Travere Therapeutics, Inc. Q4 FY2025 earnings call

• 2025 was a strong year for Travere with achievements in reaching patients with approved medicines and pipeline advancement. - In IgA nephropathy, physician confidence in FILSPARI is building with real-world experience reinforcing its role. - For FSGS, working towards the April 13 PDUFA date and confident in FILSPARI's clinical profile. - Pegtibatinase has potential as a disease-modifying therapy for classical homocystinuria with Phase III study resuming. - Fourth quarter 2025 had strong commercial execution for FILSPARI with record demand and revenue. - Financials: Q4 2025 U.S. net product sales $126.6M, full year 2025 total net product sales $410.5M, etc.

In IgA nephropathy, FILSPARI had record demand and strong revenue growth in Q4 2025. Fourth quarter net product sales were $103 million, full year 2025 was $322 million, a 144% YOY growth. In FSGS, the sNDA for FILSPARI has a new PDUFA target action date of April 13, 2026. For pegtibatinase for classical homocystinuria, site activation for the pivotal Phase III HARMONY study has resumed.

Anticipate meaningful net product sales growth from FILSPARI in IgA nephropathy to continue. Modestly higher gross to net discounts expected compared to last year. Expect moderate operating expense growth in 2026 driven by various factors. No near-term need for additional capital with strong balance sheet.

Q: Dig deeper into IgAN performance, new patient starts, competition, etc.

A: Driven by new and repeat prescribers, strong demand continued into 2026.

Q: FDA data requests for FSGS sNDA, ALIGN trial data comparison.

A: On track for April 13 PDUFA date, can't make cross-trial comparisons but highlighted FILSPARI's data.

Q: Elaborate on clinical benefit characterization for FSGS sNDA, proportion of 4Q PSFs with proteinuria <1.5g/g.

A: FDA info requests focused on clinical benefit, demand includes more patients with proteinuria <1.5g/g.

Q: Sales infrastructure for IgAN and expansion for FSGS approval.

A: Prescriber base overlap, expanded field team.

Q: Elaborate on gross to net and evolution in 2026.

A: Anticipate similar flow, mid-20% gross to net for full year 2026.

Q: Confidence in FSGS approval, Otsuka's launch impact on IgAN.

A: Confidence high in FILSPARI's profile, Otsuka's launch reflects market growth.

Q: U.S. market penetration for FILSPARI, expansion potential.

A: Cumulative patient start forms <10% of addressable population, strong growth opportunity.

Q: Plans for communicating with investor community re FSGS PDUFA.

A: Enter quiet period, update on FDA decision.

Q: Expectations for 1Q demand, label discussions for FSGS.

A: Strong demand in 1Q, label negotiation to begin closer to action date.

Q: Halo effect of FSGS approval on IgAN.

A: Likely synergistic effect.

Q: FDA interactions re FSGS filing, label consistency.

A: Some review team changes but continuity in key areas.

Q: Lag between start forms and revenue growth, pegtibatinase study endpoints.

A: Time lag between start forms and revenue, HARMONY study design to achieve primary endpoint