Esperion (NASDAQ: ESPR) today announced preliminary, unaudited
fourth-quarter 2022 financial results and highlighted key upcoming
anticipated milestones which represent continued execution of the
Company’s transformational plan.
“Esperion stands committed to our strategic vision of driving
accelerated growth and expansion of our bempedoic acid franchise,
with the ultimate goal of reducing LDL cholesterol and improving
cardiovascular outcomes, particularly in patients who are unable to
tolerate or reach their goals with statins,” said Sheldon Koenig,
Esperion’s president and chief executive officer. “With the robust
CLEAR Outcomes data being presented and supporting regulatory
submissions in the first half of 2023, we are poised to deliver
significant value for shareholders in the coming months, as we look
forward to potential label expansion and believe we will be
entitled to receive partner milestone payments upon regulatory
approvals. In line with our goal of increasing cardiovascular
health awareness, we are also pleased to announce a new partnership
with RFK Racing, which will provide ample opportunities for
community engagement and education to their large and diverse
consumer base. We look forward to building on our momentum in 2023
and beyond as we seek to maximize our opportunity with NEXLETOL®
(bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) and
drive the franchise towards blockbuster status.”
Preliminary Q4 2022 Financial Results
Preliminary, unaudited fourth-quarter 2022 net U.S. product
sales are expected to be between $14.4 to $15.1 million; FY growth
between 38% and 40% year over year.
As of December 31, 2022, cash and investment securities
available-for-sale totaled approximately $167 million and there
were approximately 74.6 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.
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 fourth quarter
and full year 2022 in late February.
Regulatory and Milestone Updates from
Partners
Esperion anticipates submission of the CLEAR Outcomes package to
the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) in the first half of 2023. Regulatory
submissions will be supported by positive CLEAR Outcomes data,
which met the major adverse cardiovascular events (MACE-4) primary
endpoint as well as several key secondary endpoints. Based on the
robustness of the CLEAR Outcomes data, the Company believes it
would be entitled to receive milestone payments from collaborative
partners upon inclusion of cardiovascular risk reduction data in
the US and European labels.
RFK Racing Partnership
Esperion is also announcing a new partnership with RFK Racing,
which is part of the company’s multi-dimensional approach to
advance consumer awareness about the benefits of lowering LDL
cholesterol and improving cardiovascular health. This 12-month,
360° marketing platform is focused on national consumer awareness,
community engagement and patient education. The campaign will
target the 10+ million RFK Racing fanbase, millions of whom report
being diagnosed with high cholesterol and are more likely than
non-fans to be diagnosed with and currently treating cardiovascular
conditions. Awareness and education events will include the big
race in February, sponsorship of the RFK Fan Day 5K road race, and
other events throughout 2023.
INDICATIONNEXLETOL and NEXLIZET are indicated
as adjuncts to diet and maximally tolerated statin therapy for the
treatment of adults with heterozygous familial hypercholesterolemia
or established atherosclerotic cardiovascular disease who require
additional lowering of LDL-C.
Limitations of Use: The effect of NEXLETOL and NEXLIZET on
cardiovascular morbidity and mortality has not been determined.
IMPORTANT SAFETY
INFORMATIONContraindications: NEXLETOL
has no contraindications. NEXLIZET is contraindicated in patients
with a known hypersensitivity to ezetimibe tablets.
Hypersensitivity reactions including anaphylaxis, angioedema, rash,
and urticaria have been reported with ezetimibe.
Warnings and Precautions: Hyperuricemia:
Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase
blood uric acid levels. Hyperuricemia may occur early in treatment
and persist throughout treatment, and may lead to the development
of gout, especially in patients with a history of gout. Assess uric
acid levels periodically as clinically indicated. Monitor for signs
and symptoms of hyperuricemia, and initiate treatment with
urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid is associated with an increased
risk of tendon rupture or injury. In clinical trials, tendon
rupture occurred in 0.5% of patients treated with bempedoic acid
versus 0% of patients treated with placebo, and involved the
rotator cuff (the shoulder), biceps tendon, or Achilles tendon.
