46,680,119 $466,801 $35,880,986 $3,652,754 $(3,843,562)$36,156,979 
                   
Issuance of stock-based compensation 10,124  101  56,149      56,250 
Compensation expense related to stock options     677,934      677,934 
Litigation settlement share issuance 95,238  952  937,142      938,094 
Issuance upon options exercised 1,110,580  11,106  1,218,894      1,230,000 
Net 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 14,615  146  97,050      97,196 
Compensation expense related to stock options     441,841      441,841 
Compensation expense related to restricted stock awards     66,135      66,135 
Net loss       (1,124,549)   (1,124,549)
BALANCE, JUNE 30, 2021 47,910,676 $479,106 $39,376,131 $1,252,067 $(3,843,562)$37,263,742 
                   
Issuance of stock-based compensation 20,988  211  142,290      142,501 
Compensation expense related to stock options     406,414      406,414 
Compensation expense related to restricted stock awards     79,362      79,362 
Net loss       (1,093,778)   (1,093,778)
BALANCE, SEPTEMBER 30, 2021 47,931,664 $479,317 $40,004,197 $158,289 $(3,843,562)$36,798,241 

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

               
    Additional Retained   Total 
  Common Stock Paid-in Earnings Treasury Stockholders’ 
  Shares Amount Capital (Deficit) Stock Equity 
                   
Three and Nine Months Ended
September 30, 2022
                  
                   
BALANCE, DECEMBER 31, 2021 48,044,162 $480,441 $40,774,245 $(910,069)$(3,843,562)$36,501,055 
                   
Issuance of stock-based compensation 47,500  475  142,025      142,500 
Compensation expense related to stock options     524,670      524,670 
Compensation expense related to restricted stock awards     170,386      170,386 
Issuance upon options exercised 29,627  296  (296)      
Net loss       (2,537,514)   (2,537,514)
BALANCE, MARCH 31, 2022 48,121,289 $481,212 $41,611,030 $(3,447,583)$(3,843,562)$34,801,097 
                   
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 
                   
Issuance of stock-based compensation 45,936  460  97,041      97,501 
Compensation expense related to stock options     514,047      514,047 
Compensation expense related to restricted stock awards     170,387      170,387 
Issuance upon options exercised 203,468  2,034  311,966        314,000)
Net loss       (1,225,560)   (1,225,560)
BALANCE, SEPTEMBER 30, 2022 48,657,023 $486,570 $43,443,201 $(7,594,484)$(3,843,562)$32,491,725 

 

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REPRO MED 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 Nine Months Ended September 30, 2020 
Three and Nine Months Ended
September 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 
Cancellation of common stock       
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 
  
Issuance of stock-based compensation 6,681 67 59,935   60,002  20,988 211 142,290   142,501 
Compensation expense related to stock options   346,323   346,323    406,414   406,414 
Issuance upon options exercised 25,006 250 (250)    
Capital raise   38,625   38,625 
Net income       249,175    249,175 
BALANCE, SEPTEMBER 30, 2020 46,671,807 $466,718 $35,331,483 $4,487,382 $(344,204)$39,941,379 
Compensation expense related to restricted stock awards   79,362   79,362 
Net loss       (1,093,778)   (1,093,778)
BALANCE, SEPTEMBER 30, 2021 47,931,664 $479,317 $40,004,197 $158,289 $(3,843,562)$36,798,241 

 

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 infusionsubcutaneous drug delivery 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 and an omnibus equity incentive 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.

The Company also maintains a non-employee director compensation plan. 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. To date the Company has only granted shares of stock for director fees under this plan and those shares of stock granted are recorded at the fair value of the shares at the grant date.

 

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

 

NET INCOMELOSS PER COMMON SHARE

 

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

Schedule of net loss per common share

                      
 Three Months Ended Nine Months Ended  Three Months Ended Nine Months Ended 
 September 30, September 30,  September 30, September 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
                        
Net (loss)/income $(1,093,778)$249,175 $(3,494,465)$(377,435)
Net loss $(1,225,560)$(1,093,778)$(6,684,415)$(3,494,465)
                  
Weighted Average Outstanding Shares:                  
Outstanding shares 44,322,335 43,914,542 44,510,021 41,326,815  45,038,181 44,322,335 44,877,366 44,510,021 
Option shares includable  0(a) 204,969(a) 0(a) 0(a)  (a) (a) (a) (a)
Total  45,038,181  44,322,335  44,877,366  44,510,021 
  44,322,335  44,119,511  44,510,021  41,326,815          
         
Net (loss)/income per share         
Net loss per share         
Basic $(0.02)$0.01 $(0.08)$(0.01) $(0.03)$(0.02)$(0.15)$(0.08)
Diluted $(0.02)$0.01 $(0.08)$(0.01) $(0.03)$(0.02)$(0.15)$(0.08)

__________

(a)

For the three months ended September 30, 2022, and 2021, option shares of 72,347 and 296,504 respectively, were not included as the impact is anti-dilutive.  For the nine months ended September 30, 2021,2022, and 2020,2021, option shares of 244,42281,723 and 203,121244,422 respectively, were not included as the impact is anti-dilutive.

