Strong Revenue Growth
Q4 revenue of $10.9M (23% year-over-year) and full year revenue of $41.1M, up 22% versus 2024; Q4 marked the third consecutive quarter with >20% revenue growth.
Robust International Performance
International Core grew 71% in Q4 and 80% for the full year, with European share rising from ~10% in 2024 to ~20% in 2025 and an approximately $50M addressable market in Europe.
Domestic Market Outperformance and Recurring Base Expansion
Domestic Core grew 18% in Q4 and 11% for the full year, outpacing the underlying SCIg market (~10% growth in 2025); recurring global patient base increased ~20% to ~59,000 patients.
Regulatory and Product Milestones
Received EU MDR certification for FREEDOM60 (prefilled syringe compatibility) and 510(k) clearance for RYSTIGGO in January (ninth drug on the Freedom system and second non-IG clearance); began shipping FREEDOM60 into the EU.
Pipeline and Pharma Collaborations Expansion
Pipeline grew to 9 active KORU opportunities (including two new deals: a Phase III nephrology and a Phase I multi-indication drug); expecting 3 commercial-stage assets on label within a year (vancomycin, deferoxamine, Phesgo) representing ~2.2M estimated annual infusions.
RYSTIGGO Commercial Opportunity
RYSTIGGO presents an estimated U.S. opportunity of ~20,000 infusions in 2025, projected to grow to >100,000 infusions by 2030; UCB reported >2,400 GMG patients globally at end of 2025 and ~65% YoY growth in RYSTIGGO sales (company-reported).
Profitability and Cash Flow Progress
Achieved positive cash flow from operations in Q3, Q4 and for the full year; ended 2025 with $8.9M cash and modest full-year cash usage of $0.7M; delivered positive adjusted EBITDA of $0.6M for 2025, a 124% improvement year-over-year and three consecutive quarters of positive adjusted EBITDA.
Operational Discipline and Margin Resilience
Operating expenses increased only 3% while revenue grew 22%, demonstrating operating leverage; full-year gross margin of 62.3% and sustained quarterly gross margins above 50% despite cost headwinds.
2026 Financial Guidance and Targets
Initiated 2026 guidance of $47.5M–$50M revenue (15%–22% growth), gross margin guidance of 61%–63%, and full-year targets of positive adjusted EBITDA and positive cash flow; management reiterated longer-term targets including $100M revenue and >65% gross margins.