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, 2020

 

Or

 

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

 

For the transition period from ________ to ________.

 

Commission File Number: 0-12305

 

REPRO MED SYSTEMS, INC.

(Exact name of registrant as specified in its charter)

 

New York

13-3044880

(State or Other Jurisdiction of Incorporation or Organization)

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

 

 

24 Carpenter Road, Chester, New York

10918

(Address of Principal Executive Offices)

(Zip Code)

 

(845) 469-2042

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

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

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, $0.01 par value

KRMD

The Nasdaq Stock Market

 

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

 

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

 

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

 

 

Large accelerated filer [  ]

Accelerated filer [  ]

 

Non-accelerated filer   [X]

Smaller reporting company [X]

 

 

Emerging growth company [  ]

 

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

 

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

 

As of November 12, 2020, 43,942,888 shares of common stock, $0.01 par value per share, were outstanding, which excludes 2,737,231 shares of treasury stock.

 



REPRO MED SYSTEMS, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2020

TABLE OF CONTENTS


 

 

PAGE

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

ITEM 1.

Financial Statements (Unaudited)

 

 

 

 

 

Balance Sheets as of September 30, 2020 and December 31, 2019

3

 

 

 

 

Statements of Operations for the three and nine months ended September 30, 2020 and 2019

4

 

 

 

 

Statements of Cash Flows for the nine months ended September 30, 2020 and 2019

5

 

 

 

 

Statements of Stockholders’ Equity for the three and nine months ended September 30, 2020 and 2019

6-7

 

 

 

 

Notes to Financial Statements

8

 

 

 

ITEM 2.

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

18

 

 

 

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

24

 

 

 

ITEM 4.

Controls and Procedures

24

 

 

 

PART II. OTHER INFORMATION

 

 

 

ITEM 1.

Legal Proceedings

25

 

 

 

ITEM 1A.

Risk Factors

25

 

 

 

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

 

 

 

ITEM 6.

Exhibits

26

 

 

 

 

Signatures

27


- 2 -



PART I – FINANCIAL INFORMATION


Item 1.  Financial Statements (Unaudited)


REPRO MED SYSTEMS, INC.

BALANCE SHEETS

(Unaudited)


 

 

September 30,

 

December 31,

 

 

 

2020

 

2019

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

32,433,811

 

$

5,870,929

 

Accounts receivable less allowance for doubtful accounts of $24,676 and $32,645 at September 30, 2020 and December 31, 2019, respectively

 

 

3,736,596

 

 

3,234,521

 

Inventory  

 

 

5,633,139

 

 

2,388,477

 

Prepaid expenses

 

 

844,496

 

 

387,396

 

TOTAL CURRENT ASSETS

 

 

42,648,042

 

 

11,881,323

 

Property and equipment, net

 

 

1,260,675

 

 

611,846

 

Patents, net of accumulated amortization of $335,686 and $288,967 at September 30, 2020 and December 31, 2019, respectively

 

 

884,635

 

 

807,135

 

Right of use assets, net

 

 

271,679

 

 

373,734

 

Deferred tax asset

 

 

349,609

 

 

188,241

 

Other assets

 

 

19,812

 

 

19,582

 

TOTAL ASSETS

 

$

45,434,452

 

$

13,881,861

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

Accounts payable

 

 

1,363,070

 

 

572,656

 

Accrued expenses

 

 

3,051,582

 

 

1,296,612

 

Accrued payroll and related taxes

 

 

440,144

 

 

190,265

 

Accrued tax liability

 

 

363,158

 

 

204,572

 

Finance lease liability – current

 

 

3,026

 

 

5,296

 

Operating lease liability – current

 

 

140,450

 

 

136,888

 

TOTAL CURRENT LIABILITIES

 

 

5,361,430

 

 

2,406,289

 

Finance lease liability, net of current portion

 

 

414

 

 

2,646

 

Operating lease liability, net of current portion

 

 

131,229

 

 

236,846

 

TOTAL LIABILITIES

 

 

5,493,073

 

 

2,645,781

 

Commitments and contingencies (Refer to Note 3)

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Common stock, $0.01 par value; 75,000,000 shares authorized, 46,671,807 and 42,239,788 shares issued, 43,934,576 and 39,502,557 shares outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

466,718

 

 

422,398

 

Additional paid-in capital

 

 

35,331,483

 

 

6,293,069

 

Treasury stock, 2,737,231 shares at September 30, 2020 and December 31, 2019, respectively, at cost

 

 

(344,204

)

 

(344,204

)

Retained earnings

 

 

4,487,382

 

 

4,864,817

 

TOTAL STOCKHOLDERS’ EQUITY

 

 

39,941,379

 

 

11,236,080

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

45,434,452

 

$

13,881,861

 


See accompanying Notes to Financial Statements.


- 3 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)


 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2020

 

2019

 

2020

 

2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET SALES

 

$

6,080,315

 

$

6,617,397

 

$

20,119,228

 

$

16,940,487

 

Cost of goods sold

 

 

2,139,592

 

 

2,234,489

 

 

7,480,415

 

 

6,033,961

 

Gross Profit

 

 

3,940,723

 

 

4,382,908

 

 

12,638,813

 

 

10,906,526

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

3,075,169

 

 

2,441,381

 

 

9,039,980

 

 

6,976,684

 

Litigation

 

 

675

 

 

864,009

 

 

2,446,747

 

 

2,481,471

 

Research and development

 

 

390,416

 

 

170,260

 

 

944,637

 

 

450,454

 

Depreciation and amortization

 

 

115,637

 

 

82,774

 

 

297,801

 

 

252,594

 

Total Operating Expenses

 

 

3,581,897

 

 

3,558,424

 

 

12,729,165

 

 

10,161,203

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Operating Profit/(Loss)

 

 

358,826

 

 

824,484

 

 

(90,352

)

 

745,323

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-Operating Income/(Expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

Gain/(Loss) on currency exchange

 

 

1,927

 

 

(9,358

)

 

(11,164

)

 

(20,283

)

Gain on disposal of fixed assets, net

 

 

22,113

 

 

 

 

16,591

 

 

49,740

 

Interest income, net

 

 

9,662

 

 

23,368

 

 

23,690

 

 

59,091

 

TOTAL OTHER INCOME/(EXPENSE)

 

 

33,702

 

 

14,010

 

 

29,117

 

 

88,548

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INCOME/(LOSS) BEFORE INCOME TAXES

 

 

392,528

 

 

838,494

 

 

(61,235

)

 

833,871

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income Tax Expense

 

 

(143,353

)

 

(186,681

)

 

(316,200

)

 

(189,265

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS)

 

$

249,175

 

$

651,813

 

$

(377,435

)

$

644,606

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET INCOME/(LOSS) PER SHARE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

$

0.02

 

$

(0.01

)

$

0.02

 

Diluted

 

$

0.01

 

$

0.02

 

$

(0.01

)

$

0.02

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

43,914,542

 

 

39,022,298

 

 

41,326,815

 

 

38,534,021

 

Diluted

 

 

44,119,511

 

 

39,298,408

 

 

41,326,815

 

 

38,734,083

 


See accompanying Notes to Financial Statements.


