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 fourth quarter and full year ended
December 31, 2017.
“The past year was significant and reflective of
the meaningful progress made by our Lipid Management Team through
the achievement of positive regulatory interactions, clinical trial
execution resulting in rapid patient enrollment in the global
pivotal Phase 3 program for bempedoic acid and the bempedoic acid /
ezetimibe combination pill, and completion of a follow-on public
offering funding our programs through the expected approvals for an
LDL-C lowering indication,” said Tim Mayleben, president and chief
executive officer of Esperion. “With the first of our Phase 3
studies expected to report top-line results in March, we are
confident 2018 will be the most transformational and defining year
in our company’s history. We look forward to reporting top-line
results from all five pivotal Phase 3 studies of the bempedoic acid
franchise throughout this very exciting year.”
Fourth Quarter Development Program and Company
Highlights
- November 2017: Announced design and initiated the pivotal Phase
3 study (1002FDC-053) for the bempedoic acid / ezetimibe
combination pill.
Upcoming Milestones
- March 2018:
- Top-line results expected from the pivotal Phase 3 Study 4
(1002-048) of bempedoic acid in atherosclerotic cardiovascular
disease (ASCVD) patients on ezetimibe and low dose statin
background therapy (high CV risk patients considered statin
intolerant);
- Top-line results expected from the Phase 2 study (1002-039)
of bempedoic acid added-on to a once-monthly injectable PCSK9
inhibitor.
- May 2018:
- Top-line results expected from the pivotal Phase 3 Study 1
(1002-040) of bempedoic acid in ASCVD and/or heterozygous
familial hypercholesterolemia (HeFH) patients on maximally
tolerated statin background therapy;
- Top-line results expected from the pivotal Phase 3 Study 3
(1002-046) of bempedoic acid in ASCVD patients on background
therapy of less than approved daily starting doses of statins (high
CV risk patients considered statin intolerant).
- August 2018:
- Top-line results expected from the pivotal Phase 3 study
(1002FDC-053) of the bempedoic acid / ezetimibe combination pill in
ASCVD and/or HeFH patients on maximally tolerated statin background
therapy.
- September 2018:
- Top-line results expected from the pivotal Phase 3 study 2
(1002-047) of bempedoic acid in ASCVD and/or HeFH patients on
maximally tolerated statin background therapy.
CLEAR Outcomes Global Cardiovascular Outcomes Trial
Enrollment Update
Esperion initiated in December 2016 its global
cardiovascular outcomes trial (CVOT) known
as Cholesterol Lowering
via BEmpedoic Acid,
an ACL-inhibiting Regimen
(CLEAR) Outcomes (1002-043). The CLEAR Outcomes study is currently
enrolling patients with hypercholesterolemia and high
cardiovascular disease risk and only those who can be considered
statin intolerant. Patient enrollment is proceeding as planned and
remains on track to fully enroll by mid-2019. Top-line results from
this study are expected to support our submissions for a
cardiovascular disease risk reduction indication in the U.S. and
Europe by 2022.
2017 Fourth Quarter and Full-Year Financial
Results
As of December 31, 2017, cash and cash equivalents and
investment securities available-for-sale totaled $273.6 million
compared with $242.5 million at December 31, 2016.
Research and development expenses were $33.4
million for the fourth quarter of 2017 and $147.6 million for the
year ended December 31, 2017, compared to $24.9 million and $57.9
million for the comparable periods in 2016. The increase in
research and development expenses was primarily related to the
further clinical development of the bempedoic acid / ezetimibe
combination pill and bempedoic acid, including costs to support the
global pivotal Phase 3 studies, the CVOT, and further
increases in our headcount and stock-based compensation
expense.
General and administrative expenses were $5.3
million for the fourth quarter of 2017 and $21.4 million for the
year ended December 31, 2017, compared to $4.4 million and $18.3
million for the comparable periods in 2016. The increase in general
and administrative expenses was primarily attributable to costs to
support public company operations, increases in our headcount and
stock-based compensation expense, and other costs to support our
growth.
Esperion had a net loss of $37.9 million for the
fourth quarter of 2017 and $167.0 million for the year ended
December 31, 2017, compared to $29.0 million and $75.0 million,
respectively, for the comparable periods in 2016.
