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 franchise
development program updates and financial results for the third
quarter ended September 30, 2017.
“We are entering the most transformative period
in Esperion’s history in a strong position. The bempedoic acid
franchise continues to deliver highly positive clinical results,
most recently with the all-oral regimen of the bempedoic acid /
ezetimibe combination plus atorvastatin lowering LDL-C by 64% and
reducing hsCRP by almost 50%. Patient enrollment was completed in
September for the bempedoic acid pivotal Phase 3 LDL-C lowering
studies, and the pivotal Phase 3 study of the bempedoic acid /
ezetimibe combination pill has been initiated. Top-line results are
on track to start reporting out by the second quarter of 2018
followed by NDA submissions by the first quarter of 2019,” said Tim
Mayleben, president and chief executive officer of Esperion
Therapeutics. “We are in a strong financial position and continue
to make rapid progress on delivering 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 lipid-modifying therapies.”
Development Program and Company Highlights
- August 2017:- Announced positive top-line results from the
Phase 2 clinical study (1002-038) of the bempedoic acid / ezetimibe
combination plus atorvastatin all-oral therapy;- Completed a
follow-on public offering of $175 million, funding the Company
through the expected regulatory approvals of the bempedoic acid /
ezetimibe combination pill and bempedoic acid in the first quarter
of 2020.
- September 2017: Completed enrollment in the global pivotal
Phase 3 program for bempedoic acid.
- November 2017: Initiated and announced design of the pivotal
Phase 3 study (1002FDC-053) of the bempedoic acid / ezetimibe
combination pill.
Upcoming Milestones
- December 2017: Planned publication of results from Mendelian
randomization studies that genetically validate ACL inhibition, the
enzyme target of bempedoic acid.
2017 Third Quarter Financial Results
As of September 30, 2017, cash and cash
equivalents and investment securities available-for-sale totaled
$309.1 million compared with $242.5 million at December 31,
2016.
Research and development expenses were $40.1
million for the third quarter of 2017 and $114.2 million for the
nine months ended September 30, 2017, compared to $13.5 million and
$33.0 million for the comparable periods 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 $5.7
million for the third quarter of 2017 and $16.1 million for the
nine months ended September 30, 2017, compared to $4.2 million and
$13.9 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 other costs to support our growth.
Esperion had a net loss of $45.2 million for the
third quarter of 2017 and $129.1 million for the nine months ended
September 30, 2017, compared to $17.4 million and $46.0 million,
respectively, for the comparable period in 2016.
Esperion had approximately 26.2 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, and $1.5 million of debt outstanding as of September
30, 2017.
2017 Financial Outlook
Esperion expects full-year 2017 net cash used in
operating activities to be approximately $135 million and its cash
and cash equivalents and investment securities to be approximately
$272 million at December 31, 2017. 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
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 LDL receptors. Previously completed Phase 2
data demonstrated that this safe and well tolerated combination
results in a 48 percent lowering of LDL-C, 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 approximately
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
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 are therefore considered to
be statin intolerant. Esperion-discovered and developed, bempedoic
acid is a targeted LDL-C lowering therapy in Phase 3 development.
The company has two convenient, cost-effective, complementary,
orally available, 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 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 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 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) |
| |
|
|
|
|
| September 30, |
|
December 31, |
|
|
2017 |
|
|
|
2016 |
|
| Cash and
cash equivalents |
$ |
21,024 |
|
|
$ |
38,165 |
|
| Working
capital |
|
171,826 |
|
|
|
197,988 |
|
|
Investments |
|
288,064 |
|
|
|
204,324 |
|
| Total
assets |
|
313,093 |
|
|
|
245,213 |
|
| Total
long-term debt |
|
- |
|
|
|
1,022 |
|
| Common
stock |
|
26 |
|
|
|
23 |
|
|
Accumulated deficit |
|
(358,400 |
) |
|
|
(229,200 |
) |
| Total
stockholders' equity |
|
278,096 |
|
|
|
228,602 |
|
| |
|
|
|
| |
| Esperion Therapeutics, Inc. |
|
|
|
|
|
|
|
|
|
|
| Statement of Operations |
| (In thousands, except share and per share
data) |
| (Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
| Research
and development |
|
$ |
40,056 |
|
|
$ |
13,498 |
|
|
$ |
114,164 |
|
|
$ |
32,987 |
|
| General
and administrative |
|
|
5,681 |
|
|
|
4,214 |
|
|
|
16,122 |
|
|
|
13,878 |
|
| Total
operating expenses |
|
|
45,737 |
|
|
|
17,712 |
|
|
|
130,286 |
|
|
|
46,865 |
|
|
Loss from operations |
|
|
(45,737 |
) |
|
|
(17,712 |
) |
|
|
(130,286 |
) |
|
|
(46,865 |
) |
|
|
|
|
|
|
|
|
|
|
| Interest
expense |
|
|
(44 |
) |
|
|
(89 |
) |
|
|
(166 |
) |
|
|
(298 |
) |
| Other
income, net |
|
|
562 |
|
|
|
399 |
|
|
|
1,355 |
|
|
|
1,141 |
|
| Net
loss |
|
$ |
(45,219 |
) |
|
$ |
(17,402 |
) |
|
$ |
(129,097 |
) |
|
$ |
(46,022 |
) |
| Net loss per common
share (basic and diluted) |
|
$ |
(1.86 |
) |
|
$ |
(0.77 |
) |
|
$ |
(5.57 |
) |
|
$ |
(2.04 |
) |
| Weighted average shares
outstanding (basic and diluted) |
|
|
24,311,844 |
|
|
|
22,550,438 |
|
|
|
23,161,847 |
|
|
|
22,541,137 |
|
| |
|
|
|
|
|
|
|
|
Media Contact:
Elliot FoxW2O
Group212.257.6724efox@w2ogroup.com
Investor Contact: Mindy LoweEsperion Therapeutics,
Inc.734.887.3903mlowe@esperion.com
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