ESPERION (NASDAQ:ESPR) today reported financial results for the
third quarter ended September 30, 2020, and provided a business
update.
“The trajectory of our U.S. launches is encouraging as quarterly
script growth increased over 500 percent and product revenue
trended similarly, despite persisting COVID-related headwinds.
Providing increasing validation by the medical community for our
medicines in the treatment of hypercholesterolemia, NEXLETOL and
NEXLIZET are now included in the American Association for Clinical
Endocrinologists’ updated lipid guidelines and the American Heart
Journal published our CLEAR Outcomes Study design,” said Tim M.
Mayleben, President and Chief Executive Officer of ESPERION.
“Momentum continues to build into the fourth quarter, exemplified
by our partner Daiichi Sankyo’s recent commercial launch in
Germany. We believe ESPERION is well-positioned to execute on our
singular focus of lipid management for everyone and drive
long-term, future growth for shareholders.”
Quarterly & Recent Highlights
Clinical and Regulatory:
- July 2020: Pooled LDL-C lowering efficacy analysis from the
four Phase 3 clinical studies of NEXLETOL was published in the
Journal of the American Medical Association Cardiology.
- August 2020: Presented two scientific posters at the European
Society of Cardiology (ESC) 2020 Congress based on a pooled
analysis from four Phase 3 clinical trials and long-term safety and
efficacy data of NEXLETOL.
- October 2020: Professor P. Barton Duell highlighted pooled data
demonstrating significant cholesterol lowering in people with
familial hypercholesterolemia with NEXLETOL at the 88th Annual
Congress of the European Atherosclerosis Society (EAS).
- October 2020: The American Heart Journal published the landmark
CLEAR Outcomes study design spotlighting the first-of-its-kind
cardiovascular outcomes trial to focus exclusively on patients with
documented intolerance on statin therapy.
Commercial:
- July 2020: Surpassed NEXLETOL and NEXLIZET one-year managed
care coverage goals, with over 80% commercial coverage and over 50%
Medicare Part D coverage with preferred brand formulary status less
than four months after initial launch.
- September 2020: Launched “Break the Cycle with NEXLETOL” a
national direct-to-consumer (DTC) campaign aimed at broadening
awareness of NEXLETOL tablets.
Corporate and Business Development:
- November 2020: Daiichi Sankyo Europe (DSE) launches NUSTENDI
and NILEMDO tablets in German market marking the initiation of
European commercialization for our medicines.
Upcoming Milestones
Fourth Quarter 2020:
- Potential Rest-of-World development and commercial
collaboration agreement(s).
2020 Third Quarter Financial Results
As of September 30, 2020, cash, cash equivalents, restricted
cash and investment securities available-for-sale totaled $215.7
million compared with $300.7 million at June 30, 2020.
Total revenue was $3.8 million for the third quarter of 2020.
This amount includes approximately $3.3 million of net product
sales and $0.5 million in partner reimbursement for the third
quarter of 2020. This compares to total revenue of $1.0 million for
the third quarter of 2019. The increase in revenue was primarily
related to U.S. net product sales of NEXLETOL and NEXLIZET.
Research and development expenses were $35.3 million for the
third quarter of 2020, compared to $48.3 million for the comparable
period in 2019. The decrease was primarily attributable to a
decline in costs related to the completion of enrollment of our
CLEAR CVOT, which was fully enrolled during the third quarter of
2019.
Selling, general and administrative expenses were $48.8 million
for the third quarter of 2020, compared to $18.5 million for the
comparable period in 2019. The increase was primarily attributable
to costs to support the commercialization of NEXLETOL and NEXLIZET
in the U.S., increases in our headcount resulting from the buildout
of our customer-facing team, stock-based compensation expense, and
other costs to support our growth.
ESPERION had net loss of $85.4 million for the third quarter of
2020, compared to net loss of $68.4 million for the comparable
period in 2019. ESPERION had a basic and diluted net loss per share
of $3.07, respectively, for the third quarter of 2020, compared to
a basic and diluted net loss per share of $2.52 for the comparable
period in 2019.
ESPERION had approximately 27.9 million shares of common stock
outstanding, with another 4.9 million issuable upon exercise of
stock options and vesting of restricted stock units, and $171.2
million of the revenue interest liability outstanding as of
September 30, 2020.
2020 Financial Outlook
Research and development expenses for the full year 2020 are
expected to be $135 million to $145 million. Selling, general and
administrative expenses for the full year 2020 are expected to be
$200 million to $210 million. These amounts do not include $30
million in non-cash stock-based compensation.
ESPERION’s cash balance as of September 30, 2020 was $215.7
million. Esperion expects that current cash resources, coupled with
future revenue from NEXLETOL and NEXLIZET commercial net product
sales are sufficient to fund continued operations. Cash proceeds
from existing partnership collaborations, an expected ROW
partnership, the additional $50 million available to Esperion, at
its option, under the Oberland Capital revenue-based funding
agreement, as well as potential non-dilutive funding sources
further secures Esperion’s sustainable cash runway.
Conference Call and Webcast Information
ESPERION's Lipid Management Team will host a conference call and
webcast on November 2, 2020 at 4:30 P.M. Eastern Time to provide a
third quarter 2020 financial results and company update. The call
can be accessed by dialing (877) 831-3840
(domestic) or (253) 237-1184 (international) five
minutes prior to the start of the call and providing the access
code 9377299.
