Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was $34 million, representing a 79% increase year-over-year [61] - US net revenue was $20.3 million, a 45% increase year-over-year, driven by a 33% year-over-year increase in retail prescription equivalents [45] - Collaboration revenue, including combined royalty and partner revenue, was $13.7 million, an increase of approximately 174% year-over-year [54] - Cost of goods sold was $13.4 million, an increase of 106% year-over-year [13] - R&D expense was $14.9 million, a decrease of 49% year-over-year [13] - SG&A expense was $33.2 million, an increase of 33% year-over-year [55] - Cash equivalents and investment securities totaled $114.8 million as of September 30, 2023, down from $166.9 million on December 31, 2022 [62] Business Line Data and Key Metrics Changes - Retail prescription equivalents (RPE) grew 33% year-over-year and 8% quarter-over-quarter [11] - New-to-brand prescriptions grew 61% from March to September 2023 [46] - Weekly RPE trend remained above the 10,000 RPE mark, setting new weekly highs [53] Market Data and Key Metrics Changes - Three additional countries (Netherlands, Slovakia, and Spain) received approvals during Q3 2023 [12] - In Europe, 158,000 patients have been treated with the therapies, representing a sequential growth of 26% since May [60] Company Strategy and Development Direction - The company is focused on expanding its label to include cardiovascular risk reduction, which is seen as a significant growth catalyst [49] - A strategic collaboration with ACC and Amgen was announced to launch a cholesterol screening campaign [50] - The company anticipates a new label approval by March 31, 2024, which will significantly increase the addressable patient population [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing litigation case and the potential for a positive ruling [20] - The company is preparing for the new label and expects to see accelerated prescription growth following the approval [49] - Management highlighted the importance of payer changes to realize the full potential of the new label [73] Other Important Information - The company is managing expenses diligently while preparing for a full-scale commercial launch next year [14] - The litigation case with Daiichi is ongoing, with a trial date set for April 15, 2024 [57] Q&A Session Summary Question: What is the outlook for gross-to-net trends in Q4? - Management noted typical seasonality in Q3 and expects continued improvement in gross-to-net trends over the longer term [19] Question: When could the milestone from the litigation case hit Esperion's balance sheet? - Management indicated that the milestone would not be recognized until early 2024, and they remain confident in the timeline [66] Question: How does the company plan to attract physicians interested in the drug? - Management mentioned that the team is unable to discuss new data until the label changes, which will help in expanding the population [22] Question: What is the typical patient profile for bempedoic acid? - The typical patient is on maximally tolerated statin therapy and not at their LDL-C goal, with a strong desire for primary prevention [80] Question: What are the approval rates for the therapies? - Approval rates have reached approximately 85% in commercial and Medicare, following presentations of CVOT data [83]
Esperion(ESPR) - 2023 Q3 - Earnings Call Transcript