Travere Therapeutics (NASDAQ:TVTX) reported third-quarter results marked by record FILSPARI sales, continued early adoption in focal segmental glomerulosclerosis (FSGS), and progress across its kidney-disease and rare-disease pipeline.
Total U.S. net product sales reached $220.2 million in the third quarter, led by $200.2 million in FILSPARI sales. FILSPARI sales increased approximately 120% from a year earlier, reflecting continued growth in immunoglobulin A nephropathy (IgAN) and the first significant revenue contribution from the recently approved FSGS indication. THIOLA and THIOLA EC generated $20 million in U.S. net product sales.
Including $4.4 million in licensing and collaboration revenue, total revenue was $224.6 million. The company ended Sept. 30 with approximately $471.8 million in cash, cash equivalents and marketable securities.
FILSPARI Demand and FSGS Launch
Chief Commercial Officer Peter Heerma said Travere received 1,932 new patient start forms for FILSPARI across IgAN and FSGS during the quarter, a period that typically experiences summer seasonality. He said demand, conversion of prescriptions to paid therapy and patient adherence remained strong.
Heerma said FSGS demand grew sequentially from the second quarter, while IgAN demand remained high but declined modestly from the prior quarter. He attributed the IgAN comparison partly to seasonality and pent-up demand in the second quarter. The company does not provide start-form guidance or break out performance by indication.
Travere said conversion to paid prescriptions in FSGS has progressed more quickly than in the earlier IgAN launch and is approaching the level seen in IgAN. Most payers have updated their FSGS-specific coverage policies to include FILSPARI, according to management.
The company said roughly 40% of first-time FSGS prescribers during the quarter were new to FILSPARI, potentially expanding the product’s reach in both FSGS and IgAN. Approximately two-thirds of physicians who have prescribed FILSPARI for FSGS have treated only one FSGS patient since the launch, which Travere views as an opportunity to deepen use within practices.
Management said use in pediatric FSGS patients, for whom FILSPARI is approved in patients age 8 and older, has been consistent with the DUPLEX clinical trial, with pediatric patients representing up to 10% of treated patients. Travere said it has not observed access differences between pediatric and adult patients.
FILSPARI’s third-quarter sales included approximately $8 million related to specialty pharmacy inventory above historical levels. Heerma said the company expects fourth-quarter net sales to be reduced by approximately the same amount as specialty pharmacies dispense existing inventory and return to normal levels.
Positioning in an Evolving IgAN Market
Travere described the IgAN market as increasingly dynamic as new therapies enter and nephrologists evaluate treatment sequencing and combinations. The company maintained that FILSPARI has an established role as a kidney-targeted treatment and could be used alongside immune-directed therapies rather than being replaced by them.
Chief Executive Officer Eric Dube said higher-risk patients, generally characterized by proteinuria above 1.5 grams and more rapid estimated glomerular filtration rate, or eGFR, decline, may receive immune-directed treatment followed by optimized kidney-directed care. He said Travere expects B-cell therapies to replace historical steroid use for some patients, while FILSPARI, SGLT2 inhibitors and B-cell therapies may be used in combination.
For the approximately 70% of IgAN patients with proteinuria below 1.5 grams, Travere sees an opportunity for earlier use of FILSPARI. Heerma said the majority of FILSPARI prescriptions are for patients without prior exposure to branded IgAN therapies.
Management said it has not seen a change in trends involving patients switching away from FILSPARI following new market entries. It also said payers have not created meaningful barriers to using FILSPARI after immune-directed therapy.
Clinical Data and Pipeline Updates
Chief Medical Officer Jula Inrig highlighted data presented at ASN Kidney Week. In the Phase III PROTECT study in IgAN, FILSPARI showed greater proteinuria reduction and slower eGFR decline versus maximally dosed irbesartan, according to the company. A new analysis from DUPLEX in FSGS patients without nephrotic syndrome showed greater proteinuria reduction and nominally significant slowing of eGFR decline.
Travere also presented final two-year results from the SPARTAN study in newly diagnosed IgAN patients. The company said 75% of patients treated with FILSPARI as first-line therapy achieved complete proteinuria remission at least once, with stable kidney function over two years without immunosuppression.
Enrollment has been completed in the SPARX study of FILSPARI in recurrent FSGS and IgAN following kidney transplantation, with data anticipated in 2027. Travere also plans to initiate SPARLIGHT later this year, a Phase IV study involving adult and pediatric FSGS patients of African ancestry who are at risk of disease progression.
For pegtibatinase, Travere said enrollment has progressed substantially in the Phase III HARMONY study in classical homocystinuria, or HCU. The company continues to expect topline results in the second half of 2027. Inrig said earlier Phase I/II COMPOSE results showed an approximately 67% mean relative reduction in total homocysteine.
Travere also said it expects to submit a U.S. investigational new drug application by year-end for civorebrutinib, an oral BTK inhibitor being evaluated for immune-mediated kidney diseases. The company is prioritizing primary membranous nephropathy, FSGS and minimal change disease for development planning.
Expenses and Leadership Transition
Total GAAP research and development and selling, general and administrative expenses were $168.7 million, including approximately $23.8 million in non-cash stock-based compensation and depreciation. The company recorded $113.1 million in in-process research and development expense, primarily related to the $112.5 million upfront payment and associated costs from its Everest licensing agreement.
Dube said he will step down in December. He said Bradley, who is scheduled to join Travere on Dec. 1, has been involved in transition planning and will lead the company in its next chapter.
Travere reiterated its expectation that FILSPARI can achieve or exceed $3 billion in annual sales by 2033.
About Travere Therapeutics (NASDAQ:TVTX)
Travere Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for rare diseases, with an emphasis on serious kidney conditions. The company’s work centers on addressing diseases with limited treatment options and improving outcomes for patients with progressive renal disorders.
Travere’s lead commercial product is FILSPARI (sparsentan), an oral treatment for adults with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of disease progression.
