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 March 31,September 30, 2022

 

or

 

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

 

For the transition period from ________ to ________.

 

Commission File Number: 0-12305

 

REPRO 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 May 4,November 9, 2022, 44,868,60545,279,948 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 MARCH 31,SEPTEMBER 30, 2022

TABLE OF CONTENTS

 

  PAGE
   
PART I. FINANCIAL INFORMATION
   
ITEM 1.Financial Statements (Unaudited)3
   
 Balance Sheets (Unaudited) as of March 31,September 30, 2022 (Unaudited) and December 31, 20213
   
 Statements of Operations (Unaudited) for the three and nine months ended March 31,September 30, 2022 and 20214
   
 Statements of Cash Flows (Unaudited) for the threenine months ended March 31,September 30, 2022 and 20215
   
 Statements of Stockholders’ Equity (Unaudited) for the three and nine months ended March 31,September 30, 2022 and 202166-7
   
 Notes to Financial Statements78
   
ITEM 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations1618
   
ITEM 3.Quantitative and Qualitative Disclosures About Market Risk1923
   
ITEM 4.Controls and Procedures2023
   
PART II. OTHER INFORMATION
   
ITEM 1.Legal Proceedings20
ITEM 1A.Risk Factors20
ITEM 2.Unregistered Sales of Equity Securities and Use of Proceeds2024
   
ITEM 6.Exhibits2124
   
 Signatures2225

 

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Table of Contents

 

PART I — FINANCIAL INFORMATION

 

Item 1.  Financial Statements (Unaudited)

 

REPRO MEDKORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

 

     
  March 31,  December 31,  September 30, December 31, 
 2022 2021  2022 2021 
            
ASSETS          
          
CURRENT ASSETS          
Cash and cash equivalents $22,577,247 $25,334,889  $16,441,268 $25,334,889 
Accounts receivable less allowance for doubtful accounts of $24,271 for March 31, 2022 and December 31, 2021 3,145,397 3,592,886 
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 6,017,737 6,106,338  6,884,156 6,106,338 
Other Receivables 680,075 718,220  686,108 718,220 
Prepaid expenses  1,510,851  1,568,821   1,660,655  1,568,821 
TOTAL CURRENT ASSETS 33,931,307 37,321,154  30,742,264 37,321,154 
Property and equipment, net 1,763,269 1,106,445  3,318,612 1,106,445 
Intangible assets, net of accumulated amortization of $278,897 and $263,729 at March 31, 2022 and December 31, 2021, respectively 795,339 808,813 
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 4,309,282 95,553  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 2,538,853 1,941,254  3,520,823 1,941,254 
Other assets  89,587  19,812   88,772  19,812 
TOTAL ASSETS $43,427,637 $41,293,031  $42,665,775 $41,293,031 
          
LIABILITIES AND STOCKHOLDERS’ EQUITY          
          
CURRENT LIABILITIES          
Accounts payable $1,267,980 $1,227,533  $1,365,610 $1,227,533 
Accrued expenses 2,171,724 2,709,704  2,568,746 2,709,704 
Note Payable 255,614 508,583  644,733 508,583 
Other Liabilities 115,625 90,000  357,491 90,000 
Accrued payroll and related taxes 506,315 160,603  824,047 160,603 
Operating lease liability - current  395,359  95,553 
Financing lease liability – current 64,467  
Operating lease liability – current  342,399  95,553 
TOTAL CURRENT LIABILITIES 4,712,617 4,791,976  6,167,493 4,791,976 
Financing lease liability, net of current portion 265,542  
Operating lease liability, net of current portion  3,913,923     3,741,015   
TOTAL LIABILITIES  8,626,540  4,791,976   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, 48,121,289 and 48,044,162 shares issued, 44,700,787 and 44,623,660 shares outstanding at March 31, 2022 and December 31, 2021, respectively 481,212 480,441 
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 41,611,030 40,774,245  43,443,201 40,774,245 
Treasury stock, 3,420,502 shares at March 31, 2022 and December 31, 2021, at cost (3,843,562) (3,843,562)
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  (3,447,583) (910,069)  (7,594,484) (910,069)
TOTAL STOCKHOLDERS’ EQUITY  34,801,097  36,501,055   32,491,725 36,501,055 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $43,427,637 $41,293,031  $42,665,775 $41,293,031 

 

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

 

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Table of Contents

 

REPRO MEDKORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

                  
 Three Months Ended  Three Months Ended Nine Months Ended 
 March 31,  September 30, September 30, 
 2022 2021  2022 2021 2022 2021 
                  
NET SALES $6,244,330 $5,430,951  $7,760,398 $6,040,544 $20,551,356 $16,999,669 
Cost of goods sold  2,622,025  2,199,097   3,438,036  2,544,794  9,260,516  7,061,881 
Gross Profit 3,622,305 3,231,854  4,322,362 3,495,750 11,290,840 9,937,788 
              
