ESPERION Reports Preliminary Fourth Quarter 2020 Financial Results and Further Commits to Unmet Patient Needs with Oral PCSK9 Inhibitor Program

– Fourth-quarter 2020 U.S. net product revenue estimated between $8.0 and $8.5 million –

– Range represents over 140 percent sequential growth for NEXLETOL (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe) tablets –

– Company provides full-year 2021 operating expense guidance –

– In-licensed oral PCSK9 inhibitor program furthers ESPERION mission; leverages singular focus on oral, LDL-C lowering medicines –  

ANN ARBOR, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced preliminary, unaudited fourth-quarter 2020 financial results and full-year 2021 operating expense guidance. Concurrently, the Company announced that it has entered into a definitive agreement with Serometrix to in-license its oral, small molecule PCSK9 inhibitor program.

“As a result of our company’s exceptional focus and hard-fought performance, we enter the new year with a strong foundation and are building momentum toward our purpose of lipid management for everybody,” said Tim M. Mayleben, president and chief executive officer of Esperion. “During 2020, despite the effects of the COVID-19 pandemic, Esperion took a huge step forward to provide physicians and patients easy and effective non-statin medicines to lower bad cholesterol, including the first-ever, fully non-statin fixed combination drug product, NEXLIZET. I am excited to reinforce our commitment to patients with the addition of our oral PCSK9 inhibitor program, which has the potential to expand oral, non-statin treatment options even further.”

The small molecule PCSK9 inhibitor program is intended for development of a convenient, oral medicine. Patients and healthcare professionals favor oral medicines for ease of administration and compliance,¹ but currently approved PCSK9 inhibitors are biologics delivered by subcutaneous injection, which, for many patients, are out of reach or may not be preferred.^2,3 An oral PCSK9 inhibitor has the potential to provide an additional non-statin treatment option between statins and injectable PCSK9 inhibitors. There are currently no oral PCSK9 inhibitors available to patients.

PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein responsible for regulating LDL receptor expression. Medicines that inhibit PCSK9 stop LDL receptors from being broken down, thus increasing the amount of LDL receptors and leading to removal of LDL-C from the blood. Inhibition of PCSK9 by injectable products has been clinically proven to reduce LDL-C and major cardiovascular events, as demonstrated by two completed cardiovascular outcomes trials (CVOTs) involving more than 46,000 patients.^4,5