ESPERION (NASDAQ:ESPR), the lipid management company, today
reported financial results for the first quarter ended March 31,
2021 and provided a business update.
“In the first quarter our team was focused on driving new
prescription growth and executing on strategic initiatives that
will enhance our ability to bring our medicines to as many patients
as possible. This includes improving Medicare Part D coverage and
positioning for NEXLETOL® and NEXLIZET®, as well as building our
scientific, health economics and outcomes research platform, all
while ensuring our landmark CLEAR cardiovascular outcomes trial
remains on track for the second half of 2022,” said Tim M.
Mayleben, president and chief executive officer of ESPERION. “The
first quarter was a challenging period, but we are encouraged by
both our refined product positioning and data indicating that
patients are returning to their physician offices, which together
are expected to translate into accelerated prescription growth in
the second half of the year. Our momentum has continued in the
early days of the second quarter as we expanded key agreements with
Daiichi Sankyo and Oberland Capital, adding $80 million in cash to
the balance sheet while deepening our relationships with these
committed and collaborative partners.”
2021 Key Accomplishments and Recent
Highlights
- Secured multi-year
Medicare Part D agreement with one of the largest payers in the
U.S. to place NEXLETOL® and NEXLIZET® on formulary, effective May
1, 2021
- Daiichi Sankyo off
to a strong start in Germany with 14,000 patients now taking
NILEMDO® and NUSTENDI® at the end of first quarter 2021
- Expanded
commercialization agreement with partner Daiichi Sankyo to
additional countries across Asia, Middle East and Latin America
with a $30 million upfront and up to $175 million in future
milestones
- Exercised the third and final tranche of the Oberland Capital
RIPA Agreement, bolstering the balance sheet with $50 million
- Otsuka dosed first patient in Japanese Phase II clinical trial
of bempedoic acid
First Quarter 2021 Financial Results
Total revenue for the first quarter ended March 31, 2021 was
$8.0 million compared to $1.8 million for the first quarter of
2020. U.S. product revenue for the first quarter ended March 31,
2021 was $6.4 million, compared to $0.9 million for the comparable
period in 2020. Royalty revenue for the first quarter ended March
31, 2021 was $0.6 million. The increase in total revenue was
primarily due to NEXLETOL and NEXLIZET being available for sale
during the entire first quarter of 2021. NEXLETOL and NEXLIZET
became commercially available in the U.S. on March 30, 2020 and
June 4, 2020, respectively.
Research and development expenses were $28.0 million for the
first quarter of 2021, compared to $34.7 million for the comparable
period in 2020. The decrease in expense during the first quarter
was primarily attributable to a decline in manufacturing costs
which were previously classified as research and development
expense prior to FDA approval of NEXLETOL and NEXLIZET in the first
quarter of 2020.
Selling, general and administrative expenses were $61.1 million
for the first quarter of 2021, compared to $41.6 million for the
comparable period in 2020. The increase in expense was primarily
attributable to salaries and benefits from the build out of our
customer-facing team and other costs to support the
commercialization of NEXLETOL and NEXLIZET in the U.S, as well as a
$13.3 million one-time charge associated with a legal
settlement.
ESPERION had a net loss of $90.9 million for the first quarter
of 2021, compared to a net loss of $78.2 million for the comparable
period in 2020. ESPERION had a basic and diluted net loss per share
of $3.50 for the first quarter of 2021, compared to $2.84 for the
comparable period in 2020.
As of March 31, 2021, cash, cash equivalents and investment
securities available-for-sale totaled $217.9 million compared with
$305.0 million at December 31, 2020. This amount does not include
the $30 million upfront payment resulting from the expanded Daiichi
Sankyo collaboration partnership or the $50 million third and final
tranche from Oberland Capital.
ESPERION ended the quarter with approximately 26.2 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 4.7 million
issuable upon exercise of stock options and vesting of restricted
stock units.
2021 Financial Outlook
Esperion’s pro-forma cash balance as of March 31, 2021 was
$297.9 million as a result of the $30 million upfront payment from
Daiichi Sankyo and the $50 million payment from Oberland Capital to
be received in May 2021.
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, May 4,
2021 at 4:30 P.M. Eastern Time to provide a first 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
6373518.
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 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
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.
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)
|
March 31,2021 |
|
December 31,2020 |
Cash and cash equivalents |
$ |
217,939 |
|
|
$ |
304,962 |
|
Working capital |
174,682 |
|
|
251,827 |
|
Total assets |
278,606 |
|
|
353,258 |
|
Revenue interest
liability |
180,956 |
|
|
176,604 |
|
Convertible notes, net of
issuance costs |
271,694 |
|
|
179,367 |
|
Common stock |
26 |
|
|
26 |
|
Accumulated deficit |
(928,204 |
) |
|
(838,817 |
) |
Total stockholders'
deficit |
(269,394 |
) |
|
(96,134 |
) |
ESPERION
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months EndedMarch 31, |
|
|
2021 |
|
|
2020 |
Revenues: |
|
|
|
Product sales, net |
$ |
6,350 |
|
|
$ |
858 |
|
Collaboration revenue |
|
1,628 |
|
|
|
982 |
|
Total Revenues |
|
7,978 |
|
|
|
1,840 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Cost of goods sold |
|
1,784 |
|
|
|
31 |
|
Research and development |
|
27,954 |
|
|
|
34,702 |
|
Selling, general and administrative |
|
61,064 |
|
|
|
41,553 |
|
Total operating expenses |
|
90,802 |
|
|
|
76,286 |
|
|
|
|
|
Loss from
operations |
|
(82,824 |
) |
|
|
(74,446 |
) |
|
|
|
|
Interest expense |
|
(8,125 |
) |
|
|
(4,171 |
) |
Other income, net |
|
14 |
|
|
|
368 |
|
Net loss |
$ |
(90,935 |
) |
|
$ |
(78,249 |
) |
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(3.50 |
) |
|
$ |
(2.84 |
) |
|
|
|
|
Weighted-average shares
outstanding - basic and diluted |
|
25,991,817 |
|
|
|
27,519,229 |
|
Contact:Kaitlyn BroscoESPERIONcorporateteam@esperion.com
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