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KORU Medical Systems Announces 2021 First Quarter Financial Results

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Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today reported financial results for the first quarter ended March 31, 2021.

First Quarter 2021 Summary:

  • Announced Linda Tharby, med-tech veteran, as President and CEO, effective April 12, 2021

  • Recorded solid net revenue of $5.4 million; robust sequential quarterly growth

  • Gross margin of 59.5%

  • Recorded a net loss of $1.3 million, including leadership change expenses totaling $1.3 million

"I am very excited and grateful for the opportunity to lead KORU Medical in its mission to improve the quality of life of home infusion patients around the globe," said Linda Tharby, KORU Medical's new CEO. "KORU Medical has built a leading market position in a growing home infusion space with its Freedom Integrated Infusion System. I look forward to working with our team in accelerating our growth potential, delivering innovation to our customers, and creating value for shareholders."

"In the first quarter of 2021, we faced difficult year-over-year quarterly revenue comparisons, which included several one-time purchases and a current year COVID-19 impact on new patient starts. I am encouraged by our strong sequential quarterly growth and increasing new pump placements, indicating newly diagnosed SCIg patients returning to pre-COVID levels."

First Quarter 2021 Financial Results

Net sales were $5.4 million for the three months ending March 31, 2021, a 14% decrease from $6.3 million in the same period of 2020, with strong sequential quarterly growth. The decrease was due principally to lower novel therapies sales compared to last year due to a non-recurring clinical trial, lower domestic core pump volume primarily due to ordering patterns, and a one-time pharmaceutical customer pump purchase in the prior year. Domestic core business also reflected a slowdown in the growth of new patient starts for SCIg therapy, as the COVID-19 pandemic continued to delay provider visits and new diagnoses.

International revenues were $1.0 million, flat with prior year.

Gross margin was 59.5% for the first quarter of 2021, roughly equivalent to the same period in 2020.

Total operating expenses for the first quarter of 2021 were $5.4 million, compared to $3.2 million for the same period in 2020. The $2.2 million increase was due principally to expenses of $1.3 million related to leadership changes, which included non-cash equity charges, as well as costs of $0.6 million associated with new hires in the second half of last year to support commercialization, business development, and medical affairs for the Company's novel therapies initiatives.

Net loss for the first quarter of 2021 was $1.3 million, or $(0.03) per diluted share, compared to a net gain of $0.4 million, or $0.01 per diluted share for the same period of 2020. Net loss for the first quarter of 2021 included $1.3 million of recent leadership change expenses, as noted above. On a non-GAAP basis, adjusted diluted earnings per share was $0.00 compared to $0.02 in the same period of 2020.

Non-GAAP adjusted EBITDA for the first quarter of 2021 was $(0.4) million, compared to $1.3 million in the first quarter of 2020.

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use specialty infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing and HIgH-Flo Subcutaneous Safety Needle Sets. These devices are used for infusions administered in the home and alternate care settings. For more information, please visit www.korumedical.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements. Forward-looking statements can be identified by words such as "may," "look forward" and "confidence." Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, uncertainties associated with the shift to increased healthcare delivery in the home, new patient diagnoses, customer ordering patterns and COVID-19, and those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, which is on file with the SEC and is available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of March 31, 2021. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law.

REPRO MED SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

March 31,

December 31,

2021

2020

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

26,774,720

$

27,315,286

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

8,058,824

6,829,772

Prepaid expenses

690,325

807,780

TOTAL CURRENT ASSETS

39,085,210

37,525,792

Property and equipment, net

1,154,368

1,167,623

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

19,812

TOTAL ASSETS

$

42,373,782

$

39,918,934

LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES

Accounts payable

$

1,915,523

$

624,920

Accrued expenses

1,755,800

2,610,413

Accrued payroll and related taxes

715,899

287,130

Finance lease liability – current

1,843

2,646

Operating lease liability – current

141,869

141,293

TOTAL CURRENT LIABILITIES

4,530,934

3,666,402

Operating lease liability, net of current portion

59,729

95,553

TOTAL LIABILITIES

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, 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

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

2,376,616

3,652,754

TOTAL STOCKHOLDERS' EQUITY

37,783,119

36,156,979

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

42,373,782

$

39,918,934

REPRO MED SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)

