8-K

KORU Medical Systems, Inc. (KRMD)

8-K 2024-08-07 For: 2024-08-07
View Original
Added on April 06, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the SecuritiesExchange Act of 1934

Date of Report (Date of earliest event reported)   August 7, 2024

KORU Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

Delaware 0-12305 13-3044880
(State or other jurisdiction<br><br>of incorporation) (Commission<br><br>File Number) (IRS Employer<br><br>Identification No.)
100 Corporate Drive, Mahwah, NJ 07430
--- ---
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code

(845) 469-2042

______________________________________________

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[_]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[_]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[_]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[_]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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.  [_]


ITEM 2.02   RESULTS OF OPERATIONS AND FINANCIALCONDITION.

On August 7, 2024, KORU Medical Systems, Inc. (“KORU Medical” or “we”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 2024. A related conference call will be held on August 7, 2024 at 4:30 pm Eastern Time.

KORU Medical is making reference to non-GAAP financial measures in both the press release and the conference call. Our management believes that investors’ understanding of KORU Medical’s performance is enhanced by disclosing the non-GAAP financial measures of Adjusted EBITDA and Adjusted EPS (each as defined below) as a reasonable basis for comparison of our ongoing results of operations. KORU Medical strongly encourages investors to review its consolidated financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by KORU Medical may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Non-GAAP measures should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. A reconciliation of GAAP to non-GAAP results is provided in the attached Exhibit 99.1 press release.

We define Adjusted EBITDA as earnings (net (loss)/income) before interest expense/(income), net, income tax (benefit)/expense, depreciation and amortization, reorganization charges, allowance for nonrealization of deferred tax assets, interest (income)/expense, net, and stock-based compensation expense. 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.

We present diluted earnings per share after eliminating items that we believe are not part of our ordinary operations and affect the comparability of the periods presented (“Adjusted EPS”). Adjusted EPS includes adjustments for income tax (benefit)/expense, depreciation and amortization, and stock-based compensation expense. We believe adjustments for these items allow investors to better understand our underlying operating results and facilitate comparisons between the periods shown. Management uses Adjusted EPS as a supplemental internal measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

ITEM 9.01   FINANCIAL STATEMENTS AND EXHIBITS.

Exhibits.

Exhibit No. Description
99.1 Press Release dated August 7, 2024
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES

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

KORU Medical Systems, Inc.<br><br>(Registrant)
Date:  August 7, 2024 By: /s/ Linda Tharby
Linda Tharby<br><br>President and Chief Executive Officer
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EXHIBIT 99.1

KORU MEDICAL SYSTEMS, INC. ANNOUNCES 2024Q2 FINANCIAL RESULTS, A RECORD QUARTER WITH 22% REVENUE GROWTH; RAISES FULL YEAR 2024 GUIDANCE

MAHWAH, NJ – August 7, 2024 – KORUMedical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today reported financial results for the second quarter ended June 30, 2024 and raised full year 2024 revenue and gross margin guidance.


Financial Highlights

Second quarter 2024 net revenues of $8.4 million, a 22% increase over the prior year with record-high quarterly revenues
Core business (U.S. and International) growth of 20% over the prior year driven by overall SCIg market growth, share gains, and geographic expansion
Gross profit of $5.5 million, a 41% increase over the prior year, and gross margin of 65%, reflecting year-over-year improvement of 890 basis points
Ending cash balance of $10.5 million and quarterly cash usage of $0.3 million driven by improved net income, increased operating leverage, and working capital improvements
Raising full year 2024 revenue guidance to $32.0-$32.5 million, representing year-over-year growth<br> of 12-14%; raising full year gross margin guidance to 61-62%

Business Highlights

Received regulatory clearance of FreedomEdge® Infusion System for use in Japan
Successfully passed feasibility for oncology biologic, progressing pathway to an infusion clinic entry in 2025
Entered Phase III clinical trial for an expanded nephrology indication expected to launch in 2026
Announced collaboration with SCHOTT Pharma to drive market expansion and optimize drug delivery in large volume subcutaneous infusion

“We delivered a great quarter, highlighted by strong double-digit growth, progress in our novel therapies pipeline and increased operating leverage,” said Linda Tharby, KORU Medical’s President and CEO. “Our US core business continues to capture share gains in a growing SCIg market. Internationally, we are increasing penetration and expanding in new geographies. We also continue to progress our novel therapies pipeline collaborations with a clear line of sight to multiple commercial launches over the next several years. We have accomplished this while also delivering on gross margin expansion and operating leverage. I’m proud of the KORU team and, as a result of our strong performance in the first half of 2024 and our confidence in continued execution moving forward, we are raising our full year 2024 revenue and gross margin guidance.”


