UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 10-Q

(Mark One)


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


For the Quarterly Period Ended September 30, 2017March 31, 2023


Oror


[  ]_]  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

New York

13-3044880

(State or Other Jurisdictionother jurisdiction of Incorporationincorporation or Organization)

organization)

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

24 Carpenter Road, Chester, 100 Corporate Drive, Mahwah, New York

Jersey

10918

07430

(Address of Principal Executive Offices)

principal executive offices)

(Zip Code)


(845) (845) 469-2042

(Registrant’s telephone number, including area code)


February 28Securities registered pursuant to Section 12(b) of the Act:

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

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] [X]Yes  [  ]  [_] No


Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).  [X]Yes [X]  [_] 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]

[X]

(Do not check if a smaller reporting company)

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] [X]No


As of November 3, 2017, 37,930,620May 4, 2023, 45,613,150 shares of common stock, $0.01$0.01 par value per share, were outstanding, which excludes 2,737,2313,420,502 shares of treasury stock.




REPRO MED

KORU MEDICAL SYSTEMS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023

TABLE OF CONTENTS


PAGE

PAGE

PART I. FINANCIAL INFORMATION

PART I FINANCIAL INFORMATION

ITEM 1.

Financial Statements (Unaudited)

3

ITEM 1.

Financial Statements

Balance Sheets as of September 30, 2017March 31, 2023 (Unaudited) and February 28, 2017

December 31, 2022

3

Statements of Operations (Unaudited) for the three and seven months ended September 30, 2017March 31, 2023 and 2016

2022

4

Statements of Cash Flows (Unaudited) for the seventhree months ended September 30, 2017March 31,2023 and 2016

2022

5

Statements of Stockholders’ Equity (Unaudited) for the three months ended March 31, 2023 and 2022

6
Notes to Financial Statements

6-11

7

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

12-18

16

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

18

20

ITEM 4.

Controls and Procedures

18

20

PART IIII. OTHER INFORMATION

ITEM 2.

1A.

Unregistered Sales of Equity Securities and Use of Proceeds

Risk Factors

18-19

21

ITEM 6.

Exhibits

19

21
Signatures22


- 2 -



Table of Contents

PART I FINANCIAL INFORMATION


Item 1.  Financial Statements (Unaudited)


REPRO MEDKORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS


(UNAUDITED)

     

 

September 30,

 

February 28,

 

 March 31, December 31, 

 

2017

 

2017

 

 2023 2022 

 

(Unaudited)

 

 

 

      

ASSETS

 

 

 

 

 

 

 

     

 

 

 

 

 

 

     

CURRENT ASSETS

 

 

 

 

 

 

     

Cash and cash equivalents

 

$

3,661,707

 

$

3,313,265

 

 $12,224,865 $17,408,257 

Certificates of deposit

 

262,314

 

 

262,314

 

Accounts receivable less allowance for doubtful accounts of $77,067 at September 30, 2017 and $18,046 at February 28, 2017

 

1,481,410

 

 

1,502,030

 

Accounts receivable less allowance for doubtful accounts of $21,459 for March 31, 2023, and for December 31, 2022 4,164,513 3,558,884 

Inventory

 

1,586,568

 

 

1,353,703

 

 6,638,418 6,404,867 

Tax Receivable

 

 

 

172,457

 

Other Receivables 1,014,761 972,396 

Prepaid expenses

 

 

225,088

 

 

175,955

 

  1,172,101  1,457,232 

TOTAL CURRENT ASSETS

 

7,217,087

 

 

6,779,724

 

 25,214,658 29,801,636 

Property and equipment, net

 

902,075

 

 

932,092

 

 3,906,067 3,886,975 

Patents, net of accumulated amortization of $195,354 and $180,137 at September 30, 2017 and February 28, 2017, respectively

 

440,565

 

 

426,943

 

Intangible assets, net of accumulated amortization of $341,755 and $325,872 at March 31, 2023 and December 31, 2022, respectively 782,531 787,182 
Operating lease right-of-use assets 3,706,874 3,786,545 
Deferred income tax assets, net 4,544,880 3,967,480 

Other assets

 

 

31,583

 

 

31,490

 

  98,970  102,625 

TOTAL ASSETS

 

$

8,591,310

 

$

8,170,249

 

 $38,253,980 $42,332,443 

 

 

 

 

 

 

     

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

     

 

 

 

 

 

 

     

CURRENT LIABILITIES

 

 

 

 

 

 

     

Deferred capital gain - current

 

$

22,481

 

$

22,481

 

Accounts payable

 

362,878

 

 

772,428

 

 $1,503,120 $2,391,799 

Accrued expenses

 

502,249

 

 

417,357

 

 1,591,737 2,889,941 
Note Payable 218,403 433,295 
Other Liabilities 261,544 257,337 

Accrued payroll and related taxes

 

123,716

 

 

177,018

 

 500,415 542,399 

Accrued tax liability

 

142,883

 

 

 

Financing lease liability – current 99,694 98,335 
Operating lease liability – current  349,304  345,834 

TOTAL CURRENT LIABILITIES

 

 

1,154,207

 

 

1,389,284

 

 4,524,217 6,958,940 

Deferred capital gain – long term

 

9,382

 

 

22,496

 

Deferred tax liability

 

 

91,039

 

 

82,422

 

Financing lease liability, net of current portion 368,844 394,283 
Operating lease liability, net of current portion  3,564,619  3,653,257 

TOTAL LIABILITIES

 

 

1,254,628

 

 

1,494,202

 

  8,457,680  11,006,480 

 

 

 

 

 

 

     

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

     

Common stock, $0.01 par value; 75,000,000 shares authorized, 40,667,851 and 40,558,429 shares issued, 37,930,620 and 37,821,198 shares outstanding at September 30, 2017 and February 28, 2017, respectively

 

406,679

 

 

405,584

 

Common stock, $0.01 par value, 75,000,000 shares authorized, 48,960,766 and 48,861,891 shares issued 45,540,264 and 45,441,389 shares outstanding at March 31, 2023, and December 31, 2022, respectively 489,608 488,619 

Additional paid-in capital

 

4,162,679

 

 

4,129,726

 

 45,132,350 44,252,117 

Retained earnings

 

 

3,111,528

 

 

2,484,941

 

 

7,680,886

 

 

7,020,251

 

Less: Treasury stock, 2,737,231 shares at September 30, 2017 and February 28, 2017

 

 

(344,204

)

 

(344,204

)

Treasury stock, 3,420,502 shares at March 31, 2023 and December 31, 2022, at cost (3,843,562) (3,843,562)
Retained deficit  (11,982,096) (9,571,211)

TOTAL STOCKHOLDERS’ EQUITY

 

 

7,336,682

 

 

6,676,047

 

  29,796,300 31,325,963 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

8,591,310

 

$

8,170,249

 

 $38,253,980 $42,332,443 


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

- 3 -


Table of Contents

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

       
  Three Months Ended 
  March 31, 
  2023 2022 
        
NET SALES $7,392,605 $6,244,330 
Cost of goods sold  3,245,570  2,622,025 
Gross Profit  4,147,035  3,622,305 
        
OPERATING EXPENSES       
Selling, general and administrative  5,425,877  5,491,213 
Research and development  1,564,869  1,148,355 
Depreciation and amortization  213,117  109,252 
Total Operating Expenses  7,203,863  6,748,820 
        
Net Operating Loss  (3,056,828) (3,126,515)
        
Non-Operating Income/(Expense)       
Loss on currency exchange  (680) (7,135)
Loss on disposal of fixed assets, net  (56,279)  
Interest income (expense), net  125,502  (1,463)
TOTAL OTHER INCOME/(EXPENSE)  68,543  (8,598)
        
LOSS BEFORE INCOME TAXES  (2,988,285) (3,135,113)
        
Income Tax Benefit  577,400  597,599 
        
NET LOSS $(2,410,885)$(2,537,514)
        
NET LOSS PER SHARE       
        
Basic $(0.05)$(0.06)
Diluted $(0.05)$(0.06)
        
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING       
        
Basic  45,487,593  44,667,977 
Diluted  45,487,593  44,667,977 

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

- 4 -


Table of Contents

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

       
  For the
Three Months Ended
 
  March 31, 
  2023 2022 
        
CASH FLOWS FROM OPERATING ACTIVITIES       
Net Loss $(2,410,885)$(2,537,514)
Adjustments to reconcile net loss to net cash used in operating activities:       
Stock-based compensation expense  881,222  837,556 
Depreciation and amortization  213,117  109,252 
Deferred income taxes  (577,400) (597,599)
Loss on disposal of fixed assets  56,279   
ROU landlord credit  (5,497)  
Changes in operating assets and liabilities:       
(Increase)/Decrease in accounts receivable  (647,994) 447,489 
Decrease in other receivables    38,145 
(Increase)/Decrease in inventory  (233,551) 88,601 
Decrease/(Increase) in prepaid expenses and other assets  288,786  (11,805)
Increase in other Liabilities  4,207  25,625 
(Decrease)/Increase in accounts payable  (888,679) 40,447 
(Decrease)/Increase in accrued payroll and related taxes  (41,984) 345,712 
Decrease in accrued expenses  (1,298,204) (537,981)
        
NET CASH USED IN OPERATING ACTIVITIES  (4,660,583) (1,752,072)
        
CASH FLOWS FROM INVESTING ACTIVITIES       
Purchases of property and equipment  (272,605) (750,908)
Purchases of intangible assets  (11,232) (1,694)
NET CASH USED IN INVESTING ACTIVITIES  (283,837) (752,602)
        
CASH FLOWS FROM FINANCING ACTIVITIES       
Payments on indebtedness  (214,892) (252,968)
Payments on finance lease liability  (24,080)  
NET CASH USED IN FINANCING ACTIVITIES  (238,972) (252,968)
        
NET DECREASE IN CASH AND CASH EQUIVALENTS  (5,183,392) (2,757,642)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD  17,408,257  25,334,889 
CASH AND CASH EQUIVALENTS, END OF PERIOD $12,224,865 $22,577,247 
        
