UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the Quarterly Period Ended ~~June 30, 2020~~March 31, 2021

Oror

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

For the transition period from ________ to ________.

Commission File Number: 0-12305

REPRO 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)

N/A

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

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


Title of each 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 and post such files). [X] Yes [ ] No

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


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

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

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

As of ~~August 5, 2020, 43,909,570~~May 12, 2021, 44,490,174 shares of common stock, $0.01 par value per share, were outstanding, which excludes ~~2,737,231~~3,420,502 shares of treasury stock.

REPRO MED SYSTEMS, INC.

TABLE OF CONTENTS


		PAGE

PART I – FINANCIAL INFORMATION

ITEM 1.	Financial Statements

	Balance Sheets as of ~~June 30, 2020~~March 31, 2021 (Unaudited) and December 31, ~~2019~~2020	3

	Statements of Operations (Unaudited) for the three ~~and six~~ months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~	4

	Statements of Cash Flows (Unaudited) for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~	5

	Statements of Stockholders’ Equity (Unaudited) for the three months ended March 31, 2021 and 2020	6

	Notes to Financial Statements	67

ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1517

ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	2320

ITEM 4.	Controls and Procedures	2321

PART II – OTHER INFORMATION

ITEM 1.	Legal Proceedings	2321

ITEM 1A.	Risk Factors	2421

ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	2521

ITEM 6.	Exhibits	2522

	Signatures	23

- 2 -

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

REPRO MED SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)


	June 30,						March 31,			December 31,
	2020			December 31,			2021			2020
	(Unaudited)			2019
ASSETS

CURRENT ASSETS
Cash and cash equivalents	$	38,129,349		$	5,870,929		$	26,774,720		$	27,315,286
Accounts receivable less allowance for doubtful accounts of $32,645 at June 30, 2020 and December 31, 2019		2,965,902			3,234,521
Accounts receivable less allowance for doubtful accounts of $24,469 for March 31, 2021, and December 31, 2020, respectively								3,561,341			2,572,954
Inventory		3,667,288			2,388,477			8,058,824			6,829,772
Prepaid expenses		543,482			387,396			690,325			807,780
TOTAL CURRENT ASSETS		45,306,021			11,881,323			39,085,210			37,525,792
Property and equipment, net		818,064			611,846			1,154,368			1,167,623
Patents, net of accumulated amortization of $319,120 and $288,967 at June 30, 2020 and December 31, 2019, respectively		926,504			807,135
Right of use assets, net		306,101			373,734
Deferred tax asset		334,011			188,241
Intangible assets, net of accumulated amortization of $214,969 and $199,899 at March 31, 2021 and December 31, 2020, respectively								844,309			843,587
Operating lease right-of-use assets								201,598			236,846
Deferred income tax assets, net								1,068,485			125,274
Other assets		19,812			19,582			19,812			19,812
TOTAL ASSETS	$	47,710,513		$	13,881,861		$	42,373,782		$	39,918,934

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES
Line of credit payable	$	3,500,000		$	—
Accounts payable		920,006			572,656		$	1,915,523		$	624,920
Accrued expenses		2,686,200			1,296,612			1,755,800			2,610,413
Accrued payroll and related taxes		523,537			190,265			715,899			287,130
Accrued tax liability		523,190			204,572
Finance lease liability - current		3,195			5,296
Operating lease liability - current		139,618			136,888
Finance lease liability – current								1,843			2,646
Operating lease liability – current								141,869			141,293
TOTAL CURRENT LIABILITIES		8,295,746			2,406,289			4,530,934			3,666,402
Finance lease liability, net of current portion		1,030			2,646
Operating lease liability, net of current portion		166,483			236,846			59,729			95,553
TOTAL LIABILITIES		8,463,259			2,645,781			4,590,663			3,761,955

Commitments and contingencies (Refer to Note 3)
STOCKHOLDERS’ EQUITY
Common stock, $0.01 par value; 75,000,000 shares authorized, 46,640,120 and 42,239,788 shares issued, 43,902,889 and 39,502,557 shares outstanding at June 30, 2020 and December 31, 2019, respectively		466,401			422,398
Common stock, $0.01 par value, 75,000,000 shares authorized, 47,896,061 and 46,680,119 shares issued; 44,475,559 and 43,259,617 shares outstanding at March 31, 2021, and December 31, 2020, respectively								478,960			466,801
Additional paid-in capital		34,886,850			6,293,069			38,771,105			35,880,986
Treasury stock, 3,420,502 shares and 3,420,502 shares at March 31, 2021 and December 31, 2020, respectively, at cost								(3,843,562	)		(3,843,562	)
Retained earnings		4,238,207			4,864,817			2,376,616			3,652,754
		39,591,458			11,580,284
Less: Treasury stock, 2,737,231 shares at June 30, 2020 and December 31, 2019, respectively, at cost		(344,204	)		(344,204	)
TOTAL STOCKHOLDERS’ EQUITY		39,247,254			11,236,080			37,783,119			36,156,979
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	47,710,513		$	13,881,861		$	42,373,782		$	39,918,934

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

- 3 -

REPRO MED SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)


	For the Three Months Ended						For the Six Months Ended						For the Three Months Ended
	June 30,						June 30,						March 31,
	2020			2019			2020			2019			2021			2020

NET SALES	$	7,708,904		$	5,348,812		$	14,038,913		$	10,323,090		$	5,430,951		$	6,330,009
Cost of goods sold		2,799,024			1,873,148			5,340,823			3,799,472			2,199,097			2,541,799
Gross Profit		4,909,880			3,475,664			8,698,090			6,523,618			3,231,854			3,788,210

OPERATING EXPENSES
Selling, general and administrative		3,201,831			2,050,435			5,964,811			4,535,303			4,992,829			2,862,138
Litigation		2,346,914			1,124,947			2,446,072			1,617,462
Research and development		298,196			178,235			554,221			280,194			336,841			256,025
Depreciation and amortization		94,940			86,169			182,164			169,820			115,473			87,224
Total Operating Expenses		5,941,881			3,439,786			9,147,268			6,602,779			5,445,143			3,205,387

Net Operating (Loss)/Profit		(1,032,001	)		35,878			(449,178	)		(79,161	)		(2,213,289	)		582,823

Non-Operating (Expense)/Income
Loss on currency exchange		(2,594	)		(1,235	)		(13,091	)		(10,925	)		(15,717	)		(10,497	)
(Loss)/Gain on disposal of fixed asset, net		(5,522	)		49,980			(5,522	)		49,740
Interest, net and other income, net		(5,002	)		18,243			14,028			35,723
Gain on disposal of fixed asset														736			—
Interest income, net														9,771			19,030
TOTAL OTHER (EXPENSE)/INCOME		(13,118	)		66,988			(4,585	)		74,538			(5,210	)		8,533

(LOSS)/INCOME BEFORE TAXES		(1,045,119	)		102,866			(453,763	)		(4,623	)		(2,218,499	)		591,356

Income Tax Expense		(30,919	)		(24,683	)		(172,847	)		(2,584	)
Income Tax Benefit/(Expense)														942,361			(141,928	)

NET (LOSS)/INCOME	$	(1,076,038	)	$	78,183		$	(626,610	)	$	(7,207	)	$	(1,276,138	)	$	449,428

NET (LOSS)/INCOME PER SHARE

Basic	$	(0.03	)	$	0.00		$	(0.02	)	$	0.00		$	(0.03	)	$	0.01
Diluted	$	(0.03	)	$	0.00		$	(0.02	)	$	0.00		$	(0.03	)	$	0.01

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

Basic		40,361,924			38,353,000			40,018,559			38,279,718			43,960,936			39,675,107
Diluted		40,524,754			39,299,800			40,201,134			39,219,752			43,960,936			39,874,989

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

- 4 -

REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

For the Six Months Ended

June 30,

2020

2019

CASH FLOWS FROM OPERATING ACTIVITIES

Net Loss

$
(626,610
)
$
(7,207
)
Adjustments to reconcile net loss to net cash provided by/(used in) operating activities:

Stock based compensation expense

784,821

529,538

Stock based litigation settlement expense

1,285,102

—

Depreciation and amortization

182,164

169,820

Deferred capital gain - building lease

—

(3,763
)
Deferred taxes

(145,770
)

66,494

Loss/(Gain) on disposal of fixed asset

5,522

(49,740
)
Changes in operating assets and liabilities:

Decrease/(Increase) in accounts receivable

268,619

(1,867,342
)
Increase in inventory

(1,278,811
)

(467,706
)
(Increase)/Decrease in prepaid expense and other assets

(156,316
)

44,874

Increase in accounts payable

347,350

76,882

Increase/(Decrease) in accrued payroll and related taxes

333,272

(249,730
)
Increase in accrued expense

1,389,588

346,181

Increase/(Decrease) in accrued tax liability

318,618

(72,210
)
NET CASH PROVIDED BY/(USED IN) OPERATING ACTIVITIES

2,707,549

(1,483,909
)

CASH FLOWS FROM INVESTING ACTIVITIES

Payments for capital expenditures

(363,750
)

(67,079
)
Payments for patents

(149,523
)

(136,182
)
Proceeds on disposal of fixed asset

—

217,821

Proceeds from certificate of deposit

—

1,517,927

NET CASH (USED IN)/PROVIDED BY INVESTING ACTIVITIES

(513,273
)

1,532,487

CASH FLOWS FROM FINANCING ACTIVITIES

Line of credit advance

3,500,000

—

Issuance of equity

26,567,861

24,700

Payment for cancelled shares

—

(2,820
)
Finance lease

(3,717
)

(2,069
)
NET CASH PROVIDED BY FINANCING ACTIVITIES

30,064,144

19,811

NET INCREASE IN CASH AND CASH EQUIVALENTS

32,258,420

68,389

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

5,870,929

3,738,803

CASH AND CASH EQUIVALENTS, END OF PERIOD

$
38,129,349

$
3,807,192

Supplemental Information

Cash paid during the periods for:

