Travere Therapeutics Reports First Quarter 2025 Financial Results

Submitted sNDA seeking full approval of FILSPARI$(R)$ (sparsentan) for FSGS in March 2025

U.S. net product sales of FILSPARI totaled $55.9 million in 1Q 2025; 703 new PSFs received in the period

FILSPARI was recently converted to full approval for the treatment of IgAN in Europe and the UK

Clinical data presented at the National Kidney Foundation Spring Clinical Meetings reinforced FILSPARI's foundational position in IgAN and potential in FSGS

Cash, cash equivalents, and marketable securities as of March 31, 2025, totaled $322 million

SAN DIEGO--(BUSINESS WIRE)--May 01, 2025-- 

Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its first quarter 2025 financial results and provided a corporate update.

"As the only fully approved, kidney-targeted therapy that has demonstrated superior efficacy in a head-to-head trial, FILSPARI is elevating the standard of care in IgAN. Our strong start to the year reflects this leadership -- in the first quarter, we delivered 13% sequential net sales growth for FILSPARI in the U.S., driven by sustained demand from both new and existing prescribers following full approval. In addition, we are seeing encouraging signs of a broader shift toward earlier treatment and lower proteinuria goals, which we believe will further amplify FILSPARI's growth potential in the years ahead," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "We also made significant progress toward our goal of expanding FILSPARI into FSGS with the submission of our sNDA, putting us on track for a potential approval later this year. Additionally, the recent conversions of FILSPARI to full approval in the EU and UK furthered our goal of enabling access to this important medicine for patients beyond the U.S. With continued strong execution and a sound financial foundation, we are well-positioned to deliver sustainable growth for all our stakeholders."

Financial Results for the Quarter Ended March 31, 2025

Net product sales for the first quarter of 2025 were $75.9 million, compared to $40.0 million for the same period in 2024. The increase is attributable to sales from the ongoing commercial launch of FILSPARI in IgAN.

Research and development (R&D) expenses for the first quarter of 2025 were $46.9 million, compared to $49.4 million for the same period in 2024. The decrease is largely attributable to lower costs associated with the development of sparsentan as our Phase 3 programs advance towards completion. On a non-GAAP adjusted basis, R&D expenses were $42.2 million for the first quarter of 2025, compared to $45.8 million for the same period in 2024.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2025 were $72.8 million, compared to $64.2 million for the same period in 2024. The difference is largely attributable to increased investment in the ongoing commercial launch of FILSPARI and higher depreciation and amortization. On a non-GAAP adjusted basis, SG&A expenses were $53.3 million for the first quarter of 2025, compared to $48.2 million for the same period in 2024.

Total other income, net for the first quarter of 2025 was $1.5 million, compared to $3.5 million for the same period in 2024. The difference is largely attributable to a decrease in interest income during the period.

Net loss for the first quarter of 2025 was $41.2 million, or $0.47 per basic share, compared to a net loss of $136.1 million, or $1.76 per basic share for the same period in 2024. On a non-GAAP adjusted basis, net loss for the first quarter of 2025 was $16.9 million, or $0.19 per basic share, compared to a net loss of $116.2 million, or $1.51 per basic share for the same period in 2024.

As of March 31, 2025, the Company had cash, cash equivalents, and marketable securities of $322.2 million.

Program Updates

FILSPARI(R) (sparsentan) -- IgAN

   -- First quarter 2025 FILSPARI U.S. net product sales grew 182% 
      year-over-year. 
 
          -- First quarter 2025 U.S. net product sales of FILSPARI totaled 
             $55.9 million. 
 
          -- In the first quarter of 2025, the Company received 703 new patient 
             start forms (PSFs) driven by growth amongst both new and repeat 
             prescribers. 
 
   -- The Company continues to expect a PDUFA target action date of August 28, 
      2025 for its supplemental New Drug Application (sNDA) requesting 
      modification of liver monitoring and removal of embryo-fetal toxicity 
      monitoring REMS for FILSPARI. 
 
