KORU Medical (NASDAQ: KRMD) Q1 2026 revenue jumps 22% as guidance held
Rhea-AI Filing Summary
KORU Medical Systems reported strong first quarter 2026 growth while remaining modestly loss-making. Net revenues rose 22.1% to $11.8 million, driven by 11.7% domestic core growth to $7.7 million, 35.2% international core growth to $3.3 million, and 166.0% growth in pharma services and clinical trials to $0.7 million.
Gross profit increased to $7.2 million, though gross margin slipped to 61.5% from 62.8% due to higher production costs and tariff-related charges. Net loss improved to $0.8 million, or $0.02 per diluted share, from $1.2 million, or $0.03 per diluted share, with adjusted EBITDA near breakeven at negative $0.01 million.
Cash and cash equivalents were $8.8 million as of March 31, 2026, with minimal cash usage of about $0.1 million in the quarter. The company reiterated full-year 2026 guidance for net revenues of $47.5–$50.0 million, gross margin of 61–63%, and positive adjusted EBITDA and positive cash flow.
Positive
- Revenue growth and improving profitability: Q1 2026 net revenues grew 22.1% to $11.8 million, while net loss narrowed to $0.8 million and adjusted EBITDA improved to nearly breakeven at negative $0.01 million.
- Reaffirmed full-year 2026 outlook: The company reiterated guidance for $47.5–$50.0 million in net revenues (15%–22% growth), gross margin of 61%–63%, and positive adjusted EBITDA and cash flow for 2026.
Negative
- None.
Insights
Q1 2026 shows 22% revenue growth, improving losses, and confirmed full-year outlook.
KORU Medical delivered net revenues of $11.8M, up 22.1% year over year, with especially strong contributions from international core sales and pharma services and clinical trials. Gross profit rose to $7.2M, while gross margin eased to 61.5% due to higher production costs and tariff-related charges.
Operating expenses increased 11.0% to $8.1M, mainly from higher legal and compensation costs, but net loss still improved to $0.8M from $1.2M. Adjusted EBITDA was close to breakeven at negative $0.01M, and cash usage was limited, with cash and equivalents at $8.8M as of March 31, 2026.
The company reaffirmed 2026 guidance for net revenues of $47.5–$50.0M, gross margin of 61–63%, and positive adjusted EBITDA and cash flow for the year. Future quarterly updates for fiscal 2026 will show whether growth in international markets and pharma services sustains this trajectory.
8-K Event Classification
Key Figures
Key Terms
adjusted EBITDA financial
adjusted diluted EPS financial
Pharma Services and Clinical Trials financial
510(k) application regulatory
SCIg market medical
Earnings Snapshot
Full-year 2026 net revenues of $47.5–$50.0M, gross margin of 61–63%, and positive adjusted EBITDA and positive cash flow.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
(a) Public Announcement or Release.
On May 6, 2026, KORU Medical Systems, Inc. (the “Company”) issued a press release announcing its financial results for the first fiscal quarter ended March 31, 2026 and reiterating 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 May 6, 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 depreciation and amortization, interest (income), net, litigation expense 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 share for depreciation and amortization, interest (income), net, litigation expense 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 diluted EPS as a supplemental internal measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.
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 May 6, 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: May 6, 2026 | By: | /s/ Linda Tharby |
| Linda Tharby Chief Executive Officer | ||
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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 ($0.00) per diluted share in the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS to the most directly comparable GAAP measures is provided at the end of this press release.
Cash and cash equivalents were $8.8 million as of March 31, 2026, reflecting cash usage of $0.1 million in the first quarter of 2026.
Reiterating 2026 Guidance
KORU Medical expects:
| ● | Reiterating full year 2026 net revenues between $47.5 - $50.0 million representing growth of 15% - 22% |
| ● | Reiterating full year 2026 gross margin between 61 - 63% |
| ● | Reiterating positive adjusted EBITDA and positive cash flow for the full year 2026 |
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, May 6, 2026, 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.
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 Systems 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™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.
