Esperion (NASDAQ: ESPR) today reported financial results for the
first quarter ended March 31, 2024, and provided a business update.
“We are proud of our strong start to 2024 and
the continued momentum and growth we again delivered in the first
quarter,” said Sheldon Koenig, President and CEO. “We posted retail
prescription equivalent growth of 43% year-over-year, generated our
highest level of revenue yet, and ended the quarter with a cash
balance that positions us to capitalize on our new label and
deliver long term value growth.”
“We also received FDA approval of our highly
anticipated label expansions for NEXLETOL and NEXLIZET, which we
believe positions us for a meaningful uptick in growth. As the only
oral LDL-cholesterol (LDL-C) lowering non-statins approved for
reducing cardiovascular risk in both primary and secondary
prevention patients, our expanded labels will enable us to
potentially reach more than 70 million new patients in need of an
alternative therapy. We believe this approval brings us closer to
bridging the statin gap, which encompasses an underserved patient
population that is unable to reach their LDL-C goal on current
therapies alone.”
“We have prioritized investment in our
commercial strategy, including ramping up our sales force,
launching our new Lipid Lurker consumer campaign, developing a
suite of new promotional materials, and initiating partnerships to
provide improved interim access with the payer and patient
communities. We’re also pleased to report utilization management
criteria updates that will be made by two major payers in the next
two months that covers 40 million lives, and anticipate additional
payers aligning with our new labels on a weekly basis. Looking to
our global ex-U.S. franchise., our partner Daiichi Sankyo Europe
(DSE) continued to drive increased sales across newly launched
territories, signaling the growth potential of these products
globally. In summary, with our reinforced commercial infrastructure
and recent payer wins, we are poised for significant growth and I
look forward to sharing our progress in the coming quarters.”
First Quarter 2024 Key Accomplishments and Recent
Highlights
- Granted expanded label from the FDA
for NEXLETOL and NEXLIZET on March 22, 2024. The label expansion
added prevention of heart attacks and reduction of cardiovascular
risk as indications and expanded the LDL-C lowering indication to
include use with or without a statin. The updates to the label
expand accessibility by approximately 70 million patients in the
U.S.
- Initiated new commercial
initiatives to increase patient awareness of NEXLETOL and
NEXLIZET’s expanded labels. Expanded our sales force to 150
representatives in the U.S. and developed new promotional materials
and tools to supplement salesforce efforts. Initiated partnerships
to provide interim patient access while working with payers to
update utilization management criteria and streamline transition to
the new and expanded labels.
- Received positive opinions from the
Committee for Medical Products for Human Use (CHMP) of the European
Medical Agency (EMA) on March 22, 2024. The opinions were based on
the updated label of NILEMDO® (bempedoic acid) and NUSTENDI®
(bempedoic acid / ezetimibe fixed dose combination), which were
recommended for the reduction of LDL-C and cardiovascular risk. The
European Commission is expected to deliver its determination on the
pending label update applications in the second quarter of
2024.
- Reported royalty revenue of $6.6
million in the first quarter, representing a year-over-year
increase of 164%. DSE launched in the Netherlands, Czech Republic,
and Slovakia during the first quarter of 2024. Daiichi Sankyo
Company, Limited (“DS ASCA”) received approvals in Thailand and
Myanmar during the first quarter of 2024.
- Presented prespecified subgroup
analyses from the CLEAR Outcomes trial at ACC 2024. The subgroup
analyses evaluated key underserved and understudied populations,
including patients with obesity, women, and Hispanics/Latinx. CLEAR
Outcomes enrolled 48% women and 17% Hispanic/Latinx patients,
setting a new standard for diversity and inclusion in clinical
trials. NEXLETOL demonstrated a 23% reduction in major adverse
cardiovascular events (MACE-4) versus placebo in obese patients and
had clinical benefits in women and Hispanic/Latinx patients with
and without cardiovascular disease.