Interest

$
13,554

$
233

Taxes

$
—

$
—

NON-CASH FINANCING AND INVESTING ACTIVITIES

Issuance of common stock as compensation

$
120,004

$
212,898


	For the Three Months Ended
	March 31,
	2021			2020

CASH FLOWS FROM OPERATING ACTIVITIES
Net (Loss)/Income	$	(1,276,138	)	$	449,428
Adjustments to reconcile net (loss)/income to net cash (used in)/provided by operating activities:
Stock-based compensation expense		734,184			360,968
Depreciation and amortization		115,473			87,224
Deferred income taxes		(943,211	)		(63,203	)
Gain on disposal of fixed assets		(736	)		—
Changes in operating assets and liabilities:
Increase in accounts receivable		(988,387	)		(185,160	)
Increase in inventory		(1,229,052	)		(700,539	)
Decrease/(Increase) in prepaid expenses and other assets		117,455			(156,288	)
Increase in accounts payable		1,290,603			524,398
Increase in accrued payroll and related taxes		428,769			39,571
Decrease in accrued expenses		(854,613	)		(408,294	)
Increase in accrued tax liability		—			205,131
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES		(2,605,653	)		153,236

CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment		(95,477	)		(99,591	)
Proceeds from disposal of property and equipment		9,065			—
Purchases of intangible assets		(15,792	)		(80,547	)
NET CASH USED IN INVESTING ACTIVITIES		(102,204	)		(180,138	)

CASH FLOWS FROM FINANCING ACTIVITIES
Borrowings from indebtedness		—			1,500,000
Proceeds from issuance of equity		1,230,000			85,500
Common stock issuance as settlement for litigation		938,094			—
Payments on finance lease liability		(803	)		(1,848	)
NET CASH PROVIDED BY FINANCING ACTIVITIES		2,167,291			1,583,652

NET (DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS		(540,566	)		1,556,750
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		27,315,286			5,870,929
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	26,774,720		$	7,427,679

Supplemental Information
Cash paid during the periods for:
Interest	$	28		$	87
Income Taxes	$	850		$	—

Schedule of Non-Cash Operating, Investing and Financing Activities:
Issuance of common stock as compensation	$	56,250		$	60,002
Issuance of common stock as settlement for litigation	$	938,094		$	—

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

- 5 -

REPRO MED SYSTEMS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(UNAUDITED)

Three Months Ended March 31, 2021


				Additional								Total
	Common Stock			Paid-in		Retained			Treasury			Stockholders’
	Shares	Amount		Capital		Earnings			Stock			Equity

BALANCE, DECEMBER 31, 2020	46,680,119	$	466,801	$	35,880,986	$	3,652,754		$	(3,843,562	)	$	36,156,979

Issuance of stock-based compensation	10,124		101		56,149		—			—			56,250
Compensation expense related to stock options	—		—		677,934		—			—			677,934
Litigation settlement share issuance	95,238		952		937,142		—			—			938,094
Issuance upon options exercised	1,110,580		11,106		1,218,894		—			—			1,230,000
Net income	—		—		—		(1,276,138	)		—			(1,276,138	)
BALANCE, MARCH 31, 2021	47,896,061	$	478,960	$	38,771,105	$	2,376,616		$	(3,843,562	)	$	37,783,119

Three Months Ended March 31, 2020


				Additional							Total
	Common Stock			Paid-in		Retained		Treasury			Stockholders’
	Shares	Amount		Capital		Earnings		Stock			Equity

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
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

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

- 6 -

REPRO MED SYSTEMS, INC.

NOTES TO THE UNAUDITED FINANCIAL STATEMENTS

NOTE 1 NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NATURE OF OPERATIONS

REPRO MED SYSTEMS, INC. d/b/a KORU Medical Systems (the ~~“Company”,~~“Company,” “KORU ~~Medical”~~Medical,” “we,” “us” or ~~“we”~~“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.

~~FISCAL YEAR END~~

~~The Company’s fiscal year end is December 31.~~

BASIS OF PRESENTATION

The accompanying unaudited financial statements as of June 30, 2020, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and with instructions to SEC regulation S-X for interim financial statements.

In the opinion of the Company’s management, the financial statements contain all adjustments consisting of normal recurring accruals necessary to present fairly the Company’s financial position as of June 30, 2020, and the results of operations and cash flow for the three and six months periods ended June 30, 2020, and 2019.

~~The results of operations for the six months ended June 30, 2020 and 2019 are not necessarily indicative of the results to be expected for the full year. These interim~~ financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2020 (“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 ~~notes thereto~~reflect all adjustments which are in the opinion of management necessary for a fair statement of the ~~Company and management’s discussion and analysis of~~Company’s financial ~~condition and~~position, results of operations, ~~included in the Company’s Annual Report~~and cash flows for the ~~twelve months ended December 31, 2019, as filed with~~periods presented. All such adjustments are of a normal, recurring nature. The Company’s results of operations and cash flows for the ~~Securities~~interim periods are not necessarily indicative of the results of operations and ~~Exchange Commission on Form 10-K.~~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.

~~- 6 -~~

The Company believes that it has no uncertain tax positions requiring disclosure or adjustment. Generally, tax years starting with ~~2017~~2018 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.

- 7 -

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
	March 31, 2021			March 31, 2020

Net (loss)/income	$	(1,276,138	)	$	449,428

Weighted Average Outstanding Shares:
Outstanding shares		43,960,936			39,675,107
Option shares includable		—	^(a)		199,882
		43,960,936			39,874,989

Net income per share
Basic	$	(0.03	)	$	0.01
Diluted	$	(0.03	)	$	0.01

__________

(a) Option shares of 183,681 were not included as the impact is anti-dilutive.

USE OF ESTIMATES IN THE FINANCIAL STATEMENTS

The preparation of financial statements in conformity with ~~U.S.~~ 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—~~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.

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 ~~volume~~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’s~~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.

- 8 -

The following table summarizes net sales by geography for the three months ended March 31, 2021 and 2020:


	Three Months Ended March 31,
	2021		2020
Sales
Domestic	$	4,446,789	$	5,340,866
International		984,162		989,143
Total	$	5,430,951	$	6,330,009

LEASES

In February 2016, the FASB issued a ~~new~~ 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 ~~U.S.~~ 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 ~~sheet,~~sheets but did not have a material impact on our ~~income statements.~~statements of operations. See ~~NOTE~~“NOTE 6 ~~LEASES.~~ — LEASES” for further detail.

~~- 7 -~~

~~RECENTLY ISSUED~~ ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in this ASU simplify the accounting for income taxes by removing several exceptions including the exception to the general methodology for calculating income taxes in an interim period when a year-to-date loss exceeds the anticipated loss for the year. The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted this standard on January 1, 2021 and it had no impact on our financial statement disclosures.

ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

In June 2016, the FASB issued ASU No. ~~2016-13—~~2016-13, Financial Instruments – Credit Losses (Topic 326);: Measurement of Credit Losses on Financial Instruments, which amends guidance on reporting credit losses for assets held at amortized cost basis and available for sale debt securities. For assets held at amortized cost basis, Topic 326 eliminates the probable initial recognition threshold in current GAAP and, instead, requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized cost basis of the financial assets to present the net amount expected to be collected. For available for sale debt securities, credit losses should be measured in a manner similar to current GAAP, however Topic 326 will require that credit losses be presented as an allowance rather than as a write-down. This ASU affects entities holding financial assets and net investment in leases that are not accounted for at fair value through net income. The amendments affect loans, debt securities, trade receivables, net investments in leases, off balance sheet credit exposures, reinsurance receivables, and any other financial assets not excluded from the scope that have the contractual right to receive cash. The amendments in this update are effective for fiscal years beginning after December 15, 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,~~March 2020, the FASB issued ASU No. ~~2019-12 Income Taxes~~2020-04, Reference Rate Reform (Topic ~~740): Simplifying the Accounting~~848), which provided elective amendments for ~~Income Taxes.~~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 ~~in this ASU simplify the accounting for income taxes by removing several exceptions including the exception~~may be applied 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~~impacted contracts 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 afterhedges prospectively through December ~~15, 2020.~~31, 2022. The Company is ~~assessing~~currently evaluating the impact ~~of the adoption of the ASU~~this guidance will have on its financial ~~statements, disclosure requirements and methods of adoption.~~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.

- 9 -

FAIR VALUE ~~OF FINANCIAL INSTRUMENTS~~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 ~~reported in the balance sheet for~~of cash ~~trade receivables,~~and cash equivalents, accounts receivable, prepaid expenses, accounts payable and accrued expenses ~~approximate~~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 ~~based on~~hierarchy during the ~~short-term maturity of these instruments.~~three months ended March 31, 2021.

~~ACCOUNTING FOR~~IMPAIRMENT OF LONG-LIVED ASSETS

The Company reviews ~~its~~ long-lived assets for impairment ~~at least annually~~whenever events or ~~whenever the~~changes in circumstances ~~and situations change such that there is an indication~~indicate that the carrying ~~amounts~~amount of the assets may not be fully recoverable. AsAn impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of ~~June 30, 2020,~~ the ~~Company does not believe that any~~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 ~~assets are impaired.~~respective fair value. No impairment losses have been recorded through March 31, 2021.

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:


	June 30, 2020			December 31, 2019			March 31, 2021			December 31, 2020

Furniture, office equipment, and leasehold improvements		1,213,254			1,135,107
Furniture and office equipment							$	770,240		$	753,536
Leasehold improvements								544,896			542,796
Manufacturing equipment and tooling		1,481,100			1,295,978			1,919,915			1,856,909
		2,694,354			2,431,085
Less: accumulated depreciation		(1,876,290	)		(1,819,239	)
Total property and equipment								3,235,051			3,153,241
Less: accumulated depreciation and amortization								(2,080,683	)		(1,985,618	)
Property and equipment, net	$	818,064		$	611,846		$	1,154,368		$	1,167,623

Depreciation expense was ~~$79,245~~$100,403 and ~~$75,073~~$72,768 for the three months ended ~~June 30,~~March 31, 2021 and March 31, 2020, ~~and 2019, respectively, and $152,013 and $148,588 for the six months ended June 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. KORU Medical is not presently a party to any litigation or other legal proceeding that is believed to be material to its financial condition.

