Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management
company focused on developing and commercializing convenient,
complementary, cost-effective, once-daily, oral therapies for the
treatment of patients with elevated low density lipoprotein
cholesterol (LDL-C), today provided bempedoic acid development
program updates and financial results for the fourth quarter and
full year ended December 31, 2016.
“Last year, Esperion was focused on building a
strong foundation for the development and initiation of our global
pivotal Phase 3 clinical development program for bempedoic acid,
which the team successfully initiated, including the CLEAR Outcomes
cardiovascular outcomes trial,” said Tim M. Mayleben, president and
chief executive officer of Esperion. “Our focus in 2017 will be on
the timely completion of patient enrollment of these LDL-C lowering
efficacy studies to enable us to report top-line results by
mid-2018. We are encouraged by the early completion of patient
enrollment in our long-term safety and tolerability study in
January, and remain focused on completing patient enrollment across
the remaining global pivotal Phase 3 studies.”
Development Program and Company Highlights
- November 2016: Publication of the definitive paper on the
mechanism of action of bempedoic acid in the journal Nature
Communications.
- December 2016: Initiation of three global pivotal Phase 3
studies and the
Cholesterol Lowering via
BEmpedoic Acid,
an ACL-inhibiting Regimen
(CLEAR) Outcomes cardiovascular outcomes trial (CVOT) for bempedoic
acid.
- January 2017: Early completion of patient enrollment in the
global pivotal Phase 3 long-term safety and tolerability study
(Study 1) of bempedoic acid.
Upcoming Milestones
- February 2017: Initiation of the open-label extension study of
the global pivotal Phase 3 long-term safety and tolerability study
(Study 1) to collect additional safety data. All patients in the
open-label extension study will receive bempedoic acid.
- March 2017:- Initiation of the Phase 2 “triplet oral therapy”
study of bempedoic acid to further explore the complementary oral
LDL-C lowering of bempedoic acid, ezetimibe and atorvastatin.-
Brian A. Ference, M.D., M.Phil, M.Sc., F.A.C.C., Associate
Professor of Medicine, Wayne State University School of Medicine,
will present “Genetic Target Validation for ATP Citrate Lyase
Inhibition” at the upcoming American College of Cardiology 66th
Annual Scientific Session.
2016 Fourth Quarter and Full-Year Financial
Results
As of December 31, 2016, cash and cash equivalents and
investment securities available-for-sale totaled $242.5 million
compared with $292.6 million at December 31, 2015.
Research and development expenses were $24.9
million for the fourth quarter of 2016 and $57.9 million for the
year ended December 31, 2016, compared to $8.0 million and $29.8
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, including the
initiation of the three global pivotal Phase 3 studies and the CVOT
in the fourth quarter of 2016.
General and administrative expenses were $4.4
million for the fourth quarter of 2016 and $18.3 million for the
year ended December 31, 2016, compared to $5.3 million and $20.2
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 $29.0 million for the
fourth quarter of 2016 and $75.0 million for the year ended
December 31, 2016, compared to $13.1 million and $49.8 million for
the comparable periods in 2015.
Esperion had approximately 22.6 million shares
of common stock outstanding, with another 3.5 million issuable upon
exercise of stock options and warrants and vesting of restricted
stock units, and $2.7 million of debt outstanding as of December
31, 2016.
2017 Financial Outlook
Esperion expects full-year 2017 net cash used in operating
activities to be approximately $125 to $135 million and its cash
and cash equivalents and investment securities to be approximately
$105 to $115 million at December 31, 2017. The Company estimates
that current cash resources are sufficient to fund operations into
early 2019 and through the announcement of top-line results from
all global pivotal Phase 3 safety and efficacy studies.
Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, orally available, once-daily 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. Completed Phase 1 and 2
studies 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+ 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 as the
lipid management company is to provide patients and physicians with
convenient, complementary, cost-effective, once-daily, oral
therapies to significantly reduce elevated levels of LDL-C in
patients inadequately treated with current lipid-modifying
therapies. It is estimated that 40 million patients in the
U.S. are taking statins with approximately 5-20 percent of
these patients only able to tolerate less than the lowest approved
daily starting dose of their statin and considered "statin
intolerant". Esperion-discovered and developed, bempedoic acid is a
targeted LDL-C lowering therapy in Phase 3 development. The Company
has two Phase 3 products in development: 1) bempedoic acid
(monotherapy) an oral, once-daily pill, and 2) an, oral, once-daily
fixed dose combination pill of bempedoic acid and ezetimibe
(BA+EZ).
