Travere Therapeutics Expects Total U.S. Net Product Sales For Q4 2025 To Be ~$127M; Expects $410M U.S. Net Product Sales For 2025; Co. To Restart Phase 3 HARMONY Study In Q1 2026; PDUFA Target Date For Filspari Approval Is January 13, 2026

Travere Therapeutics, Inc. (NASDAQ:TVTX) today announced that, based on preliminary and unaudited financial data, the Company expects total U.S. net product sales for the fourth quarter of 2025 to be approximately $127 million. For the fiscal year 2025, the Company expects total U.S. net product sales to be approximately $410 million. The Company ended 2025 with approximately $323 million in cash, cash equivalents, and marketable securities. The Company also provided an update on key corporate, clinical, and regulatory development initiatives, including anticipated 2026 milestones.

"The fourth quarter closed out an exceptional year of commercial execution with FILSPARI, as our teams were able to reach a record number of patients with IgAN, reinforcing its role as foundational therapy," said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. "As we move into 2026, we are focused on sustaining this momentum while preparing for a successful commercial launch of FILSPARI in FSGS, which, if approved, would be the first approved medication for these patients facing potential kidney failure. In addition, we are well-positioned to restart the pivotal Phase 3 HARMONY Study of pegtibatinase in the first quarter now that we have further optimized our manufacturing process. This marks an important next step in advancing our pipeline and delivering the first potentially disease-modifying therapy for people living with classical HCU."

Program Updates and Anticipated 2026 Milestones

FILSPARI® (sparsentan) – IgA Nephropathy (IgAN)

• 908 new patient start forms (PSFs) were received during the quarter, driven by continued demand from repeat and new prescribers.
• Preliminary U.S. net product sales of FILSPARI totaled approximately $103 million in the fourth quarter of 2025, representing 108% growth year-over-year; approximately $322 million for the full year 2025.
• In October 2025, the Company received a $40 million milestone payment from its collaborator CSL Vifor, following market access achievements. CSL Vifor has launched FILSPARI in Germany, Austria, Switzerland, Luxembourg, and the UK, and Travere remains eligible to receive additional market access and sales-based milestones.
• In 2026, the Company expects to continue generating clinical evidence to support FILSPARI's role as foundational therapy in IgAN, including through ongoing and planned studies and presentations at key medical meetings.
• In 2026, the Company's partner Chugai Pharmaceutical expects to submit a New Drug Application for sparsentan in Japan. Travere remains eligible to receive regulatory, development and sales-based milestone payments, as well as tiered royalties on net sales of sparsentan.

FILSPARI – Focal Segmental Glomerulosclerosis (FSGS)

• The Company's PDUFA target action date for its sNDA seeking full approval for FILSPARI in FSGS is January 13, 2026. The Company recently received additional information requests from the FDA to further characterize the clinical benefit of FILSPARI and recently submitted responses to address the Agency's questions, which are currently under review by the Agency. If approved, FILSPARI would be the first and only medication approved for FSGS, a rare kidney disorder and a leading cause of kidney failure.
• The Company is well positioned for a successful commercial launch of FILSPARI in FSGS, if approved.

Pegtibatinase – Classical Homocystinuria (HCU)

• Following further optimization of its manufacturing process in 2025, the Company is on track to restart the pivotal Phase 3 HARMONY Study in the first quarter of 2026.

The Company will present at the 44th Annual J.P. Morgan Healthcare Conference today at 4:30 p.m. PT, and expects to announce complete full year 2025 financial results and provide a corporate update in February.