KORU Medical Systems, Inc. reported preliminary unaudited results for the fourth quarter and full year ended December 31, 2025, showing a 23% year‑over‑year increase in Q4 revenue to $10.9 million from $8.9 million in 2024, and a 22% rise in full‑year revenue to $41.1 million from $33.7 million in 2024. The growth was driven by continued strength in the core immunoglobulin business and an expanding recurring patient base, which together offset modest headwinds in legacy product lines.
The company ended the year with $8.9 million in cash and generated positive operating cash flow for both the quarter and the full year, marking a milestone in its financial health. Positive cash flow indicates that the company’s core operations are generating sufficient cash to fund ongoing growth and strategic initiatives without relying on external financing.
KORU also announced a 510(k) submission for the Freedom Infusion System with Phesgo®, a co‑formulated therapy for HER2+ breast cancer. The submission represents a strategic move into oncology, expanding the company’s product portfolio beyond immunoglobulin and positioning it to capture a new, high‑growth market. The company expects FDA clearance and a market launch in the coming months, which could open a significant revenue stream.
Management indicated that final Q4 and full‑year 2025 results, along with 2026 guidance, will be released in early March 2026. The timing of the guidance release signals the company’s confidence in its current performance trajectory and its readiness to provide investors with a clearer outlook for the next fiscal year.
President and CEO Linda Tharby said, “We delivered strong fourth‑quarter results and enter 2026 with solid momentum, driven by continued strength in our core immunoglobulin business and growth in our recurring patient base. Our international expansion strategy is on track, and our recent 510(k) submission for clearance of the Freedom Infusion System for use with Phesgo® represents a key milestone in expanding beyond Ig into oncology. With continued disciplined execution on all aspects of our strategy, we are positioned well for sustainable growth in 2026 and beyond.”
Segment analysis shows that the core immunoglobulin business remains the largest revenue driver, while the newly launched oncology segment is expected to contribute incremental revenue as the product gains market acceptance. The company’s Pharma Services and Clinical Trials segments also contributed to overall growth, reflecting a diversified revenue mix that supports long‑term stability.
Gross margin for Q3 2025 was 60.2%, a slight decline from 62.9% in Q4 2024, reflecting higher manufacturing costs and tariff‑related charges. Management expects margin improvement in Q4 2025 as the company benefits from scale and cost‑control initiatives, which should help offset the impact of rising input costs.
The results accelerate the company’s growth trajectory, with revenue growth outpacing the 18% increase seen in 2024. International expansion remains on track, and the oncology initiative provides a new tailwind that could offset competitive pressures in the immunoglobulin market. However, the company acknowledges ongoing tariff costs and potential supply‑chain constraints that could pose short‑term challenges. Overall, the earnings release signals robust execution and a clear path toward sustained growth in 2026 and beyond.
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