OPERATING EXPENSES              
Selling, general and administrative 5,491,213 4,992,829  4,825,349 3,901,830 15,846,584 12,980,604 
Research and development 1,148,355 336,841  862,148 800,020 3,314,233 1,523,739 
Depreciation and amortization  109,252  115,473   164,344  115,934  399,479  349,822 
Total Operating Expenses  6,748,820  5,445,143   5,851,841  4,817,784  19,560,296  14,854,165 
              
Net Operating Loss (3,126,515) (2,213,289) (1,529,479) (1,322,034) (8,269,456) (4,916,377)
              
Non-Operating Expense     
Non-Operating Income/(Expense)         
Loss on currency exchange (7,135) (15,717) (10,057) (7,283) (38,897) (21,761)
Gain on disposal of fixed assets, net  736   273  1,009 
Interest (Expense)/Income, net  (1,463) 9,771 
TOTAL OTHER EXPENSE  (8,598) (5,210)
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 BEFORE INCOME TAXES (3,135,113) (2,218,499) (1,497,060) (1,331,882) (8,263,774) (4,920,246)
              
Income Tax Benefit  597,599  942,361   271,500  238,104  1,579,359  1,425,781 
              
NET LOSS $(2,537,514)$(1,276,138) $(1,225,560)$(1,093,778)$(6,684,415)$(3,494,465)
              
NET LOSS PER SHARE              
              
Basic $(0.06)$(0.03) $(0.03)$(0.02)$(0.15)$(0.08)
Diluted $(0.06)$(0.03) $(0.03)$(0.02)$(0.15)$(0.08)
              
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING              
              
Basic  44,667,977  43,960,936   45,038,181  44,322,335  44,877,366  44,510,021 
Diluted  44,667,977  43,960,936   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 MEDKORU MEDICAL SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

             
 For the
Three Months Ended
  For the
Nine Months Ended
 
 March 31,  September 30, 
 2022 2021  2022 2021 
           
CASH FLOWS FROM OPERATING ACTIVITIES          
Net Loss $(2,537,514)$(1,276,138) $(6,684,415)$(3,494,465)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation expense 837,556 734,184  2,361,085 1,967,632 
Depreciation and amortization 109,252 115,473  399,479 349,822 
Deferred income taxes (597,599) (943,211) (1,579,569) (1,440,060)
Gain on disposal of fixed assets  (736)
     
Loss on disposal of fixed assets  (1,009)
ROU landlord credit 218,044  
Changes in operating assets and liabilities:          
Decrease/(Increase) in accounts receivable 447,489 (988,387)
Decrease in other receivables 38,145  
Decrease/(Increase) in inventory 88,601 (1,229,052)
(Increase)/Decrease in prepaid expenses and other assets (11,805) 117,455 
Increase in accounts receivable (1,445,079) (549,711)
Increase in inventory (777,818) (138,160)
Increase in prepaid expenses and other assets (160,794) (529,039)
Increase in other Liabilities 267,491  
Increase in accounts payable 40,447 1,290,603  138,077 760,493 
Increase in accrued payroll and related taxes 345,712 428,769  663,444 45,684 
Decrease in accrued expenses (537,981) (854,613) (140,958) (573,565)
Increase in other liabilities  25,625   
     
NET CASH USED IN OPERATING ACTIVITIES  (1,752,072) (2,605,653)  (6,741,013) (3,602,378)
          
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchases of property and equipment (750,908) (95,477) (2,541,693) (301,720)
Proceeds from disposal of property and equipment  9,065   9,065 
Purchases of intangible assets  (1,694) (15,792)  (36,003) (25,838)
NET CASH USED IN INVESTING ACTIVITIES  (752,602) (102,204)  (2,577,696) (318,493)
          
CASH FLOWS FROM FINANCING ACTIVITIES          
Borrowings from indebtedness 644,733 924,389 
Payments on indebtedness (252,968)   (508,583) (251,255)
Proceeds from issuance of equity  1,230,000  314,000 1,230,000 
Common stock issuance as settlement for litigation  938,094   938,094 
Payments on finance lease liability    (803)  (25,062) (2,232)
NET CASH (USED IN)/PROVIDED BY FINANCING ACTIVITIES  (252,968) 2,167,291 
NET CASH PROVIDED BY FINANCING ACTIVITIES  425,088  2,838,996 
          
NET DECREASE IN CASH AND CASH EQUIVALENTS (2,757,642) (540,566) (8,893,621) (1,081,875)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  25,334,889  27,315,286   25,334,889  27,315,286 
CASH AND CASH EQUIVALENTS, END OF PERIOD $22,577,247 $26,774,720  $16,441,268 $26,233,411 
          
Supplemental Information          
Cash paid during the periods for:          
Interest $4,425 $28  $15,700 $6,194 
Income Taxes $ $850  $ $850 
          
Schedule of Non-Cash Operating, Investing and Financing Activities:          
Issuance of common stock as compensation $142,500 $56,250  $355,505 $295,947 
Issuance of common stock as settlement for litigation $ $938,094  $ $938,094 

 

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

 

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REPRO MEDKORU MEDICAL SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

               
    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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Three Months Ended March 31, 2022

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

Table of Contents

 

Three Months Ended March 31, 2021

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

              
    Additional Retained   Total 
  Common Stock Paid-in Earnings Treasury Stockholders’ 
  Shares Amount Capital (Deficit) 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.

