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, there will be a question and answer session. Please be advised that today's conference call may be recorded. I'd like to hand the conference over to Alina Bencia, Director of Investor Relations for Experian Therapeutics. Please go ahead.

Thank you, operator. Good morning, and welcome to Experian's third quarter 2024 earnings conference call. With us today 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 this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 7, 2024. 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. As I look back over the past year, I continue to be so proud of all our team has accomplished. It has truly been a watershed year for Aspirion in which we, successfully expanded our Nexlatal Nexlazet labels to include broad new indications for primary and secondary cardiovascular risk reduction, scaled up our commercial team and launched these new indications, and broadened payer access and implemented marketing programs that have enhanced awareness of our new indications among healthcare providers to drive prescription growth. As a result of our team's collective efforts, we have posted double-digit prescription growth in both quarters since the launch. In addition, we've supported international growth and further expansion of Nalemdo and Newstendi, which continue to be impressive and support our continued confidence in the global market opportunity for our Bempadoic acid products. And importantly, we substantially strengthened our balance sheet by monetizing the European royalties on our Bempadoic acid product sales and allocated the proceeds for the early discounted payoff and termination of our previous revenue interest facility. We also continue to focus on additional ways to fortify our capital structure. Any one of these accomplishments would be meaningful on its own. Collectively, they have transformed Aspirion and laid a strong foundation from which to build and grow global revenues for our benpidoic acid products and to expand and advance our very promising clinical development program of ACLY inhibitors. Now let me turn to our progress with our U.S. commercialization efforts, which are gaining additional momentum as demonstrated by U.S. net product revenue growth of Nexazet and Nexazol in Q3 2024 of 10% sequential and 53% year-over-year growth. These increases were driven by the meaningful progress we continued to make during the first six months of the launch for our label expansions. As a reminder, our expanded labels have three significant differences. They now include CV risk reduction benefits, expand the patient population by including primary prevention, and enable use in patients that are unable to tolerate or maximize statin therapy. We have done an exceptional job building a strong foundation with the three key pillars for success, payers, physicians, and patients. We understand the necessity to remain committed to addressing the needs of each of these constituencies in order to successfully bring the benefits of Nexlital and Nexlivet to the 70 million patients eligible under the expanded labels. Starting with the payers, where we initially focused on making sure the utilization management criteria, or UM, for the expanded labels were in place. As of mid-July, more than 80% of UM criteria were updated to reflect the new label update, and more importantly, a significantly less burdensome prior authorization process was put in place. These updates totaled more than 114 million lives. Since then, we have grown that number to more than 165 million patient lives across all payers who have updated their UM criteria. This is a foundational building block to securing reimbursement and removing significant restrictions and barriers to access so physicians can now prescribe Nexlatol and Nexlazet with increased confidence. Another milestone achievement on this front was the expansion of our commercial and Medicare formulary coverage for Nexlatol and Nexlazet. In early September, we made new additions to Medicare formularies at Optum, United AARP, and CVS SilverScript, Coupled with our earlier coverage with Humana, we currently have access to more than 65% of Medicare-insured lives and more than 92% of commercially-insured lives under the new labels and UM criteria. Again, we expect this expanded payer coverage to drive further increases in physician confidence to prescribe Nexlital and Nexlizet, ultimately leading to higher product sales in the upcoming quarters and beyond. In tandem, we further advanced our sales and marketing campaigns aimed at educating healthcare providers about the clinical benefits of Nexlital and Nexlavet and empowering patients to talk with their clinicians about their cardiovascular risk. We continue to optimize our commercial tactics and remain efficient in allocating resources to initiatives that are yielding the most favorable ROIs. As a result of these combined initiatives by our managed care, sales force, and marketing teams in these first six months of launch, We now have nearly 24,000 healthcare practitioners writing scripts with total retail prescription equivalents, increasing approximately 12% and new to brand prescriptions, approximately 18% compared with the second quarter. This is just the type of momentum we want to see in the first six months of launch to drive accelerated growth in the coming quarters and into the new year. In fact, Our October 2024 results further validate