Esperion Therapeutics Inc (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with elevated LDL-C, today provided bempedoic acid (ETC-1002) development program updates and financial results for the first quarter ended March 31, 2016.
“The Esperion team has maintained a clear focus on the development of bempedoic acid as evidenced by our continued accomplishments this past quarter,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We continue to work with major regulatory authorities and key opinion leaders around the world to design the clinical studies that will support the potential global approval of bempedoic acid for LDL-C lowering in statin intolerant patients. We look forward to sharing our Phase 3 statin intolerant clinical and regulatory plans by the end of this quarter.”
Development Program and Company Highlights
- January 12, 2016:
- Esperion announced initiation of the Phase 2 pharmacokinetics/pharmacodynamics (PK/PD) clinical study of bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin (1002-035).
- January 13, 2016:
- Esperion announced initiation of the Phase 3 clinical program — known as Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibitingRegimen (CLEAR) — with the start of the 52-week, long-term safety and tolerability study in patients with hyperlipidemia treated with bempedoic acid (1002-040).
- January 30, 2016:
- Full results from the completed 1002-008 study were published on the Journal of Clinical Lipidology website, “Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL-cholesterol in hypercholesterolemic patients with or without statin intolerance,” with the article in press.
- February 22, 2016:
- Esperion initiated a Phase 1 clinical pharmacology study to assess the safety and tolerability of bempedoic acid, as well as the effects of bempedoic acid on the PK of single doses of the highest doses of the most commonly prescribed statins: atorvastatin 80 mg, rosuvastatin 40 mg, simvastatin 40 mg and pravastatin 80 mg (1002-037).
- Q2 2016:
- By the end of June, Esperion plans to announce details of the global clinical and regulatory development plan for the Phase 3 CLEAR program of bempedoic acid in statin intolerant patients;
- By the end of June, Esperion expects to file an Investigational New Drug Application for the fixed-dose combination of bempedoic acid and ezetimibe for statin intolerant patients.
- Q3 2016:
- Esperion plans to announce details of the cardiovascular outcomes trial (CVOT) for bempedoic acid in statin intolerant patients;
- Esperion plans to announce top-line results from the Phase 2 PK/PD clinical study of bempedoic acid in patients treated with high-dose atorvastatin (1002-035) and top-line results from the Phase 1 clinical pharmacology study to assess the safety and tolerability of bempedoic acid and PK of the highest doses of the most commonly prescribed statins (1002-037).
- Q4 2016:
- Esperion plans to initiate the Phase 3 CLEAR clinical efficacy studies for bempedoic acid in statin intolerant patients;
- Esperion plans to initiate the CVOT for bempedoic acid in statin intolerant patients.
2016 First Quarter Financial Results
As of March 31, 2016, cash and cash equivalents and available-for-sale investment securities totaled $282.7 million compared with $292.6 million at December 31, 2015.
Research and development expenses were $9.8 million for the first quarter of 2016, compared to $7.4 million for the comparable period in 2015. The increase in research and development expenses was primarily related to the further clinical development of bempedoic acid, which includes increases in our headcount and increased stock-based compensation expense.
General and administrative expenses were $5.0 million for the first quarter of 2016, compared to $4.0 million for the comparable period in 2015. The increase in general and administrative expenses was primarily attributable to costs to support public company operations, increases in our headcount, which includes increased stock-based compensation expense, and other costs to support Esperion’s growth.
Esperion had a net loss of $14.6 million for the first quarter of 2016, compared to $11.5 million for the comparable period in 2015.
Esperion had approximately 22.5 million shares of common stock outstanding, with another 3.2 million issuable upon exercise of stock options and warrants, and $3.9 million of debt outstanding as of March 31, 2016.
2016 Financial Outlook
Esperion expects full-year 2016 net cash used in operating activities to be approximately $80 to $90 million and its cash and cash equivalents and investment securities to be approximately $200 million at December 31, 2016. The Company estimates that current cash resources are sufficient to fund the Company through at least the end of 2018 and the potential approval of bempedoic acid. (Original Source)
Shares of Esperion closed yesterday at $15.57, down $0.46 or -2.87%. ESPR has a 1-year high of $120.96 and a 1-year low of $12.61. The stock’s 50-day moving average is $17.23 and its 200-day moving average is $20.01.
On the ratings front, Esperion has been the subject of a number of recent research reports. In a report issued on April 4, JMP analyst Jason Butler reiterated a Hold rating on ESPR, with a price target of $67, which represents a potential upside of 330.3% from where the stock is currently trading. Separately, on February 26, Chardan’s Gbola Amusa MD CFA maintained a Hold rating on the stock and has a price target of $13.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Butler and Gbola Amusa MD CFA have a total average return of 43.2% and -8.5% respectively. Butler has a success rate of 55.6% and is ranked #90 out of 3838 analysts, while CFA has a success rate of 35.1% and is ranked #3671.
Esperion Therapeutics, Inc. is a clinical stage biopharmaceutical company, which focuses on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. The company operates through one segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C. Esperion Therapeutics was founded by Roger S. Newton in January 2008 and is headquartered in Ann Arbor, MI.