- 4 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(Unaudited)


 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2020

 

2019

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

 

Net (Loss)/Income

 

$

(377,435

)

$

644,606

 

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

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

1,191,146

 

 

897,300

 

Stock-based litigation settlement expense

 

 

1,285,102

 

 

 

Depreciation and amortization

 

 

297,801

 

 

252,594

 

Deferred capital gain - building lease

 

 

 

 

(3,763

)

Deferred taxes

 

 

(161,368

)

 

134,563

 

Gain on disposal of fixed assets

 

 

(16,591

)

 

(49,740

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Increase in accounts receivable

 

 

(502,075

)

 

(2,120,780

)

Increase in inventory

 

 

(3,244,662

)

 

(634,803

)

Increase in prepaid expenses and other assets

 

 

(457,330

)

 

(206,560

)

Increase in accounts payable

 

 

790,414

 

 

421,479

 

Increase/(Decrease) in accrued payroll and related taxes

 

 

249,879

 

 

(310,355

)

Increase in accrued expenses

 

 

1,754,970

 

 

490,053

 

Increase/(Decrease) in accrued tax liability

 

 

158,586

 

 

(16,608

)

NET CASH PROVIDED BY/(USED IN) OPERATING ACTIVITIES

 

 

968,437

 

 

(502,014

)

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(908,323

)

 

(158,193

)

Purchases of patents

 

 

(124,216

)

 

(188,274

)

Proceeds from disposal of property and equipment

 

 

25,000

 

 

217,821

 

Proceeds from certificate of deposit

 

 

 

 

1,517,927

 

NET CASH (USED IN)/PROVIDED BY INVESTING ACTIVITIES

 

 

(1,007,539

)

 

1,389,281

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 

Proceeds from issuance of equity

 

 

26,606,486

 

 

508,900

 

Payments for cancelled shares

 

 

 

 

(2,820

)

Borrowings from indebtedness

 

 

4,976,508

 

 

 

Payments on indebtedness

 

 

(4,976,508

)

 

 

Payments on finance lease liability

 

 

(4,502

)

 

(3,122

)

NET CASH PROVIDED BY FINANCING ACTIVITIES

 

 

26,601,984

 

 

502,958

 

 

 

 

 

 

 

 

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

 

26,562,882

 

 

1,390,225

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

5,870,929

 

 

3,738,803

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

32,433,811

 

$

5,129,028

 

 

 

 

 

 

 

 

 

Supplemental Information

 

 

 

 

 

 

 

Cash paid during the periods for:

 

 

 

 

 

 

 

Interest

 

$

27,698

 

$

280

 

Income taxes

 

$

318,983

 

$

103,465

 


See accompanying Notes to Financial Statements.


- 5 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Common Stock

 

Paid-in

 

Retained

 

Treasury

 

Stockholders’

 

 

 

Shares

 

Amount

 

Capital

 

Earnings

 

Stock

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three and Nine Months Ended September 30, 2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE, DECEMBER 31, 2019

 

42,239,788

 

$

422,398

 

$

6,293,069

 

$

4,864,817

 

$

(344,204

)

$

11,236,080

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

9,189

 

 

92

 

 

59,910

 

 

 

 

 

 

60,002

 

Compensation expense related to stock options

 

 

 

 

 

300,966

 

 

 

 

 

 

300,966

 

Cancellation of common stock

 

 

 

 

 

 

 

 

 

 

 

 

Issuance upon options exercised

 

175,000

 

 

1,750

 

 

83,750

 

 

 

 

 

 

85,500

 

Net income

 

 

 

 

 

 

 

449,428

 

 

 

 

449,428

 

BALANCE, MARCH 31, 2020

 

42,423,977

 

$

424,240

 

$

6,737,695

 

$

5,314,245

 

$

(344,204

)

$

12,131,976

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

7,999

 

 

80

 

 

59,922

 

 

 

 

 

 

60,002

 

Compensation expense related to stock options

 

 

 

 

 

363,851

 

 

 

 

 

 

363,851

 

Litigation settlement options

 

 

 

 

 

347,008

 

 

 

 

 

 

347,008

 

Litigation settlement share issuance

 

95,238

 

 

952

 

 

937,142

 

 

 

 

 

 

938,094

 

Issuance upon options exercised

 

519,156

 

 

5,192

 

 

5,189

 

 

 

 

 

 

10,381

 

Capital raise

 

3,593,750

 

 

35,937

 

 

26,436,043

 

 

 

 

 

 

26,471,980

 

Net loss

 

 

 

 

 

 

 

(1,076,038

)

 

 

 

(1,076,038

)

BALANCE, JUNE 30, 2020

 

46,640,120

 

$

466,401

 

$

34,886,850

 

$

4,238,207

 

$

(344,204

)

$

39,247,254

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

6,681

 

 

67

 

 

59,935

 

 

 

 

 

 

60,002

 

Compensation expense related to stock options

 

 

 

 

 

346,323

 

 

 

 

 

 

346,323

 

Issuance upon options exercised

 

25,006

 

 

250

 

 

(250

)

 

 

 

 

 

 

Capital raise

 

 

 

 

 

38,625

 

 

 

 

 

 

38,625

 

Net income

 

 

 

 

 

 

 

249,175

 

 

 

 

249,175

 

BALANCE, SEPTEMBER 30, 2020

 

46,671,807

 

$

466,718

 

$

35,331,483

 

$

4,487,382

 

$

(344,204

)

$

39,941,379

 


See accompanying Notes to Financial Statements.


- 6 -



REPRO MED SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)


 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Common Stock

 

Paid-in

 

Retained

 

Treasury

 

Stockholders’

 

 

 

Shares

 

Amount

 

Capital

 

Earnings

 

Stock

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three and Nine Months Ended September 30, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BALANCE, DECEMBER 31, 2018

 

40,932,911

 

$

409,329

 

$

4,595,214

 

$

4,300,468

 

$

(344,204

)

$

8,960,807

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

8,914

 

 

89

 

 

176,161

 

 

 

 

 

 

176,250

 

Compensation expense related to stock options

 

 

 

 

 

121,875

 

 

 

 

 

 

121,875

 

Repurchase of shares

 

(2,000

)

 

(20

)

 

(2,800

)

 

 

 

 

 

(2,820

)

Net loss

 

 

 

 

 

 

 

(85,390

)

 

 

 

(85,390

)

BALANCE, MARCH 31, 2019

 

40,939,825

 

$

409,398

 

$

4,890,450

 

$

4,215,078

 

$

(344,204

)

$

9,170,722

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

116,386

 

 

1,164

 

 

35,484

 

 

 

 

 

 

36,648

 

Compensation expense related to stock options

 

 

 

 

 

194,765

 

 

 

 

 

 

194,765

 

Issuance upon options exercised

 

65,000

 

 

650

 

 

24,050

 

 

 

 

 

 

24,700

 

Net income

 

 

 

 

 

 

 

78,183

 

 

 

 

78,183

 

BALANCE, JUNE 30, 2019

 

41,121,211

 

$

411,212

 

$

5,144,749

 

$

4,293,261

 

$

(344,204

)

$

9,505,018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of stock-based compensation

 

12,447

 

 

124

 

 

43,502

 

 

 

 

 

 

43,626

 

Compensation expense related to stock options

 

 

 

 

 

324,135

 

 

 

 

 

 

324,135

 

Issuance upon warrants exercised

 

1,000,000

 

 

10,000

 

 

440,000

 

 

 

 

 

 

450,000

 

Issuance upon options exercised

 

95,000

 

 

950

 

 

33,250

 

 

 

 

 

 

34,200

 

Net income

 

 

 

 

 

 

 

651,813

 

 

 

 

651,813

 

BALANCE, SEPTEMBER 30, 2019

 

42,228,658

 

$

422,286

 

$

5,985,636

 

$

4,945,074

 

$

(344,204

)

$

11,008,792

 


See accompanying Notes to Financial Statements.


- 7 -



REPRO MED SYSTEMS, INC.

NOTES TO FINANCIAL STATEMENTS

(Unaudited)


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


NATURE OF OPERATIONS


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


BASIS OF PRESENTATION


The accompanying financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2019 (“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.


