Esperion (NASDAQ: ESPR) today reported financial results for the
fourth quarter and full year ended December 31, 2022, and provided
a business update.
“I’m proud of the entire organization at Esperion and our
ability to deliver on the commitments we made in 2022. From prudent
expense management to consistent quarter over quarter growth to
timely completion of the landmark CLEAR Outcomes study, we
successfully executed on our stated goals,” said Sheldon Koenig,
president and chief executive officer of Esperion. “In 2023, we
look forward to working tirelessly to ensure the data from CLEAR
Outcomes serve as the catalyst for improved clinical management for
millions of patients. These are practice changing data. NEXLETOL
(bempedoic acid) is the first oral LDL-C lowering therapy to
deliver clinically meaningful reductions in hard endpoints in
almost 20 years. We look forward to presenting these data in a few
weeks at the ACC.23 Annual Scientific Session & Expo together
with the World Congress of Cardiology and encourage you to join –
online or in person – on March 4, 2023, in New Orleans, LA.”
2022 Key Accomplishments and Recent
Highlights
- CLEAR Outcomes met its primary endpoint, demonstrating
statistically significant risk reduction in MACE-4 in patients
treated with 180 mg/day NEXLETOL compared to placebo. Key secondary
endpoints also met.
- Expanded access and reimbursement to help more patients reach
their LDL-C goals with additional formulary wins at Tufts (Point 32
Health), Summa Health Care and Connecticare across all Medicare,
commercial, Medicaid and Health Exchange formularies
- Established Scientific Advisory Board to support pipeline and
life cycle management
- Hosted virtual R&D Day on November 9, 2022, which
highlighted pipeline programs
- Appointed Ben Halladay as Chief Financial Officer
- Announced new partnership with RFK Racing to advance consumer
and brand awareness in their national fanbase
Fourth Quarter and Full Year 2022 Financial
Results
Total revenue for the fourth quarter ended December 31, 2022,
was $18.8 million and $75.5 million for the full year ended
December 31, 2022, compared to $15.4 million and $78.4 million for
the comparable periods in 2021, an increase of 22% and a decrease
of 4%, respectively. The increase for the fourth quarter ended
December 31, 2022, is related to increases in net U.S. product
revenue and royalty revenue. The decrease for the full year ended
December 31, 2022, is due to a one-time milestone payment of $30.0
million from our collaboration partner in the second quarter of
2021, partially offset by increases in net U.S. product revenue,
royalty revenue, and product sales to collaboration partners under
our supply agreements.
U.S. product revenue for the fourth quarter ended December 31,
2022, was $15.0 million and $55.9 million for the full year ended
December 31, 2022, compared to $12.2 million and $40.0 million for
the comparable periods in 2021, an increase of 23% and
approximately 40%, respectively.
Royalty revenue for the fourth quarter ended December 31, 2022,
was $2.3 million and $6.5 million for the full year ended December
31, 2022, compared to $0.8 million and $3.6 million for the
comparable periods in 2021, an increase of 188% and 81%,
respectively.
Research and development expenses for the fourth quarter ended
December 31, 2022, were $33.0 million and $118.9 million for the
full year ended December 31, 2022, compared to $27.6 million and
$106.0 million for the comparable periods in 2021, an increase of
20% and 12%, respectively. The increases are primarily related to
an acceleration in CVOT costs as we achieved 100% MACE and closed
out the study earlier than anticipated.
Selling, general and administrative expenses for the fourth
quarter ended December 31, 2022, were $24.1 million and $109.1
million for the full year ended December 31, 2022, compared to
$38.3 million and $185.0 million for the comparable periods in
2021, a decrease of 37% and 41%, respectively. These decreases
reflect savings from the transformative plan implemented in the
fourth quarter of 2021.
Esperion had net losses of $55.5 million for the fourth quarter
of 2022 and $233.7 million for the full year ended December 31,
2022, compared to net losses of $65.1 million and $269.1 million
for the comparable periods in 2021. Esperion had basic and diluted
net losses per share of $0.76 for the fourth quarter of 2022 and
$3.52 for the year ended December 31, 2022, compared to basic and
diluted net losses per share of $1.77 and $9.31, respectively, for
the comparable periods in 2021.
As of December 31, 2022, cash, cash equivalents, restricted cash
and investment securities available-for-sale totaled $166.9 million
compared with $309.3 million on December 31, 2021.
Esperion ended the quarter with 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.