Supplemental Information       
Cash paid during the periods for:       
Interest $12,326 $4,425 
Income Taxes $ $ 
        
Schedule of Non-Cash Operating, Investing and Financing Activities:       
Issuance of common stock as compensation $175,776 $142,500 

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

- 5 -


Table of Contents

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

Three Months Ended March 31, 2023

                   
    Additional     Total 
  Common Stock Paid-in Retained Treasury Stockholders’ 
  Shares Amount Capital Deficit Stock Equity 
                   
BALANCE, DECEMBER 31, 2022 48,861,891 $488,619 $44,252,117 $(9,571,211)$(3,843,562)$31,325,963 
Issuance of stock-based compensation 48,875  489  175,287      175,776 
Compensation expense related to stock options     535,059      535,059 
Compensation related to Restricted Stock 50,000  500  169,887      170,387 
Net loss       (2,410,885)   (2,410,885)
BALANCE, MARCH 31, 2023 48,960,766 $489,608 $45,132,350 $(11,982,096)$(3,843,562)$29,796,300 

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 

The accompanying notes are an integral part of these financial statements


- 36 -



REPRO MED

Table of Contents

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS (UNAUDITED)


 

 

For the

Three Months Ended

 

For the

Seven Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET SALES

 

$

3,849,338

 

$

3,221,502

 

$

9,188,414

 

$

7,293,695

 

Cost of goods sold

 

 

1,470,680

 

 

1,188,558

 

 

3,539,662

 

 

2,643,925

 

Gross Profit

 

 

2,378,658

 

 

2,032,944

 

 

5,648,752

 

 

4,649,770

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

1,893,911

 

 

2,114,407

 

 

4,536,954

 

 

4,887,608

 

Research and development

 

 

14,852

 

 

75,198

 

 

47,564

 

 

147,136

 

Depreciation and amortization

 

 

77,517

 

 

70,935

 

 

179,874

 

 

167,513

 

Total Operating Expenses

 

 

1,986,280

 

 

2,260,540

 

 

4,764,392

 

 

5,202,257

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Operating Profit/(Loss)

 

 

392,378

 

 

(227,596

)

 

884,360

 

 

(552,487

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-Operating Income/(Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain/(Loss) on currency exchange

 

 

10,419

 

 

(4,096

)

 

65,079

 

 

8,237

 

Interest and other income

 

 

361

 

 

262

 

 

1,104

 

 

1,336

 

TOTAL OTHER INCOME/(EXPENSE)

 

 

10,780

 

 

(3,834

)

 

66,183

 

 

9,573

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PROFIT/(LOSS) BEFORE TAXES

 

 

403,158

 

 

(231,430

)

 

950,543

 

 

(542,914

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Tax (Expense)Benefit

 

 

(137,404

)

 

78,217

 

 

(323,956

)

 

183,819

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS)

 

$

265,754

 

$

(153,213

)

$

626,587

 

$

(359,095

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS) PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

$

 

$

0.02

 

$

(0.01

)

Diluted

 

$

0.01

 

$

 

$

0.02

 

$

(0.01

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

37,898,357

 

 

37,779,427

 

 

37,856,074

 

 

37,885,432

 

Diluted

 

 

38,056,604

 

 

37,779,427

 

 

38,014,321

 

 

37,885,432

 


The accompanying notes are an integral part of these financial statements


- 4 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)


 

 

For the Seven Months Ended

 

 

 

September 30,

 

 

 

2017

 

2016

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

Net Income (Loss)

 

$

626,587

 

$

(359,095

)

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

 

 

 

 

 

 

 

Amortization of deferred compensation cost

 

 

 

 

14,000

 

Stock based compensation expense

 

 

53,407

 

 

126,006

 

Depreciation and amortization

 

 

179,874

 

 

167,513

 

Deferred capital gain - building lease

 

 

(13,113

)

 

(13,113

)

Deferred taxes

 

 

8,617

 

 

(30,288

)

Provision for returns and doubtful accounts

 

 

58,941

 

 

(14,102

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Increase in accounts receivable

 

 

(38,321

)

 

(293,821

)

Increase in inventory

 

 

(232,865

)

 

(71,011

)

Decrease/(Increase) in prepaid expense and other assets

 

 

123,231

 

 

(78,602

)

(Decrease)/Increase in accounts payable

 

 

(409,550

)

 

357,384

 

Decrease in accrued payroll and related taxes

 

 

(53,302

)

 

(31,204

)

Increase in accrued expense

 

 

84,892

 

 

168,732

 

Increase/(Decrease) in accrued tax liability

 

 

142,883

 

 

(155,075

)

NET CASH PROVIDED BY/(USED IN) OPERATING ACTIVITIES

 

 

531,281

 

 

(212,676

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

Payments for property and equipment

 

 

(134,640

)

 

(123,689

)

Payments for patents

 

 

(28,839

)

 

(106,355

)

NET CASH USED IN INVESTING ACTIVITIES

 

 

(163,479

)

 

(230,044

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

Payment for cancelled shares

 

 

(19,360

)

 

 

Purchase of treasury stock

 

 

 

 

(120,577

)

NET CASH USED IN FINANCING ACTIVITIES

 

 

(19,360

)

 

(120,577

)

 

 

 

 

 

 

 

 

NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

348,442

 

 

(563,297

)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

3,313,265

 

 

4,201,949

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

3,661,707

 

$

3,638,652

 

 

 

 

 

 

 

 

 

Supplemental Information

 

 

 

 

 

 

 

Cash paid during the periods for:

 

 

 

 

 

 

 

Interest

 

$

 

$

 

Taxes

 

$

 

$

 

 

 

 

 

 

 

 

 

NON-CASH FINANCING AND INVESTING ACTIVITIES

 

 

 

 

 

 

 

Issuance of common stock as compensation

 

$

78,750

 

$

43,468

 


The accompanying notes are an integral part of these financial statements


- 5 -



REPRO MED SYSTEMS, INC.

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS


NOTE 1 NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES


NATURE OF OPERATIONS


REPRO MEDKORU MEDICAL SYSTEMS, INC. (the “Company”, “RMS”,“Company,” “KORU Medical,” “we,” “us” or “we”“our”) designs, manufactures and markets proprietary portable and innovative medical devices primarily for the ambulatory infusionsubcutaneous drug delivery market and emergency medical applications as governed by the United States Food and Drug Administration (the “FDA”) quality and regulatory system and international standards for quality management systems.system management. The Company operates as one segment.


FISCAL YEAR END


On March 22, 2017, the Board of Directors approved a change in the Company’s fiscal year end from February 28 to December 31.


BASIS OF PRESENTATION


The accompanying unaudited financial statements as of September 30, 2017, have been prepared in accordance with generally accepted accounting principles and with instructions to SEC regulation S-X for interim financial statements.


In the opinion of the Company’s management, the financial statements contain all adjustments consisting of normal recurring accruals necessary to present fairly the Company’s financial position as of September 30, 2017, and the results of operations and cash flow for the three and seven month periods ended September 30, 2017, and 2016.


The results of operations for the three and seven months ended September 30, 2017, and 2016 are not necessarily indicative of the results to be expected for the full year.  These interim financial statements should be read in conjunction with the financial statements and notes thereto of the Company and management’s discussion and analysis of financial condition and results of operations included in the Company’s Annual Reportannual report on Form 10-K for the year ended February 28, 2017,December 31, 2022 (“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.

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 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 filed withthey occur.

NET LOSS PER COMMON SHARE

Basic earnings per share are computed on the Securitiesweighted 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 Exchange Commission on Form 10-K.consultant stock options.  See “NOTE 4 — STOCK-BASED COMPENSATION” for further detail.


Schedule of net income per common share

       
  Three Months Ended 
  March 31, 
  2023 2022 
        
Net loss $(2,410,885)$(2,537,514)
        
Weighted Average Outstanding Shares:       
Outstanding shares  45,487,593  44,667,977 
Option shares includable  (a) (a)
Restricted stock includable  (b) (b)
Total  45,487,593  44,667,977 
        
Net loss per share       
Basic $(0.05)$(0.06)
Diluted $(0.05)$(0.06)

(a)For the three months ended March 31, 2023, and 2022, option shares of 14,626 and 346,020 respectively, were not included as the impact is anti-dilutive.
(b)For the three months ended March 31, 2023, and 2022, Linda Tharby’s 900,000 and 1,000,000 shares of restricted stock, 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 U.S. generally accepted accounting principles (“U.S. GAAP”)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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RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS


Table of Contents

REVENUE RECOGNITION

Our revenues are derived from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies.  Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“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 (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.

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 revenues.

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 May 2017,addition, rebates are provided to customers for meeting growth targets.  Provisions for both distributor pricing and customer growth rebates are variable consideration and are recorded as a reduction of revenue in the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09—Compensation-Stock Compensation (Topic 718), which provides claritysame period the related sales are recorded or when it is probable the growth target will be achieved.

Our novel therapies revenues can fluctuate and reduces both (1) diversity in practicemay not be consistent from period to period. Engineering work performed on our product may be specialized and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a changetailored to the termsspecific needs of each independent clinical trial and not uniform in nature. The clinical trial size and scope of protocols may also range greatly from customer to customer, and there is no expectation of repeat customers on a consistent basis compared to our core business. We recognize NRE revenue under an input method, which recognizes revenue on the basis of our efforts or conditionsinputs (for example, resources consumed, labor hours expended, costs incurred, or time elapsed) to the satisfaction of a share-based payment award.performance obligation relative to the total expected inputs to the satisfaction of that performance obligation (ie completion milestone). The amendments in this update affect any entityinput method that changeswe use is based on costs incurred.