- 810 -

~~NOTE 3 LEGAL PROCEEDINGS~~On March 26, 2021, a putative class action lawsuit was filed in the United States District Court for the Southern District of New York against the Company and its Chief Financial Officer and former Chief Executive Officer, alleging they made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations and prospects, in the Company’s earnings communications and Form 10-Q filed during the period August 4, 2020 and January 25, 2021. The plaintiff is seeking unspecified compensatory damages, an award of reasonable costs and expenses, including counsel fees and expert fees, and such other relief as the Court may deem just and proper. The Company believes that the plaintiff’s allegations are without merit and intends to vigorously defend against the claims. Because the litigation is in its early stages, the Company is unable to estimate a reasonable possible loss or range of loss, if any, that may result from this matter.

From 2013 until May 2020, we were involved in several lawsuits with our principal competitor, EMED, ~~Technologies Corporation~~which were all settled in May 2020.

OTHER

On November 11, 2020, the Company entered into a Manufacturing and Supply Agreement with Command Medical Products, Inc. (“~~EMED”~~Command”)~~. EMED alleged that our~~, pursuant to which Command has agreed to manufacture and supply the Company’s subassemblies, needle sets ~~infringed various patents controlled by EMED. Certain of these lawsuits also alleged antitrust violations, unfair business practices,~~ and ~~various other business tort claims. On May 26,~~tubing products pursuant to the Company’s specifications and purchase orders. The first binding purchase order pursuant to the Manufacturing and Supply Agreement was made on November 17, 2020 the parties announced the settlement of all of the litigation between KORU Medical and EMED. The settlement agreement provides KORU Medical with freedom to operate under EMED’s existing patent portfolio, dismissal of all litigation with prejudice (including the claims against Andrew Sealfon, our former President and Chief Executive Officer), and an equity payment by KORU Medical to EMED. The settled litigation is described below.(the “Effective Date”).

The ~~initial case involving EMED was filed~~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 usthe 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 ~~United States District Court~~Agreement. If the Company terminates the Manufacturing and Supply Agreement other than for those reasons within the ~~Eastern District of California on September 20, 2013 (the “California case”), in response~~first three years from the Effective Date, the Company is obligated to a letter from EMED claiming patent infringement by us, and sought a declaratory judgment establishing the invalidity of the patent referenced in the letter – EMED’s US patent 8,500,703 – “’703.” EMED answered the complaint and asserted patent infringement of the ’703 patent and several counterclaims relating generallypay an early termination fee to claims of unfair business practices against us. We responded by adding several claims against EMED, generally relating to claims of unfair business practices on EMED’s part. On June 16, 2015, the California court entered a preliminary injunction against KORU Medical for making certain statements regarding products cleared for use by the FDA, or that could be safely used, with KORU Medical’s Freedom60 pump, without voiding the product warranty. On September 11, 2015, we requested an ex parte reexamination of the ’703 patent by the U.S. Patent and Trademark Office (“USPTO”). The ex parte reexamination resulted in the Patent Trial and Appeal Board (“PTAB”) of the USPTO determining that claims 1-10 of the ’703 patent are invalid, leaving claim 11 as the only surviving claim of the ’703 patent. Claim 11 of the ’703 patent, however, was not asserted in the California case. EMED informed KORU Medical it will neither appeal the PTAB’s decision nor pursue a claim based on infringement of claim 11 of the ’703 patent in the California case.Command.

The second court case was filed by EMED in the United States District Court for the Eastern District of Texas (the “Texas Court”) on June 25, 2015, claiming patent infringement on another of its patents (US 8,961,476 – “’476”), by our needle sets,Manufacturing and ~~seeking unspecified monetary damages (“ED Texas ’476 matter”). This ’476 patent is related~~Supply Agreement also includes customary provisions relating to, ~~the invalid claims of the EMED ’703 patent.~~

~~On September 17, 2015, we requested an inter partes review (“IPR”) of the ’476 patent,~~among other things, delivery, inspection procedures, warranties, quality management, business continuity plans, handling and subsequently after a trial the PTAB issued a Final Written Decision in our favor, invalidating all claims but one (“dependent Claim 9”) of the ’476 patent. EMED appealed the PTAB’s ruling to the United States Court of Appeals for the Federal Circuit (the “CAFC”), which affirmed the PTAB’s Final Written Decision in our favor on April 3, 2018.

During the IPR proceedings regarding the ’476 patent, EMED filed a new patent application that subsequently issued as US 9,808,576 – “’576” on November 7, 2017. On this same date, EMED filed a new case (the “third case”) in the Texas Court claiming patent infringement of the ’576 patent by our needle sets,transport, intellectual property, confidentiality and seeking unspecified damages and a preliminary injunction against marketing and sales of our needle sets. We moved to dismiss or transfer venue to the United States District Court for the Southern District of New York (“SDNY”), which resulted in the transfer of the third case to SDNY (“SDNY ’576 matter”) on May 30, 2018.indemnification.

On April 23, 2018, EMED filed a new civil case (the “fourth case”) against us in the Texas Court asserting antitrust, defamation and unfair business practice claims, and seeking unspecified damages, similar to those previously presented in the California case, described above. The fourth case also named Andrew Sealfon, then President and Chief Executive Officer of KORU Medical, individually as a defendant. Following a hearing held on November 14, 2018 to address a motion we had filed to transfer venue, on December 7, 2018, the Texas Court transferred the fourth case to the United States District Court for the Eastern District of California (the “California Court”). We then moved to dismiss that complaint, and Andrew Sealfon filed a separate motion to dismiss the case as to him for lack of jurisdiction.

~~- 9 -~~

At the same hearing on November 14, 2018, the Texas Court granted EMED leave to amend its infringement contentions to assert infringement of that sole remaining claim 9 of the ’476 patent. In April 2019, EMED served its damages expert’s report opining that EMED’s past infringement damages amount to $1.5 million, and in May KORU Medical served its damages expert’s rebuttal report opining that EMED’s expert miscalculated damages which if properly calculated would amount to less than $100,000. We moved to dismiss the case for lack of infringement. On June 24, 2019, the Texas Court Magistrate Judge issued a Report and Recommendation decision granting summary judgment in our favor, finding no infringement, literally or under the doctrine of equivalents, by KORU Medical’s accused products. EMED’s objections were overruled and on June 28, 2019, the Texas Court issued a Final Judgment in favor of KORU Medical, awarded court costs to KORU Medical, and dismissed the case. A final judgment was entered and KORU Medical submitted its Bill of Costs for approximately $16,000, which was ordered granted by the Texas Court. KORU Medical also moved to declare the case exceptional and for recovery of its attorney fees and expenses of approximately $2.5 million in defense of EMED’s assertion of the ’476 Patent. EMED appealed the non-infringement judgment to the CAFC. On April 9, 2020, the CAFC issued a unanimous decision affirming the Texas Court’s judgment of non-infringement. The Texas Court had stayed proceedings in the district court until the appeal process was completed.

The SDNY ’576 matter proceeded in the New York court through claim construction on the ’576 Patent, whereupon KORU Medical filed a motion for summary judgement of non-infringement. That motion was granted on August 30, 2019, and the New York court dismissed the lawsuit and entered a final judgement. KORU Medical submitted a Bill of Costs for approximately $1,500, to which EMED objected, and moved the New York court to declare the case exceptional and for recovery of its attorney fees and expenses of at least $1.16 million. On November 12, 2019, the Magistrate Judge issued a Report and Recommendation that KORU Medical’s fee motion be granted, and KORU Medical be awarded approximately $1.1 million in fees and expenses. EMED filed objections to that Report and Recommendation. EMED also appealed the New York court’s judgment of non-infringement to the CAFC, which the parties had fully briefed, and were awaiting a decision from the CAFC Court.

~~The aforementioned district court litigation has now been finally dismissed with prejudice, and all associated appeals dismissed.~~

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 at their annual meeting on April 23, ~~2019,~~2019.

On January 15, 2021, under the Plan, the Company issued to James M. Beck, its Interim Chief Executive Officer, a non-qualified option to purchase up to 150,000 shares of the Company’s common stock at an exercise price of $4.37 per share, of which 100,000 vested on January 15, 2021 and 50,000 vested on March 22, 2021.

On March 15, 2021, under the ~~2019 Annual Meeting~~Plan, the Company issued to Linda Tharby, its incoming President and Chief Executive Officer, a non-qualified stock option to purchase up to 1,000,000 shares of ~~Shareholders.~~the Company’s common stock at an exercise price of $3.875 per share, subject to vesting as follows: 25% on March 15, 2022 and 25% each twelve months thereafter.

As of ~~June 30, 2020,~~March 31, 2021, the Company had options to purchase ~~3,785,000~~3,172,494 shares of Common Stock outstanding to certain executives, key employees and consultants under the Plan, of which ~~60,000~~1,250,000 were issued during the ~~six~~three months ended ~~June 30, 2020.~~March 31, 2021.

Prior to January 1, 2021, each non-employee director of the Company was eligible to receive $50,000 annually (effective January 1, 2019), plus $10,000 for chairing a Board committee (effective February 20, 2019), all to be paid quarterly half in cash and half in common stock. The Chairman of the Board was eligible to receive an additional $50,000 annually (effective October 1, 2019), all to be paid in common stock.

- 11 -

On May 20, 2020, the Company entered into a Settlement Agreement with EMED ~~as described above~~Technologies Corporation (“EMED”) to settle all claims in ~~NOTE 3 LEGAL PROCEEDINGS.~~connection with all pending litigation matters between them. Pursuant to the Settlement Agreement, the Company issued to EMED (i) 95,238 restricted stock units, which vested on May 21, 2020 and 95,238 restricted stock units, ~~vesting~~which vested on January 1, 2021, and (ii) an option to purchase up to 400,000 shares of the Company’s common stock at an exercise price of $11.21 per share prior to February 1, 2021, which ~~can be settled in cash in lieu of common stock at~~was not exercised.

On February 16, 2021, Donald Pettigrew, the Company’s ~~sole discretion, provided that the number of~~former Chief Executive Officer, exercised options held by him for an aggregate 1,000,000 shares of common stock ~~and/or amount~~for an aggregate exercise price 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%.$1,230,000.

On ~~February 20, 2019, the~~March 22, 2021, our Board of Directors adopted the 2021 Omnibus Equity Incentive Plan (the “2021 Equity Plan”), subject to approval 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 caseour shareholders at their annual meeting to be ~~paid quarterly half in cash and half in common stock at~~held on May 18, 2021. There have been no awards made pursuant to 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,2021 Equity Plan 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.~~date.

