ESPERION (NASDAQ:ESPR), the lipid management company, today
reported financial results for the second quarter ended June 30,
2021 and provided a business update.
“During the second quarter we made significant progress
strengthening the foundation for our long-term success. We executed
on our commercial priorities, which have already begun to
demonstrate traction throughout the quarter, including substantial
improvements to net price. Growth across key commercial metrics –
including new prescriptions, new writers, prescriptions per writer
and total patients treated – continues to give us confidence that
we are poised for our next phase of growth,” said Sheldon Koenig,
president and CEO of Esperion. “We also welcomed Dr. JoAnne Foody
as Chief Medical Officer, a renowned cardiologist and industry
veteran who brings an indispensable expertise to the company as we
approach the highly anticipated readout of our unprecedented CLEAR
Outcomes trial. As we enter the second half of the year, Esperion
is positioned to bring NEXLETOL® and NEXLIZET® to more patients –
many of whom are now re-engaging with their physicians.”
Second Quarter 2021 Highlights
- Named Sheldon Koenig President and Chief Executive Officer,
leveraging commercial and operational expertise to drive
optimization across Esperion organization
- Appointed JoAnne Micale Foody, MD, FACC, FAHA as Chief Medical
Officer, strengthening Esperion’s management team with critical
academic, industry and firsthand cardiovascular expertise
- Grew U.S. net product revenue 67% sequentially, driven by
increased demand for NEXLETOL® and NEXLIZET®, as well as improved
net price
- Revised product positioning of NEXLETOL® and NEXLIZET®
resonating positively with both physicians and payers evident in
increased formulary adoption
- Added $80 million to
balance sheet by expanding commercialization agreement with Daiichi
Sankyo into new territories as well as exercising the third tranche
of the Oberland Capital RIPA Agreement
Second Quarter 2021 Financial Results
U.S. net product revenue was $10.6 million for the second
quarter of 2021 and $17.0 million for the six months ended June 30,
2021, compared to $0.6 million and $1.5 million for the comparable
periods in 2020. Royalty revenue for the second quarter 2021 was
$1.0 million and $1.6 million for the six months ended June 30,
2021. Total revenue for the second quarter ended June 30, 2021 was
$40.7 million and $48.6 million for the six months ended June 30,
2021, compared to $212.2 million and $214.1 million for the
comparable periods in 2020. The decrease in total revenue was
primarily attributable to reductions in collaboration revenue
associated with milestone payments from partnerships as compared to
the second quarter of 2020.
Research and development expenses were $25.1 million for the
second quarter of 2021 and $53.0 million for the six months ended
June 30, 2021, compared to $35.0 million and $69.7 million for the
comparable periods in 2020. The decrease in expenses was primarily
attributable to an overall reduction in ongoing clinical research
activities including compensation costs.
Selling, general and administrative expenses were $46.3 million
for the second quarter of 2021 and $107.4 million for the six
months ended June 30, 2021, compared to $47.7 million and $89.2
million for the comparable periods in 2020. The increase in expense
for the six months ended June 30, 2021 was primarily attributable
to a $13.3 million one-time charge associated with a legal
settlement as well as increases in salaries and benefits, including
stock-based compensation, from the build out of our customer facing
team and other costs to support the commercialization of NEXLETOL
and NEXLIZET in the U.S.
ESPERION had a net loss of $43.7 million for the second quarter
of 2021 and $134.6 million for the six months ended June 30, 2021,
compared to net income of $124.6 million and of $46.4 million for
the comparable periods in 2020. ESPERION had a basic and diluted
net loss per share of $1.67 for the second quarter of 2021 and
$5.16 for the six months ended June 30, 2021, compared to basic and
diluted net income per share of $4.50 and $4.32, and basic and
diluted net income per share of $1.68 and $1.60, respectively, for
the comparable periods in 2020.
As of June 30, 2021, cash and cash equivalents totaled $219.2
million compared with $305.0 million at December 31, 2020.
ESPERION ended the quarter with approximately 26.3 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 4.9 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 continues to expect 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, August
3, 2021 at 8:00 A.M. Eastern Time to provide a second quarter 2021
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
4975714.
