Esperion Therapeutics Provides Bempedoic Acid Development Program Update; Reports Fourth Quarter and Full Year 2015 Financial...
March 09 2016 - 7:46PM
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 development program updates and financial results
for the fourth quarter and full year ended December 31, 2015.
“The past year was eventful for Esperion, with
positive clinical data reported from bempedoic acid as an ‘add-on’
to statins and in patients with hypercholesterolemia and
hypertension,” said Tim M. Mayleben, president and chief executive
officer of Esperion. “With a strong clinical foundation resulting
from more than 700 patients treated with bempedoic acid across ten
Phase 1 and 2 clinical studies, our team is now focused on the
Phase 3 ‘CLEAR’ clinical development program in statin intolerant
patients. We look forward to announcing our global clinical and
regulatory development plans late next quarter.”
Development Program and Company Highlights
- November 9, 2015: Delivered two presentations at
the American Heart Association Scientific Sessions
in Orlando, FL:
- "Identification of a Tissue Specific Very Long Chain Acyl-CoA
Synthetase Involved in the Inhibition of ATP-Citrate Lyase (ACL) by
ETC-1002: A Novel Mechanism for Cholesterol Biosynthesis Inhibition
in the Liver," presented by Stephen Pinkosky,
Senior Scientist, Head of Translational
Research, Esperion;
- "ETC-1002 Incrementally Lowers Low Density Lipoprotein
Cholesterol in Patients with Hypercholesterolemia Receiving Stable
Statin Therapy," presented by Christie
Ballantyne, MD, Baylor College of Medicine.
- January 12, 2016: Esperion announced initiation of a 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 (ETC-1002-035).
- January 13, 2016: Esperion announced initiation of the Phase 3
clinical program — known as Cholesterol Lowering via ETC-1002, an
ACL-inhibiting Regimen (CLEAR) — with the start of the 52-week,
long-term safety and tolerability study in patients with
hyperlipidemia treated with bempedoic acid (ETC-1002-040).
- January 30, 2016: Full results from the completed ETC-1002-008
study were published in the Journal of Clinical Lipidology,
“Treatment with ETC-1002 alone and in combination with ezetimibe
lowers LDL-cholesterol in hypercholesterolemic patients with or
without statin intolerance,” with article in press.
- February 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 (ETC-1002-037).
Upcoming Milestones
- Q2 2016:
- Esperion plans to announce the global clinical and regulatory
development plans for the ‘CLEAR’ Phase 3 program for bempedoic
acid in statin intolerant patients;
- Esperion plans to announce the design of the cardiovascular
outcomes trial (CVOT) for bempedoic acid in statin intolerant
patients.
- Q3 2016:
- 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 (ETC-1002-035);
- Esperion plans to announce 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 (ETC-1002-037).
- Q4 2016:
- Esperion plans to initiate the ‘CLEAR’ Phase 3 LDL-C efficacy
studies of bempedoic acid in statin intolerant patients;
- Esperion expects to file an Investigational New Drug
Application for the fixed-dose combination of bempedoic acid and
ezetimibe for statin intolerant patients;
- Esperion expects to initiate the planned CVOT for bempedoic
acid in statin intolerant patients.
2015 Fourth Quarter and Full-Year Financial
Results
As of December 31, 2015, cash and cash equivalents and
investment securities available-for-sale totaled $292.6 million
compared with $141.6 million at December 31, 2014.
Research and development expenses were $8.0 million for the
fourth quarter of 2015 and $29.8 million for the year ended
December 31, 2015, compared to $6.2 million and $25.3 million for
the comparable periods in 2014. The increase in research and
development expenses was primarily related to the further clinical
development of bempedoic acid.
General and administrative expenses were $5.3
million for the fourth quarter of 2015 and $20.2 million for the
year ended December 31, 2015, compared to $3.2 million and $10.9
million for the comparable periods in 2014. The increase in general
and administrative expenses was primarily attributable to costs
associated with pre-commercialization activities for bempedoic
acid, increases in headcount, which includes increased stock-based
compensation expense for awards granted during the period, and
other costs to support public company operations and Esperion's
growth.
Esperion had a net loss of $13.1 million for the
fourth quarter of 2015 and $49.8 million for the year ended
December 31, 2015, compared to $9.5 million and $36.4 million for
the comparable periods in 2014.
Esperion had approximately 22.5 million shares
of common stock outstanding, with another 2.9 million issuable upon
exercise of stock options and warrants, and $4.3 million of debt
outstanding as of December 31, 2015.
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.