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.

~~- 10 -~~

2015 STOCK OPTION PLAN, as amended

Time Based Stock Options

The per share weighted average fair value of stock options granted during the ~~six~~three months ended ~~June 30,~~March 31, 2021 and March 31, 2020 was $3.06 and ~~June 30, 2019 was $6.68 and $1.16,~~zero, respectively. The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the ~~six~~three months ended ~~June 30,~~March 31, 2021 and March 31, 2020. Historical information was the primary basis for the selection of the expected volatility, expected dividend yield and the expected lives of the options. The risk-free interest rate was selected based upon yields of the U.S. Treasury issues with a term equal to the expected life of the option being valued. We have recognized tax benefits associated with stock-based compensation of $43,067 and $15,598 for the three months ended March 31, 2021 and 2020, respectively.


	March 31,
	2021		2020

Dividend yield		0.00%		—
Expected Volatility		74.01%-74.28%		—
Weighted-average volatility		—		—
Expected dividends		—		—
Expected term (in years)		10		—
Risk-free rate		1.2-1.62%		—

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


	Three Months Ended March 31,
	2021			2020
	Shares	Weighted Average Exercise Price		Shares		Weighted Average Exercise Price

Outstanding at January 1	2,922,494	$	2.46		3,647,000	$	1.32
Granted	1,250,000	$	3.94		—	$	—
Exercised	1,000,000	$	1.23		175,000	$	0.49
Forfeited	—	$	—		—	$	—
Outstanding at March 31	3,172,494	$	3.43		3,472,000	$	1.36
Options exercisable at March 31	803,119	$	2.09		1,306,635	$	1.05
Weighted average fair value of options granted during the period	—	$	3.06		—	$	—
Stock-based compensation expense		$	1,086,681			$	175,239

Total stock-based compensation expense was $1,086,681 and ~~June 30, 2019.~~$175,239 for the three months ended March 31, 2021 and March 31, 2020, respectively. Cash received from option exercises for the three months ended March 31, 2021 and 2020 was $1,230,000 and $85,500, respectively.

- 12 -

The weighted-average grant-date fair value of options granted during the three months ended March 31, 2021 and March 31, 2020, was $3.8 million and zero, respectively. There were 1.0 million options exercised during the three months ended March 31, 2021 and 175,000 during the three months ended March 31, 2020.

The following table presents information pertaining to options outstanding at March 31, 2021:


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	3,172,494	8.1 years	$	3.43	803,119	$	2.09

As of March 31, 2021, there was $6.1 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan. That cost is expected to be recognized over a weighted-average period of 46 months. The total fair value of shares vested as of March 31, 2021 and March 31, 2020, was $1,230,434 and $868,012, respectively.

Performance Based Stock Options

The per share weighted average fair value of stock options granted during the three months ended March 31, 2021 and 2020 was zero for both periods. The fair value of each award is estimated on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in the three months ended March 31, 2021 and March 31, 2020. 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.

June 30,

2020

2019

Dividend yield

0.00%

0.00%

Expected Volatility

62.1%

58.9-60.3%

Weighted-average volatility

—

—

Expected dividends

—

—

Expected term (in years)

10 Years

10 Years

Risk-free rate

0.63%

2.12-2.72%

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

Six Months Ended June 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

60,000

$
9.76

1,300,000

$
1.66

Exercised

722,000

$
0.58

65,000

$
0.38

Forfeited

200,000

$
2.09

—

$
—

Outstanding at June 30

2,785,000

$
1.64

3,654,000

$
1.24

Options exercisable at June 30

812,760

$
1.37

804,260

$
0.63

Weighted average fair value of options granted during the period

$
6.68

—

$
1.16

Stock-based compensation expense

—

$
290,991

—

$
274,731

Total stock-based compensation expense totaled $290,991 and $274,731 for the six months ended June 30, 2020 and 2019, respectively. Cash received from option exercises for the six months ended June 30, 2020 and 2019 was $95,880 and $24,700, respectively.

The weighted-average grant-date fair value of options granted during the six months ended June 30, 2020 and 2019 was $0.4 million and $1.5 million, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2020 and 2019 was $253,386 and $12,796, respectively.

~~The following table presents information pertaining to options outstanding at June 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

2,785,000

7.6 years

$
1.64

812,760

$
1.37

~~- 11 -~~

As of June 30, 2020, there was $2,011,224 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 June 30, 2020 and 2019, was $1,110,068 and $313,714, respectively.

~~Performance Based Stock Options~~

The per share weighted average fair value of stock options granted during the six months ended June 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 six months ended June 30, 2020 and June 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.


	June 30,				March 31,
	2020		2019		2021		2020

Dividend yield		—		0.00%		—		—
Expected Volatility		—		58.9%		—		—
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:


	Six Months Ended June 30,							Three months Ended March 31,
	2020			2019				2021				2020
	Shares	Weighted Average Exercise Price		Shares		Weighted Average Exercise Price		Shares	Weighted Average Exercise Price			Shares		Weighted Average Exercise Price

Outstanding at January 1	1,000,000	$	1.70		—	$	—	1,000,000	$	1.70			1,000,000	$	1.70
Granted	—	$	—		1,000,000	$	1.70	—	$	—			—	$	—
Exercised	—	$	—		—	$	—	—	$	—			—	$	—
Forfeited	—	$	—		—	$	—	1,000,000	$	1.70			—	$	—
Outstanding at June 30	1,000,000	$	1.70		1,000,000	$	1.70
Options exercisable at June 30	—	$	—		—	$	—
Outstanding at March 31								—	$	—			1,000,000	$	1.70
Options exercisable at March 31								—	$	—			—	$	—
Weighted average fair value of options granted during the period	—	$	—		—	$	1.16	—	$	—			—	$	—
Stock-based compensation expense	—	$	373,826		—	$	41,909	—	$	(408,747	)		—	$	125,727

Total performance stock-based compensation expense totaled ~~$373,826~~($408,747) and ~~$41,909~~$125,727 for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ respectively.

- 13 -

The weighted-average grant-date fair value of options granted during the ~~six~~three months ended ~~June 30,~~March 31, 2021 and March 31, 2020, ~~and June 30, 2019,~~ was zero ~~and $1,162,561, respectively.~~for both periods.

The following table presents information pertaining to ~~performance based~~performance-based options outstanding at ~~June 30, 2020:~~March 31, 2021:

Range of Exercise Price

Number
Outstanding

Weighted
Average
Remaining
Contractual
Life

Weighted
Average
Exercise
Price

Number
Exercisable

Weighted
Average
Exercise
Price

—

~~- 12 -~~

As of ~~June 30, 2020,~~March 31, 2021, there was ~~$495,372~~zero dollars 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 ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was zero for both periods.

NOTE 5 DEBT OBLIGATIONS

On February 8, 2018, the Company issued a Promissory 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 ~~the~~ KeyBank ~~National Association (the “Bank”)~~ in the aggregate principal amount of $3.5 million (the “Note”) as an extension of its line of credit, replacing its then current line of credit agreement and promissory note with the Bank dated February 8, 2018 (the “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%.agreement. The $3.5 million Note is in the form of a variable rate non-disclosable revolving line of credit with an interest rate of Prime Rate announced by the Bank minus 0.75%. 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 ~~$3.5 million and zero~~no amount outstanding against the line of credit as of ~~June 30, 2020 and 2019, respectively.~~

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.March 31, 2021.

On April 27, 2020, the Company entered into a Progress Payment Loan and Security Agreement (“PPLSA”) and a Master Security Agreement (the “MSA”), each dated as of April 20, 2020, with Key Equipment Finance, a division of the Bank (“KEF”), to provide up to $2.5 million in financing for equipment purchases from third party vendors. The PPLSA allows the Company to make draws with KEF to make certain payments to the equipment suppliers prior to the commencement of periodic payments under a term loan. Each draw under the PPLSA will bear interest at a variable rate equal to the then-current Prime Rate and will be secured by the financed equipment under the MSA. At the end of each calendar quarter or year, the advances made under the PPLSA will be converted to term loans, subject to KEF’s approval of the equipment and certain other closing conditions being met. Once the draws under the PPLSA are converted into a term loan, each promissory note will bear interest at a fixed rate of 4.07% per annum, subject to adjustment based on KEF’s cost of funds, with principal and interest payable in 84 equal consecutive monthly installments. Each fixed rate installment promissory note may be prepaid, subject to a penalty if prepaid before the fifth anniversary of its issuance. As of ~~June 30, 2020,~~March 31, 2021, the Company had ~~zero~~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 32 years, some of which include options to extend the leases annually and some with options to terminate the leases within 1 year.

- 1314 -

The components of lease expense were as follows:


	For the Three Months Ended				For the Six Months Ended				Three Months Ended
	June 30,				June 30,				March 31,
	2020		2019		2020		2019		2021		2020

Operating lease cost	$	37,921	$	37,921	$	75,843	$	73,750	$	37,921	$	37,922
Short-term lease cost										34,889		5,457
Total lease cost									$	72,810	$	43,379

Finance lease cost:
Amortization of right-of-use assets	$	1,855	$	1,061	$	3,711	$	2,121	$	795	$	1,856
Interest on lease liabilities		65		59		152		131		28		87
Total finance lease cost	$	1,920	$	1,120	$	3,863	$	2,252	$	823	$	1,943

Supplemental cash flow information related to leases was as follows:

For the
Three Months Ended

For the
Six Months Ended

June 30,

June 30,

2020

2019

2020

2019

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

Finance cash flows from finance leases

$
1,869

$
1,041

$
3,717

$
2,069

Finance lease cost:

Amortization of right-of-use assets

$
1,855

$
1,061

$
3,711

$
2,121

Interest on lease liabilities

65

59

152

131

Total finance lease cost

$
1,920

$
1,120

$
3,863

$
2,252


	Three Months Ended
	March 31,
	2021		2020

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases	$	35,248	$	33,616
Financing cash flows from finance leases		803		1,848

Supplemental balance sheet information related to leases was as follows:


	For the Six Months Ended
	June 30,
	2020			2019			March 31, 2021			December 31, 2020

Operating Leases
Operating lease right-of-use assets	$	306,101		$	439,782		$	201,598		$	236,846

