Travere Therapeutics, Inc. Q2 FY2025 earnings call

• FILSPARI Progress: Strong commercial performance in Q2 with $72M in U.S. net product sales, growing prescriber base (745 new patient start forms in Q2, ~43% Y/Y increase). Continued generation of clinical evidence, access expansion including potential REMS modifications, and growing recommendation by nephrologists. - Clinical Programs: SPARTAN trial showed FILSPARI-treated patients achieved ~70% proteinuria reduction and ~60% complete remission; PROTECT trial showed proteinuria reduction and stable eGFR; FSGS sNDA review advancing with PDUFA date Jan 13, 2026; HCU program on track for Phase III study enrollment restart. - Financials: Revenue grew 82% Y/Y, R&D expenses decreased due to reduced clinical activity in HARMONY study, SG&A expenses increased due to amortization and launch preparations, net loss decreased Y/Y on a non-GAAP basis.

FILSPARI: U.S. net product sales reached approximately $71.9 million in Q2 2025, representing significant year-over-year growth. THIOLA and THIOLA EC contributed $23 million in net product sales for Q2 2025, with anticipated generic competition in the coming quarters. FILSPARI's revenue contribution is substantial due to its strong growth in the U.S. market.

• Continued revenue growth expected from robust demand for FILSPARI and IgA nephropathy. - Anticipated REMS modifications for FILSPARI, including potential removal or modification. - FSGS approval expected in early 2026, which could be a significant growth opportunity. - HCU program on track for Phase III enrollment restart next year.

• Generic competition for THIOLA and THIOLA EC could impact revenue. - Regulatory uncertainties around REMS modifications and FSGS approval. - Market dynamics in the evolving IgA nephropathy and FSGS treatment landscapes, including competition.

Q: For FSGS, what do you anticipate the major topics could be for the ADCOM and how to respond?

A: An educational component on the disease and pathophysiology, educating panelists on biologic plausibility of proteinuria as validated endpoint, why eGFR is challenging in FSGS, and strong clinical data showing FILSPARI reduced proteinuria vs active comparator.

Q: Comment on the cadence and level of engagement with the agency for REMS update?

A: Interactions progressing as expected, similar to prior NDA review for full approval in IgA nephropathy, engaged and active review team.

Q: When would you gain insight into the timing of the Advisory Committee panel meeting?

A: Don't know at this stage, but anticipate it should be sometime in Q4 given PDUFA date Jan 13, 2026.

Q: What would it take after the REMS PDUFA to get REMS potentially removed entirely?

A: 2-step process, seeking first to lessen testing frequency then full removal, continuing dialogue with agency to evaluate opportunities to remove REMS ahead of PMR completion.

Q: How are the new data from SPIC and SPARTAN studies being received by the nephrology community?

A: Received very positively, excitement about data showing effect on disease-modifying biomarkers, plan to present more data from large Phase III study to support positioning.

Q: Comment on conversion rate of patient start forms to number of patients on the drug and market penetration?

A: At top end of best practice in rare disease for conversion, penetration rate still low with less than 10% of addressable population, but sustainable growth expected as market evolves.

Q: On FSGS, comment on eGFR curves and FDA's expectations?

A: Focus on proteinuria as surrogate endpoint due to less variability for predicting kidney failure, eGFR curves consistent with expectations but not a large focus for ADCOM as proteinuria is the key focus.

Q: Comment on gross-to-net trends in 2Q and expectations for rest of the year?

A: Saw relief this quarter vs last, expect incremental increases in discounts in 3Q, 4Q, squarely in line with guidance at low 20%.

Q: Any bottlenecks in uptakes and difference in drug use for new patient segments?

A: Main issue was urgency to treat, more treatment options and KDIGO guideline will help, REMS modification aligns with clinical practice for lower proteinuria segments.

Q: Comment on distribution of patient start forms in the quarter?

A: Consistent demand during the quarter, with typical rare disease variability month-over-month but continued in July.