Esperion (NASDAQ:ESPR) today provided bempedoic acid franchise
development program updates and financial results for the first
quarter ended March 31, 2019.
“The potential of bempedoic acid is being broadly realized as
evidenced by publication and presentation of Phase 3 clinical study
results in the New England Journal of Medicine, the American
College of Cardiology 2019 Scientific Sessions and other industry
leading platforms. This high-profile external validation of
the potential of bempedoic acid to meet the LDL-C lowering needs of
the millions of patients with high LDL-C despite the use of
currently accessible therapies confirms the beliefs of our Lipid
Management Team,” said Tim M. Mayleben, president and chief
executive officer of Esperion. “We will continue to work closely
with regulatory authorities to bring our LDL-C lowering therapies
to physicians, payers and their patients.”
Recent Development Program Highlights
January 2019:
- Entered into a license and
collaboration agreement (the LCA) with Daiichi
Sankyo Europe (DSE) to commercialize bempedoic acid and the
bempedoic acid / ezetimibe combination tablet in the European
Economic Area and Switzerland. Payments to Esperion under the
agreement include $150 million upfront upon execution of the LCA,
$150 million upon first commercial sale in the territory (as
defined by the LCA), up to $600 million in additional regulatory
and commercial milestones payments as well as 15% to 25% tiered
royalties on net territory sales.
February 2019:
- Submitted two New Drug Applications (NDAs) for bempedoic acid
and the bempedoic acid / ezetimibe combination tablet to the U.S.
Food and Drug Administration (FDA).
- Completed the formal validation process with the European
Medicines Agency (EMA) of Esperion’s two Marketing Authorization
Applications (MAAs) and officially started the review procedure for
both bempedoic acid and the bempedoic acid / ezetimibe combination
tablet. The MAAs for bempedoic acid and the bempedoic acid /
ezetimibe combination tablet were submitted to the EMA on February
11, 2019.
March 2019:
- Publication of bempedoic acid Study 1 (1002-040) results in The
New England Journal of Medicine. The research was authored by
Professor Kausik Ray.
- Presentation of Study 2 (1002-047) results at the American
College of Cardiology 2019 Scientific Sessions by Dr. Anne C
Goldberg.
- Publication of bempedoic acid Study 3 (1002-046) results in The
Journal of American Heart Association. The research was authored by
Dr. med Ulrich Laufs.
May 2019:
- Acceptance for filing and review of the NDAs for bempedoic acid
and the bempedoic acid / ezetimibe combination tablet by the FDA
with a target action Prescription Drug User Fee Act (PDUFA) date of
February 21, 2020 and February 26, 2020, respectively. The FDA has
communicated that there is no current plan to hold an advisory
committee meeting to discuss the applications.
- Results from the initial clinical study of the 100 mg sustained
release formulation of bempedoic acid demonstrated consistent (29%)
LDL-C lowering (with approximately one-half the active
pharmaceutical ingredient of the current 180 mg bempedoic acid
tablet) as well as favorable safety and PK parameters. These
results provide initial proof-of-concept for the sustained release
formulation of bempedoic acid to increase efficacy, extend the
patent life of the bempedoic acid franchise into 2038 while
utilizing a 505(b)(2) regulatory pathway to approval, and reduce
manufacturing costs.
Upcoming Milestones
Second quarter 2019:
- Esperion to host Analyst and Investor Day on May 30th
Third quarter 2019:
- Completion of enrollment in the 12,604 patient CLEAR
Cardiovascular Outcomes study
Second half 2019:
- Top-line results from the 12-week, Phase 2 clinical study
(1002-058) of the bempedoic acid / ezetimibe combination tablet in
242 patients with elevated LDL-C and type 2 diabetes mellitus
- Pivotal Phase 3 trial initiation of bempedoic acid in patients
with elevated LDL-C and type 2 diabetes, to support a glycemic
control indication in adults with both hypercholesterolemia and
type 2 diabetes mellitus
2019 Financial Outlook
Esperion expects full-year 2019 net cash used in operations to
be $25 to $35 million, driven by the following components:
Collaboration and license agreement cash source |
$150
million |
R&D cash used |
$115 million to $120 million |
SG&A cash used |
$60 million to $65 million |
Esperion expects that current cash resources, coupled with
expected milestone payments under the European commercial
collaboration agreement, as well as bempedoic acid and the
bempedoic acid / ezetimibe combination tablet commercial sales, are
sufficient to fund operations until operating cash flow is
positive.
2019 First Quarter Financial Results
As of March 31, 2019, cash, cash equivalents, restricted cash
and investment securities available-for-sale totaled $229.7 million
compared with $136.3 million at December 31, 2018.
Revenue was $145.4 million for the first quarter of 2019,
compared to $0.0 million for the comparable period in 2018. Revenue
was attributable to the initial recognition of the upfront payment
from the DSE collaboration agreement.
