Esperion (NASDAQ:ESPR), the Lipid Management
Company focused on developing and commercializing
complementary, convenient, cost-effective, once-daily, oral
therapies for the treatment of patients with elevated low density
lipoprotein cholesterol (LDL-C), today provided bempedoic acid
franchise development program updates and financial results for the
third quarter ended September 30, 2018.
“The Lipid Management Team has made tremendous progress this
year with positive top-line results reported from five pivotal
Phase 3 studies. As we learned at our investor day in July,
leading physicians and key opinion leaders have a highly favorable
view of both bempedoic acid and the bempedoic acid / ezetimibe
combination pill,” said Tim M. Mayleben, president and chief
executive officer of Esperion. “With results from the
completed Phase 3 LDL-C lowering program in hand, we remain
on-track to submit New Drug Applications for both drugs during the
first quarter of 2019. We look forward to working with
regulatory authorities to bring our convenient, cost-effective and
complementary once-daily, oral bempedoic acid-based LDL-cholesterol
lowering therapies to the millions of patients who are not reaching
their LDL-C lowering goals with existing treatment options."
Recent Development Program Highlights
August 2018:
- Final Study 1 (1002-040) results were presented by Prof. Kausik
Ray at the European Society of Cardiology Congress.
- Announced positive top-line results from the global, pivotal
Phase 3 study (1002FDC-053) evaluating the safety and tolerability
of the bempedoic acid 180 mg / ezetimibe 10 mg combination pill
compared to bempedoic acid, ezetimibe or placebo in high-risk
patients treated with maximally tolerated statins. The
bempedoic acid / ezetimibe combination pill was observed to be safe
and well tolerated in this study, and provided an additional 35
percent LDL-C lowering and 34 percent hsCRP reduction. In patients
taking no statin background therapy, the bempedoic acid / ezetimibe
combination pill lowered LDL-C by 43 percent.
October 2018:
- Announced positive top-line results from Study 2 (1002-047),
the global, pivotal Phase 3 study of bempedoic acid 180 mg
evaluating the LDL-C lowering efficacy and the safety and
tolerability of bempedoic acid versus placebo in patients with
atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous
familial hypercholesterolemia (HeFH) who are inadequately
controlled with current lipid-modifying therapies, including
maximally tolerated statin therapy. Bempedoic acid was
observed to be safe and well-tolerated in this study and provided
an additional 18 percent LDL-C lowering and 19 percent hsCRP
reduction.
- Announced positive cumulative results from our Phase 3 LDL-C
lowering development program of bempedoic acid. The program
consisted of four pivotal, Phase 3, randomized, double-blind,
placebo controlled studies which evaluated the LDL-C lowering
efficacy and safety and tolerability of bempedoic acid 180 mg
compared to placebo in high cardiovascular risk patients including
ASCVD and/or HeFH patients. Bempedoic acid achieved all
safety and tolerability objectives in the Phase 3 program and
provided patients an additional 18% to 31% LDL-C lowering, 19% to
33% hsCRP reductions, as well as 0.19% to 0.31% hemoglobin A1c
reductions.
Upcoming Milestones
November 2018:
- Presentation of final Study 3 (1002-046) results at the
American Heart Association Scientific Sessions in Chicago.
First quarter 2019:
- NDA submissions of bempedoic acid and the bempedoic acid /
ezetimibe combination pill to the US Food and Drug
Administration.
Second quarter 2019:
- MAA submissions of bempedoic acid and the bempedoic acid /
ezetimibe combination pill to the European Medicines Agency.
- Top-line results from the Phase 1 study of bempedoic acid
sustained release (SR) in overweight subjects measuring traditional
lipid parameters together with de novo lipogenesis.
2018 Financial Outlook
Esperion expects notably lower research and development expenses
beginning this quarter due to the completion of the global pivotal
Phase 3 LDL-C lowering development program of bempedoic acid and
the bempedoic acid / ezetimibe combination pill in October
2018.
The company continues to expect full-year 2018 net cash used in
operating activities to be approximately $135 to $145
million and its cash and cash equivalents and investment
securities to be approximately $130 to $140
million at December 31, 2018.
The Company estimates that current cash resources are sufficient
to fund operations through the expected approvals of the bempedoic
acid / ezetimibe combination pill and bempedoic acid in the first
quarter of 2020.
2018 Third Quarter Financial Results
As of September 30, 2018, cash and cash equivalents and
investment securities available-for-sale totaled $164.4
million compared with $273.6
million at December 31, 2017.
Research and development expenses were $41.6
million for the third quarter of 2018 and $122.0
million for the nine months ended September 30, 2018,
compared to $40.1 million and $114.2
million for the comparable periods in 2017. The increase in
research and development expenses was primarily related to clinical
development costs for the bempedoic acid / ezetimibe combination
pill and bempedoic acid, including costs to support the completion
of three global pivotal Phase 3 studies for bempedoic acid and
the pivotal Phase 3 study for the bempedoic acid / ezetimibe
combination pill during the period, the ongoing CLEAR CVOT, and
increases in our headcount and stock-based compensation
expense.
