Esperion(ESPR) - 2021 Q3 - Quarterly Report

Financial Performance - For the three and nine months ended September 30, 2021, the company reported net losses of $69.4 million and $204.0 million, respectively, compared to net losses of $85.4 million and $39.1 million for the same periods in 2020[156]. - The net loss for Q3 2021 was $69.4 million, an improvement of $16.1 million compared to a net loss of $85.4 million in Q3 2020[190]. - Net cash used in operating activities totaled $206.1 million for the nine months ended September 30, 2021, compared to $16.6 million for the same period in 2020[213][214]. - The company anticipates incurring losses for the foreseeable future due to significant costs related to the commercialization of NEXLETOL and NEXLIZET[212]. Revenue and Sales - Product sales, net for Q3 2021 were $10.9 million, up from $3.3 million in Q3 2020, an increase of $7.6 million primarily due to prescription growth of NEXLETOL and NEXLIZET[190]. - Product sales, net for the nine months ended September 30, 2021, were $27.9 million, an increase of $23.1 million from $4.8 million in the same period in 2020, driven by a 33% growth in prescriptions[199]. - Collaboration revenue for Q3 2021 was $3.5 million, compared to $0.5 million in Q3 2020, an increase of $3.0 million mainly from product sales to collaboration partners and royalty revenue[191]. - Collaboration revenue for the nine months ended September 30, 2021, was $35.2 million, a significant decrease of $177.9 million from $213.1 million in the same period in 2020[201]. Expenses and Cost Management - The company reduced operational expenses through a corporate workforce reduction of approximately 40%[153]. - Research and development expenses for Q3 2021 were $25.3 million, down from $35.3 million in Q3 2020, a decrease of $9.9 million[190]. - Selling, general and administrative expenses for Q3 2021 were $39.3 million, down from $48.8 million in Q3 2020, a decrease of $9.6 million[190]. - Selling, general and administrative expenses for the nine months ended September 30, 2021, were $146.6 million, an increase of approximately $8.5 million from $138.1 million in the same period in 2020[204]. - Interest expense for the nine months ended September 30, 2021, was $32.9 million, an increase of $19.2 million compared to $13.7 million for the same period in 2020[205]. Cash Position and Funding - As of September 30, 2021, the company's cash and cash equivalents totaled $153.7 million, including $50 million that is restricted[210]. - The company expects its current cash runway to allow operations into the second quarter of 2022, excluding $50.0 million of restricted cash[223]. - The company anticipates needing additional financing to support ongoing operations and product development[158]. - Future funding requirements will depend on successful development and commercialization of NEXLETOL and NEXLIZET, costs of clinical studies, and ability to establish collaborations[221]. - If additional funds are not raised, the company may need to delay or terminate product development efforts[223]. - The company may face dilution of stockholder ownership if additional capital is raised through equity or convertible debt securities[223]. Clinical Trials and Product Development - NEXLETOL demonstrated an average 18% placebo-corrected LDL-C lowering in Phase 3 studies involving over 3,000 patients[159]. - NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added to maximally tolerated statins in Phase 3 data[160]. - The CLEAR Outcomes trial is designed to evaluate the effect of bempedoic acid on major adverse cardiovascular events, with an expected completion of the target number of events in the second half of 2022[168]. - The CLEAR Outcomes trial has over 14,000 patients enrolled across 1,200 sites in 32 countries, targeting patients with high cardiovascular disease risk[165]. - The company expects to incur significant expenses and operating losses due to ongoing CLEAR Outcomes trial and commercialization activities for NEXLETOL and NEXLIZET[221]. Corporate Strategy and Market Impact - The company plans to focus commercialization efforts on a streamlined sales force and digital initiatives to increase awareness and utilization of its medicines[174]. - The ongoing COVID-19 pandemic has materially adversely affected the company's business, financial condition, and results of operations[170]. - The company continues to monitor supply chain disruptions related to COVID-19, ensuring continuity of manufacturing and supply[175]. - The company has implemented a corporate workforce reduction of approximately 40% to optimize its cost structure in response to the COVID-19 pandemic[174].