Strong Full-Year Revenue Growth
Total net revenue for 2025 was $184,000,000 versus $76,000,000 in 2024, an increase of approximately 142% year-over-year, reflecting a full commercial year for Rytelo.
Solid Q4 Performance and Commercial Traction
Rytelo Q4 net revenue was $48,000,000 (in line with expectations). Demand grew 9% quarter-over-quarter and prescribing accounts increased ~13% in Q4, expanding the footprint to approximately 1,300 accounts (about 150 new accounts added).
Clear 2026 Revenue Guidance and Growth Plan
Management reiterated 2026 Rytelo net revenue guidance of $220,000,000 to $240,000,000 (midpoint implies ~25% growth versus 2025) and expects a greater portion of growth in the back half of the year, driven by focused second-line commercial strategy.
Focused Commercial Strategy and Addressable Market
Company is prioritizing eligible second-line lower-risk MDS patients in the U.S., estimating an addressable population of ~8,000 patients and reporting ~30% of patient starts are in first- and second-line on a rolling 12-month basis.
Clinical and Medical Affairs Progress
IMPACT MF trial is fully enrolled with an expected interim overall survival death-event trigger in H2 2026 (final analysis planned for 2028). Company aligned to support over 10 investigator-sponsored trials (ISTs) and real-world evidence efforts, with initial RWE data expected in 2026.
Operational Discipline and Expense Reduction Target
2026 total operating expense guidance of $230,000,000 to $240,000,000 represents roughly a $20,000,000 year-over-year reduction at the midpoint versus 2025 operating expenses of $255,000,000; R&D and SG&A trends reflect cost control and targeted commercial investment.
Balance Sheet and Financing Optionality
As of 12/31/2025, cash, cash equivalents, restricted cash and marketable securities were approximately $400,000,000. The company amended its Pharmakon loan to extend potential access to an additional $125,000,000 through 07/30/2026 and plans a new shelf registration and ATM filing.