General and administrative expenses were $9.0
million for the third quarter of 2018 and $21.9
million for the nine months ended September 30, 2018,
compared to $5.7 million and $16.1 million for
the comparable periods in 2017. The increase in general and
administrative expenses was primarily attributable to costs to
support public company operations, including costs to support
pre-commercialization activities, further increases in our
headcount and stock-based compensation expense, and other costs to
support our growth.
Esperion had a net loss of $49.9 million for the third
quarter of 2018 and $141.8 million for the nine months
ended September 30, 2018, compared to $45.2
million and $129.1 million, respectively, for the
comparable periods in 2017.
Esperion had approximately 26.8 million shares of common stock
outstanding, with another 4.6 million issuable upon exercise of
stock options and warrants and vesting of restricted stock units as
of September 30, 2018.
About Esperion's Global Pivotal Phase 3 LDL-C Lowering
Program
Esperion initiated its global, pivotal, Phase 3 clinical
development program in January 2016 to evaluate the
safety, tolerability and consistent, complementary LDL-C-lowering
efficacy of bempedoic acid and the bempedoic acid / ezetimibe
combination pill in patients with atherosclerotic cardiovascular
disease (ASCVD), or who are at a high risk for ASCVD, with
hypercholesterolemia who continue to have elevated levels of LDL-C
despite the use of maximally-tolerated statins and ezetimibe,
leaving them at high risk for cardiovascular events. The program
includes five studies in approximately 4,000 patients, four for
bempedoic acid and one for the bempedoic acid / ezetimibe
combination pill.
- Two pivotal studies evaluating bempedoic acid (Studies 1 &
2) in 3,008 patients with ASCVD on maximally-tolerated statins,
with top-line results reported in May 2018 and October 2018,
respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 &
4) in 613 patients with ASCVD, or at a high risk for ASCVD,
considered statin intolerant, with top-line results reported in May
2018 and March 2018, respectively;
- One pivotal study evaluating the bempedoic acid / ezetimibe
combination pill (053 Study) in 382 patients with ASCVD, or at high
risk for ASCVD, on maximally tolerated statins, with top-line
results reported in August 2018.
Esperion plans to submit New Drug Applications (NDAs) to
the U.S. Food and Drug Administration (FDA) for bempedoic
acid and the bempedoic acid / ezetimibe combination pill for LDL-C
lowering indications during the first quarter of 2019.
Additionally, Esperion plans to submit Marketing Authorization
Applications (MAAs) to the European Medicines
Agency (EMA) during the second quarter of 2019.
Bempedoic Acid / Ezetimibe Combination Pill
Through the complementary mechanisms of action of inhibition of
cholesterol synthesis (bempedoic acid) and inhibition of
cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe
combination pill is our lead, non-statin, orally available,
once-daily, LDL-C lowering therapy. Inhibition of ATP Citrate Lyase
(ACL) by bempedoic acid reduces cholesterol biosynthesis and lowers
LDL-C by up-regulating the LDL receptor. Inhibition of Niemann-Pick
C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of
cholesterol from the gastrointestinal tract, thereby reducing
delivery of cholesterol to the liver, which in turn upregulates the
LDL receptors. Phase 3 data demonstrated that this safe and
well tolerated combination results in a 35 percent lowering of
LDL-C when used with maximally tolerated statins, a 43 percent
lowering of LDL-C when used as a monotherapy, and a 34 percent
reduction in high sensitivity C-reactive protein (hsCRP).
Bempedoic Acid
With a targeted mechanism of action, bempedoic acid is a
first-in-class, complementary, orally available, once-daily ATP
Citrate Lyase (ACL) inhibitor that, reduces cholesterol
biosynthesis and lowers LDL-C by up-regulating the LDL receptor.
Similar to statins, bempedoic acid also reduces hsCRP, a key marker
of inflammation associated with cardiovascular disease. Completed
Phase 2 and Phase 3 studies conducted in almost 4,800 patients, and
approximately 3,100 patients treated with bempedoic acid, have
produced an additional 20 percent LDL-C lowering when used with
maximally tolerated statins, up to 30 percent LDL-C lowering as
monotherapy, 35 percent LDL-C lowering in combination with
ezetimibe when used with maximally tolerated statins, and up to 48
percent LDL-C lowering in combination with ezetimibe as
monotherapy.
