ESPERION (NASDAQ:ESPR), the lipid management company, today
reported financial results for the fourth quarter and full year
ended December 31, 2020 and provided a business update.
“Even though 2020 was an exceptionally challenging year, we made
progress in our mission of Lipid Management for Everyone. Successes
include the U.S. FDA approval of NEXLETOL® and NEXLIZET®, our
innovative oral, once-daily, non-statin LDL-C lowering medicines
for indicated patients, the EU EMA approval of NILEMDO® and
NUSTENDI® and the first-ever EU product royalty revenue from
Daiichi Sankyo Europe, establishing a collaboration with another
world-class partner for our medicines in Japan and making
uninterrupted progress on our landmark CLEAR Outcomes trial in
statin intolerant patients, all while battling the headwinds of the
COVID-19 pandemic,” said Tim M. Mayleben, president and chief
executive officer of ESPERION. “While navigating the unprecedented
environment, we adjusted our commercial and operational footprint,
while also optimizing our cost structure to position our team to
realize the full potential of our medicines as the negative impact
of the pandemic recedes. I am very optimistic for our future growth
prospects.”
2020 Key Accomplishments and Recent
Highlights
- Achieved U.S. FDA approval for NEXLETOL® and NEXLIZET®, the
first ever non-statin fixed-dose combination medicine for LDL-C
lowering
- Secured EU approval of NILEMDO® and NUSTENDI® in Europe and
transferred marketing authorizations to Daiichi Sankyo Europe
(DSE)
- Reported first royalty revenue from DSE following initial
European launch of NILEMDO® and NUSTENDI® in Germany during
November, reaching 4,000 patients by year end
- Entered development and commercialization agreement with Otsuka
Pharmaceutical in Japan
- Accumulated over 50% of the 4-component MACE primary endpoints
in the CLEAR Outcomes Study which has 14,000 statin intolerant
patients enrolled
- Strengthened the balance sheet with $210 million in
collaboration milestones and $280 million convertible debt
financing
- In-licensed pre-clinical oral PCSK9 inhibitor program
furthering the ESPERION mission
Fourth Quarter and Full Year Financial
Results
Total revenue for the fourth quarter and full year ended
December 31, 2020 was $9.6 million and $227.5 million,
respectively, compared to $1.0 million and $148.4 million for the
comparable periods in 2019. U.S. product revenue for the fourth
quarter and full year ended December 31, 2020 was $8.2 million and
$13.0 million, respectively. Royalty revenue for the fourth quarter
and full year ended December 31, 2020 was $0.2 million. The
increase in total revenue was primarily due to the U.S.
commercialization of NEXLETOL and NEXLIZET and collaboration
revenue from our partnerships.
Research and development expenses were $42.0 million for the
fourth quarter and $146.9 million for the full year of 2020,
compared to $38.2 million and $175.6 million for the comparable
periods in 2019. The increase in expense during the fourth quarter
was primarily attributable to the upfront payment associated with
the in-license of the oral, small molecule PCSK9 inhibitor program,
partially offset by a decline in costs related to the completion of
enrollment of our CLEAR cardiovascular outcomes trial (CVOT) in
2019.
Selling, general and administrative expenses were $61.6 million
for the fourth quarter and $199.6 million for the full year of
2020, compared to $21.7 million and $65.9 million for the
comparable periods in 2019. The increase in expense was primarily
attributable to costs associated with the commercialization of
NEXLETOL and NEXLIZET in the U.S., increases in our headcount
resulting from the build out of our customer-facing team, and
stock-based compensation expense.
ESPERION had net loss of $104.5 million for the fourth quarter
of 2020 and a net loss of $143.6 million for the full year ended
December 31, 2020, compared to a net loss of $61.9 million and
$97.2 million for the comparable periods in 2019. ESPERION had a
basic and diluted net loss per share of $3.89 for the fourth
quarter of 2020 and $5.23 for the full year ended December 31,
2020, compared to $2.26 and $3.59 for the comparable periods in
2019.
As of December 31, 2020, cash, cash equivalents and investment
securities available-for-sale totaled $305.0 million compared with
$201.7 million at December 31, 2019.
