ANN ARBOR—Esperion Therapeutics Inc. (NASDAQ:ESPR), the Ann Arbor-based pharmaceutical startup that’s about to introduce a new class of cholesterol-fighting drugs, reported a loss of $54.2 million or $2.01 a share in the second quarter ended June 30, compared to a loss of $45.7 million or $1.71 a share in the second quarter of 2018.
Revenue was $982,000, vs. zero revenue a year earlier.
The higher loss was the product of higher spending on both research and development, and general and administrative costs.
For the six months, the company posted net income of $33.2 million or $1.16 a share, vs. a loss of $91.9 million or $3.44 a share in the first half of 2018. Revenue was $146.4 million, vs. zero income a year earlier.
The company also provided updates on the regulatory approval process for its drug candidate, bempedoic acid. The federal Food and Drug Administration has accepted the company’s New Drug Application for both a bempedoic acid tablet and a bempedoic acid and ezetimibe combination tablet.
“This year continues the momentum we’ve come to expect from our team of lipid management experts,” said Esperion President and CEO Tim M. Mayleben. “Already in 2019, we completed precedent-setting agreements with Daiichi Sankyo Europe and Oberland Capital which validated the economic value of the global bempedoic acid franchise. We also achieved the filing and acceptance of New Drug Applications in the U.S. and Marketing Authorization Applications in the EU for both bempedoic acid and the bempedoic acid-ezetimibe combination tablet. We look forward to accelerating this momentum in the months ahead as we prepare to bring our convenient, once-daily oral LDL-cholesterol lowering therapies to the millions of patients who are not reaching their LDL-C lowering goals despite the use of currently accessible therapies.”
Company officials say they expect top-line results from a 12-week Phase 2 clinical study of the bempedoic acid-ezetimibe combination tablet in 179 patients with elevated cholesterol and Type 2 diabetes by Sept. 30.
They also said they expect a full-year 2019 net increase in cash of approximately $90 million to $100 million, driven by $150 million from its collaboration and licensing agreement with Daiichi Sankyo Europe and $125 million from Oberland Capital, vs. R&D spending of $115 million to $120 million and selling, general, and administrative expenses of $60 million to $65 million.
Esperion expects that current cash resources, coupled with expected milestone payments under the European commercial collaboration agreement and Oberland Capital revenue-based funding agreement, and bempedoic acid and the bempedoic acid-ezetimibe combination tablet commercial sales, will be sufficient to fund operations until operating cash flow is positive.
Esperion had approximately 27.0 million shares of common stock outstanding, with another 5.4 million issuable upon exercise of stock options and vesting of restricted stock units, and $124.4 million of the revenue interest liability outstanding as of June 30.
Bempedoic acid provides a non-statin approach to cholesterol reduction, offering people who can’t tolerate today’s statin drugs a new way to reduce cholesterol and inflammation in their cardiovascular system. More at www.esperion.com.