Esperion Therapeutics, Inc. (NASDAQ:ESPR), a pharmaceutical company
focused on developing and commercializing oral therapies for the
treatment of patients with elevated low density lipoprotein
cholesterol (LDL-C), today provided bempedoic acid (ETC-1002)
development program updates and financial results for the second
quarter ended June 30, 2016.
“The Esperion team is focused on the fourth quarter initiation
of our global pivotal Phase 3 CLEAR LDL-C lowering efficacy studies
in patients with hypercholesterolemia and the global CLEAR Outcomes
trial in statin intolerant patients,” said Tim Mayleben, president
and chief executive officer of Esperion Therapeutics. “We also look
forward to sharing top-line results from our Phase 1 and Phase 2
clinical studies of bempedoic acid added-on to high-dose statins in
September.”
Development Program and Company Highlights
- June 2016:
- Esperion announced global clinical development and regulatory
plans for the bempedoic acid statin intolerance program following
discussions with the United States Food and Drug Administration
(FDA) and European Medicines Agency (EMA). The clinical program has
two major components: 1) the global pivotal Phase 3
Cholesterol Lowering via BEmpedoic Acid,
an ACL-inhibiting Regimen (CLEAR) LDL-C lowering efficacy
and safety studies in patients with hypercholesterolemia, and 2)
the global CLEAR Outcomes cardiovascular outcomes trial (CVOT) in
patients with elevated LDL-C levels who are unable to tolerate
statins (statin intolerance).
- Esperion received acceptance for filing of an Investigational
New Drug Application by the FDA for the fixed-dose combination
(FDC) of 180 mg of bempedoic acid and 10 mg of ezetimibe.
- July 2016:
- Esperion initiated a Phase 1 (1002-034) bioavailability study
for the FDC.
Upcoming Milestones
- September 2016:
- Esperion plans to announce top-line results from the Phase 1
(1002-037) and Phase 2 (1002-035) clinical studies of bempedoic
acid and high-dose statins.
- Q4 2016:
- Esperion plans to initiate the global pivotal Phase 3 CLEAR
LDL-C lowering efficacy studies and the global CLEAR Outcomes
trial.
2016 Second Quarter Financial Results
As of June 30, 2016, cash and cash equivalents and investment
securities available-for-sale totaled $274.8 million compared with
$292.6 million at December 31, 2015.
Research and development expenses were $9.7
million for the second quarter of 2016 and $19.5 million for the
six months ended June 30, 2016, compared to $7.2 million and $14.6
million for the comparable periods in 2015. The increase in
research and development expenses was primarily related to the
further clinical development of bempedoic acid, which includes
increases in the Company’s headcount and stock-based compensation
expense.
General and administrative expenses were $4.6
million for the second quarter of 2016 and $9.7 million for the six
months ended June 30, 2016, compared to $5.3 million and $9.3
million for the comparable periods in 2015. The decrease in general
and administrative expenses for the second quarter of 2016 was
primarily attributable to a reduction in pre-commercialization
activities and the increase in general and administrative expenses
for the six months ended June 30, 2016, was primarily attributable
to increases in costs to support public company operations,
increases in headcount, which includes increased stock-based
compensation expense, and other costs to support Esperion’s
growth.
Esperion had a net loss of $14.0 million for the
second quarter of 2016 and $28.6 million for the six months ended
June 30, 2016, compared to $12.4 million and $23.9 million,
respectively, for the comparable periods in 2015.
Esperion had approximately 22.5 million shares of common stock
outstanding, with another 3.4 million issuable upon exercise of
stock options and warrants and vesting of restricted stock units,
and $3.5 million of debt outstanding as of June 30, 2016.
2016 Financial Outlook
Esperion expects full-year 2016 net cash used in
operating activities in 2016 will be approximately $65 to $75
million and that its cash and cash equivalents and investment
securities to be approximately $220 million at December 31, 2016.
The Company estimates that current cash resources are sufficient to
fund operations into 2019 and the anticipated announcement of
top-line results from the global pivotal Phase 3 CLEAR LDL-C
lowering efficacy and safety studies.
About Bempedoic Acid
Bempedoic acid is a first-in-class ACL inhibitor that reduces
cholesterol biosynthesis and lowers elevated levels of LDL-C by
up-regulating the LDL receptor, but with reduced potential for
muscle-related side effects. Phase 1 and 2 studies conducted
previously in more than 700 patients treated with bempedoic acid
have produced clinically relevant LDL-C lowering results of up to
30 percent as monotherapy, approximately 50 percent in combination
with ezetimibe, and an incremental 24 percent when added to stable
statin therapy.