CERTIFICATE OF DEPOSIT


The certificate of deposit was recorded at cost plus accrued interest.  The certificate of deposit earned interest at a rate of 1.73% and matured in May 2019.


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 2017 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.


- 8 -



STOCK-BASED COMPENSATION


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


NET INCOME PER COMMON SHARE


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


 

 

Three Months Ended

 

 

 

September 30, 2020

 

 

September 30, 2019

 

 

 

 

 

 

 

 

Net income

 

$

249,175

 

 

$

651,813

 

 

 

 

 

 

 

 

 

 

Weighted Average Outstanding Shares:

 

 

 

 

 

 

 

 

Outstanding shares

 

 

43,914,542

 

 

 

39,022,298

 

Option shares includable

 

 

204,969

 

 

 

276,110

 

 

 

 

44,119,511

 

 

 

39,298,408

 

 

 

 

 

 

 

 

 

 

Net income per share

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

 

$

0.02

 

Diluted

 

$

0.01

 

 

$

0.02

 


 

 

Nine Months Ended

 

 

 

September 30, 2020

 

 

September 30, 2019

 

 

 

 

 

 

 

 

Net (loss)/income

 

$

(377,435

)

 

$

644,606

 

 

 

 

 

 

 

 

 

 

Weighted Average Outstanding Shares:

 

 

 

 

 

 

 

 

Outstanding shares

 

 

41,326,815

 

 

 

38,534,021

 

Option shares includable

 

 

(a)

 

 

200,062

 

 

 

 

41,326,815

 

 

 

38,734,083

 

 

 

 

 

 

 

 

 

 

Net income per share

 

 

 

 

 

 

 

 

Basic

 

$

(0.01

)

 

$

0.02

 

Diluted

 

$

(0.01

)

 

$

0.02

 

__________

(a)  Option shares of 203,121 were not included as the impact is anti-dilutive.


USE OF ESTIMATES IN THE FINANCIAL STATEMENTS


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


REVENUE RECOGNITION


The Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers, which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers.  We adopted this ASU effective January 1, 2018 on a full retrospective basis.  Adoption of this standard did not result in significant changes to our accounting policies, business processes, systems or controls, or have a material impact on our financial position, results of operations and cash flows or related disclosures.  As such, prior period financial statements were not recast.


- 9 -



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


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


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


The following table summarizes net sales by geography for the three and nine months ended September 30, 2020 and 2019:


 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2020

 

2019

 

2020

 

2019

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

5,372,536

 

$

5,856,203

 

$

17,459,212

 

$

14,308,994

 

International

 

 

707,779

 

 

761,194

 

 

2,660,016

 

 

2,631,493

 

Total

 

$

6,080,315

 

$

6,617,397

 

$

20,119,228

 

$

16,940,487

 


LEASES


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


ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED


In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820):  Disclosure Framework – Changes to the Disclosure for Fair Value Measurement.  The amendments in this ASU modify the disclosure requirements on fair value measurements in Topic 820 based on the concepts in the Concepts Statement, including the consideration of costs and benefits.  The amendments in this ASU are effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019.  The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption.  All other amendments should be applied retrospectively to all periods presented upon their effective date.  Early adoption is permitted upon issuance of this ASU.  An entity is permitted to early adopt any removed or modified disclosures upon issuance of this ASU and delay adoption of the additional disclosures until their effective date.  The Company adopted this standard on January 1, 2020 and it had no impact on our financial statement disclosures.


In August 2018, the FASB issued ASU No. 2018-15, Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.  The amendments in this ASU align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal use software license).  The accounting for the service element of a hosting arrangement that is a service contract is not affected by the amendments in this ASU.  The amendments in this ASU are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years.  Early adoption of the amendments in this ASU is permitted, including adoption in any interim period, for all entities.  The amendments in this ASU should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption.  The Company adopted this new accounting guidance on January 1, 2020, on a prospective basis.  The implementation of this standard did not have a material impact on the Company’s operating results, cash flows, financial condition or related disclosures.


- 10 -



ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED


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


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


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


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


FAIR VALUE MEASUREMENTS


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


Level 1 – Quoted prices in active markets for identical assets or liabilities.

 

 

Level 2 – Inputs other than Level 1 that are observable for the asset or liability, either directly or indirectly, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data by correlation or other means.

 

 

Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.  Value is determined using pricing models, discounted cash flow methodologies, or similar techniques and includes instruments for which the determination of fair value requires significant judgment or estimation.


The carrying amounts of cash and cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses are considered to be representative of their fair values because of the short-term nature of those instruments.  There were no transfers between levels in the fair value hierarchy during the nine months ended September 30, 2020.


- 11 -



IMPAIRMENT OF LONG-LIVED ASSETS


The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable.  An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than the carrying amount.  The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value.  No impairment losses have been recorded through September 30, 2020.


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 — PROPERTY AND EQUIPMENT


Property and equipment consists of the following at:


 

 

September 30, 2020

 

December 31, 2019

 

Furniture, office equipment, and leasehold improvements

 

$

1,291,985

 

$

1,135,107

 

Manufacturing equipment and tooling

 

 

1,856,881

 

 

1,295,978

 

Total property and equipment

 

 

3,148,866

 

 

2,431,085

 

Less: accumulated depreciation

 

 

(1,888,191

)

 

(1,819,239

)

Property and equipment, net

 

$

1,260,675

 

$

611,846

 


Depreciation expense was $99,071 and $69,740 for the three months ended September 30, 2020 and 2019, respectively, and $251,084 and $218,328 for the nine months ended September 30, 2020 and 2019, respectively.


NOTE 3 — COMMITMENTS AND CONTINGENCIES


LEGAL PROCEEDINGS


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


Litigation


Refer to Form 10-Q for the quarterly period ended June 30, 2020 regarding the dismissed case with our principal competitor, EMED Technologies Corporation (“EMED”).


NOTE 4 — STOCK-BASED COMPENSATION


On June 29, 2016, the Board of Directors amended the Company’s 2015 Stock Option Plan (as amended, the “Plan”)  authorizing the Company to grant awards to certain executives, key employees, and consultants under the Plan, which was approved by shareholders at the Annual Meeting of Shareholders held on September 6, 2016.  The total number of shares of Common Stock, with respect to which awards may be granted pursuant to the Plan, may not exceed 6,000,000 pursuant to an amendment to the Plan approved by shareholders on April 23, 2019, at the 2019 Annual Meeting of Shareholders.


On May 20, 2020, the Company entered into a Settlement Agreement related to its litigation with EMED as described above in “NOTE 3 COMMITMENTS AND CONTINGENCIES.”  Pursuant to the Settlement Agreement, the Company issued to EMED (i) 95,238 restricted stock units, which vested on May 21, 2020 and 95,238 restricted stock units vesting on January 1, 2021, and (ii) an option to purchase up to 400,000 shares of the Company’s common stock at an exercise price of $11.21 per share prior to February 1, 2021, which can be settled in cash in lieu of common stock at the Company’s sole discretion, provided that the number of shares of common stock and/or amount of cash paid by the Company upon exercise will be capped at a value of $16.21 per share.  The option was recorded at $347,008, the estimated fair value of the option using the Black-Scholes option pricing model with a volatility rate of 52.68% and a risk-free rate of 0.17%.  The Settlement Agreement includes mutual releases and covenants not to sue for any claim arising before May 20, 2020 and the Company covenants not to challenge any EMED patents that were the subject of the Claims unless EMED asserts them in the future against Company products.  This was a non-cash settlement from which we recognized expense in the amount of $2.2 million in the second quarter of 2020.


