Esperion (NASDAQ: ESPR) today announced its plan to align
operational and expense structure to better enable future growth
for its two first-in-class oral medicines, NEXLETOL® (bempedoic
acid) and NEXLIZET® (bempedoic acid and ezetimibe) and prioritize
its investment in CLEAR Outcomes. The Company also issued updated
expense guidance for fiscal year 2021 and fiscal year 2022
reflecting lower than previously estimated operating costs and
pre-announced preliminary, unaudited U.S. net product revenue of
$10.5 to $11.0 million for the quarter ended September 30, 2021.
“In-person access to health care providers has
been negatively impacted by the ongoing COVID-19 pandemic. We are
adapting to meet their needs in a more effective way that grows
awareness of our products at the same time,” said Sheldon Koenig,
president and CEO of Esperion. “Cardiovascular disease remains the
number one cause of death in the world. ESPERION is fortunate to
have two well-received first-in-class medicines approved and
available, providing us the opportunity to become a leader in the
cardiovascular market. Today’s decision will help to further grow
NEXLETOL and NEXLIZET while conserving resources to support our
critically important and differentiated CLEAR Outcomes trial, which
we believe has the potential to dramatically increase adoption of
our innovative cholesterol-lowering agents.”
After a systematic review of our organization
and the challenges associated with launching NEXLETOL and NEXLIZET
during the COVID-19 pandemic, the Company has implemented changes
to align the business with the realities of the current market
environment. The Company will be reducing operational expense
across the organization through a 40 percent corporate workforce
reduction and through targeted program savings.
The Company will focus its commercialization
efforts on an optimized blend of focused outreach including a
streamlined sales force, directed to targeted cardiologists and
primary care physicians, and a suite of digital initiatives
designed to increase awareness and utilization of its medicines in
appropriate patients. This flexible model will reduce expenses yet
preserve our ability to deliver consistent growth leading up to the
read-out of the Clear Outcomes trial and beyond.
Financial Outlook Update:
ESPERION revised its 2021 operating expense
guidance and expects at least $20 million of savings from prior
issued mid-point expense guidance. The Company now estimates
Research and Development expenses for fiscal year 2021 to be $110
to $115 million (from $120 to $130 million previously) and Selling,
General and Administrative expenses for fiscal year 2021 to be $195
to $200 million (from $200 to $210 million previously), inclusive
of $25 million of non-cash, stock-based compensation expense. These
reductions reflect optimization activities already implemented that
the Company expects to be realized in expense for the third and
fourth quarter of this year.
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.
As of September 30, 2021, total cash, cash equivalents, and
restricted cash totaled approximately $153.7 million, assuming
$50.0 million will become restricted cash subject to a block
account control agreement pursuant to the Amendment to the Security
Agreement and Waiver (the “Amendment and Waiver”) by and among the
Company, Eiger Partners II LP and Eiger III SA LLC (“Oberland”)
after Specified Net Revenue (as defined in the Amendment and
Waiver) for the quarter ended September 30, 2021 did not exceed
$15.0 million, unless we are able to negotiate a waiver with
Oberland on terms that are acceptable to both parties. There were
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.
The preliminary unaudited results described in this press
release are estimates only and are subject to revision until the
Company reports its full financial results for the third quarter
2021 on November 2, 2021.
Conference Call and Webcast
Information
ESPERION will host a conference call and webcast
today, October 18, 2021 at 8:00 A.M. Eastern Time to provide more
information on today’s announcement and to answer questions. 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 7683898.
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.
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.
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, 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.
Contact:Esperion Corporate
TeamCorporateteam@esperion.com
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From May 2024 to Jun 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Jun 2023 to Jun 2024