Travere Therapeutics(US:TVTX)2025-10-30 20:46Financial Performance - Net product sales for Q3 2025 reached $113.15 million, a 85.5% increase from $61.00 million in Q3 2024[18] - Total revenue for the nine months ended September 30, 2025, was $361.04 million, compared to $158.39 million for the same period in 2024, reflecting a 128.3% increase[18] - Operating income for Q3 2025 was $24.93 million, compared to an operating loss of $56.15 million in Q3 2024[18] - The company reported a net income of $25.71 million for Q3 2025, a significant improvement from a net loss of $54.81 million in Q3 2024[18] - For the nine months ended September 30, 2025, the net loss was $28,275 thousand, a significant improvement compared to a net loss of $261,281 thousand for the same period in 2024[26] - Basic net loss per share for the three months ended September 30, 2025, was $0.29, compared to a loss of $0.70 for the same period in 2024, showing an improvement in performance[138] Cash and Assets - Cash and cash equivalents increased to $110.93 million as of September 30, 2025, up from $58.54 million at the end of 2024[16] - Total assets decreased to $538.58 million as of September 30, 2025, down from $594.13 million at the end of 2024[16] - Total liabilities decreased to $465.02 million as of September 30, 2025, compared to $535.05 million at the end of 2024[16] - Cash and cash equivalents at the end of the period were $110,930 thousand, up from $36,409 thousand at the end of September 2024[26] - As of September 30, 2025, accounts receivable was $83.0 million, significantly up from $27.1 million at December 31, 2024, including a $40.0 million milestone payment[149] Expenses - Research and development expenses for Q3 2025 were $51.89 million, slightly up from $51.68 million in Q3 2024[18] - Selling, general and administrative expenses increased to $86.45 million in Q3 2025, compared to $65.62 million in Q3 2024[18] - Share-based compensation for the nine months ended September 30, 2025, was $33,404 thousand, compared to $27,699 thousand in 2024[26] - The Company reported amortization expense of $15.4 million for the three months ended September 30, 2025, compared to $10.8 million for the same period in 2024, indicating a year-over-year increase of approximately 43%[120] - Total share-based compensation for the three months ended September 30, 2025 was $11.263 million, compared to $8.021 million for the same period in 2024[147] Product Development and Regulatory Approvals - The FDA granted full approval for FILSPARI® (sparsentan) on September 5, 2024, to slow kidney function decline in adults with primary IgAN[30] - FILSPARI had previously received accelerated approval in February 2023 based on positive long-term results from the PROTECT Study[31] - The Company initiated the pivotal Phase 3 HARMONY Study for pegtibatinase in December 2023, with the first patients dosed in early 2024[37] - Renalys initiated an open label registration study of sparsentan in Japan in the second quarter of 2024, achieving full enrollment by January 2025[33] - The FDA accepted the supplemental New Drug Application (sNDA) for FILSPARI for the treatment of FSGS, with a target action date of January 13, 2026[36] Market and Sales - Over 98% of the Company's net product sales come from the United States, with product sales consisting of FILSPARI and tiopronin products[77] - Revenue from FILSPARI sales is recognized upon delivery to specialty pharmacies, with payment terms generally set at 30 days from shipment[78] - The company recognized $51.7 million in license and collaboration revenue for the three months ended September 30, 2025, including a market access milestone of $40.0 million from the CSL Vifor License Agreement[93] - The company received an upfront payment of $55.0 million under the CSL Vifor License Agreement and is eligible for up to $845.0 million in total potential value from regulatory and sales-based milestone payments[87] Investments and Securities - As of September 30, 2025, the company's marketable debt securities totaled $143.60 million, a decrease from $312.17 million as of December 31, 2024[96] - The Company does not intend to sell its investments in marketable debt securities, and unrealized losses are primarily due to fluctuations in short-term interest rates[102] - The investment portfolio is limited to investment-grade credit-rated securities, minimizing credit-related losses[240] Corporate Actions and Agreements - The Company entered into an exclusive licensing agreement with Renalys for sparsentan in January 2024, covering multiple Asian countries[33] - The Company completed the repurchase of $207.1 million aggregate principal amount of 2025 Notes for cash, resulting in a remaining principal amount of $68.9 million, which was repaid upon maturity on September 15, 2025[131] - The Company entered into a definitive stock purchase agreement with Chugai Pharmaceutical Co., Ltd. for the acquisition of full ownership of Renalys, which includes rights to develop sparsentan in Japan, South Korea, and Taiwan[156] Miscellaneous - Recent inflationary pressures have primarily increased labor costs, but have not impacted the current business outlook[242] - The Company has capitalized $181.5 million related to the Thiola intangible asset, which includes an up-front license fee and guaranteed minimum royalties[119] - The Company has not sold any shares under the $100.0 million At-the-Market Equity Offering agreement as of September 30, 2025[151]