Esperion had approximately 26.3 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 $1.0 million of debt outstanding as of December
31, 2017.
2018 Financial Outlook
Esperion 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.
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), and may
potentially be associated with a lower occurrence of muscle-related
side effects.
Bempedoic Acid
With a targeted mechanism of action, bempedoic
acid is a first-in-class, complementary, orally available,
once-daily ACL inhibitor that reduces cholesterol biosynthesis and
lowers 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 conducted in more than
1,300 patients and over 800 patients treated with bempedoic acid
have produced clinically relevant LDL-C lowering results of up to
30 percent as monotherapy 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
complementary, convenient, cost-effective, once-daily, oral
therapies to significantly reduce elevated levels of LDL-C in
high-risk patients with hypercholesterolemia, including patients
inadequately treated with current lipid-modifying
therapies. It is estimated that 40 million patients with
hypercholesterolemia in the U.S. are taking statins, approximately
12 million of those patients are at high-risk with atherosclerotic
cardiovascular disease (ASCVD) and/or heterozygous familial
hypercholesterolemia (HeFH) and with LDL-C that is not adequately
controlled despite receiving maximally tolerated lipid-modifying
background therapy. The 12 million high-risk patients include
patients only able to tolerate less than the lowest approved daily
starting dose of their statin and are considered statin intolerant.
Esperion-discovered and developed, bempedoic acid is a targeted
LDL-C lowering therapy in Phase 3 development. The company has two
bempedoic acid-based LDL-C lowering therapies in Phase 3
development: 1) a once-daily, oral bempedoic acid / ezetimibe
combination pill, and 2) bempedoic acid, a once-daily, oral
pill.
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 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 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, the global pivotal Phase 3
clinical development program for bempedoic acid, 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, 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) |
|
|
|
|
December 31,2017 |
|
December
31,2016 |
|
|
|
|
Cash and
cash equivalents |
$ |
34,468 |
|
|
$ |
38,165 |
|
Working
capital |
|
170,780 |
|
|
|
197,988 |
|
Investments |
|
239,151 |
|
|
|
204,324 |
|
Total
assets |
|
277,835 |
|
|
|
245,213 |
|
Total
long-term debt |
|
— |
|
|
|
1,022 |
|
Common
stock |
|
26 |
|
|
|
23 |
|
Accumulated
deficit |
|
(396,291 |
) |
|
|
(229,200 |
) |
Total
stockholders' equity |
|
244,691 |
|
|
|
228,602 |
|
|
|
|
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
|
Statement of Operations |
(In thousands, except share and per share
data)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months
EndedDecember 31, |
|
Year
EndedDecember 31, |
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
$ |
33,439 |
|
|
$ |
24,881 |
|
|
$ |
147,603 |
|
|
$ |
57,868 |
|
|
General and
administrative |
|
5,257 |
|
|
|
4,404 |
|
|
|
21,379 |
|
|
|
18,282 |
|
|
Total operating
expenses |
|
38,696 |
|
|
|
29,285 |
|
|
|
168,982 |
|
|
|
76,150 |
|
|
Loss from
operations |
|
(38,696 |
) |
|
|
(29,285 |
) |
|
|
(168,982 |
) |
|
|
(76,150 |
) |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(32 |
) |
|
|
(78 |
) |
|
|
(198 |
) |
|
|
(376 |
) |
|
Other income, net |
|
837 |
|
|
|
407 |
|
|
|
2,192 |
|
|
|
1,548 |
|
|
Net
loss |
$ |
(37,891 |
) |
|
$ |
(28,956 |
) |
|
$ |
(166,988 |
) |
|
$ |
(74,978 |
) |
|
Net loss per common
share (basic and diluted) |
$ |
(1.44 |
) |
|
$ |
(1.29 |
) |
|
$ |
(6.98 |
) |
|
$ |
(3.33 |
) |
|
Weighted average shares
outstanding (basic and diluted) |
|
26,222,397 |
|
|
|
22,554,418 |
|
|
|
23,933,273 |
|
|
|
22,544,475 |
|
|
Media Contact:
Elliot FoxW2O
Group212.257.6724efox@w2ogroup.com
Investor Contact:Audrey GrossW2O
Group212.301.7214agross@w2ogroup.com
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