Esperion (NASDAQ: ESPR) today reported financial results for the
fourth quarter and full year ended December 31, 2021 and provided a
business update.
“In 2021, Esperion strengthened its balance
sheet and established a strong and efficient operating model that
will serve as the foundation for our next phase of growth,” said
Sheldon Koenig, President and CEO of Esperion. “We enter 2022
reinvigorated, as it will be an exciting year for Esperion as we
expect to achieve 100% MACE accumulation of our unprecedented CLEAR
Outcomes trial during the second half of the year and progress
towards a topline readout in the first quarter of 2023. With over
$300 million in capital on our balance sheet as of the end of the
year, we significantly extended our cash runway beyond the CLEAR
Outcomes topline results. As the first and only outcomes study to
focus predominantly on statin intolerant patients, CLEAR has
potential to demonstrate to physicians and payers that NEXLETOL®
improves cardiovascular outcomes in these high-risk patients,
irrespective of statins, and thus be practice changing in the
treatment of cardiovascular disease.”
2021 Key Accomplishments and Recent
Highlights
- Achieved 90% MACE Accumulation in
the CLEAR Outcomes Trial in February 2022
- Secured approximately $209 million
of net proceeds in December 2021 equity offering, extending cash
runway beyond CLEAR Outcomes top-line readout
- Announced transformative strategic
plan to optimize Esperion’s organizational structure and market
approach for better alignment with the current environment in order
to support long-term growth of NEXLETOL and NEXLIZET while
generating $80 million in annualized expense savings
- Expanded Daiichi Sankyo partnership
to additional countries across Asia, Middle East and Latin America
and continued European rollout of NILEMDO® and NUSTENDI® with
Daiichi Sankyo into UK and most recently Austria in January 2022;
over 45,000 European patients now on therapy as of December
2021
- Otsuka dosed first patient in
Japanese Phase II clinical trial of bempedoic acid; clinical trial
fully enrolled as of December 31, 2021
Fourth Quarter and Full Year 2021 Financial
Results
U.S. net product revenue was $12.2 million for
the fourth quarter of 2021 and $40.0 million for the full year
ended December 31, 2021, compared to $8.2 million and $13.0 million
for the comparable periods in 2020. Royalty revenue for the fourth
quarter 2021 was $0.8 million and $3.6 million for the full year
ended December 31, 2021, compared to $0.2 million for the
comparable periods in 2020. Total revenue for the fourth quarter of
2021 was $15.4 million and $78.4 million for the full year ended
December 31, 2021, compared to $9.6 million and $227.5 million for
the comparable periods in 2020. The decrease in total revenue for
the full year of 2021 was primarily attributable to a reduction in
one-time collaboration revenue from our partnerships.
Research and development expenses were $27.6
million for the fourth quarter of 2021 and $106.0 million for the
full year ended December 31, 2021, compared to $42.0 million and
$146.9 million for the comparable periods in 2020. The decrease in
expenses was primarily attributable to a decline in contract
research organization and compensation expense.
Selling, general and administrative expenses
were $38.3 million for the fourth quarter of 2021 and $185.0
million for the full year ended December 31, 2021, compared to
$61.6 million and $199.6 million for the comparable periods in
2020. The decrease in the fourth quarter and full year 2021 was
primarily attributable to a decrease in advertising and commercial
compensation expense.
Esperion had net losses of $65.1 million for the
fourth quarter of 2021 and $269.1 million for the full year ended
December 31, 2021, compared to net losses of $104.5 million and
$143.6 million for the comparable periods in 2020. Esperion had
basic and diluted net losses per share of $1.77 for the fourth
quarter of 2021 and $9.31 for the full year ended December 31,
2021, compared to basic and diluted net losses per share of $3.89
and $5.23, respectively for the comparable periods in 2020.
As of December 31, 2021, cash, cash equivalents,
restricted cash and investment securities available-for-sale
totaled $309.3 million compared with $305.0 million on December 31,
2020.
