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 third
quarter ended September 30, 2016.
“With the delivery of positive top-line results
from the clinical studies of bempedoic acid in combination with
high-dose statins, we will enroll patients with
hypercholesterolemia on maximally tolerated lipid-modifying
therapy, including patients on any statin at any dose, into our
global pivotal Phase 3 program,” said Tim Mayleben, president and
chief executive officer of Esperion Therapeutics. “While we
continue to rapidly enroll patients into the global long-term
safety study, we look forward to initiating the global pivotal
Phase 3 LDL-C lowering efficacy studies and cardiovascular outcomes
trial for bempedoic acid before year-end. With our available cash
resources, we remain focused on delivering top-line results from
our Phase 3 efficacy and long-term safety studies by mid-2018.”
Development Program and Company Highlights
- October 2016:
- Esperion announced positive top-line results of the Phase 1
(1002-037) and Phase 2 (1002-035) clinical studies of bempedoic
acid in combination with high-dose statins.
- Esperion amended and expanded the global Phase 3 CLEAR Harmony
(1002-040) 52-week, long-term safety study to include 1,950
patients with hypercholesterolemia on maximally tolerated lipid
modifying therapy, including patients on any statin at any
dose.
- Esperion announced high-level design details for three global
pivotal Phase 3 CLEAR LDL-C lowering efficacy studies of bempedoic
acid – 1002-046, 1002,047, and 1002-048.
- Esperion announced the proposed global pivotal Phase 3 clinical
development plan is expected to support global regulatory
submissions for an LDL-cholesterol lowering indication in patients
with hypercholesterolemia on maximally tolerated background lipid
modifying therapy who require additional LDL-cholesterol lowering,
with a special focus on patients considered “statin
intolerant”.
Upcoming Milestones
- Q4 2016:
- Esperion plans to initiate the three global pivotal Phase 3
CLEAR LDL-C lowering efficacy studies and the global CLEAR Outcomes
cardiovascular outcomes trial.
- Esperion plans to publish the definitive scientific paper on
the mechanism of action for bempedoic acid in a top-tier
journal.
2016 Third Quarter Financial Results
As of September 30, 2016, cash and cash equivalents
and investment securities available-for-sale totaled $259.7 million
compared with $292.6 million at December 31, 2015.
Research and development expenses were $13.5
million for the third quarter of 2016 and $33.0 million for the
nine months ended September 30, 2016, compared to $7.2 million and
$21.8 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 $4.2
million for the third quarter of 2016 and $13.9 million for the
nine months ended September 30, 2016, compared to $5.7 million and
$15.0 million for the comparable periods in 2015. The decrease in
general and administrative expenses was primarily related to a
reduction in pre-commercialization activities, partially offset by
increases in costs to support public company operations, increases
in the Company’s headcount, and other costs to support Esperion’s
growth.
Esperion had a net loss of $17.4 million for the
third quarter of 2016 and $46.0 million for the nine months ended
September 30, 2016, compared to $12.8 million and $36.7 million,
respectively, for the comparable periods in 2015.
Esperion had approximately 22.6 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 $3.1 million of debt outstanding as of September
30, 2016.
2016 Financial Outlook
Esperion expects full-year net cash used in operating activities
in 2016 will be approximately $65 million and that its cash and
cash equivalents and investment securities to be approximately $225
million at December 31, 2016. The Company expects to announce
top-line results from the global pivotal Phase 3 CLEAR LDL-C
lowering efficacy and safety studies in mid-2018, and that current
cash resources are sufficient to fund operations into early
2019.
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 800 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 20 to 22 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 in patients inadequately treated with current
lipid-modifying therapies. 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 fixed dose combination (FDC) with
ezetimibe, with a particular focus on patients inadequately treated
with current lipid-modifying therapies. It is estimated that
approximately 5-20 percent of patients who are prescribed statins
are only able to tolerate less than the lowest approved daily
starting dose of their statin (“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 patients inadequately treated with
current lipid-modifying therapies. 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 Company’s timing, designs, plans, and announcement of
results regarding its global Phase 3 program and timing of an NDA
submission for bempedoic acid, in each case including that
submissions for an LDL-C lowering indication could be filed in the
United States and Europe prior to the completion of a
cardiovascular outcomes trial, or CVOT, its upcoming milestones,
and its cash position and financial 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 the Company’s studies, including in patient enrollment, 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 prior clinical studies of
bempedoic acid, including from 1002-035 and 1002-037, 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 for
the year ended December 31, 2015 and subsequently filed 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) |
|
|
|
|
September 30, |
|
December 31, |
|
2016 |
|
|
|
2015 |
|
Cash and
cash equivalents |
$ |
47,140 |
|
|
|
77,336 |
|
Working
capital |
|
205,307 |
|
|
|
208,769 |
|
Investments |
|
212,607 |
|
|
|
215,240 |
|
Total
assets |
|
263,791 |
|
|
|
295,572 |
|
Total
long-term debt |
|
1,451 |
|
|
|
2,688 |
|
Common
stock |
|
23 |
|
|
|
23 |
|
Accumulated deficit |
|
(200,244 |
) |
|
|
(154,222 |
) |
Total
stockholders' equity |
|
254,180 |
|
|
|
287,259 |
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
13,498 |
|
|
$ |
7,247 |
|
|
$ |
32,987 |
|
|
$ |
21,846 |
|
General and administrative |
|
4,214 |
|
|
|
5,672 |
|
|
|
13,878 |
|
|
|
14,960 |
|
Total
operating expenses |
|
17,712 |
|
|
|
12,919 |
|
|
|
46,865 |
|
|
|
36,806 |
|
Loss from operations |
|
(17,712 |
) |
|
|
(12,919 |
) |
|
|
(46,865 |
) |
|
|
(36,806 |
) |
|
|
|
|
|
|
|
|
Interest
expense |
|
(89 |
) |
|
|
(130 |
) |
|
|
(298 |
) |
|
|
(399 |
) |
Other
income, net |
|
399 |
|
|
|
248 |
|
|
|
1,141 |
|
|
|
543 |
|
Net
loss |
$ |
(17,402 |
) |
|
$ |
(12,801 |
) |
|
$ |
(46,022 |
) |
|
$ |
(36,662 |
) |
Net loss per common
share (basic and diluted) |
$ |
(0.77 |
) |
|
$ |
(0.57 |
) |
|
$ |
(2.04 |
) |
|
$ |
(1.68 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
22,550,438 |
|
|
|
22,494,075 |
|
|
|
22,541,137 |
|
|
|
21,854,685 |
|
|
|
|
|
|
|
|
|
Media Contact:
Audrey Gross
W2O Group
212.301.7214
agross@w2ogroup.com
Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jul 2023 to Jul 2024