KORU Medical Systems Reports 27% Third Quarter Revenue Growth and Raises Full-Year 2025 Guidance
KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology firm dedicated to the development, manufacturing, and commercialization of patient-centric large-volume subcutaneous infusion solutions, today announced its financial results for the third quarter ended September 30, 2025. The Company delivered another strong performance marked by accelerating revenue growth, robust profitability improvements, and solid operational execution.
Third Quarter 2025 Highlights
- Net revenues of $10.4 million, a 27% year-over-year increase compared to the same period in 2024.
- Core business (Domestic and International) net revenues reached $9.8 million, up 30% from the prior-year period.
- Gross profit increased 21% to $6.3 million, with a gross margin of 60.2%.
- Net loss improved by 51% year-over-year to ($0.8) million, while adjusted EBITDA turned positive at $0.09 million, marking a 121% improvement over Q3 2024.
- Quarterly cash generation of $0.4 million, bringing the ending cash balance to $8.5 million.
- Two new Pharma Services and Clinical Trials (PST) collaborations were signed during the quarter, expanding access to new patient populations.
- Raised full-year 2025 revenue guidance to $40.5 – $41.0 million, representing 20% – 22% year-over-year growth, up from the prior range of $39.5 – $40.5 million.
- Reaffirmed full-year gross margin guidance of 61% – 63%, along with expectations for positive operating cash flow and an ending cash balance above $8.2 million.
Management Commentary
“During the third quarter, KORU Medical achieved another period of strong financial and operational execution,” said Linda Tharby, President and Chief Executive Officer of KORU Medical. “We delivered our second consecutive quarter of more than 20% revenue growth, driven by continued strength in our core subcutaneous immunoglobulin (SCIg) business. Importantly, we achieved positive adjusted EBITDA and generated cash, reflecting the scalability of our model and the discipline of our operational execution.”
Tharby continued, “We also expanded our pharmaceutical partnerships, entering two new collaborations that allow us to reach additional patient populations and further extend the use of our Freedom System across therapeutic categories. Looking ahead, our focus remains on accelerating revenue growth, advancing our innovation pipeline, expanding our international footprint, and developing strategic pharmaceutical collaborations that enable more patients globally to benefit from our technology.”
Detailed Third Quarter 2025 Financial Results
Net Revenues
For the three months ended September 30, 2025, total net revenues were $10.4 million, representing a 27.2% increase, or $2.2 million higher than the $8.2 million recorded in the third quarter of 2024.
| Revenue Segment | Q3 2025 | Q3 2024 | Change ($) | Change (%) | % of Total Revenue (2025) | % of Total Revenue (2024) |
|---|---|---|---|---|---|---|
| Domestic Core | $6,122,365 | $6,447,469 | ($325,104) | (5.0%) | 58.9% | 78.8% |
| International Core | $3,695,524 | $1,121,196 | $2,574,328 | 229.6% | 35.5% | 13.7% |
| Total Core | $9,817,889 | $7,568,665 | $2,249,224 | 29.7% | 94.4% | 92.5% |
| Pharma Services & Clinical Trials | $584,274 | $611,312 | ($27,038) | (4.4%) | 5.6% | 7.5% |
| Total | $10,402,163 | $8,179,977 | $2,222,186 | 27.2% | 100% | 100% |
Domestic Core
Domestic core revenues totaled $6.1 million, representing a 5.0% decline year-over-year. The decrease was primarily due to a U.S. distributor purchasing KORU products through one of the Company’s international distributors and subsequently reducing inventory levels. These factors were partially offset by continued market expansion through new patient starts and share gains in key accounts.
International Core
International core revenues surged 229.6% year-over-year to $3.7 million, compared to $1.1 million in Q3 2024. This sharp increase was primarily driven by strong distributor demand in strategic markets, particularly related to the transition from vial-based to prefilled systems, growth in existing markets from new patient initiations, and sales from international distributors into the U.S. to meet domestic demand.
Pharma Services and Clinical Trials (PST)
Revenues from pharma services and clinical trials were $0.6 million, down 4.4% compared to the prior year. The decline was attributed to timing variations in non-recurring engineering (NRE) work, which can fluctuate from quarter to quarter due to project-based activity inherent to this business segment.
Gross Profit and Margin
Gross profit rose to $6.3 million, a 20.8% increase compared to $5.2 million in Q3 2024. Despite the higher revenue, gross margin decreased to 60.2%, compared to 63.4% in the prior-year period.
The decline in gross margin was primarily driven by higher manufacturing costs, unfavorable geographic sales mix, and tariff-related expenses. Management expects gross margin improvement in the fourth quarter of 2025, reflecting pricing adjustments, continued operational efficiency, and a more balanced mix between domestic and international sales.
