Esperion Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome. 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 call may be recorded. I would like to hand the conference call over to Alexis Callahan, Head of Investor Relations at Esperion. Please go ahead, Alexis.

Thank you, Operator. Good morning, and welcome to Asperion's second 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, August 1st, 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 second quarter results and the recent progress we've made. Our business is continuing to grow each quarter. We are pleased to report total revenue for the second quarter of $25.8 million, which is a 37% increase year over year. We reported $20.3 million in U.S. revenue, reflecting 49% year-over-year growth. We attribute the strength of our U.S. business to increased awareness of our brands and our clinical data, as well as solid execution of our commercial strategy as we prepare for full launch. Second quarter retail prescription equivalents from Nexotol and Nexoset grew 26% year-over-year, and we've been regularly hitting new weekly highs in prescriptions since our ACC presentation in the first quarter, bolstered by additional data released in the second quarter. New-to-brand prescriptions have also continued to grow, driven first by the robustness of our clear outcomes, cardiovascular risk reduction data presented at ACC in March, and second by the impressive primary prevention data presented at ADA in June. In the period from ACC through the end of June, we showed 60% growth in new-to-brand prescriptions. For the second quarter, NBRX increased by 28% quarter-over-quarter. Let me next walk you through some additional key highlights from the quarter. As I just mentioned, we saw continued RPE growth in the second quarter of 26% year-over-year. We are pleased with this trend, which we've been able to accomplish with the current label and promotional footprint. As promised, we submitted our regulatory filings during the second quarter in both the US and EU to meaningfully expand our labels in both jurisdictions. Our clinical and regulatory teams worked tirelessly to compile the vast amount of data required for these submissions and which comes out of an outcomes trial of this scale, and we're proud of their execution. We anticipate a standard 10-month review for both submissions and therefore expect regulatory approvals of expanded labels in both the US and EU in the first half of 2024. We are continuing to pave the way for the significant growth we believe will result following label change. Our targeted commercial approach involves strategically presenting relevant analysis to the right audiences at a regular cadence, which enables us to effectively educate the market and target different segments of the population. In June, we presented impressive new primary prevention data at the American Diabetes Association Congress, which showed significant and clinically meaningful reductions in cardiovascular risk and LDL cholesterol. This means that our therapies are not only effective in patients who have already had a cardiovascular event, but who are at high risk of one, and meaningfully expands our addressable market. This primary provincial analysis was also simultaneously published in a prestigious journal of the American Medical Association, reinforcing its clinical significance. We also presented new intentions to treat and on treatment analysis at the Endocrine Society Congress, demonstrating improved outcomes and consistency of benefit, which is comparable to statins and better than PCSK9 inhibitors. We will continue to present results throughout the year at the highest level congresses and meetings we believe are the right fit, including two-way breaker presentations at the European Society of Cardiology in August. We are pleased to share that our partnership with CURAC launched in early Q3, as did another 20 in-house Salesforce members who joined Aspirion in new territories. We look forward to seeing increased traction over time as these new additions ramp up their territories in subsequent quarters. Lastly, we continue to have positive conversations with payers, and to date, we've now presented outcomes data to pharmacy benefit managers and national payers who represent over 80% of total U.S. pharmacy lives. Feedback has been extremely positive across the board, and payers are already adapting utilization management criteria to reflect our CBOT data. 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. Our current label is indicated for a small subset of patients with diagnosed atherosclerotic cardiovascular disease, ASEVD, and heterozygous familial hypercholesterolemia who cannot meet their goal on a maximally tolerated statin. Our new and expanded label will add a broad cardiovascular risk reduction indication in both primary and secondary populations, as well as remove current limitations, including the requirement of a maximally tolerated statin therapy. From a commercialization perspective, label expansion means we'll be able to meaningfully increase our adjustable patient population. Our clear outcomes data increases the total addressable population to approximately 70 million patients in the U.S. alone. Currently, our label covers approximately 10 million patients with documented ASCVD who are on a maximally tolerated statin and who are still not at their LDL cholesterol goal. Our new label will enable us to treat not only that population, but also an additional 15 million high-risk primary prevention patients who are taking the statin. 5 million patients with ASCVD or at high risk for ASCVD and who are statin intolerant. In total, our post-label change focus will be on these 30 million patients with additional potential upside from the untreated high-risk patient population, which represents another 40 million patients. We are confident that Nexlatal and Nexlozet have blockbuster commercial potential And we look forward to being able to reach even more patients who are 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 second quarter performance.