Travere Therapeutics, Inc. Q4 FY2024 earnings call

• Eric Dube highlighted the full FDA approval of FILSPARI for IgA nephropathy in September, with Q4 net sales growth of FILSPARI. Plans to submit an sNDA for an FSGS indication around the end of Q1 2025 and progress on pegtibatinase manufacturing.
• Jula Inrig discussed physician feedback on FILSPARI, complete remission data, plans to expand the SPARTAN study, clinical data for FSGS, and progress on pegtibatinase.
• Peter Heerma shared commercial success of FILSPARI in Q4, with 693 new patient start forms, growth driven by new prescribers and repeat prescribers, and advancements in payer formularies.

FILSPARI was the key growth driver. In the fourth quarter, net product sales of FILSPARI were $50 million, a nearly 40% increase from the prior quarter. For the full year 2024, FILSPARI generated $132.2 million in net product sales. Thiola and Thiola EC contributed $23.9 million in net product sales for the fourth quarter and $94.5 million for the full year 2024.

• Expect a moderate increase in gross to net discounts compared to 2024.
• Anticipate significant growth in FILSPARI net product sales in 2025 and outpace benchmark launches.
• Prepare for a potential launch in FSGS and restart enrollment in the pegtibatinase Phase III study.
• Anticipate incoming milestone payments from CSL Vifor upon FILSPARI's full approval in Europe and market access milestones.

• Uncertainties regarding regulatory approvals, such as REMS modifications and potential competitive landscape impacts.
• Market acceptance and payer coverage for new indications like FSGS.

Q: Can you give a sense of gross to net and how you're thinking about it for this year?

A: Chris Cline said they expect a high teens to low 20s range for gross to net, with the greatest impact early in the year.

Q: What are the steps towards full removal of the REMS for FILSPARI?

A: Bill Rote explained the first step is changing to quarterly monitoring upon REMS modification approval, with further steps depending on data accumulation to reach full removal.

Q: How are you thinking about the potential use of two branded medicines in IgAN?

A: Peter Heerma mentioned payers will evaluate combinations, but FILSPARI has strong payer inclusion criteria and is priced for broad access.

Q: What is the potential impact commercially from a REMS modification for FILSPARI?

A: Peter Heerma said a REMS modification could broaden patient selection for physicians by easing monthly monitoring requirements.

Q: Can you provide additional color regarding prelaunch activities in FSGS?

A: Jula Inrig and Peter Heerma discussed educating on proteinuria as a biomarker, leveraging the overlap in prescribers with IgAN, and preparing for FSGS launch with established teams and patient journey understanding.

Q: What specific questions might an ADCOM have regarding FSGS and FILSPARI?

A: Jula Inrig said ADCOM questions would focus on clinical meaningfulness of proteinuria reduction and benefit-risk assessment.

Q: What are the pre-commercial activities for FSGS?

A: Peter Heerma mentioned preparing and understanding patient and physician needs, leveraging established organization and physician overlap with IgAN.