2020 Annual Report will be remembered as the year everything changed. While the world changed around us in obvious ways, If anything, the pandemic and the resulting disruption of the Esperion changed as a company: We received our first healthcare system has reinforced our belief in the need for marketing approvals for NEXLETOL® (bempedoic acid) Tablet new, easier medicines to treat high cholesterol. and NEXLIZET® (bempedoic acid and ezetimibe) Tablet, moving us from a late-stage development company to a What we do remains the same: We work hard to make commercial organization and partner. medicines that are easy to get, easy to take and easy to have. Our commitment to grow our pipeline was bolstered We launched our first products in the U.S. in March and by the in-licensing of an oral PCSK9 inhibitor development June (respectively), secured additional approvals for both program. We look forward to sharing more progress on our medicines in the European Union, the U.K. and Switzerland, plans for this program later this year. and worked with our commercial partner Daiichi Sankyo Europe to launch in Germany, all as the world faced the There were few changes to how we work and no impacts from COVID-19. “learning curve” for us to work virtually – we were already doing it. Our remote workforce was an advantage as we Just as everything in our lives became more complicated launched our products at the height of the pandemic – errands, visits to family and friends, travel – so did last spring. managing a chronic disease. Not only are people with cardiovascular disease at increased risk of severe COVID-19, Undistracted, we continued our work for adult patients the pandemic has made it more difficult for them to manage trying to manage their low-density lipoprotein cholesterol their treatment. Medical services were disrupted around (LDL-C), especially those whose needs are not met by the the world; 75% of countries reported that healthcare for status quo. noncommunicable diseases, including cardiovascular disease, has been disrupted during the pandemic.1 In some And, importantly, your support of our company has not cases, the only solution was to stop seeking care unless it changed. Just as we are grateful to the patients and was urgent, and about 40% of adults in the U.S. said they physicians placing their trust in our products, we are postponed medical care in the summer of 2020.2 grateful to our shareholders for your ongoing trust in Esperion. We take pride in our Despite all of these difficulties, despite the fact that it accomplishments and would have been easier to put their health on hold for a few look forward to achieving months, more than 21,000 patients went to their doctors more together. and got a prescription for an Esperion medicine in 2020. We are grateful for the trust these patients and their physicians have placed in our treatments.
And although everything seems to have changed in 2020,
ESPERION Tim M. Mayleben some things did not. Our team at Esperion is as committed President and Chief as ever to our purpose of lipid management for everybody. Executive Officer
1 WHO. “Rapid assessment of service delivery for NCDs during the COVID-19 pandemic” publication. https://www.who.int/publications/m/item/rapid-assessment-of- service-delivery-for-ncds-during-the-covid-19-pandemic. Published 29 May 2020. Accessed 11 Feb 2021. 2 U.S. Census Bureau. “Measuring Household Experiences during the Coronavirus Pandemic” Household Pulse Survey, Phase 1. https://www.census.gov/data-tools/demo/hhp/assets/resources/phase-one-household-pulse-
02 survey-tool-summary.xlsx. Accessed 11 Feb 2021. Our belief: patients deserve better than the status quo
Unmet Need As The Lipid Management Company, the only publicly traded company fully focused on medicines to lower bad cholesterol, we constantly seek to better understand patients’ experiences, especially the experiences of those whose needs aren’t being met by current treatment options.
Up to Nearly 20% >1/3 80% 8.7 9.6 of people who of patients of very high-risk million patients million patients in could be treated discontinue patients did not in the U.S. don't the U.S. with high with a statin treatment with meet a guideline- reach their LDL-C LDL-C are not on experience statin a statin within recommended goals despite statins, often due to intolerance3 a year4 LDL-C target5 taking a statin6 tolerability concerns6 ESPERION 03 MILLIONS OF PEOPLE NEED OUR HELP
In 2020, we supported the Familial More than three-quarters of women who Hypercholesterolemia (FH) Global Summit — responded said side effects from statins made the only conference dedicated to the care them not feel like themselves, and 78% would and treatment of inherited cardiovascular like a non-statin choice for managing bad disorders, including FH and high lipoprotein(a) cholesterol. Nearly a quarter of respondents — which was held virtually for the first time. said they do not regularly take their medicine for high cholesterol, leaving them at increased We supported HealthyWomen in their survey risk for cardiovascular events. “Women and High Blood Cholesterol.” ESPERION
3 Bruckert E, Hayem G, Dejager S, Yau C and Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005;19:403-14. 4 Ofori-Asenso R, Zoungas S and Liew D. Reinitiation of Statin Therapy After Discontinuation: A Meta-analysis. Mayo Clin Proc. 2018;93:666-668. 5 Yan AT, Yan RT, Tan M, et al. Contemporary management of dyslipidemia in high-risk patients: targets still not met. Am J Med. 2006;119(8):676-683. 6 04 doi:10.1016/j.amjmed.2005.11.015. ZS Associates primary and secondary research, Sep-Oct 2018. Primary research N = 350 healthcare practitioners. Our business: making medicine easy We work to discover, develop and commercialize innovative medicines and combinations with established medicines that are easy to get, easy to take and easy to have.
