KORU Medical Systems NASDAQ: KRMD reported a “record start to the year” in the first quarter of 2026, posting revenue of $11.8 million, up 22% from the prior-year period, as the company pointed to domestic share gains in subcutaneous immunoglobulin (SCIg), accelerating international growth tied to prefilled syringe conversions, and continued progress expanding its infusion platform to additional drugs.
Leadership transition underway
Chief Executive Officer Linda Tharby opened the call by noting it would be her final earnings call as CEO. As previously announced, President and Chief Commercial Officer Adam Kalbermatten is slated to succeed her on July 1. Tharby said the transition “is well underway and is progressing extremely well,” adding that she has “great confidence in Adam’s leadership.”
Q1 revenue growth led by international and recurring consumables
Tharby said the quarter’s results reflected “the strength and consistency of a recurring revenue model business built on the foundation of approximately 60,000 patients on the KORU platform.” She highlighted 12% year-over-year growth in the Domestic Core business and 35% growth in International Core.
Chief Financial Officer Tom Adams attributed U.S. growth to “higher consumable volumes from new patient starts and market share gains within new and existing accounts against a healthy SCIg market backdrop.” International growth was driven by “higher pumps and consumable volumes in support of pre-filled syringe conversions in the EU market,” with Adams noting strong first-quarter distributor orders in a new 50 mL prefill market and an expectation that “end user pull-through of our consumables” would follow.
Adams also said PST revenues rose 166% from the prior-year period due to higher clinical trial product revenue from pharmaceutical collaborations. He cautioned that the PST business remains “variable based on milestone and clinical trial timing,” though he described underlying activity with pharmaceutical companies as high.
Margins, profitability, and cash usage
Gross margin was 61.5% for the quarter versus 62.8% a year earlier. Adams said the decline primarily reflected higher production costs related to the timing of production runs late in 2025 that were amortized in Q1, as well as “tariff-related charges that did not occur in the prior period.” He added that favorable geographic sales mix partially offset those impacts, and that excluding an 87-basis-point tariff effect, gross margin would have been 62.4%.
Despite the quarter’s tariff headwinds, Adams reiterated confidence in full-year gross margin guidance of 61% to 63%.
On profitability, Adams said net loss improved 33% to $800,000, while adjusted EBITDA was essentially break-even at negative $10,000, a 95% improvement year over year. Operating expenses increased 11% as the company continued to invest in sales and marketing and R&D “while maintaining spending discipline.”
Cash usage was minimal. Tharby said the company used only $100,000 in cash in the quarter, ending with $8.8 million in cash. Adams characterized cash flow from operations as “essentially break even,” and said Q2 is expected to be the heaviest cash usage quarter due to annual bonus payouts made in April. He reiterated expectations for positive cash flow in the back half of the year and noted the company has access to an unused $10 million debt facility for additional flexibility.
Strategy: domestic SCIg, international expansion, and adding drugs
Kalbermatten framed company priorities around three pillars: protecting and growing the domestic core business, expanding internationally, and adding more drugs to the Freedom Infusion System platform.
On the domestic side, Kalbermatten said the U.S. business continues to outperform the underlying SCIg market, supported by new patient diagnosis starts in legacy accounts and competitive conversions. In response to an analyst question, Adams cited third-party market data suggesting the U.S. SCIg market grew “right around 8%” in Q1, while KORU outpaced that rate.
Kalbermatten also discussed the company’s rollout tied to recent clearance for RYSTIGGO on KORU’s label, noting clinical evaluations are underway with specialty pharma companies. He said incremental revenue contribution from RYSTIGGO this year is expected to be “modest,” but described the launch as an entry point into the ambulatory infusion clinic channel because RYSTIGGO is administered in both home and clinic settings.
Kalbermatten highlighted secondary immunodeficiency (SID) as an emerging opportunity, noting that outside the U.S., SID is already a priority for major pharma players and that several pivotal trials are expected to reach endpoints in 2027. He said expanded reimbursement could broaden the U.S. SCIg opportunity and that SID growth has been tracking ahead of the broader SCIg market, currently driven primarily by immunologists.
Internationally, Kalbermatten said the company’s growth has been led by SCIg and that KORU is establishing a footprint intended to support expansion into non-IG drugs over time. He said key EU markets are coming online in 2026 through manufacturer-driven vial-to-prefilled syringe conversions, but warned growth rates could be variable as the company deepens its capabilities across reimbursement, pharmaceutical, and home care partnerships. In Q&A, he said KORU is tracking conversion activity across five countries the company has previously identified as large-volume prefilled syringe markets.
Pipeline updates: phase III progress, regulatory submissions, and oncology focus
Management also detailed progress on expanding beyond immunoglobulin (IG). Tharby said two existing pharma collaborations advanced assets within phase III clinical trials, including one for an expanded indication and another that restarted trials for a new drug application. Kalbermatten said KORU now has eight active non-IG opportunities in development, which together represent “more than 6 million annual infusions worldwide.”
- Kalbermatten said Apellis advanced EMPAVELI into phase III trials for its fourth indication (delayed graft function), which he estimated represents an additional 25,000 annual infusions across a pediatric patient base.
- He said an undisclosed partner reinitiated phase III clinical trials on another asset that KORU believes represents 500,000 annual infusions annually.
- Tharby and Kalbermatten said KORU submitted a 510(k) application in Q1 for use of the Freedom Infusion System with deferoxamine, which Kalbermatten estimated at approximately 200,000 annual infusions.
- Kalbermatten said the company removed vancomycin from its active development pipeline after assessing market opportunity, current usage, and the “risk of an infusion to the central artery,” adding the incremental 2026 revenue previously expected from vancomycin had been modest.
On oncology, Kalbermatten said the company is in “active communication with the FDA” regarding its PHESGO submission and is also in early discussions around an additional high-volume oncology asset. In Q&A, he described oncology as “almost a $40 million market opportunity” today that could grow over the next five years to “over $120 million,” and estimated PHESGO alone at approximately 1.1 million to 1.2 million units per year. He said the company hopes to provide an update on PHESGO “towards the end of this year, hopefully in the next quarter.”
Kalbermatten also said KORU plans to submit a 510(k) and MDR applications in 2026 for the next generation Freedom60 pump and is targeting submission of a flow controller in late 2026 or early 2027. In response to a question, he said the next-generation device—referred to as the Freedom 360 pump—is nearing the end of development and is undergoing design verification testing, with regulatory submissions in the U.S. and Europe expected in the second half of 2026.
Guidance reiterated; management cites variability factors
Adams reiterated full-year 2026 guidance for revenue of $47.5 million to $50 million (15% to 22% growth), gross margin of 61% to 63%, and positive adjusted EBITDA and positive cash flow. Management said Q1 revenue benefited from strong clinical trial-related PST revenue and strong distributor orders in international prefill markets, and executives said they want to monitor end-user adoption following those distributor orders.
Asked why guidance was unchanged despite the strong quarter, Kalbermatten said variability remains around the pace of vial-to-prefilled syringe conversions in Europe and market-by-market entry dynamics. Adams added that international phasing often includes initial pump orders for launches, followed by adoption and then stronger pull-through later, similar to prior-year patterns.
Adams also said the company incorporated geopolitical risk related to the Middle East into its guidance. In Q&A, he said KORU is cautious due to regional risk and has not seen strength in orders so far this year from its primary distributor there, though he described it as “not a meaningful part of our business.”
Tharby closed by thanking employees, partners, and shareholders, saying she was “extremely proud” of the company’s performance and expressed confidence in the strategy and leadership transition.
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.
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