Financial Performance - The company reported net losses of $31.3 million and $84.5 million for the three and nine months ended September 30, 2025, compared to $29.5 million and $30.4 million for the same periods in 2024, indicating ongoing financial challenges [166]. - The company has never been profitable and may need additional financing to support ongoing operations and product development [166]. - For the nine months ended September 30, 2025, net cash used in operating activities was $58.3 million, compared to a net cash provided of $11.3 million for the same period in 2024 [214]. - The company anticipates ongoing operating losses due to substantial expenses related to the commercialization of NEXLETOL and NEXLIZET, as well as research and development activities [210]. - Interest expense for Q3 2025 was $22.1 million, an increase of $7.0 million from $15.1 million in Q3 2024, primarily due to interest on the term loan [193]. - Interest expense for the nine months ended September 30, 2025 was $62.0 million, an increase of approximately $19.2 million from $42.8 million in the same period of 2024, primarily due to interest on the term loan [201]. Product Development and Efficacy - NEXLETOL demonstrated an average 20.0% placebo-corrected LDL-C lowering in the CLEAR Outcomes trial, resulting in a 13% lower risk of major cardiovascular events versus placebo [167]. - NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added to maximally tolerated statins, showcasing its efficacy in cholesterol management [168]. - The FDA approved expanded indications for NEXLETOL and NEXLIZET in March 2024, enhancing their market potential [163]. - NILEMDO received an expanded indication from the EC in May 2024 to reduce cardiovascular risk in patients with or at high risk for ASCVD [169]. - The company continues to focus on commercializing NEXLETOL and NEXLIZET in the U.S. while pursuing other research and development activities [170]. Revenue and Sales - Product sales, net for Q3 2025 were $40.7 million, an increase of $9.6 million from $31.1 million in Q3 2024, primarily due to prescription growth of NEXLETOL and NEXLIZET [188]. - Collaboration revenue for Q3 2025 was $46.7 million, up approximately $26.2 million from $20.5 million in Q3 2024, driven by increased royalty sales growth and product sales to collaboration partners [189]. - Collaboration revenue for the three and nine months ended September 30, 2025, was primarily related to sales of bulk tablets and royalty revenue from collaboration partners [175]. - Product sales, net for the nine months ended September 30, 2025 were $115.8 million, an increase of approximately $31.6 million from $84.2 million in the same period of 2024 [196]. - Collaboration revenue for the nine months ended September 30, 2025 was $118.8 million, a decrease of $60.2 million from $179.0 million in the same period of 2024, mainly due to a prior settlement agreement [197]. Expenses and Costs - The company incurred $8.8 million in expenses related to ongoing clinical studies during the nine months ended September 30, 2025, up from $5.6 million in the same period of 2024 [172][173]. - Cost of goods sold for Q3 2025 increased to $41.3 million from $17.3 million in Q3 2024, an increase of $24.0 million, mainly due to higher product sales to collaboration partners [190]. - Cost of goods sold for the nine months ended September 30, 2025 was $101.4 million, an increase of $58.4 million from $43.0 million in the same period of 2024, attributed to increased product sales [198]. - Selling, general and administrative expenses for Q3 2025 were $41.8 million, up approximately $1.8 million from $40.0 million in Q3 2024, mainly due to increased legal and media costs [192]. - Research and development expenses for Q3 2025 were $14.1 million, an increase of $3.7 million from $10.4 million in Q3 2024, primarily due to costs for ongoing clinical studies [191]. Financing and Capital Structure - The company completed an underwritten public offering of 56,700,000 shares at $1.50 per share, resulting in net proceeds of approximately $90.7 million after deducting $7.1 million in underwriting discounts and expenses [208]. - The company issued $100.0 million in 5.75% Convertible Senior Subordinated Notes due in June 2030, exchanging approximately $210.1 million of 2025 Notes [209]. - The company entered into a Credit Agreement for a $150.0 million term loan, which was fully borrowed at closing, with an annual interest rate of 9.75% if paid in cash [220]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $6.0 million, primarily from the 2023 ATM program [216]. - The company repurchased Revenue Interests for $343.8 million, eliminating future payment obligations under the Revenue Interest Purchase Agreement [223]. Future Outlook and Risks - The company expects research and development expenses to increase in 2025 as it begins its phase III pediatric trial and progresses its preclinical pipeline [179]. - Current cash resources and future proceeds from product sales and collaboration agreements are estimated to be sufficient to fund operations for the foreseeable future [228]. - Future funding requirements will depend on various factors, including the successful development and commercialization of product candidates [230]. - The company anticipates financing cash needs through collaborations, strategic alliances, licensing arrangements, debt financings, and equity offerings [229]. - Potential dilution of stockholder ownership may occur if additional capital is raised through equity or convertible debt securities [229]. - The company may need to relinquish valuable rights to technologies or future revenue streams through collaborations or licensing arrangements [231]. - Adverse macroeconomic conditions could materially affect the ability to consummate equity or debt financing on favorable terms [231]. - There have been no off-balance sheet arrangements as defined by SEC rules during the reported periods [232]. - No material changes have occurred regarding market risk disclosures since the last annual report [233].
Esperion(ESPR) - 2025 Q3 - Quarterly Report