Esperion Therapeutics Inc. (NASDAQ: ESPR) released its first-quarter financial results and a business update before the markets opened on Wednesday. Although the firm’s Phase 3 cholesterol medication trial was fairly positive, there were still some safety concerns. Also, the quarterly results were not up to par.
The biotech said that it had a net loss of $1.73 per share for the quarter. The consensus estimate from Thomson Reuters had called for a net loss of $1.56 per share. The same period of last year had a net loss of $1.80 per share.
At the end of the quarter, cash and cash equivalents and investment securities available-for-sale totaled $239.6 million, compared with $273.6 million in December.
Looking ahead, Esperion expects full-year 2018 net cash used in operating activities to be roughly $135 million to $145 million and its cash and cash equivalents and investment securities to be $130 million to $140 million as of December 31, 2018. The company expects that current cash resources are sufficient to fund operations through the expected approvals of the bempedoic acid/ezetimibe combination pill and bempedoic acid in the first quarter of 2020.
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Separately, the firm announced positive top-line results from the second pivotal Phase 3 study, the long-term safety study of bempedoic acid 180 mg, in this case evaluating the safety, tolerability and efficacy of bempedoic acid versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD).
The study ultimately met the primary endpoint of safety and tolerability and the key efficacy endpoint with on-treatment LDL-C lowering of an additional 20% at 12. Patients treated with bempedoic acid also achieved a significant reduction of 22% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease.
In the study, adverse effects for individuals happened at a rate of nearly 80%, and serious adverse effects were seen at nearly 11%, with the company noting there were “no clinically relevant differences” for those measures between the therapy and the placebo groups.
Tim M. Mayleben, president and CEO of Esperion, commented:
In the coming months, results from our three remaining pivotal Phase 3 studies are expected to further validate the safety, efficacy and tolerability profile of bempedoic acid and the bempedoic acid / ezetimibe combination pill, definitively establishing these once-daily oral therapies as convenient and complementary to existing treatments for the 13 million people in the U.S. with ASCVD who live with elevated levels of LDL-cholesterol despite taking maximally-tolerated lipid-modifying therapy and remain at high risk for further cardiovascular disease or events, including heart attack and stroke.
Shares of Esperion were last seen down about 20% at $56.30, with a consensus analyst price target of $100.54 and a 52-week range of $30.95 to $82.68.
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