The following table summarizes net revenues by geography for the terms or conditionsthree months ended March 31, 2023, and 2022:

Schedule of net sales by geography

  Three Months Ended March 31, % of Total Revenues 
  2023 2022 2023 2022 
Revenues             
Domestic $6,283,965 $5,301,388  85%  85% 
International  1,108,640  942,942  15%  15% 
Total $7,392,605 $6,244,330       

LEASES

The FASB issued a share-based payment award.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.   The amendments in this updatestandard requires 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 effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017.  Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for whichrequired to meet the objective of enabling users of financial statements have not yet been issuedto assess the amount, timing, and (2) all other entitiesuncertainty of cash flows arising from leases.  See “NOTE 6 LEASES” for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this update should be applied prospectively to an award modified on or after the adoption date.  Based upon our initial evaluation, we do not expect the adoption of the standard to have a material effect on our financial statements, disclosure requirements and methods of adoption.further detail.


ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED

In June 2016, the FASB issued ASU No. 2016-13—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, 2019, including interim periods within those fiscal years.  The Company adopted the pronouncement above on January 1, 2022, and there is assessing theno impact of the adoption of the ASU on its financial statements, disclosure requirements and methods of adoption.statements.


In May 2014, the FASB issued ASU No. 2014-09—Revenue from Contracts with Customers. The ASU clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP and International Financial Reporting Standards (“IFRS”) that removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of the financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. The amendments in this update are effective for the annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Full or modified retrospective adoption is required and early application is not permitted. On July 9, 2015, the FASB issued ASU No. 2015-14 Revenue from Contracts with Customers (Topic 606); Deferral of the Effective Date, which (a) delays the effective date of ASU 2014-09, Revenue from Contracts with Customers (Topic 606), by one year to annual periods beginning after December 15, 2017 and (b) allows early adoption of the ASU by all entities as of the original effective date for public entities.  We currently anticipate adopting the new standard using the modified retrospective method beginning January 1, 2018.  In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers (Topic 606); Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations and the effective date is the same as the requirements in ASU 2014-09.  In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers (Topic 606); Identifying Performance Obligations and Licensing, which is intended to clarify identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas and the effective date is the same as the requirements in ASU 2014-09.  In May 2016, FASB issued ASU No. 2016-12—Revenue from Contracts with Customers (Topic 606); Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis.  The effective date and transition requirements for the amendments in this update are the same as the effective date and transition requirements for Topic 606 (and any other Topic amended by update 2014-09).  In December 2016, the FASB issued ASU No. 2016-20 Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which represents changes to make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities.  This update is the final, combined version of Proposed Accounting Standards Updates 2016-240 and 2016-320 (both entitled Technical Corrections and Improvements), which have been deleted.  We do not expect the adoption of the standard and related amendments to have a material effect on our financial condition or results of operations.


In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842).  The main difference between the current requirement under GAAP and this ASU is the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases.  This ASU requires that a lessee recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term (other than leases that meet the definition of a short-term lease).  The liability will be equal to the present value of lease payments.  The asset will be based on the liability, subject to adjustment, such as for initial direct costs.  For income statement purposes, the FASB retained a dual model, requiring leases to be classified as either operating or finance.  Operating leases will result in straight-line expense (similar to current operating leases) while finance leases will result in a front-loaded expense pattern (similar to current capital leases).  Classification will be based on criteria that are largely similar to those applied in current lease accounting.  For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases.  This is effective for annual and interim periods beginning after December 15, 2018 and early adoption is permitted.  This ASU must be adopted using a modified retrospective transition, and provides for certain practical expedients.  Transition will require application of the new guidance at the beginning of the earliest comparative period presented.  We are currently assessing the potential impact of this ASU on our financial statements, disclosure requirements and methods of adoption.


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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.


STOCK-BASED COMPENSATIONFAIR 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 Company maintains a long-term incentive stock benefit plan under which it grants stock optionscarrying amounts of cash and restricted stockcash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses are considered to certain directors and key employees.  Thebe representative of their fair value of each option grant is estimated on the datevalues because of the grant using the Black-Scholes option-pricing model. All options are charged against income at their fair value.  The entire compensation expenseshort-term nature of the award is recognized over the vesting period. Shares of stock granted are recorded atthose instruments.  There were no transfers between levels in the fair value of the shares at the grant date, over the vesting period.


RECLASSIFICATION


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


NOTE 2  RELATED PARTY TRANSACTIONS


On December 20, 2013, we executed an agreement effective March 1, 2014, with a Company director, Dr. Mark Baker, to provide clinical research and support services related to new and enhanced applications for the FREEDOM60® Syringe Infusion System. Authorized by the Board of Directors, the agreement provided for payment of 420,000 shares of common stock valued at $0.20 per share over a three-year period.  Amortization amounted to zero and $7,000 forhierarchy during the three months ended September 30, 2017 and 2016, respectively, and zero and $14,000 for the seven months ended September 30, 2017 and 2016, respectively.March 31, 2023.


On October 21, 2015, Cyril Narishkin was appointed to the Board of Directors and Interim Chief Operating Officer of the Company. Also effective October 21, 2015, we entered into a consulting agreement with Mr. Narishkin, to support our expanded management team and accelerate our growth opportunities under his role of Interim Chief Operating Officer.  The agreement provided for payment of $16,000 per month for eight days per month, of which half was to be paid in cash and half was to be paid in shares of common stock. Effective January 1, 2016, the agreement provided for the same payment of $16,000 per month, of which seventy-five percent was to be paid in cash and twenty-five percent was to be paid in shares of common stock.IMPAIRMENT OF LONG-LIVED ASSETS


On June 24, 2016, Cyril Narishkin executed a termination and general release agreement, which terminated his previous consulting agreement, and resigned as an officer and director for personal reasons.  Mr. Narishkin was compensated for services as a consultant through January 31, 2017 at a monthly rate of $16,000 per month for up to eight days of service a month upon request of the Company.  Mr. Narishkin’s compensation was zero and $48,000 for the three months ended September 30, 2017 and 2016, respectively and zero and $166,000 for the seven months ended September 30, 2017 and 2016, respectively.  In accordance with the agreement, the Company repurchased 96,542 shares of common stock of the Company owned by Mr. Narishkin at an aggregate purchase price of $43,393 in July 2016.


LEASED AIRCRAFT


The Company leases an aircraftreviews 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 a company controlled by Andrew Sealfon, the Company’s Presidentuse of the asset and Chief Executive Officer.its eventual disposition are less than the carrying amount.  The lease payments were $3,876 and $5,375 forimpairment loss, if recognized, would be based on the three months ended September 30, 2017 and 2016, respectively and $9,544 and $12,542 forexcess of the seven months ended September 30, 2017 and 2016, respectively.  The original lease agreement has expired andcarrying value of the Company is currently on a month-to-month basis for rental payments.


BUILDING LEASE


Mr. Mark Pastreich, a director, is a principal in the entity that owns the building leased by Company.impaired asset over its respective fair value.  The Company is in year nineteen of a twenty-year lease. There have been no changes to lease terms since his directorship and none are expecteddid not record any impairment losses through the life of the current lease.  With a monthly lease amount of $11,042, the lease payments were $33,126 for each of the three months ended September 30, 2017 and 2016 and $77,294 for each of the seven months ended September 30, 2017 and 2016.  The Company also paid property taxes for the three months ended September 30, 2017 and 2016 in the amount of $12,862 and $12,334, respectively, and $29,098 and $28,159 for the seven months ended September 30, 2017 and 2016, respectively.March 31, 2023.


We are currently negotiating a lease extension at our current facility as we continue to assess what our strategy for future expansion and growth requirements will be.


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Table of Contents

NOTE 3  2 — PROPERTY AND EQUIPMENT


Property and equipment consists of the following at:


Schedule of property and equipment

 

 

September 30, 2017

 

February 28, 2017

 

 

 

 

 

 

 

 

 

Land

 

$

54,030

 

$

54,030

 

Building

 

 

171,094

 

 

171,094

 

Furniture, office equipment, and leasehold improvements

 

 

1,054,971

 

 

1,022,942

 

Manufacturing equipment and tooling

 

 

1,074,157

 

 

1,003,166

 

 

 

 

2,354,252

 

 

2,251,232

 

Less: accumulated depreciation

 

 

(1,452,177

)

 

(1,319,140

)

Property and equipment, net

 

$

902,075

 

$

932,092

 

  March 31, 2023 December 31, 2022 
        
Furniture and office equipment $1,325,908 $1,456,745 
Leasehold improvements  1,888,245  2,413,820 
Manufacturing equipment and tooling  2,916,577  2,810,813 
   Total property and equipment  6,130,730  6,681,378 
Less: accumulated depreciation and amortization  (2,224,663) (2,794,403)
Property and equipment, net $3,906,067 $3,886,975 


Leasehold improvements decrease of $0.5 million is due to the write-off of Chester location leasehold improvements resulting from the manufacturing site closure.

Depreciation expense was $197,233 and $94,085 for the three months ended March 31, 2023 and 2022, respectively.

NOTE 4  3 — COMMITMENTS AND CONTINGENCIES

LEGAL PROCEEDINGS


Lawyers representing EMED Technologies Corp. (“EMED”) sent RMS a letter dated, May 1, 2013, which alleged that the RMS High-Flo Butterfly design infringed a patent controlled by EMED.  RMS disputed this claimThe Company has been and believes that our design did not infringemay again become involved in legal proceedings, claims and that the EMED patent itself was not valid.  Under advice of counsel, on September 20, 2013, the Company commencedlitigation arising in the United States District Court for the Eastern Districtordinary course of Californiabusiness.  KORU Medical is not presently a Declaratory Judgment action against competitor, EMEDparty to establish the invalidity of one of EMED’s patents and non-infringement of the Company’s needle sets. EMED answered the complaint and asserted patent infringement and unfair business practice counterclaims. any litigation or other legal proceeding that is believed to be material to its financial condition.

NOTE 4 — STOCK-BASED COMPENSATION

The Company responded by asserting its own unfair business practice claims against EMED. Both parties have requested injunctive relief and monetary damages. Discovery is ongoing.


