Travere Therapeutics(TVTX) - 2025 Q4 - Annual Results

Financial Performance - U.S. net product sales for FILSPARI in Q4 2025 reached approximately $103 million, representing 108% year-over-year growth[5] - Total U.S. net product sales for the fiscal year 2025 are expected to be approximately $410 million[1] - The company ended 2025 with approximately $323 million in cash, cash equivalents, and marketable securities[1] - A $40 million milestone payment was received from CSL Vifor in October 2025 following market access achievements[5] Product Development and Approvals - The PDUFA target action date for FILSPARI's sNDA seeking full approval in FSGS is January 13, 2026[5] - The pivotal Phase 3 HARMONY Study of pegtibatinase is set to restart in Q1 2026 after optimization of the manufacturing process[6] - Chugai Pharmaceutical is expected to submit a New Drug Application for sparsentan in Japan in 2026[5] - If approved, FILSPARI would be the first and only medication approved for FSGS, a rare kidney disorder[5] - The company is preparing for a New Drug Application for sparsentan for the treatment of IgAN in Japan, indicating market expansion efforts[21] Market Launch and Acceptance - The company is making continued progress with the FILSPARI launch in IgAN, with preliminary estimates of metrics related to this launch[21] - The company anticipates potential approval and commercial launch of FILSPARI in FSGS, although there are risks regarding the timing and outcome of the sNDA[21] - The ongoing commercial launch of FILSPARI in IgAN is facing risks related to market acceptance, including efficacy, safety, and pricing[21] Clinical Evidence and Research - The company anticipates continued generation of clinical evidence to support FILSPARI's role as foundational therapy in IgAN throughout 2026[5] - The company is focused on the Phase 3 HARMONY Study, with expectations to restart study activities, although timelines may be subject to change[21] Risks and Challenges - There are uncertainties regarding the company's ability to raise additional funding required for product development due to macroeconomic conditions[21] - Risks associated with the manufacturing scale-up and successful execution of commercial strategies for FILSPARI are present[21] - The company faces potential disruptions to clinical trials and commercialization activities due to global and macroeconomic conditions[21] - The company is dependent on contractors for clinical drug supply and commercial manufacturing, which introduces additional risks[21] - The company is monitoring serum potassium levels in patients treated with FILSPARI, especially when used with other agents that increase serum potassium[22]