2024 Second Quarter Financial Results

Three Months Ended June 30, Change from Prior Year % of Net Revenues
2024 2023 % 2024 2023
Net Revenues
Domestic Core $ 6,156,098 $ 5,388,172 14.3% 73.0% 77.7%
International Core 1,628,191 1,117,004 45.8% 19.3% 16.1%
Total Core 7,784,289 6,505,176 19.7% 92.3% 93.8%
Novel Therapies 645,800 430,754 49.9% 7.7% 6.2%
Total $ 8,430,089 $ 6,935,930 21.5% 100% 100%

All values are in US Dollars.

Total net revenues increased $1.5 million, or 21.5%, to $8.4 million for the three months ended June 30, 2024, as compared with the same period in 2023. Domestic core revenues increased by 14.3% to $6.2 million, primarily due to higher consumable and pump volumes driven by new patients starts and share gains. International core revenues increased by 45.8% to $1.6 million, primarily due to higher consumable and pump volumes driven largely by increased Ig supply, increased penetration within certain approved indications, and geographic expansion. International orders were expedited for certain distribution partners of $0.3 million in the second quarter of 2024 related to the BSI regulatory review process which has since been successfully appealed. Novel therapies net revenues increased by 49.9% to $0.6 million in the second quarter of 2024, primarily driven by Phase III clinical trial orders and milestone completion from our collaboration agreements.

Gross profit increased $1.6 million, or 41%, to $5.5 million in the three months ended June 30, 2024, compared to $3.9 million in the same period in 2023. Gross margin increased to 65.0% in the second quarter of 2024 compared to 56.1% in the second quarter of 2023.  The increase in gross margin was primarily driven by increased production efficiencies, favorable sales mix driven by clinical trial orders, and increased average selling prices when compared to the prior year period. We also had a positive inventory valuation adjustment of $0.1 million during the second quarter of 2024 which is not expected to recur in 2024.

Total operating expenses for the second quarter of 2024 were $6.7 million, a decrease of $0.4 million, or 6.2%, compared to $7.1 million in the prior year period driven primarily by a decrease of $0.5 million in research and development expenses primarily due to timing of project spend.

Net loss for the second quarter of 2024 was $1.0 million, or $(0.02) per diluted share, compared to a net loss of $2.5 million, or ($0.05) per diluted share, for the same period of 2023, primarily driven by an increase in gross profit of $1.6 million and an interest income of $0.1 million, partially offset by a decrease in tax benefit of $0.6 million and in operating expenses of $0.4 million. Adjusted EBITDA for the second quarter of 2024 was ($0.4) million, or ($0.01) per diluted share, compared to adjusted EBITDA of ($2.3) million, or ($0.04) per diluted share, for the same period of 2023. A reconciliation of adjusted EBITDA and adjusted diluted EPS is provided at the end of this press release.

Cash and cash equivalents were $10.5 million as of June 30, 2024, reflecting cash usage of $0.3 million in the second quarter of 2024.

2024 Guidance

Raising full year 2024 net revenue guidance to $32.0 - $32.5, representing growth of 12-14%; increased from previously issued guidance of $31.2 - $32.2 million, or 10% to 13%
Raising full year 2024 gross margin guidance to 61% - 62%; increased from previously issued guidance of 59% - 61%
Reaffirming guidance of 2024 year-end cash balance greater than $8.0 million and achieving cash flow breakeven in the fourth quarter of 2024 and cash flow positive for full year 2025

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, August 7, 2024, at 4:30 PM ET.

To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website.

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Non-GAAP Measures

This press release includes the non-GAAP financial measures “adjusted diluted EPS” and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. 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 KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release.


About KORU Medical Systems

KORU Medical develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The FREEDOM Syringe Infusion System (“the FREEDOM 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, including, but not limited to, oncology biologic clinic entry, launch an expanded nephrology indication, success of novel therapies collaborations and related commercial launches, financial guidance and expected operating performance for fiscal 2024. Forward-looking statements discuss the Company’s current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forward-looking statements can be identified by words such as “guidance”, “expect”, “plan”, “believe” and “will”. 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 SCIg market growth, prefilled syringe penetration, plasma supply, clinical trial activity and success, approval and commercialization of new drug indications, the Company’s EU certification, the shift to increased healthcare delivery in the home, new patient diagnoses, customer ordering patterns, global health crises, innovation and competition, labor and supply price increases, inflationary impacts, labor supply, 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, 2024 , which is on file with the SEC and 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 August 7, 2024. 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.

