U.S. FDA Approves Broad New Labels for NEXLETOL and NEXLIZET to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use - Seite 2

“NEXLETOL and NEXLIZET are once-daily, accessible, oral medications that reduce LDL-C and cardiovascular risk, but without the side effects most common to statins. NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients. We believe this significantly differentiated profile is a game changer for patients and healthcare providers alike and that we expect sales to meaningfully inflect as a result. I want to thank the entire Esperion team for its unwavering commitment to patients and to getting us to this stage. I have the utmost confidence in our future success.”

The Company’s pending label expansions in Europe remain on track, with a positive opinion received from the Committee for Medicinal Products for Human Use (CHMP) on March 21, 2024. The Company anticipates a final determination by the European Medicines Agency in the second quarter of 2024.

The U.S. approvals of NEXLIZET and NEXLETOL for cardiovascular risk reduction and LDL-C lowering were based on data generated from the CLEAR Outcomes trial, which was published in the New England Journal of Medicine in March 2023, assessing the effect of NEXLETOL on cardiovascular outcomes in nearly 14,000 patients with, or at high risk, of cardiovascular disease. Patients were followed for a median duration of 3.4 years and bempedoic acid (contained in NEXLETOL and NEXLIZET) was generally safe and well tolerated. In the study, LDL-C was reduced by 20%, hsCRP was reduced by 22%, and glucose was not elevated by bempedoic acid compared to placebo. Patients who received bempedoic acid in the trial experienced a relative risk reduction of:

• 15% for MACE-3 (death from a cardiovascular cause, nonfatal stroke, or nonfatal myocardial infarction)
• 27% for nonfatal myocardial infarction
• 19% for coronary revascularization
• 39% for MACE-3 in primary prevention patients

Conference Call and Webcast Information
Esperion will host a conference call and webcast on Monday, March 25 at 8:00 a.m. ET to discuss these FDA approvals and its new and expanded indications for NEXLETOL and NEXLIZET. Please click here to participate in the conference call.

The live webcast can also be accessed on the Investors and Media section of the Esperion website. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Company’s website for approximately 90 days.