 

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REPRO MEDKORU 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, 2021 (“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 2019 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.

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 LOSS 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 incomeloss per common share

                 
 Three Months Ended  Three Months Ended Nine Months Ended 
 March 31,  September 30, September 30, 
 2022 2021  2022 2021 2022 2021 
                   
Net loss $(2,537,514)$(1,276,138) $(1,225,560)$(1,093,778)$(6,684,415)$(3,494,465)
              
Weighted Average Outstanding Shares:              
Outstanding shares 44,667,977 43,960,936  45,038,181 44,322,335 44,877,366 44,510,021 
Option shares includable  0(a) 0(a)  (a) (a) (a) (a)
Total  44,667,977  43,960,936   45,038,181  44,322,335  44,877,366  44,510,021 
              
Net loss per share              
Basic $(0.06)$(0.03) $(0.03)$(0.02)$(0.15)$(0.08)
Diluted $(0.06)$(0.03) $(0.03)$(0.02)$(0.15)$(0.08)

__________

(a)

For the three months ended March 31,September 30, 2022, and March 31, 2021, option shares of 346,02072,347 and 183,681 296,504 respectively, were not included as the impact is anti-dilutive.  For the threenine months ended March 31,September 30, 2022, and March 31, 2021, restrictedoption shares of 1,000,00081,723 and zero244,422 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 nine 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.

 

 

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

 

Our revenues deriveare 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 (“Product Revenue”) for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use.

 

For 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.

 

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 NRE revenue will be complimentary to our existing product line offering. This revenue streamnovel therapies revenues can fluctuate and may not be consistent from period to period, as the main area of opportunity is in relation to clinical trial support.period. Engineering work performed on our product may be specialized and tailored to the specific needs of each independent clinical trial and not uniform in nature. The clinical trial size and scope of protocols may also range greatly from customer to customer, and there is no expectation of repeat customers on a consistent basis compared to our normal course ofcore business. We recognize NRE revenue under an input method, which recognizes revenue on the basis of our efforts or inputs to the satisfaction of a performance obligation (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the satisfaction of a performance obligation relative to the total expected inputs to the satisfaction of that performance obligation.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 March 31,September 30, 2022, and 2021:

 

Schedule of net sales by geography

 Three Months Ended March 31, % of Total Net Sales  Three Months Ended September 30, Nine Months Ended September 30, 
 2022 2021 2022 2021  2022 2021 2022 2021 
Net Sales            
Sales             
Domestic $5,301,388 $4,446,789 84.9% 81.9%  $6,661,196 $5,254,336 $17,475,083 $14,346,895 
International  942,942  984,162 15.1% 18.1%   1,099,202  786,208  3,076,273  2,652,774 
Total Net Sales $6,244,330 $5,430,951     
Total $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.

 

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 threenine months ended March 31,September 30, 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 March 31,September 30, 2022.

 

RECLASSIFICATION

 

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

 

 

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NOTE 2 —PROPERTY AND EQUIPMENT

 

Property and equipment consists of the following at:

Schedule of property and equipment

  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 

 

  March 31, 2022 December 31, 2021 
        
Furniture and office equipment $826,503 $818,897 
Construction in progress  638,489   
Leasehold improvements  556,907  556,907 
Manufacturing equipment and tooling  2,134,764  2,042,675 
   Total property and equipment  4,156,663  3,418,479 
Less: accumulated depreciation and amortization  (2,393,394) (2,312,034)
Property and equipment, net $1,763,269 $1,106,445 

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 $94,085130,882 and $100,403100,502 for the three months ended March 31,September 30, 2022 and 2021, respectively, and $329,526 and $301,469 for the nine months ended September 30, 2022 and 2021, respectively.

 

NOTE 3 — COMMITMENTS AND CONTINGENCIES

 

LEGAL PROCEEDINGS

 

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

 

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 March 31,September 30, 2022, there were options to purchase 3,638,7502,650,000 shares of the Company’s common stock outstanding to certain executives, key employees and consultants under the 2015 Plan, of which 135,000zero were issued during the three months ended March 31,September 30, 2022 and 295,000 were issued during the nine months ended September 30, 2022. Additional options may be issued under the 2015 Plan as outstanding options are forfeited, subject to a maximum 6,000,000available 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. ForDuring the quarterthree and nine months ended March 31,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, 2022, there had been issued 47,50020,988 shares of common stock as directors fees under the 2021 Plan.