Investor Contact:

Louisa Smith

investor@korumedical.com

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KORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS

(UNAUDITED)

December 31,
2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents 10,458,001 $ 11,482,240
Accounts receivable less allowance for credit losses of 24,777 as of June 30, 2024 and December 31, 2023 5,846,082 4,045,211
Inventory 2,588,750 3,481,301
Other receivables 28,889
Prepaid expenses 472,864 1,218,288
TOTAL CURRENT ASSETS 19,365,697 20,255,929
Property and equipment, net 3,678,984 3,837,657
Intangible assets, net of accumulated amortization of 423,834 and 390,341 as of June 30, 2024 and December 31, 2023, respectively 745,084 754,361
Operating lease right-of-use assets 3,414,831 3,514,055
Deferred income tax assets, net of allowance for non-realization of deferred tax assets of 6,581,206 and 6,002,777 as of June 30, 2024 and December 31, 2023, respectively
Other assets 98,970 98,970
TOTAL ASSETS 27,303,566 $ 28,460,972
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable 1,595,691 $ 975,193
Accrued expenses 2,144,722 1,711,427
Note payable 314,344
Other liabilities 447,788 512,520
Accrued payroll and related taxes 444,251 462,941
Financing lease liability – current 112,689 109,540
Operating lease liability – current 391,699 368,313
TOTAL CURRENT LIABILITIES 5,136,840 4,454,278
Financing lease liability, net of current portion 259,479 316,623
Operating lease liability, net of current portion 3,202,697 3,336,300
TOTAL LIABILITIES 8,599,016 8,107,201
STOCKHOLDERS’ EQUITY
Common stock, 0.01<br>par value, 75,000,000 shares<br>authorized, 49,257,812 and 49,089,864<br>shares issued 45,819,286 and 45,669,362<br>shares outstanding as of June 30, 2024, and December 31, 2023, respectively 492,398 490,899
Additional paid-in capital 48,331,591 47,018,707
Treasury stock, 3,438,526 shares as of June 30, 2024 and December 31, 2023, at cost (3,882,493 ) (3,843,562 )
Accumulated deficit (26,236,946 ) (23,312,273 )
TOTAL STOCKHOLDERS’ EQUITY 18,704,550 20,353,771
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY 27,303,566 $ 28,460,972

All values are in US Dollars.

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KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)

Three Months Ended Six Months Ended
June 30, June 30,
2024 2023 2024 2023
NET REVENUES $ 8,430,089 $ 6,935,931 $ 16,627,887 $ 14,328,536
Cost of goods sold 2,950,339 3,047,807 6,044,839 6,293,377
Gross Profit 5,479,750 3,888,124 10,583,048 8,035,159
OPERATING EXPENSES
Selling, general and administrative 5,319,688 5,303,167 10,677,308 10,729,044
Research and development 1,134,232 1,596,614 2,609,907 3,161,483
Depreciation and amortization 217,864 212,919 449,233 426,036
Total Operating Expenses 6,671,784 7,112,700 13,736,448 14,316,563
Net Operating Loss (1,192,034 ) (3,224,576 ) (3,153,400 ) (6,281,404 )
Non-Operating Income/(Expense)
Loss on currency exchange (10,680 ) (2,472 ) (22,159 ) (3,152 )
Loss on disposal of fixed assets, net (300 ) (56,279 )
Interest income, net 213,999 131,167 251,186 256,669
TOTAL OTHER INCOME 203,319 128,695 228,727 197,238
LOSS BEFORE INCOME TAXES (988,715 ) (3,095,881 ) (2,924,673 ) (6,084,166 )
Income Tax Benefit 599,995 1,177,395
NET LOSS $ (988,715 ) $ (2,495,886 ) $ (2,924,673 ) $ (4,906,771 )
NET LOSS PER SHARE
Basic $ (0.02 ) $ (0.05 ) $ (0.06 ) $ (0.11 )
Diluted $ (0.02 ) $ (0.05 ) $ (0.06 ) $ (0.11 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
Basic 45,811,373 45,606,603 45,761,799 45,547,427
Diluted 45,811,373 45,606,603 45,761,799 45,547,427
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KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

