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 now like to hand the conference call over to Ben Church, Investor Relations and Corporate Communications at Asperion. Please go ahead, sir.

Thank you, operator. Good afternoon and welcome to Asperion's fourth quarter and full year of 2020 financial results and company update conference call. I'm Ben Church, and I'm responsible for investor relations and corporate communications here at Aspirion. With me on today's call are Tim Mayleben, President and Chief Executive Officer, Sheldon Koenig, Chief Operating Officer, and Rick Bartram, Chief Financial Officer. 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 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 23rd 2021 we undertake no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call in webcast as a reminder this conference call and webcast are being recorded and archived we issued a press release this afternoon detailing the content of today's call a copy can be found at www.esperian.com within the investors and media section we will begin with 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 investorrelations at aspirion.com to schedule 15 minutes to speak with our team. I'd now like to turn the call over to our president and CEO, Tim Mayleben. Tim?

Thank you, Ben, and good afternoon, everyone. We appreciate you joining us today as we update you on Aspirion and the significant opportunity that we believe still lies ahead. Since we announced preliminary financial results several weeks ago, we'll keep our prepared remarks brief and get into Q&A. Now, for many, 2020 will be remembered as the year everything changed. While the world changed around us in obvious ways, Aspirion changed fundamentally as a company. We received our first marketing approvals for Nexla Tall, Bempadoc Acid, and Nexla Zet, the first ever non-statin fixed-dose combination tablets. of benpidoic acid and azetamide, moving us from an R&D company to an R&D and commercial organization and global partner. This was an accomplishment more than 10 years in the making and one that most companies never realized our team did. We also secured additional marketing approvals in Europe, the UK, and Switzerland under the brand names Nelendo and Newstendi. We worked with our EU commercial partner Daiichi Sankyo Europe to launch in Germany in 2004, while earlier announcing a strategic collaboration with Otsuka Pharmaceutical to develop and commercialize our medicines in Japan. All of this as we and the rest of the world battled against the uneven impacts of COVID-19 and the vast majority of people stayed safely at home. Following their approvals by FDA, we launched our medicines in the U.S. in the second quarter of 2020, and while we haven't yet achieved the commercial potential for our medicines, we're confident the long-term opportunity remains intact. Throughout 2020, far fewer patients ventured to their healthcare providers in avoidance of the virus, resulting in fewer written statin prescriptions and non-statin prescriptions for lowering bad cholesterol than the year before. This was the first time in history that statin prescriptions declined year over year. But despite this, 21,000 patients in the U.S. filled Nexlatol and Nexlazet prescriptions in 2020. We continue to hear resoundingly positive feedback about how Nexlatol and Nexlazet are working to lower patients' LDL cholesterol levels in combination with diet and maximally tolerated statins, which is an important metric for our future success. As the lipid management company, we are constantly seeking to better understand patients' experiences, especially those whose needs aren't being met by current treatment options. We work to discover, develop, and commercialize innovative medicines in combinations with established medicines that are easy to get, easy to take, and easy to have. We have an enviable track record in delivering upon our development commitments with a world-class R&D team. The team is now fully focused on successfully completing our landmark, clear cardiovascular outcomes trial, what we call a CVOT, that will determine the ability of benpidoic acid to reduce cardiovascular events such as heart attacks and strokes. We've invested in the CVOT because there is tremendous unmet need for additional drugs that reduce the risk of cardiovascular events, the number one leading cause of death in the world. We believe patients around the world deserve better than the status quo. We aim to change the therapeutic landscape, a landscape that has resulted in an overall underinvestment in the development of new cholesterol-lowering therapies for cardiovascular disease. In particular, There is a significant need among people who can't reach their LDL cholesterol goals with maximally tolerated statins who, as a result, are at high cardiovascular risk and in need of non-statin options. This statin intolerant patient population is a group you have heard us speak about many times in the past. There are more than 35 million patients considered statin intolerant in the US, Japan, and the EU. Statin intolerance impacts up to 20% of individuals who have been treated with the statin. Literally tens of millions of adults need to lower their levels of bad cholesterol beyond diet and maximally tolerated statins. And the vast majority need convenient, non-statin, once daily pills that are affordable. Clear Outcomes is a pioneering event-driven trial, the first of its kind, focusing on statin-intolerant patients. With over 14,000 patients enrolled, it is powered for success and is optimally designed to demonstrate the full potential of bumpidoic acid, impressive LDL cholesterol lowering for patients that can't or won't take statins, statin-like levels of HSCRP reduction in a non-statin oral medicine, and the potential for showing additional positive glycemic effects. Despite the pandemic, the CVOT remains on track. In fact, we collected 50% of the major adverse cardiac events, the primary endpoints, during the third quarter of 2020 and remain on target for the second half of next year. Positive results from the CVOT will have the potential to once again prove our leadership and our willingness to take on the hard challenges for patient groups that have been underserved. We're also working with other purpose-driven companies to deliver upon our promise around the world. We've entered into collaborations with Daiichi Senkyo in Europe and Otsuka in Japan, both of which have extensive experience in the cardiovascular field. In Germany alone, 4,000 patients were on our medicines within the first two months of the launch by DSC. For Japan, Otsuka plans to initiate a phase two study in Q1, in fact, this quarter. We continue to work through the last major piece of the global benpidoic acid network, completing a rest-of-world partnership that will further increase the future opportunities of our medicines to reach patients around the world. Perhaps most importantly, even after completing the rest-of-world partnership, Aspirion will still own exclusive rights to almost 70% of the global benpanoic acid franchise value. In closing, 2020 will be remembered as the year everything changed, including leaps forward for patients struggling with high levels of bad cholesterol. We're grateful to the patients and healthcare providers who placed their trust in our company and our medicines. We thank our shareholders for your ongoing support of Aspirion. And we take pride in our accomplishments and look forward to the post-pandemic world with great optimism. Next, Sheldon, who recently joined us as our Chief Operating Officer, will share how he is applying his extensive experience in cardiovascular to bring us to a leadership position with our medicines as the pandemic recedes. Then, Rick Bartram, our CFO, will highlight how we are reinforcing the company's ability to grow with diversified revenue streams, conservative expense management, especially during what remains of the pandemic, and our focus on maintaining a strong cash position. With that, I'll turn it to Sheldon. Sheldon?