For the
Three Months Ended

March 31,

2021

2020

NET SALES

$

5,430,951

$

6,330,009

Cost of goods sold

2,199,097

2,541,799

Gross Profit

3,231,854

3,788,210

OPERATING EXPENSES

Selling, general and administrative

4,992,829

2,862,138

Research and development

336,841

256,025

Depreciation and amortization

115,473

87,224

Total Operating Expenses

5,445,143

3,205,387

Net Operating (Loss)/Profit

(2,213,289

)

582,823

Non-Operating (Expense)/Income

Loss on currency exchange

(15,717

)

(10,497

)

Gain on disposal of fixed asset

736

Interest income, net

9,771

19,030

TOTAL OTHER (EXPENSE)/INCOME

(5,210

)

8,533

(LOSS)/INCOME BEFORE TAXES

(2,218,499

)

591,356

Income Tax Benefit/(Expense)

942,361

(141,928

)

NET (LOSS)/INCOME

$

(1,276,138

)

$

449,428

NET (LOSS)/INCOME PER SHARE

Basic

$

(0.03

)

$

0.01

Diluted

$

(0.03

)

$

0.01

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

Basic

43,960,936

39,675,107

Diluted

43,960,936

39,874,989

REPRO MED SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

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

$

REPRO MED SYSTEMS, INC.

SUPPLEMENTAL INFORMATION

(UNAUDITED)

Three Months Ended

Reconciliation of Reported Diluted EPS to

March 31,

Non-GAAP Adjusted Diluted EPS:

2021

2020

Reported Diluted Earnings Per Share

$

(0.03

)

$

0.01

Reorganization Charges

0.02

Discontinued Product Expense

Litigation Expenses

Manufacturing Initiative Expenses

0.01

Reorganization Stock-based Compensation Expense

0.01

Tax (Expense) adjustment

Non-GAAP Adjusted Diluted Earnings Per Share

$

0.00

$

0.02

Three Months Ended

Reconciliation of GAAP Net (Loss)/Income

March 31,

to Non-GAAP Adjusted EBITDA:

2021

2020

GAAP Net (Loss)/Income

$

(1,276,138

)

$

449,428

Tax (Benefit)/Expense

(942,361

)

141,928

Depreciation/Amortization

115,473

87,224

Interest Income, Net

(9,771

)

(19,030

)

Reorganization Charges

969,274

Discontinued Product Expense

109,558

Litigation Expenses

99,158

Manufacturing Initiative Expenses

51,723

109,803

Stock-based Compensation Expense

734,184

360,968

Non-GAAP Adjusted EBITDA

$

(357,616

)

$

1,339,037

Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. We incurred significant expenses in connection with the departure and replacement of our chief executive officer and the recruiting of two new board members, which we would not have otherwise incurred in periods presented as part of our continuing operations.

Discontinued Product Expense. We have excluded the effect of expenses related to a discontinued product line in calculating our non-GAAP measures. We expected to retire our Res-Q-Vac product line towards the end of 2020, but due to the failure of equipment used to manufacture the product, the discontinuation and resulting expense was accelerated into the first quarter of 2020 which we would not have otherwise incurred in periods presented as part of our continuing operations. We did not incur any related expense in 2021.

Litigation. We have excluded litigation expenses in calculating our non-GAAP measures. Litigation expenses in 2020 included professional fees associated with our litigation with EMED, which discontinued as a result of the settlement on May 20, 2020.

Manufacturing Initiative Expenses. We have excluded the effect of expenses related to creating manufacturing efficiencies, in calculating our non-GAAP measures. We incurred expenses in connection with these initiatives which we would not have otherwise incurred in periods presented as part of our continuing operations. We expect to incur related expenses for the next nine to fifteen months.

Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expense related to grants of options for executives, employees and consultants, and grants of restricted shares to our board of directors. 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. Adjusted EBITDA for the three months ended March 31, 2021 included stock-based compensation expense of $0.4 million related to the departure and replacement of our chief executive officer. This expense is included in Reorganization Stock-based Compensation Expense in calculating Adjusted Diluted EPS.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210512005858/en/

Contacts

Investor Contact:
Greg Chodaczek
347-620-7010
investor@korumedical.com