The effect of bempedoic acid on cardiovascular morbidity and
mortality has not yet been determined. The company initiated a
global cardiovascular outcomes trial (CVOT) to assess the effects
of bempedoic acid on the occurrence of major cardiovascular events
in patients with, or at high risk for, cardiovascular disease (CVD)
who are only able to tolerate less than the lowest approved daily
starting dose of a statin and considered "statin intolerant." The
CVOT — known as Cholesterol Lowering via Bempedoic Acid,
an ACL-inhibiting Regimen (CLEAR) Outcomes — is an
event-driven, global, randomized, double-blind, placebo-controlled
study expected to enroll approximately 12,600 patients with
hypercholesterolemia and high CVD risk at over 1,000 sites in
approximately 30 countries.
Esperion's Commitment to Patients with
Hypercholesterolemia
High levels of LDL-C can lead to a build-up of fat and
cholesterol in and on artery walls (known as atherosclerosis),
potentially leading to cardiovascular events, including heart
attack or stroke. In the U.S., 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. There are
approximately 13 million people in the U.S. with atherosclerotic
cardiovascular disease (ASCVD) who live with elevated levels of
LDL-C despite taking maximally-tolerated lipid-modifying therapy —
including individuals considered statin intolerant — leaving them
at high risk for cardiovascular events. More than 6 million
patients with ASCVD and/or HeFH on maximally tolerated statins
require less than 30 percent additional LDL-C lowering to achieve
treatment goals.
Esperion's mission as the Lipid Management Company is
to deliver once-daily, oral therapies that complement existing oral
drugs to provide the additional LDL-C lowering that these patients
need.
The Lipid Management Company
Esperion 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 cardiovascular disease; the
leading cause of death around the world. Bempedoic acid and the
company's lead product candidate, the bempedoic acid / ezetimibe
combination pill, are targeted therapies that have been shown to
significantly lower 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 the bempedoic acid / ezetimibe combination
pill and bempedoic acid and the therapeutic potential of, clinical
development plan for, the bempedoic acid / ezetimibe combination
pill and bempedoic acid, including Esperion's timing, designs,
plans and announcement of results regarding its global pivotal
Phase 3 clinical development program for bempedoic acid and the
bempedoic acid / ezetimibe combination pill, Esperion's timing and
plans for submission of NDAs to the FDA and MAAs to the
EMA and Esperion's expectations for the market for therapies to
lower LDL-C, including the market adoption of bempedoic acid and
the bempedoic acid / ezetimibe combination pill, if approved, the
expected upcoming milestones described in this press release, and
our 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 Esperion’s studies, that positive results from a clinical study
of bempedoic acid may not be sufficient for FDA or EMA
approval or necessarily be predictive of the results of future or
ongoing clinical studies, that notwithstanding the completion of
Esperion’s Phase 3 clinical development program for LDL-C lowering,
the FDA or EMA may require additional development in connection
with seeking regulatory approval, that existing cash resources may
be used more quickly than anticipated, and the risks detailed in
Esperion's filings with the Securities and Exchange
Commission. 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, |
|
2018 |
|
2017 |
Cash and cash
equivalents |
$ |
26,755 |
|
|
$ |
34,468 |
|
Working capital |
|
125,925 |
|
|
|
170,780 |
|
Investments |
|
137,644 |
|
|
|
239,151 |
|
Total assets |
|
174,030 |
|
|
|
277,835 |
|
Common stock |
|
27 |
|
|
|
26 |
|
Accumulated
deficit |
|
(538,062 |
) |
|
|
(396,291 |
) |
Total stockholders'
equity |
|
131,745 |
|
|
|
244,691 |
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
$ |
41,551 |
|
|
$ |
40,056 |
|
|
$ |
122,015 |
|
|
$ |
114,164 |
|
General and
administrative |
|
9,011 |
|
|
|
5,681 |
|
|
|
21,921 |
|
|
|
16,122 |
|
Total
operating expenses |
|
50,562 |
|
|
|
45,737 |
|
|
|
143,936 |
|
|
|
130,286 |
|
Loss from operations |
|
(50,562 |
) |
|
|
(45,737 |
) |
|
|
(143,936 |
) |
|
|
(130,286 |
) |
|
|
|
|
|
|
|
|
Other
income, net |
|
651 |
|
|
|
518 |
|
|
|
2,165 |
|
|
|
1,189 |
|
Net
loss |
$ |
(49,911 |
) |
|
$ |
(45,219 |
) |
|
$ |
(141,771 |
) |
|
$ |
(129,097 |
) |
Net loss per common
share (basic and diluted) |
$ |
(1.86 |
) |
|
$ |
(1.86 |
) |
|
$ |
(5.30 |
) |
|
$ |
(5.57 |
) |
Weighted average shares
outstanding (basic and diluted) |
|
26,804,026 |
|
|
|
24,311,844 |
|
|
|
26,732,733 |
|
|
|
23,161,847 |
|
|
|
|
|
|
|
|
|
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Elliot Fox W2O Group 212-257-6724
efox@w2ogroup.com
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