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, market adoption of bempedoic acid tablet and the bempedoic
acid / ezetimibe fixed dose combination tablet in the United States
and European Union and the Company’s overall growth, and ESPERION’s
financial outlook, including expectations for future revenues from
its product sales, partnership collaborations and other sources,
future research and development expenses and operating expenses.
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 the commercialization plans of both ESPERION and Daiichi Sankyo
group, failure to obtain the approval of bempedoic acid or the
bempedoic acid / ezetimibe combination tablet or expanded
indications in countries outside of the U.S., or approval of
expanded indications, that existing cash resources may be used more
quickly than anticipated, that Otsuka and Daiichi Sankyo are able
to successfully commercialize its products, the impact of the
evolving COVID-19 pandemic 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.
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.Contact:Kaitlyn
BroscoESPERIONcorporateteam@esperion.com
ESPERION
Therapeutics, Inc.
Balance Sheet Data(In
thousands)(Unaudited)
|
|
June 30,2021 |
|
December 31,2020 |
Cash and cash equivalents |
|
|
$ |
219,186 |
|
|
|
|
$ |
304,962 |
|
|
Working capital |
|
192,530 |
|
|
|
251,827 |
|
|
Total assets |
|
280,461 |
|
|
|
353,258 |
|
|
Revenue interest
liability |
|
238,231 |
|
|
|
176,604 |
|
|
Convertible notes, net of
issuance costs |
|
272,098 |
|
|
|
179,367 |
|
|
Common stock |
|
26 |
|
|
|
26 |
|
|
Accumulated deficit |
|
(971,872) |
|
|
|
(838,817) |
|
|
Total stockholders'
deficit |
|
(304,310) |
|
|
|
(96,134) |
|
|
ESPERION
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months Ended June 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
10,610 |
|
|
|
$ |
609 |
|
|
|
$ |
16,960 |
|
|
|
$ |
1,467 |
|
|
Collaboration revenue |
30,049 |
|
|
|
211,627 |
|
|
|
31,677 |
|
|
|
212,609 |
|
|
Total Revenues |
40,659 |
|
|
|
212,236 |
|
|
|
48,637 |
|
|
|
214,076 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
1,800 |
|
|
|
398 |
|
|
|
3,584 |
|
|
|
429 |
|
|
Research and development |
25,074 |
|
|
|
34,987 |
|
|
|
53,028 |
|
|
|
69,689 |
|
|
Selling, general and administrative |
46,318 |
|
|
|
47,681 |
|
|
|
107,382 |
|
|
|
89,234 |
|
|
Total operating expenses |
73,192 |
|
|
|
83,066 |
|
|
|
163,994 |
|
|
|
159,352 |
|
|
|
|
|
|
|
|
|
|
(Loss) income from
operations |
(32,533 |
) |
|
|
129,170 |
|
|
|
(115,357 |
) |
|
|
54,724 |
|
|
|
|
|
|
|
|
|
|
Interest expense |
(11,144 |
) |
|
|
(4,640 |
) |
|
|
(19,269 |
) |
|
|
(8,811 |
) |
|
Other income, net |
9 |
|
|
|
81 |
|
|
|
23 |
|
|
|
449 |
|
|
Net (loss)
income |
$ |
(43,668 |
) |
|
|
$ |
124,611 |
|
|
|
$ |
(134,603 |
) |
|
|
$ |
46,362 |
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common
share - basic |
$ |
(1.67 |
) |
|
|
$ |
4.50 |
|
|
|
$ |
(5.16 |
) |
|
|
$ |
1.68 |
|
|
Net (loss) income per common
share - diluted |
$ |
(1.67 |
) |
|
|
$ |
4.32 |
|
|
|
$ |
(5.16 |
) |
|
|
$ |
1.60 |
|
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding - basic |
26,225,073 |
|
|
|
27,665,728 |
|
|
|
26,109,089 |
|
|
|
27,592,479 |
|
|
Weighted-average shares
outstanding - diluted |
26,225,073 |
|
|
|
28,854,445 |
|
|
|
26,109,089 |
|
|
|
28,948,058 |
|
|
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