 

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor were eligible to receive of $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 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-


Table 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 for her employment.Contents

 

2015 STOCK OPTION PLAN, as amended

 

Time Based Stock Options

 

The per share weighted average fair value of stock options granted during the threenine months ended March 31,September 30, 2022 and March 31,September 30, 2021 was $2.45$2.10 and $3.06,$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 threenine months ended March 31,September 30, 2022 and March 31,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 $49,406151,736 and $43,06756,102 for the threenine months ended March 31,September 30, 2022 and 2021, respectively.

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Schedule of time based stock optionoptions

 March 31,  September 30, 
 2022 2021  2022 2021 
            
Dividend yield 0.00% 0.00%  0.00% 0.00% 
Expected Volatility 76.177.5% 74.0174.28%  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 1.811.87% 1.201.62%  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 option planoptions

 Three Months Ended March 31,  Nine Months Ended September 30, 
 2022 2021  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 3,672,500 $3.42 2,922,494 $2.46  3,672,500 $3.42  2,922,494 $2.46 
Granted 135,000 $3.07 1,250,000 $3.94  295,000 $2.70 1,650,000 $3.75 
Exercised 75,000 $1.60 1,000,000 $1.23  831,250 $1.57 1,000,000 $1.23 
Forfeited 93,750 $1.57 0 $0  486,250 $2.73 187,494 $3.36 
Outstanding at March 31 3,638,750 $3.49 3,172,494 $3.43 
Options exercisable at March 31 1,358,750 $2.83 803,119 $2.09 
Outstanding at September 30 2,650,000 $4.05 3,385,000 $3.39 
Options exercisable at September 30 825,000 $4.41 1,005,625 $2.65 
Weighted average fair value of options granted during the period  $2.45  $3.06   $2.10  $2.93 
Stock-based compensation expense  $524,670  $1,086,681   $1,465,567  $1,934,935 

 

Total stock-based compensation expense was $524,670$1,465,567 and $1,086,681$1,934,935 for the threenine months ended March 31,September 30, 2022, and 2021, respectively. Cash received from option exercises for the threenine months ended March 31,September 30, 2022, and 2021 was $0314,000 and $1,230,000, respectively.

 

The weighted-average grant-date fair value of options granted during the threenine months ended March 31,September 30, 2022, and 2021 was $0.30.6 million and $3.84.8 million,, respectively.  There were 75,000831,250 options exercised during the threenine months ended March 31,September 30, 2022, and 1.0 million during the threenine months ended March 31,September 30, 2021.

 

The following table presents information pertaining to options outstanding at March 31,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
  Number
Outstanding
 Weighted
Average
Remaining
Contractual
Life
 Weighted
Average
Exercise
Price
 Number
Exercisable
 Weighted
Average
Exercise
Price
 
                          
$1.57-$9.76 3,638,750 8.5 years $3.49 1,358,750 $2.83 
$1.57-$9.49 2,650,000 8.1 years $4.05 825,000 $4.41 

 

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As of March 31,September 30, 2022, there was $5,861,4444,581,923 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2015 Plan.  That cost is expected to be recognized over a weighted-average period of 4645 months.  The total fair value of shares vested as of March 31,September 30, 2022, and March 31,September 30, 2021, was $2,815,9432,679,152 and $1,230,4341,909,141, respectively.

 

Performance Based Stock Options

 

There were no performance based stock options granted during the threenine months ended March 31,September 30, 2022, and 2021.

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

Schedule of performance base stock options outstanding

 Three Months Ended March 31,  Nine Months Ended September 30, 
 2022 2021  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 
Granted 0 $0 0 $   $  $ 
Exercised 0 $0 0 $   $  $ 
Forfeited  $ 1,000,000 $1.70   $  $ 
Outstanding at March 31 0 $0  $ 
Options exercisable at March 31 0 $0 0 $0 
Outstanding at September 30  $ 1,000,000 $1.70 
Options exercisable at September 30  $  $ 
Weighted average fair value of options granted during the period 0 $0  $   $  $ 
Stock-based compensation expense  $  $(408,747)  $  $(408,747)

 

Total performance stock-based compensation expense totaled zero and ($408,747) for the threenine months ended March 31,September 30, 2022, and 2021, respectively. All performance-basedperformance based stock options were forfeited as of September 30, 2021, and there was no 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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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 threenine months ended March 31,September 30, 2022, and 2021.

Schedule of activities for our unvested restricted stock awards

 Three Months Ended March 31,  Nine Months Ended September 30, 
 2022 2021  2022 2021 
 Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
  Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
 
          
Unvested at January 1 1,000,000 $3.01 0 $0   $  $ 
Granted 0 $0 0 $0  1,000,000 $3.01 1,000,000 $3.01 
Vested 0 $0 0 $0  50,000 $3.31  $ 
Forfeited/canceled 0 $0 0 $0   $  $ 
Unvested at March 31 1,000,000 $3.01 0 $0 
Unvested at September 30 950,000 $2.99 1,000,000 $3.01 

 

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As of March 31,September 30, 2022, and 2021, there was $2,129,3391,788,565 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 $35,781 107,344and $zero30,554 for the threenine months ended March 31,September 30, 2022 and 2021, respectively.