Operating lease current liabilities		139,618			133,417			141,869			141,293
Operating lease long term liabilities		166,483			306,365			59,729			95,553
Total operating lease liabilities	$	306,101		$	439,782		$	201,598		$	236,846

Finance Leases
Property and equipment, at cost	$	12,725		$	6,363		$	12,725		$	12,725
Accumulated depreciation		(8,549	)		(2,121	)		(10,934	)		(10,139	)
Property and equipment, net	$	4,176		$	4,242		$	1,791		$	2,586

Finance lease current liabilities		3,195			4,295			1,843			2,646
Finance lease long term liabilities		1,030			—			—			—
Total finance lease liabilities	$	4,225		$	4,295		$	1,843		$	2,646


	March 31, 2021	December 31, 2020

Weighted Average Remaining Lease Term
Operating leases	1.1 Years	1.4 Years
Finance leases	0.5 Years	0.7 Years

Weighted Average Discount Rate
Operating leases	4.75%	4.75%
Finance leases	4.75%	4.75%

- 1415 -

Six Months Ended
June 30, 2020

Six Months Ended
June 30, 2019

Weighted Average Remaining Lease Term

Operating leases

2 Years

3 Years

Finance leases

1 Year

1 Year

Weighted Average Discount Rate

Operating leases

4.75%

4.75%

Finance leases

4.75%

4.75%

Maturities of lease liabilities are as follows:

Year Ending December 31,

Operating Leases

Finance Leases

2020

75,843

1,664

2021

149,476

2,705

2022

97,256

—

Total lease payments

322,575

4,369

Less imputed interest

(16,474
)

(144
)
Total

$
306,101

$
4,225


Year Ending December 31,	Operating Leases			Finance Leases
2021 (excluding the three months ended March 31, 2021)		111,554			1,873
2022		97,257			—
2023		—			—
2024		—			—
2025		—			—
Thereafter		—			—
Total undiscounted lease payments		208,811			1,873
Less: imputed interest		(7,213	)		(30	)
Total lease liabilities	$	201,598		$	1,843

NOTE 7 ~~RELATED PARTY TRANSACTIONS~~EQUITY

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

~~Mark Pastreich,~~On November 16, 2020, the Company announced that its Board of Directors had authorized a ~~former director~~stock repurchase program under which the Company may purchase up to $10.0 million of its outstanding common stock through December 31, 2021. As of March 31, 2021, the Company had purchased 683,271 shares for an aggregate $3,499,358 pursuant to this program.

NOTE 8 SUBSEQUENT EVENTS

On April ~~2019,~~12, 2021, pursuant to an employment agreement entered into on March 15, 2021 with Linda Tharby, the Company’s President and Chief Executive Officer, the Company issued three restricted stock awards as follows, each vesting subject to employment on the respective vesting date:

(1) 600,000 shares of common stock to vest vesting as follows: if the Company’s Net Sales Growth (defined below) for any of the fiscal years ended December 31, 2022, 2023, 2024 or 2025 (each, a “Target Year”) is at least the applicable Net Sales Target set forth on the schedule to the restricted stock award agreement, then, on the applicable Vesting Date, a ~~principal~~corresponding portion of the restricted stock award will vest as set forth on such schedule. Additionally, if Net Sales Growth is less than any of the Net Sales Targets set forth in such schedule in any Target Year (a “Miss Year”), vesting of the restricted stock award in the ~~entity that owns~~following Target Years (each such subsequent Target Year, a “Catch-up Year”) shall be further subject to 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, 2019following catch-up vesting provisions: if the Net Sales Growth in the Miss Year(s) when averaged with the ~~option to renew six times at~~Net Sales in each Catch-up Year(s) equals or exceeds a ~~monthly lease amount of $12,088. The Company exercised four~~Net Sales Target in any single Miss Year that has not previously been obtained, then on the applicable Vesting Date, an additional portion of the ~~six additional renewal options~~Award shall vest as if the applicable Net Sales Target had been met in the Miss Year(s). Notwithstanding the foregoing, the restricted stock award shall automatically vest in full upon the Company maintaining, for ~~September~~a period of at least two consecutive fiscal quarters after January 1, ~~2019, through August 31, 2021.~~2022, at least a specified run rate over the previous four fiscal quarters, as reported in the Company’s filings pursuant to the Securities Exchange Act of 1934, as amended.

~~The lease payments were $36,264~~(2) 200,000 shares of common stock vesting 25% on April 12, 2022 and 25% on each twelve months thereafter.

(3) 200,000 shares of common stock, vesting as follows: (i) 50,000 shares on the first date on which the Company’s Market Capitalization for ~~both three months ended June 30, 2020, and 2019 and $72,528 and $70,436 for the six months ended June 30, 2020 and 2019, respectively. The Company also paid property taxes~~a period of 90 consecutive days has been, or there has been a Change of Control (as defined in the ~~amount~~employment agreement) of ~~$13,238~~the Company with an enterprise value of, at least $500,000,000 but less than $600,000,000; (ii) 50,000 shares on the first date on which the Company’s Market Capitalization for a period of 90 consecutive days has been, or there has been a Change of Control of the Company with an enterprise value of, at least $600,000,000 but less than $750,000,000; and ~~$12,989~~(iii) 100,000 shares on the date on which the Company’s Market Capitalization for ~~three months ended June 30, 2020~~a period of 90 consecutive days has been, or there has been a Change of Control of the Company with an enterprise value of, at least $750,000,000. “Market Capitalization” shall be determined by (A) multiplying the number of shares reported as outstanding on the cover of the Company’s most recent Form 10-K or 10-Q, as applicable, as filed with the Securities and ~~2019, respectively~~Exchange Commission, by (B) the Fair Market Value of the Common Stock (as defined in the Company’s 2015 Stock Option Plan, as amended) on each day. Notwithstanding the foregoing, no portion of the restricted stock award shall vest on or following the fifth anniversary of the award date.

- 16 -

On April 12, 2021, the Company entered into a Transition Services Agreement with James M. Beck, its then Interim Chief Executive Officer, which terminated his employment agreement dated January 22, 2021 and ~~$26,659 and $25,416~~provides for his transition services for a period of thirty days in exchange for $119,500, to be paid in two cash installments in accordance with the ~~six months ended June 30, 2020 and 2019, respectively.~~Company’s regular payroll.

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

This Quarterly Report on Form 10-Q contains 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, customer ordering patterns, ability to convert inventory to a source of cash, 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~~our research and development effort, expanding the market of FREEDOM60^®demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the outcome of litigation, 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,~~” the “Company,~~” “we,” “us” ~~and~~or “our” ~~refer~~refers to Repro Med Systems, Inc.

-RECENT DEVELOPMENTS

On January 22, 2021, Donald B. Pettigrew, President and Chief Executive Officer, resigned his employment effective immediately. Also, on January 22, 2021, James M. Beck, currently serving as a director, was appointed as Chief Executive Officer on an interim basis. Mr. Beck has remained a director, and Robert Allen, also currently a director, replaced Mr. Beck as Chairman of the Compensation Committee.

On March 15, -2021, Linda Tharby entered into an employment agreement with the Company providing for her appointment as President and Chief Executive Officer of KORU Medical Systems, effective April 12, 2021. Mr. Beck resigned as interim Chief Executive Officer upon the appointment of Ms. Tharby and will continue as a member of the Board of Directors.

OVERVIEW

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

KORU Medical continues to monitor its operations and government recommendations and has made modifications to its normal operations because of the COVID-19 ~~outbreak,~~pandemic, 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 duration of the pandemic is known, we cannot predict the effects the pandemic may have on our business, in particular with respect to demand for our products, our strategy, and our prospects, the effects on our customers, or the impact on our financial results. For example, our future net sales growth may continue to be impacted due to fewer new prescriptions for individuals with Primary Immune Deficiency Disease (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) as a result of patients not seeking care during the pandemic.

~~On April 14, 2020,~~- 17 -

Our revenues derive from three business sources: (i) domestic core, (ii) international core, and (iii) novel therapies. Our core revenues consist of sales of our products for the ~~Company issued a promissory note~~delivery of SCIg to treat PIDD, CIDP, and other disease states that are not included in novel therapies. Novel therapies currently consist of revenues from clinical trials, which include sales of pumps, tubing and needles.

Total net sales were $5.4 million, or 14% lower for the three months ended March 31, 2021 as compared to the ~~KeyBank National Association (the “Bank”)~~prior year period. The decrease was due principally to lower novel therapies compared with last year due to a non-recurring clinical trial, lower pump volume in our domestic core business due to prior year ordering patterns and a one-time pharmaceutical customer pump purchase. Domestic core net sales also reflected a slowdown in the ~~aggregate principal~~growth of new patient starts for SCIg therapy.

We incurred a significant amount of ~~$3.5~~expenses totaling $1.3 million ~~as an extension of its line of credit, replacing its current line of credit agreement and promissory note with~~during the Bank dated February 8, 2018 (the “Original Note”). In response to concerns about the potential impact of COVID-19, the Company elected to draw the additional $2.0 million available under the line of credit, drawing the full amount available of $3.5 million on its line of credit.

~~On April 20, 2020, the Company entered into a Loan Agreement with the Bank (the “PPP Loan Agreement”) pursuant~~quarter related to the ~~Paycheck Protection Program under the Coronavirus Aid, Relief,~~departure and ~~Economic Security Act (the “CARES Act”), providing for a loan in the principal amount~~replacement of ~~$1.5 million (the “PPP Loan”). The PPP Loan was funded on April 27, 2020. On May 13, 2020, the Company returned the funds it received.~~

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, 2020our Chief Executive Officer and the ~~Company covenants not to challenge any EMED patents that were the subject~~recruitment of ~~the Claims unless EMED asserts them in the future against Company products. The aggregate~~two new Board members, which included non-cash ~~litigation settlement expense recognized during the period ended June 30, 2020 was $2.2~~equity charges of $0.4 million.

~~On June 18,~~Our inventory position increased $1.2 million from at December 31, 2020 as we transition manufacturing to our secondary source. As transition is completed, this inventory is expected to convert to a source of cash in 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 with proceeds to the Company net of discounts, commissions, fees and expenses of $26.5 million.future.