ESPERION ended the year with approximately 25.9 million shares
of common stock outstanding, excluding the 2.0 million treasury
shares to be purchased in the prepaid forward transaction as part
of the convertible debt financing with another 4.6 million issuable
upon exercise of stock options and vesting of restricted stock
units.
2021 Financial Outlook
Research and development expenses for the full year 2021 are
expected to be $120 million to $130 million. Selling, general and
administrative expenses for the full year 2021 are expected to be
$200 million to $210 million.
ESPERION expects full-year 2021 operating expenses to be
approximately $320 million to $340 million, inclusive of $30
million of non-cash, stock-based compensation.
Conference Call and Webcast Information
ESPERION will host a conference call and webcast today, February
23, 2021 at 4:30 P.M. Eastern Time to provide a fourth quarter and
full year 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
2689156.
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 ESPERION 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 1,200
sites in 32 countries.
ESPERION Therapeutics
ESPERION is The Lipid Management Company. Our goal is lipid
management for everybody, that’s why we work hard to make our
medicines easy to get, easy to take and easy to have. We discover,
develop and commercialize innovative medicines and combinations to
lower cholesterol, especially for patients whose needs aren’t being
met by the status quo. Our entrepreneurial team of industry leaders
is inclusive, passionate and resourceful. We are singularly focused
on managing cholesterol so you can improve your health easily. 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 global 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 prospects for success of 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, the development of ESPERION’s
in-licensed pre-clinical oral PCSK9 inhibitor program, 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, supply chain, commercial development and
launch 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.
Contact:Kaitlyn
BroscoESPERIONcorporateteam@esperion.com
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)
|
|
December 31,2020 |
|
December 31,2019 |
Cash and cash equivalents |
|
$ |
304,962 |
|
|
$ |
166,130 |
|
Working capital |
|
251,827 |
|
|
145,634 |
|
Investments |
|
— |
|
|
34,651 |
|
Restricted cash |
|
— |
|
|
928 |
|
Total assets |
|
353,258 |
|
|
214,447 |
|
Revenue interest
liability |
|
176,604 |
|
|
132,544 |
|
Convertible notes, net of
issuance costs |
|
179,367 |
|
|
— |
|
Common stock |
|
26 |
|
|
27 |
|
Accumulated deficit |
|
(838,817 |
) |
|
(695,266 |
) |
Total stockholders' (deficit)
equity |
|
(96,134 |
) |
|
19,950 |
|
ESPERION
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
8,167 |
|
|
$ |
— |
|
|
$ |
12,965 |
|
|
$ |
— |
|
Collaboration revenue |
1,471 |
|
|
982 |
|
|
214,582 |
|
|
148,364 |
|
Total Revenues |
9,638 |
|
|
982 |
|
|
227,547 |
|
|
148,364 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
$ |
1,688 |
|
|
$ |
— |
|
|
$ |
2,392 |
|
|
$ |
— |
|
Research and development |
41,964 |
|
|
38,234 |
|
|
146,936 |
|
|
175,611 |
|
Selling, general and administrative |
61,555 |
|
|
21,712 |
|
|
199,615 |
|
|
65,854 |
|
Total operating expenses |
105,207 |
|
|
59,946 |
|
|
348,943 |
|
|
241,465 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
(95,569 |
) |
|
(58,964 |
) |
|
(121,396 |
) |
|
(93,101 |
) |
|
|
|
|
|
|
|
|
Interest expense |
(8,931 |
) |
|
(4,124 |
) |
|
(22,670 |
) |
|
(8,120 |
) |
Other income, net |
24 |
|
|
1,142 |
|
|
515 |
|
|
4,056 |
|
Net loss |
$ |
(104,476 |
) |
|
$ |
(61,946 |
) |
|
$ |
(143,551 |
) |
|
$ |
(97,165 |
) |
|
|
|
|
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(3.89 |
) |
|
$ |
(2.26 |
) |
|
$ |
(5.23 |
) |
|
$ |
(3.59 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding - basic and diluted |
26,882,830 |
|
|
27,371,067 |
|
|
27,473,873 |
|
|
27,090,284 |
|
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jul 2023 to Jul 2024