Sheldon Koenig
Analyst · Jefferies
Thank you, Alina. Good morning, everyone, and thank you for joining us. As I've noted in prior calls, 2024 was a transformational year for Esperion as we received the expanded labels for our bempedoic acid products in the U.S., supported global expansion with our partners in key markets and significantly strengthened our financial structure to enhance our balance sheet and provide us with financial and operational flexibility to support our future growth. Importantly, the advances and improvements we made during 2024 formed a strong foundation from which we can focus on our bold vision for the future that is centered around 3 strategic pillars for building a blockbuster company: continued revenue growth, operating profitability and portfolio expansion and pipeline advancement. Focusing on our first pillar, increasing revenue and operating profitability, let us turn now or look at our progress and plans moving forward with the sales and marketing of our bempedoic acid products in the U.S. and global markets. In March 2024, we received U.S. FDA approval for the expanded labels for NEXLETOL and NEXLIZET, making them the only FDA-approved nonstatins to lower LDL-cholesterol and reduce the risk of myocardial infarction and coronary revascularization in both primary and secondary prevention patients. Since that time, we have consistently posted double-digit sequential quarterly growth in total retail prescription equivalents, or TRPEs. During the fourth quarter of 2024, we achieved 12% sequential quarterly growth in TRPEs compared to the third quarter of 2024, substantially expanded payer access and now have more than 173 million lives covered in the U.S. We are also proud that NEXLETOL and NEXLIZET have been recently added as preferred agents to the U.S. Department of Defense Uniform Formulary, now accessible to the 9 million active duty dependents and retirees covered under this program. In tandem, we increased our prescriber base by 10% from last quarter and now have more than 25,000 health care providers writing scripts. The large and growing prescriber base is an important indicator of potential future growth as we have the opportunity to grow their base as they prescribe our products to more and more of their eligible patients. We expect to continue to build on this momentum throughout 2025 and believe that the established cardiovascular clinical benefits of our products, combined with an expanding awareness among health care providers and ever improving and growing patient access will support increasing TRPEs and revenues. To drive both physician and patient awareness of the prevalence of statin intolerance, we are introducing a series of lead behind resources that highlight the fact that up to 30% of patients are statin intolerant and showcase the evidence that demonstrate how NEXLETOL and NEXLIZET can effectively manage these patients at high risk of cardiovascular disease. Our goal is to continue to underscore the persistent unmet need while promoting our safe and effective solution. Consequently, to further aid health care professionals in the management of partial statin intolerance, we are developing triple combination products in the U.S. that would provide physicians with the flexibility of a suite of options that include monotherapy NEXLETOL, dual therapy NEXLIZET, and triple combination therapy, bempedoic acid, ezetimibe and either atorvastatin or rosuvastatin. This represents an exciting opportunity to expand our role in the cardiovascular prevention market as the published literature suggest triple combination products can lower LDL-cholesterol in excess of 60%. This level of efficacy has the potential to rival both existing and emerging injectable and oral therapies offering a valuable oral option for both patients and physicians. Now turning to the meaningful progress we're making internationally through our partnerships. We are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches in key geographies. First, we are particularly pleased that our Japanese partner, Otsuka Pharmaceutical, has submitted a new drug application for the manufacture and sale of our bempedoic acid product in Japan for LDL-cholesterol lowering. They expect approval and national health insurance pricing in the second half of 2025. The Japanese market is the world's third largest cardiovascular prevention market, and we believe the royalties on Japanese product sales will be a meaningful revenue contributor over time. Turning now to the European market. Our European partner, DSE, continues to successfully market NILEMDO and NUSTENDI and has demonstrated strong revenue growth. Our royalty revenue from DSE increased 9% sequentially to $9.7 million in the fourth quarter of 2024. For the full year of 2024, royalty revenue increased 116% year-over-year to $32.6 million. As of the end of December, approximately 453,000 patients have been treated with our therapies in Europe, representing 19% sequential growth over the past 3 months since September. This continued expansion gives us confidence that with our label expansion, we can build a sizable market in the U.S. The tech transfer for both NILEMDO and NUSTENDI are also progressing nicely. Yesterday, we are pleased to announce that we partnered with CSL Seqirus to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand. Under the terms of the agreement, we received an upfront payment and are eligible for near-term milestones along with a profitable transfer price on product sales. This is an important market for our products as cardiovascular disease affects 1.2 million people and the leading cause of death in Australia. In New Zealand, an estimated 175,000 adults are living with cardiovascular disease and 1 in 3 deaths are caused by cardiovascular disease. Furthering our international expansion, we entered into a licensing agreement with Neopharm Israel for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Israel and expect to file an NDA for marketing approval in Israel in the first half of 2025. In addition, we filed new drug submissions to Health Canada for NEXLIZET and NEXLIZET and anticipate market approval in the fourth quarter of 2025. Collectively, our international partnerships are delivering increasing royalty revenue, further demonstrating the global potential of our bempedoic acid products and supporting our strategic focus on driving revenue growth and operating profitability. Finally, we continue to reinforce the cardiovascular risk reduction benefits of our products with the ongoing presentation and publication of compelling clinical data. In the coming weeks, we look forward to presenting 2 post-hoc analysis from our CLEAR Outcomes study and poster presentations at the upcoming American College of Cardiology's Annual Scientific Session being held in Chicago. Importantly, we will be presenting these data to an audience of key physicians who play a critical role in treatment decisions. In addition, we will have an interactive exhibit booth, allowing health care professionals to engage with our clinical and commercial teams to gain deeper insights into the cardiovascular benefits of our bempedoic acid products. For those attending this year's ACC, we welcome you to visit us at our booth. Turning our attention to our other pillars for growth, portfolio expansion and pipeline advancement, our commitment to R&D strengthens all 3 strategic pillars: continued revenue growth, operating profitability and portfolio expansion and pipeline advancement. With a strengthened balance sheet, we are well positioned to in-license or acquire synergistic cardiometabolic assets while continuing to advance our clinical pipeline. Leveraging our leadership in ACLY biology, we are actively exploring new therapeutic opportunities and developing next-generation inhibitors designed to address serious diseases, including rare and orphan chronic liver and kidney diseases. We look forward to sharing more details on our clinical development plans at our R&D Day on April 24, 2025, where we will announce a lead indication and introduce our first candidate for development. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the fourth quarter. Ben?