A live audio webcast can be accessed on the investors and media
section of the ESPERION website at investor.esperion.com. Access to
the webcast replay will be available approximately two hours after
completion of the call and will be archived on the Company's
website for approximately 90 days.
CLEAR Cardiovascular Outcomes Trial
The effect of bempedoic acid on cardiovascular morbidity and
mortality has not 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 are considered "statin averse." The
CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an
event-driven, global, randomized, double-blind, placebo-controlled
study that completed enrollment in August 2019 of over 14,000
patients with hypercholesterolemia and high CVD risk at over 1,400
sites in 32 countries.
ESPERION Therapeutics
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 medicines that will make a substantial impact on reducing
global cardiovascular disease, the leading cause of death around
the world. For more information, please visit www.esperion.com and
follow us on Twitter at www.twitter.com/EsperionInc.
ESPERION Therapeutics’ Commitment to Patients with
Hyperlipidemia
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 and 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. living 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 events1. In the United States,
more than 50 percent of atherosclerotic cardiovascular disease
(ASCVD) patients and heterozygous familial hypercholesterolemia
(HeFH) patients who are not able to reach their guideline
recommended LDL-C levels with statins alone need less than a 40
percent reduction to reach their LDL-C threshold goal2.
ESPERION's mission as the Lipid Management Company is to deliver
oral, once-daily medicines that complement existing oral drugs to
provide the additional LDL-C lowering that these patients need.
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 clinical
development and commercialization plans for bempedoic acid tablet
and the bempedoic acid / ezetimibe fixed dose combination tablet,
including ESPERION's timing, designs, plans for announcement of
results regarding its CLEAR Outcomes study and other ongoing
clinical studies for bempedoic acid tablet and the bempedoic acid /
ezetimibe combination fixed dose tablet, timing for the review and
approval of expanded indications for their effect on cardiovascular
events, ESPERION's expectations for the market for medicines
to lower LDL-C, including the commercial launch and market adoption
of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed
dose combination tablet in the United States and European Union,
and ESPERION’s financial outlook, including expectations for future
revenues from its product sales, partnership collaborations and
other sources. 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 clinical
development and commercialization plans, or approval of expanded
indications, that existing cash resources may be used more quickly
than anticipated, that Otsuka and DSE are able to successfully
commercialize its products, the impact of COVID-19 on our business,
clinical activities and commercial development plans, and the risks
detailed in ESPERION's filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and 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.
References(1) ESPERION market research on
file: research project interviewing 350 physicians. ESPERION
Therapeutics, Inc. Sept-Oct 2018.(2) Data on file: analysis
of NHANES database. ESPERION Therapeutics, Inc. 2018.
Esperion
Therapeutics, Inc.
Balance Sheet Data(In
thousands)(Unaudited)
|
|
September 30, 2020 |
|
December 31, 2019 |
Cash and cash equivalents |
|
$ |
215,748 |
|
|
|
$ |
166,130 |
|
|
Working capital |
|
166,856 |
|
|
|
145,634 |
|
|
Investments |
|
— |
|
|
|
34,651 |
|
|
Restricted cash |
|
— |
|
|
|
928 |
|
|
Total assets |
|
250,969 |
|
|
|
214,447 |
|
|
Revenue interest
liability |
|
171,173 |
|
|
|
132,544 |
|
|
Common stock |
|
28 |
|
|
|
27 |
|
|
Accumulated deficit |
|
(734,341 |
) |
|
|
(695,266 |
) |
|
Total stockholders'
equity |
|
8,960 |
|
|
|
19,950 |
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
3,331 |
|
|
|
$ |
— |
|
|
|
$ |
4,798 |
|
|
|
$ |
— |
|
|
Collaboration revenue |
502 |
|
|
|
981 |
|
|
|
213,111 |
|
|
|
147,382 |
|
|
Total Revenues |
3,833 |
|
|
|
981 |
|
|
|
217,909 |
|
|
|
147,382 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
$ |
275 |
|
|
|
$ |
— |
|
|
|
$ |
704 |
|
|
|
$ |
— |
|
|
Research and development |
35,283 |
|
|
|
48,281 |
|
|
|
104,972 |
|
|
|
137,377 |
|
|
Selling, general and administrative |
48,826 |
|
|
|
18,468 |
|
|
|
138,060 |
|
|
|
44,142 |
|
|
Total operating expenses |
84,384 |
|
|
|
66,749 |
|
|
|
243,736 |
|
|
|
181,519 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
(80,551 |
) |
|
|
(65,768 |
) |
|
|
(25,827 |
) |
|
|
(34,137 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
(4,928 |
) |
|
|
(3,996 |
) |
|
|
(13,739 |
) |
|
|
(3,996 |
) |
|
Other income, net |
42 |
|
|
|
1,387 |
|
|
|
491 |
|
|
|
2,914 |
|
|
Net loss |
$ |
(85,437 |
) |
|
|
$ |
(68,377 |
) |
|
|
$ |
(39,075 |
) |
|
|
$ |
(35,219 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(3.07 |
) |
|
|
$ |
(2.52 |
) |
|
|
$ |
(1.41 |
) |
|
|
$ |
(1.30 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding - basic and diluted |
27,830,281 |
|
|
|
27,171,769 |
|
|
|
27,672,325 |
|
|
|
26,995,661 |
|
|
Contact: Kaitlyn BroscoESPERION
investorrelations@esperion.com
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