Esperion’s Commitment to Cardiometabolic
Disease
Esperion is committed to improving the lives of patients by
developing therapies to lower elevated LDL-C. Esperion scientists
discovered bempedoic acid and the LDL-C lowering therapy is in late
stage development. Esperion plans to develop both bempedoic acid
and a fixed-dose combination of bempedoic acid and ezetimibe with a
particular focus on patients with elevated LDL-C who are considered
intolerant of statin therapy. It is estimated that approximately
10% of patients who are prescribed statins, 3.5 million patients in
the U.S., are considered statin intolerant.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a pharmaceutical company
focused on developing and commercializing first-in-class, oral,
LDL-C lowering therapies for the treatment of patients with
elevated LDL-C. Bempedoic acid, the Company’s lead product
candidate, is an inhibitor of ATP Citrate Lyase, a
well-characterized enzyme on the cholesterol biosynthesis pathway.
Bempedoic acid inhibits cholesterol synthesis in the liver,
decreases intracellular cholesterol and up-regulates LDL-receptors,
resulting in increased LDL-C clearance and reduced plasma levels of
LDL-C. For more information, please
visit www.esperion.com and follow us on Twitter
at https://twitter.com/EsperionInc.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding the therapeutic
potential of, and clinical development plan for, bempedoic acid and
the fixed-dose combination of bempedoic acid and ezetimibe, the
design and timing of the announcement of top-line results from
ETC-1002-035 and ETC-1002-037, the Company’s plans regarding its
Phase 3 program and the timing and design of the planned
cardiovascular outcomes trial, and the Company’s expected cash and
liquidity position. Any express or implied statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. Forward-looking
statements involve risks and uncertainties that could cause
Esperion’s actual results to differ significantly from those
projected, including, without limitation, delays or failures in
patient enrollment in the Company’s studies, the risk that FDA may
require additional studies or data, including prior to approval
that might cause approval to be delayed, that Esperion may need to
change the design of its Phase 3 program, including upon feedback
from regulatory authorities, that positive results from a clinical
study of bempedoic acid and the fixed-dose combination of bempedoic
acid and ezetimibe may not necessarily be predictive of the results
of future clinical studies, particularly in different or larger
patient populations, or in all statin doses, including high-doses,
that existing cash resources may be used more quickly than
anticipated, that the planned cardiovascular outcomes trial may not
demonstrate that bempedoic acid leads to cardiovascular risk
reduction, or the risk that other unanticipated developments or
data could interfere with the scope of development and
commercialization of bempedoic acid and the fixed-dose combination
of bempedoic acid and ezetimibe, as well as other risks detailed in
Esperion’s filings with the Securities and Exchange Commission,
including our Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
release. Esperion disclaims any obligation or undertaking to update
or revise any forward-looking statements contained in this press
release, other than to the extent required by law.
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
77,336 |
|
|
$ |
85,038 |
|
|
Working
capital |
|
208,769 |
|
|
|
101,208 |
|
|
Investments |
|
215,240 |
|
|
|
56,544 |
|
|
Total
assets |
|
295,572 |
|
|
|
143,276 |
|
|
Total
long-term debt |
|
2,688 |
|
|
|
4,231 |
|
|
Common
stock |
|
23 |
|
|
|
20 |
|
|
Accumulated deficit |
|
(154,222 |
) |
|
|
(104,438 |
) |
|
Total
stockholders' equity |
|
287,259 |
|
|
|
133,554 |
|
|
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
Statement of Operations |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended December
31, |
|
Year Ended December
31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
7,956 |
|
|
$ |
6,200 |
|
|
$ |
29,802 |
|
|
$ |
25,302 |
|
General and administrative |
|
5,278 |
|
|
|
3,180 |
|
|
|
20,238 |
|
|
|
10,922 |
|
Total
operating expenses |
|
13,234 |
|
|
|
9,380 |
|
|
|
50,040 |
|
|
|
36,224 |
|
Loss from operations |
|
(13,234 |
) |
|
|
(9,380 |
) |
|
|
(50,040 |
) |
|
|
(36,224 |
) |
|
|
|
|
|
|
|
|
Interest
expense |
|
(121 |
) |
|
|
(134 |
) |
|
|
(520 |
) |
|
|
(270 |
) |
Other
income, net |
|
233 |
|
|
|
57 |
|
|
|
776 |
|
|
|
119 |
|
Net
loss |
$ |
(13,122 |
) |
|
$ |
(9,457 |
) |
|
$ |
(49,784 |
) |
|
$ |
(36,375 |
) |
Net loss per common
share (basic and diluted) |
$ |
(0.58 |
) |
|
$ |
(0.49 |
) |
|
$ |
(2.26 |
) |
|
$ |
(2.22 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
22,515,136 |
|
|
|
19,276,639 |
|
|
|
22,019,818 |
|
|
|
16,374,102 |
|
|
|
|
|
|
|
|
|
Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
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