Esperion (ESPR) Reports Wider-Than-Expected Loss In Q4
Zacks Investment Research | Feb 28, 2019 09:39PM ET
Esperion Therapeutics, Inc. (NASDAQ:ESPR) incurred a loss of $2.24 per share in the fourth quarter of 2018, wider than the Zacks Consensus Estimate of $1.33. The company’s loss was $1.44 per share in the year-ago period.
With no approved products in its portfolio, the company did not generate any revenues in the reported quarter. However, the company has filed regulatory applications seeking approval for its key candidates – bempedoic acid monotherapy and bempedoic acid / Merck’s (NYSE:MRK) Zetia (ezetimibe) combination pill.
Esperion’s shares have lost significant value in the past year, falling 40.1%.
Quarter in Details
Research and development (R&D) expenses surged 47.9% from the year-ago period to $49.5 million. The rise was primarily due to higher cost needed to support development of bempedoic acid monotherapy and combination therapy, including five pivotal studies and one cardiovascular outcomes study.
General and administrative (G&A) expenses more than doubled year over year to $11.2 million primarily driven by costs related to support pre-commercialization activities for both the candidates.
As of Dec 31, 2018, Esperion had cash, cash equivalents and investment securities of $136.3 million compared with $273.6 million as of Dec 31, 2017.
Full-Year Results
Esperion incurred a loss of $7.54 per share, wider than the year-ago loss of $6.98 due to increase in operating expense to support the progress of its pipeline. The company generated no revenues during the period.
2019 Guidance
Esperion provided 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.
Pipeline Update
In February 2019, Esperion submitted regulatory applications in the United States and EU seeking approval for bempedoic acid monotherapy as well as bempedoic acid/Zetia combination tablet. The regulatory applications, seeking approval 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.
In January 2019, Esperion announced an agreement with Daiichi Sankyo Europe, granting exclusive rights to the latter to commercialize bempedoic acid and the bempedoic acid/Zetia combination pill in Europe and Switzerland. The company is eligible to receive up to $900 million in payments from Daiichi including an upfront payment of $150 million and additional future milestone and royalty payments.
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