Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to Experian Therapeutics Third Quarter 2023 Financial Results Call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference may be recorded. I would now like to hand the conference over to Alexis Callahan, Head of Investor Relations at Experian. Please go ahead, Alexis.

Thank you, Operator. Good morning. and welcome to Aspirion's third quarter 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. 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, November 7th, 2023. We undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the day of this conference call and webcast. As a reminder, this conference call and webcast are being recorded and archived. 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. 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 third quarter results and the progress we continue to make. We are pleased to report another strong quarter. Total revenue was $34 million, which represents a 79% increase year over year. U.S. net revenue came in at $20.3 million, which represents a 45% increase year-over-year, and was driven by a 33% year-over-year increase in retail prescription equivalents. We are proud of the continued strength of our U.S. business into the second half of the year, and believe this reflects the robustness of our clinical data, the efficacy of our life-saving medications, Nexlatal and Nexlavet, as well as disciplined execution of our commercial strategy. We're also pleased to build upon our momentum in new-to-brand prescriptions in the seven months following our clear outcomes readout at ACC in March, bolstered by the cadence of additional impressive data releases and publications since then, most recently at the European Society of Cardiology Congress in August. From March through the end of September, new-to-brand prescriptions grew 61%, with momentum continuing from the second quarter into the third quarter. Next, let me walk through additional highlights from the quarter. As I already mentioned, we delivered continued RPE growth in the third quarter of 33% year over year, demonstrating consistent growth even with our narrow indication. After submitting our regulatory filings to include cardiovascular risk reduction in Nexatol and Nexazet labels last quarter, we're pleased to announce FDA acceptance of our submission with a PDUFA or approval date of March 31st, which is ahead of when we originally anticipated approval. Lastly, regulatory review of our cardiovascular risk reduction label submission in the EU remains on track, and we continue to anticipate its approval in the first half of 2024. During the third quarter, we continue to disseminate new data from Clear Outcomes to educate the market about the benefits of our product. We presented two new analysis at the European Society of Cardiology in August that further support cardiovascular risk reduction. The first analysis demonstrated that benpidoic acid reduces total major adverse cardiovascular events, reinforcing the value of long-term benpidoic acid use and reducing not just the first, but multiple events over time. The second analysis also demonstrated that benpidoic acid reduces time to first major adverse cardiovascular events in patients with diabetes and does not increase the rate of new onset diabetes, which is a key differentiating feature compared to statins and underscores its safety and efficacy in patients both with and without diabetes. Patients with diabetes who are at increased risk for cardiovascular events constitute a large proportion of the primary prevention population that we studied in Clear Outcomes. So, this finding is important. These analyses continue to demonstrate the efficacy and safety of benpatoic acid, further differentiating it from existing LDL cholesterol-lowering therapies, and highlighting its first-in-class mechanism of action. It is not an overstatement to say that our focus is on expanding our label to include cardiovascular risk reduction, which, as we've always said, is the real growth catalyst. And following that is when we will begin to see accelerated prescription growth. To that end, our entire organization is now focused on preparing for this update, and we've begun laying the groundwork to make changes to our sales organization so that we can hit the ground running the moment we receive approval of our new expanded label. Next, our ongoing conversations with payers are continuing to pay off. With recent wins for improved coverage, and utilization management criteria that aligns with clear outcomes data. It is encouraging to see these types of mid-cycle changes with national and regional payers, which are not common, and we look forward to continued progress. Finally, we announced a strategic collaboration with ACC and Amgen to launch the Cholesterol Screening Campaign with the goal of increasing awareness of the importance of LVL screening to help healthcare practitioners more easily identify patients at high risk of a cardiac event who could benefit from treatment. Based on our clear outcomes data, we believe we have the potential to benefit a much larger group of patients than is characterized by our current label, which is quite narrow and indicated only for a small subset of patients. The label we anticipate receiving in March will add a broad cardiovascular risk reduction indication in both primary and secondary populations, as well as remove current limitations. From a commercial perspective, our addressable patient population will significantly increase when we get our new CVOT label next year. Right now, our therapies are only indicated for about 10 million secondary prevention patients with documented ASCVD or HEFH and who are on a maximally cholerated statin therapy. Our new label that we anticipate by March 31st will reflect our clear outcomes data and enable us to be indicated for an additional 20 million high-risk primary prevention patients. And these 30 million patients in total will be our primary focus. There are another 40 million patients in the US who are untreated and at high risk for an event, and those patients represent additional potential upside. We look forward to being able to address the needs of millions of patients who are currently still unable to achieve their LDL cholesterol goals on current therapies alone. With that, I will now hand it over to Ben Halliday, our Chief Financial Officer, for a more detailed overview of our third quarter performance.