- 12 -



On February 20, 2019, the Board of Directors of the Company approved an increase in compensation for each non-employee director from $25,000 to $50,000 annually effective January 1, 2019, and an additional $10,000 annually for the chair of each Board committee effective February 20, 2019, in each case to be paid quarterly half in cash and half in common stock at the end of each fiscal quarter.  On September 30, 2019, the Board of Directors of the Company named R. John Fletcher, a current KORU Medical director, as Chairman, replacing Executive Chairman, Daniel S. Goldberger, who remains a non-executive member of KORU Medical’s Board of Directors.  In Mr. Fletcher’s role as Chairman, he receives an additional $50,000 in annual compensation, to be paid quarterly in shares of KORU Medical common stock based on the closing price of the stock on the last day of each quarter.


Pursuant to Daniel S. Goldberger’s employment agreement dated October 12, 2018, on February 1, 2019, when Donald B. Pettigrew was appointed to President and Chief Executive Officer, Mr. Goldberger was awarded a performance bonus in the amount of $270,000 to be paid half in cash and half in stock.  The number of shares that were issued totaled 90,604 and was based upon the closing price of the Common Stock of the Company on February 1, 2019, as reported by the OTCQX.  These shares were issued on April 3, 2019.


2015 STOCK OPTION PLAN, as amended


Time Based Stock Options


The per share weighted average fair value of stock options granted during the nine months ended September 30, 2020 and September 30, 2019 was $6.53 and $1.33, respectively.  The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the nine months ended September 30, 2020 and September 30, 2019.  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.


 

 

September 30,

 

 

 

2020

 

2019

 

 

 

 

 

 

 

 

 

Dividend yield

 

 

0.00%

 

 

0.00%

 

Expected Volatility

 

 

62.11 – 62.18%

 

 

56.10 – 60.70%

 

Weighted-average volatility

 

 

 

 

 

Expected dividends

 

 

 

 

 

Expected term (in years)

 

 

10 Years

 

 

10 Years

 

Risk-free rate

 

 

0.63 – 0.64%

 

 

1.60 – 2.72%

 


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


 

 

Nine Months Ended September 30,

 

 

 

2020

 

2019

 

 

 

Shares

 

Weighted
Average
Exercise
Price

 

Shares

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

Outstanding at January 1

 

3,647,000

 

$

1.32

 

2,419,000

 

$

1.00

 

Granted

 

360,000

 

$

9.54

 

1,650,000

 

$

1.92

 

Exercised

 

747,006

 

$

0.65

 

160,000

 

$

0.37

 

Forfeited

 

200,000

 

$

2.09

 

12,000

 

$

0.87

 

Outstanding at September 30

 

3,059,994

 

$

2.40

 

3,897,000

 

$

1.41

 

Options exercisable at September 30

 

1,009,629

 

$

1.36

 

1,037,885

 

$

0.81

 

Weighted average fair value of options granted during the period

 

 

$

6.53

 

 

$

1.33

 

Stock-based compensation expense

 

 

$

572,775

 

 

$

473,139

 


Total stock-based compensation expense totaled $572,775 and $473,139 for the nine months ended September 30, 2020 and 2019, respectively.  Cash received from option exercises for the nine months ended September 30, 2020 and 2019 was $95,880 and $58,900, respectively.


The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2020 and 2019 was $6.53 and $1.33, respectively.  The total intrinsic value of options exercised during the nine months ended September 30, 2020 and 2019 was $296,226 and $30,022, respectively.


- 13 -



The following table presents information pertaining to options outstanding at September 30, 2020:


Range of Exercise Price

 

Number
Outstanding

 

Weighted
Average
Remaining
Contractual
Life

 

Weighted
Average
Exercise
Price

 

Number
Exercisable

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$0.50 – 9.76

 

3,059,994

 

7.5 years

 

$

2.40

 

1,009,629

 

$

1.36

 


As of September 30, 2020, there was $3,679,084 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 48 months.  The total fair value of shares vested as of September 30, 2020 and 2019, was $874,041 and $506,729, respectively.


Performance Based Stock Options


The per share weighted average fair value of stock options granted during the nine months ended September 30, 2020 and 2019 was zero and $1.16, respectively.  The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the nine months ended September 30, 2020 and September 30, 2019.  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.


 

 

September 30,

 

 

 

2020

 

2019

 

 

 

 

 

 

 

 

 

Dividend yield

 

 

 

 

0.00%

 

Expected Volatility

 

 

 

 

58.90%

 

Weighted-average volatility

 

 

 

 

 

Expected dividends

 

 

 

 

 

Expected term (in years)

 

 

 

 

10 Years

 

Risk-free rate

 

 

 

 

2.07%

 


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


 

 

Nine Months Ended September 30,

 

 

 

2020

 

2019

 

 

 

Shares

 

Weighted
Average
Exercise
Price

 

Shares

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

Outstanding at January 1

 

1,000,000

 

$

1.70

 

 

$

 

Granted

 

 

$

 

1,000,000

 

$

1.70

 

Exercised

 

 

$

 

 

$

 

Forfeited

 

 

$

 

 

$

 

Outstanding at September 30

 

1,000,000

 

$

1.70

 

1,000,000

 

$

1.70

 

Options exercisable at September 30

 

333,333

 

$

1.70

 

 

$

 

Weighted average fair value of options granted during the period

 

 

$

 

 

$

1.16

 

Stock-based compensation expense

 

 

$

438,365

 

 

$

167,636

 


Total performance stock-based compensation expense totaled $438,365 and $167,636 for the nine months ended September 30, 2020 and 2019, respectively.


The weighted-average grant-date fair value of options granted during the nine months ended September 30, 2020 and 2019, was zero and $1.16, respectively.


- 14 -



The following table presents information pertaining to performance based options outstanding at September 30, 2020.


Range of Exercise Price

 

Number
Outstanding

 

Weighted
Average
Remaining
Contractual
Life

 

Weighted
Average
Exercise
Price

 

Number
Exercisable

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

$1.70

 

1,000,000

 

8.7 years

 

$

1.70

 

333,333

 

$

1.70

 


As of September 30, 2020, there was $430,833 of total unrecognized compensation cost related to non-vested performance share option based compensation arrangements granted under the Plan.  That cost is expected to be recognized over a weighted-average period of 31 months.  The total fair value of shares vested as of September 30, 2020 and 2019 was $387,520 and zero, respectively.


NOTE 5 — DEBT OBLIGATIONS


On February 8, 2018, the Company issued a promissory note (the “Original Note”) to KeyBank National Association (“KeyBank”) in the amount of $1.5 million as a variable rate revolving line of credit loan due on demand with an interest rate of LIBOR plus 2.25%, collateralized with a certificate of deposit in the amount of $1.5 million.  On September 25, 2018, KeyBank released the certificate of deposit as collateral for the loan and the Company executed a Commercial Security Agreement as collateral for the loan.


On April 14, 2020, the Company issued a promissory note to KeyBank in the aggregate principal amount of $3.5 million (the “Note”) as an extension of its line of credit, replacing its current line of credit agreement and Original Note.  The Company drew on the additional $2.0 million on April 23, 2020.  The Original Note was in the form of a variable rate revolving line of credit with an interest rate of LIBOR plus 2.25%.  The $3.5 million Note is in the form of a variable rate non-disclosable revolving line of credit with an interest rate of Prime Rate announced by the Bank minus 0.75%.  Interest is due monthly, and all principal and unpaid interest is due on June 1, 2021.  The $3.5 million Note may be prepaid at any time prior to maturity with no prepayment penalties.  The $3.5 million Note contains events of default and other provisions customary for a loan of this type.


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


The Company had no amount outstanding against the line of credit as of September 30, 2020.


On April 20, 2020, the Company entered into a Loan Agreement with the Bank (the “PPP Loan Agreement”) pursuant to the Paycheck Protection Program under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), providing for a loan in the principal amount of $1,476,508 (the “PPP Loan”).  The PPP Loan was funded on April 27, 2020.  On May 13, 2020, the Company returned the funds it received.


