KRMD

EX-99

2 ex_99-1.htm

PRESS RELEASE, DATED MAY 6, 2026

EXHIBIT 99.1

KORU Medical Systems Announces First Quarter 2026 Results

MAHWAH, NJ – May 6, 2026 – KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today reported financial results for the first quarter ended March 31, 2026. The Company also reiterated guidance for the full year 2026.

Recent Highlights

● First quarter 2026 net revenues of $11.8 million grew 22% over the prior year period

● First quarter 2026 gross profit grew 20% over the prior year period to $7.2 million, with gross margin of 61.5%

● First quarter 2026 net loss improved 31% to ($0.8) million

● Ending cash balance of $8.8 million reflects cash usage of approximately $0.1 million in the first quarter of 2026

● Submitted 510(k) application for use of the Freedom Infusion System with deferoxamine

● Two existing non-Ig pharma collaborations advanced to Phase III clinical trials

“We are proud to deliver a record start to 2026, with $11.8 million in revenue, representing 22% growth,” said Linda Tharby, CEO of KORU Medical. “Our Core business continues to outperform the underlying SCIg market, driven increased share gains in current and new accounts. Internationally, momentum remains robust as we expand into prefilled syringe markets with our patient-preferred Freedom Infusion System. With a growing recurring patient base and scalable commercial model, Koru is well positioned for further success.”

Adam Kalbermatten, President and Chief Commercial Officer, added, "Equally exciting to our strength in core markets is the momentum we are building in new drug categories with our support of late-stage molecules through their regulatory pathways, including compelling oncology opportunities ahead. A strong team, a clear strategic roadmap, and an expanding platform to access new therapies and new geographies, makes me confident in our long-term strategy and the strong foundation we have built to execute."

2026 First Quarter Financial Results

Three Months Ending March 31,

Change from Prior Year

% of Net Revenues

2026

2025

$

%

2026

2025

Net Revenues

Domestic Core

$ 7,739,872

$ 6,927,964

$ 811,908

11.7%

65.8%

71.9%

International Core

3,284,041

2,428,662

855,379

35.2%

27.9%

25.2%

Total Core

11,023,913

9,356,626

1,667,287

17.8%

93.7%

97.1%

Pharma Services and Clinical Trials

740,711

278,449

462,262

166.0%

6.3%

2.9%

Total

$ 11,764,624

$ 9,635,075

$ 2,129,549

22.1%

100%

100%

Total net revenues increased $2.1 million, or 22.1%, to $11.8 million for the three months ending March 31, 2026, as compared to $9.6 million in the prior year period. Domestic core revenues were $7.7 million, an increase of 11.7% over the prior year period, primarily due to higher consumable volumes, driven by new patient starts and market share gains within new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $3.3 million, an increase of 35.2% over the prior year period, primarily due to higher pump and consumable volumes, driven by distributor purchases supporting pre-filled syringe (PFS) conversions for a key EU market. Pharma services and clinical trials net revenues were $0.7 million, an increase of 166.0% over the prior year period, primarily due to higher clinical trial product revenues for advancing existing collaborations.

Gross profit increased $1.2 million, or 19.6%, to $7.2 million in the three months ending March 31, 2026, as compared to $6.0 million in the prior year period. Gross margin decreased to 61.5% in the three months ending March 31, 2026, as compared to 62.8% in the prior year period. The decrease in gross margin was primarily driven by higher production costs based on timing of production runs in the prior quarter that were amortized in the three months ended March 31, 2026, and tariff-related charges that did not occur in the prior year period, partially offset by a favorable geographic sales mix.

Total operating expenses increased $0.8 million, or 11.0%, to $8.1 million for the first quarter of 2026 primarily driven by an increase of $0.6 million in selling, general, and administrative expenses, and an increase of $0.2 million in research and development expenses. The increase in selling, general and administrative expenses was primarily driven by increases in legal fees and compensation expenses related to salary and stock compensation, partially offset by lower temporary labor expenses.

Net loss decreased $0.4 million to $0.8 million or ($0.02) per diluted share for the first quarter of 2026, compared to a net loss of $1.2 million, or ($0.03) per diluted share, for the prior year period. Adjusted EBITDA for the quarter was ($0.01) million, or $0.00 per diluted share versus ($0.2) million or ($

Form 8-K

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2026-03-12 2026-03-12

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported)   March 12, 2026

KORU Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

Delaware 0-12305 13-3044880

(State or other jurisdiction

of incorporation) (Commission

File Number) (IRS Employer

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 FINANCIAL CONDITION.

(a)   Public Announcement or Release.

On March 12, 2026, KORU Medical Systems, Inc. (the “Company”) issued a press release announcing its financial results for the fourth fiscal quarter and full year ended December 31, 2025 and financial guidance for the fiscal year ended December 31, 2026. The Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A related conference call will be held on March 12, 2026 at 4:30pm 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 diluted 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 tax benefit and allowance for the utilization of tax benefit related to deferred tax assets, interest (income)/expense, net, depreciation and amortization, reorganization charges, tax expense (refund) 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 adjusted diluted earnings per share (“adjusted diluted EPS”) after eliminating items that we believe are not part of our ordinary operations and affect the comparability of the periods presented. Adjusted diluted EPS includes adjustments from reported diluted earnings per shar

Form 8-K

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0000704440

2026-01-12 2026-01-12

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported)   January 12, 2026

KORU Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

Delaware 0-12305 13-3044880

(State or other jurisdiction

of incorporation) (Commission

File Number) (IRS Employer

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 FINANCIAL CONDITION.

(a)   Public Announcement or Release.

On January 12, 2026, KORU Medical Systems, Inc. (the “Company”) issued a press release announcing certain preliminary financial results for the fiscal quarter and year ended December 31, 2025. The Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The preliminary financial results included in the press release are based on the Company’s current estimate of its results for the fiscal quarter and year ended December 31, 2025, and remain subject to change based on the completion of closing and review procedures.

The information contained in this Item 2.02 of the Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d)   Exhibits.

Exhibit No.

Description

99.1

Press Release, dated January 12, 2026

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.

(Registrant)

Date:  January 12, 2026 By: /s/ Linda Tharby

Linda Tharby

President and Chief Executive Officer

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