Operating Expenses
Operating expenses totaled $7.1 million, up 3.5%, or $0.2 million, from $6.9 million in Q3 2024. The increase was primarily due to:
- Higher compensation and benefits, including bonus accruals linked to stronger revenue performance,
- Increased legal and professional fees,
- Partially offset by lower research and development (R&D) costs due to the absence of prior-year severance charges and reduced project spending in the current period.
Net Income (Loss)
The Company reported a net loss of $0.8 million, a 51% improvement compared to a net loss of $1.6 million in Q3 2024. The improvement was mainly driven by:
- The $1.1 million increase in gross profit due to higher revenues,
- Partially offset by a modest increase in operating expenses.
Adjusted EBITDA
Adjusted EBITDA turned positive at $0.09 million, compared to ($0.4) million in the prior-year period, reflecting a 121% improvement. On a per-share basis, adjusted EBITDA was $0.00 per diluted share, compared to ($0.01) per diluted share in Q3 2024.
This improvement underscores the effectiveness of KORU Medical’s ongoing cost discipline, pricing optimization, and operational leverage as revenues continue to scale.
Cash Flow and Balance Sheet
KORU Medical ended the quarter with $8.5 million in cash and cash equivalents, an increase of $0.4 million compared to the prior quarter, reflecting positive cash generation during Q3 2025.
Management reaffirmed expectations for positive cash flow from operations for the full year 2025, with an ending cash balance above $8.2 million, underscoring the Company’s healthy liquidity position and prudent financial management.
Updated 2025 Financial Guidance
Following its strong third-quarter results, KORU Medical raised its full-year outlook for 2025 as follows:
- Net Revenues: Increased to $40.5 – $41.0 million, representing 20% – 22% year-over-year growth, up from the previous range of $39.5 – $40.5 million.
- Gross Margin: Reaffirmed guidance of 61% – 63% for full-year 2025.
- Cash Flow: Reiterated expectations for positive cash flow from operations and an ending cash balance exceeding $8.2 million.
The Company emphasized that its revised guidance reflects continued momentum in its core SCIg franchise, sustained international growth, and expanding contributions from pharma services collaborations.
Strategic Outlook
KORU Medical’s growth strategy is centered on four key priorities:
- Expanding its Core SCIg Business: Driving adoption of the Freedom Infusion System across new and existing accounts, while improving patient access through targeted partnerships and educational initiatives.
- Advancing Innovation: Continuing development of next-generation subcutaneous infusion technologies that improve patient comfort, convenience, and adherence.
- Global Expansion: Strengthening international distributor relationships and entering new geographies where demand for self-administered biologic therapies is rising.
- Pharmaceutical Collaborations: Partnering with biopharmaceutical companies to support drug delivery innovation and expand into new therapeutic areas beyond immunology.
Tharby concluded, “Our performance this quarter demonstrates that KORU Medical’s strategic investments are delivering measurable results. We are better positioned than ever to capture growth opportunities in the expanding home infusion and specialty drug markets.”
Conference Call and Webcast Information
KORU Medical will host a live conference call and webcast to review its third-quarter results and provide a corporate update on Wednesday, November 12, 2025, at 4:30 p.m. Eastern Time.
A replay of the webcast will be available following the event for investors unable to attend live.
Non-GAAP Financial Measures
This release includes certain non-GAAP financial measures, including “adjusted diluted EPS” and “adjusted EBITDA.” These metrics are not recognized under generally accepted accounting principles (GAAP) and may differ from similarly titled measures used by other companies.
KORU Medical defines adjusted EBITDA as net income (loss) excluding interest, taxes, depreciation, amortization, stock-based compensation, and other non-recurring items. These measures provide investors with supplemental insights into operational performance and cash generation, but should not be considered a substitute for GAAP results.
Reconciliations of these non-GAAP measures to their most directly comparable GAAP metrics are included in the financial tables accompanying the Company’s full press release.
About KORU Medical Systems
KORU Medical Systems, Inc. (NASDAQ: KRMD) is a U.S.-based medical technology company specializing in the development, manufacturing, and commercialization of innovative, patient-friendly infusion therapy solutions. Its flagship Freedom Infusion System provides large-volume subcutaneous delivery for immunoglobulin (IgG) therapies and other specialty biologics, enabling patients to safely self-administer treatments at home.
Through continuous innovation and strategic collaborations with pharmaceutical partners, KORU Medical is committed to improving patient quality of life, enhancing clinical outcomes, and expanding access to advanced infusion therapy worldwide. For more information, visit www.korumedical.com.
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