For the three months ended September 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 nine months ended September 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 (including testing and registration services) 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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Rebates are provided to distributors for the difference in selling price to distributor and pricing specified to select customers.  In addition, rebates are provided to customers for meeting growth targets.  Provisions for both 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 core 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 nine months ended September 30, 2021,2022, and 2020:2021:

 Schedule of net sales by geography

 Three Months Ended September 30, Nine Months Ended September 30,  Three Months Ended September 30, Nine Months Ended September 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
Sales                         
Domestic $5,254,336 $5,372,536 $14,346,895 $17,459,212  $6,661,196 $5,254,336 $17,475,083 $14,346,895 
International  786,208  707,779  2,652,774  2,660,016   1,099,202  786,208  3,076,273  2,652,774 
Total $6,040,544 $6,080,315 $16,999,669 $20,119,228  $7,760,398 $6,040,544 $20,551,356 $16,999,669 

 

 

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 has had no impact on our financial statement disclosures.

 

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ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

 

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

 

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

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

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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 nine months ended September 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 September 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 atat:

Schedule of property and equipment:

  September 30, 2022 December 31, 2021 
        
Furniture and office equipment $896,655 $818,897 
Construction in progress  803,931   
Leasehold improvements  1,598,037  556,907 
Manufacturing equipment and tooling  2,646,962  2,042,675 
   Total property and equipment  5,945,585  3,418,479 
Less: accumulated depreciation and amortization  (2,626,973) (2,312,034)
Property and equipment, net $3,318,612 $1,106,445 

 

  September 30, 2021 December 31, 2020 
        
Furniture and office equipment $799,761 $753,536 
Leasehold improvements  556,907  542,796 
Manufacturing equipment and tooling  2,028,807  1,856,909 
   Total property and equipment  3,385,475  3,153,241 
Less: accumulated depreciation and amortization  (2,225,656) (1,985,618)
Property and equipment, net $1,159,819 $1,167,623 

Construction in progress and leasehold improvement increases of $0.8 million and $1.0 million, respectively are due to the new corporate headquarters and manufacturing facility buildout.

 

Depreciation expense was $100,502130,882 and $99,071100,502 for the three months ended September 30, 2021,2022 and 2020,2021, respectively, and $301,469329,526 and $251,084301,469 for the nine months ended September 30, 2022 and 2021, and 2020, respectively.

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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.

 

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

 

The Company has twothree equity incentive plans: the 2015 Stock Option Plan, as amended (the “2015 Plan”) and, the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”). , and the Non-Employee Director Compensation Plan. The Company has also issued restricted stock as employment inducement awards to its Chief Executive Officer.

As of September 30, 2021,2022, there were options to purchase 3,385,0002,650,000 shares of the Company’s common stock outstanding to certain executives, key employees and consultants under the 2015 Plan, of which 1,650,000zero were issued during the three months ended September 30, 2022 and 295,000 were issued during the nine months ended September 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.

The 2021 Plan provides for the grant of up to 1,000,000 incentive stock options, nonqualified stock options, stock awards, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, consultants and directors. During the three and nine months ended September 30, 2022, there were issued zero 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 Plan. As of September 30, 2021,2022, there had been issued 20,988 shares of common stock as directors fees under the 2021 Plan.

Prior to January 1, 2021, each non-employee director of the Company was eligible to receive $50,000 annually (effective January 1, 2019), plus $10,000 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.

 

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor were eligible to receive of $75,000 annually, to be paid quarterly $12,500 in cash and $6,250 in common stockstock..  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 stockstock..   Effective May 18, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor are eligible to receive of $110,000 annually, to be paid quarterly $12,500 in cash and $15,000 in common stockstock..  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 stockstock.. 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.

 

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

On 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. These awards were issued as an inducement employment.

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2015 STOCK OPTION PLAN, as amended

 

Time Based Stock Options

 

The per share weighted average fair value of stock options granted during the nine months ended September 30, 20212022 and September 30, 20202021 was $2.93$2.10 and $6.53,$2.93, 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 nine months ended September 30, 20212022 and September 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 $56,102151,736 and $150,56656,102 for the nine months ended September 30, 20212022 and 2020,2021, respectively.

Schedule of time based stock options

 September 30,  September 30, 
 2021 2020  2022 2021 
            
Dividend yield 0.00% 0.00%  0.00% 0.00% 
Expected Volatility 74.0176.77% 62.1162.18%  65.9% - 77.5% 74.01% - 76.77% 
Weighted-average volatility 0 0    
Expected dividends 0 0    
Expected term (in years) 10 10  10 10 
Risk-free rate 1.201.62% 0.63 0.64%  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:

Schedule of status of time based stock options

 Nine Months Ended September 30,  Nine Months Ended September 30, 
 2021 2020  2022 2021 
 Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
            
Outstanding at January 1 2,922,494 $2.46 3,647,000 $1.32  3,672,500 $3.42  2,922,494 $2.46 
Granted 1,650,000 $3.75 360,000 $9.54  295,000 $2.70 1,650,000 $3.75 
Exercised 1,000,000 $1.23 747,006 $0.65  831,250 $1.57 1,000,000 $1.23 
Forfeited 187,494 $3.36 200,000 $2.09  486,250 $2.73 187,494 $3.36 
Outstanding at September 30 3,385,000 $3.39 3,059,994 $2.40  2,650,000 $4.05 3,385,000 $3.39 
Options exercisable at September 30 1,005,625 $2.65 1,009,629 $1.36  825,000 $4.41 1,005,625 $2.65 
Weighted average fair value of options granted during the period  $2.93  $6.53   $2.10  $2.93 
Stock-based compensation expense  $1,934,935  $572,775   $1,465,567  $1,934,935 

 

Total stock-based compensation expense was $1,934,9351,465,567 and $572,7751,934,935 for the nine months ended September 30, 2021,2022, and 2020,2021, respectively. Cash received from option exercises for the nine months ended September 30, 2021,2022, and 20202021 was $1,230,000314,000 and $95,8801,230,000, respectively.

