Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in listen-only mode. Following the presentation, it will be a question-and-answer session. Please be advised that today's conference call will be recorded. I would now like to hand the conference over to Alina Venezia, Director of Investor Relations for Experion Therapeutics. Please go ahead.

Thank you, Operator. Good morning, and welcome to Experion's first quarter 2025 earnings conference call. With us on today's call are Sheldon Koenig, President and CEO, and Ben Halliday, CFO. Other members of the executive team will be available for Q&A following our prepared remarks. We issued a press release earlier this morning detailing the content of today's call. A copy can be found on the investor page of our website, together with a copy of the presentation that we will also be referencing. I want to remind callers that the information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to the risks and uncertainties associated with the business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release. and in our SEC filings. The content of the conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 6, 2025. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. We will begin the call with prepared remarks and then open the line for your questions. I now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. Throughout the first quarter, we continued to make progress across our three pillars for growth, revenue growth, portfolio expansion, and pipeline advancement. We posted year-over-year net U.S. product sales growth, enhanced reimbursement and access efforts, introduced new marketing initiatives targeting both physicians and patients, and advanced our ACLY pipeline with our declaration of our lead indication in primary sclerosing cholangitis, known as PSC. Turning to our progress and plans moving forward with our first pillar, increasing revenue and operating profitability, let me start with the sales and marketing of our benpidoic acid products in the U.S. and global markets. We are pleased with our performance this past quarter, which despite an overall flat lipid market in the U.S., saw green shoots of progress with significant strides in expanding our reach both domestically and internationally. Total revenue for the first quarter 2025 grew 63% year over year to $65 million after adjusting for a one-time milestone received in the first quarter 2024. U.S. net product revenue grew 41% year over year to $34.9 million driven by the expanded label and commercial initiatives started in 2024. First quarter 2025 script growth increased 2% sequentially compared to fourth quarter 2024. This was somewhat muted by the impact of a flat lipid lowering market in the first quarter 2025 that experienced seasonal headwinds due to changes in Medicare Part D and higher out-of-pocket costs as patients need to meet their annual insurance deductibles. In the US, we expanded our field reimbursement support team threefold and now have 15 seasoned payer access specialists strategically aligned with the 15 sales regions to support our growing prescriber base and educate on the favorable reimbursement landscape for our products. Our market access team achieved a number of victories this quarter. We had more than 30 plans, including several of the nation's largest insurance, removed prior authorizations, implemented electronic step edits, and included new formulary additions. These milestones highlight the strong clinical profile and competitive pricing of Nexlatol and Nexlazet, instilling greater confidence in healthcare providers to prescribe these treatments. These achievements not only broaden access for patients, but also reinforce our commitment to improving cardiovascular health on a large scale. In further support of our sales and marketing efforts, we are particularly pleased to report that Nexlatol and Nexlazet, were recently added to the new 2025 ACC AHA multi-society guidelines for the management of patients with acute coronary syndrome, or ACS. Bevidoic acid earned level 1A recommendations, the highest level of guidance, indicating strong recommendation where benefit greatly outweighs risk for patients with ACS already on maximally tolerated statin therapy and in patients with ACS who are statin intolerant. Bempatoic acid also earned a level 2A recommendation, meaning that moderate evidence exists and a recommendation is reasonable for patients with ACS who are already on maximally tolerated statin therapy. Here again, a non-statin lipid lowering therapy is recommended to reduce the risk of MACE. Inclusion in these guidelines allows us to more effectively market our Bempatoic acid products to healthcare practitioners. Combined with expanded payer coverage, reductions in prior authorization requirements, and the available reimbursement support resources, we believe we have significantly improved the access environment for patients and physicians alike. To better leverage this broader patient access, we recently introduced a series of payer and provider tactics that highlight the fact that up to 30% of patients are statin intolerant and showcase the evidence to demonstrate how Nexlital and Nexlizet are the only approved therapies proven to reduce cardiovascular events in statin-intolerant patients. Our goal is to underscore the persistent unmet need while promoting our safe and effective therapies. As a result of our efforts, we began seeing a shift in prescribing behavior starting in March. Early Q2 trends are encouraging, with prescription volume currently tracking approximately 8% higher than Q1. We expect this growth to continue as momentum builds and patient access improves further, particularly as copay levels continue to decline. To further support healthcare practitioners in the management of their LDL cholesterol levels, we are excited by the opportunity for the triple combination product we are developing in the U.S. as it will provide physicians with the flexibility of a suite of options that include monotherapy Nexlatol, dual therapy Nexlazet, and triple combination therapy benpidoic acid, ezetimibe, and either atorvastatin or rosuvastatin. We view this as a compelling opportunity to expand our role in the cardiovascular prevention market, as the published literature suggests that the triple combo products can lower LDL cholesterol in excess of 60%. This level of efficacy has the potential to rival existing injectable and emerging oral therapies, offering a valuable oral option for both patients and physicians. We expanded our partnerships with regulatory experts and others in the field to advance this important work with a goal to complete the clinical requirements and commercialize this triple combination in 2027. Moving on to international markets, where we and our partners are making great strides. We continue to see compelling growth from our partner Daiichi Sankyo Europe, where they are making meaningful progress expanding the use of Nalemdo and Eustendi to benefit patients at risk of cardiovascular disease who cannot manage their LDL cholesterol levels. In addition, we are looking ahead to an exciting year of continued growth in Europe and new product approvals and launches across a number of key geographies. Our royalty revenue from DSE increased 8% from the fourth quarter of 2024 to $10.5 million in the first quarter of 2025. As of the end of February, approximately 472,500 patients have been treated with our therapies in Europe. The ongoing growth in these European markets give us confidence that with our label expansion, we can build a sizable market in the U.S. In addition, the tech transfer for both Nalendo and Eustendia are also progressing nicely. Our Japanese partner, Otsuka Pharmaceutical, submitted for approval of our pembatoic acid product in Japan for LDL cholesterol lowering and remain on track for 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. Looking to the progress we made during the first quarter 2025, we expanded the breadth of our global reach by entering commercial partnerships with CSL Sequeris in Australia and New Zealand. As an update, Nino Farm Israel filed for regulatory approval during the first quarter and expects to receive approval in early 2026. In addition, Experion filed submissions for approval in Canada for Nexlatal and Nexlazet, and we anticipate market approval in the fourth quarter of 2025. Our international partnerships continue to deliver increasing royalty revenue, further demonstrating the global potential of our pembatoic acid products and supporting our strategic focus to drive revenue growth and operating profitability. Turning to advancing the pipeline pillar, we recently hosted our R&D Day in New York, where we introduced our novel program targeting PSC. PSC is a rare progressive liver disease with no approved therapies and represents a major unmet need with an estimated $1 billion annual market opportunity. This program reflects our strategy to expand into high need, high value indications, and highlights the broader potential of ACLY biology. The R&D Day event was very engaging and featured KOL discussions, a patient advocacy representative for the PCS community, a patient video, and an engaging Q&A session. I encourage those of you who may have missed it to listen to the archive of the event that is available on the Investor Relations section of our website. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the first quarter. Ben?