Record Demand and New Patient Starts
908 new patient start forms for FILSPARI in Q4 2025 (record quarter) with continued strong demand into Q1 2026; growth driven by both new prescribers and increased use among established prescribers, with broader community adoption.
Robust FILSPARI Revenue Growth
FILSPARI U.S. net product sales of approximately $103.3 million in Q4 2025 and $322 million for full year 2025, representing 144% year-over-year growth for the year.
Overall Company Revenue and Profitability Improvement
Company U.S. net product sales of $126.6 million in Q4 and total net product sales of $410.5 million for full year 2025; Q4 GAAP net income of $2.7 million ($0.03 per basic share) vs. net loss of $60.3 million in Q4 2024; non-GAAP net income of $33.3 million ($0.37) vs. non-GAAP loss prior year.
Pipeline Progress — FSGS Regulatory Milestone
sNDA for FILSPARI in FSGS under active FDA review with a new PDUFA target action date of April 13, 2026; company reports continued conviction in clinical profile and proteinuria as an approvable surrogate endpoint.
Pegtibatinase Advancement for Classical HCU
Resumed site activations for pivotal Phase III HARMONY and long-term extension ENSEMBLE after manufacturing process optimizations; Phase I/II COMPOSE showed ~67% reduction in total homocysteine in cohorts and durable effects out to one year for some patients.
Stronger Balance Sheet and One-Time Gains
Cash, cash equivalents and marketable securities of approximately $322.8 million as of December 31, 2025; Q4 benefitted from ~ $40 million CSL milestone, ~$10 million from Renalys transaction proceeds and a $25 million discontinued-operations milestone (Mirum), supporting liquidity.
Commercial Readiness and Field Expansion
Expanded commercial field team from ~80 to over 100 field-based personnel to support IgAN and potential FSGS launch; reported ~96% of patients have a pathway to reimbursement for FILSPARI.