this trajectory, with total retail prescription equivalents up 17% and new-to-brand prescriptions rising 20% compared to the first four weeks of the third quarter. This positive trend speaks to the effectiveness of our strategy, and we remain focused on sustaining this momentum to drive continued growth and long-term success. Notably, the three reasons that give us continued confidence in the blockbuster opportunity for Nexotol and Nexlovet and our ability to realize that potential remain unchanged. One, we have compelling data from the Clear Outcomes Study that support and validate the safety and efficacy of Nexotol and Nexlovet to reduce cardiovascular risk. Two, there is a massive underserved patient population of 70 million people at risk who need additional treatment options. And three, we have the right plan and the right people to drive adoption in this market and successfully execute our strategy. Let me now shift to the tremendous international progress we and our partners are making. In Europe, our partner DSE continues to post strong prescription and revenue growth as evidenced by approximately 19% sequential increase in our royalty revenue, which was $8.9 million in the third quarter of 2024. DSE received its approved expanded labels for Nalemdo and Newstendi from the European Commission in May and consequently kicked off their country launches with the new indications for cardiovascular risk reduction and expanded LDL cholesterol lowering in primary and secondary prevention patients. With up to 80% of patients in Europe unable to reach guideline recommended levels for LDL cholesterol despite taking statins, there is a meaningful market opportunity for DSE. Beyond Europe, our partner Daiichi Sankyo Company Limited gained approval for Nalemdo in Taiwan on October 7, 2024. The totality of expected country launches enhances the global awareness of the cardiovascular benefits of our benpatoic acid product and is expected to incrementally contribute to royalty revenue over time. Our Japanese partner, Otsuka Pharmaceutical, remains on track to file a new drug application in Japan by year-end 2024 with expected approval and national health insurance pricing anticipated in 2025. We are enthusiastic about the continued momentum in Japan as it is one of the largest markets for lipid-lowering therapies. This is a substantial market for Otsuka as well as a valuable royalty contributor for Aspirion growth in the future. Turning to our own efforts internationally, we expect to file a new drug application for approval in Canada this month and are optimistic about finalizing a partnership soon. Additionally, we expect potential submissions and or partnerships in Australia and Israel in the first half of 2025. Collectively, these advances expand the global commercial opportunity for our Bempatoic acid products, incrementally add to growing global revenue and position Aspirion as an attractive potential partner with a compelling value position. Finally, we continue to build a growing body of scientific and clinical knowledge that supports the cardiovascular risk reduction benefits of our products. To that end, we are delighted to be presenting key data at the American Heart Association Scientific Session, which will be taking place next week in Chicago. The AHA Scientific Sessions draw approximately 18,000 healthcare providers, including primary care physicians from more than 100 countries. This offers Aspirion an exceptional opportunity to showcase the clinical benefits of Nexotol and Nexoset before an audience of key physicians we aim to influence to prescribe our therapeutics. We are honored to have been selected for an oral featured presentation in the Late Breaker Featured Science Track, where our products will be highlighted in a presentation titled, Bempatoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease. new insights from the CLEAR Outcomes Trial. We also have three poster presentations at AHA. Statin intolerance due to muscle symptoms affects management of patients, insights from the CLEAR Outcomes Trial. Liver steatosis and liver fibrosis predict major adverse cardiovascular events in the CLEAR Outcomes Trial, and effectiveness of lipid-lowering therapy with benpidoic acid plus azetamide in a real-world cohort. In addition to these U.S. presentations, DSC had a strong medical and commercial showing at the European Society of Cardiology Congress, or ESC, in late August. ESC is the largest cardiovascular medical meeting of the year and is well attended by key opinion leaders from around the globe, including the United States. Consequently, we expect the efforts DSC made at ESC will also benefit our efforts to enhance the awareness and visibility for our product among U.S. healthcare practitioners. Beyond ESE, DSE reported final two-year real-world results from the Mylos German cohort at DGK Herzog 2024 in Hamburg, Germany, in late September. The data demonstrated a strong increase in the achievement of LDL cholesterol goals with the addition of benpidoic acids. The ongoing publication and presentation of data in support of the cardiovascular benefits of our product strongly validates our clinical value proposition and enhances awareness of their benefits among a growing physician base who are responsible for prescribing our products to their patients. We will look forward to updating you on our further progress over the coming months. 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. Ben?