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


NOTE 6 — LEASES


We have finance and operating leases for our corporate office and certain office and computer equipment.  Our leases have remaining lease terms of 1 to 3 years, some of which include options to extend the leases annually and some with options to terminate the leases within 1 year.


- 15 -



The components of lease expense were as follows:


 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2020

 

2019

 

2020

 

2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease cost

 

$

37,921

 

$

37,922

 

$

113,764

 

$

111,672

 

Short-term lease cost

 

 

19,846

 

 

5,535

 

 

33,535

 

 

18,196

 

Total lease cost

 

$

57,767

 

$

43,457

 

$

147,299

 

$

129,868

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Finance lease cost:

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of right-of-use assets

 

$

791

 

$

1,061

 

$

4,502

 

$

3,182

 

Interest on lease liabilities

 

 

47

 

 

47

 

 

199

 

 

178

 

Total finance lease cost

 

$

838

 

$

1,108

 

$

4,701

 

$

3,360

 


Supplemental cash flow information related to leases was as follows:


 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2020

 

2019

 

Cash paid for amounts included in the measurement of lease liabilities:

 

 

 

 

 

 

 

Operating cash flows from operating leases

 

$

113,764

 

$

111,672

 

Financing cash flows from finance leases

 

 

4,502

 

 

3,122

 


Supplemental balance sheet information related to leases was as follows:


 

 

September 30,
2020

 

December 31,
2019

 

 

 

 

 

 

 

 

 

Operating Leases

 

 

 

 

 

 

 

Operating lease right-of-use assets

 

$

271,679

 

$

373,734

 

 

 

 

 

 

 

 

 

Operating lease current liabilities

 

 

140,450

 

 

136,888

 

Operating lease long term liabilities

 

 

131,229

 

 

236,846

 

Total operating lease liabilities

 

$

271,679

 

$

373,734

 

 

 

 

 

 

 

 

 

Finance Leases

 

 

 

 

 

 

 

Property and equipment, at cost

 

$

12,725

 

$

12,725

 

Accumulated depreciation

 

 

(9,344

)

 

(4,837

)

Property and equipment, net

 

$

3,381

 

$

7,888

 

 

 

 

 

 

 

 

 

Finance lease current liabilities

 

 

3,026

 

 

5,296

 

Finance lease long term liabilities

 

 

414

 

 

2,646

 

Total finance lease liabilities

 

$

3,440

 

$

7,942

 


 

 

September 30,
2020

 

December 31,
2019

 

 

 

 

 

 

 

Weighted Average Remaining Lease Term

 

 

 

 

 

Operating leases

 

1.6 Years

 

2.4 Years

 

Finance leases

 

1 Year

 

1.3 Years

 

 

 

 

 

 

 

Weighted Average Discount Rate

 

 

 

 

 

Operating leases

 

4.75%

 

4.75%

 

Finance leases

 

4.75%

 

4.75%

 


- 16 -



Maturities of lease liabilities are as follows:


Year Ending December 31,

 

Operating Leases

 

Finance Leases

 

2020 (excluding the nine months ended September 30, 2020)

 

$

37,922

 

$

832

 

2021

 

 

149,476

 

 

2,705

 

2022

 

 

97,256

 

 

 

2023

 

 

 

 

 

2024

 

 

 

 

 

2025

 

 

 

 

 

Thereafter

 

 

 

 

 

Total undiscounted lease payments

 

 

284,654

 

 

3,537

 

Less: imputed interest

 

 

(12,975

)

 

(97

)

Total lease liabilities

 

$

271,679

 

$

3,440

 


NOTE 7 — RELATED PARTY TRANSACTIONS


BUILDING LEASE


Mark Pastreich, a former director through April 2019, is a principal in the entity that owns the building leased by us for our corporate headquarters and manufacturing facility at 24 Carpenter Road, Chester, New York 10918.  On February 28, 2019, we completed year twenty of a twenty-year lease with monthly lease payments of $11,042.  On November 14, 2017, we executed a lease extension, which calls for six-month extensions beginning March 1, 2019 with the option to renew six times at a monthly lease amount of $12,088.  The Company exercised four of the six additional renewal options for September 1, 2019 through August 31, 2021.


The lease payments were $36,264 for both three months ended September 30, 2020 and 2019, and $108,792 and $106,700 for the nine months ended September 30, 2020 and 2019, respectively.  The Company also paid property taxes in the amount of $12,546 and $13,749 for three months ended September 30, 2020 and 2019, respectively and $39,205 and $39,165 for the nine months ended September 30, 2020 and 2019, respectively.


NOTE 8 — EQUITY


On June 18, 2020, the Company entered into a Purchase Agreement with Piper Sandler & Co. and Canaccord Genuity LLC, as representatives of the several underwriters named therein (the “Underwriters”), pursuant to which the Company agreed to issue and sell 3,125,000 shares of its common stock.  Under the terms of the Purchase Agreement, the Company granted to the Underwriters an option, exercisable for a period of 30 days, to purchase up to an additional 468,750 shares of the Company’s common stock, which the Underwriters exercised in full on June 19, 2020.  The Underwriters purchased the shares pursuant to the Purchase Agreement, including the shares subject to the option, at a price of $7.52 per share.  Proceeds to the Company, net of discounts, commissions, fees and expenses, were $26.5 million.


NOTE 9 — SUBSEQUENT EVENT


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


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


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


- 17 -



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


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


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


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


OVERVIEW


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


The following discussion and analysis for the three and nine months ended September 30, 2020 should be read in conjunction with the financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements for the year ended December 31, 2019 included in our 2019 Annual Report on Form 10-K.


KORU Medical continues to monitor its operations and government recommendations and has made modifications to its normal operations because of the COVID-19 outbreak, including requiring most of its non-production related team members to work remotely or on a staggered work shift.  The Company has continued to maintain a manufacturing operational capacity at its manufacturing facility located in Chester, New York, and has instituted heightened cleaning and sanitization standards and several health and safety protocols and procedures to safeguard its team members who do continue to report in person. Until the ultimate extent and duration of the pandemic is known, we cannot predict the ultimate effects the pandemic may have on our business, in particular with respect to demand for our products, our strategy, and our prospects, the effects on our customers, or the impact on our financial results. For example, our future net sales growth may be impacted due to fewer new prescriptions for individuals with Primary Immune Deficiency Disease (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) as a result of the pandemic. Refer to “PART II – OTHER INFORMATION, ITEM 1A. RISK FACTORS” of this Quarterly Report on Form 10-Q for further discussion of the potential impact of the COVID-19 pandemic on our business.


We ended the third quarter of 2020 with net sales of $6.1 million, down 8.1% versus the prior year’s third quarter. Our net sales were negatively impacted principally by reduced U.S. clinical trial activity and higher allowances consisting of pricing and growth rebates related to certain customers and payment discounts and distribution fees at our largest distributor under new contract terms.  The third quarter of 2019 included two unusually large orders, and the third quarter of 2020 included a significant order from our largest distributor placed early in exchange for a nominal discount, which may impact our net sales for the fourth quarter of 2020.


