Esperion announced full results from landmark CLEAR outcomes study

Esperion announced the full results from the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen, or CLEAR, Outcomes trial, which were presented at the American College of Cardiology’s Annual Scientific Session & Expo together with the World Congress of Cardiology and simultaneously published in the New England Journal of Medicine. CLEAR Outcomes was a global study of nearly 14,000 patients with or at risk for cardiovascular disease who were unable to maximize or tolerate a statin. The study showed that NEXLETOL significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, as compared to placebo. These results were seen in a broad population of primary and secondary prevention patients who are unable to maximize or tolerate a statin. The proportions of patients experiencing adverse events and serious adverse events were similar between the active and placebo treatment groups. Bempedoic acid now becomes the first LDL-C lowering therapy since statins proven to lower hard ischemic events, not only in those with ASCVD but also in the large number of primary prevention patients for whom limited therapies exist. The Company believes that it remains on track to submit regulatory filings to the FDA and EMA in 1H 2023. Based on the robustness of the CLEAR Outcomes data, the Company believes it would be entitled to receive $300 million in partner milestone payments upon inclusion of certain required cardiovascular risk reduction data in the EU label, for which payment is tied to the magnitude of the risk percentage reduction included in the label and ranges from $200 million to $300 million, and up to $140 million in partner milestone payments upon the achievement of other regulatory milestones, including inclusion of certain required cardiovascular risk reduction data in the U.S. label. Recently conducted quantitative market research also validates the significant role NEXLETOL and NEXLIZET will have as the preferred next step after statins. The Company expects full-year 2023 operating expenses to be approximately $225 million to $245 million, including $25 million in non-cash expense related to stock-compensation.