 

The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2021,2022, and 20202021 was $4.80.6 million and $2.44.8 million,, respectively.  There were 1.0 million831,250 options exercised during the nine months ended September 30, 2021,2022, and 747,0061.0 million during the nine months ended September 30, 2020.2021.

 

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

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
 
              
$1.57-$9.49 2,650,000 8.1 years $4.05 825,000 $4.41 

 

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 3,385,000 7.8 years $3.39 1,005,625 $2.65 

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As of September 30, 2021,2022, there was $5.84,581,923 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 4645 months.  The total fair value of shares vested as of September 30, 2021,2022, and September 30, 2020,2021, was $1,909,1412,679,152 and $874,0411,909,141, respectively.

 

Performance Based Stock Options

 

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

 

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

Schedule of performance base stock options:

 Nine Months Ended September 30,  Nine Months Ended September 30, 
 2021 2020  2022 2021 
 Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 1,000,000 $1.70 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 September 30 0 $ 1,000,000 $1.70   $ 1,000,000 $1.70 
Options exercisable at September 30 0 $0 333,333 $1.70   $  $ 
Weighted average fair value of options granted during the period 0 $ 0 $   $  $ 
Stock-based compensation expense  $(408,747) $438,365   $  $(408,747)

 

Total performance stock-based compensation expense totaled zero and ($408,747) and $438,365 for the nine months ended September 30, 2021,2022, and 2020,2021, respectively. All performance-basedperformance based stock options were forfeited as of September 30, 2021, and there was 0no unrecognized compensation cost remaining.

2021 STOCK OPTION PLAN, as amended

Time Based Stock Options

The per share weighted average fair value of stock options granted during the nine months ended September 30, 2022 and September 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 nine months ended September 30, 2022 and September 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 $20,677 and $0 for the nine months ended September 30, 2022 and 2021, respectively.

Schedule of time based stock options

  September 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

  Nine Months Ended September 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 September 30 475,000 $2.67   $ 
Options exercisable at September 30 0 $   $ 
Weighted average fair value of options granted during the period  $1.99   $ 
Stock-based compensation expense  $98,460   $ 

Total stock-based compensation expense was $98,460 and $0 for the nine months ended September 30, 2022, and 2021, respectively. There were no options exercised during the nine months ended September 30, 2022 and September 30, 2021.

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

The following table presents information pertaining to options outstanding at September 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 9.6 years $2.67 0 $0 

As of September 30, 2022, there was $846,755 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 September 30, 2022, and September 30, 2021, was zero and zero, respectively.

 

RESTRICTED STOCK AWARDS

 

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

Schedule of activities for restricted stock awards

  Nine Months Ended September 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 September 30 950,000 $2.99 1,000,000 $3.01 

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Table of Contents

 

  Nine Months Ended September 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 September 30 1,000,000 $3.01 0 $0 

As of September 30, 2022, and 2021, there was $1,788,565 and $2,379,089 of unrecognized compensation cost related to unvested employee restricted shares. This amount is expected to be recognized over a weighted-average period of 3921 months. We have recognized tax benefits associated with restricted stock award compensation of $30,554107,344 and $030,554 for the nine months ended September 30, 2022 and 2021, and 2020, respectively.

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NOTE 5 — DEBT OBLIGATIONS

 

On July 26,June 29, 2022, the Company entered into a Loan Modification Extension Agreement (the “Modification Agreement”) with Keybank National Association (“Lender”) to modify its revolving line of credit with Lender in the amount of $3,500,000 (the “Loan”) that was originally made available on April 14, 2020 and renewed on June 24, 2021. Among other things, the Modification Agreement: (i) extends the maturity date of the Loan from June 1, 2022 to June 1, 2023; (ii) changes the interest rate applicable to the Loan from Prime – 1.50% to Prime + 0%; (iii) releases the Company from its obligations under a certain security agreement dated June 24, 2021 pursuant to which the Company had previously granted the Lender a first priority security interest in all equipment, inventory, accounts, instruments, chattel paper and general intangibles of the Company (the “Security Agreement”); and (iv) replaces the Security 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’s bank accounts as collateral security for the Loan. The Company had no amount outstanding against the line of credit as of September 30, 2022.

On August 5, 2022, the Company entered into a commercial insurance premium finance and security agreement with AON Premium Finance, LLC in the aggregate principal amount of $0.90.8 million bearing an annual percentage rate of 4.176.5%, to finance its insurance premiums. Monthly payments arewere due on the first of each month beginning August 1, 20212022 through June 1, 2022.

