Travere Therapeutics(US:TVTX)2025-08-06 21:16Financial Performance - Net product sales for Q2 2025 reached $94.842 million, a 81.6% increase from $52.176 million in Q2 2024[19] - Total revenue for the first half of 2025 was $196.180 million, compared to $95.490 million in the same period of 2024, reflecting a 105.7% growth[19] - Operating loss for Q2 2025 was $12.650 million, significantly improved from a loss of $67.704 million in Q2 2024[19] - The company reported a net loss of $12.755 million for Q2 2025, compared to a net loss of $70.409 million in Q2 2024[19] - For the six months ended June 30, 2025, the net loss was $53,981,000 compared to a net loss of $206,470,000 for the same period in 2024, indicating a significant reduction in losses[27] - For the three months ended June 30, 2025, the company reported a net loss of $12.8 million, resulting in a basic and diluted loss per share of $0.14, compared to a net loss of $69.7 million and a loss per share of $0.90 for the same period in 2024[134] - For the six months ended June 30, 2025, the net loss was $54.0 million, with a basic and diluted loss per share of $0.61, compared to a net loss of $206.5 million and a loss per share of $2.67 for the same period in 2024[134] Cash and Liquidity - Cash and cash equivalents increased to $75.154 million as of June 30, 2025, up from $58.535 million at the end of 2024[16] - Cash and cash equivalents at the end of the period were $75,154,000, up from $32,291,000 at the end of June 2024[27] - The company reported a net cash used in operating activities of $37,211,000 for the six months ended June 30, 2025, compared to $159,248,000 for the same period in 2024, reflecting improved cash flow management[27] - As of June 30, 2025, the company held cash equivalents and marketable debt securities totaling approximately $319.5 million[236] Research and Development - Research and development expenses for the first half of 2025 totaled $96.251 million, down from $103.750 million in the same period of 2024[19] - Total research and development expenses for the first half of 2025 were $96.3 million, down 7% from $103.8 million in the same period of 2024[152] - Research and development expenses include costs related to sparsentan and pegtibatinase, with all costs expensed as incurred[52] - The company is focused on developing and commercializing products, including FILSPARI, and is facing risks related to market acceptance and regulatory approvals[13] - The company is focused on expanding its product pipeline through licenses and acquisitions to address rare diseases with significant unmet medical needs[30] Product Sales and Market Performance - FILSPARI sales reached $71.9 million for the three months ended June 30, 2025, compared to $27.1 million in 2024, marking a 165.5% increase[81] - Total net product sales for the three months ended June 30, 2025, were $94.8 million, a significant increase from $52.2 million in the same period of 2024, representing an 81.5% growth[81] - For the six months ended June 30, 2025, total net product sales were $170.7 million, up from $92.2 million in 2024, indicating an 85.2% increase[81] - Tiopronin products generated $22.9 million in sales for the three months ended June 30, 2025, slightly down from $25.1 million in 2024, reflecting a 4.4% decrease[81] Regulatory and Compliance - The company’s approved product FILSPARI® received full FDA approval on September 5, 2024, for slowing kidney function decline in adults with primary IgAN[31] - FILSPARI® was previously granted accelerated approval in February 2023 based on positive long-term results from the PROTECT Study[32] - The FDA accepted the sNDA for FILSPARI for the treatment of FSGS, with a target action date of January 13, 2026[36] - The Company received a regulatory milestone payment of $17.5 million in May 2025 following the standard marketing authorization for FILSPARI in Europe[33] Equity and Financing - The weighted average common shares outstanding increased to 88,945,624 in Q2 2025 from 77,500,245 in Q2 2024[19] - The company issued 1,529,161 shares of common stock under the equity incentive plan, raising $4,706,000 in capital[25] - The total stockholders' equity as of June 30, 2025, was $32,747,000, compared to $15,147,000 as of June 30, 2024, showing growth in equity[25] - The Company received net proceeds of $306.4 million from the issuance of the 2.25% Convertible Senior Notes due 2029[119] Expenses and Liabilities - Selling, general and administrative expenses increased to $149.1 million in the first half of 2025, up 15.6% from $129.0 million in the first half of 2024[152] - Total liabilities as of June 30, 2025, were $522.562 million, a decrease from $535.048 million at the end of 2024[16] - As of June 30, 2025, total accrued expenses amounted to $81.682 million, down from $86.028 million at December 31, 2024[131] Inventory and Accounts Receivable - As of June 30, 2025, total inventory was $37.7 million, a decrease from $41.9 million as of December 31, 2024, with raw materials at $27.0 million and finished goods at $8.6 million[144] - Accounts receivable, net of reserves, increased to $38.7 million as of June 30, 2025, up from $27.1 million at December 31, 2024[145] Market Conditions and Risks - A 100 basis point increase in interest rates would result in an estimated $0.7 million decrease in the fair value of the company's investments[236] - The company does not currently hedge against foreign currency exchange rate risks, which may affect contracts with international vendors[238] - Inflation has primarily increased labor costs, but it has not adversely affected the company's current outlook or business objectives[239] - The company maintains a full valuation allowance for its net deferred federal income tax assets, indicating no expected material change from the new tax law[153] Other Significant Events - The company completed the sale of its bile acid business to Mirum Pharmaceuticals in August 2023, with potential contingent payments of up to $235.0 million based on future sales milestones[148] - The Company announced a voluntary pause of enrollment in the Phase 3 HARMONY Study to address manufacturing scale-up issues[38]