Esperion Therapeutics, Inc.

Hello, ladies and gentlemen, and thank you for standing by. Welcome to Asperian's Third Quarter 2025 Financial Results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Alina Venezia, Head of Investor Relations for Asperian Therapeutics. Please go ahead.

Thank you, Operator. Good morning and welcome to Experian's third 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 provision of the Private Security 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 RICC filings. The content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 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 up the line for your questions. I'll now turn the call over to Sheldon.

Thank you, Alina. Good morning, everyone, and thank you for joining us. Once again, we are very pleased to be reporting another strong quarter. Total revenue for the third quarter 2025 grew 69% year-over-year to $87.3 million. Looking at our strong U.S. performance, we saw nearly double-digit sequential quarterly prescription growth, with U.S. net product revenue growing 31% year over year to $40.7 million. During the third quarter, we continue to lay the groundwork for the future by investing in enhanced patient access programs that are intended to drive prescription growth and revenue in the months and years ahead. While this impacted sequential growth this quarter, these were important one-time costs that we are confident will provide significant return on investment. That said, this was also our strongest third quarter of record, a particularly meaningful achievement given that this period has historically delivered more modest growth due to summer months and both patient and physician vacations. This outstanding performance reflects the strength of our execution and a growing recognition of benpitoic acid as a differentiated treatment for patients, especially those who cannot tolerate statins. Our commercial strategy is resonating. Prescriber engagement is up. patient access is expanding, and our creative campaigns are winning industry recognition. In addition to our commercial momentum, we made important strategic progress this quarter. We finalized agreements with four generic manufacturers, including Dr. Reddy's, not to market generic versions of Nexatol and Nexazet prior to April 2040, which supports the long-term value for our Blockbuster franchise. We also saw our Bempatoic Acid products included in the ESC EAS guidelines, a significant validation of their clinical benefit, and a strong signal for expanded use. We expect similar inclusion in U.S. guidelines in early 2026, further reinforcing our leadership in cardiovascular risk reduction in both primary and secondary prevention for patients who need alternatives to statins. Turning to our progress in the U.S. market, during the third quarter, we outpaced the broader adjunct lipid-lowering market, delivering growth that exceeded all other non-statin products in the category, including branded products. This momentum reflects both the clinical relevance of our benfatoic acid products and the effectiveness of our winning commercial strategy. I want to take a moment to recognize the outstanding work of our commercial team. From sales and marketing to reimbursement and market access, their execution has been nothing short of exceptional, a textbook example of what commercial excellence looks like in our industry. Our continued growth is a direct result of making smart strategic choices, striking the right balance between in-person and digital engagement, investing in top-tier talent and high-impact programs, and delivering bold, award-winning marketing campaigns that resonate with our audience. Their dedication and agility have been instrumental in driving performance and positioning us for sustained growth. In further support of these achievements, we are excited to welcome John Harlow to our team as Chief Commercial Officer effective November 17th. John joins us with more than two decades of experience building and scaling commercial organizations across both large and emerging pharmaceutical companies. Most recently, he was Chief Commercial Officer at Melinda Therapeutics, where he led a team of 80 professionals across all commercial functions, where he nearly doubled revenue, delivering approximately 85% growth in 2024 from 2020. His proven ability to drive performance and inspire teams will be invaluable as we expand our reach, scale our operations, and unlock the full potential of our portfolio. Turning now to our commercial progress, last quarter we launched several strategic marketing initiatives, including a targeted campaign aimed at patients who are statin intolerant. a population that represents a significant unmet need. Our research indicates that nearly 50% of individuals who begin statin therapy either discontinued treatment or had over a six-month gap in therapy within two years. This gap leaves many patients vulnerable to cardiovascular events and presents a substantial market opportunity for Nexlatal and Nexlazet. To address this, we introduced our Can't Take a Statin? Make Nexlazet Happen campaign This initiative has already begun to elevate brand awareness among our key demographics, with healthcare professionals reporting a significant increase in their perception of rating of Nexlital and Nexlivet for statin-intolerant patients based on quantitative data. These findings further support the transition from awareness to use and the impact of our powerful marketing. On September 22nd, we launched a pilot promotional ads on connected TV platforms such as Hulu and Disney+. Building on that momentum, we began airing branded commercials during Grey's Anatomy on Disney Plus and Hulu starting October 10th. These ads feature our award-winning lipid lurkers and are designed to spotlight the issue of statin intolerance while positioning Nexlaton and Nexlaset as compelling alternatives. We anticipate these commercials will generate approximately 18 million impressions specifically targeting adults over the age of 50 who have a history of stat use but have not been on therapy for at least a year. As of mid-October, we have already had greater than 6 million views of the full length of the commercial. We remain deeply committed to expanding the reach of these successful programs and are confident in their continued contribution to our growth trajectory. In addition to driving demand for our benpatoic acid products, we have made meaningful progress improving the access environment for patients and physicians alike. In the third quarter, we achieved an 87% average approval rate