Travere Therapeutics(US:TVTX)2025-10-30 20:06Financial Performance - U.S. net product sales of FILSPARI grew 155% year-over-year to $90.9 million in Q3 2025, with 731 new patient start forms received during the quarter[1] - Total revenue for Q3 2025 was $164.9 million, including U.S. net product sales of $113.2 million and a $40 million market-access milestone from CSL Vifor[3] - Net income for Q3 2025 was $25.7 million, or $0.29 per basic share, compared to a net loss of $54.8 million, or $0.70 per basic share for the same period in 2024[7] - Total net product sales for Q3 2025 reached $113.15 million, a significant increase from $61.00 million in Q3 2024, representing an 85.5% growth[40] - License and collaboration revenue surged to $51.71 million in Q3 2025, compared to just $1.90 million in Q3 2024, marking a 2,628% increase[40] - Total revenue for the nine months ended September 2025 was $361.04 million, up from $158.39 million in the same period of 2024, reflecting a 128.5% increase[40] - Operating income for Q3 2025 was $24.93 million, a turnaround from an operating loss of $56.15 million in Q3 2024[40] - Net income for Q3 2025 was $25.71 million, compared to a net loss of $54.81 million in Q3 2024, indicating a substantial improvement[40] - Non-GAAP net income for Q3 2025 was $52.77 million, compared to a net loss of $35.64 million in Q3 2024[42] Expenses - Research and development expenses for Q3 2025 were $51.9 million, slightly up from $51.7 million in Q3 2024, while total R&D expenses for the nine months ended September 30, 2025, decreased to $148.1 million from $155.4 million in 2024[4] - Selling, general, and administrative expenses for Q3 2025 were $86.5 million, compared to $65.6 million for the same period in 2024, largely due to preparations for a potential FSGS launch in January 2026[5] - Selling, general and administrative expenses increased to $86.45 million in Q3 2025 from $65.62 million in Q3 2024, a rise of 31.7%[40] Assets and Liabilities - As of September 30, 2025, total assets decreased to $538.6 million from $594.1 million as of December 31, 2024[36] - Cash and cash equivalents increased to $110.9 million from $58.5 million, while accounts receivable rose significantly to $83.0 million from $27.1 million[36] - Total current liabilities decreased to $135.1 million from $200.8 million, with accounts payable dropping to $18.2 million from $23.5 million[37] - Stockholders' equity increased to $73.6 million from $59.1 million, driven by an increase in additional paid-in capital to $1.55 billion[38] - The accumulated deficit widened to $1.48 billion from $1.45 billion, indicating ongoing financial challenges[38] Product Development and Regulatory - The FDA is reviewing the supplemental New Drug Application for FILSPARI in FSGS, with a target action date of January 13, 2026[13] - The company achieved a $40 million EU market access milestone, further strengthening its financial foundation[1] - The updated KDIGO guidelines include FILSPARI for earlier, first-line use in patients at risk of progression in IgAN[13] - The company is preparing for a potential FDA approval and commercial launch of FILSPARI for FSGS in Q1 2026[2] - The company has successfully manufactured the first commercial-scale batches of pegtibatinase and is engaging with the FDA to restart enrollment in the Phase 3 HARMONY Study in 2026[13] - The company is focused on the continued launch of FILSPARI for IgAN, with expectations for long-term growth trajectories[33] - There are plans for the potential approval of FILSPARI for FSGS, although the timing remains uncertain[33] - The company is restarting enrollment in the pivotal HARMONY Study of pegtibatinase, with anticipated timelines for progress[33] Risks and Monitoring - Risks include potential delays in FDA approval processes and challenges related to the commercial launch of FILSPARI[33] - The company is monitoring for adverse reactions related to FILSPARI, including hyperkalemia and hypotension, which have been observed in treated patients[29]