- 18 -



RESULTS OF OPERATIONS


Three months ended September 30, 2020 compared to September 30, 2019


Net Sales


The following table summarizes our net sales for the three months ended September 30, 2020 and 2019:


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

% of Sales

 

 

 

2020

 

2019

 

$

 

%

 

2020

 

2019

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

5,372,536

 

$

5,856,203

 

$

(483,667

)

(8.3%

)

88.4%

 

88.5%

 

International

 

 

707,779

 

 

761,194

 

 

(53,415

)

(7.0%

)

11.6%

 

11.5%

 

Total

 

$

6,080,315

 

$

6,617,397

 

$

(537,082

)

(8.1%

)

 

 

 

 


Total net sales decreased $0.5 million or 8.1% to $6.1 million for the three months ended September 30, 2020 compared with the same period last year.  Net sales decreased primarily due to reduced U.S. clinical trial activity ($0.4 million).  Higher allowances consisting of pricing and growth rebates related to certain customers and payment discounts and distribution fees at our largest distributor under new contract terms and lower international sales also contributed to lower net sales in the three months ended September 30, 2020.  There were two unusually large orders in the third quarter of 2019, one domestic from our largest distributor and one international.  Sales in the third quarter of 2020 included a $1.0 million order from our largest distributor placed early in exchange for a nominal discount, which may impact our net sales for the fourth quarter of 2020.


Gross Profit


Our gross profit for the three months ended September 30, 2020 and 2019 is as follows:


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Gross Profit

 

$

3,940,723

 

$

4,382,908

 

$

(442,185

)

(10.1%

)

Stated as a Percentage of Net Sales

 

 

64.8%

 

 

66.2%

 

 

 

 

 

 


Gross profit decreased $0.4 million or 10.1% in the three months ended September 30, 2020, compared to the same period in 2019, driven by lower net sales as described above, partially offset by favorable production variances.


Selling, general and administrative, Litigation and Research and development


Our selling, general and administrative expenses, litigation and research and development costs for the three months ended September 30, 2020 and 2019 are as follows:


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Selling, general and administrative

 

$

3,075,169

 

$

2,441,381

 

$

633,788

 

26.0%

 

Litigation

 

 

675

 

 

864,009

 

 

(863,334

)

(99.9%

)

Research and development

 

 

390,416

 

 

170,260

 

 

220,156

 

129.3%

 

 

 

$

3,466,260

 

$

3,475,650

 

$

(9,390

)

(0.3%

)

Stated as a Percentage of Net Sales

 

 

57.0%

 

 

52.5%

 

 

 

 

 

 


Selling, general and administrative expenses increased $0.6 million, or 26.0%, during the three months ended September 30, 2020 compared to the same period last year, mostly due to higher salary, related benefits and recruiting fees of $0.4 million resulting from new hires in the 2020 period.  Higher consulting fees related to marketing and regulatory initiatives of $0.1 million also added to the increase, as well as higher directors and officer’s insurance premiums and other miscellaneous expenses totaling $0.2 million. Offsetting these increases were lower trade show and travel expenses of $0.1 million as a result of COVID-19 related travel restrictions.


Litigation fees decreased $0.9 million during the three months ended September 30, 2020 compared to the same period last year primarily due to the negotiation of and entry into a litigation settlement agreement with EMED in May 2020.  


- 19 -



Research and development expenses increased $0.2 million during the three months ended September 30, 2020 compared with the same period last year mostly due to higher consulting services and additional testing related to development initiatives.


Depreciation and amortization


Depreciation and amortization expense increased by 39.7% to $115,637 in the three months ended September 30, 2020 compared with $82,774 in the three months ended September 30, 2019.  We continue to invest in capital assets, mostly related to manufacturing and computer equipment.


Net Income


 

 

Three Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Net Income

 

$

249,175

 

$

651,813

 

$

(402,638

)

(61.8%

)

Stated as a Percentage of Net Sales

 

 

4.1%

 

 

9.9%

 

 

 

 

 

 


Our net income for the three months ended September 30, 2020 was $0.2 million, compared to net income of $0.7 million for the three months ended September 30, 2019, primarily due to lower net sales of $0.5 million with total operating expenses remaining flat for the same periods.


Nine months ended September 30, 2020 compared to September 30, 2019


Net Sales


The following table summarizes our net sales for the nine months ended September 30, 2020 and 2019:


 

 

Nine Months Ended September 30,

 

Change from Prior Year

 

% of Sales

 

 

 

2020

 

2019

 

$

 

%

 

2020

 

2019

 

Sales

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Domestic

 

$

17,459,212

 

$

14,308,994

 

$

3,150,218

 

22.0%

 

86.8%

 

84.5%

 

International

 

 

2,660,016

 

 

2,631,493

 

 

28,523

 

1.1%

 

13.2%

 

15.5%

 

Total

 

$

20,119,228

 

$

16,940,487

 

$

3,178,741

 

18.8%

 

 

 

 

 


Total net sales increased $3.2 million or 18.8% for the nine months ended September 30, 2020 as compared to the prior year period.  The increase was due principally to an increase in product sales volume, as well as higher U.S. clinical trial activity ($1.0 million). We believe the increase in product sales volume reflects an increase in continued growth in diagnosis of PIDD and CIDP. Also contributing to the increase in product sales volume was a $1.0 million order from our largest distributor placed early in exchange for a nominal discount, which may impact our net sales for the fourth quarter of 2020. Partially offsetting net sales were higher allowances consisting of pricing and growth rebates related to certain customers and payment discounts at our largest distributor under new contract terms.


Gross Profit


Our gross profit for the nine months ended September 30, 2020 and 2019 is as follows:


 

 

Nine Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Gross Profit

 

$

12,638,813

 

$

10,906,526

 

$

1,732,287

 

15.9%

 

Stated as a Percentage of Net Sales

 

 

62.8%

 

 

64.4%

 

 

 

 

 

 


Gross profit increased $1.7 million or 15.9% in the nine months ended September 30, 2020, compared to the same period last year, reflecting net sales growth described above as well as favorable production variances in the third quarter of 2020.  Gross profit for the nine months was negatively impacted by overtime costs related to COVID-19 absenteeism and an obsolescence reserve resulting from a discontinued product line, partially offset by favorable production variances in the third quarter of 2020.


- 20 -



Selling, general and administrative, Litigation and Research and development


Our selling, general and administrative expenses, litigation and research and development costs for the nine months ended September 30, 2020 and 2019 are as follows:


 

 

Nine Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Selling, general and administrative

 

$

9,039,980

 

$

6,976,684

 

$

2,063,296

 

29.6%

 

Litigation

 

 

2,446,747

 

 

2,481,471

 

 

(34,724

)

(1.4%

)

Research and development

 

 

944,637

 

 

450,454

 

 

494,183

 

109.7%

 

 

 

$

12,431,364

 

$

9,908,609

 

$

2,522,755

 

25.5%

 

Stated as a Percentage of Net Sales

 

 

61.8%

 

 

58.5%

 

 

 

 

 

 


Selling, general and administrative expenses increased $2.1 million, or 29.6%, during the nine months ended September 30, 2020 compared to the same period last year, mostly due to higher salary and related benefits, severance, bonus and recruiting fees in aggregate totaling $1.4 million.  Also contributing to the increase were consulting fees of $0.5 million related to marketing, regulatory and strategic initiatives, as well as increased director fees and higher insurance premiums related to our directors and officers’ insurance policy in aggregate totaling $0.3 million, and miscellaneous expenses of $0.3 million.  Offsetting the increase were lower trade show and travel expenses of $0.4 million as a result of COVID-19 related travel restrictions.


Litigation fees decreased $34,724 compared to the same period last year due primarily to the negotiation of and entry into a litigation settlement agreement reached with EMED in May 2020 resulting in a non-cash expense of $2.2 million.


Research and development expenses increased $0.5 million during the nine months ended September 30, 2020 compared with the same period last year mostly due to increased salary and related benefits due to higher headcount and additional testing as we continue our development initiatives.


Depreciation and amortization


Depreciation and amortization expense increased by 17.9% to $297,801 in the nine months ended September 30, 2020 compared with $252,594 in the nine months ended September 30, 2019.  We continued to invest in capital assets, mostly related to manufacturing and computer equipment.


