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'll 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 Ben Church, Investor Relations and Corporate Communications at Esperion. Please go ahead, sir.

Thank you, operator. Good morning and welcome to Esperion's fourth quarter and full year 2021 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Experian. 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 the 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 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 22, 2022. 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 issued a press release this morning detailing the content of today's call. A copy can be found at www.asperian.com within the investors and media section. We will begin prepared comments and then open the call for your questions. Following today's call, the team will be available for follow-up questions. Please email corporate team at asperian.com to schedule time to speak with the team. With us today are Sheldon Koenig, President and CEO of Rick Bartram, CFO, Dr. Joanne Foody, our Chief Medical Officer, Eric Warren, our Head of Sales and Marketing, and Betty Jean Swartz, Senior VP of Market Access, HEOR, and Policy. I'll now turn the call over to Sheldon for prepared remarks. Sheldon?

Thanks, Ben, and good morning, everyone. Over this past year, the team at Aspirion worked diligently to rebuild a strong foundation and set a course for future success. As a result, we entered 2022 in the position of strength and re-energize for the opportunity that lies ahead. Through our transformational plan announced back in October, we have optimized our business to better align with the current healthcare environment. An extensive review of the organization and return on investment drove our decision to establish a new hybrid commercial model through which we are able to reduce our commercial footprint down to a core sales team of 80 territories while generating $80 million in annualized cost savings, maintaining our ability to drive consistent growth of our medicine and the flexibility to scale up in the future. During this transitional period, sequential demand of our medicines grew 9% in the fourth quarter, with U.S. net product revenue of $12.2 million, up 12% in the same period, and over 200% for full year 2021. These strong results were also the culmination of the enhanced product positioning and refined patient support programs we initiated in 2021. Further, in mid-January of this year, we deployed a contract sales organization on a trial basis to drive awareness among our targeted physicians within the white space between our 80 focus territories. This CSO can also be easily scaled up or down dependent on productivity and is something we view as a cost-effective growth resource. Overall, the results of the fourth quarter give us increased confidence that we'll continue to deliver consistent growth leading up to the top-line readout of the Clear Outcomes Trial in the first quarter of 2023. With the additional $209 million in net proceeds from our December financing, our cash runway now extends beyond this pivotal milestone. With $309 million in cash as of December 31st, Experion is well positioned to execute on its strategy in these current market conditions. More importantly, our unprecedented CLEAR outcomes trial continues to progress unencumbered. The trial reached 90% of its required major adverse cardiac events this February, indicating CLEAR is tracking in line to slightly ahead of expectations. With a top-line readout anticipated in Q1 2023, we are now less than one year away from a major inflection point in our growth trajectory. As such, in addition to executing on our plan to drive commercial growth of Nexlatel and Nexlovet, a major focus of Aspirion for 2022 is successfully closing out the Pivotal Clear Outcomes trial. As a reminder, CLEAR Outcomes is a 14,000-patient randomized outcomes trial, one of the largest outcomes trials of non-statin therapies yet, evaluating benpidoic acid ability to reduce incidence of adverse cardiovascular events in a unique patient population that is unable to adequately address their CV risk with the current standard of care. The trial design was developed in partnership with regulators, and is headed by the world-renowned trialist, Dr. Stephen Nissen. This, along with the size, scale, and scope of the study, gives us great confidence. A positive CVOT not only has the potential to expand our current label indication, but also to be practice-changing for physicians and life-changing for millions of patients around the world. During 2021, Daiichi Sankyo accelerated its commercial launch in Germany while also expanding into the UK and Austria, amassing over 45,000 patients on therapy through December. Even more so, we expanded our partnership with Daiichi to bring benfidoic acid and its combination with ezetimibe to the APAC region. Aspirion continues to evaluate any and all opportunities such as this to accelerate the distribution of our medicines to patients not being treated to LVLC goals. Otsuka, our partner in Japan, continues to progress along its clinical pathway. Its phase two study was initiated in Q1 2021 and was fully enrolled by end of December. While 2022 will be an important year for Aspirion as we prepare for several milestones, it also is critical for the millions of people living with heart disease and those recovering from COVID-19. In 2022, the world hopes to finally see a retreat of the COVID-19 pandemic. However, this devastating disease has taken its toll on global health in longer term and insidious ways. Already the number one killer worldwide, cardiovascular disease was worsened by the COVID-19 pandemic, driving an acceleration of cardiac events and increasing the number of patients at risk. According to a recent study published by Nature Medicine, COVID-19 survivors are left with a 63% higher risk for heart attack and a 52% higher risk of stroke. Study researchers found COVID is an equal opportunity offender, increasing the risk of cardiovascular problems for all people, no matter age, gender, or health status. The time is now more than ever for increased efforts to protect our heart health and as such, we expect a renewed focus from physicians on cardiovascular health and a heightened sense of urgency in getting patients to goal. Nexlatal and Nexlavet are commercially available today to provide the necessary benefits to struggling, indicated patients immediately. As a leading biotech in cardiovascular disease prevention, our focus will remain steadfast on diligently completing the CLEAR Outcomes Trial educating doctors about its implications and continuing to progress our pipeline that includes an oral PCSK9 inhibitor and an ACL inhibitor platform in order to benefit more patients worldwide. I look forward to updating you on our continued progress throughout the year and demonstrating our commitment to innovation for patients. I'll now pass it over to Rick for additional commentary on our quarterly and annual results.