Travere Therapeutics, Inc. Q1 FY2025 earnings call

• FILSPARI in IgA nephropathy: Net sales grew 182% YOY and 13% Q/Q post-full approval in fall. High compliance rates, growing patient base, and expanding prescribers. Full approvals in EU and UK for FILSPARI in IgAN, enabling CSL Vifor to expand access. Partner Renalys on track for Japan regulatory submission in H2 2025.
• FSGS: Submitted sNDA for FSGS indication in March, expect FDA acceptance later this month. Potential priority review leads to possible Sept approval, making FILSPARI first approved for FSGS. Team preparing for launch if approved.
• Pegtibatinase (PEG T): Progress on Phase 3 HARMONY study for HCU, Phase 1/2 COMPOSE study manuscript accepted for publication in Genetics in Medicine, highlighting potential as disease-modifying treatment.
• Clinical: FILSPARI's clinical data supports long-term kidney preservation and proteinuria reduction. FSGS data shows efficacy across subtypes. PEG T's anti-inflammatory effects noted.
• Commercial: FILSPARI net sales $56M in Q1, 703 new patient start forms. Broad payer coverage, eased criteria post-full approval. High patient satisfaction with Travere Total Care services.

FILSPARI generated net product sales of $55.9 million in the first quarter, representing significant growth year-over-year and sequentially. Thiola and Thiola EC contributed $20 million in net product sales for the first quarter. License and collaboration revenue was $5.9 million, with $3.8 million from drug product sales to partner CSL Vifor for FILSPARI's launch in Europe. Overall, total revenue for the first quarter of 2025 was $81.7 million.

• Expect strong demand for FILSPARI in 2025 with meaningful growth. Anticipate $17.5M milestone from CSL Vifor in Q2 due to EU full approval. Plan to invest in FSGS launch readiness and PEG T enrollment restart. Confident in funding strategic initiatives with strong balance sheet.

Legislative developments and geopolitical uncertainties, though impact on FILSPARI is not expected to be material.

Q: Elaborate on interactions with the agency since filing the sNDA for FSGS and how they compare to competitor Dimerix?

A: Bill Rote said interactions with FDA for FSGS sNDA are consistent with IgAN process, and FDA feedback supports proteinuria as an approval-based endpoint for FSGS similar to what was seen with another product.

Q: Thoughts on the label for FSGS, including potential restrictions?

A: Bill Rote expects the indication to be for patients ages 8 and up, covering broad FSGS subtypes including primary, genetic, and pediatric forms, as data shows consistent efficacy across these subgroups.

Q: Comments on sales reps' experience with Novartis's IgAN therapy and patient start forms?

A: Peter Heerma said there's early impact, but continued strong demand for FILSPARI with growth continuing in April. Physicians value FILSPARI's profile of long-term kidney preservation and convenience.

Q: Impact of removing REMS program on new patient starts in IgAN?

A: Peter Heerma said REMS hasn't been an obstacle, and removal is expected to further support new patient starts as FILSPARI is well-positioned with broad label and guidelines supporting earlier treatment.

Q: Breakdown of new vs repeat prescribers for FILSPARI and compliance rates?

A: Peter Heerma said it's slightly skewed to experienced prescribers but with healthy new prescribers. Compliance and persistence rates are high, reflecting patient satisfaction with FILSPARI.