Tendon rupture occurred within weeks to months of starting
bempedoic acid. Tendon rupture may occur more frequently in
patients over 60 years of age, patients taking corticosteroid or
fluoroquinolone drugs, patients with renal failure, and patients
with previous tendon disorders. Discontinue NEXLETOL or NEXLIZET at
the first sign of tendon rupture. Avoid NEXLETOL and NEXLIZET in
patients who have a history of tendon disorders or tendon
rupture.
Adverse Reactions: In NEXLETOL
clinical trials, the most commonly reported adverse reactions were
upper respiratory tract infection, muscle spasms, hyperuricemia,
back pain, abdominal pain or discomfort, bronchitis, pain in
extremity, anemia, and elevated liver enzymes. Reactions reported
less frequently, but still more often than with placebo, included
benign prostatic hyperplasia and atrial fibrillation.
In the NEXLIZET clinical trial, the most commonly reported
adverse reactions observed with NEXLIZET, but not observed in
clinical trials of bempedoic acid or ezetimibe, a component of
NEXLIZET, and occurring more frequently than with placebo, were
urinary tract infection, nasopharyngitis, and constipation.
Adverse reactions reported in clinical trials of ezetimibe, and
occurring at an incidence greater than with placebo, included upper
respiratory tract infection, diarrhea, arthralgia, sinusitis, pain
in extremity, fatigue, and influenza. Other adverse reactions
reported in postmarketing use of ezetimibe included
hypersensitivity reactions, including anaphylaxis, angioedema,
rash, and urticaria; erythema multiforme; myalgia; elevated
creatine phosphokinase; myopathy/rhabdomyolysis; elevations in
liver transaminases; hepatitis; abdominal pain; thrombocytopenia;
pancreatitis; nausea; dizziness; paresthesia; depression; headache;
cholelithiasis; cholecystitis.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use with bempedoic acid results in increased
concentrations and increased risk of simvastatin or
pravastatin-related myopathy. Use of either NEXLETOL or NEXLIZET
with greater than 20 mg of simvastatin or 40 mg of pravastatin
should be avoided.
Cyclosporine: Caution should be exercised when using NEXLIZET
and cyclosporine concomitantly due to increased exposure to both
ezetimibe and cyclosporine. Monitor cyclosporine concentrations in
patients receiving NEXLIZET and cyclosporine. In patients treated
with cyclosporine, the potential effects of the increased exposure
to ezetimibe from concomitant use should be carefully weighed
against the benefits of alterations in lipid levels provided by
NEXLIZET.
Fibrates: Coadministration of
NEXLIZET with fibrates other than fenofibrate is not recommended.
Fenofibrate and ezetimibe may increase cholesterol excretion into
the bile, leading to cholelithiasis. If cholelithiasis is suspected
in a patient receiving NEXLIZET and fenofibrate, gallbladder
studies are indicated and alternative lipid-lowering therapy should
be considered.
Cholestyramine: Concomitant use of NEXLIZET and cholestyramine
decreases ezetimibe concentration. This may result in a reduction
of efficacy. Administer NEXLIZET either at least 2 hours before, or
at least 4 hours after, bile acid sequestrants.
Lactation and Pregnancy: It is not recommended
that NEXLETOL or NEXLIZET be taken during breastfeeding.
Discontinue NEXLETOL or NEXLIZET when pregnancy is recognized,
unless the benefits of therapy outweigh the potential risks to the
fetus. Based on the mechanism of action of bempedoic acid, NEXLETOL
and NEXLIZET may cause fetal harm.
Please see full Prescribing Information here.
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. For more information, please visit 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 expected operational expenses, expected
revenue of our commercial products, future operations, expected
milestone payments from partners, commercial products and expected
growth, clinical development, 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
Communicationscorporateteam@esperion.com
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