Travere Therapeutics, Inc. earnings

Management highlights

- Achieved first FDA approval in FSGS, established Filspari as first and only approved medicine for FSGS. - Exceptional commercial performance in IgA nephropathy with record new patient start forms. - Dosed first new patient in phase three Harmony study of PEG-2-batinase following restart of enrollment. - Dr. Jula Enrich discussed Filspari's approval in FSGS, including patient eligibility and data from studies. - Peter Hirma shared commercial performance, Filspari's revenue growth, and strong launch in FSGS with early positive feedback. - Chris Klein provided financial update, including total revenue, operating expenses, net loss/gain, and cash position.

Guidance

- FSGS is expected to further contribute to top-line trajectory. - Continued strong demand and the product are expected to drive sustained revenue growth.

Segment performance

In the first quarter, Filspari's U.S. net product sales grew approximately 88% year-over-year to $105.2 million. Viola and Fiola EC contributed $19.3 million in U.S. product sales during the first quarter, and license and collaboration revenue was $2.7 million. Total revenue for the first quarter was $127.2 million. Filspari's revenue contribution in IgA nephropathy and FSGS is significant, with an estimated potential peak sales opportunity of $3 billion for Filspari.

Analyst Q&A

• Q: Will speaking on for Joe asked about FSGS launch progress vs IGAN launch and if early seen is supportive of faster FSGS launch.

  A: Peter said they are confident in faster uptake in FSGS due to high unmet need, strong brand awareness, and payer access foundation.

• Q: Greg on for Tyler asked about FSGS PSFs recorded, proportion of early starts via payer auth vs exceptions/appeals.

  A: Peter said too early to quantify but everything seen confirms faster uptake than initial IGAN launch in terms of demand and payer approval rate.

• Q: Anupam asked about FSGS launch physician education on product label.

  A: Peter said need to build awareness, educate on label like not being in nephrotic syndrome, Jule added positive feedback from physicians and alignment with KDGO.

• Q: Prakhar asked about FSGS uptake comparison to IGAN launch and access for secondary FSGS.

  A: Eric said not providing guidance on PSF by indication, Peter said seen higher first pass approval at payer level than initial IGAN.

• Q: Vamil asked about confusion on nephrotic syndrome history and prescribing Filspari.

  A: Jule said history of nephrotic syndrome should not reserve physician, aligned with KDGO, Peter said payers understand nephrotic syndrome is dynamic.

• Q: Gavin asked about discontinuation rates in IgA nephropathy and comparison to phase three.

  A: Peter said compliance and persistence rates high, Jule said consistent with PROTECT trial.

• Q: Sadia asked about conversion rate of patient start forms to treatment.

  A: Peter said continue to convert rapidly, no drop-offs seen.

• Q: Laura asked about competitive landscape for IgA nephropathy and PSF increase with FSGS approval.

  A: Peter said market growth not from competitive share but growing market, Philspari well positioned, Laura's PSF increase in Q1 from IG nephropathy.

• Q: Maury asked about estimating IGAN PSFs going forward and competitive launch of Atuka.

  A: Peter said no reason to believe can't continue performance, peak sales based on growth in both indications.

• Q: Jason asked about Filspari's use sequence in FSGS.

  A: Jula said vast majority of patients on RAS inhibitor, SGLT2 inhibitor used but not as prevalent, Joel added on immunosuppressant use in active nephrotic syndrome.

• Q: Alex asked about shipping week impact and PEG-2-batinase phase three.

  A: Chris said don't typically break down individual weeks, Bill said had breakthrough therapy designation, reached alignment on endpoint with FDA for Harmony study