ANN ARBOR – Esperion Therapeutics Inc. (NASDAQ:ESPR), the pharmaceutical startup developing a new cholesterol-fighting drug, reported a loss of $60 million in the fourth quarter, up from a loss of $37.9 million a year earlier. For the full year the loss was $201.8 million, up from $167 million a year earlier.
The company has no revenue, but is in the final stages of gaining regulatory approval for its key new product, bempedoic acid.
“2018 was an exciting and incredibly productive year for our lipid management team highlighted by positive top-line results reported from five pivotal Phase 3 studies,” president and CEO Tim Mayleben said. “Already in 2019, we’ve continued this momentum by completing an EU commercialization agreement with Daiichi Sankyo Europe and submitting our NDAs and MAAs to FDA and EMA, respectively. Our team of lipid management experts will be working closely with regulatory authorities throughout 2019 to bring our LDL-cholesterol lowering therapies to the millions of patients who are not reaching their LDL-C lowering goals with existing treatment options.”
Bempedoic acid has been showed to reduce cholesterol and other risk factors for cardiovascular disease in people who have bad reactions to existing statin therapies.
The commercialization agreement with DSE includes the European Economic Area and Switzerland. Payments to Esperion under the agreement included $150 million upfront, $150 million upon first commercial sale in the territory, up to $600 million in additional regulatory and commercial milestones payments as well as 15 to 25 percent tiered royalties on net territory sales.
The company submitted its New Drug Applications (NDAs) for bempedoic acid and the bempedoic acid / ezetimibe combination tablet to the U.S. Food and Drug Administration (FDA) in February.
Esperion expects 2019 net cash used in operations to be $25 to $35 million, driven by $150 million in collaboration and license agreement revenue, $115 million to $120 million in research and development spending, and $60 million to $65 million in selling, general, and administrative expenses.
Esperion expects that current cash resources, coupled with expected milestone payments under the European commercial collaboration agreement, as well as bempedoic acid and the bempedoic acid / ezetimibe combination tablet commercial sales, are sufficient to fund operations until operating cash flow is positive.
More at www.esperion.com.