On April 14, 2020, the Company issued a promissory note to KeyBank in the aggregate principal amount of $3.5 million (the “Note”) as an extension of its line of credit, replacing its then current line of credit agreement.  The $3.5 million Note is in the form of a variable rate non-disclosable revolving line of credit with an interest rate of Prime Rate announced by the Bank minus 0.75%.  The Note was renewed on June 24, 2021, in the same form with an interest rate of Prime Rate announced by the Bank minus 1.50%. Interest is due monthly, and all principal and unpaid interest is due on June 1, 20222023.  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, the Company entered into a Commercial Security Agreement with the Bank dated April 14, 2020 (the “Security Agreement”), pursuant to which the Company granted a security interest in substantially all assets of the Company to secure the obligations of the Company under the Note.  The Security Agreement contains terms and conditions typical for the granting of security interests of this kind.

The Company had no amount outstanding against the line of credit as of September 30, 2021.

On April 27, 2020, the Company entered into a Progress Payment Loan and Security Agreement (“PPLSA”) and a Master Security Agreement (the “MSA”), each dated as of April 20, 2020, with Key Equipment Finance, a division of the Bank (“KEF”), to provide up to $2.5 million in financing for equipment purchases from third party vendors.  The PPLSA allows the Company to make draws with KEF to make certain payments to the equipment suppliers prior to the commencement of periodic payments under a term loan. Each draw under the PPLSA will bear interest at a variable rate equal to the then-current Prime Rate and will be secured by the financed equipment under the MSA.  At the end of each calendar quarter or year, the advances made under the PPLSA will be converted to term loans, subject to KEF’s approval of the equipment and certain other closing conditions being met.  Once the draws under the PPLSA are converted into a term loan, each promissory note will bear interest at 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 of September 30, 2021, the Company had no amount outstanding against the PPLSA.

 

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. On September 29, 2022, we extended our existing lease in Chester NY through March 31, 2023 with the same payment terms. 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 1 year.5 years.

 

The components of lease expense were as follows:

Schedule of components of lease expense

                        
 Three Months Ended Nine Months Ended  Three Months Ended Nine Months Ended 
 September 30, September 30,  September 30, September 30, 
 2021 2020 2021 2020  2022 2021 2022 2021 
              
Operating lease cost $37,093 $37,921 $112,383 $113,764  $157,076 $37,093 $396,658 $112,383 
Short-term lease cost  35,960  19,846  104,396  33,535   18,300  35,960  96,588  104,396 
Total lease cost $73,053 $57,767 $216,779 $147,299  $175,376 $73,053 $493,246 $216,779 
  
Finance lease cost:  
Amortization of right-of-use assets $597 $791 $2,188 $4,502  $17,754 $597 $23,672 $2,188 
Interest on lease liabilities  10  47  57  199   1,381  10  1,381  57 
Total finance lease cost $607 $838 $2,245 $4,701  $19,135 $607 $25,053 $2,245 

 

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Supplemental cash flow information related to leases was as follows:

Schedule of cash flow information related to leases

             
 Nine Months Ended  Nine Months Ended 
 September 30,  September 30, 
 2021 2020  2022 2021 
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows from operating leases $105,618 $113,764  $301,150 $105,618 
Financing cash flows from finance leases 2,232 4,502  26,443 2,232 

 

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Table of Contents

 

Supplemental balance sheet information related to leases was as follows:

Schedule of balance sheet information related to leases

  September 30,
2022
 December 31,
2021
 
        
Operating Leases       
Operating lease right-of-use assets $3,865,370 $95,553 
        
Operating lease current liabilities  342,399  95,553 
Operating lease long term liabilities  3,741,015   
Total operating lease liabilities $4,083,414 $95,553 
        
Finance Leases       
Property and equipment, at cost $355,071 $12,725 
Accumulated depreciation  23,671  (12,725)
Property and equipment, net $331,400 $ 
        
Finance lease current liabilities  64,467   
Finance lease long term liabilities  265,542   
Total finance lease liabilities $330,009 $ 

 

  September 30,
2021
 December 31,
2020
 
        
Operating Leases       
Operating lease right-of-use assets $131,228 $236,846 
        
Operating lease current liabilities  131,228  141,293 
Operating lease long term liabilities    95,553 
Total operating lease liabilities $131,228 $236,846 
        
Finance Leases       
Property and equipment, at cost $12,725 $12,725 
Accumulated depreciation  (12,327) (10,139)
Property and equipment, net $398 $2,586 
        
Finance lease current liabilities  414  2,646 
Finance lease long term liabilities     
Total finance lease liabilities $414 $2,646 
  September 30,
2022
 December 31,
2021
 
      
Weighted Average Remaining Lease Term     
Operating leases 10.1 Years 0.6 Years 
Finance leases 4.9 Years 0 Years 
      
Weighted Average Discount Rate     
Operating leases 4.02% 4.75% 
Finance leases 4.25% 4.75% 

 

  September 30,
2021
 December 31,
2020
 
      
Weighted Average Remaining Lease Term     
Operating leases 0.9 Years 1.4 Years 
Finance leases 0.2 Years 0.7 Years 
      
Weighted Average Discount Rate     
Operating leases 4.75% 4.75% 
Finance leases 4.75% 4.75% 

Maturities of lease liabilities are as follows:

Schedule of maturities of lease liabilities

Year Ending December 31, Operating Leases Finance Leases 
2022 (excluding the nine months ended September 30, 2022)  124,876  19,832 
2023  499,503  79,329 
2024  499,503  79,329 
2025  499,503  79,329 
2026  499,503  79,329 
Thereafter  2,830,519  33,052 
Total undiscounted lease payments  4,953,407  370,200 
Less: imputed interest  (869,993) (40,191)
Total lease liabilities $4,083,414 $330,009 

