Financial Data and Key Metrics Changes - Total revenue for Q2 2023 was $25.8 million, a 37% increase year-over-year [4][34] - U.S. revenue reached $20.3 million, reflecting a 49% year-over-year growth [4][34] - Retail prescription equivalents (RPE) grew 26% year-over-year and 16% quarter-over-quarter [33] - Cash, cash equivalents, and investment securities totaled $138.5 million as of June 30, 2023, down from $166.9 million on December 31, 2022 [34] Business Line Data and Key Metrics Changes - Retail prescription equivalents from NEXLETOL and NEXLIZET increased by 26% year-over-year [13] - New-to-brand prescriptions grew by 60% from ACC presentation to the end of June [13] - Collaboration revenue, including royalties and partner revenue, was $5.5 million, a 4% increase year-over-year [34] Market Data and Key Metrics Changes - In Europe, 123,000 patients have been treated with the therapies, representing a 26% growth since February [22] - The total addressable patient population in the U.S. is expected to increase to approximately 70 million following label expansion [19] Company Strategy and Development Direction - The company is focused on expanding its label to include a broader cardiovascular risk reduction indication [8][19] - A strategic approach is being employed to present relevant analyses to target different segments of the population [14] - The company anticipates significant growth following label expansion and full commercial launch in mid-2024 [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving blockbuster status for NEXLETOL and NEXLIZET, emphasizing the potential to reach more patients [20][38] - Positive feedback from payers has been received, with over 80% of U.S. pharmacy lives represented in discussions [16] - The company is preparing for a significant sales inflection post-label expansion [26] Other Important Information - R&D expenses for Q2 were $22.1 million, a decrease of 32% year-over-year [57] - SG&A expenses were $34 million, an increase of 15% year-over-year, reflecting upfront training costs and higher legal costs [57] - The company has sufficient cash runway through mid-2024, which aligns with expected regulatory approvals [35] Q&A Session Summary Question: What is the status of the April 2024 trial date? - Management expressed confidence that the trial date is set and that they expect a favorable outcome [64][70] Question: How are prescription volumes impacting gross to net? - Management indicated that gross to net has been stable, with increased volumes expected to improve it over the next one to two years [71] Question: Where are the increases in prescriptions coming from? - Increases are seen in both depth and breadth among current prescribers, with a balanced split between primary care and cardiology [74] Question: What is the current status of reimbursement dynamics? - There has been an increase in prior authorization approval rates, with efforts focused on educating offices about the process [106] Question: How is the detailing process being affected by the current label? - The sales team is focusing on the current strategy, with increases attributed to clinician appreciation for the data despite the label not being updated [103]
Esperion(ESPR) - 2023 Q2 - Earnings Call Transcript