On June 16, 2015, the Court issued what it termed a “narrow” Preliminary Injunction against the Company from making certain statements regarding some of EMED’s products. On June 23, 2016, EMED filed a Motion seeking to have the Company held in contempt, claiming that certain language in the Company’s device labeling does not comply with the injunction. In response to a Show Cause Order, the Company advised the Court that the language in the Company’s labeling that EMED challenged is language that the FDA directed the Company to use in its labeling. The Court discharged the Show Cause Order, effectively rejecting EMED’s contempt argument.


On March 24, 2016, EMED filed a Motion seeking a second Preliminary Injunction prohibiting RMS from sellinghas three of its products in California.  The Company opposed that Motion on April 19, 2016.  The Order denying this second Preliminary Injunction was issued June 6, 2017.


On August 22, 2017, the Company filed a Motion seeking a Preliminary Injunction prohibiting EMED from making false statements and claims regarding the products of both companies.  EMED filed a Response and Objections to Company’s motion on September 21, 2017, and Company filed a subsequent Reply on September 28, 2017.  The Court issued a Minute Order on September 22, 2017 vacating a hearing set for October 5, 2017, and stating that if the Court determines oral hearings to be required, the parties will be notified.  Presently, the parties are awaiting further action by the Court.


On June 25, 2015, EMED filed a claim of patent infringement for the second of its patents, also directed to the Company’s needle sets, in the United States District Court for the Eastern District of Texas.  This second patent is related to the one concerning the Company’s declaratory judgment action. Given the close relationship between the two patents, the Company requested that the Texas suit be transferred to California.  Also, based on a validity review of the patent in the U.S. Patent and Trademark Office (“USPTO”), discussed below, the Company requested the Texas suit be stayed.  On May 12, 2016, the Court entered an order staying the case until after the Patent Trial and Appeal Board (“PTAB”) at the USPTO issued a final written decision regarding the validity of the patent.  On January 12, 2017, the PTAB issued its final written decision invalidating the claims asserted by EMED in the Texas litigation. On January 26, 2017, the Company and EMED requested that the Texas case remain stayed pending EMED’s appeal of the PTAB’s final ruling to the Court of Appeals for the Federal Circuit (“CAFC”).


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On September 11, 2015, the Company requested an ex parte reexamination of the patent in the first filed case, and on September 17, 2015 the Company requested an inter partes review (“IPR”) of the patent in the second filed case. On November 20, 2015, the USPTO instituted the ex parte reexamination request having found a substantial new question of patentability concerning EMED’s patent in the first filed case. All EMED claims have been rejected by the USPTO Examiner in a Final Office Action dated July 19, 2017.  EMED filed a response to this Final Office Action on September 15, 2017 that is awaiting consideration by the Examiner.  Thus, the ex parte reexamination is ongoing.  A decision to institute the IPR for EMED’s patent in the second filed case was ordered by the USPTO on February 19, 2016 having determined a reasonable likelihood all claims of the patent may be found to be unpatentable.  Oral argument for the IPR was held on November 22, 2016 and a final ruling issued on January 12, 2017.  In its final ruling, the PTAB held the claim asserted by EMED against the Company in the second filed case was invalid.  EMED appealed the PTAB’s final ruling, and EMED’s opening brief in the CAFC was filed on June 26, 2017.  The Company’s response brief was filed on August 3, 2017.  EMED filed a reply brief on August 17, 2017.  Presently, the parties are awaiting further action by the CAFC.


Although the Company believes it has meritorious claims and defenses in these actions and proceedings, their outcomes cannot be predicted with any certainty. We believe that it is likely both patents will be determined invalid, however, if any of these actions against the Company are successful, they could have a material adverse effect on the Company’s business, results of operations, financial condition and cash flows.


NOTE 5  STOCKHOLDERS’ EQUITY


On September 30, 2015, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s outstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases.  As of September 30, 2017, the Company had repurchased 396,606 shares at an average price of $0.45.  The management of the Company has decided to discontinue repurchasing its outstanding common stock under the program for an undetermined period of time to utilize cash for capital investments needed to expand the business.


NOTE 6  STOCK-BASED COMPENSATION


On September 30, 2015, the Board of Directors approvedequity incentive plans: the 2015 Stock Option Plan, (“as amended (the “2015 Plan”), the 2021 Omnibus Equity Incentive Plan (the “2021 Plan”) authorizing, and the Non-Employee Director Compensation Plan. The Company to granthas also issued restricted stock optionas employment inducement awards to certain officers, employees and consultants under the Plan, subject to shareholder approval at the Annual Meeting of Shareholders held on September 6, 2016.  The total number of shares of common stock of the Company, par value $0.01 per share (“Common Stock”), with respect to which awards may be granted pursuant to the Plan was not to exceed 2,000,000 shares.its Chief Executive Officer.


On June 29, 2016, the Board of Directors approved the amendment to the Plan increasing the total number of shares of Common Stock to be subject to awards granted under the Plan to 4,000,000 shares.  On September 6, 2016, at the Annual Shareholder Meeting, the Company’s shareholders approved the Plan as amended.


As of September 30, 2017,March 31, 2023, there were outstanding 1,163,000 options awardedto purchase 2,600,000 shares of the Company’s common stock outstanding to certain executives, key employees and advisory board membersconsultants under the 2015 Plan, of which 40,000 were issued during the three months ended March 31, 2023. Additional options may be issued under the 2015 Plan as outstanding options are forfeited, subject to a maximum 6,000,000 available for issuance under the 2015 Plan.


On October 21, 2015,The 2021 Plan provides for the Boardgrant of Directorsup to 1,000,000 incentive stock options, nonqualified stock options, stock awards, restricted stock awards, restricted stock units and/or stock appreciation rights to employees, consultants and directors. During the three months ended March 31, 2023, there were no awards under the 2021 Plan. As of March 31, 2023, there had been 156,758 shares of common stock issued as directors fees and 475,000 shares issued as executive compensation under the 2021 Plan in total.

Each non-employee director of the Company approved non-employee director compensation(other than the Chairman of $25,000 each the Board) is eligible to receive $110,000 annually, to be paid quarterly half$12,500 in cash and half$15,000 in common stock, beginning September 1, 2015.stock.  The Chairman of the Board is eligible to receive $140,000 annually, to be paid quarterly $12,500 in cash and $22,500 in common stock. From May 18, 2021 to May 6, 2022, non-employee director compensation was paid pursuant to the 2021 Plan. Since May 6, 2022, non-employee director compensation has been paid pursuant to the Non-Employee Director Compensation Plan. All payments were and are pro-rated for partial service.


2015 STOCK OPTION PLAN, as amended

Time Based Stock Options

The per share weighted average fair value of stock options granted during the seventhree months ended September 30, 2017March 31, 2023 and September 30, 2016March 31, 2022 was $0.26$2.83 and zero,$2.45, 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 seventhree months ended September 30, 2017March 31, 2023 and September 30, 2016.March 31, 2022. 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:valued. We have recognized tax benefits associated with stock-based compensation of $49,817 and $49,406 for the three months ended March 31, 2023 and 2022, respectively.


Schedule of time based stock options

 

September 30,

 

 March 31, 

 

2017

 

2016

 

 2023 2022 

 

 

 

 

 

 

 

      

Dividend yield

 

 

0.00%

 

 

 

 0.00% 0.00% 

Expected Volatility

 

 

70.1-72.2%

 

 

 

 61.3% 76.1% - 77.5% 

Weighted-average volatility

 

 

 

 

 

   

Expected dividends

 

 

 

 

 

   

Expected term (in years)

 

 

5 Years

 

 

 

 10 10 

Risk-free rate

 

 

2.30-2.36%

 

 

 

 3.53% 1.81% - 1.87% 


- 10 -



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


Schedule of status of time based stock options

 Three Months Ended March 31, 

 

Seven Months Ended September 30,

 

 2023 2022 

 

2017

 

2016

 

 Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 

 

Shares

 

Weighted
Average
Exercise
Price

 

Shares

 

Weighted
Average
Exercise
Price

 

       

 

 

 

 

 

 

 

 

 

Outstanding at March 1

 

1,345,000

 

$

0.39

 

 

1,060,000

 

$

0.37

 

Outstanding at January 1 2,560,000 $4.15  3,672,500 $3.42 

Granted

 

68,000

 

$

0.44

 

 

 

$

 

 40,000 $3.91 135,000 $3.07 

Exercised

 

 

$

 

 

 

$

 

  $ 75,000 $1.60 

Forfeited

 

250,000

 

$

0.36

 

 

155,000

 

$

0.36

 

  $ 93,750 $1.57 

Outstanding at September 30

 

1,163,000

 

$

0.40

 

 

905,000

 

$

0.37

 

Options exercisable at September 30,

 

573,000

 

$

0.38

 

 

 

$

 

Outstanding at March 31 2,600,000 $4.15 3,638,750 $3.49 
Options exercisable at March 31 1,010,000 $4.63 1,358,750 $2.83 

Weighted average fair value of options granted during the period

 

 

$

 

 

 

$

 

  $2.83  $2.45 

Stock-based compensation expense

 

 

$

(25,343

)

 

 

$

86,876

 

  $475,983  $524,670 


Total stock-based compensation expense net of estimated forfeitures for stock option awards totaled $(25,343)was $475,983 and $86,876$524,670 for the seventhree months ended September 30, 2017March 31, 2023, and September 30, 2016,2022, respectively. No cash was received from option exercises for the three months ended March 31, 2023, and 2022 .


The weighted-average grant-date fair value of options granted during the seventhree months ended September 30, 2017March 31, 2023, and September 30, 2016,2022 was $17,961$0.1 million and zero,$0.3 million, respectively.  The total intrinsic value ofThere were no options exercised during the seventhree months ended September 30, 2017March 31,2023 and September 30, 2016, was zero for both periods.75,000 options exercised during the three months ended March 31, 2022, respectively.