 

Year Ending December 31, Operating Leases Finance Leases 
2021 (excluding the nine months ended September 30, 2021)  $37,092  $417 
2022  97,257  0 
2023  0  0 
2024  0  0 
2025  0  0 
Thereafter  0  0 
Total undiscounted lease payments  134,349  417 
Less: imputed interest  (3,121) (3)
Total lease liabilities $131,228 $414 

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NOTE 7 — EQUITY

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

On November 16, 2020, the Company announced that its Board of Directors had authorized a stock repurchase program under which the Company may purchase up to $10.0 million of its outstanding common stock through December 31, 2021.  As of September 30, 2021, the Company had purchased 683,271 shares for an aggregate $3,499,358 pursuant to this program. Management does not intend to make any further purchases before the end of the year.

 

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Table of Contents

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 and the SCIg market, our ability to partner with biopharmaceutical companies in our novel therapies business, 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® FREEDOM system 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, reduction of inventory, 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 infusionsubcutaneous drug delivery 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.

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 Medical syringe driver.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 transition 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.

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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 first quarter 2023.

The Company ended the 2022 third fiscal quarter with $7.8 million in net sales, werea 28.5% increase, compared with $6.0 million for the third quarter of 2021, nearly even within the same period last year which included inventory stockingdriven by growth in all three of $0.6 million last year. Sequential quarter net sales fromour business sources.

Gross profit, for the three months ended JuneSeptember 30, 2021, grew 9%, driven by domestic core growth2022, was $4.3 million, an increase of 10%.

Our gross margin, which is our gross profit,23.7% from the same period last year, and stated as a percentage of net sales for the period was 57.9%55.7%, a decline from 57.9% in the prior year of 64.8%. The majority of the decline, or (9.2) percentage points, was driven by delays in the transition to our secondary manufacturing source. We also recorded a reserve for in-process material scrap, or (3.6) percentage points. This was partially offset by 5.7 percentage points of favorability mostly due to price/mix as we sold more pumps and needles when compared to last year.period.

 

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Operating expenses for the three months ended September 30, 2022, were $5.9 million, up from $4.8 million for the same period last year, driven primarily by research and development, and for selling, general and administrative for new hires to support commercialization, business development, quality, and regulatory capabilities.

 

RESULTS OF OPERATIONS

 

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

 

Net Sales

 

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

 

 Three Months Ended September 30, Change from Prior Year % of Net Sales  Three Months Ended September 30, Change from Prior Year % of Net Sales 
 2021 2020 $ % 2021 2020  2022 2021 $ % 2022 2021 
Net Sales                                
Domestic Core $5,076,294 $5,289,076 $(212,782)(4.0%)84.0% 87.0%  $5,900,042 $5,076,294 $823,748 16.2% 76.0% 84.0% 
Novel Therapies  178,042  83,460  94,582 113.3% 2.9% 1.4% 
Total Domestic 5,254,336 5,372,536 (118,200)(2.2%)87.0% 88.4% 
 
International Core 747,281 702,034 45,247 6.4% 12.4% 11.5%  1,096,746 747,281 349,465 46.8% 14.1% 12.4% 
Novel Therapies  38,927  5,745  33,182 577.6% 0.6% 0.1%   763,610  216,969  546,641 251.9% 9.9% 3.6% 
Total International  786,208  707,779  78,429 11.1% 13.0% 11.6% 
Total $6,040,544 $6,080,315 $(39,771)(0.7%)  $7,760,398 $6,040,544 $1,719,854 28.5% 

 

Total net sales decreased $39,771,increased $1.7 million, or 0.7%28.5%, for the three months ended September 30, 2021, as compared with the same period last year, which included approximately $0.6 million of inventory stocking related net sales. International core net sales for the three months ended September 30, 2021, grew 6.4% as compared with the same period last year driven by increased consumables sales. Novel therapies sales also increased for the three months ended September 30, 2021,2022, as compared with the same period last year as we continuesaw double digit growth across all businesses. Domestic core growth was primarily driven by increased volume attributed to expandSCIg market growth and label expansions including prefill syringes, as well as clearing of $0.3 million in backorders from the second quarter of 2022. Novel therapies sales grew by 252% in the third quarter of 2022 related to services performed on an NRE innovation development agreement for a pharmaceutical customer and increases in clinical trial product sales for several pharmaceutical customers. Sales growth in our pharmaceutical pipeline.international core business was driven by volume growth in certain EU markets compared with prior year.

 

Gross Profit

 

Our gross profit for the three months ended September 30, 2021,2022 and 20202021 is as follows:

 

 Three Months Ended September 30, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2021 2020 $  %  2022 2021 $  % 
Gross Profit $3,495,750 $3,940,723 $(444,973) (11.3%) $4,322,362 $3,495,750 $826,612  23.7% 
Stated as a Percentage of Net Sales 57.9% 64.8%    55.7% 57.9%   

 

Gross profit decreased $0.4increased $0.8 million or 11.3%23.7% in the three months ended September 30, 2021, as2022, compared to the same period in 2020.

