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 first quarter ended
March 31, 2017.
“With FDA having confirmed the pathway to
approval for an LDL-C lowering indication for bempedoic acid, we
remain on track to submit the NDA and MAA global regulatory filings
by the first half of 2019. We expect to begin reporting top-line
results from our global pivotal Phase 3 studies starting in the
second quarter of 2018,” said Tim Mayleben, president and chief
executive officer of Esperion Therapeutics. “Our near-term focus is
the completion of patient enrollment in our Phase 3 LDL-C lowering
efficacy studies, and later this quarter we look forward to
announcing details of our clinical development and regulatory
strategy for our doublet pill, the fixed dose combination of
bempedoic acid and ezetimibe.”
Development Program and Company Highlights
- February 2017: Initiated 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 (1002-050) will receive bempedoic
acid.
- March 2017:-- U.S. Food and Drug Administration (FDA) confirmed
the ongoing global pivotal Phase 3 LDL-C lowering program is
adequate to support approval for an LDL-C lowering indication for
bempedoic acid;-- Brian A. Ference, M.D., M.Phil, M.Sc., F.A.C.C.,
Associate Professor of Medicine, Wayne State University School of
Medicine, presented "Genetic Target Validation for ATP Citrate
Lyase Inhibition," at the American College of Cardiology
66th Annual Scientific Session; -- Initiated the Phase 2
triplet oral therapy study (1002-038) to further explore the
complementary oral LDL-C lowering of bempedoic acid, ezetimibe and
atorvastatin.
Upcoming Milestones
- June 2017:-- Announce the clinical development and regulatory
pathway for the doublet pill, the fixed dose combination of
bempedoic acid 180 mg and ezetimibe 10 mg (BA+EZ).
- 2H 2017:-- Initiate and announce the design of a Phase 2 study
of bempedoic acid added-on to a PCSK9i;-- Announce top-line results
of the Phase 2 triplet oral therapy study (1002-038);-- Complete
patient enrollment of the three ongoing global pivotal Phase 3
LDL-C lowering efficacy studies (Studies 2, 3 and 4);-- Dr. Brian
A. Ference to publish results from the Mendelian randomization
studies that genetically validate ACL inhibition in a top-tier
medical journal.
2017 First Quarter Financial Results
As of March 31, 2017, cash and cash equivalents
and investment securities available-for-sale totaled $207.8 million
compared with $242.5 million at December 31, 2016.
Research and development expenses were $35.9
million for the first quarter of 2017, compared to $9.8 million for
the comparable period in 2016. The increase in research and
development expenses was primarily related to the further clinical
development of bempedoic acid, including costs to support the
global pivotal Phase 3 LDL-C lowering program and the
cardiovascular outcomes trial (CVOT), and further increases in our
headcount and stock-based compensation expense.
General and administrative expenses were $5.0
million for the first quarter of 2017 and 2016. Decreases in
stock-based compensation expense were offset by increases in costs
to support public company operations and other costs to support our
growth.
Esperion had a net loss of $40.5 million for the
first quarter of 2017, compared to $14.6 million for the comparable
period in 2016.
Esperion had approximately 22.6 million shares
of common stock outstanding, with another 4.4 million issuable upon
exercise of stock options and warrants and vesting of restricted
stock units, and $2.3 million of debt outstanding as of March 31,
2017.
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 through the announcement of top-line results from
all global pivotal Phase 3 safety and efficacy studies and into
early 2019.
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, and may
potentially be associated with a lower occurrence of 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 has been shown to significantly reduce 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
regulatory approval pathway for bempedoic acid, 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 long-term safety and
tolerability program and CVOT for bempedoic acid, 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, including interpretation of guidance
given by the FDA, 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, changes in the FDA
guidance for regulatory approval, delays or failures in the
Company’s studies, including risks regarding the FDA’s
interpretation of the Company’s clinical trial results, the risk
that U.S. Food and Drug Administration may require additional
studies or data, 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 be sufficient for FDA approval or
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 Phase 3 long-term safety and
tolerability program for bempedoic acid may not produce sufficient
safety or tolerability results or show meaningful change in LDL-C,
that the CVOT may not demonstrate that bempedoic acid leads to
cardiovascular risk reduction or other key lipid measures of
patients, if approved that Esperion’s product could have labeling
restrictions that impact its marketing and adoption, 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. The FDA guidance described in this release
was given as of a specific date and the FDA could change its
position on the clinical endpoints or other standards for
review/approval. You are cautioned not to place undue reliance on
the forward-looking statements, which speak only as of the date of
this release. Actual results could differ from those described
therein. 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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|
|
March 31, |
|
|
|
December 31, |
|
|
|
2017 |
|
|
|
|
|
2016 |
|
Cash and
cash equivalents |
|
|
$ |
19,867 |
|
|
|
|
$ |
38,165 |
|
Working
capital |
|
|
|
166,408 |
|
|
|
|
|
197,988 |
|
Investments |
|
|
|
187,937 |
|
|
|
|
|
204,324 |
|
Total
assets |
|
|
|
214,612 |
|
|
|
|
|
245,213 |
|
Total
long-term debt |
|
|
|
585 |
|
|
|
|
|
1,022 |
|
Common
stock |
|
|
|
23 |
|
|
|
|
|
23 |
|
Accumulated deficit |
|
|
|
(269,844 |
) |
|
|
|
|
(229,200 |
) |
Total
stockholders' equity |
|
|
|
192,422 |
|
|
|
|
|
228,602 |
|
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Esperion Therapeutics, Inc. |
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Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
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Three Months Ended
March 31, |
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2017 |
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2016 |
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Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
|
|
$ |
35,860 |
|
|
|
|
$ |
9,791 |
|
General
and administrative |
|
|
|
5,029 |
|
|
|
|
|
5,031 |
|
Total
operating expenses |
|
|
|
40,889 |
|
|
|
|
|
14,822 |
|
Loss from operations |
|
|
|
(40,889 |
) |
|
|
|
|
(14,822 |
) |
|
|
|
|
|
|
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|
Interest
expense |
|
|
|
(67 |
) |
|
|
|
|
(110 |
) |
Other
income, net |
|
|
|
415 |
|
|
|
|
|
347 |
|
Net
loss |
|
|
$ |
(40,541 |
) |
|
|
|
$ |
(14,585 |
) |
Net loss per common
share (basic and diluted) |
|
|
$ |
(1.80 |
) |
|
|
|
$ |
(0.65 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
|
|
22,563,152 |
|
|
|
|
|
22,532,031 |
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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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