Esperion (NASDAQ: ESPR) today reported financial results for
the third quarter ended September 30, 2021 and provided a business
update.
“In the past months, we have made significant strides to align
our organization and cost structure with the current environment,
preserve flexibility for future scale-up and position Esperion for
long-term growth as we advance our mission of making lipid
management accessible and convenient for everyone,” said Sheldon
Koenig, president and CEO of Esperion. “We are now focusing on our
most productive prescribers and strengthening our capabilities in
non-personal promotion. We continued to observe positive momentum
and growth in key commercial metrics and are invigorated to
introduce these therapies to more patients as they resume
engagement with their physicians. Looking ahead, our CLEAR Outcomes
study remains on track for complete MACE accumulation in the second
half of 2022, and to report topline results in Q1 2023. We remain
optimistic that a positive study result will drive an inflection in
the growth trajectory for NEXLETOL and NEXLIZET.”
Third Quarter 2021 and Recent Highlights
- Announced transformative strategic plan to align Esperion’s
operational and expense structure to support the long-term growth
of NEXLETOL and NEXLIZET
- Achieved 80% MACE Accumulation in the CLEAR Outcomes Trial in
October
- Hosted investor webinar on the current landscape and future
directions in the treatment of elevated cholesterol during National
Cholesterol Awareness Month, featuring a discussion with
world-renowned cardiologist Steven Nissen, M.D., from the Cleveland
Clinic
- Eliminated complete buy-down to align co-pay card program to
industry standards
- Partnered with Asembia, an accredited call-center of highly
qualified clinical specialists and care coordinators that work
hand-in-hand with prescribers, patients, payers and pharmacies
throughout the patient journey, to launch a customized prescription
support program to facilitate prescription fulfillment
- Continued European rollout of NILEMDO® and NUSTENDI® with
partner Daiichi Sankyo; over 28,000 patients now on therapy as of
third quarter 2021
- Entered into an agreement to exchange $15 million of Esperion
convertible notes for common stock, strengthening the Company’s
capital position and providing future financial flexibility
- Appointed Seth H.Z. Fisher to Esperion Board of Directors
Third Quarter 2021 Financial Results
U.S. net product revenue was $10.9 million for the third quarter
of 2021 and $27.9 million for the nine months ended September 30,
2021, compared to $3.3 million and $4.8 million for the comparable
periods in 2020. Royalty revenue for the third quarter 2021 was
$1.2 million and $2.8 million for the nine months ended September
30, 2021. Total revenue for the third quarter ended September 30,
2021 was $14.4 million and $63.0 million for the nine months ended
September 30, 2021, compared to $3.8 million and $217.9 million for
the comparable periods in 2020. The increase in total revenue in
the third quarter of 2021 was primarily attributable to
prescription growth of NEXLETOL and NEXLIZET.
Research and development expenses were $25.3 million for the
third quarter of 2021 and $78.4 million for the nine months ended
September 30, 2021, compared to $35.3 million and $105.0 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 $39.3 million
for the third quarter of 2021 and $146.6 million for the nine
months ended September 30, 2021, compared to $48.8 million and
$138.1 million for the comparable periods in 2020. The decrease in
the third quarter of 2021 was primarily attributable to a decrease
in commercial compensation expense.
Esperion had net losses of $69.4 million for the third quarter
of 2021 and $204.0 million for the nine months ended September 30,
2021, compared to net losses of $85.4 million and $39.1 million for
the comparable periods in 2020. Esperion had basic and diluted net
losses per share of $2.62 for the third quarter of 2021 and $7.78
for the nine months ended September 30, 2021, compared to basic and
diluted net losses per share of $3.07 and $1.41 for the comparable
periods in 2020.
As of September 30, 2021, cash, cash equivalents, and restricted
cash totaled $153.7 million ($50.0 million classified as restricted
cash). As of December 31, 2020, cash and cash equivalents totaled
$305.0 million.
Esperion ended the quarter with approximately 26.8 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 & 2022 Financial Outlook
Research and Development expenses for the full year 2021 are
expected to be $110 million to $115 million. Selling, General and
Administrative expenses for the full year 2021 are expected to be
$195 million to $200 million. Esperion expects full-year 2021
operating expenses to be approximately $305 million to $315
million, inclusive of $25 million of non-cash, stock-based
compensation.
