KORU Medical Systems (NASDAQ:KRMD) reported second-quarter revenue of $12 million, up 18% from a year earlier, as domestic patient starts, market-share gains and international demand supported growth. The company also said it achieved positive net income for the first time since 2019 and raised its full-year gross-margin outlook, while narrowing revenue guidance because certain international prefilled-syringe market launches are taking longer to develop than expected.
President and CEO Adam Kalbermatten, reporting his first quarter in the role, said revenue rose 20% during the first half of 2026. He described KORU as serving approximately 60,000 chronic and recurring immunoglobulin, or IG, patients through its Freedom Infusion System and said the company is positioned to benefit as subcutaneous drug delivery shifts from hospitals toward infusion centers and home settings.
Revenue growth led by domestic and international core business
International core revenue increased 59% to $3.5 million. Adams attributed the increase to growth in established markets, as well as distributor volumes supporting a European conversion to prefilled syringe formats. Kalbermatten said the company has seen both pump and consumables demand from distributors supporting those conversions.
Pharma Services and Technology, or PST, revenue was $600,000, down 35% from the prior-year period. Adams said the decline reflected lower clinical-trial orders because of customer order timing, and reiterated that PST revenue can vary meaningfully between quarters based on pharmaceutical customer timelines.
Gross margin was 65.1%, compared with 63.5% a year earlier. Adams cited manufacturing productivity and efficiency gains, higher average selling prices and a favorable customer mix. He also said KORU extended a key supplier contract under a multiyear agreement that provided improved pricing expected to support further margin expansion as the business grows.
The company ended the quarter with $8.3 million in cash, reflecting approximately $500,000 in cash usage during the period. Adams said KORU generated positive cash flow from operations during what management had expected to be its highest cash-use quarter, while also completing its technology asset acquisition. The company also has an unused $10 million debt facility, though it did not draw on that facility to fund the acquisition.
International timing prompts narrower revenue outlook
KORU narrowed its full-year revenue outlook to a range of $47.5 million to $48.5 million. Management previously expected the second half to carry more of the year’s growth, largely due to new prefilled-syringe geographies ramping up.
Kalbermatten said some non-tender international markets require the company to establish distribution, reimbursement and home-care relationships before volumes can build. In tender markets, pharmaceutical wins can convert volume quickly, he said, while competitive markets require more gradual patient-by-patient conversions similar to the U.S. market.
“Unlocking this opportunity is simply taking us a little longer than forecasted in our assumptions,” Kalbermatten said.
Adams said KORU now expects to recognize the opportunity in certain markets more meaningfully in 2027 rather than in the second half of 2026. Management characterized the revision as primarily related to timing and said the broader European prefilled-syringe conversion trend remains favorable.
At the same time, KORU raised full-year gross-margin guidance to 62% to 64%, from 61% to 63%, following the supplier agreement. The company now expects year-end cash to exceed $7.5 million, reflecting the connected-technology acquisition and related research-and-development staffing costs. It reaffirmed expectations for positive adjusted EBITDA for the full year.
Connected technology acquisition and pipeline updates
During the quarter, KORU acquired a connected monitoring technology asset intended to add data and connectivity capabilities to its mechanical infusion systems. Kalbermatten said the technology could eventually support patient communication, infusion data collection, adherence tracking and real-world evidence for specialty pharmacies and pharmaceutical partners.
He emphasized that the initiative remains a multiyear build and is still in early stages. Management said connected capabilities could be especially valuable in clinical trials by providing real-time dosing data and supporting trial integrity and reimbursement evidence.
KORU also withdrew its U.S. Food and Drug Administration 510(k) submission seeking use of the Freedom system with PHESGO. Kalbermatten said discussions with the FDA identified considerations related to the PHESGO drug label that made other high-volume oncology biologics more attractive for the company’s initial U.S. oncology entry.
The company said its conviction in the oncology opportunity remains unchanged, but its U.S. entry is likely to shift from the previously anticipated second-half timing as it evaluates alternative molecules. KORU continues to pursue PHESGO internationally, where management said it sees a compelling long-term opportunity and where annual infusion volumes are higher than in the U.S.
KORU’s active 510(k) submission for deferoxamine remains under FDA review. Management said clearance could support an estimated 200,000 annual U.S. infusions. The company also said development of its next-generation Freedom 360 pump has completed its final higher-risk stages and remains on track for a 510(k) submission by the end of 2027.
Longer-term growth priorities
Management highlighted secondary immunodeficiencies as a potential future catalyst for its SCIg business. Kalbermatten said several pharmaceutical companies are conducting pivotal trials involving patients who develop immunodeficiencies after treatments such as chemotherapy, cell therapies and immunosuppressive drugs. He said trial endpoints are expected over the next 12 to 18 months, while an analyst discussion referenced some trial endpoints toward the end of 2027.
KORU said many of the SCIg drugs used in those trials are already on its label, potentially allowing the company to serve additional patients if new indications receive approval and reimbursement coverage expands.
Kalbermatten reiterated KORU’s long-term targets of $100 million in revenue, gross margin above 65% and EBITDA margin of 20% or greater. He said the company’s strategy remains centered on domestic IG growth, international expansion and adding new therapies through pharmaceutical partnerships.
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.