for Medicare coverage with out-of-pocket costs of $29 for a 30-day supply compared to $64 for a 30-day supply in the first quarter of 2025. In the third quarter, we averaged an 86% approval rate for commercial coverage with an out-of-pocket cost of $36 for a 30-day supply compared to $55 for the first quarter of 2025. In addition, the benefits of these copay programs have improved patients fulfilling their prescriptions by 17%. These are meaningful cost reductions that underscore the growing payer confidence in our therapies and the fact that patient access for Nexlatal and Nexlazet has never been easier. Importantly, we added and enhanced coverage with two major Medicare providers beginning October 1st. While this coverage required near-term investment, we believe it will drive volume into the future that will more than compensate for these one-time costs. We now have greater than 90% of commercial lives and more than 80% of Medicare beneficiaries covered, with all national commercial and Medicare payers covering all indications. This combined progress, including expanded payer coverage, reduced prior authorization barriers, enhanced reimbursement support resources, and our balanced approach to direct and digital marketing resulted in a 9% increase in total retail prescription equivalents from Q2 2025, and a 7% increase in the number of healthcare professionals prescribing Nexlatal and NexlaZet, bringing our total prescriber base to more than 30,000 healthcare practitioners. This growth validates the rising confidence among clinicians and the expanding role our therapies are playing in addressing the unmet needs of statin intolerant patients. The combined strength of our statin intolerance campaign, improving pair dynamics, and the continued success of our lipid lurkers campaigns position us well for sustained momentum in the quarters ahead. A very important advancement during the third quarter was the inclusion of benpidoic acid as a class one level A recommendation in the 2025 ESC EAS guidelines. This endorsement by Europe's leading cardiovascular societies validates the clinical impact of our therapy for patients unable to tolerate statins and reinforces our commitment to expanding access to innovative lipid lowering solutions. As I noted earlier, we believe this recognition will be reflected similarly in the forthcoming US guidelines expected in Q1, 2026. In preparation, we are laying the foundation to leverage this growth opportunity by increasing patient support programs, market access contract activation, engagement with integrated delivery networks, and direct-to-consumer initiatives such as our Connected TV campaign. Turning now to the progress we are making through our international partners around the world, where we continue to see significant growth in both geographic expansion and in licensing product sales, Let's start with Europe, where our partner Daiichi Sankyo Europe continues to deliver robust revenue growth and expand market share for both Nalemdo and Nusendi. We expect the recent inclusion of ESC-AS guidelines to support its expanded utilization across the 30 countries of the European Union, where Daiichi Sankyo Europe already has in excess of 600,000 patients who have been treated with our therapies in Europe. DSC also expanded their geographic reach for the launch of Nalemdo in Denmark, Sweden, and Finland. Third quarter royalty revenue from DSC increased 21% sequentially to $16.4 million compared to the second quarter of 2025. In August 2025, DSC announced the development of oral triple combination liquid lowering tablets with the Santorini study simulation showing improved LDL-C goal attainment aligned with the 2025 ESE EAS guidelines. We continue to make progress advancing multiple processes for the technology transfer for manufacturing of Nalimdo and Newstendi to DSE with expectations for DSE to ramp up beginning in early 2026 and with certainly working capital benefits expected in 2025. In September, we were delighted to report that our Japanese partner, Otsuka Pharmaceutical, received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for Nexletol as a treatment for hypercholesterolemia and familial hypercholesterolemia. Most recently, Otsuka received favorable preliminary pricing approval from the National Health Insurance in Japan, which will trigger significant milestone payments from Otsuka upon final pricing approval. This favorable pricing is particularly encouraging as the Japanese market is the world's third largest cardiovascular prevention market, and the royalties on Japanese product sales will be a meaningful revenue contributor over time. We are also expanding our international reach in a variety of other regional markets where, cumulatively, we are building meaningful revenue streams through commercial partnerships. Our Canadian partner, HLS Therapeutics, has already filed new drug submissions to Health Canada for Nexlithol and Nexlivet, and are on track for market approval by year-end 2025. Our partner in Israel, Neofarm Israel, also expects market approval of Nexotal and Nexoset by year-end 2025. CSL Seqirus, our partner in Australia and New Zealand, filed a marketing submission for Nexotal and Nexoset in July and expects to receive market approval in the fourth quarter of 2026. Progress with these international partnerships is expected to deliver a steady cadence of approval and product launches over the coming months and year that will provide a growing royalty stream and a few potential milestone payments, all of which support our strategic focus to drive revenue growth and profitability. Turning to our pipeline, where our strategy is to expand into high-need, high-value indications that highlight the broader potential of our novel ACLI biology beyond cardiovascular disease, here we were excited to nominate ESP2001 our highly specific ACLY inhibitor as our first preclinical development candidate for the treatment of primary sclerosing cholangitis, or PSE. With this candidate selection, we will begin IND enabling studies with a goal to file an IND with the FDA to initiate first in human clinical studies in 2026. PSE is a devastating condition with no approved treatment, and our preclinical data suggests ESP2001 has the potential to meaningfully impact disease progression. We're proud to advance a candidate that reflects the capabilities of our next generation ACLY inhibitor program and our commitment to addressing areas of high unmet need. With that overview of the business, let me turn the call over to Ben for a detailed review of our financial progress during the third quarter.