2021. This increase in the 2022 third quarter was driven by volume increase in net sales of $1.7 million as described above. Gross profit statedas a percent of sales decreased to 55.7% compared to 57.9% from the third quarter of 2021.  The decline in the gross profit percent was primarily caused by higher manufacturing costs associated with labor and materials, and production rework completed in the current quarter. Product mix had a negative impact as we saw increased consumable sales across our core domestic business, and NRE service revenue mix contributed to a lower gross profit as a percentage of sales, which is referred to as gross margin, declined (6.9) percentage points. The majoritysales. Partially offsetting these declines was an increase in average selling prices.

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Table of the decline, (9.2) percentage points, was driven by delays in the transition to our secondary manufacturing source. We also recorded a reserve for in-process material scrap of (3.6) percentage points. This was partially offset by 5.7 percentage points of favorability due to price/mix.Contents

 

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 September 30, 2021,2022 and 20202021 are as follows:

 

 Three Months Ended September 30, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Selling, general and administrative $3,901,830 $3,075,169 $826,661 26.9%  $4,825,349 $3,901,830 $923,519 23.7% 
Litigation  675 (675)(100.0%)
Research and development  800,020  390,416  409,604 104.9%   862,148  800,020  62,128 7.8% 
 $4,701,850 $3,466,260 $1,235,590 35.6%  $5,687,497 $4,701,850 $985,647 21.1% 
Stated as a Percentage of Net Sales 77.8% 57.0%  73.3% 77.8% 

 

Selling, general and administrative expenses increased $0.8$0.9 million, or 26.9%23.7%, during the three months ended September 30, 20212022 compared to the same period last year, primarily due primarily to higher salary$0.7 million in compensation and related benefits as we build our executive team, as well as consulting fees for our 510K filings and commercialization efforts,associated with new hires, $0.2 million in aggregate $0.6 million. The remaining amount wasseverance relating to the employment termination of the Chief Operating Officer, $0.2 million in building expenses related to higher boardour manufacturing move, $0.1 million in stock compensation partially offset by lower consulting costs of director fees$0.1 million and related liability insurance in aggregatelower recruitment costs of $0.2 million.

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Research and development expenses increased $0.4$0.1 million during the three months ended September 30, 2021,2022 compared with the same period last year, as we have higher salary and related expensesprimarily due to building our internal research and development team and consulting fees$0.3 million in new hires to support product development for novel therapies, as well as the disposalour innovation efforts, which was partially offset by lower testing material costs of expired samples$0.2 million and lower recruiting costs of $0.2$0.1 million.

 

Depreciation and amortization

 

Depreciation and amortization expense increased by 0.3 %41.8% to $164,344 in the three months ended September 30, 2022 compared with $115,934 in the three months ended September 30, 2021 compared with $115,637resulting from investment in the three months ended September 30, 2020.  We continue to invest in capital assets, mostly related toour corporate office and manufacturing and computer equipment, offset by assets reaching their remaining useful life.site move.

 

Net (Loss)/IncomeLoss

 

 Three Months Ended September 30, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Net (Loss)/Income $(1,093,778$249,175 $(1,342,953)(539.0%)
Net Loss $(1,225,560)$(1,093,778)$(131,782)12.1% 
Stated as a Percentage of Net Sales (18.1% 4.1%  (15.8%) (18.1%) 

 

Our net loss was $1.1increased $0.1 million in the three months ended September 30, 2021,2022 compared with net income of $0.2 million inthe same period last year mostly driven by lower gross profit,higher operating expenses due to higher selling, general and administrative expenses and higher research and development expenses all as described above.related to our strategy to build our novel therapies business and innovation. A favorable tax benefit for the periodof $0.3 million resulting from the loss was also recognizedrecorded during the three months ended September 30, 2021.period.

 

Nine months ended September 30, 2021,2022 compared to September 30, 20202021

 

Net Sales

 

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

 

 Nine Months Ended September 30, Change from Prior Year % of Net Sales  Nine Months Ended September 30, Change from Prior Year % of Net Sales 
 2021 2020 $ % 2021 2020  2022 2021 $ % 2022 2021 
Net Sales                                
Domestic Core $14,084,552 $15,719,419 $(1,634,867)(10.4%)82.9% 78.1%  $15,890,369 $14,084,552 $1,805,817 12.8% 77.3% 82.9% 
Novel Therapies  262,343  1,739,793  (1,477,450)(84.9%)1.5% 8.6% 
Total Domestic 14,346,895 17,459,212 (3,112,317)(17.8%)84.4% 86.8% 
 
International Core 2,585,881 2,539,944 45,937 1.8% 15.2% 12.6%  2,943,173 2,585,881 357,292 13.8% 14.3% 15.2% 
Novel Therapies  66,893  120,072  (53,179)(44.3%)0.4% 0.6%   1,717,814  329,236  1,388,578 421.8% 8.4% 1.9% 
Total International  2,652,774  2,660,016  (7,242)(0.3%)15.6% 13.2% 
Total $16,999,669 $20,119,228 $(3,119,559)(15.5%)  $20,551,356 $16,999,669 $3,551,687 20.9% 

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Table of Contents

 

Total net sales decreased $3.1increased $3.6 million or 15.5%20.9% for the nine months ended September 30, 2021,2022, as compared to the prior year period, driven primarily by lowerhigher domestic core net sales of $1.8 million driven by volume growth in our consumables and pump business resulting from our label expansions including prefills, existing customers, and an overall SCIg market growth. Further contributing were higher novel therapies sales of $1.5$1.4 million compared with last year mostly due to a non-recurringcompletion of two NRE product innovation milestones and clinical trial last year and lower domestic core netproduct sales driven by what we believe to be inventory stocking andfor an early order $1.3 million last year at our largest distributor.expanded pharmaceutical pipeline. International core net sales were $2.6higher by $0.4 million 1.8% higher than within the same period last year,first nine months of 2022, driven by volume growth in our European expansion activity.consumables and pump business.