Esperion’s Commitment to Patients with
Hypercholesterolemia
In the United States, 78 million people, or more than 20 percent
of the population, have elevated LDL-C; an additional 73 million
people in Europe and 30 million people in Japan also live with
elevated LDL-C. Esperion’s mission is to provide patients and
physicians with a new oral therapy to significantly reduce elevated
levels of LDL-C, without muscle-related side effects.
Esperion-discovered and developed, bempedoic acid is an oral LDL-C
lowering therapy in Phase 3 development. The Company plans to
develop bempedoic acid as a monotherapy as well as a FDC with
ezetimibe, with a particular focus on patients with elevated LDL-C
who are unable to tolerate statin therapy. It is estimated that
approximately 5-20 percent of patients who are prescribed statins
are considered statin intolerant.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a pharmaceutical company
focused on developing and commercializing oral therapies for the
treatment of patients with elevated LDL-C. Through scientific and
clinical excellence, and a deep understanding of cholesterol
biology, the team at Esperion is committed to developing new LDL-C
lowering therapies that will make a substantial impact on reducing
global cardiovascular disease; the leading cause of death around
the world. Bempedoic acid, the Company’s lead product candidate,
significantly reduces elevated LDL-C levels in patients with
hypercholesterolemia, including those with statin intolerance. 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,
including the timing of announcement of top-line results from the
Company’s Phase 1 (1002-037) and Phase 2 (1002-035) clinical
studies, the Company’s timing and plans regarding its Phase 3
program and CVOT, in each case including that submissions for an
LDL-C lowering indication could be filed in the United States and
Europe, and the Company’s expected cash and liquidity position and
outlook. 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 that Esperion may need to change the design of its Phase 3
program, the impact of future changes in FDA’s view of LDL-C
lowering as a surrogate endpoint or standard-of-care treatment for
patients with elevated LDL-C levels, that positive results from a
clinical study of bempedoic acid may not necessarily be predictive
of the results of future clinical studies, particularly in
different or larger patient populations, that existing cash
resources may be used more quickly than anticipated, the CVOT 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, as well as other risks
detailed in Esperion’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K. 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. |
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Balance Sheet Data |
|
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
48,768 |
|
|
$ |
77,336 |
|
|
Working
capital |
|
201,453 |
|
|
|
208,769 |
|
|
Investments |
|
226,047 |
|
|
|
215,240 |
|
|
Total
assets |
|
277,466 |
|
|
|
295,572 |
|
|
Total
long-term debt |
|
1,871 |
|
|
|
2,688 |
|
|
Common
stock |
|
23 |
|
|
|
23 |
|
|
Accumulated deficit |
|
(182,842 |
) |
|
|
(154,222 |
) |
|
Total
stockholders' equity |
|
267,960 |
|
|
|
287,259 |
|
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
9,698 |
|
|
$ |
7,209 |
|
|
$ |
19,489 |
|
|
$ |
14,599 |
|
General and administrative |
|
4,633 |
|
|
|
5,253 |
|
|
|
9,664 |
|
|
|
9,288 |
|
Total
operating expenses |
|
14,331 |
|
|
|
12,462 |
|
|
|
29,153 |
|
|
|
23,887 |
|
Loss from operations |
|
(14,331 |
) |
|
|
(12,462 |
) |
|
|
(29,153 |
) |
|
|
(23,887 |
) |
|
|
|
|
|
|
|
|
Interest
expense |
|
(99 |
) |
|
|
(135 |
) |
|
|
(209 |
) |
|
|
(269 |
) |
Other
income, net |
|
395 |
|
|
|
202 |
|
|
|
742 |
|
|
|
295 |
|
Net
loss |
$ |
(14,035 |
) |
|
$ |
(12,395 |
) |
|
$ |
(28,620 |
) |
|
$ |
(23,861 |
) |
Net loss per common
share (basic and diluted) |
$ |
(0.62 |
) |
|
$ |
(0.55 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.11 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
22,541,455 |
|
|
|
22,465,175 |
|
|
|
22,536,438 |
|
|
|
21,531,509 |
|
|
|
|
|
|
|
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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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