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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, financial guidance and expected operating performance for fiscal 2026. 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” 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 inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction and adoption 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 our research and development effort, expanding the market of the Freedom System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the impact of recent accounting pronouncements, 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, 2025, 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 May 6, 2026. 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
| March 31, | December 31, | ||||||
| 2026 | 2025 | ||||||
| (UNAUDITED) | |||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 8,767,774 | $ | 8,872,212 | |||
| Accounts receivable | 5,982,536 | 6,209,950 | |||||
| Inventory, net | 4,476,304 | 3,678,131 | |||||
| Other receivables | 335,206 | 319,955 | |||||
| Prepaid expenses | 1,026,614 | 908,542 | |||||
| TOTAL CURRENT ASSETS | 20,588,434 | 19,988,790 | |||||
| Property and equipment, net | 4,335,882 | 4,471,386 | |||||
| Intangible assets, net of accumulated amortization of $545,302 and $527,949 as of March 31, 2026 and December 31, 2025, respectively | 711,211 | 684,841 | |||||
| Operating lease right-of-use assets | 2,857,341 | 2,956,192 | |||||
| Other assets | 98,970 | 98,970 | |||||
| TOTAL ASSETS | $ | 28,591,838 | $ | 28,200,179 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable | $ | 2,635,701 | $ | 2,267,473 | |||
| Accrued expenses | 5,271,100 | 4,828,830 | |||||
| Other liabilities | 11,068 | 27,722 | |||||
| Accrued payroll and related taxes | 385,890 | 531,972 | |||||
| Financing lease liability | 126,323 | 124,913 | |||||
| Operating lease liability | 421,727 | 413,448 | |||||
| TOTAL CURRENT LIABILITIES | 8,851,809 | 8,194,358 | |||||
| Financing lease liability, net of current portion | 46,560 | 78,675 | |||||
| Operating lease liability, net of current portion | 2,771,115 | 2,879,224 | |||||
| TOTAL LIABILITIES | 11,669,484 | 11,152,257 | |||||
| STOCKHOLDERS’ EQUITY | |||||||
| Common stock, $0.01 par value, 75,000,000 shares authorized, 49,933,502 and 49,790,934 shares issued 46,133,000 and 46,370,432 shares outstanding as of March 31, 2026, and December 31, 2025, respectively | 499,335 | 497,909 | |||||
| Additional paid-in capital | 54,795,722 | 52,449,339 | |||||
| Treasury stock, 3,818,526 and 3,438,526 shares as of March 31, 2026 and December 31, 2025, respectively, at cost | (5,548,793 | ) | (3,882,494 | ) | |||
| Accumulated deficit | (32,823,910 | ) | (32,016,832 | ) | |||
| TOTAL STOCKHOLDERS’ EQUITY | 16,922,354 | 17,047,922 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 28,591,838 | $ | 28,200,179 | |||
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KORU MEDICAL SYSTEMS, INC.
STATEMENTS OF OPERATIONS
(UNAUDITED)
| Three Months Ended | |||||||
| March 31, | |||||||
| 2026 | 2025 | ||||||
| NET REVENUES | $ | 11,764,624 | $ | 9,635,075 | |||
| Cost of goods sold | 4,533,235 | 3,588,740 | |||||
| Gross Profit | 7,231,389 | 6,046,335 | |||||
| OPERATING EXPENSES | |||||||
| Selling, general and administrative | 6,582,178 | 5,959,374 | |||||
| Research and development | 1,316,603 | 1,114,609 | |||||
| Depreciation and amortization | 197,531 | 217,357 | |||||
| Total Operating Expenses | 8,096,312 | 7,291,340 | |||||
| Net Operating Loss | (864,923 | ) | (1,245,005 | ) | |||
| Non-Operating Income/(Expense) | |||||||
| Gain/(Loss) on currency exchange | (23,150 | ) | 5,588 | ||||
| Interest income, net | 80,995 | 73,180 | |||||
| TOTAL OTHER INCOME | 57,845 | 78,768 | |||||
| LOSS BEFORE INCOME TAXES | (807,078 | ) | (1,166,237 | ) | |||
| Income Tax Refund (Expense) | — | — | |||||
| NET LOSS | $ | (807,078 | ) | $ | (1,166,237 | ) | |
| NET LOSS PER SHARE | |||||||
| Basic & Diluted | $ | (0.02 | ) | $ | (0.03 | ) | |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |||||||
| Basic & Diluted | 46,364,905 | 45,981,826 | |||||
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KORU MEDICAL SYSTEMS, INC.