Esperion anticipates Research and Development expenses for
fiscal year 2022 to be $100 to $110 million and Selling, General
and Administrative expenses for fiscal year 2022 to be $120 to $130
million. Esperion expects fiscal year 2022 operating expenses to be
$220 to $240 million, inclusive of $25 million of non-cash,
stock-based compensation expense.
Conference Call and Webcast InformationEsperion
will host a conference call and webcast today, November 2, 2021 at
8:00 A.M. Eastern Time to provide a third 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
2646847.
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 TrialThe 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 TherapeuticsEsperion 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. For more information, please visit
www.esperion.com and follow us on Twitter at
www.twitter.com/EsperionInc.
Esperion Therapeutics’ Commitment to Patients with
HyperlipidemiaHigh 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 StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding marketing strategy and commercialization
plans, restructuring and operational expenses, future operations,
commercial products, clinical development including the timing,
designs and plans for the CLEAR Outcomes study and its results,
plans for potential future product candidates, financial condition
and outlook, and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “suggest,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue,” and similar
expressions. 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 impact of the ongoing COVID-19 pandemic on
our business, revenues, results of operations and financial
condition, the net sales, profitability, and growth of Esperion’s
commercial products, clinical activities and results, 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:Ben
Churchbchurch@esperion.com 734-864-6774
Esperion
Therapeutics, Inc.
Balance Sheet Data(In
thousands)(Unaudited)
|
|
September 30,2021 |
|
December 31,2020 |
Cash and cash equivalents |
|
|
$ |
103,672 |
|
|
|
|
$ |
304,962 |
|
|
Restricted cash |
|
50,000 |
|
|
|
— |
|
|
Working capital |
|
92,183 |
|
|
|
251,827 |
|
|
Total assets |
|
225,256 |
|
|
|
353,258 |
|
|
Revenue interest
liability |
|
247,568 |
|
|
|
176,604 |
|
|
Convertible notes, net of
issuance costs |
|
272,508 |
|
|
|
179,367 |
|
|
Common stock |
|
27 |
|
|
|
26 |
|
|
Accumulated deficit |
|
(1,041,258 |
) |
|
|
(838,817 |
) |
|
Total stockholders'
deficit |
|
(362,705 |
) |
|
|
(96,134 |
) |
|
Esperion
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months Ended September 30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
10,895 |
|
|
|
$ |
3,331 |
|
|
|
$ |
27,855 |
|
|
|
$ |
4,798 |
|
|
Collaboration revenue |
3,514 |
|
|
|
502 |
|
|
|
35,191 |
|
|
|
213,111 |
|
|
Total Revenues |
14,409 |
|
|
|
3,833 |
|
|
|
63,046 |
|
|
|
217,909 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
5,558 |
|
|
|
275 |
|
|
|
9,142 |
|
|
|
704 |
|
|
Research and development |
25,331 |
|
|
|
35,283 |
|
|
|
78,359 |
|
|
|
104,972 |
|
|
Selling, general and administrative |
39,265 |
|
|
|
48,826 |
|
|
|
146,647 |
|
|
|
138,060 |
|
|
Total operating expenses |
70,154 |
|
|
|
84,384 |
|
|
|
234,148 |
|
|
|
243,736 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
(55,745 |
) |
|
|
(80,551 |
) |
|
|
(171,102 |
) |
|
|
(25,827 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
(13,654 |
) |
|
|
(4,928 |
) |
|
|
(32,923 |
) |
|
|
(13,739 |
) |
|
Other income, net |
13 |
|
|
|
42 |
|
|
|
36 |
|
|
|
491 |
|
|
Net loss |
$ |
(69,386 |
) |
|
|
$ |
(85,437 |
) |
|
|
$ |
(203,989 |
) |
|
|
$ |
(39,075 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(2.62 |
) |
|
|
$ |
(3.07 |
) |
|
|
$ |
(7.78 |
) |
|
|
$ |
(1.41 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
26,455,209 |
|
|
|
27,830,281 |
|
|
|
26,225,730 |
|
|
|
27,672,325 |
|
|
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