The following table presents information pertaining to options outstanding at September 30, 2017:March 31, 2023:


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
 

 

 

 

 

 

 

 

 

 

 

 

 

 

             

$0.36 - $0.46

 

1,163,000

 

5 years

 

$

0.40

 

573,000

 

$

0.38

 

$2.25-$9.49 2,600,000 8.6 years $4.15 1,010,000 $4.63 


As of September 30, 2017,March 31, 2023, there was $115,384$3,936,268 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan.  That cost is expected to be recognized over a weighted-average period of 1745 months.  The total fair value of shares vested as of March 31, 2023, and March 31, 2022, was $3,511,874 and $2,815,943, respectively.

2021 STOCK OPTION PLAN, as amended

Time Based Stock Options

The per share weighted average fair value of stock options granted during the seventhree months ended September 30, 2017March 31, 2023 and September 30, 2016,March 31, 2022 was $17,873zero and zero 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 three months ended March 31, 2023 and March 31, 2022. 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 $12,406 and zero for the three months ended March 31, 2023 and 2022, respectively.


Schedule of time based stock options

  March 31, 
  2023 2022 
        
Dividend yield  0.00%  0.00% 
Expected Volatility  0.00%  0.00% 
Weighted-average volatility     
Expected dividends     
Expected term (in years)  0  0 
Risk-free rate  0.00%  0.00% 

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

  Three Months Ended March 31, 
  2023 2022 
  Shares Weighted
Average
Exercise
Price
 Shares Weighted
Average
Exercise
Price
 
          
Outstanding at January 1 475,000 $2.67   $ 
Granted  $   $ 
Exercised  $   $ 
Forfeited  $   $ 
Outstanding at March 31 475,000 $2.67   $ 
Options exercisable at March 31  $   $ 
Weighted average fair value of options granted during the period  $   $ 
Stock-based compensation expense  $59,076   $ 

Total stock-based compensation expense was $59,076 and zero for the three months ended March 31, 2023, and 2022, respectively. There were no options exercised during the three months ended March 31, 2023 and March 31, 2022.

The weighted-average grant-date fair value of options granted during the three months ended March 31, 2023, and 2022 was zero million and zero million, respectively.  There were zero options exercised during the three months ended March 31, 2023, and March 31, 2022.

The following table presents information pertaining to options outstanding at March 31, 2023:

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 9.1 years $2.67  $ 

As of March 31, 2023, there was $728,603 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 March 31, 2023, and March 31, 2022, was zero and zero, respectively.

RESTRICTED STOCK AWARDS

The following table summarizes the activities for our restricted stock awards for the three months ended March 31, 2023, and 2022.

  Three Months Ended March 31, 
  2023 2022 
  Shares Weighted
Average
Grant-Date Fair Value
 Shares Weighted
Average
Grant-Date Fair Value
 
          
Unvested at January 1 950,000 $3.04 1,000,000 $3.01 
Granted  $  $ 
Vested 50,000 $3.31  $ 
Forfeited/canceled  $  $ 
Unvested at March 31 900,000 $2.93 1,000,000 $3.01 

As of March 31, 2023, and 2022, there was $1,447,790 and $2,129,339 of unrecognized compensation cost related to unvested employee restricted shares. This amount is expected to be recognized over a weighted-average period of 21 months. We have recognized tax benefits associated with restricted stock award compensation of $35,781 and $35,781 for the three months ended March 31, 2023 and 2022, respectively.

NOTE 5 — DEBT OBLIGATIONS

On 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 March 31, 2023.

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 $0.8 million bearing an annual percentage rate of 6.5%, to finance its insurance premiums. Monthly payments are due on the first of each month beginning August 1, 2022 through June 1, 2023. The balance of AON note was $433,295 and $218,403 at December 31, 2022 and March 31, 2023, respectively.

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Table of Contents

NOTE 6 — LEASES

We have an operating lease for our corporate office, and 2 finance leases for certain office and computer equipment.  Our operating lease has remaining lease term of nine years and 4 months. Our finance leases, which were entered into in June 2022 and October 2022, respectively, have remaining lease terms of 4.2 and 4.5 years, respectively.

The components of lease expense were as follows:

Schedule of components of lease expense

       
  Three Months Ended 
  March 31, 
  2023 2022 
        
Operating lease cost $112,522 $78,442 
Short-term lease cost  52,894  49,709 
Total lease cost $165,416 $128,151 
        
Finance lease cost:       
Amortization of right-of-use assets $27,223 $ 
Interest on lease liabilities  6,720   
Total finance lease cost $33,943 $ 

Supplemental cash flow information related to leases was as follows:

Schedule of cash flow information related to leases

       
  Three Months Ended 
  March 31, 
  2023 2022 
Cash paid for amounts included in the measurement of lease liabilities:       
Operating cash flows from operating leases $113,813 $63,193 
Financing cash flows from finance leases  30,800   

Supplemental balance sheet information related to leases was as follows:

Schdeule of balance sheet information related to leases

      
  March 31,
2023
 December 31,
2022
 
        
Operating Leases       
Operating lease right-of-use assets $3,706,874 $3,786,545 
        
Operating lease current liabilities  349,304  345,834 
Operating lease long term liabilities  3,564,619  3,653,257 
Total operating lease liabilities $3,913,923 $3,999,091 
        
Finance Leases       
Property and equipment, at cost $544,468 $544,468 
Accumulated depreciation  (78,118)  (50,895)
Property and equipment, net $466,350 $493,573 
        
Finance lease current liabilities  99,694  98,335 
Finance lease long term liabilities  368,844  394,283 
Total finance lease liabilities $468,538 $492,618 

  March 31,
2023
 December 31,
2022
 
      
Weighted Average Remaining Lease Term     
Operating leases 9.4 Years 9.7 Years 
Finance leases 4.3 Years 4.6 Years 
      
Weighted Average Discount Rate     
Operating leases 4.00% 4.0% 
Finance leases 4.25% 4.25% 

Maturities of lease liabilities are as follows:

Schedule of maturities of lease liabilities

Year Ending December 31, Operating Leases Finance Leases 
2023 (excluding the three months ended March 31, 2023)  374,627  92,400 
2024  499,503  123,200 
2025  499,503  123,200 
2026  499,503  123,200 
2027  499,503  65,957 
Thereafter  2,331,014   
Total undiscounted lease payments  4,703,653  527,957 
Less: imputed interest  (789,730) (59,419)
Total lease liabilities $3,913,923 $468,538 

PART I ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.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 global health crises, 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, unpredictability relatedgrowth 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, limited liquidity,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 theour research and development effort, expanding the market of FREEDOM60®FREEDOM system demand in the SCIg market, availability of sufficient capital to continue operations,if or when needed, dependence on key personnel, and the outcomeimpact of litigationrecent accounting pronouncements, as well as those risks and regulatory investigation.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, 2022 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 2023 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.  These statements involve risks and uncertainties with respect to the ability to raise capital if or when needed to develop and market new products, acceptance of and demand for new and existing products, ability to penetrate new markets, our success in enforcing and obtaining patents, obtaining required Government approvals, attracting and maintaining key personnel and succeeding in litigation claims that could cause the actual results to differ materially. Our actual results, performance and achievements could differ materially from those expressed or implied in these forward-looking statements. 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, “RMS,” the “Company,” “KORU Medical,” “we,” “us” andor “our” referrefers to Repro MedKORU Medical Systems, Inc.


- 16 -


Table of Contents

OVERVIEW


On March 22, 2017,The Company develops, manufactures and markets proprietary portable and innovative medical devices primarily for the Boardsubcutaneous 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.

Our revenues derive from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies.  Our domestic core and international core revenues consist of Directors approved a changesales of our products for the delivery of subcutaneous drugs that are FDA cleared for use with the Freedom Infusion System, with the primary use being for the delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Novel therapies consist of product revenues from 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 Company’sdrug 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.

In March 2023, the Company completed its transition of finished goods manufacturing of needle and tubing sets to Command Medical Products, a third-party contract manufacturing organization, which began in 2021. The transition provides for dual source manufacturing capability and expected cost improvements.

The Company entered into a lease commencing March 1, 2022 for a new corporate headquarters and manufacturing facility located in Mahwah, NJ. During the quarter ended June 30, 2022, the Company completed the first phase of the move, the headquarters and office staff to the new location, and completed the move of manufacturing during the first quarter of 2023.

The Company ended the 2023 first fiscal quarter with $7.4 million in net revenues, an 18.4% increase, compared with $6.2 million in the same period last year end from February 28 to December 31.driven by growth in all three of our business sources.


DuringGross profit, for the three months ended September 30, 2017,March 31, 2023, was $4.1 million, an increase of 14.5% from the same period last year and, stated as a percentage of net revenues was 56.1%, a decline from 58% in the prior year period.

Operating expenses for the three months ended March 31, 2023, were $7.2 million, up from $6.7 million for the same period last year, driven primarily by an increase of $0.4 million in research and development expense and an increase of $0.1 million in depreciation expense, which was partially offset by a reduction of $0.07 million in selling, general and administrative expenses.

RESULTS OF OPERATIONS

Three months ended March 31, 2023, compared to March 31, 2022

Net Revenues

The following table summarizes our total net sales were up 19.5%revenues for the three months ended March 31, 2023, and 2022:

  Three Months Ended March 31, Change from Prior Year % of Net Revenue 
  2023 2022 $ % 2023 2022 
Net Revenues                
Domestic Core $5,719,135 $4,993,536 $725,599 14.5% 77.4% 80.0% 
International Core  1,097,490  894,942  202,548 22.6% 14.8% 14.3% 
Novel Therapies  575,980  355,852  220,128 61.9% 7.8% 5.7% 
Total $7,392,605 $6,244,330 $1,148,275 18.4%     

Total net revenues increased $1.1 million, or 18.4%, for the three months ended March 31, 2023, as compared with the same period last year with the majoritydouble-digit growth across all businesses. Domestic Core growth of the increase coming14.5% was primarily driven by increased growth in pumps and consumables from higher volume from our domestic customers.  Our gross margin percentage, 61.8%a growing SCIg market, new account wins, increased prefilled syringe adoptions, and increases in average selling prices. International Core growth of 22.6%, was not as high asdriven by strength across several EU markets, expanded distribution, and growing global Immunoglobulin drug volume availability. Novel Therapies net revenues grew by 61.9% in the same period last year, 63.1%, mostly due to higher production costsfirst quarter of 2023 primarily related to scrap during quality inspections as we continue to work to implementservices performed on an NRE innovation development agreement for a nondestructive testing protocol, which we expect to have implemented before the end of the calendar year.  Our selling, general and administrative costs were 10.4% lower for the three months ended September 30, 2017 compared with the same period last year mostly due to a significant reduction in legal fees for the quarter related to our litigation and regulatory efforts.pharmaceutical customer.