- Initiated the technology transfer
process for NILEMDO and NUSTENDI tablet manufacturing to DSE for
its territories, which we expect to be completed in the second half
of 2025. Additionally, as part of our amended partnership, we
authorized DSE to proceed with commercialization of a triple
formulation product comprising bempedoic acid, ezetimibe, and a
statin, which, if approved, has the potential to meaningfully
extend the product’s lifecycle in Europe.
- Our collaboration with Otsuka in
Japan remains on track, with Otsuka’s phase III study expected to
close out in Q2 2024, an anticipated Japan New Drug Application
(JNDA) filing in late 2024, and approval and National Health
Insurance (NHI) pricing in 2025.
First Quarter 2024 Financial Results
Total revenue was $137.7 million, compared to
$24.3 million for the comparable period in 2023, an increase of
approximately 467%.
U.S. net product revenue was $24.8 million,
compared to $17.0 million for the comparable period in 2023, an
increase of approximately 46%, driven by retail prescription growth
of 43%.
Collaboration revenue was $113.0 million,
compared to $7.3 million for the comparable period in 2023, an
increase of 1,448%, driven by increased tablet sales to our
international partners and sales growth within partner territories
along with the settlement related milestone payment.
Research and development expenses were $13.4
million, compared to $31.4 million for the comparable period in
2023, a decrease of 57%. The decrease is primarily related to the
close-out of our CLEAR Outcomes study.
Selling, general and administrative expenses
were $42.0 million, compared to $29.9 million for the comparable
period in 2023, an increase of 40%. The increase is primarily
related to the ramp up of our sales force ahead of our commercial
launch in addition to bonus payments and promotional costs.
Total net income for the quarter was $61.0
million, compared to a net loss of $61.7 million for the comparable
period in 2023.
Basic net income per share was $0.36, compared
to basic and diluted net loss per share of $0.79 for the comparable
period in 2023. Diluted net income per share was $0.34.
As of March 31, 2024, cash and cash equivalents
totaled $226.6 million, which includes our legal settlement and
$90.7 million in net proceeds from our underwritten public offering
in January 2024, compared with $82.2 million as of December 31,
2023.
The Company ended the quarter with approximately
187.9 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.
2024 Financial OutlookThe
Company still expects full year 2024 operating expenses to be
approximately $225 million to $245 million, including $20 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.
A live audio webcast can be accessed on the
investor and media section of the Esperion website at
esperion.com/investor-relations/events. 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.
INDICATION NEXLIZET and
NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering
therapies, to reduce LDL-C in adults with primary hyperlipidemia,
including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies,
or alone when concomitant LDL-C lowering therapy is not possible,
to reduce LDL-C in adults with primary hyperlipidemia, including
HeFH.
IMPORTANT SAFETY
INFORMATIONNEXLIZET and NEXLETOL are contraindicated in
patients with a prior hypersensitivity to bempedoic acid or
ezetimibe or any of the excipients. Serious hypersensitivity
reactions including anaphylaxis, angioedema, rash, and urticaria
have been reported.
Hyperuricemia: Bempedoic acid, a component of
NEXLIZET and NEXLETOL, may increase blood uric acid levels, which
may lead to gout. Hyperuricemia may occur early in treatment and
persist throughout treatment, returning to baseline following
discontinuation of treatment. 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, a component of
NEXLIZET and NEXLETOL, is associated with an increased risk of
tendon rupture or injury. Tendon rupture may occur more frequently
in patients over 60 years of age, in those taking corticosteroid or
fluoroquinolone drugs, in patients with renal failure, and in
patients with previous tendon disorders. Discontinue NEXLIZET or
NEXLETOL at the first sign of tendon rupture. Consider alternative
therapy in patients who have a history of tendon disorders or
tendon rupture.
The most common adverse reactions in the primary
hyperlipidemia trials of bempedoic acid, a component of NEXLIZET
and NEXLETOL, in ≥2% of patients and greater than placebo were
upper respiratory tract infection, muscle spasms, hyperuricemia,
back pain, abdominal pain or discomfort, bronchitis, pain in
extremity, anemia, and elevated liver enzymes.
