MAHWAH, N.J. / May 07, 2025 / Business Wire / KORU Medical 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 first quarter ended March 31, 2025.

Recent Highlights

• First quarter 2025 net revenues of $9.6 million, an 18% increase over the prior year period
• Core business (Domestic and International) net revenues of $9.4 million, a 21% increase over the prior year period
• Gross profit of $6.0 million, a 19% increase over the prior year period, and gross margin of 62.8%, a 50-basis point improvement over the prior year period
• Ending cash balance of $8.7 million and quarterly cash usage of $0.8 million
• Announcing plans to submit for FDA 510(k) clearance for 2 commercialized drugs with the Freedom Infusion System™ in 2025
• Raising full year 2025 revenue guidance to $38.5 – $39.5 million from prior range of $38.0 - $39.0 million; reiterating full year gross margin guidance of 61% - 63%, and positive cash flow from operations for full year 2025

“We are off to a strong start this year, with over 20% growth in our core business driven by new patient starts and continued market share gains both domestically and internationally, all contributing to the expansion of our recurring revenue base,” said Linda Tharby, President and CEO of KORU Medical. “We are also advancing our novel therapies pipeline and announcing plans to submit two previously commercialized drugs for 510(k) clearance with the Freedom Infusion system by year-end. Despite a challenging macroeconomic backdrop, the positive momentum in our business gives us confidence in our ability to deliver through the remainder of the year, and we are raising our full-year revenue guidance accordingly.”

Total net revenues increased $1.4 million, or 17.5%, to $9.6 million for the three months ended March 31, 2025, as compared to $8.2 million in the prior year period. Domestic core revenues were $6.9 million, an increase of 16.4% over the prior year period, primarily due to higher pump and 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 $2.4 million, an increase of 35.6% over the prior year period, primarily due to higher pump and consumable volumes, driven by geographical expansion and a tender win with an Ig pharma partner. International growth was impacted by approximately $0.4 million of distributor stocking to support expansion, compared to $0.3 million of distributor stocking in the prior year as a result of the BSI regulatory review process. Pharma services and clinical trials net revenues were $0.3 million, a decrease of 38.6% over the prior year period, primarily due to lower clinical trial revenue.

Gross profit increased $0.9 million, or 18.5%, to $6.0 million in the three months ended March 31, 2025, as compared to $5.1 million in the prior year period. Gross margin increased to 62.8% in the three months ended March 31, 2025, as compared to 62.3% in the prior year period. The increase in gross margin was primarily driven by favorable changes in product revenue mix.

Total operating expenses for the first quarter of 2025 were $7.3 million, an increase of $0.2 million, or 3.2%, over the prior year period driven by increases in compensation-related expenses for temporary staff to support product development and legal fees, partially offset by lower severance and research and development expenses.

Net loss decreased $0.8 million in the three months ended March 31, 2025, as compared to the prior year period, primarily driven by an increase in gross profit of $0.9 million, driven by increased revenues, partially offset by operating expense increases of $0.2 million.

Adjusted EBITDA for the first quarter of 2025 was ($0.2) million, or ($0.00) per diluted share, compared to adjusted EBITDA of ($0.9) million, or ($0.02) per diluted share, for the for the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS is provided at the end of this press release.

Cash and cash equivalents were $8.7 million as of March 31, 2025, reflecting cash usage of $0.8 million in the first quarter of 2025.

2025 Guidance

• Raising full year 2025 net revenues guidance to $38.5 - $39.5, representing growth of 15% - 17% from prior range of $38.0 - $39.0 million
• Reiterating full year 2025 gross margin guidance of 61% - 63%
• Reiterating positive cash flow from operations 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, May 7, 2025, 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 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 Novel Therapies 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.

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, timing of 510(k) clearances and financial guidance for fiscal 2025. 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 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, tariffs 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 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which are 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 7, 2025. 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.

*Numbers presented are rounded to the nearest whole cent and percentage

Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. In 2024 and 2025 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 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 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.