The Lipid Management Company
Esperion Therapeutics, Inc. is the lipid management company
passionately committed to developing and commercializing
convenient, complementary, cost-effective, once-daily, oral
therapies for the treatment of patients with elevated LDL-C.
Through scientific and clinical excellence, and a deep
understanding of cholesterol biology, the experienced lipid
management team at Esperion is committed to developing new LDL-C
lowering therapies that will make a substantial impact on reducing
global CVD; the leading cause of death around the world. Bempedoic
acid, the Company's lead product candidate, is a targeted therapy
that 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 pivotal Phase 3
program for bempedoic acid, patient enrollment in the Company’s
Phase 3 clinical studies, the Company’s Phase 2 triplet oral
therapy study, the Company’s cash position and liquidity outlook
and the Company’s plans for regulatory submission of bempedoic acid
for an LDL-C lowering indication prior to the completion of a CVOT.
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
the risk that U.S. Food and Drug Administration may require
additional studies or data, 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 Esperion
may need to change the design of its Phase 3 program, 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,
that Esperion’s global pivotal Phase 3 program for bempedoic acid
may not produce sufficient safety or tolerability results or show
meaningful change in LDL-C or other key lipid measures of patients,
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, and the risks detailed in
Esperion's filings with the Securities and Exchange Commission. 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.
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Esperion Therapeutics, Inc. |
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Balance Sheet Data |
|
(In thousands) |
|
(Unaudited) |
|
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|
|
|
|
|
December 31, |
|
December 31, |
|
|
2016 |
|
2015 |
|
|
Cash and cash
equivalents |
$ |
38,165 |
|
|
$ |
77,336 |
|
|
|
Working capital |
|
197,988 |
|
|
|
208,769 |
|
|
|
Investments |
|
204,324 |
|
|
|
215,240 |
|
|
|
Total assets |
|
245,213 |
|
|
|
295,572 |
|
|
|
Total long-term
debt |
|
1,022 |
|
|
|
2,688 |
|
|
|
Common stock |
|
23 |
|
|
|
23 |
|
|
|
Accumulated
deficit |
|
(229,200 |
) |
|
|
(154,222 |
) |
|
|
Total stockholders'
equity |
|
228,602 |
|
|
|
287,259 |
|
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|
|
Esperion Therapeutics, Inc. |
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Statement of Operations |
(In thousands, except share and per share
data) |
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Three Months Ended
December 31, |
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Year Ended
December 31, |
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2016 |
|
2015 |
|
2016 |
|
2015 |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
24,881 |
|
|
$ |
7,956 |
|
|
$ |
57,868 |
|
|
$ |
29,802 |
|
General
and administrative |
|
4,404 |
|
|
|
5,278 |
|
|
|
18,282 |
|
|
|
20,238 |
|
Total
operating expenses |
|
29,285 |
|
|
|
13,234 |
|
|
|
76,150 |
|
|
|
50,040 |
|
Loss from operations |
|
(29,285 |
) |
|
|
(13,234 |
) |
|
|
(76,150 |
) |
|
|
(50,040 |
) |
|
|
|
|
|
|
|
|
Interest
expense |
|
(78 |
) |
|
|
(121 |
) |
|
|
(376 |
) |
|
|
(520 |
) |
Other
income, net |
|
407 |
|
|
|
233 |
|
|
|
1,548 |
|
|
|
776 |
|
Net
loss |
$ |
(28,956 |
) |
|
$ |
(13,122 |
) |
|
$ |
(74,978 |
) |
|
$ |
(49,784 |
) |
Net loss per common
share (basic and diluted) |
$ |
(1.29 |
) |
|
$ |
(0.58 |
) |
|
$ |
(3.33 |
) |
|
$ |
(2.26 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
22,554,418 |
|
|
|
22,515,136 |
|
|
|
22,544,475 |
|
|
|
22,019,818 |
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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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