Esperion (NASDAQ: ESPR) today reported financial results for the
first quarter ended March 31, 2023 and provided a business update.
“In the first quarter of 2023, we were proud to report
clinically meaningful results from our landmark CLEAR Outcomes
trial at ACC.23/WCC and simultaneously published in the prestigious
New England Journal of Medicine, confirming bempedoic acid’s
cardiovascular benefits,” said Sheldon Koenig, President and Chief
Executive Officer of Esperion. “Since our announcement, we have
seen significant public interest and enthusiasm for bempedoic acid,
garnering over one billion total impressions from multiple print
media and broadcast outlets in the U.S. In addition, we are already
witnessing rapid adoption in demand for this practice-changing
treatment from prescribers and pharmacists. International Lipid
Expert Panel guidelines now recommend bempedoic acid ahead of PCSK9
inhibitors, and we anticipate more guideline updates in the future.
We remain on track to submit regulatory filings in both the U.S.
and Europe in the first half of 2023.”
“In the short period of time post ACC, we have presented CLEAR
Outcomes data to national payers/PBMS, including the VA, that
account for nearly half of total pharmacy lives. Payers have
committed to reviewing utilization management criteria to align
with CLEAR results prior to label change and considering potential
off-cycle (Q3) additions to Medicare plans, which would improve
Medicare coverage from 34% to 70%. We believe we are well
positioned in a large market and remain committed to driving growth
and providing value to patients, providers, and shareholders alike.
Additionally, we recently announced a pay-for-performance
commercial partnership with Currax that effectively doubles our
promotional footprint. This partnership is expected to help drive
sustained growth in 2023 and effectively bridge us to our internal,
organic expansion, which is expected to be completed in advance of
the anticipated FDA label update in the first half of 2024.”
“This is just the beginning of the roll-out of these highly
impactful data. What’s next? Multiple high-profile presentations
and publications anticipated in top tier journals to continue to
support the utility of NEXLETOL® and NEXLIZET® in clinical
practice,” he concluded.
First Quarter 2023 Key Accomplishments and Recent
Highlights
- Announced a pay-for-performance commercial partnership with
Currax Pharmaceuticals, LLC, which effectively doubles promotional
footprint.
- Robustness of CLEAR Outcomes data drove global awareness of the
benefits of bempedoic acid (contained in NEXLETOL and NEXLIZET),
which we expect will continue to lead to wide acceptance by
providers, patients, and payers.
- The International Lipid Expert Panel (ILEP) recommended use of
bempedoic acid ahead of PCSK9 inhibitors in managing lipid
disorders and cardiovascular risk. Following the “Lower Is Better
for Longer” approach to lipid management, the ILEP’s recently
published paper provides evidence-based guidance on bempedoic acid
utilization ahead of PSCK9i therapy, either in combination with or
after ezetimibe treatment, in patients with atherosclerotic
cardiovascular disease (ASCVD), heterozygous familial
hypercholesterolemia (HeFH) and statin intolerance.
- The Italian Medicines Agency (AIFA) approved reimbursement of
bempedoic acid and the fixed-dose combination of bempedoic acid and
ezetimibe for the treatment of adult patients with high blood
LDL-cholesterol levels, despite taking statins or other
hypolipidemic therapies. In addition, marketing approvals were
obtained in Turkey for bempedoic acid and the fixed-dose
combination of bempedoic acid and ezetimibe.
- Launched new scientific website, esperionscience.com, designed
specifically for the scientific and medical communities, featuring
information about the Company’s CLEAR program and the clinical
trials comprising the CLEAR program, the Company’s pipeline, and
information about cardiometabolic disease.
First Quarter 2023 Financial Results
Total revenue was $24.3 million, compared to $18.8 million for
the comparable period in 2022, an increase of 29%.
U.S. net product revenue was $17.0 million, compared to $13.4
million for the comparable period in 2022, an increase of
approximately 27%, driven by retail prescription growth of 15%.
Collaboration revenue was $7.3 million, compared to $5.5 million
for the comparable period in 2022, an increase of 33%, driven by
increased tablet sales to our international partners and sales
growth within partner territories.
Research and development expenses were $31.4 million, compared
to $24.3 million for the comparable period in 2022, an increase of
29%. The increase is primarily related to costs associated with the
announcement and presentation of our CLEAR Outcomes study results,
associated close-out activities, and regulatory submission
preparation.
Selling, general and administrative expenses were $29.9 million,
compared to $30.4 million for the comparable period in 2022, a
decrease of 2%.
Total net loss for the quarter was $61.7 million, compared to a
net loss of $56.7 million for the comparable period in 2022. Basic
and diluted net loss per share was $0.79, compared to basic and
diluted net loss per share of $0.93 for the comparable period in
2022.