Our net sales for the seven months ended September 30, 2017 increased 26.0%, versus the same period last year.  Part of the increase was the result of backorders of $0.4 million at February 28, 2017 which were filled during the three month period ended June 30, 2017.  Excluding these backorders, net sales grew 18.0% driven by growth both domestically and internationally, which included a larger pump order from a national customer in the period and a large return of product related to a market withdrawal last year.  Our selling, general and administrative costs were 7.2% lower for the seven months ended September 30, 2017 compared with the same period last year. We saw a significant reduction in legal fees related to our litigation and regulatory efforts.  However, we cannot predict whether this trend will continue, nor can we predict the outcome of the litigation or regulatory process.  We also had reductions in sales and marketing spend driven by reduced consulting fees that were incurred last year related to our website redesign, public relations, sales training and lead generation efforts and the timing of spend for current year marketing initiatives.  Offsetting these savings were increased salary and related benefit costs in our regulatory department due to headcount to support our regulatory compliance requirements and the addition of our Chief Operating Officer.


We continue to expand internationally, generating our first sales in Asia and Africa in the 2017 quarter.  The FDA issued a new 510(k) clearance for our Integrated Catch-Up Freedom Syringe Driver System, the first ever fully integrated 510(k) cleared system by the FDA, confirming the science behind the performance of using the dedicated RMS system.  It is also the only mechanical infusion system cleared for both subcutaneous drugs (SCIg) and intravenous (antibiotics), clearing the path for customers to invest in one system to meet all their needs.  The FDA renewed our Certificate to Foreign Government which is used to communicate to foreign governments that the FDA certified that RMS meets good manufacturing practices and quality system regulations.  We received registrations in new countries, launched our new flow controller in Europe and started several clinical trials with drug companies. Furthermore, we have launched a new marketing campaign, redesigned our packaging and entered the social media world to help extend our brand awareness.  We plan to continue to focus on global sales growth, cost control and new product development.  We have requested an extension on the lease for our facility as we continue to assess what our strategy for future expansion and growth requirements will be.


- 1217 -



RESULTS OF OPERATIONS


Table of Contents

Three months ended September 30, 2017 compared to September 30, 2016


Net Sales


The following table summarizes our net sales for the three months ended September 30, 2017 and 2016:


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

% of Sales

 

 

 

2017

 

2016

 

$

 

%

 

2017

 

2016

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

3,209,345

 

$

2,597,905

 

$

611,440

 

23.5%

 

83.4%

 

80.6%

 

International

 

 

639,993

 

 

623,597

 

 

16,396

 

2.6%

 

16.6%

 

19.4%

 

Total

 

$

3,849,338

 

$

3,221,502

 

$

627,836

 

19.5%

 

 

 

 

 


Total net sales increased $0.6 million or 19.5% for the three months ended September 30, 2017 compared with the same period last year. This growth was driven mostly by increased volume from domestic sales.  We continue to concentrate the majority of our efforts in our infusion product lines, specifically towards new applications in both domestic and international markets.  During the quarter we generated our first sales in Asia and Africa, and we continue to pursue registrations in new countries.  We also continue to expand our sales efforts into the antibiotic market.


Gross Profit


Our gross profit for the three months ended September 30, 2017March 31, 2023 and 20162022 is as follows:


 

Three Months Ended September 30,

 

Change from Prior Year

 

 Three Months Ended March 31, Change from Prior Year 

 

2017

 

2016

 

$

 

%

 

 2023 2022 $  % 

Gross Profit

 

$

2,378,658

 

$

2,032,944

 

$

345,714

 

17.0%

 

 $4,147,035 $3,622,305 $524,730  14.5% 

Stated as a Percentage of Net Sales

 

 

61.8%

 

 

63.1%

 

 

 

 

 

 

Stated as a Percentage of Net Revenues 56.1% 58.0%   


Gross profit increased $0.3$0.5 million or 17.0%14.5% in the three months ended September 30, 2017,March 31, 2023, compared to the same period in 2016. This2022. The 2023 first quarter gross profit increase in the quarter was mostly driven by the increase in net salesrevenues of $0.6 million.  Partially offsetting this$1.1 million as described above. Gross profit as a percentage of revenues decreased to 56.1% in the first quarter of 2023 compared to 58% from the first quarter of 2022.  The decline in the gross profit as a percentage of revenues was primarily caused by higher manufacturing costs associated with labor and materials partially offset by an increase were higher production costs related to scrap during quality inspections as we work to implement a nondestructive testing protocol, which we expect to have implemented before the end of the calendar year.  Additionally, we still incurred slightly higher payroll costs as we built up inventory.in average selling prices.


Selling, general and administrative and Researchresearch and development


Our selling, general and administrative expenses and research and development costs for the three months ended September 30, 2017March 31, 2023 and 20162022 are as follows:


 

Three Months Ended September 30,

 

Change from Prior Year

 

 Three Months Ended March 31, Change from Prior Year 

 

2017

 

2016

 

$

 

%

 

 2023 2022 $ % 

Selling, general and administrative

 

$

1,893,911

 

$

2,114,407

 

$

(220,496

)

(10.4

)

 $5,425,877 $5,491,213 $(65,336) -1.2% 

Research and development

 

 

14,852

 

 

75,198

 

 

(60,346

)

(80.2

)

  1,564,869  1,148,355  416,514 36.3% 

 

$

1,908,763

 

$

2,189,605

 

$

(280,842

)

(12.8

)

 $6,990,746 $6,639,568 $351,178 5.3% 

Stated as a Percentage of Net Sales

 

 

49.6%

 

 

68.0%

 

 

 

 

 

 

Stated as a Percentage of Net Revenues 94.6% 106.3% 


Selling, general and administrative expenses decreased $0.2$0.07 million, or 10.4%1%, during the three months ended September 30, 2017March 31, 2023 compared to the same period last year.  Theyear, primarily due to a $0.1 million decrease was the result ofin liability insurance, a significant reduction$0.1 million decrease in legal fees of $0.3stock compensation, and a $0.1 million related to our litigation and regulatory efforts.  We cannot predict whether this trend will continue, nor can we predict the outcome of the litigation.  We also had reduced expensesdecrease in sales and marketing of $0.1 million mostly due to lower salary and related costs due to attrition in Europe, lower overall marketing spend due to timing, allcommissions, partially offset by recruiting feesa $0.1 million increase in Europe.  Further offsetting the savings were increased costs oftravel and entertainment expense and $0.1 million in our regulatory departmentbuilding expense and tax.

Research and development expenses increased $0.4 million, or 36% during the three months ended March 31, 2023 compared with the same period last year, primarily due to headcount$0.2 million in compensation and benefits, $0.1 million in stock compensation and $0.1 million in recruiting associated with new hires to support our regulatory compliance requirements and the addition of our Chief Operating Officer, as well as an increase in bad debt expense of $65,000 related to an international customer.  Research and development expense decreased 80.2% due to attrition.  We are committed to our research and development activities and are actively searching to replace the open positions.innovation efforts.


- 13 -



Depreciation and amortization


Depreciation and amortization expense increased by 9.3% up95.07% to $77,517$213,117 in the three months ended September 30, 2017March 31, 2023 compared with $70,935$109,252 in the three months ended September 30, 2016 as a resultMarch 31, 2022 resulting from prior year investments in support of continued investment in computer equipment, testing equipment, patent applicationsour corporate office and maintenance of existing patents.manufacturing site relocation.


Net Income/(Loss)Loss


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

 

 

2017

 

2016

 

$

 

Net Income/(Loss)

 

$

265,754

 

$

(153,213

)

$

418,967

 

Stated as a Percentage of Net Sales

 

 

6.9%

 

 

(4.8%

)

 

 

 

  Three Months Ended March 31, Change from Prior Year 
  2023 2022 $ % 
Net Loss $(2,410,885)$(2,537,514)$126,629 5.0% 
Stated as a Percentage of Net Revenues  (32.6%) (40.6%)     


Our net income forloss decreased $0.1 million in the three months ended September 30, 2017 was $0.3 million compared to a net loss of $0.2 million for the three months ended September 30, 2016.  This $0.4 million change was mostly a result of the increase in net sales and the reduced selling, general and administrative expenses as described above.  Additionally, the Company recognized a $10,419 foreign exchange gain for the period.


Seven months ended September 30, 2017 compared to September 30, 2016


Net Sales


The following table summarizes our net sales for the seven months ended September 30, 2017 and 2016:


 

 

Seven Months Ended September 30,

 

Change from Prior Year

 

% of Sales

 

 

 

2017

 

2016

 

$

 

%

 

2017

 

2016

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

7,463,949

 

$

5,885,669

 

$

1,578,280

 

26.8%

 

81.2%

 

80.7%

 

International

 

 

1,724,465

 

 

1,408,026

 

 

316,439

 

22.5%

 

18.8%

 

19.3%

 

Total

 

$

9,188,414

 

$

7,293,695

 

$

1,894,719

 

26.0%

 

 

 

 

 


Total net sales increased $1.9 million or 26.0% for the seven months ended September 30, 2017March 31, 2023 compared with the same period last year and wasmostly driven by both domestichigher net revenues of $1.1 million and international sales.  Partassociated higher gross margin of the increase was the result of backorders$0.5 million, offsetting operating expenses of $0.4 million, at February 28, 2017 which were filled during the three month period ended June 30, 2017.  Excluding these backorders, net sales grew 18.0%.  The launchand higher other income of a new drug generated increased needle sales as customers built inventory, a larger pump order was received from a national customer in the period and last year included a large return of product related to a market withdrawal.  We continue to concentrate the majority of our efforts in our infusion product lines, specifically towards new applications in both domestic and international markets.  We generated our first sales in Asia and Africa during the period, and we continue to pursue registrations in new countries.  We also continue to expand our sales efforts into the antibiotic market.


