Esperion Therapeutics, Inc. (ESPR - Free Report) incurred a loss of $2.01 per share in the second quarter of 2019, wider than the Zacks Consensus Estimate of $1.86. The company had incurred loss of $1.71 per share in the year-ago period.
The company generated revenues of $1 million, which beat the Zacks Consensus Estimate of $0.93 million. Revenues were mainly attributable to initial recognition of the upfront payment related to the commercial agreement with Daiichi Sankyo Europe in January. The agreement grants exclusive rights to Daiichi Sankyo to commercialize Esperion’s bempedoic acid and the bempedoic acid/ Merck’s (MRK - Free Report) Zetia combination pill in Europe and Switzerland
Esperion’s shares have declined 15.2% so far this year against the industry’s 7.5% increase.
Quarter in Details
Research and development (R&D) expenses increased 10.8% from the year-ago period to $42.8 million. The rise was primarily due to higher cost needed to support cardiovascular outcomes study on bempedoic acid and manufacturing of its candidates for commercial supply.
General and administrative (G&A) expenses were up 94% year over year to $13.5 million primarily due to costs related to support pre-commercialization activities for both the candidates.
As of Jun 30, 2019, Esperion had cash, cash equivalents and investment securities of $302.2 million compared with $229.7 million as of Mar 31, 2018.
In June, Esperion entered into a revenue interest purchase agreement of $200 million with an investor group to extend its resources. The company has received $125 million upfront. The company will receive $25 million after bempedoic acid monotherapy and combination therapy are approved and the remaining $50 million upon launch of the products.
Esperion maintained its guidance for collaborations revenues and operating expenses in 2019. The company expects income from collaboration and license agreement to be $150 million. R&D expense is estimated between $115 million and $120 million while G&A expense is expected in the range of $60-$65 million.
In May, the company’s new drug applications seeking approval for its key candidates — bempedoic acid monotherapy and bempedoic acid/ Zetia (ezetimibe) combination pill – were accepted for review by the FDA. A decision from the FDA is expected in February 2020. The regulatory applications, seeking approval of these medicines for cholesterol (LDL-C) lowering indications, were filed based on data from several pivotal studies evaluating the candidates.
Data from four phase III studies evaluating bempedoic acid monotherapy, presented previously, demonstrated that treatment with the therapy led to additional 18% reduction in LDL-C over 31% LDL-C reduction in statin-treated patients on maximally tolerated statin.
Data from the phase III study evaluating bempedoic acid/Zetia combination pill showed that the combination regimen reduced bad cholesterol by 35% compared with 24% for Zetia (20mg) monotherapy, 20% for bempedoic acid and 3% for placebo in patients receiving maximally tolerated statins.
Meanwhile, the company expects to complete enrollment in the CLEAR cardiovascular outcomes study by the end of September. The study is evaluating bempedoic acid for occurrence of major cardiovascular events in statin averse patients with or at high-risk of cardiovascular disease.
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech/drugs sector are Theravance Biopharma (TBPH - Free Report) and Neurocrine Biosciences (NBIX - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Theravance’s loss estimates narrowed from $4.74 to $4.28 for 2019 and from $4.27 to $4.01 for 2020 over the past 60 days.
Estimates for Neurocrine have improved from a loss of 35 cents to earnings of 80 cents for 2019 and increased from $3.01 to $3.36 for 2020 over the past 60 days.
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