Schedule of restricted stock units

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

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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%2023.  The Note was renewed on June 24, 2021, in the same form with an interest rate of Prime Rate announced by the Bank minus 1.50%. Interest is due monthly, and all principal and unpaid interest is due on June 1, 2022.  The $3.5 million Note may be prepaid at any time prior to maturity with no prepayment penalties.  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 March 31, 2022.

On April 27, 2020, the Company entered into a Progress Payment Loan and Security Agreement (“PPLSA”) and a Master Security Agreement (the “MSA”), each dated as of April 20, 2020, with Key Equipment Finance, a division of the Bank (“KEF”), to provide up to $2.5 million in financing for equipment purchases from third party vendors.  The PPLSA allows the Company to make draws with KEF to make certain payments to the equipment suppliers prior to the commencement of periodic payments under a term loan. Each draw under the PPLSA will bear interest at a variable rate equal to the then-current Prime Rate and will be secured by the financed equipment under the MSA.  At the end of each calendar quarter or year, the advances made under the PPLSA will be converted to term loans, subject to KEF’s approval of the equipment and certain other closing conditions being met.  Once the draws under the PPLSA are converted into a term loan, each promissory note will bear interest at 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 March 31, 2022, the Company had no amount outstanding against the PPLSA.

 

NOTE 6 —LEASES

 

We have finance and operating leases for our new corporate office location and our existing corporate offices.  Thesecertain office and computer equipment.  Our two operating leases have remaining lease terms of 10.5ten years and 9 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 5 years.

 

The components of lease expense were as follows:

Schedule of components of lease expense

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

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  Three Months Ended Nine Months Ended 
  September 30, September 30, 
  2022 2021 2022 2021 
              
Operating lease cost $157,076 $37,093 $396,658 $112,383 
Short-term lease cost  18,300  35,960  96,588  104,396 
Total lease cost $175,376 $73,053 $493,246 $216,779 
              
Finance lease cost:             
Amortization of right-of-use assets $17,754 $597 $23,672 $2,188 
Interest on lease liabilities  1,381  10  1,381  57 
Total finance lease cost $19,135 $607 $25,053 $2,245 

 

Supplemental cash flow information related to leases was as follows:

Schedule of cash flow information related to leases

             
 Three Months Ended  Nine Months Ended 
 March 31,  September 30, 
 2022 2021  2022 2021 
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows from operating leases $63,193 $35,248  $301,150 $105,618 
Financing cash flows from finance leases  803  26,443 2,232 

 

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Supplemental balance sheet information related to leases was as follows:

SchdeuleSchedule of balance sheet information related to leases

 March 31,
2022
 December 31,
2021
  September 30,
2022
 December 31,
2021
 
            
Operating Leases  
Operating lease right-of-use assets $4,309,282 $95,553  $3,865,370 $95,553 
  
Operating lease current liabilities 395,359 95,553  342,399 95,553 
Operating lease long term liabilities  3,913,923     3,741,015   
Total operating lease liabilities $4,309,282 $95,553  $4,083,414 $95,553 
  
Finance Leases  
Property and equipment, at cost $ $12,725  $355,071 $12,725 
Accumulated depreciation    (12,725)  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 $ 

 

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

  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% 

 

Maturities of lease liabilities are as follows:

Schedule of maturities of lease liabilities

Year Ending December 31, Operating Leases Finance Leases  Operating Leases Finance Leases 
2022 (excluding the three months ended March 31, 2022) $435,067 $0 
2022 (excluding the nine months ended September 30, 2022)  124,876  19,832 
2023 499,503 0  499,503 79,329 
2024  499,503 0   499,503 79,329 
2025  499,503 0   499,503 79,329 
2026  499,503 0   499,503 79,329 
Thereafter  2,830,518  0   2,830,519  33,052 
Total undiscounted lease payments  5,263,597 0   4,953,407 370,200 
Less: imputed interest  (954,315) 0   (869,993) (40,191)
Total lease liabilities $4,309,282 $  $4,083,414 $330,009 

 

 

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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 domestic and international core revenues consist of sales of our products for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary use being for the delivery for immunoglobulin to treat PIDD and CIDP. Novel therapies consist of product revenues offrom our infusion system (syringe drivers, tubing and 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 revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use.

 

We 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 begancontinued its implementationtransition of secondary sourcingfinished goods manufacturing of our needle and tubing sets to Command at the beginning ofMedical Products, a third-party contract manufacturing organization, which began in 2021 and is expectedexpects to complete the implementation bybefore the second halfend of 2022. first quarter 2023. This move is intended to create a dual source of manufacturing and improve costs.

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The Company has entered into a lease commencing March 1, 2022 for a new corporate headquarters and manufacturing facility and corporate headquarters, into whichlocated 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 in June 2022.of manufacturing before the end of the first quarter 2023.