STATEMENTS OF CASH FLOWS
(UNAUDITED)
| For the Three Months Ended |
|||||||
| March 31, | |||||||
| 2026 | 2025 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
| Net Loss | $ | (807,078 | ) | $ | (1,166,237 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Stock-based compensation expense and warrant expense | 681,510 | 697,590 | |||||
| Depreciation and amortization | 197,531 | 217,357 | |||||
| Non-cash leasing charges | (979 | ) | — | ||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 227,414 | (228,661 | ) | ||||
| Inventory | (798,173 | ) | (474,977 | ) | |||
| Prepaid expenses and other assets | (133,323 | ) | (8,094 | ) | |||
| Other liabilities | (16,655 | ) | 80,828 | ||||
| Accounts payable | 368,228 | 363,608 | |||||
| Accrued payroll and related taxes | (146,081 | ) | 227,316 | ||||
| Accrued expenses | 442,269 | 53,803 | |||||
| NET CASH FROM/(USED IN) OPERATING ACTIVITIES | 14,663 | (237,467 | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
| Purchases of property and equipment | (46,163 | ) | (443,438 | ) | |||
| Purchases of intangible assets | (43,722 | ) | (3,400 | ) | |||
| NET CASH USED IN INVESTING ACTIVITIES | (89,885 | ) | (446,838 | ) | |||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
| Payments on insurance finance indebtedness | — | (133,973 | ) | ||||
| Payments on finance lease liability, net of asset | (29,216 | ) | (26,835 | ) | |||
| NET CASH USED IN FINANCING ACTIVITIES | (29,216 | ) | (160,808 | ) | |||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (104,438 | ) | (845,113 | ) | |||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 8,872,212 | 9,580,947 | |||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 8,767,774 | $ | 8,735,834 | |||
| Supplemental Information | |||||||
| Cash paid during the periods for: | |||||||
| Interest | $ | 2,155 | $ | 5,385 | |||
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KORU MEDICAL SYSTEMS, INC.
SUPPLEMENTAL INFORMATION
(UNAUDITED)
A reconciliation of our non-GAAP measures is below:
| Three Months Ended | |||||||
| Reconciliation of GAAP Net Loss | March 31, | ||||||
| to Non-GAAP Adjusted EBITDA: | 2026 | 2025 | |||||
| GAAP Net Loss | $ | (807,078 | ) | $ | (1,166,237 | ) | |
| Depreciation and Amortization* | 197,531 | 217,357 | |||||
| Interest (Income), Net | (80,996 | ) | (73,180 | ) | |||
| Litigation Expense | — | 133,411 | |||||
| Stock-based Compensation Expense* | 681,510 | 697,590 | |||||
| Adjusted EBITDA | $ | (9,032 | ) | $ | (191,059 | ) | |
| Weighted average number of common shares | 46,364,905 | 45,981,826 | |||||
| Three Months Ended | |||||||
| Reconciliation of Reported Diluted EPS | March 31, | ||||||
| to Non-GAAP Adjusted Diluted EPS: | 2026 | 2025 | |||||
| Reported Diluted Earnings Per Share | $ | (0.02 | ) | $ | (0.03 | ) | |
| Depreciation and Amortization* | 0.00 | 0.00 | |||||
| Interest (Income), Net | (0.00 | ) | (0.00 | ) | |||
| Litigation Expense | — | 0.00 | |||||
| Stock-based Compensation Expense* | 0.01 | 0.02 | |||||
| Adjusted Diluted Earnings Per Share | $ | (0.00 | ) | $ | (0.00 | ) | |
*Numbers presented are rounded to the nearest whole cent and percentage
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 options and restricted shares for executives, employees and consultants, and grants of 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.
Litigation Expense. We have excluded the effect of start-up litigation expense in calculating our non-GAAP measures. In the first quarter 2025 we incurred legal fees with respect to a claim filed by the Company alleging patent infringement, which we would not have otherwise incurred in the period presented as part of continuing operations.
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