Esperion ended the year with approximately 60.9
million shares of common stock outstanding, after accounting for
2.0 million treasury shares to be purchased in the prepaid forward
transaction as part of the convertible debt financing.
2022 Financial Outlook
Research and Development expenses for the full
year 2022 are expected to be $100 million to $110 million. Selling,
General and Administrative expenses for the full year 2022 are
expected to be $120 million to $130 million.
Esperion expects full-year 2022 operating
expenses to be approximately $220 million 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, February 22, 2022, at 8:00 A.M. Eastern Time to
discuss fourth quarter and full year 2021 financial results and
provide a 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
7349619.
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
works 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. Esperion commercializes
NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and
ezetimibe) Tablets and is the leader in the development of
convenient oral, once-daily non-statin LDL-cholesterol lowering
drugs for patients with high levels of bad cholesterol. 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.
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 current and planned
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,
including expected cash runway, 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:Corporate CommunicationsBen Church/Kaitlyn
Broscobchurch@esperion.com / kbrosco@esperion.com
Esperion
Therapeutics, Inc.Balance Sheet
Data(In
thousands)(Unaudited)
| |
December 31,2021 |
|
December 31,2020 |
|
Cash and cash equivalents |
$ |
208,892 |
|
|
$ |
304,962 |
|
| Restricted cash |
50,000 |
|
|
— |
|
| Investments |
50,441 |
|
|
— |
|
| Working capital |
255,620 |
|
|
251,827 |
|
| Total assets |
381,590 |
|
|
353,258 |
|
| Revenue interest
liability |
257,039 |
|
|
176,604 |
|
| Convertible notes, net of
issuance costs |
258,280 |
|
|
179,367 |
|
| Common stock |
61 |
|
|
26 |
|
| Accumulated deficit |
(1,106,377 |
) |
|
(838,817 |
) |
| Total stockholders'
deficit |
(196,944 |
) |
|
(96,134 |
) |
| |
|
|
|
|
|
Esperion
Therapeutics, Inc.Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
| |
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
| |
2021 |
|
2020 |
|
2021 |
|
2020 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
12,192 |
|
|
$ |
8,167 |
|
|
$ |
40,047 |
|
|
$ |
12,965 |
|
|
Collaboration revenue |
3,209 |
|
|
1,471 |
|
|
38,400 |
|
|
214,582 |
|
| Total Revenues |
15,401 |
|
|
9,638 |
|
|
78,447 |
|
|
227,547 |
|
| |
|
|
|
|
|
|
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
5,075 |
|
|
1,688 |
|
|
14,217 |
|
|
2,392 |
|
|
Research and development |
27,616 |
|
|
41,964 |
|
|
105,975 |
|
|
146,936 |
|
|
Selling, general and administrative |
38,338 |
|
|
61,555 |
|
|
184,985 |
|
|
199,615 |
|
| Total operating expenses |
71,029 |
|
|
105,207 |
|
|
305,177 |
|
|
348,943 |
|
| |
|
|
|
|
|
|
|
| Loss from
operations |
(55,628 |
) |
|
(95,569 |
) |
|
(226,730 |
) |
|
(121,396 |
) |
| |
|
|
|
|
|
|
|
| Interest expense |
(13,430 |
) |
|
(8,931 |
) |
|
(46,353 |
) |
|
(22,670 |
) |
| Other income, net |
3,939 |
|
|
24 |
|
|
3,975 |
|
|
515 |
|
| Net loss |
$ |
(65,119 |
) |
|
$ |
(104,476 |
) |
|
$ |
(269,108 |
) |
|
$ |
(143,551 |
) |
| |
|
|
|
|
|
|
|
| Net loss per common share –
basic and diluted |
$ |
(1.77 |
) |
|
$ |
(3.89 |
) |
|
$ |
(9.31 |
) |
|
$ |
(5.23 |
) |
| |
|
|
|
|
|
|
|
| Weighted-average shares
outstanding – basic and diluted |
36,845,550 |
|
|
26,882,830 |
|
|
28,902,507 |
|
|
27,473,873 |
|
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