 

Gross Profit

 

Our gross profit for the nine months ended September 30, 2021,2022 and 20202021 is as follows:

 

 Nine Months Ended September 30, Change from Prior Year  Nine Months Ended September 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Gross Profit $9,937,788 $12,638,813 $(2,701,025)(21.4%) $11,290,840 $9,937,788 $1,353,052 13.6% 
Stated as a Percentage of Net Sales 58.5% 62.8%  54.9% 58.5% 

 

Gross profit decreased $2.7increased $1.4 million or 21.4%13.6% in the nine months ended September 30, 2021, as2022, compared to the same period last year. Gross margin declined (4.3) percentage points. The majorityThis increase in the first nine months of the decline, (2.8) percentage points,2022 was mostly driven by the increase in net sales of $3.5 million as described above. Gross profit, stated as a delaypercentage of net sales, was impacted by higher manufacturing costs due to supply chain issues, labor and material costs, and higher NRE revenue at lower margins recorded in the transition to our secondary manufacturing source and unfavorable mix impactnine months of (2.1) percentage points driven2022, partially offset by lower pump sales compared to last year due what we believe to be covid related stocking last year.

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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 nine months ended September 30, 2021,2022 and 20202021 are as follows:

 Nine Months Ended September 30, Change from Prior Year  Nine Months Ended September 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Selling, general and administrative $12,980,604 $9,039,980 $3,940,624 43.6%  $15,846,584 $12,980,604 $2,865,980 22.1% 
Litigation  2,446,747 (2,446,747)(100.0%)
Research and development  1,523,739  944,637  579,102 61.3%   3,314,233  1,523,739  1,790,494 117.5% 
 $14,504,343 $12,431,364 $2,072,979 16.7%  $19,160,817 $14,504,343 $4,656,474 32.1% 
Stated as a Percentage of Net Sales 85.3% 61.8%  93.2% 85.3% 

 

Selling, general and administrative expenses increased $3.9$2.9 million, or 43.6%22.1%, during the nine months ended September 30, 2021,2022 compared to the same period last year, primarily due primarily to $1.6$2.1 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 higher salary and related benefits of $1.0 million from new hires in the second half of last yearsales, quality and regulatory to support commercialization, business developmentour strategic growth initiatives, $0.3 million in recruitment fees, $0.3 million in stock compensation, $0.3 million in building related expense, $0.2 million in travel related costs and medical affairs for our novel therapies initiatives, as well as infrastructure. Market research, testing and consulting fees to support commercialization and regulatory filings of $0.9$0.1 million and higher director fees and director and officerin liability insurance, which was partially offset by lower restructuring costs of $0.6 million also contributed. Offsetting these expenses were the Covid-related heroes bonus paid last year and lower other miscellaneous expenses, in aggregate $0.2$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 $0.6$1.8 million during the nine months ended September 30, 2021,2022 compared with the same period last year mostlyprimarily due to increases$1.0 million in consulting fees and $0.8 million in compensation and benefits for new hires to support product development for novel therapies, as well as the write-off of expired samples.and $0.1 million in stock compensation, which was partially offset by $0.1 million in reduced testing material expense.

 

Depreciation and amortization

 

Depreciation and amortization expense increased by 17.5%14.2% to $399,479 the nine months ended September 30, 2022 compared with $349,822 in the nine months ended September 30, 2021 compared with $297,801due to investment in the nine months ended September 30, 2020.  We continue to invest in capital assets, mostly related toour corporate office and manufacturing and computer equipment.site move.

 

Net (Loss)/IncomeLoss

 Nine Months Ended September 30, Change from Prior Year  Nine Months Ended September 30, Change from Prior Year 
 2021 2020 $ %  2022 2021 $ % 
Net Loss $(3,494,465)$(377,435)$(3,117,030)825.8%  $(6,684,415)$(3,494,465)$(3,189,950)91.3% 
Stated as a Percentage of Net Sales (20.6%) (1.9%)  (32.5%) (20.6%) 

 

Our net loss for the nine months ended September 30, 2021,2022 was $3.5$6.7 million compared to net loss of $0.4$3.5 million for the nine months ended September 30, 2020,2021, driven by lower gross profit, higher selling, general and administrative expenses and research and development expenses, offset by litigation expenses incurred last year, all as described above. Offsetting the loss was a tax benefitexpenses.

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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 $26.2$16.4 million as of September 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, funding of research and related costs, anddevelopment, selling, general and administrative expenses. To develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in manufacturing technologies, facilities and equipment, and research and development. We estimate operating expenses to be between $26.5 million and $27.5 million in 2022.