As of March 31, 2023, cash, cash equivalents, and investment
securities available-for-sale totaled $162.3 million, compared with
$166.9 million on December 31, 2022.
The Company ended the quarter with approximately 87.2 million
shares of common stock outstanding, excluding 2.0 million treasury
shares to be purchased in the prepaid forward transaction as part
of the convertible debt financing.
Reiterating 2023 Financial Outlook
The Company still expects full year 2023 operating expenses to
be approximately $225 million to $245 million, including $25
million in non-cash expenses related to stock compensation.
Conference Call and Webcast InformationEsperion
will host a webcast at 8:00 a.m. ET to discuss financial results
and business progress. Please click here to pre-register to
participate in the conference call and obtain your dial in number
and PIN. You can also visit the Esperion website to listen to the
call via live webcast. A recorded version will be available under
the same link immediately following the conclusion of the
conference call. Already registered? Access with your PIN here.
A live webcast can be accessed on the investors and media
section of the Esperion website. Access to the webcast replay will
be available approximately two hours after completion of the call
and will be archived on the Company’s website for approximately 90
days.
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 TherapeuticsAt Esperion, we discover,
develop, and commercialize innovative medicines to help improve
outcomes for patients with or at risk for cardiovascular and
cardiometabolic diseases. The status quo is not meeting the health
needs of millions of people with high cholesterol – that is why our
team of passionate industry leaders is breaking through the
barriers that prevent patients from reaching their goals. Providers
are moving toward reducing LDL-cholesterol levels as low as
possible, as soon as possible; we provide the next steps to help
get patients there. Because when it comes to high cholesterol,
getting to goal is not optional. It is our life’s work. For more
information, visit esperion.com and esperionscience.com and follow
us on Twitter at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is part of the CLEAR clinical research program for
NEXLETOL and NEXLIZET. The CLEAR Program seeks to generate
important clinical evidence on the safety and efficacy of bempedoic
acid, a first in class ATP citrate lyase inhibitor contained in
NEXLETOL and NEXLIZET and its potential role in addressing
additional critical unmet medical needs. More than 60,000 people
will have participated in the program by the time of its
completion. The CLEAR Program includes 5 label-enabling Phase III
studies as well as other key Phase IV studies with the potential to
reach more than 30 million people with or at risk for CVD based on
elevated LDL-C.
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, 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, the outcomes
of legal proceedings, 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.
Esperion Contact Information:Investors: Alexis
Callahaninvestorrelations@esperion.com (406) 539-1762
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
Esperion Therapeutics, Inc.Balance
Sheet Data(In
thousands)(Unaudited) |
|
|
March 31,2023 |
|
December 31,2022 |
Cash and cash equivalents |
|
$ |
144,911 |
|
|
$ |
124,775 |
|
Investments |
|
|
17,427 |
|
|
|
42,086 |
|
Working capital |
|
|
155,119 |
|
|
|
154,375 |
|
Total assets |
|
|
251,819 |
|
|
|
247,939 |
|
Revenue interest
liability |
|
|
251,819 |
|
|
|
243,605 |
|
Convertible notes, net of
issuance costs |
|
|
260,316 |
|
|
|
259,899 |
|
Common stock |
|
|
87 |
|
|
|
75 |
|
Accumulated deficit |
|
|
(1,401,755 |
) |
|
|
(1,340,036 |
) |
Total stockholders'
deficit |
|
|
(329,663 |
) |
|
|
(323,778 |
) |
Esperion Therapeutics, Inc.Statement
of Operations(In thousands, except share and per
share data)(Unaudited) |
|
Three Months EndedMarch 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
Revenues: |
|
|
|
|
Product sales, net |
$ |
17,031 |
|
|
$ |
13,354 |
|
|
Collaboration revenue |
|
7,298 |
|
|
|
5,482 |
|
|
Total Revenues |
|
24,329 |
|
|
|
18,836 |
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Cost of goods sold |
|
11,652 |
|
|
|
7,125 |
|
|
Research and development |
|
31,381 |
|
|
|
24,319 |
|
|
Selling, general and administrative |
|
29,901 |
|
|
|
30,381 |
|
|
Total operating expenses |
|
72,934 |
|
|
|
61,825 |
|
|
|
|
|
|
|
Loss from
operations |
|
(48,605 |
) |
|
|
(42,989 |
) |
|
|
|
|
|
|
Interest expense |
|
(14,387 |
) |
|
|
(14,062 |
) |
|
Other income, net |
|
1,273 |
|
|
|
320 |
|
|
Net loss |
$ |
(61,719 |
) |
|
$ |
(56,731 |
) |
|
|
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(0.79 |
) |
|
$ |
(0.93 |
) |
|
|
|
|
|
|
Weighted-average shares
outstanding - basic and diluted |
|
78,440,266 |
|
|
|
60,954,755 |
|
|
|
|
|
|
|
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