Gross Profit


Our gross profit for the seven months ended September 30, 2017 and 2016 is as follows:


 

 

Seven Months Ended September 30,

 

Change from Prior Year

 

 

 

2017

 

2016

 

$

 

%

 

Gross Profit

 

$

5,648,752

 

$

4,649,770

 

$

998,982

 

21.5%

 

Stated as a Percentage of Net Sales

 

 

61.5%

 

 

63.8%

 

 

 

 

 

 


Gross profit increased $1.0$0.1 million or 21.5% in the seven months ended September 30, 2017, compared to the same period in 2016. This increase was driven by the increase in net sales of $1.9 million.  Partially offsetting this increase were higher production costs related to scrap during quality inspections as we work to implement a nondestructive testing protocol, higher sterilization costs due to more frequent cycles required to meet demand and backlog and increased shipping costs due to a backlog. We also had higher production salary and related benefits costsinterest income from overtime and the addition of a second shift to meet increased demand.


- 14 -



Selling, general and administrative and Research and development


Our selling, general and administrative expenses and research and development costs for the seven months ended September 30, 2017 and 2016 are as follows:


 

 

Seven Months Ended September 30,

 

Change from Prior Year

 

 

 

2017

 

2016

 

$

 

%

 

Selling, general and administrative

 

$

4,536,954

 

$

4,887,608

 

$

(350,654

)

(7.2%

)

Research and development

 

 

47,564

 

 

147,136

 

 

(99,572

)

(67.7%

)

 

 

$

4,584,518

 

$

5,034,744

 

$

(450,226

)

(8.9%

)

Stated as a Percentage of Net Sales

 

 

49.9%

 

 

69.0%

 

 

 

 

 

 


Selling, general and administrative expenses decreased $0.4 million, or 7.2%, during the seven months ended September 30, 2017 compared to the same period last year.  The decrease was the result of a significant reduction in legal feesour treasury bill investments. A tax benefit of $0.6 million related to our litigation and regulatory efforts.  We cannot predict whether this trend will continue, nor can we predictresulting from the outcome of the litigation.  Weloss was also had reductions in sales and marketing spend of $0.2 million driven by lower consulting fees related to our website redesign last year, timing of spend this year on marketing initiatives and tradeshows and lower salary and related costs due to attrition in Europe.  Partially offsetting these savings were increased costs in our regulatory department due to headcount to support our regulatory compliance requirements and the addition of our Chief Operating Officer, totaling $0.4 million, as well as an increase in bad debt expense of $65,000, related to an international customer.  Research and development expense decreased by $0.1 million, or 67.7%, primarily due to attrition for the period.  We are committed to our research and development activities and are actively searching to replace the open positions.


Depreciation and amortization


Depreciation and amortization expense increased by 7.4% up to $179,874 in the seven months ended September 30, 2017 compared with $167,513 in the seven months ended September 30, 2016 as a result of continued investment in computer equipment, testing equipment, patent applications and maintenance of existing patents.


Net Income/(Loss)


 

 

Seven Months Ended September 30,

 

Change from Prior Year

 

 

 

2017

 

2016

 

$

 

Net Income/(Loss)

 

$

626,587

 

$

(359,095

)

$

985,682

 

Stated as a Percentage of Net Sales

 

 

6.8%

 

 

(4.9%

)

 

 

 


Our net income for the seven months ended September 30, 2017 was $0.6 million compared to a net loss of $0.4 million for the seven months ended September 30, 2016..  This $1.0 million change was mostly a result of the increase in net sales and the reduced selling, general and administrative expenses as described above.  Additionally, the Company recognized $65,079 in foreign exchange gain forrecorded during the period.


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Table of Contents

LIQUIDITY AND CAPITAL RESOURCES


Our principal source of liquidity is our cash on hand of $3.7$12.2 million as of September 30, 2017, and cash flows from operations.March 31, 2023.  Our principal source of operating cash inflows is from sales of our products and NRE services to customers. Our principal cash outflows relate to the purchase and production of inventory, funding of research and related costs,development, and selling, general and administrative expenses, capital expendituresexpenses. To develop new products, support future growth, achieve operating efficiencies, and patent costs.maintain product quality, we are continuing to invest in research and development, manufacturing technologies, and equipment.


Our inventory position was $6.6 million at March 31, 2023, which reflected an increase of $0.2 million from December 31, 2022. We have completed the transition of our manufacturing operations to Command and expect to significantly reduce our inventory position during the future quarters of 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. We expect the credit to be received before the end of 2023.

We believeexpect that as of September 30, 2017,our cash on hand, cash flows from operations and cash expected to be generated from future operating activitiesavailable financing sources will be sufficient to fundmeet our operations,requirements at least through March 31, 2024. 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. Our future capital requirements may vary from those currently planned and will depend on many factors, including furtherour rate of revenue growth, the timing and extent of spending on various strategic initiatives including research and development, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including inflation, rising interest rates, increased demand for equity investor capital expenditures forand the next 12 months.  We believepotential impact of global supply imbalances on the FREEDOM System continues to find a solid following inglobal financial markets. To the SCIg market,extent that current and this market isanticipated future sources of liquidity are or are expected to continuebe insufficient to increase both domesticallyfund our future business activities and internationally.  In addition,requirements, we expect many of the SCIg providers, and others, will see benefit in using the FREEDOM System formay be required to seek additional uses such as antibiotics, chemotherapeutics, and pain medications.


We continue toequity or debt financing sooner. There can be in litigation with a competitor, EMED Technologies Corp. (“EMED”) and have incurred a significant amount of legal fees in connection with that process.  Althoughno assurance the Company believes it has meritorious claims and defenses inwill be able to obtain the actions and proceedings, their outcomes cannot be predicted with any certainty. If any of these actions againstfinancing or raise the Company are successful, they could have a material adverse effect on the Company’s business, results ofcapital required to fund its operations financial condition and cash flows.or planned expansion.


- 15 -



On September 30, 2015, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s outstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases.  As of September 30, 2017, the Company had repurchased 396,606 shares at an average price of $0.45.  The management of the Company has decided to discontinue repurchasing its outstanding Common Stock for an undetermined period of time to utilize cash for capital investments needed to expand the business.


Cash Flows


The following table summarizes our cash flows:


 Three Months Ended
March 31, 2023
 Three Months Ended
March 31, 2022
 

 

Seven Months Ended
September 30, 2017

 

Seven Months Ended
September 30, 2016

 

Net cash provided by/(used in) operating activities

 

$

531,281

 

$

(212,676

)

Net cash used in operating activities $(4,660,583)$(1,752,072)

Net cash used in investing activities

 

$

(163,479

)

$

(230,044

)

 $(283,837)$(752,602)

Net cash used in financing activities

 

$

(19,360

)

$

(120,577

)

 $(238,972)$(252,968)


Operating Activities


Net cash provided by operating activities of $0.5 million for the seven months ended September 30, 2017 was primarily attributable to net income of $0.6 million, non-cash charges of $0.2 million for depreciation and amortization of long lived tangible and intangible assets, a decrease in tax receivable of $0.1 million, and an increase in tax liability of $0.1 million.  Offsetting these were an increase in inventory of $0.2 million as we built up finished goods inventory after our backorder position at February 28, 2017 and the reduction of accounts payable of $0.4 million which was the result of the payment of legal fees accrued at February 28, 2017.


Net cash used in operating activities of $0.2$4.7 million for the seventhree months ended September 30, 2016March 31, 2023 was primarily attributabledue to the operatingnet loss of $0.4$2.4 million, working capital changes which included an increase in accounts receivable of $0.3$0.6 million, an increase in inventory of $0.2 million, a decrease in accrued expenses of $1.3 million, a decrease in accounts payable of $0.9 million and a decrease in prepaid expense of $0.1 million mostly due to$0.3 million.  Further contributing was an incomeincrease in deferred tax receivableassets of $0.1 million due to the loss in the period and the decrease in tax liability of $0.2$0.6 million.  Partially offsettingOffsetting these were primarily non-cash charges for stock-based compensation of $0.2$0.9 million, for depreciation and amortization of long lived tangible$0.2 million and intangiblea loss on disposal of fixed assets stock based compensation expense of $0.1 million.

Net cash used in operating activities of $1.8 million for the three months ended March 31, 2022, was primarily due to the net loss of $2.5 million and an increase in accounts payablethe deferred tax asset of $0.6 million, offset by favorable net working capital of $0.4 million mostly due to raw material purchasesdriven by accounts receivable collections and legal fees.non-cash charges for stock-based compensation of $0.8 million, and depreciation and amortization of $0.1 million.


- 19 -


Table of Contents

Investing Activities


Our netNet cash used in investing activities of $0.2$0.3 million for the seventhree months ending March 31, 2023, was for capital expenditures for research and development and office equipment.

Net cash used in investing activities of $0.8 million for the three months ended September 30, 2017March 31, 2022, was for capital improvement expenditures for our new location and September 30, 2016 was primarily attributable to our continued investment in capital assets mostly related to productionmanufacturing and for new patent applications and maintenance of existing patents.office equipment.


Financing Activities


Our netNet cash used in financing activities was $19,360 and $120,577 for the seventhree months ended September 30, 2017March 31, 2023, is from $0.2 million of net borrowings on our indebtedness for a note payable for insurance premium financing.