 

The Company ended the 2022 third fiscal quarter with $6.2$7.8 million in net revenues, orsales, a 15.0%28.5% increase, compared with $5.4$6.0 million in the same period last year driven by growth in domestic core, both pumps and consumables, and novel therapies.all three of our business sources.

 

Our gross margin, which is our grossGross profit, for the three months ended September 30, 2022, was $4.3 million, an increase of 23.7% from the same period last year, and stated as a percentage of net sales for the three months ended March 31, 2022, was 58.0%55.7%, a decline from 57.9% in the prior year period of 59.5%. The majority of the decline was driven by more lower margin NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer in the 2022 period and year over year higher manufacturing costs in our core business due to increasing raw material and labor costs, partially offset by increased price and mix.

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period.

 

Operating expenses for the three months ended March 31,September 30, 2022, were $6.7$5.9 million, up from $5.4$4.8 million for the same period last year, driven primarily by research and development, efforts to support our core and novel therapies business,for selling, general and byadministrative for new hires to support commercialization, and business development, and quality, and regulatory consulting, partially offset by reorganization costs of $1.0 million last year.capabilities.

 

RESULTS OF OPERATIONS

 

Three months ended March 31,September 30, 2022, compared to March 31,September 30, 2021

 

Net Sales

 

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

 

 Three Months Ended March 31, Change from Prior Year % of Total Net Sales  Three Months Ended September 30, Change from Prior Year % of Net Sales 
 2022 2021 $ % 2022 2021  2022 2021 $ % 2022 2021 
Net Sales                                
Domestic Core $4,993,536 $4,412,417 $581,119 13.2% 80.0% 81.2%  $5,900,042 $5,076,294 $823,748 16.2% 76.0% 84.0% 
International Core 894,942 978,906 (83,964)(8.6%)14.3% 18.0%  1,096,746 747,281 349,465 46.8% 14.1% 12.4% 
Novel Therapies  355,852  39,628  316,224 798.0% 5.7% 0.8%   763,610  216,969  546,641 251.9% 9.9% 3.6% 
Total $6,244,330 $5,430,951 $813,379 15.0%  $7,760,398 $6,040,544 $1,719,854 28.5% 

 

Total net sales were $6.2increased $1.7 million, or 28.5%, for the three months ended March 31,September 30, 2022, a 15.0% increase from $5.4 million inas compared with the same period of 2021, with stronglast year over yearas we saw double digit growth across all businesses. Domestic core growth was primarily driven by domestic core, up 13.2%, dueincreased volume attributed to SCIg market growth in pumps and consumables driven by an overall increase in the subcutaneous immunoglobulin market,label expansions including prefill syringes, as well as our key growth initiatives including prefills and label expansions. Total novelclearing of $0.3 million in backorders from the second quarter of 2022. Novel therapies sales were $0.4 million forgrew by 252% in the three months ended March 31,third quarter of 2022 a $0.3 million increase from the same period of 2021 primarily duerelated to recognition of initialservices performed on an NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer. Internationalpharmaceutical customer and increases in clinical trial product sales for several pharmaceutical customers. Sales growth in our international core business was down 8.6% year over year, due to quarterly buying pattern changes of a few smaller customers.driven by volume growth in certain EU markets compared with prior year.

 

Gross Profit

 

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

 

 Three Months Ended March 31, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2022 2021 $  %  2022 2021 $  % 
Gross Profit $3,622,305 $3,231,854 $390,451  12.1%  $4,322,362 $3,495,750 $826,612  23.7% 
Stated as a Percentage of Net Sales 58.0% 59.5%    55.7% 57.9%   

 

Gross profit increased by $0.4$0.8 million or 12.1%23.7% in the firstthree months ended September 30, 2022, compared to the same period in 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 as a percent of sales decreased to 55.7% compared to 57.9% from the third quarter of 2022, while2021.  The decline in the gross margin decreasedprofit percent was primarily caused by 1.5 margin points to 58.0% primarily driven by increased lower margin NRE revenues for a pre-commercialization innovation development agreement for a large SCIg customer and year over year 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, dueand NRE service revenue mix contributed to increasing raw material and labor costs, partially offset by increased price and mix.a lower gross profit as a percentage of sales. Partially offsetting these declines was an increase in average selling prices.

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Selling, general and administrative and Research and development

 

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

 

 Three Months Ended March 31, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2022 2021 $ %  2022 2021 $ % 
Selling, general and administrative $5,491,213 $4,992,829 $498,384 10.0%  $4,825,349 $3,901,830 $923,519 23.7% 
Research and development  1,148,355  336,841  811,514 240.9%   862,148  800,020  62,128 7.8% 
 $6,639,568 $5,329,670 $1,309,898 24.6%  $5,687,497 $4,701,850 $985,647 21.1% 
Stated as a Percentage of Net Sales 106.3% 98.1%  73.3% 77.8% 

 

Selling, general and administrative expenses increased $0.5$0.9 million, or 10.0%23.7%, during the three months ended March 31,September 30, 2022 compared to the same period last year, driven by $1.5primarily due to $0.7 million in costscompensation and benefits associated with new hires, $0.2 million in severance relating to the second halfemployment termination of 2021the Chief Operating Officer, $0.2 million in building expenses related to support commercialization and business development, and quality and regulatory consulting,our manufacturing move, $0.1 million in stock compensation partially offset by lower consulting costs associated with the departureof $0.1 million and replacementlower recruitment costs of the former chief executive officer and the recruitment of two new Board members of $1.0 million last year.

