ANN ARBOR—Esperion Therapeutics Inc., the Ann Arbor developer of novel cholesterol-fighting drugs, announced preliminary financial results and a new licensing agreement with Pittsford, N.Y.-based drug developer Serometrix.
“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 CEO 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 for a non-statin cholesterol reducing medicine that does not have to be administered by injection. PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that acts on blood chemistry to reduce the level of low-density lipoprotein, the so-called bad cholesterol, in the bloodstream. Inhibition of PCSK9 by injectable products has been clinically proven to reduce LDL-C and major cardiovascular events, as demonstrated by two completed trials involving more than 46,000 patients.
Serometrix developed the oral PCSK9 inhibitor program with its proprietary technology to discover drugs for difficult protein targets. As part of the agreement, Esperion made an upfront cash payment of $12.5 million in December to Serometrix, with payments in future years tied to specific milestones. Esperion officials say they anticipate sharing more information later this year on the potential timing for an Investigational New Drug (IND) application.
As for the preliminary financial results, Esperion officials said unaudited fourth-quarter 2020 net U.S. product sales are expected to be between $8 million and $8.5 million.
As of Dec. 31, cash, cash equivalents, and investment securities available-for-sale totaled approximately $305 million, and there were approximately 25.9 million shares of common stock outstanding.
Company officials said they expect 2021 operating expenses to be approximately $320 million to $340 million, inclusive of $30 million of non-cash stock-based compensation.
More at www.esperion.com.