 

- 21 -Our 2022 capital investments for manufacturing and leasehold improvements for our new facility is expected to be in the aggregate between $1.5 million and $2.0 million, net of pre-approved financing arrangements and leasehold improvement credits totaling $0.9 million and $0.2 million respectively, which are expected to be fully executed in the fourth quarter of 2022.


Our accounts receivable balance was $5.1 million at September 30, 2022, which reflected a $1.5 million increase since the beginning of the year. Supply chain issues which caused back-orders in the second quarter of 2022 that were cleared at the end of the third quarter of 2022, resulted in higher receivable balances due to end of quarter shipments.

Our inventory position was $6.9 million at September 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, labor shortages, and our second quarter 2022 backorder. 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 September 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:

 

 Nine Months Ended
September 30, 2021
 Nine Months Ended
September 30, 2020
  Nine Months Ended
September 30, 2022
 Nine Months Ended
September 30, 2021
 
Net cash (used in)/provided by operating activities $(3,602,378)$968,437 
Net cash used in operating activities $(6,741,013)$(3,602,378
Net cash used in investing activities $(318,493)$(1,007,539) $(2,577,696)$(318,493)
Net cash provided by financing activities $2,838,996 $26,601,984  $425,088 $2,838,996 

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Table of Contents

 

Operating Activities

Net cash used in operating activities of $6.7 million for the nine months ended September 30, 2022 was primarily due to the net loss of $6.7 million, working capital changes which included an increase in accounts receivable of $1.4 million, an increase in inventory of $0.7 million, an increase in prepaid expense of 0.2 million, and a decrease in accrued expenses of $0.1 million, offset by an increase in accrued payroll of $0.7 million and an increase in accounts payable and other liabilities of $0.4 million.  Further contributing were deferred tax assets of $1.6 million increased for book to tax differences related to stock option expense.  Offsetting these were primarily non-cash charges for stock-based compensation of $2.7 million, and depreciation and amortization of $0.4 million.

 

Net cash used in operating activities of $3.6 million for the nine months ended September 30, 2021 was primarily due to the net loss of $3.5 million, working capital changes which included an increase in accounts receivable of $0.5 million due to timing, an increase in prepaids of $0.5 million due to insurance renewals, and a decrease in accrued expenses of $0.6 million most of which was non-cash activity related to the issuance of common stock in settlement of litigation. Further contributing were deferred tax assets of $1.4 million mostly increased for book to tax differences related to stock option expense.  Offsetting these were an increase in accounts payable of $0.8 million, non-cash charges for stock-based compensation of $2.0 million, and depreciation and amortization of $0.3 million.

 

Investing Activities

Net cash provided by operatingused in investing activities of $1.0$2.6 million for the nine months endedending September 30, 2020,2022, was mostly attributable to non-cash charges for stock-based compensationcapital expenditures for manufacturing and litigation settlement expense of $2.5 million, an increase in accounts payable, accrued expensesoffice equipment for our corporate office and accrued payroll of $2.8 million, driven by the litigation settlement with EMED, the capital raise and customer rebates.  Further adding to the increase was an increase in depreciation and amortization of $0.3 million and an increase in the accrued tax liability of $0.2 million, resulting from book to tax differences related to stock option expense.  Offsetting these were primarily working capital changes which include an increase in inventory of $3.2 million as we built inventory to keep pace with sales growth and to insure timely order fulfillment, an increase in accounts receivable of $0.5 million due to timing of collections, and an increase in prepaid expenses and other assets of $0.5 million relating to increased insurance premiums.

Investing Activitiesmanufacturing facilities move.

 

Net cash used in investing activities of $0.3 million for the nine months ending September 30, 2021, was for capital expenditures for manufacturing and office equipment.

 

Net cash used in investingFinancing Activities

The $0.4 million provided by financing activities of $1.0 million for the nine months ended September 30, 2020, was primarily2022, is from $0.3 million in option exercises and $0.1 million net borrowings on our indebtedness for capital expendituresa note payable for research and development and strategic initiatives.

Financing Activitiesinsurance premium financing.

 

The $2.8 million provided by financing activities for the nine months ended September 30, 2021, is from options exercised, the non-cash activity related to the issuance of common stock in settlement of litigation and a note payable for insurance premium financing.

 

Net cash provided by financing activities for the nine months ended September 30, 2020, of $26.6 million is from the $26.5 million capital raise, net of expenses 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.

ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

 

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

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

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ITEM 4.  CONTROLS AND PROCEDURES

 

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

 

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

 

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Table of Contents

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.

 

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 in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which could adversely affect our business, financial condition, results of operations, cash flows, and the trading price of our common stock.  There have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2020.

 

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

The Company issued an aggregate 20,988 shares of common stock to its non-employee directors during the three months ended September 30, 2021 under its 2021 Omnibus Equity Incentive Plan.

During the three months ended September 30, 2021, we issued 400,000 options at a weighted average exercise price of $3.17 to two new employees under the 2015 Stock Option Plan.

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 Securities

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

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PART II – ITEM 6.  EXHIBITS.

 

Exhibit No.Description
  
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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Table of Contents

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.
  
November 10, 20219, 2022/s/ Linda Tharby
 Linda Tharby, President and Chief Executive Officer
(Principal Executive Officer)
  
November 10, 20219, 2022/s/ Karen FisherThomas Adams
 Karen Fisher,Thomas Adams, Interim Chief Financial Officer and Treasurer
(Principal Financial Officer)

 

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