KORU Medical Systems (NASDAQ:KRMD) reported fourth-quarter and full-year 2025 results that management said reflected continued share gains in its core subcutaneous immunoglobulin (SCIG) business, accelerating international growth, and progress expanding its Freedom Infusion System platform into additional therapies.
Leadership transition announced
On the call, President and CEO Linda Tharby said she will retire and resign as CEO effective June 13, and that Chief Commercial Officer Adam Kalbermatten has been selected as her successor. Tharby said she will remain on KORU’s board and serve in an advisory capacity through the end of 2026. Kalbermatten will be appointed president effective March 15 and is expected to assume the CEO role on July 1.
Revenue growth outpaced the SCIG market
Management said both domestic and international core businesses outperformed the underlying SCIG market, which it estimated grew about 10% in 2025. In the fourth quarter, domestic core grew 18% and international core grew 71%, supported by a recurring base of approximately 59,000 patients. Tharby said the company’s global chronic SCIG patient base on the Freedom system increased about 20% during the year.
International expansion driven by prefilled syringe conversions
KORU highlighted strong momentum in Europe, where Tharby described a roughly $50 million SCIG pump and consumables market. The company said it grew its European share from about 10% in 2024 to about 20% in 2025, with much of the share gain driven by a prefilled syringe conversion in a major European market. Tharby emphasized that the shift from vials to prefilled syringes can simplify administration, citing up to an 80% reduction in drug preparation tasks.
As a key regulatory milestone, KORU said it received EU MDR certification for the Freedom60 with prefilled syringe compatibility. Combined with an earlier MDR clearance for FreedomEDGE, management said it now has two cleared pumps for prefilled administration in Europe and has begun shipping the updated Freedom60 into the market.
In Q&A, Tharby said the prefilled rollout is expected to expand across several existing geographies where KORU already operates but has relatively low penetration. She said the company started 2026 with a second market “going live” and expects “a new market being added one to two every quarter” as the year progresses.
Platform expansion beyond immunoglobulin, including RYSTIGGO and oncology filing
KORU also highlighted progress expanding beyond SCIG. Tharby said the company received 510(k) clearance in January for RYSTIGGO on the Freedom Infusion System, marking the ninth drug cleared on the platform and the second non-immunoglobulin clearance. Management said the clearance supports its strategy to expand beyond IG and opens a channel in infusion clinics.
On the call, management described RYSTIGGO as indicated for generalized myasthenia gravis and cited UCB’s public reporting that it reached more than 2,400 gMG patients globally by the end of 2025. Tharby said KORU projects its U.S. market opportunity at about 20,000 infusions in 2025, growing to more than 100,000 infusions in 2030. Executives noted that RYSTIGGO had already been used off-label with the Freedom system, and the clearance enables more proactive commercial efforts.
Tharby also said KORU filed a 510(k) in the fourth quarter for Roche’s Phesgo and is “anticipating entry into the oncology market in the second half of 2026.” In closing remarks, she reiterated that RYSTIGGO and the Phesgo filing represent two non-IG drugs moving toward commercial potential in 2026.
Financial results, margin drivers, and 2026 outlook
Chief Financial Officer Tom Adams said fourth-quarter revenue rose 23% year over year to $10.9 million. Domestic revenue growth of 18% was driven by new patient starts and market share gains, while international revenue growth of 71% was fueled by new patient starts and greater penetration in established European markets, with prefilled conversions a key tailwind.
Adams said the company’s PST (pharmaceutical services and clinical trials) business declined 30% year over year in the quarter due to timing of milestone-based revenue recognition. He emphasized that the decline reflected milestone timing rather than a reduction in the activity level of KORU’s collaboration portfolio.
Gross margin in the fourth quarter declined 30 basis points from the prior year, which Adams attributed to higher material costs and tariffs, mostly offset by a stronger customer mix in the U.S. The company reported full-year gross margin of 62.3%, with year-over-year pressure from packaging costs, tariff-related charges, and geographic sales mix due to growing international revenue.
KORU ended 2025 with $8.9 million in cash, and Adams said the company achieved positive cash flow from operations in the third and fourth quarters and for the full year. He also said operating expenses increased just 3% for the year despite 22% revenue growth, and that KORU generated positive adjusted EBITDA of $600,000, a 124% improvement versus the prior year and the third consecutive quarter of positive adjusted EBITDA.
For 2026, management initiated revenue guidance of $47.5 million to $50 million, implying growth of 15% to 22%, with expected gross margin of 61% to 63%. The company also guided for positive adjusted EBITDA and positive cash flow for the full year. Adams said key revenue drivers include continued U.S. and international share gains in SCIG, non-recurring engineering revenue from at least four new collaborations (two already signed), and modest incremental revenue from recent or expected 510(k) clearances. Management said it also incorporated some geopolitical risk tied to recent events in the Middle East.
In discussing cadence, Adams said 2025’s first half benefited from a prefilled inventory build in a key EU market that is not expected to repeat at the same level in 2026, while management anticipates a ramp in the back half of 2026 tied to revenue recognition from 510(k) clearances and additional prefilled syringe introductions in new geographies.
Looking ahead, Tharby outlined 2026 milestones including expected 510(k) and MDR submissions for the next-generation Freedom360 pump and a projected Precision Flow Rate Tubing submission in late 2026 or early 2027. She also said KORU anticipates two additional 510(k) submissions in 2026 for deferoxamine and vancomycin.
About KORU Medical Systems (NASDAQ:KRMD)
KORU Medical Systems, Inc develops and manufactures medical devices and supplies in the United States and internationally. It offers the freedom infusion systems to deliver life-saving therapies to patients with chronic illnesses, such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, and paroxysmal nocturnal hemoglobinuria. Its products include the FREEDOM60 syringe infusion system, the FreedomEdge syringe driver, HIgH-Flo subcutaneous safety needle sets, and precision flow rate tubing products.