Research and development expenses were $46.3 million for the
first quarter of 2019, compared to $40.9 million for the comparable
period in 2018. The increase in research and development expenses
was primarily related to the clinical development costs for
bempedoic acid and the bempedoic acid / ezetimibe combination
tablet, including costs to support the ongoing CLEAR CVOT,
regulatory submissions and increases in our headcount.
General and administrative expenses were $12.2 million for the
first quarter of 2019, compared to $6.0 million for the comparable
period in 2018. 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 gain of $87.4 million for the first quarter
of 2019, compared to a net loss of $46.1 million for the comparable
period in 2018.
Esperion had approximately 26.9 million shares of common stock
outstanding, with another 5.3 million issuable upon exercise of
stock options and warrants and vesting of restricted stock units as
of March 31, 2019.
Bempedoic Acid
Bempedoic acid is our lead, non-statin, complementary, orally
available, once-daily, LDL-C lowering therapy. With a targeted
mechanism of action, bempedoic acid is a first-in-class, 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 high sensitivity C-reactive
protein (hsCRP), a key marker of inflammation associated with
cardiovascular disease. Completed Phase 3 studies conducted in more
than 4,000 patients, with over 2,600 patients treated with
bempedoic acid, have produced an additional 18 percent LDL-C
lowering when used with moderate- and high-intensity statins and 28
percent LDL-C lowering when used with no background statin.
Bempedoic Acid / Ezetimibe Combination
Tablet
Through the complementary mechanisms of action of inhibition of
cholesterol synthesis (bempedoic acid) and inhibition of
cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe
combination tablet is a 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 combination
results in a 29 percent LDL-C lowering when used with maximally
tolerated statins, a 44 percent LDL-C lowering when used with no
background statin (post-hoc analysis), and a 34 percent reduction
in hsCRP.
CLEAR Outcomes
The effect of bempedoic acid on cardiovascular morbidity and
mortality has not yet been determined. Esperion 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 averse." The CVOT
— known as 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., 96 million people, or more than 37
percent of the adult population have elevated LDL-C. There are
approximately 18 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 averse — leaving them at
high risk for cardiovascular events. More than 50 percent of ASCVD
patients who are not able to reach their LDL-C goals with statins
alone need less than a 40 percent reduction to reach their LDL-C
threshold.
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, cost-effective,
convenient, 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
bempedoic acid / ezetimibe combination tablet 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 bempedoic acid and the bempedoic acid /
ezetimibe combination tablet and the therapeutic potential of,
clinical development plan for, bempedoic acid and the bempedoic
acid / ezetimibe combination tablet, including Esperion's timing,
designs, plans and announcement of results regarding its CLEAR
Outcomes study and other ongoing clinical studies for bempedoic
acid and the bempedoic acid / ezetimibe combination tablet, timing
for the review and approval of the NDAs and the MAAs 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 tablet, if approved, Esperion’s cash position
and financial outlook, and the expected upcoming milestones
described in this press release. 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) |
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
Cash and cash equivalents |
$ |
174,836 |
|
|
$ |
36,973 |
|
|
Working capital |
|
175,196 |
|
|
|
78,299 |
|
|
Investments |
|
53,692 |
|
|
|
99,293 |
|
|
Restricted cash |
|
1,193 |
|
|
|
- |
|
|
Total assets |
|
236,482 |
|
|
|
143,451 |
|
|
Common stock |
|
27 |
|
|
|
27 |
|
|
Accumulated deficit |
|
(510,722) |
|
|
|
(598,101) |
|
|
Total stockholders' equity |
|
175,010 |
|
|
|
79,118 |
|
|
|
|
|
|
|
Esperion
Therapeutics, Inc. |
|
|
|
|
Statement of
Operations |
(In
thousands, except share and per share data) |
(Unaudited) |
|
|
|
Three Months Ended March
31, |
|
|
2019 |
|
|
2018 |
Revenues: |
|
|
|
Collaboration revenue |
$ |
145,419 |
|
$ |
- |
Total Revenues |
|
145,419 |
|
|
- |
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
|
46,308 |
|
|
40,940 |
General and administrative |
|
12,182 |
|
|
5,954 |
Total operating expenses |
|
58,490 |
|
|
46,894 |
|
|
|
|
Income (loss) from operations |
|
86,929 |
|
|
(46,894) |
|
|
|
|
Other income, net |
|
450 |
|
|
764 |
Net income (loss) |
$ |
87,379 |
|
$ |
(46,130) |
|
|
|
|
Net income (loss) per common share - basic |
$ |
3.26 |
|
$ |
(1.73) |
Net income (loss) per common share - diluted |
$ |
3.07 |
|
$ |
(1.73) |
|
|
|
|
Weighted average shares outstanding - basic |
|
26,842,785 |
|
|
26,605,189 |
Weighted average shares outstanding - diluted |
|
28,449,767 |
|
|
26,605,189 |
|
|
|
|
Investor Contact: Alex Schwartz Esperion 734-249-3386
aschwartz@esperion.com
Media Contact: Elliot Fox W2Opure 212-257-6724
efox@purecommunications.com
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