   -- At the National Kidney Foundation (NKF) Spring Clinical Meeting (April 
      10-13), the Company presented analyses further reinforcing FILSPARI's 
      unique position as the only kidney-targeted medicine to replace the 
      historical standard of care in IgAN. Highlights included: 
 
          -- Data from the Phase 2 SPARTAN Study demonstrated approximately 70% 
             proteinuria reduction from baseline and stable eGFR over 24 weeks 
             with nearly 60% complete remission rates in newly diagnosed 
             patients with IgAN; 
 
          -- Approximately 50% reduction in u-sCD163, which is the first 
             demonstration of sparsentan's anti-inflammatory effect in humans 
             and supports preclinical data that also showed attenuation of 
             immune and pro-inflammatory signaling with sparsentan. 
             Additionally, real-world case series supported the safety and 
             effectiveness of sparsentan achieving or maintaining low 
             proteinuria in patients with IgAN, with 83% of patients reaching 
             or maintaining UPCR <=0.5 g/g, regardless of UPCR or eGFR prior to 
             sparsentan initiation, treatment history, and time since 
             diagnosis. 
 
   -- The ongoing SPARTAN Study is expanding to include post-kidney transplant 
      patients with recurring IgAN and the Company is initiating a new open 
      label study of FILSPARI in post kidney-transplant patients with recurrent 
      IgAN or FSGS. 
 
   -- In 2025, the Company anticipates the publication of the final version of 
      the updated Kidney Disease Improving Global Outcomes (KDIGO) clinical 
      guidelines for IgAN. The draft guidelines published in August 2024 
      recommended FILSPARI as a foundational kidney-targeted therapy and 
      lowered the targeted proteinuria level for all IgAN patients to under 0.5 
      g/day or ideally complete remission (under 0.3 g/day). 
 
   -- In April 2025, the European Commission converted conditional marketing 
      authorization $(CMA)$ of FILSPARI to standard marketing authorization $(MA)$ 
      for the treatment of adults with primary IgAN in Europe. As a result, the 
      Company expects to receive a $17.5 million milestone payment from CSL 
      Vifor in the second quarter of 2025, and the Company remains eligible to 
      receive additional milestone payments related to market access and 
      sales-based achievements. 
 
   -- In April 2025, the UK Medicines and Healthcare products Regulatory Agency 
      (MHRA) converted the conditional FILSPARI approval to standard approval 
      for treatment of adults with primary IgAN. 
 
   -- The Company's collaborator, CSL Vifor, has launched FILSPARI for the 
      treatment of IgAN in Germany, Austria and Switzerland. 
 
   -- The Company's partner, Renalys Pharma, Inc., expects topline results from 
      its registrational Phase 3 clinical trial of sparsentan for the treatment 
      of IgAN in Japan in the second half of 2025. 

FILSPARI(R) (sparsentan) -- FSGS

   -- In the first quarter of 2025, the Company submitted an sNDA seeking 
      priority review for traditional approval of FILSPARI in FSGS. 
 
          -- The sNDA submission is based on the results from the Phase 3 
             DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS, two of the 
             largest interventional clinical trials conducted in FSGS to-date. 
 
          -- The Company expects to receive notice regarding the acceptance and 
             timeline for sNDA review from the FDA in May 2025. 
 
          -- If approved, FILSPARI would be the first and only approved 
             medicine indicated for FSGS, a rare kidney disorder and a leading 
             cause of kidney failure. 
 
   -- At the NKF Spring Clinical Meeting (April 10-13), the Company presented 
      new analyses from the Phase 3 DUPLEX Study showing that partial and 
      complete proteinuria remission were achieved earlier and more frequently 
      with FILSPARI than irbesartan, and patients that achieved proteinuria 
      remission had markedly reduced risk of progression to kidney failure. 
      These findings represent the first data from a randomized clinical trial 
      to validate the observational results from PARASOL, providing robust 
      support for its recommendation of proteinuria as a surrogate endpoint in 
      FSGS. 

Pegtibatinase (TVT-058) -- Classical HCU

   -- The Company is on track to restart enrollment in the Phase 3 HARMONY 
      Study in 2026. 
 
   -- The COMPOSE primary manuscript, highlighting positive results from the 
      Phase 1/2 COMPOSE Study, including the safety and efficacy of 
      pegtibatinase in adults with HCU, has been accepted to the top-tier 
      peer-reviewed journal, Genetics in Medicine (GiM). 

Conference Call Information

Travere Therapeutics will host a conference call and webcast today, May 1, 2025, at 4:30 p.m. ET to discuss company updates as well as first quarter 2025 financial results. To participate in the conference call, dial +1 (800) 549-8228 (U.S.) or +1 (646) 564-2877 (International), conference ID 39415 shortly before 4:30 p.m. ET. The webcast can be accessed on the Investor page of Travere's website at ir.travere.com/events-and-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company's website.

Use of Non-GAAP Financial Measures

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