Adverse reactions reported in ≥2% of patients
treated with ezetimibe (a component of NEXLIZET) and at an
incidence greater than placebo in clinical trials were upper
respiratory tract infection, diarrhea, arthralgia, sinusitis, pain
in extremity, fatigue, and influenza.
In the primary hyperlipidemia trials of
NEXLIZET, the most commonly reported adverse reactions (incidence
≥3% and greater than placebo) observed with NEXLIZET, but not
observed in clinical trials of bempedoic acid or ezetimibe, were
urinary tract infection, nasopharyngitis, and constipation.
The most common adverse reactions in the
cardiovascular outcomes trial for bempedoic acid, a component of
NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than
placebo were hyperuricemia, renal impairment, anemia, elevated
liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when pregnancy
is recognized unless the benefits of therapy outweigh the potential
risks to the fetus. Because of the potential for serious adverse
reactions in a breast-fed infant, breastfeeding is not recommended
during treatment with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics,
Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for
NEXLIZET and NEXLETOL.
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 X at
twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes
TrialCLEAR Outcomes is part of the CLEAR clinical research
program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET®
(bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to
generate important clinical evidence on the safety and efficacy of
bempedoic acid, a first in a 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 70 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 net sales, profitability, and growth of
Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch plans, the outcomes
and anticipated benefits of legal proceedings and settlements, 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:
investorrelations@esperion.com
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
Esperion
Therapeutics, Inc.
Balance Sheet Data(In
thousands)(Unaudited)
|
|
March 31,2024 |
|
December 31,2023 |
Cash and cash equivalents |
|
$ |
226,609 |
|
|
$ |
82,248 |
|
Working capital |
|
|
201,094 |
|
|
|
44,841 |
|
Total assets |
|
|
373,060 |
|
|
|
205,796 |
|
Revenue interest
liability |
|
|
279,883 |
|
|
|
274,778 |
|
Convertible notes, net of
issuance costs |
|
|
262,033 |
|
|
|
261,596 |
|
Common stock |
|
|
188 |
|
|
|
118 |
|
Accumulated deficit |
|
|
(1,488,262 |
) |
|
|
(1,549,284 |
) |
Total stockholders'
deficit |
|
|
(294,298 |
) |
|
|
(454,994 |
) |
|
|
|
|
|
|
|
|
|
Esperion
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months EndedMarch 31, |
|
2024 |
|
2023 |
Revenues: |
|
|
|
Product sales, net |
$ |
24,756 |
|
|
$ |
17,031 |
|
Collaboration revenue |
|
112,979 |
|
|
|
7,298 |
|
Total Revenues |
|
137,735 |
|
|
|
24,329 |
|
|
|
|
|
Operating
expenses: |
|
|
|
Cost of goods sold |
|
10,075 |
|
|
|
11,652 |
|
Research and development |
|
13,403 |
|
|
|
31,381 |
|
Selling, general and administrative |
|
41,988 |
|
|
|
29,901 |
|
Total operating expenses |
|
65,466 |
|
|
|
72,934 |
|
|
|
|
|
Income (loss) from
operations |
|
72,269 |
|
|
|
(48,605 |
) |
|
|
|
|
Interest expense |
|
(14,024 |
) |
|
|
(14,387 |
) |
Other income, net |
|
2,777 |
|
|
|
1,273 |
|
Net income
(loss) |
$ |
61,022 |
|
|
$ |
(61,719 |
) |
|
|
|
|
Net income (loss) per common
share - basic |
$ |
0.36 |
|
|
$ |
(0.79 |
) |
Net income (loss) per common
share - diluted |
$ |
0.34 |
|
|
$ |
(0.79 |
) |
|
|
|
|
Weighted-average shares
outstanding - basic |
|
169,258,564 |
|
|
|
78,440,266 |
|
Weighted-average shares
outstanding - diluted |
|
189,641,251 |
|
|
|
78,440,266 |
|
|
|
|
|
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