Travere Therapeutics(TVTX) - 2025 Q2 - Quarterly Results

Financial Performance - U.S. net product sales of FILSPARI grew 165% year-over-year to $71.9 million in Q2 2025, with 745 new patient start forms received[15] - Total revenue for Q2 2025 was $114.4 million, including a $17.5 million milestone payment from CSL Vifor[3] - Total net product sales for Q2 2025 reached $94.842 million, a significant increase of 81.6% compared to $52.176 million in Q2 2024[39] - FILSPARI sales were $71.887 million in Q2 2025, up from $27.125 million in Q2 2024, representing a growth of 164.5%[39] - Total revenue for the first half of 2025 was $196.180 million, compared to $95.490 million in the same period of 2024, marking a 105.5% increase[39] Expenses - R&D expenses for Q2 2025 were $49.4 million, a decrease from $54.3 million in Q2 2024, primarily due to lower costs associated with pegtibatinase development[4] - SG&A expenses for Q2 2025 were $76.2 million, up from $64.8 million in Q2 2024, driven by increased investment in FILSPARI commercialization[5] - Operating expenses for Q2 2025 totaled $127.099 million, slightly higher than $121.820 million in Q2 2024[39] - Research and development expenses for Q2 2025 were $49.362 million, down from $54.330 million in Q2 2024[41] Net Loss and Income - Net loss for Q2 2025 was $12.8 million, or $0.14 per basic share, significantly improved from a net loss of $70.4 million, or $0.91 per basic share in Q2 2024[7] - The net loss for Q2 2025 was $12.755 million, a decrease from a net loss of $70.409 million in Q2 2024[39] - Non-GAAP net income for Q2 2025 was $11.930 million, compared to a loss of $50.059 million in Q2 2024[41] - The company reported a non-GAAP operating loss of $6.368 million for the first half of 2025, an improvement from a loss of $167.039 million in the same period of 2024[41] Cash and Assets - Cash, cash equivalents, and marketable securities totaled approximately $319.5 million as of June 30, 2025[8] - Total current assets decreased from $416,702,000 as of December 31, 2024, to $379,567,000 as of June 30, 2025, representing a decline of approximately 9%[36] - Cash and cash equivalents increased from $58,535,000 to $75,154,000, reflecting a growth of about 28%[36] - Accounts receivable rose from $27,116,000 to $38,718,000, indicating an increase of approximately 43%[36] - Total liabilities decreased from $535,048,000 to $522,562,000, a reduction of about 2%[36] - Stockholders' equity dropped from $59,077,000 to $32,747,000, a decline of approximately 45%[36] - The company reported an accumulated deficit of $1,501,148,000 as of June 30, 2025, compared to $1,447,167,000 at the end of 2024[36] Product Development and Regulatory - The FDA has set a PDUFA target action date of January 13, 2026, for the supplemental New Drug Application for FILSPARI in FSGS[15] - FILSPARI received standard marketing authorization in the EU and UK for the treatment of adults with primary IgAN, resulting in a $17.5 million milestone payment[15] - The ongoing SPARTAN Study is expanding to include post-kidney transplant patients with recurring IgAN[15] - The company anticipates the publication of updated KDIGO clinical guidelines for IgAN in the second half of 2025, recommending FILSPARI as a foundational therapy[15] - The company is focused on advancing FILSPARI towards approval for the treatment of FSGS, with expectations regarding the timing of this process[34] - The company is preparing for potential modifications to the REMS program and expects updates that could support broader access to FILSPARI[34] - The company anticipates continued progress with the FILSPARI launch in IgAN and aims for FILSPARI to become a foundational treatment[34] - The company faces risks related to the ongoing commercial launch of FILSPARI, including market acceptance and regulatory challenges[34] Future Growth - The company is focusing on expanding its product offerings and enhancing its research and development capabilities to drive future growth[40]