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$0.2 million.

 

Research and development expenses increased $0.8$0.1 million or 240.9%, during the three months ended March 31,September 30, 2022 compared with the same period last year, primarily due to higher salary and related expenses to build our internal capability and consulting fees$0.3 million in new hires to support product development.our innovation efforts, which was partially offset by lower testing material costs of $0.2 million and lower recruiting costs of $0.1 million.

 

Depreciation and amortization

 

Depreciation and amortization expense decreasedincreased by 5.4%41.8% to $109,252$164,344 in the three months ended March 31,September 30, 2022 compared with $115,473$115,934 in the three months ended March 31, 2021.  We continue to investSeptember 30, 2021 resulting from investment 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

 

 Three Months Ended March 31, Change from Prior Year  Three Months Ended September 30, Change from Prior Year 
 2022 2021 $ %  2022 2021 $ % 
Net Loss $(2,537,514)$(1,276,138)$(1,261,376)(98.8%) $(1,225,560)$(1,093,778)$(131,782)12.1% 
Stated as a Percentage of Net Sales (40.6%) (23.5%)  (15.8%) (18.1%) 

 

Our net loss was $2.5increased $0.1 million in the three months ended March 31,September 30, 2022 compared with net loss of $1.3 million inthe same period last year mostly driven by higher operating expenses due to higher selling, general and administrative expenses and higher research and development expenses partially offset by higher gross profit, all as described above.related to our strategy to build our novel therapies business and innovation. A tax benefit of $0.6$0.3 million resulting from the loss was also recorded during the threeperiod.

Nine months ended March 31, 2022.September 30, 2022 compared to September 30, 2021

Net Sales

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

  Nine Months Ended September 30, Change from Prior Year % of Net Sales 
  2022 2021 $ % 2022 2021 
Net Sales                
Domestic Core $15,890,369 $14,084,552 $1,805,817 12.8% 77.3% 82.9% 
International Core  2,943,173  2,585,881  357,292 13.8% 14.3% 15.2% 
Novel Therapies  1,717,814  329,236  1,388,578 421.8% 8.4% 1.9% 
Total $20,551,356 $16,999,669 $3,551,687 20.9%     

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Total net sales increased $3.6 million or 20.9% for the nine months ended September 30, 2022, as compared to the prior year period, driven primarily by higher 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 $1.4 million compared with last year due to completion of two NRE product innovation milestones and clinical product sales for an expanded pharmaceutical pipeline. International core net sales were higher by $0.4 million in the first nine months of 2022, driven by volume growth in our consumables and pump business.

Gross Profit

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

  Nine Months Ended September 30, Change from Prior Year 
  2022 2021 $ % 
Gross Profit $11,290,840 $9,937,788 $1,353,052 13.6% 
Stated as a Percentage of Net Sales  54.9%  58.5%      

Gross profit increased $1.4 million or 13.6% in the nine months ended September 30, 2022, compared to the same period last year. This increase in the first nine months of 2022 was mostly driven by the increase in net sales of $3.5 million as described above. Gross profit, stated as a percentage 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 nine months of 2022, partially offset by increased average selling prices.

Selling, general and administrative and Research and development

Our selling, general and administrative expenses and research and development costs for the nine months ended September 30, 2022 and 2021 are as follows:

  Nine Months Ended September 30, Change from Prior Year 
  2022 2021 $ % 
Selling, general and administrative $15,846,584 $12,980,604 $2,865,980 22.1% 
Research and development  3,314,233  1,523,739  1,790,494 117.5% 
  $19,160,817 $14,504,343 $4,656,474 32.1% 
Stated as a Percentage of Net Sales  93.2%  85.3%      

Selling, general and administrative expenses increased $2.9 million, or 22.1%, during the nine months ended September 30, 2022 compared to the same period last year, primarily due to $2.1 million in compensation and benefits related mostly to new hires in sales, quality and regulatory to support our 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 $0.1 million in liability insurance, which was partially offset by lower restructuring costs of $0.4 million.

Research and development expenses increased $1.8 million during the nine months ended September 30, 2022 compared with the same period last year primarily due to $1.0 million in consulting fees and $0.8 million in compensation and benefits for new hires to support product development for novel therapies, 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 14.2% to $399,479 the nine months ended September 30, 2022 compared with $349,822 in the nine months ended September 30, 2021 due to investment in our corporate office and manufacturing site move.