We ended the second quarter of 2020 with net sales of $7.7 million, an increase of 44% compared with the same period last year, driven primarily by higher sales volume in needle sets, tubing and pump sales, due to what we believe was continued demand increases which included clinical trials, as well as increased purchasing to support the trends towards at-home infusion therapy and in response to the uncertainties created by COVID-19.

Our gross margin percentage, which is gross profit stated as a percentage of net sales, was 63.7% down from 65.0% in the prior year mostly due to overtime costs related to COVID-19 absenteeism. Gross margin was 65.4% when adjusted for overtime.

Net loss was $1.1 million for the quarter, compared with net income of $0.1 million for the previous year, driven by the $2.2 million stock based litigation settlement expense, partially offset by higher net sales compared with last year.

As of June 30, 2020, the Company had $38.1 million cash on hand, including $26.5 million resulting from the capital raise during the quarter described above, and a draw of $3.5 million on the line of credit.

~~- 16 -~~

RESULTS OF OPERATIONS

Three months ended ~~June 30, 2020~~March 31, 2021 compared to ~~June 30, 2019~~March 31, 2020

Net Sales

The following table summarizes our net sales for the three months ended ~~June 30, 2020~~March 31, 2021 and ~~2019:~~2020:

Three Months Ended June 30,

Change from Prior Year

% of Sales

2020

2019

$

%

2020

2019

Sales

Domestic

$
6,745,810

$
4,569,226

$
2,176,584

47.6%

87.5%

85.4%

International

963,094

779,586

183,508

23.5%

12.5%

14.6%

Total

$
7,708,904

$
5,348,812

$
2,360,092

44.1%


	Three Months Ended March 31,				Change from Prior Year					% of Net Sales
	2021		2020		$			%		2021	2020
Net Sales
Domestic Core	$	4,412,417	$	4,872,766	$	(460,349	)	(9.4%	)	81.2%	77.0%
Novel Therapies		34,372		468,100		(433,728	)	(92.7%	)	0.7%	7.4%
Total Domestic		4,446,789		5,340,866		(894,077	)	(16.7%	)	81.9%	84.4%

International Core		978,906		984,867		(5,961	)	(0.6%	)	18.0%	15.5%
Novel Therapies		5,256		4,276		980		22.9%		0.1%	0.1%
Total International		984,162		989,143		(4,981	)	(0.5%	)	18.1%	15.6%
Total	$	5,430,951	$	6,330,009	$	(899,058	)	(14.2%	)

Total net sales ~~increased $2.4~~decreased $0.9 million or ~~44.1%~~14.2% for the three months ended ~~June 30, 2020~~March 31, 2021 compared with the same period last year, driven primarily by ~~higher sales~~lower novel therapies of $0.4 million compared with last year due to a non-recurring clinical trial, lower pump volume in ~~needle sets, tubing and pump sales, mostly~~our domestic core business of $0.4 million primarily due to ~~what we believe was continued demand increases which included clinical trials, as well as increased purchasing to support~~prior year ordering patterns and a one-time pharmaceutical customer pump purchase. Domestic core net sales also reflected a slowdown in the ~~trends towards at-home infusion therapy and in response to~~growth of new patient starts for SCIg therapy. International core net sales were $1.0 million, nearly even with the ~~uncertainties created by COVID-19.~~same period last year.

Gross Profit

Our gross profit for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ is as follows:


	Three Months Ended June 30,				Change from Prior Year			Three Months Ended March 31,				Change from Prior Year
	2020		2019		$		%	2021		2020		$			%
Gross Profit	$	4,909,880	$	3,475,664	$	1,434,216	41.3%	$	3,231,854	$	3,788,210	$	(556,356	)	(14.7%	)
Stated as a Percentage of Net Sales		63.7%		65.0%					59.5%		59.9%

Gross profit ~~increased $1.4~~decreased $0.6 million or ~~41.3%~~14.7% in the three months ended ~~June 30, 2020,~~March 31, 2021, compared to the same period in ~~2019.~~2020. This ~~increase~~decrease in the quarter was mostly driven by the ~~increase~~decrease in net sales of ~~$2.4 million. Gross margin declined compared with last year mostly due to overtime costs related to COVID-19 absenteeism.~~$0.9 million as described above. Gross margin was ~~65.4% when adjusted for overtime.~~slightly lower due primarily to lower volume in pump sales where we have a higher gross margin, partially offset by favorable production variances.

- 18 -

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 ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ are as follows:


	Three Months Ended June 30,				Change from Prior Year			Three Months Ended March 31				Change from Prior Year
	2020		2019		$		%	2021		2020		$		%
Selling, general and administrative	$	3,201,831	$	2,050,435	$	1,151,396	56.2%	$	4,992,829	$	2,862,138	$	2,130,691	74.4%
Litigation		2,346,914		1,124,947		1,221,967	108.6%
Research and development		298,196		178,235		119,961	67.3%		336,841		256,025		80,816	31.6%
	$	5,846,941	$	3,353,617	$	2,493,324	74.3%	$	5,329,670	$	3,118,163	$	2,211,507	70.9%
Stated as a Percentage of Net Sales		75.9%		62.7%					98.1%		49.3%

Selling, general and administrative expenses increased ~~$1.2~~$2.1 million, or ~~56.2%~~74.4%, during the three months ended ~~June 30, 2020~~March 31, 2021 compared to the same period last year, mostly due to $1.3 million in costs associated with the departure and replacement of the former chief executive officer and the recruitment of two new Board members, which includes non-cash equity expense of $0.4 million. Further contributing to the increase was higher salary and related benefits of ~~$0.9~~$0.6 million ~~due to~~from new hires in the second half of last year ~~severance~~to support commercialization, business development and ~~a bonus~~medical affairs for ~~employee service during the COVID-19 pandemic. Adding to the increase were consulting and recruiting fees of $0.2 million related to marketing, regulatory and strategic~~our pharmaceutical channel initiatives, and several new hires in regulatory and sales. Also contributing to the increase were higher distribution related fees incurred with our largest distributor, higher director fees and insurance premiums related to our directors and officers insurance policy, in aggregate totaling $0.2 million. Offsetting these increases were lower trade show and travel expenses of $0.1 million due to COVID-19 related travel restrictions.as well as infrastructure.

Litigation fees increased $1.2 million 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 resulting in a non-cash expense of $2.2 million.

~~- 17 -~~

Research and development expenses increased $0.1 million during the three months ended ~~June 30, 2020~~March 31, 2021 compared with the same period last year mostly due to ~~increased salary and related benefits due~~increases to ~~higher headcount as we continue to increase our development initiatives.~~support pharmaceutical product development.

Depreciation and amortization

Depreciation and amortization expense increased by ~~10.2%~~32.4 % to ~~$94,940~~$115,473 in the three months ended ~~June 30, 2020~~March 31, 2021 compared with ~~$86,169~~$87,224 in the three months ended ~~June 30, 2019.~~March 31, 2020. We continue to invest in capital assets, mostly related to manufacturing and computer ~~equipment, and in patent applications and their maintenance.~~equipment.

Net ~~(Loss)/~~Income


	Three Months Ended June 30,					Change from Prior Year			Three Months Ended March 31,					Change from Prior Year
	2020			2019		$			2021			2020		$
Net (Loss)/Income	$	(1,076,038	)	$	78,183	$	(1,154,221	)	$	(1,276,138	)	$	449,428	$	(1,725,566	)
Stated as a Percentage of Net Sales		(14.0%	)		1.5%					(23.5%	)		7.1%

Our net loss for the three months ended ~~June 30, 2020~~March 31, 2021 was ~~$1.1~~$1.3 million compared to net income of ~~$0.1~~$0.4 million for the three months ended ~~June 30, 2019,~~March 31, 2020, driven by ~~the litigation settlement expense~~lower gross profit and higher selling, general and administrative expenses ~~partially offset by higher sales, as described above.~~

~~Six months ended June 30, 2020 compared to June 30, 2019~~

~~Net Sales~~

~~The following table summarizes our net sales for the six months ended June 30, 2020 and 2019:~~

Six Months Ended June 30,

Change from Prior Year

% of Sales

2020

2019

$

%

2020

2019

Sales

Domestic

$
12,086,676

$
8,452,791

$
3,633,885

43.0%

86.1%

81.9%

International

1,952,237

1,870,299

81,938

4.4%

13.9%

18.1%

Total

$
14,038,913

$
10,323,090

$
3,715,823

36.0%

Total net sales increased $3.7 million or 36.0% for the six months ended June 30, 2020. The volume increase was driven by what we believe was continued growth in diagnosis of primary immunodeficiency diseases (“PIDD”) and expansion into the neurology market with expanded Hizentra® indication for chronic inflammatory demyelinating polyneuropathy (“CIDP”) and clinical trials, as well as increased purchasing to support the trend towards at-home infusion therapy and in response to the uncertainties created by COVID-19.

~~Gross Profit~~

~~Our gross profit for the six months ended June 30, 2020 and 2019 is as follows:~~

Six Months Ended June 30,

Change from Prior Year

2020

2019

$

%

Gross Profit

$
8,698,090

$
6,523,618

$
2,174,472

33.3%

Stated as a Percentage of Net Sales

62.0%

63.2%

~~Gross profit increased $2.2 million or 33.3%% in the six months ended June 30, 2020, compared to the same period last year. Gross margin declined compared with last year~~ mostly due to ~~overtime~~ costs ~~related to COVID-19 absenteeism in~~described above. Offsetting the ~~second quarter, as well as the expense for an obsolescence reserve resulting from~~loss was a ~~discontinued product line. Excluding these items gross margin would have been 63.4%.~~

~~- 18 -~~

~~Selling, general and administrative, Litigation and Research and development~~

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

Six Months Ended June 30,

Change from Prior Year

2020

2019

$

%

Selling, general and administrative

$
5,964,811

$
4,535,303

$
1,429,508

31.5%

Litigation

2,446,072

1,617,462

828,610

51.2%

Research and development

554,221

280,194

274,027

97.8%

$
8,965,104

$
6,432,959

$
2,532,145

39.4%

Stated as a Percentage of Net Sales

63.9%

62.3%

Selling, general and administrative expenses increased $1.4 million, or 31.5%, during the six months ended June 30, 2020 compared to the same period last year, mostly due to higher salary and related benefits and recruiting fees in aggregate $1.0tax benefit of $0.5 million resulting from ~~new hires after June 30, 2019. Also contributing~~book to ~~the increase were consulting fees of $0.3 million~~tax differences related to marketing, regulatory and strategic initiatives, as well as higher distribution related fees incurred with our largest distributor, director fees and insurance premiums related to our directors and officers insurance policy in aggregate totaling $0.3 million. Offsetting the increases were lower trade show and travel expenses of $0.2 million due to the impact of COVID-19 related travel restrictions.

