Record Quarterly Revenue and Strong Top-Line Growth
Q1 2026 revenue of $11.8 million, up 22% year-over-year, described as a record start to the year and driven by recurring revenue from ~60,000 patients on the KORU platform.
Domestic and International Core Growth
Domestic core revenue grew 12% YoY, driven by new patient starts and competitive conversions; International core grew 35% YoY, led by prefilled syringe conversions and strong distributor orders in key EU markets.
Clinical Trial / PST Revenue Surge
PST (pharma/clinical trial) revenues increased 166% YoY driven by higher clinical trial product orders from advancing pharma collaborations.
Profitability and Cash Discipline Progress
Adjusted EBITDA was essentially breakeven at -$10,000 (a 95% improvement YoY); net losses improved 33% to $800,000; minimal cash usage of $0.1 million in Q1 and ending cash balance of $8.8 million.
Reiterated 2026 Guidance
Company reiterated full-year 2026 guidance: revenue $47.5M–$50M (growth 15%–22%), gross margin target 61%–63%, and expectations of positive adjusted EBITDA and positive cash flow for the full year.
Advancing Non-Ig Pipeline and Regulatory Progress
Two non-Ig pharma collaborations advanced to Phase III (including Empaveli for a 4th indication and an undisclosed partner restarting Phase III); submitted 510(k) for Freedom Infusion System with deferoxamine; eight active non-Ig opportunities representing >6 million annual infusions collectively.
Product and Market Expansion Milestones
EU MDR clearance for Freedom60 with prefilled syringe compatibility achieved; ongoing commercial rollout for RYSTIGGO (new label) and active Phesgo 510(k) engagement with FDA; development of next-gen Freedom60 pump with planned 510(k)/MDR filings in 2026.
Strategic Leadership Transition with Positive Tone
CEO transition planned (Adam Kalbermatten to become CEO on July 1st) described as well underway, with management expressing confidence in strategy execution and long-term targets ($100M revenue, >65% gross margin, 20%+ EBITDA margin).