Net Loss

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

Our net loss for the nine months ended September 30, 2022 was $6.7 million compared to net loss of $3.5 million for the nine months ended September 30, 2021, driven by higher selling, general and administrative and research and development expenses.

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LIQUIDITY AND CAPITAL RESOURCES

 

Our principal source of liquidity is our cash on hand of $22.6$16.4 million as of March 31,September 30, 2022.  Our principal source of operating cash inflows is from sales of our products and NRE services to customers. Our principal cash outflows relate to the purchase and production of inventory, and related costs,funding of research and development, expenses and selling, general and administrative expenses.

To develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in manufacturing technologies, facilities and equipment, and research and development. We estimate operating expenses to be between $27.0$26.5 million and $28.0$27.5 million in 2022. We expect our

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 approximately $1.0$0.9 million and $0.2 million respectively, which are expected to be fully executed in the secondfourth 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 $6.0$6.9 million at March 31,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 these levels to rise inreduce our inventory position when the short term as we build to ensure timely order fulfillment as we complete the transition of the manufacturing of our needle sets and tubing products to our secondary source and for supply continuity as we move our manufacturing facility to our new location in 2022. As the relocation and transition to our secondary manufacturing source areis completed, which we expect by the end of 2022, this inventory is expected to convert to a source of cash.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 March 31,September 30, 2022, the credit has not been received.

 

We expect that our cash on hand and cash flows from operations and our available credit facility will be sufficient to meet our requirements at least through the next 12 months. Continued execution on our longer-term strategic plan may require the Company to take on additional debt or raise capital through issuance of equity, or a combination of both in the periods post 12/31/2023. Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including 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.

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Cash Flows

 

The following table summarizes our cash flows:

 

 Three Months Ended
March 31, 2022
 Three Months Ended
March 31, 2021
  Nine Months Ended
September 30, 2022
 Nine Months Ended
September 30, 2021
 
Net cash used in operating activities $(1,752,072)$(2,605,653) $(6,741,013)$(3,602,378
Net cash used in investing activities $(752,602)$(102,204) $(2,577,696)$(318,493)
Net cash (used in)/provided by financing activities $(252,968)$2,167,291 
Net cash provided by financing activities $425,088 $2,838,996 

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Operating Activities

 

Net cash used in operating activities of $1.8$6.7 million for the threenine months ended March 31,September 30, 2022 was primarily due to the net loss of $2.5$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 the deferred tax asseta decrease in accrued expenses of $0.6$0.1 million, offset by favorable net working capitalan 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 driven by accounts receivable collections andincreased for book to tax differences related to stock option expense.  Offsetting these were primarily non-cash charges for stock-based compensation of $0.8$2.7 million, and depreciation and amortization of $0.1$0.4 million.

 

Net cash used in operating activities of $2.6$3.6 million for the threenine months ended March 31,September 30, 2021 was primarily due to the net loss of $1.3$3.5 million, working capital changes which include an increase in inventory of $1.2 million related to the transition of manufacturing to our secondary source,included an increase in accounts receivable of $1.0$0.5 million due to delayed payments at our largest distributor, as well astiming, an increase in prepaids of $0.5 million due to insurance renewals, and a decrease in accrued expenses of $0.9$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 $0.9$1.4 million mostly increased for book to tax differences related to stock option expense.  Offsetting these were primarilyan increase in accounts payable of $0.8 million, non-cash charges for stock-based compensation of $0.7$2.0 million, an increase in accounts payableand depreciation and amortization of $1.3 million due to timing of payments and an increase in accrued payroll of $0.4 million related to the separation agreement with our former chief executive officer.$0.3 million.

 

Investing Activities

 

Net cash used in investing activities of $0.8$2.6 million for the threenine months ended March 31,ending September 30, 2022, was for capital improvement expenditures for our new location and manufacturing and office equipment.equipment for our corporate office and manufacturing facilities move.

 

Net cash used in investing activities of $0.1$0.3 million for the threenine months ended March 31,ending September 30, 2021, was for capital expenditures for manufacturing and office equipment.

 

Financing Activities

 

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

The $2.2$0.4 million provided by financing activities for the threenine months ended March 31,September 30, 2022, is from $0.3 million in option exercises and $0.1 million net borrowings on our indebtedness for a note payable for insurance premium financing.

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

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.litigation and a note payable for insurance premium financing.

 

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 March 31,September 30, 2022, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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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, 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, 2021.

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

On March 4, 2022, we issued 20,107 shares of our common stock to our Chief Executive Officer as a portion of her 2021 annual bonus in accordance with the terms of her employment agreement. These shares were issued in reliance on the exemption from registration under Section 4(2) under the Securities Act of 1933, as amended.

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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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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.
  
May 4,November 9, 2022/s/ Linda Tharby
 Linda Tharby, President and Chief Executive Officer
(Principal Executive Officer)
  
May 4,November 9, 2022/s/ Karen FisherThomas Adams
 Karen Fisher,Thomas Adams, Interim Chief Financial Officer and Treasurer
(Principal Financial Officer)

 

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