Litigation fees increased $0.8 million 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 $0.3 million during the six months ended June 30, 2020 compared with the same period last year mostly due to increased salary and related benefits due to higher headcount as we continue to increase our development initiatives.

~~Depreciation and amortization~~

Depreciation and amortization expense increased by 7.3% to $182,164 in the six months ended June 30, 2020 compared with $169,820 in the six months ended June 30, 2019. We continued to invest in capital assets, mostly related to manufacturing and computer equipment, and in patent applications and their maintenance.

~~Net (Loss)/Income~~

Six Months Ended June 30,

Change from Prior Year

2020

2019

$

Net Loss

$
(626,610
)
$
(7,207
)

$
(619,403
)
Stated as a Percentage of Net Sales

(4.5%
)

(0.1%
)

Our net loss for the six months ended June 30, 2020 was $0.6 million compared to a net loss of $7,207 for the six months ended June 30, 2019, driven by the EMED settlement charge, higher selling, general and administrative expenses, partially offset by higher sales all as described above.stock option expense.

LIQUIDITY AND CAPITAL RESOURCES

Our principal source of liquidity is our cash on hand of ~~$38.1~~$26.8 million as of ~~June 30, 2020,~~March 31, 2021, which includes the net proceeds from the ~~recent~~2020 capital raise ~~described below~~ totaling $26.5 million and a $3.5 million draw against our line of credit. In response to concerns about the potential impact of COVID-19, the Company elected to draw $3.5 million, the full amount available on its line of credit.$26.6 million. 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, and selling, general and administrative expenses.

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 with proceeds to the Company net of discounts, commissions, fees and expenses of $26.5 million.

~~- 19 -~~

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. This was a non-cash settlement from which we recognized expense in the amount of $2.2 million in the second quarter of 2020.

The Company’s operations continue to remain active, as we currently qualify as an “essential business” under New York state government guidelines. With the COVID-19 outbreak, the need to ensure vulnerable patients have access to home-based treatments is more apparent than ever. Home infusion therapy keeps high-risk patients with immune diseases and other conditions out of institutional settings and allows them to receive treatment at home.

We believe that as of June 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.

Cash Flows

The following table summarizes our cash flows:

Six Months Ended
June 30, 2020

Six Months Ended
June 30, 2019

Net cash provided by/(used in) operating activities

$
2,707,549

$
(1,483,909
)
Net cash (used in)/provided by investing activities

$
(513,273
)
$
1,532,487

Net cash provided by financing activities

$
30,064,144

$
19,811


	Three Months Ended March 31, 2021			Three Months Ended March 31, 2020
Net cash (used in)/provided by operating activities	$	(2,605,653	)	$	153,236
Net cash used in by investing activities	$	(102,204	)	$	(180,138	)
Net cash provided by financing activities	$	2,167,291		$	1,583,652

- 19 -

Operating Activities

Net cash used in operating activities of $2.6 million for the three months ended March 31, 2021 was primarily due to the net loss of $1.3 million, working capital changes which include an increase in inventory of $1.2 million related to the transition of manufacturing to our secondary source, an increase in accounts receivable of $1.0 million due to delayed payments at our largest distributor, as well as a decrease in accrued expenses of $0.9 million most of which was non-cash activity related to the issuance of common stock in settlement of litigation. Further contributing were deferred tax assets of $0.9 million increased for book to tax differences related to stock option expense. Offsetting these were primarily non-cash charges for stock-based compensation of $0.7 million, an increase in accounts payable of $1.3 million due to timing of payments and an increase in accrued payroll of $0.4 million related to the separation agreement with our former chief executive officer.

Net cash provided by operating activities of ~~$2.7~~$0.2 million for the ~~six~~three months ended ~~June 30,~~March 31, 2020 was mostly attributable to net income of $0.4 million, non-cash charges for stock-based compensation ~~and litigation settlement expense~~ of ~~$2.1~~$0.4 million, an increase in accounts payable ~~accrued expenses~~of $0.5 million and ~~accrued payroll of $2.1 million, driven by the litigation settlement with EMED, the capital raise and customer rebates. Further adding to the increase was~~ an increase in tax liability of ~~$0.3 million, resulting from book tax differences related to option expense. Collection against accounts receivable also contributed $0.3~~$0.2 million. Offsetting these were an increase in inventory of ~~$1.3~~$0.7 million, and a decrease in accrued expenses of $0.4 million mostly related to cash payments for bonuses accrued for at December 31, 2019, net of current year accrual for bonuses, offset by higher rebates. Further offsetting the cash provided by operating activities was an increase in prepaid expenses of $0.2 million, as ~~we built inventory to keep pace with sales growth and to insure timely order fulfillment.~~

~~Net cash used in operating activities of $1.5 million for the six months ended June 30, 2019 was mostly attributable to increased~~well as higher accounts receivable of $1.9 million as one of our major customer’s payment terms changed on January 1, 2019 from net 30 to net 60 days, and increased inventory of $0.5 million as we look to build stock to keep pace with sales growth. Partially offsetting these were our non-cash charges for stock based compensation of $0.5 million and depreciation and amortization of long lived tangible and intangible asset of $0.2 million.

Investing Activities

Net cash used in investing activities of ~~$0.5~~$0.1 million for the ~~six~~three months ending ~~June 30,~~March 31, 2021 was for capital expenditures for manufacturing and office equipment.

Net cash used in investing activities of $0.2 million for the three months ending March 31, 2020 was for capital expenditures for research and development and strategic initiatives as well as for patent and trademark applications. Net cash of $1.5 million provided by investing activities for the six months ended June 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 and patent application and maintenance of $0.2 million.

~~- 20 -~~

Financing Activities

The ~~$30.1~~$2.2 million provided by financing activities for the ~~six~~three months ended ~~June 30,~~March 31, 2021 is from options exercised and the non-cash activity related to the issuance of common stock in settlement of litigation.

The $1.6 million provided by financing activities for the three months ended March 31, 2020 is from the ~~$26.5~~$1.5 million ~~capital raise, net of expenses, a $3.5 million draw~~drawn down on the line of credit and $0.1 million from options exercised. ~~The $19,811 provided by financing activities for the six months ended June 30, 2019 is a result of options exercised less payments for cancelled shares and leased office equipment.~~

~~RECENTLY ISSUED~~ ACCOUNTING PRONOUNCEMENTS RECENTLY ADOPTED

~~In June 2016,~~Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 itsaccompanying financial statements, ~~disclosure requirements and methods of adoption.~~which is incorporated herein by reference.

~~In December 2019,~~ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED

Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in 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 itsaccompanying financial statements, ~~disclosure requirements and methods of adoption.~~which is incorporated herein by reference.

~~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.

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.

~~- 21 -~~

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) before interest, income taxes, depreciation and amortization, reorganization charges, and litigation, manufacturing initiative and stock option expenses. Prior to January 1, 2020, discontinued product expense and manufacturing initiative expense was 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

Six Months Ended
Reconciliation of GAAP Net (Loss)/Income

June 30,

June 30,
to Non-GAAP Adjusted EBITDA:

2020

2019

2020

2019
GAAP Net (Loss)/Income

$
(1,076,038
)

$
78,183

$
(626,610
)
$
(7,207
)
Tax Expense

30,919

24,683

172,847

2,584

Depreciation/Amortization

94,940

86,169

182,164

169,820

Interest Expense/(Income), Net

5,002

(18,243
)

(14,028
)

(35,723
)
Reorganization Charges

—

—

—

354,926

Discontinued Product Expenses

(31,581
)

—

77,977

—

Litigation Expenses

2,346,914

1,124,947

2,446,072

1,617,462

Manufacturing Initiative Expenses

25,957

—

135,759

—

Stock Option Expense

363,851

194,765

664,817

316,640

Non-GAAP Adjusted EBITDA

$
1,759,964

$
1,490,504

$
3,038,998

$
2,418,502

~~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 sunset our Res-Q-Vac product line in 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 quarter of 2020 we sold off a portion of the discontinued inventory previously reserved. We do not expect to incur any 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 Expenses.~~ 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 as a result 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.

~~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.

~~- 22 -~~

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

Not Applicable.

- 20 -

PART I – 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 ~~quarter~~three months ended ~~June 30, 2020,~~March 31, 2021, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II – OTHER INFORMATION

None.

ITEM 1. LEGAL PROCEEDINGS

On March 26, 2021, a putative class action lawsuit was filed in the United States District Court for the Southern District of New York against the Company and its Chief Financial Officer and former Chief Executive Officer, alleging they made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations and prospects, in the Company’s earnings communications and Form 10-Q filed during the period August 4, 2020 and January 25, 2021. The plaintiff is seeking unspecified compensatory damages, an award of reasonable costs and expenses, including counsel fees and expert fees, and such other relief as the Court may deem just and proper. The Company believes that the plaintiff’s allegations are without merit and intends to vigorously defend against the claims. Because the litigation is in its early stages, the Company is unable to estimate a reasonable possible loss or range of loss, if any, that may result from this matter.

From 2013 until May 2020, we were involved in several lawsuits with our principal competitor, EMED, ~~Technologies Corporation (“EMED”). EMED alleged that~~which were all settled in May 2020. Refer to our needle sets infringed various patents controlled by EMED. Certain of these lawsuits also alleged antitrust violations, unfair business practices, and various other business tort claims. On May 26, 2020, the parties announced the settlement of all of the litigation between KORU Medical and EMED. The settlement agreement provides KORU Medical with freedom to operate under EMED’s existing patent portfolio, dismissal of all litigation with prejudice (including the claims against Andrew Sealfon, our former President and Chief Executive Officer), and an equity payment by KORU Medical to EMED. The settled litigation is described below.