Conference Call and Webcast Information
Esperion 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 is
indicated as an adjunct 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 on cardiovascular
morbidity and mortality has not been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia:
NEXLETOL 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: NEXLETOL is associated with an increased risk of
tendon rupture or injury. In clinical trials, tendon rupture
occurred in 0.5% of patients treated with NEXLETOL 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 NEXLETOL. 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 at the first sign of tendon rupture. Avoid
NEXLETOL in patients who have a history of tendon disorders or
tendon rupture.
Adverse Reactions: In 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.
Drug Interactions: Simvastatin and Pravastatin:
Concomitant use results in increased concentrations and increased
risk of simvastatin or pravastatin-related myopathy. Use with
greater than 20 mg of simvastatin or 40 mg of pravastatin should be
avoided.
Lactation and Pregnancy: It is not recommended
that NEXLETOL be taken during breastfeeding. Discontinue NEXLETOL
when pregnancy is recognized, unless the benefits of therapy
outweigh the potential risks to the fetus. Based on the mechanism
of action, NEXLETOL may cause fetal harm.
Please see full Prescribing Information here.
CLEAR Cardiovascular Outcomes TrialCLEAR
Outcomes is a Phase 3, event-driven, randomized, multicenter,
double-blind, placebo-controlled trial designed to evaluate whether
treatment with NEXLETOL reduces the risk of cardiovascular events
in patients with or who are at high risk for cardiovascular disease
with documented statin intolerance (inability to tolerate 2 or more
statins, one at a low dose) and elevated LDL-C levels (fasting
blood LDL-C ≥ 100 (2.6 mmol/L). The study, which includes over
14,000 patients at over 1,200 sites in 32 countries, accumulated
the targeted 1,620 primary major adverse cardiovascular events
(MACE-4) in August 2022.
Esperion Therapeutics
Esperion 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 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 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 expected partner milestone payments, 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
|
ESPERION Therapeutics, Inc.Balance
Sheet Data(In
thousands)(Unaudited) |
|
|
|
December 31,2022 |
|
December 31,2021 |
Cash and cash equivalents |
|
$ |
124,775 |
|
|
$ |
208,892 |
|
Restricted cash |
|
|
— |
|
|
|
50,000 |
|
Investments |
|
|
42,086 |
|
|
|
50,441 |
|
Working capital |
|
|
154,375 |
|
|
|
255,620 |
|
Total assets |
|
|
247,939 |
|
|
|
381,590 |
|
Revenue interest
liability |
|
|
243,605 |
|
|
|
257,039 |
|
Convertible notes, net of
issuance costs |
|
|
259,899 |
|
|
|
258,280 |
|
Common stock |
|
|
75 |
|
|
|
61 |
|
Accumulated deficit |
|
|
(1,340,036 |
) |
|
|
(1,106,377 |
) |
Total stockholders'
deficit |
|
|
(323,778 |
) |
|
|
(196,944 |
) |
|
ESPERION Therapeutics, Inc.Statement
of Operations(In thousands, except share and per
share data)(Unaudited) |
|
|
Three Months Ended December 31, |
|
Year EndedDecember 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
14,967 |
|
|
$ |
12,192 |
|
|
$ |
55,863 |
|
|
$ |
40,047 |
|
Collaboration revenue |
3,851 |
|
|
3,209 |
|
|
19,612 |
|
|
38,400 |
|
Total Revenues |
18,818 |
|
|
15,401 |
|
|
75,475 |
|
|
78,447 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
4,160 |
|
|
5,075 |
|
|
26,967 |
|
|
14,217 |
|
Research and development |
33,033 |
|
|
27,616 |
|
|
118,927 |
|
|
105,975 |
|
Selling, general and administrative |
24,138 |
|
|
38,338 |
|
|
109,082 |
|
|
184,985 |
|
Total operating expenses |
61,331 |
|
|
71,029 |
|
|
254,976 |
|
|
305,177 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
(42,513 |
) |
|
(55,628 |
) |
|
(179,501 |
) |
|
(226,730 |
) |
|
|
|
|
|
|
|
|
Interest expense |
(14,329 |
) |
|
(13,430 |
) |
|
(56,810 |
) |
|
(46,353 |
) |
Other income, net |
1,355 |
|
|
3,939 |
|
|
2,652 |
|
|
3,975 |
|
Net loss |
$ |
(55,487 |
) |
|
$ |
(65,119 |
) |
|
$ |
(233,659 |
) |
|
$ |
(269,108 |
) |
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(0.76 |
) |
|
$ |
(1.77 |
) |
|
$ |
(3.52 |
) |
|
$ |
(9.31 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
73,487,416 |
|
|
36,845,550 |
|
|
66,407,242 |
|
|
28,902,507 |
|
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From Apr 2024 to May 2024
Esperion Therapeutics (NASDAQ:ESPR)
Historical Stock Chart
From May 2023 to May 2024