The $0.3 million used in financing activities for the three months ended March 31, 2022, was for financed director and September 30, 2016, respectively, and were a result of the repurchase of shares of the Company’s common stock.officer liability insurance.


FDAACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED


RMS had an inspection by the FDA in June 2015, which included, among other items, a review of customer complaints, quality controls, quality assurance and documentation. The FDA inspection was then expanded as a consequence of an extensive “trade complaint” filed on behalf of a competitor which resultedRefer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the issuance of an FDA FORM 483.  Eight months later, on February 29, 2016 we received a Warning Letter.  Since that time the Company has successfully addressed all quality and regulatory issues cited in the Warning Letter and the FDA FORM 483.  On October 2, 2017, the FDA conducted another inspection as a last step in closing the Warning Letter.  We anticipate the Warning Letter to be closed in the near future.


On April 19, 2017, the FDA renewed our Certificate to Foreign Governmentaccompanying financial statements, which is used to communicate to foreign governments that the FDA confirmed and certified that RMS meets U.S. FDA good manufacturing practices and quality system regulations.incorporated herein by reference.


- 16 -



RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS


In May 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2017-09—Compensation-Stock Compensation (Topic 718), which provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a change to the terms or conditions of a share-based payment award.  The amendments in this update affect any entity that changes the terms or conditions of a share-based payment award. The amendments in this update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017.  Early adoption is permitted, including adoption in any interim period, for (1) public business entities for reporting periods for which financial statements have not yet been issued and (2) all other entities for reporting periods for which financial statements have not yet been made available for issuance. The amendments in this update should be applied prospectively to an award modified on or after the adoption date.  Based upon our initial evaluation, we do not expect the adoption of the standard to have a material effect on our financial statements, disclosure requirements and methods of adoption.


In June 2016, 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, 2019, 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 May 2014, the FASB issued ASU No. 2014-09—Revenue from Contracts with Customers. The ASU clarifies the principles for recognizing revenue and develops a common revenue standard for U.S. GAAP and International Financial Reporting Standards (“IFRS”) that removes inconsistencies and weaknesses in revenue requirements, provides a more robust framework for addressing revenue issues, improves comparability of revenue recognition practices across entities, industries, jurisdictions and capital markets, provides more useful information to users of the financial statements through improved disclosure requirements and simplifies the preparation of financial statements by reducing the number of requirements to which an entity must refer. The amendments in this update are effective for the annual reporting periods beginning after December 15, 2016, including interim periods within that reporting period. Full or modified retrospective adoption is required and early application is not permitted. On July 9, 2015, the FASB issued ASU No. 2015-14 Revenue from Contracts with Customers (Topic 606); Deferral of the Effective Date, which (a) delays the effective date of ASU 2014-09, Revenue from Contracts with Customers (Topic 606), by one year to annual periods beginning after December 15, 2017 and (b) allows early adoption of the ASU by all entities as of the original effective date for public entities.  We currently anticipate adopting the new standard using the modified retrospective method beginning January 1, 2018.  In March 2016, the FASB issued ASU No. 2016-08 Revenue from Contracts with Customers (Topic 606); Principal versus Agent Considerations (Reporting Revenue Gross versus Net), which is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations and the effective date is the same as the requirements in ASU 2014-09.  In April 2016, the FASB issued ASU No. 2016-10 Revenue from Contracts with Customers (Topic 606); Identifying Performance Obligations and Licensing, which is intended to clarify identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas and the effective date is the same as the requirements in ASU 2014-09.  In May 2016, FASB issued ASU No. 2016-12—Revenue from Contracts with Customers (Topic 606); Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis.  The effective date and transition requirements for the amendments in this update are the same as the effective date and transition requirements for Topic 606 (and any other Topic amended by update 2014-09).  In December 2016, the FASB issued ASU No. 2016-20 Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which represents changes to make minor improvements to the Codification that are not expected to have a significant effect on current accounting practice or create a significant administrative cost to most entities.  This update is the final, combined version of Proposed Accounting Standards Updates 2016-240 and 2016-320 (both entitled Technical Corrections and Improvements), which have been deleted.  We do not expect the adoption of the standard and related amendments to have a material effect on our financial condition or results of operations.


- 17 -



In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842).  The main difference between the current requirement under GAAP and this ASU is the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases.  This ASU requires that a lessee recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term (other than leases that meet the definition of a short-term lease).  The liability will be equal to the present value of lease payments.  The asset will be based on the liability, subject to adjustment, such as for initial direct costs.  For income statement purposes, the FASB retained a dual model, requiring leases to be classified as either operating or finance.  Operating leases will result in straight-line expense (similar to current operating leases) while finance leases will result in a front-loaded expense pattern (similar to current capital leases).  Classification will be based on criteria that are largely similar to those applied in current lease accounting.  For lessors, the guidance modifies the classification criteria and the accounting for sales-type and direct financing leases.  This is effective for annual and interim periods beginning after December 15, 2018 and early adoption is permitted.  This ASU must be adopted using a modified retrospective transition, and provides for certain practical expedients.  Transition will require application of the new guidance at the beginning of the earliest comparative period presented.  We are currently assessing the potential impact of this ASU on our financial statements, disclosure requirements and methods of adoption.


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.


PART I – ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.RISK


Not Applicable.applicable.


PART I – ITEM 4.  CONTROLS AND PROCEDURES.PROCEDURES


The Company’s management, including the Company’s Principal Executive Officer and Principal Financial Officer, havehas 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 quarterthree months ended September 30, 2017,March 31, 2023, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.


- 20 -


Table of Contents

PART II – OTHER INFORMATION


PART II – ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.1A.  RISK FACTORS


On October 21, 2015,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 Boardyear ended December 31, 2022 and described below, which could adversely affect our business, financial condition, results of Directors ofoperations, cash flows, and the Company approved non-employee director compensation of $25,000 each annually, to be paid quarterly half in cash and half in common stock, beginning September 1, 2015.  The number of shares to be issued each quarter is calculated based upon the closingtrading price of theour common stockstock.

Bank failures or other events affecting financial institutions could have a material adverse effect on the last dayour business, results of each fiscal quarter as reported by the OTCQX.  The Company issued 53,196 and 97,314 shares of common stock to its non-employee directors during the three and seven month period ended September 30, 2017, respectively.operations or financial condition, or have other adverse consequences.


The Company issued 42,553 and 56,108 shares of common stock to Dr. Fred Ma, its Chief Medical Officer, under the terms of his employment agreement, during the three and seven month period ended September 30, 2017, respectively.


On September 30, 2015, RMS’s Board of Directors authorized the Company to make open market purchases of up to 2,000,000 shares of the Company’s outstanding Common Stock.  The purchases are made through a broker designated by the Company, with price, timing and volume restrictions based on average daily trading volume, consistent with the rules of the Securities and Exchange Commission for such repurchases. As of September 30, 2017, the Company had repurchased 396,606 shares at an average price of $0.45.  There were no repurchases of common stock by the Company during the quarter ended September 30, 2017.  The management of the Company has decided to discontinue repurchasing its outstanding Common Stock for an undetermined period of time to utilize cash for capital investments needed to expand the business.  There is no expiration date to the repurchase plan.


- 18 -



On September 30, 2015, the Board of Directors approved the 2015 Stock Option Plan authorizing the Company to grant awards to certain employees under the plan at fair market value, which was approved by shareholders at the Annual Meeting held on September 6, 2016.  The total number of shares of Common Stock, with respect to which awards may be granted pursuant to the Plan, shall not exceed 4,000,000 shares.  As of September 30, 2017, there were outstanding 1.2 million options awarded to certain executives, key employees and advisory board members under the Plan.


All of our cash deposits are held by Federal Deposit Insurance Corporation (“FDIC”) insured banks, which amounts exceed the securities issued byFDIC insurance limits. Through various overnight “sweep account” programs, we also invest a significant portion of our cash balances in U.S. Treasury-based funds, which are invested through brokerage firms affiliated with the Company as describedbanks at which our deposits are held. The failure of a bank or related brokerage firm that we use, or events involving limited liquidity, non-performance or other adverse conditions in this Item were issuedthe financial or credit markets impacting financial institutions at which we maintain balances, or concerns or rumors about such events, may lead to disruptions in relianceaccess to our cash balances, adversely impact our liquidity, including our ability to borrow under our credit facility, or limit our ability to pay our vendors. In the event of a failure of a bank or other financial institution that holds our cash deposits, there can be no assurance that our deposits in excess of the FDIC or other comparable insurance limits will be recoverable or, even if ultimately recoverable, there may be significant delays in our ability to access those funds. Furthermore, bank failures, non-performance, or other adverse developments that affect financial institutions could impair the ability of one or more of the banks participating in our credit facility from honoring their commitments. Such events could have a material adverse effect on the exemption from registration under Section 4(2) under the Securities Actour financial condition or results of 1933, as amended.operations.


PART II – ITEM 6.  EXHIBITS.


Exhibit No.Description

31.1

31.1Certification of Principal Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002

31.2

Certification of Principal Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act 2002

32.1

Certification of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002

32.2

Certification of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act 2002

101*

101.INS

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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 Notes.

contained in Exhibit 101)


* In accordance with Regulation S-T, the Interactive Data Files in Exhibit 101 to the Quarterly Report on Form 10-Q shall be deemed “furnished” and not “filed”.


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SIGNATURES


Table of Contents

SIGNATURES

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



KORU MEDICAL SYSTEMS, INC.

REPRO MED SYSTEMS, INC.

May 4, 2023

/s/ Linda Tharby

November 3, 2017

/s/ Andrew I. Sealfon

Andrew I. Sealfon,Linda Tharby, President Chairman of the Board, Director,and Chief Executive Officer


(Principal Executive Officer)

November 3, 2017

May 4, 2023

/s/ Karen Fisher

Thomas Adams

Karen Fisher,Thomas Adams, Interim Chief Financial Officer and Treasurer


(Principal Financial Officer)


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