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Esperion Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Company Update - Landmark CLEAR Outcomes Trial Successfully Completed and Met the Major Adverse Cardiovascular Events (MACE-4) Primary End

Key Takeaway: Esperion reported its fourth quarter and full year 2022 financial results, highlighting a successful completion of the CLEAR Outcomes Trial, which met its primary endpoint. U.S. net sales for Q4 reached $15 million, up 23% year-over-year, with total sales for the year at $56 million, a 40% increase. The company also reduced its selling and administrative expenses significantly by 41%. However, despite these achievements, Esperion reported net losses of $55.5 million for the quarter and $233.7 million for the year.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful completion of the CLEAR Outcomes Trial meeting major endpoints.
  • Significant increase in U.S. net sales with a 23% rise in Q4 2022 compared to Q4 2021.
  • Reduction in Selling, General and Administrative expenses by 41% year-over-year.

CONCERNS & RISKS

  • Despite revenue growth, net losses totaled $55.5 million for Q4 2022.
  • Full year net losses were $233.7 million, although improved from previous year.

Full Press Release Details

Esperion Reports Fourth Quarter and Full Year
2022 Financial Results and Provides Company Update
- Landmark CLEAR Outcomes Trial Successfully
Completed and Met the Major Adverse Cardiovascular Events (MACE-4) Primary Endpoint and Additional Key Secondary Endpoints; Additional
Details in 11 Days at ACC.23/WCC -
- Generated $15M in U.S. Net Sales in
Q4 (+23% vs Q4 2021) and Full Year U.S. Net Sales of $56M (+40% Year over Year) with a Concurrent 41% Reduction in Selling, General and
Administrative Expenses -
ANN ARBOR, Mich., February 21, 2023 (GLOBE NEWSWIRE) -- Esperion
(NASDAQ: ESPR) today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business
"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,
2022 Key Accomplishments and Recent Highlights
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.
NEXLETOL 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 Trial
CLEAR 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
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,

Frequently Asked Questions

What were Esperion's Q4 2022 net sales figures?

Esperion generated $15 million in net sales in Q4 2022, a 23% increase.

How much did Esperion reduce its administrative expenses?

The company achieved a 41% reduction in selling and administrative expenses.

What is the primary focus of the CLEAR Outcomes Trial?

The trial evaluates NEXLETOL's effectiveness in reducing cardiovascular events.

What was Esperion's total revenue for full year 2022?

Total revenue for 2022 was $75.5 million, a 4% decrease from 2021.

What significant milestone did NEXLETOL achieve?

NEXLETOL is the first oral LDL-C lowering therapy in 20 years to show major outcomes.

Last updated: Feb 21, 2023