2020 Achievements
Esperion became a commercial company, gaining marketing authorizations in key The two products also launched geographies and launching NEXLETOL in Germany through our partner Daiichi (bempedoic acid) Tablet* and NEXLIZET Sankyo Europe, under the brand names (bempedoic acid and ezetimibe) Tablet* NILEMDO® and NUSTENDI®.* in the U.S.
NEW ORAL MEDICINE TO LOWER MARKETING LDL-C IN NEARLY AUTHORIZATIONS 20 YEARS FOR 2 PRODUCTS 1ST FOR INDICATED PATIENTS 8 authorizations received in U.S., E.U., U.K. and Switzerland * NEXLETOL and NEXLIZET are approved as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypocholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined. ESPERION
NILEMDO (bempedoic acid) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated.
NUSTENDI (bempedoic acid and ezetimibe) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, in patients already being
05 treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin. 06 ESPERION commercialize ourproducts inJapan. Co.Pharmaceutical develop tofurther and We withOtsuka announcedapartnership cardiovascular medicine. evolution intoacommercial in leader operations expertise Esperion’s willsupport officer inDecember, andhisstrategy and Sheldon Koenig was namedchiefoperating strong cashposition. diversified revenue streams ontopofour company’s togrow, opportunity with convertible the debtfinancingtosupport In November, we secured $280 millionin in payments from Otsuka during2020. ever inJapan.Esperionreceived $60 million plus 15-30% inroyalties, makingitthelargest anddevelopmentmillion inmilestones costs, The agreement more includes than$600 Our science: cholesterol management beyond the status quo
Even as we launched NEXLETOL and NEXLIZET, we continued to gather and publish data on bempedoic acid at key congresses and in key publications.
CLEAR Outcomes Trial First-of-its-kind, landmark CVOT in patients with statin intolerance
CLEAR Outcomes, our ongoing Cardiovascular Recruited patients in 32 countries Outcomes Trial (CVOT) for bempedoic acid, is on track despite the pandemic and reached 50% of major adverse cardiac events (MACE) endpoints 48% of enrolled patients are women in the third quarter of 2020. In 2019, the trial had fully enrolled over 14,000 patients who are statin intolerant, a population with great unmet needs and few treatment options, and is designed to On track to be completed in the evaluate bempedoic acid’s ability to reduce second half of 2022
ESPERION the risk of cardiovascular events in patients who have or are at high risk for cardiovascular disease. CLEAR Outcomes is on track to be completed in the second half of 2022. 07 Looking toward our future
We in-licensed an oral PCSK9 inhibitor program, furthering Esperion’s mission and leveraging our singular focus on oral, non-statin LDL-C lowering medicines.
At the American Heart Association Scientific Sessions in November, a presentation of a Publications pooled analysis from multiple studies showed Atherosclerosis: NEXLETOL significantly lowered LDL-C with a More than 90% of patients mean reduction of 26.5% vs. placebo in people treated with bempedoic acid, who cannot tolerate statins. ezetimibe and atorvastatin
In late December, an analysis published in triple therapy achieved Atherosclerosis showed that a combination guideline-recommended of bempedoic acid, ezetimibe and LDL-C levels atorvastatin significantly lowered LDL-C by 60.5% vs. placebo. American Heart Association 2020 Scientific Sessions: In a pooled efficacy analysis published inJAMA NEXLETOL significantly lowered Cardiology, NEXLETOL lowered LDL-C by a mean LDL-C with a mean reduction of 18% vs. placebo for patients on background of 26.5% vs. placebo in pooled statins and by a mean of 24% vs. placebo for patients with statin intolerance. analysis of people who cannot tolerate statins The analyses referenced here are investigational only and warrant further clinical research. ESPERION 08 09 ESPERION 2020 NetProduct2020 Revenue >$1 billion Ex-U.S.Collaboration Milestones 1st royalty from DSE in Q4 Ex-U.S. Royalty Revenues Recorded 1st product sale in Q1 U.S. Net Product Sales recognition oftheinaugural royalty revenues diversifiedfurther its revenue stream through Sankyo Europe's launchinGermany, Esperion of thefirst quarter. With Daiichi ourpartner ever product salefrom NEXLETOL attheend commercial company, recording ourfirst- During 2020, Esperiontransitioned toa $0.9 M $0.9 Q1 $0.6 M $0.6 Q2 $3.3 M $3.3 Q3 Financial $8.2 M $8.2 Q4 FY FY 2020 $13.0 M $13.0 financing, further strengtheningfinancing, further thecash throughadditional capital aconvertible debt approached, Esperion tookactiontosecure company was well positionedasthenew year for NILEMDOandNUSTENDI. To ensure the position for thefuture. Results Available for Sale for Available Securities Investment & Cash Restricted Cash, Cash Equivalents, Revenue2020 Collaboration Net Product Revenue Product Net FY 2018 FY $136.3M $148.4 M $148.4 FY 2019 FY FY 2019 FY $201.7M FY 2020 FY $227.5 M $227.5 FY 2020 FY $ 3 0 5. 0 M
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