Esperion Therapeutics, Inc.

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to Aspirin's fourth quarter 2023 earnings conference call. 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 would now like to hand the conference over to Alexis Calhoun, head of investor relations. Please go ahead.

Thank you, operator. Good morning and welcome to Asperion's fourth quarter and full year 2023 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 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, February 27, 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'll now turn the call over to Sheldon Koenig, President and Chief Executive Officer.

Thank you, Alexis, and good morning, everyone. Thank you for joining us today to discuss our fourth quarter and full year results and the significant progress we continue to make. We are pleased to report another strong quarter, as well as key material events in January that we believe put our company on solid footing and further position us for continued long-term success. Starting with our quarterly performance, total revenue was $32.3 million, which represents a 72% increase year-over-year. U.S. net revenue came in at $20.8 million, which represents a 39% increase year-over-year, driven by a 44% year-over-year increase in retail prescription equivalents. We believe the continued growth seen in both the U.S. and in our global territories is a testament to the strength of our clinical data, the unmet need in the market, and our teams' and partners' abilities to execute. Listed here are several recent accomplishments worth calling out. We delivered another strong quarter that positions us for continued success in the long term and significantly transforms our capital position and investment profile. Prescription growth continued at a strong pace, and we're proud of the momentum that we sustained through the end of the year. Additionally, we resolved our pending litigation with DSE and expanded our partnership on mutually beneficial terms. We further strengthened our balance sheet with additional capital, emphasizing our strong cash position and bringing in several new long-term biotech investors. Our label expansion approvals remain on track in both the US and Europe. We published additional important data from our clear outcomes trial, and we remain focused on preparation for our new label, expanding our commercial organization to ensure we're ready to fully capitalize on the opportunity when we receive approval next month. On January 3rd, we announced the settlement agreement and an amendment to our collaboration with Daiichi Sankyo Europe which marked the resolution of our pending litigation. Our settlement was mutually beneficial and reflects both parties' commitment to our ongoing partnership to deliver our medications to patients worldwide and address global unmet needs. Importantly, we believe the closure of this matter significantly strengthens our investment profile, reduces costs associated with the litigation, and is an excellent outcome for both parties. It provides for significant near-term cash payments, inventory and gross margin savings, and potentially extends our European product lifecycle while generating additional potential royalty streams in the DF territories. The net result of all components of our agreement provides both near and long-term value and allows us to continue focusing on running our business. Combining our year-end cash balance with the $100 million settlement payment received in January and proceeds from our recent offering, we significantly strengthen our liquidity position, which enables us to invest in initiatives that support the long-term success of Aspirion. With the litigation now resolved and the infusion of additional cash, we are poised for significant growth in 2024. Now let me turn to our upcoming label expansion, which we anticipate will include a new broad cardiovascular risk reduction indication, expand access to the primary prevention patient population, or those at risk of an event, not just those who have already had one, and remove the statin use requirement. These are significant changes to our current label, supported by our robust, clear outcomes data, and are expected to drive substantial future growth. I'm pleased to share that reviews of our pending applications with the FDA and EMA are progressing extremely well, and these positive discussions remain in line with our strategic goals. We are on track with an FDA PDUFA date of March 31st with an expected decision by the EMA on our European label likely coming in the second quarter. Based on our existing label and narrow indication, our current addressable market is around 10 million patients in the US. Upon approval of our new anticipated label, our models predict an opportunity that triples to around 30 million patients. That figure, however, does not include an additional 40 million untreated individuals who are at high risk and who are still not at their LDL cholesterol goal. we see vast potential for our products to help millions more patients in the future, reiterating our eagerness for the FDA's anticipated approval. Today, I'd like to outline the five core pillars that will ensure our life-saving products, Nexlatol and Nexlazet, reach the appropriate patients. One, our expanded label. Our anticipated new label will reflect clear outcomes data, and will also create a differentiated and expanded indication that includes high-risk primary prevention patients. Two, all new promotion. Current promotional resources for Nexlatal and Nexlazet are focused on LDL cholesterol reduction in patients with ASCVD on maximum tolerated statins and still not at their LDL cholesterol goal. Based on the anticipated new label, the team has prepared a powerful suite of promotional tools that will communicate the clear outcomes data across the expected new and expanded patient population. Extensive market research has been conducted to ensure the right sequence of data will be communicated at the right time. Three, deeper reach. I'm proud to announce that we've completed our Salesforce expansion and have recently deployed 60 new territory managers into the field bringing our team up to 150 representatives. These motivated individuals, together with improved digital resources, will allow us to expand our depth and breadth to reach a target universe of 45,000 healthcare providers comprised of both primary care providers and specialists. Four, patient activation. We've created a bold new consumer campaign to drive awareness and ensure appropriate patients have discussions with our healthcare providers about NexLatal and NexLisette. And five, payer access and reimbursement. Finally, we continue to align payers utilization management criteria with our anticipated label to include primary prevention and primary hyperlipidemia, while at the same time enhancing our patient service programs to support both patients and healthcare providers alike. We're also pleased to announce that ICER, the Institute for Clinical and Economic Review just determined Nexlozet as a cost-effective therapy which adds support for its value proposition to payers. We believe our recent achievements and changes we've implemented set us up for long-term sustained growth. Shown here are a series of important commercial, clinical, regulatory, and financial milestones that we expect to be achieved along the way. you'll see that this steady stream of catalysts begin to form a roadmap for long-term value growth. We've already expanded our sales force and anticipate label expansions in both the U.S. and Europe. With expected new global labels, we anticipate guidelines to be updated. In addition, we expect to file INDs, or Investigational New Drug Applications, for our next-generation ACLY inhibitors to lay the groundwork for growing our product pipeline beyond benpidoic acid. Furthermore, our partners will continue launching our products in even more new territories on a regular cadence, creating additional revenue streams and bolstering our growing global franchise. Longer term, the optimization of our balance sheet and partnership-related cost savings should enable us to continue to enhance our capital position over time. We also see meaningful revenue contribution stemming from the potential for a triple combination therapy in Europe, additional milestone payments from our network of partners, additional XUS opportunities, and continued growth stemming from further advancement of our preclinical pipeline. On that note, I'm excited to announce our intent to hold an R&D day later this year to review our pipeline of next-gen ACLY inhibitors in more depth. With that, I will now hand it over to Ben Halliday, our Chief Financial Officer, for a more detailed review of our fourth quarter performance.