For theSix Months Ended
June 30,
2024 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss $ (2,924,673 ) $ (4,906,771 )
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense and warrant expense 1,314,384 1,681,955
Depreciation and amortization 449,233 426,036
Deferred income taxes (1,177,395 )
Loss on disposal of fixed assets 300 56,279
Non-cash lease adjustments (10,994 ) (10,994 )
Changes in operating assets and liabilities:
Accounts receivable (1,800,871 ) (239,590 )
Inventory 892,551 1,126,643
Prepaid expenses and other assets 774,313 687,994
Other liabilities (64,731 ) 5,916
Accounts payable 620,498 (817,169 )
Accrued payroll and related taxes (18,691 ) (119,776 )
Accrued expenses 433,296 (1,527,648 )
NET CASH USED IN OPERATING ACTIVITIES (335,385 ) (4,814,520 )
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment (257,367 ) (375,246 )
Purchases of intangible assets (24,216 ) (17,298 )
NET CASH USED IN INVESTING ACTIVITIES (281,583 ) (392,544 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on insurance finance indebtedness (314,344 ) (433,295 )
Payments on finance lease liability (53,995 ) (48,493 )
Payments for taxes related to net share settlement of equity awards (38,932 )
NET CASH USED IN FINANCING ACTIVITIES (407,271 ) (481,788 )
NET DECREASE IN CASH AND CASH EQUIVALENTS (1,024,239 ) (5,688,852 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 11,482,240 17,408,257
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 10,458,001 $ 11,719,405
Supplemental Information
Cash paid during the periods for:
Interest $ 20,491 $ 20,165
Income taxes $ $ 3,160
Schedule of Non-Cash Operating, Investing and Financing Activities:
Issuance of common stock as compensation $ 221,182 $ 266,023
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KORU MEDICAL SYSTEMS, INC.

SUPPLEMENTAL INFORMATION

(UNAUDITED)

A reconciliation of our non-GAAP measures is below:

Three Months Ended Six Months Ended
Reconciliation of GAAP Net (Loss) June 30, June 30,
to Non-GAAP Adjusted EBITDA: 2024 2023 2024 2023
GAAP Net Loss $ (988,715 ) $ (2,495,886 ) $ (2,924,673 ) $ (4,906,771 )
Tax (Benefit)/Expense (189,754 ) (599,995 ) (578,429 ) (1,177,395 )
Allowance for DTA 189,754 578,429
Reorganization Charges 99,329
Depreciation and Amortization 217,864 212,919 449,233 426,036
Interest (Income)/Expense, Net (213,999 ) (188,126 ) (251,186 ) (256,669 )
Stock-based Compensation Expense 614,666 800,733 1,314,384 1,681,955
Non-GAAP Adjusted EBITDA $ (370,184 ) $ (2,270,355 ) $ (1,312,913 ) $ (4,232,844 )
Weighted average number of common shares 45,811,373 45,606,603 45,761,799 45,547,427
Three Months Ended Six Months Ended
--- --- --- --- --- --- --- --- --- --- --- --- ---
Reconciliation of Reported Diluted EPS June 30, June 30,
to Non-GAAP Adjusted Diluted EPS: 2024 2023 2024 2023
Reported Diluted Earnings Per Share $ (0.02 ) $ (0.05 ) $ (0.06 ) $ (0.11 )
Depreciation and Amortization 0.00 0.00 0.01 0.01
Stock-based Compensation Expense 0.01 0.02 0.03 0.04
Tax (Expense) Adjustment 0.00 (0.01 ) 0.00 (0.03 )
Non-GAAP Adjusted Diluted Earnings Per Share $ (0.01 ) $ (0.04 ) $ (0.02 ) $ (0.09 )

*Numbers presented are rounded to thenearest whole cent

Allowance for nonrealization of deferred tax assets(DTA). We have excluded the effect of recording a full valuation allowance on our deferred tax assets in the second quarter ended 2024 in the amount of $0.2 million. It was determined that no valuation allowance was

necessary in the second quarter ended 2023.

Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. In 2024 we incurred severance expenses related to the reorganization of the leadership team, which we would not have otherwise

incurred in periods presented as part of continuing operations.

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 expenses related to grants of equity-based awards for executives, employees, consultants, and directors. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but is expected to recur in future periods.

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