Net (Loss)/Income


 

 

Nine Months Ended September 30,

 

Change from Prior Year

 

 

 

2020

 

2019

 

$

 

%

 

Net (Loss)/Income

 

$

(377,435

)

$

644,606

 

$

(1,022,041

)

(158.6%

)

Stated as a Percentage of Net Sales

 

 

(1.9%

)

 

3.8%

 

 

 

 

 

 


Our net loss for the nine months ended September 30, 2020 was $0.4 million compared to net income of $0.6 million for the nine months ended September 30, 2019, driven by the EMED settlement charge and higher selling, general and administrative expenses, partially offset by higher sales as described above.


LIQUIDITY AND CAPITAL RESOURCES


Our principal source of liquidity is our cash on hand of $32.4 million as of September 30, 2020, which includes the net proceeds from the recent capital raise totaling $26.5 million.  In response to concerns about the potential impact of COVID-19, the Company elected to draw $3.5 million during the three months ended June 30, 2020, the full amount available on its line of credit, and paid it back during the three months ended September 30, 2020.  Our principal source of operating cash inflows is from sales of our products to customers.  Our principal cash outflows relate to the purchase and production of inventory and related costs, selling, general and administrative expenses.


- 21 -



Cash Flows


The following table summarizes our cash flows:


 

 

Nine Months Ended
September 30, 2020

 

Nine Months Ended
September 30, 2019

 

Net cash provided by/(used in) operating activities

 

$

968,437

 

$

(502,014

)

Net cash (used in)/provided by investing activities

 

$

(1,007,539

)

$

1,389,281

 

Net cash provided by financing activities

 

$

26,601,984

 

$

502,958

 


Operating Activities


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


Net cash used in operating activities of $0.5 million for the nine months ended September 30, 2019 was mostly attributable to increased accounts receivable of $2.1 million as one of our major customer’s payment terms changed on January 1, 2019 from net 30 to net 60 days, increased inventory of $0.6 million as we build stock to keep pace with sales growth, as well as severance payments and payments for insurance renewals.  Partially offsetting these were our non-cash charges for stock based compensation of $0.9 million and depreciation and amortization of long lived tangible and intangible asset of $0.3 million, as well as increases in accounts payable of $0.4 million primarily for major supplier invoices and accrued expenses of $0.5 million primarily due to legal fees and bonus accruals.


Investing Activities


Net cash used in investing activities of $1.0 million for the nine months ended September 30, 2020 was primarily for capital expenditures for research and development and strategic initiatives.  Our net cash provided by investing activities of $1.4 million for the nine months ended September 30, 2019 was mostly the result of the maturation of a certificate of deposit for $1.5 million and the sale of the house the Company owned for $0.2 million, offset by capital expenditures of $0.2 million, and patent applications and maintenance of existing applications of $0.2 million.


Financing Activities


Net cash provided by financing activities for the nine months ended September 30, 2020 of $26.6 million is from the $26.5 million capital raise, net of expenses and $0.1 million from options exercised.  The $0.5 million provided by financing activities for the nine months ended September 30, 2019 is a result of warrants and options exercised during the period.  


See “NOTE 5 — DEBT OBLIGATIONS” for further detail regarding the promissory note and loan agreement, and “NOTE 8 — EQUITY” regarding the equity offering.


We believe that as of September 30, 2020, cash on hand and cash expected to be generated from future operating activities will be sufficient to fund our operations, including further research and development and capital expenditures, for the next 12 months, as well as accelerate execution of our strategic initiatives.  We believe KORU Medical’s home infusion products continue to find a solid following in the subcutaneous immunoglobulin (“SCIg”) market, as well as into new markets like neurology where Hizentra® received an expanded indication for CIDP.


NON-GAAP FINANCIAL MEASURES


Management of the Company believes that investors’ understanding of the Company’s performance is enhanced by disclosing non-GAAP financial measures as a reasonable basis for comparison of the Company’s ongoing results of operations.  These non-GAAP measures should not be considered a substitute for GAAP-basis measures and results.  Our non-GAAP measures may not be comparable to non-GAAP measures of other companies.  The table below provides a disclosure of these non-GAAP financial measures to the most closely analogous measure determined in accordance with GAAP.


- 22 -



Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.  They are limited in value because they exclude charges that have a material effect on our reported results and, therefore, should not be relied upon as the sole financial measures to evaluate our financial results.  The non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results.


We disclose and discuss Adjusted EBITDA as a non-GAAP financial measure in our public releases, including quarterly earnings releases, and other filings with the Securities and Exchange Commission.  We define Adjusted EBITDA as earnings (net income/(loss)) before interest, income tax expense, depreciation and amortization, discontinued product expense, reorganization charges, litigation expenses including stock-based settlement expense, manufacturing initiative and stock option expenses.  Prior to January 1, 2020, discontinued product expense and manufacturing initiative expenses were not included in our definition of Adjusted EBITDA. We believe that Adjusted EBITDA is used by investors and other users of our financial statements as a supplemental financial measure that, when viewed with our GAAP results and the accompanying reconciliation, we believe provides additional information that is useful to gain an understanding of the factors and trends affecting our business.  We also believe the disclosure of Adjusted EBITDA helps investors meaningfully evaluate and compare our cash flow generating capacity from quarter to quarter and year to year.  Adjusted EBITDA is used by management as a supplemental internal measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.  Because management uses Adjusted EBITDA for such purposes, the Company uses Adjusted EBITDA as a significant criterion for determining the amount of annual cash incentive compensation paid to our executive officers and employees.  We have historically found that Adjusted EBITDA is superior to other metrics for our company-wide cash incentive program, as it is more easily explained and understood by our typical employee.


A reconciliation of our non-GAAP measures is below:


 

 

Three Months Ended

 

 

Nine Months Ended

Reconciliation of GAAP Net Income/(Loss)

 

September 30,

 

 

September 30,

to Non-GAAP Adjusted EBITDA:

 

2020

 

 

2019

 

 

2020

 

2019

GAAP Net Income/(Loss)

 

$

249,175

 

 

$

651,813

 

 

$

(377,435

)

$

644,606

 

Income Tax Expense

 

 

143,353

 

 

 

186,681

 

 

 

316,200

 

 

189,265

 

Depreciation and Amortization

 

 

115,637

 

 

 

82,774

 

 

 

297,801

 

 

252,594

 

Interest Income, Net

 

 

(9,662

)

 

 

(23,368

)

 

 

(23,690

)

 

(59,091

)

Reorganization Charges

 

 

 

 

 

 

 

 

 

 

354,926

 

Discontinued Product Expense

 

 

(6,659

)

 

 

 

 

 

71,318

 

 

 

Litigation

 

 

675

 

 

 

864,009

 

 

 

2,446,747

 

 

2,481,471

 

Manufacturing Initiative Expenses

 

 

59,045

 

 

 

120,386

 

 

 

194,804

 

 

120,386

 

Stock Option Expense

 

 

346,323

 

 

 

324,135

 

 

 

1,011,140

 

 

640,775

 

Non-GAAP Adjusted EBITDA

 

$

897,887

 

 

$

2,206,430

 

 

$

3,936,885

 

$

4,624,932

 


Discontinued Product Expense.  We have excluded the effect of expenses related to a discontinued product line in calculating our non-GAAP Adjusted EBITDA measure.  We expected to retire our Res-Q-Vac product line towards the end of 2020, but due to the failure of equipment used to manufacture the product, the discontinuation and resulting expense was accelerated into the first quarter of 2020 which we would not otherwise incur in periods presented as part of our continuing operations.  Subsequently, in the second and third quarter of 2020, we sold off a portion of the discontinued inventory previously reserved.  We do not expect to incur any significant related expenses in the future.