~~The initial case involving EMED was filed by us in the United States District Court~~Form 10-Q for the Eastern District of California on September 20, 2013 (the “California case”), in response to a letter from EMED claiming patent infringement by us, and sought a declaratory judgment establishing the invalidity of the patent referenced in the letter – EMED’s US patent 8,500,703 – “’703.” EMED answered the complaint and asserted patent infringement of the ’703 patent and several counterclaims relating generally to claims of unfair business practices against us. We responded by adding several claims against EMED, generally relating to claims of unfair business practices on EMED’s part. Onquarterly period ended June 16, 2015, the California court entered a preliminary injunction against KORU Medical for making certain statements regarding products cleared for use by the FDA, or that could be safely used, with KORU Medical’s Freedom60 pump, without voiding the product warranty. On September 11, 2015, we requested an ex parte reexamination of the ’703 patent by the U.S. Patent and Trademark Office (“USPTO”). The ex parte reexamination resulted in the Patent Trial and Appeal Board (“PTAB”) of the USPTO determining that claims 1-10 of the ’703 patent are invalid, leaving claim 11 as the only surviving claim of the ’703 patent. Claim 11 of the ’703 patent, however, was not asserted in the California case. EMED informed KORU Medical it will neither appeal the PTAB’s decision nor pursue a claim based on infringement of claim 11 of the ’703 patent in the California case.

The second court case was filed by EMED in the United States District Court for the Eastern District of Texas (the “Texas Court”) on June 25, 2015, claiming patent infringement on another of its patents (US 8,961,476 – “’476”), by our needle sets, and seeking unspecified monetary damages (“ED Texas ’476 matter”). This ’476 patent is related to the invalid claims of the EMED ’703 patent.

On September 17, 2015, we requested an inter partes review (“IPR”) of the ’476 patent, and subsequently after a trial the PTAB issued a Final Written Decision in our favor, invalidating all claims but one (“dependent Claim 9”) of the ’476 patent. EMED appealed the PTAB’s ruling to the United States Court of Appeals for the Federal Circuit (the “CAFC”), which affirmed the PTAB’s Final Written Decision in our favor on April 3, 2018.

During the IPR proceedings regarding the ’476 patent, EMED filed a new patent application that subsequently issued as US 9,808,576 – “’576” on November 7, 2017. On this same date, EMED filed a new case (the “third case”) in the Texas Court claiming patent infringement of the ’576 patent by our needle sets, and seeking unspecified damages and a preliminary injunction against marketing and sales of our needle sets. We moved to dismiss or transfer venue to the United States District Court for the Southern District of New York (“SDNY”), which resulted in the transfer of the third case to SDNY (“SDNY ’576 matter”) on May 30, ~~2018.~~2020.

~~- 23 -~~

~~The aforementioned district court litigation has now been finally dismissed with prejudice, and all associated appeals dismissed.~~

ITEM 1A. RISK FACTORS

Our operations and financial results are subject to various risks and uncertainties, including those described in ~~Part I, Item 1A, “Risk Factors”~~“PART 1, ITEM 1A. RISK FACTORS” in our Annual Report on Form 10-K for the year ended December 31, ~~2019,~~2020, which could adversely affect our business, financial condition, results of operations, cash flows, and the trading price of our common stock. ~~The following are~~There have been no material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, ~~2019:~~

~~Our business could 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 disruptions during the quarter ended June 30, 2020 from the COVID-19 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 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), 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, 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 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,

~~- 24 -~~

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.2020.

PART II – ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

~~Each~~Prior to January 1, 2021, each non-employee director of the Company iswas 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.~~stock. The Chairman of the Board iswas eligible to receive an additional $50,000 annually (effective October 1, 2019), all to be paid in common stock.

Effective January 1, 2021, each non-employee director of the Company (other than the Chairman of the Board) and Board advisor are eligible to receive of $75,000 annually, to be paid quarterly $12,500 in cash and $6,250 in common stock. The Chairman of the Board is eligible to receive $100,000 annually, to be paid quarterly $12,500 in cash and $12,500 in common stock. All payments were and are pro-rated for partial service. The Company issued an aggregate ~~of 7,999 and 17,188~~10,124 shares of common stock to its non-employee directors during the ~~three-month and six-month period~~three months ended ~~June 30, 2020, respectively.~~March 31, 2021.

~~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.~~- 21 -

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.

During the three months ended March 31, 2021, 1,250,000 options to purchase shares of the Company’s common stock atwere issued to key employees under the Company’s ~~sole discretion, provided that~~2015 Stock Option Plan, as amended, as follows:


●	on January 15, 2021, options to purchase up to 150,000 shares to the Company’s interim Chief Executive Officer at an exercise price of $4.37 per share, of which all have vested;

●	on March 15, 2021, options to purchase up to 1,000,000 shares to the Company’s incoming President and Chief Executive Officer at an exercise price of $3.875 per share, subject to vesting; and

●	on March 1, 2021, options to purchase up to 100,000 shares to a key employee at an exercise price of $3.94 per share, subject to vesting.

On February 16, 2021, Donald Pettigrew, the ~~number of~~Company’s former Chief Executive Officer, exercised options held by him for an aggregate 1,000,000 shares of common stock ~~and/or amount~~for an aggregate exercise price 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.$1,230,000.

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

Issuer Purchases of Equity Securities

On November 16, 2020, the Company announced that its Board of Directors had authorized a stock repurchase program under which the Company may purchase up to $10.0 million of its outstanding common stock through December 31, 2021. As of March 31, 2021, the Company had purchased 683,271 shares for an aggregate $3,499,358 pursuant to this program.

The following table sets forth information regarding our repurchases of securities for each calendar month in the three months ended March 31, 2021:


Period	Total Number of Shares Purchased	Average Price Paid per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs	Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs
January 1 to 31, 2021	—	$	0.00	—	$	6,500,642
February 1 to 28, 2021	—		0.00	—	$	6,500,642
March 1 to 31, 2021	—		0.00	—	$	6,500,642
Total	—	$	0.00	—

PART II – ITEM 6. EXHIBITS.


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”.

- 2522 -

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.

~~August 5, 2020~~May 12, 2021	/s/ ~~Donald B. Pettigrew~~Linda Tharby
	~~Donald B. Pettigrew,~~Linda Tharby, President and Chief Executive Officer (Principal Executive Officer)

~~August 5, 2020~~May 12, 2021	/s/ Karen Fisher
	Karen Fisher, Chief Financial Officer and Treasurer (Principal Financial Officer)

- 2623 -


	For the Six Months Ended
	June 30,
	2020			2019

CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss	$	(626,610	)	$	(7,207	)
Adjustments to reconcile net loss to net cash provided by/(used in) operating activities:
Stock based compensation expense		784,821			529,538
Stock based litigation settlement expense		1,285,102			—
Depreciation and amortization		182,164			169,820
Deferred capital gain - building lease		—			(3,763	)
Deferred taxes		(145,770	)		66,494
Loss/(Gain) on disposal of fixed asset		5,522			(49,740	)
Changes in operating assets and liabilities:
Decrease/(Increase) in accounts receivable		268,619			(1,867,342	)
Increase in inventory		(1,278,811	)		(467,706	)
(Increase)/Decrease in prepaid expense and other assets		(156,316	)		44,874
Increase in accounts payable		347,350			76,882
Increase/(Decrease) in accrued payroll and related taxes		333,272			(249,730	)
Increase in accrued expense		1,389,588			346,181
Increase/(Decrease) in accrued tax liability		318,618			(72,210	)
NET CASH PROVIDED BY/(USED IN) OPERATING ACTIVITIES		2,707,549			(1,483,909	)

CASH FLOWS FROM INVESTING ACTIVITIES
Payments for capital expenditures		(363,750	)		(67,079	)
Payments for patents		(149,523	)		(136,182	)
Proceeds on disposal of fixed asset		—			217,821
Proceeds from certificate of deposit		—			1,517,927
NET CASH (USED IN)/PROVIDED BY INVESTING ACTIVITIES		(513,273	)		1,532,487

CASH FLOWS FROM FINANCING ACTIVITIES
Line of credit advance		3,500,000			—
Issuance of equity		26,567,861			24,700
Payment for cancelled shares		—			(2,820	)
Finance lease		(3,717	)		(2,069	)
NET CASH PROVIDED BY FINANCING ACTIVITIES		30,064,144			19,811

NET INCREASE IN CASH AND CASH EQUIVALENTS		32,258,420			68,389
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD		5,870,929			3,738,803
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	38,129,349		$	3,807,192

Supplemental Information
Cash paid during the periods for:
Interest	$	13,554		$	233
Taxes	$	—		$	—

NON-CASH FINANCING AND INVESTING ACTIVITIES
Issuance of common stock as compensation	$	120,004		$	212,898


	Six Months Ended June 30, 2020	Six Months Ended June 30, 2019
Weighted Average Remaining Lease Term
Operating leases	2 Years	3 Years
Finance leases	1 Year	1 Year

Weighted Average Discount Rate
Operating leases	4.75%	4.75%
Finance leases	4.75%	4.75%


	Three Months Ended June 30,				Change from Prior Year			% of Sales
	2020		2019		$		%	2020	2019
Sales
Domestic	$	6,745,810	$	4,569,226	$	2,176,584	47.6%	87.5%	85.4%
International		963,094		779,586		183,508	23.5%	12.5%	14.6%
Total	$	7,708,904	$	5,348,812	$	2,360,092	44.1%


	Three Months Ended						Six Months Ended
Reconciliation of GAAP Net (Loss)/Income	June 30,						June 30,
to Non-GAAP Adjusted EBITDA:	2020			2019			2020			2019
GAAP Net (Loss)/Income	$	(1,076,038	)	$	78,183		$	(626,610	)	$	(7,207	)
Tax Expense		30,919			24,683			172,847			2,584
Depreciation/Amortization		94,940			86,169			182,164			169,820
Interest Expense/(Income), Net		5,002			(18,243	)		(14,028	)		(35,723	)
Reorganization Charges		—			—			—			354,926
Discontinued Product Expenses		(31,581	)		—			77,977			—
Litigation Expenses		2,346,914			1,124,947			2,446,072			1,617,462
Manufacturing Initiative Expenses		25,957			—			135,759			—
Stock Option Expense		363,851			194,765			664,817			316,640
Non-GAAP Adjusted EBITDA	$	1,759,964		$	1,490,504		$	3,038,998		$	2,418,502