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 second quarter ended June 30, 2018.
“The Lipid Management Team has made tremendous progress during
the first half of 2018, with positive top-line results reported
from three pivotal Phase 3 studies and one Phase 2 study.
Full results of completed Phase 3 studies are being prepared for
presentation and publication, with full Study 4 results already
presented and published last month. Additionally, at our
recent Investor Day, key opinion leaders expressed their agreement
that bempedoic acid is safe and well-tolerated, and has
demonstrated clinically meaningful LDL-C lowering in completed
Phase 2 and 3 studies,” said Tim M. Mayleben, president and chief
executive officer of Esperion. “We remain on-track to report
top-line results for the final two pivotal Phase 3 studies at the
end of August and September, as well as submit NDAs no later than
the first quarter of 2019. We are on the cusp of delivering
two once-daily, oral bempedoic acid-based LDL-cholesterol lowering
therapies to the millions of patients who are inadequately treated
with, or unable to gain access to, current LDL-C lowering
therapies."
Second Quarter Development Program
Highlights
May 2018:
- Announced positive top-line results from the global, pivotal
Phase 3 long-term study (Study 1 or 1002-040) of bempedoic acid 180
mg evaluating the safety and tolerability of bempedoic acid versus
placebo in very high-risk patients with atherosclerotic
cardiovascular disease (ASCVD) 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 20 percent
LDL-C lowering and 22 percent hsCRP reduction.
- Announced positive top-line results from the third global,
pivotal Phase 3 study of bempedoic acid in patients with ASCVD or
at high risk for ASCVD on background therapy of less than approved
daily starting doses of statins (high CV risk patients considered
statin intolerant). Bempedoic acid was observed to be safe
and well-tolerated in this study, and provided an additional 26
percent LDL-C lowering and 25 percent hsCRP reduction.
June 2018:
- Presented full Study 4 (1002-048) results at the International
Symposium on Atherosclerosis in Toronto and simultaneously
published in Atherosclerosis.
Upcoming Milestones
August 2018:
- Top-line results expected from the 12-week, pivotal Phase
3 Study (1002FDC-053) of the bempedoic acid / ezetimibe
combination pill in ASCVD patients on maximally tolerated statin
background therapy.
- Present Study 1 (1002-040) results at the European Society of
Cardiology (ESC) meeting in Munich, Germany.
September 2018:
- Top-line results expected from the 52-week, pivotal Phase
3 Study 2 (1002-047) of bempedoic acid in ASCVD patients on
maximally tolerated statin background therapy.
2018 Financial Outlook
Esperion expects notably lower research and development
expenses, beginning 4Q18, as the global pivotal Phase 3 development
program will have been completed.
The company expects 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 Second Quarter Financial Results
As of June 30, 2018, cash and cash equivalents and investment
securities available-for-sale totaled $201.8 million compared with
$273.6 million at December 31, 2017.
Research and development expenses were $39.5 million for the
second quarter of 2018 and $80.5 million for the six months ended
June 30, 2018, compared to $38.2 million and $74.1 million for the
comparable periods in 2017. As expected, 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 during the period, the
ongoing CLEAR CVOT, and increases in our headcount and stock-based
compensation expense.
General and administrative expenses were $7.0 million for the
second quarter of 2018 and $12.9 million for the six months ended
June 30, 2018, compared to $5.4 million and $10.4 million for the
comparable periods in 2017. The increase in general and
administrative expenses was primarily attributable to costs to
support public company operations, modest increases in our
headcount and stock-based compensation expense, and other costs to
support our growth.
Esperion had a net loss of $45.7 million for the second quarter
of 2018 and $91.9 million for the six months ended June 30, 2018,
compared to $43.3 million and $83.9 million, respectively, for the
comparable periods in 2017.
Esperion had approximately 26.8 million shares of common stock
outstanding, with another 4.5 million issuable upon exercise of
stock options and warrants and vesting of restricted stock units,
and $0.2 million of debt outstanding as of June 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 3,009 patients with ASCVD on maximally tolerated statin
therapy, with top-line results reported in May 2018, and
expected in September 2018, respectively;
- Two pivotal studies evaluating bempedoic acid (Studies 3 &
4) in 614 patients with ASCVD, or at high risk for ASCVD, who are
considered statin intolerant, with top-line results reported in May
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 statin therapy, with
top-line results expected 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 no later than the first quarter of 2019.
Additionally, Esperion plans to submit Marketing Authorization
Applications (MAAs) to the European Medicines
Agency (EMA) no later than 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. Previously completed Phase 2 data demonstrated that
this safe and well tolerated combination results in a 48 percent
lowering of LDL-C, and a 26 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 1, Phase 2 and Phase 3 studies conducted in more than 4,100
patients, and over 2,700 patients treated with bempedoic acid have
produced 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.
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 up to 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. The vast majority of these
patients, 9.5 million, 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 complementary,
convenient, 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 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 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. |
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Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2018 |
|
2017 |
|
Cash and cash equivalents |
$ |
24,380 |
|
$ |
34,468 |
|
Working capital |
|
153,919 |
|
|
170,780 |
|
Investments |
|
177,424 |
|
|
239,151 |
|
Total assets |
|
210,881 |
|
|
277,835 |
|
Common stock |
|
27 |
|
|
26 |
|
Accumulated deficit |
|
(488,151) |
|
|
(396,291) |
|
Total stockholders' equity |
|
175,917 |
|
|
244,691 |
|
|
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, |
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
39,524 |
|
$ |
38,248 |
|
$ |
80,464 |
|
$ |
74,108 |
General and administrative |
6,956 |
|
5,412 |
|
12,910 |
|
10,441 |
Total operating expenses |
46,480 |
|
43,660 |
|
93,374 |
|
84,549 |
Loss from operations |
(46,480) |
|
(43,660) |
|
(93,374) |
|
(84,549) |
|
|
|
|
|
|
|
|
Other income, net |
750 |
|
323 |
|
1,514 |
|
671 |
Net
loss |
$ |
(45,730) |
|
$ |
(43,337) |
|
$ |
(91,860) |
|
$ |
(83,878) |
Net loss
per common share (basic and diluted) |
$ |
(1.71) |
|
$ |
(1.92) |
|
$ |
(3.44) |
|
$ |
(3.72) |
Weighted
average shares outstanding (basic and diluted) |
26,786,796 |
|
22,591,326 |
|
26,696,495 |
|
22,577,317 |
|
|
|
|
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Investor Contact:Alex
SchwartzEsperion734-249-3386aschwartz@esperion.com
Media Contact: Elliot Fox W2O Group 212-257-6724
efox@w2ogroup.com
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