Reorganization Charges.  We have excluded the effect of reorganization charges in calculating our non-GAAP Adjusted EBITDA measure.  We incurred significant expenses in connection with the termination and replacement of C-suite executives and senior management which we would not otherwise incur in periods presented as part of our continuing operations.  Reorganization charges include costs related to the replacement of C-suite executives including a transition bonus and recruiting fees, prior to March 31, 2019.


Litigation.  We have excluded litigation expenses in calculating our non-GAAP Adjusted EBITDA measure.  Litigation expenses include stock-based litigation settlement expense of $2.2 million related to the settlement agreement entered into with EMED on May 20, 2020.  We continue to evaluate our business performance excluding litigation fees; however, we expect these expenses related to the EMED litigation to discontinue soon because of the settlement.


Manufacturing Initiative Expenses.  We have excluded the effect of expenses related to the implementation of those portions of our strategic plan related to creating manufacturing efficiencies, in calculating our non-GAAP Adjusted EBITDA measure.  We incurred expenses in connection with executing on these initiatives which we would not otherwise incur in periods presented as part of our continuing operations.  We expect to incur related expenses for the next twelve to eighteen months as we continue to execute on our strategic plan.


- 23 -



Stock Option Expense.  We have excluded the effect of stock option expenses in calculating our non-GAAP Adjusted EBITDA measure.  Although stock option compensation is a key incentive offered to our employees, we continue to evaluate our business performance excluding stock option compensation expenses.  We record non-cash compensation expense related to grants of options and depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in future periods.


ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED


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


ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED


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


ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


Not applicable.


ITEM 4.  CONTROLS AND PROCEDURES


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


There have been no changes in the Company’s internal control over financial reporting during the three months ended September 30, 2020, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.


PART II – OTHER INFORMATION


On November 11, 2020, Repro Med Systems, Inc. d/b/a KORU Medical Systems (the “Company”) entered into a Manufacturing and Supply Agreement with Command Medical Products, Inc. (“Command”), pursuant to which Command has agreed to manufacture and supply the Company’s subassemblies, needle sets and tubing products pursuant to the Company’s specifications and purchase orders. The first binding purchase order pursuant to the Manufacturing and Supply Agreement is expected to be made within the next ten days (the “Effective Date”).


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


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


The foregoing description of the Manufacturing and Supply Agreement is not complete and is qualified in its entirety by reference to the full text of the Manufacturing and Supply Agreement, a copy of which is attached as an exhibit to this Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020.


- 24 -



ITEM 1.  LEGAL PROCEEDINGS


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


Litigation


Refer to Form 10-Q for the quarterly period ended June 30, 2020 regarding the dismissed case with our principal competitor, EMED Technologies Corporation (“EMED”).  


ITEM 1A.  RISK FACTORS


Our operations and financial results are subject to various risks and uncertainties, including those described in “PART 1, ITEM 1A. RISK FACTORS” in our Annual Report on Form 10-K for the year ended December 31, 2019, which could adversely affect our business, financial condition, results of operations, cash flows, and the trading price of our common stock.  The following are material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2019:


Our business has been and could continue to be adversely affected by the COVID-19 pandemic.


The COVID-19 pandemic has and will continue affecting economies and businesses around the world.  We are closely monitoring the impact of COVID-19 on all aspects of our business, including how it may impact our employees and business operations. While we did not incur significant manufacturing disruptions during the quarter ended September 30, 2020 from the COVID-19 pandemic, customer purchasing patterns and clinical trial activity have been less predictable as a result of the pandemic. We may experience disruptions that could severely impact our results of operations and financial condition.  We are unable to predict the impact that COVID-19 will have on our future operating results and financial condition due to numerous uncertainties.  These uncertainties include the geographic spread of the pandemic, the severity of the virus, the impact of the virus directly on our employees or those of our suppliers, the duration of the outbreak, governmental actions, travel restrictions and social distancing, business closures or business disruptions (including those impacting our supply chain), delays in clinical trials, the effectiveness of actions taken in the United States and other countries to contain and treat the disease, the availability of plasma and drugs that are administered by our products, the number of new prescriptions for PIDD and CIDP, purchasing patterns of customers in response to the pandemic, changes to our operations, or whether the United States and additional countries are required to move to complete lock-down status, among others.  Our sales representatives are unable to hold in-person meetings with customers and health care providers to discuss our products, which may further impact our sales.  As local jurisdictions continue to put restrictions in place, our ability to continue to manufacture our products may also be limited. Such events may result in a period of business and manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and results of operations. The health of our workforce and our ability to meet staffing needs at our facility cannot be predicted and is vital to our operations. We will continue to monitor the COVID-19 situation closely and intend to follow health and safety guidelines as they evolve.  Further, the spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, it has resulted in significant disruption of global financial markets, which could reduce our ability to access capital, negatively affecting our liquidity. In addition, the recession resulting from the spread of COVID-19 could materially affect our business and the value of our common stock. The ultimate long-term impact of COVID-19 is highly uncertain and cannot be predicted with confidence.


- 25 -



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


Each non-employee director of the Company is eligible to receive of $50,000 annually (effective January 1, 2019) plus $10,000 for chairing a Board committee (effective February 20, 2019), all to be paid quarterly half in cash and half in common stock and pro-rated for partial service.  The Chairman of the Board is eligible to receive an additional $50,000 annually (effective October 1, 2019), all to be paid in common stock.  The Company issued an aggregate of 6,681 and 23,869 shares of common stock to its non-employee directors for the three and nine months ended September 30, 2020, respectively.


On January 7, 2020, Manuel Marques, the Company’s Chief Operating Officer, exercised options held by him for an aggregate 175,000 shares of common stock for an aggregate exercise price of $85,500.


On May 9, 2020, Karen Fisher, the Company’s Chief Financial Officer, exercised options held by her for an aggregate 535,000 shares of common stock through delivery of previously owned shares having an aggregate fair market value of $322,294.


On May 20, 2020, the Company entered into a Settlement Agreement with EMED Technologies Corporation (“EMED”) to settle all claims in connection with all pending litigation matters between them (the “Claims”).  Pursuant to the Settlement Agreement, the Company issued to EMED (i) 95,238 restricted stock units, which vested on May 21, 2020 and 95,238 restricted stock units vesting on January 1, 2021, and (ii) an option to purchase up to 400,000 shares of the Company’s common stock at an exercise price of $11.21 per share prior to February 1, 2021, which can be settled in cash in lieu of common stock at the Company’s sole discretion, provided that the number of shares of common stock and/or amount of cash paid by the Company upon exercise will be capped at a value of $16.21 per share.  The Settlement Agreement includes mutual releases and covenants not to sue for any claim arising before May 20, 2020 and the Company covenants not to challenge any EMED patents that were the subject of the Claims unless EMED asserts them in the future against Company products.


All of the securities issued by the Company as described in this Item were issued in reliance on the exemption from registration under Section 4(2) under the Securities Act of 1933, as amended.


ITEM 6.  EXHIBITS.


10.1

Manufacturing and Supply Agreement dated as of November 11, 2020 between Repro Med Systems, Inc. and Command Medical Products.  Certain information has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

 

 

31.1

Certification 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*

Interactive Data Files of Financial Statements and Notes.


* 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”.


- 26 -



SIGNATURES


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



 

REPRO MED SYSTEMS, INC.

 

 

November 12, 2020

/s/ Donald B. Pettigrew

 

Donald B. Pettigrew, President and Chief Executive Officer
(Principal Executive Officer)

 

 

November 12, 2020

/s/ Karen Fisher

 

Karen Fisher, Chief Financial Officer and Treasurer
(Principal Financial Officer)


- 27 -