Esperion (NASDAQ: ESPR) today reported financial results for the
second quarter ended June 30, 2023, and provided a business update.
“We posted strong results in the second quarter of 2023,
reflecting continued prescription growth and an unwavering
commitment to execution of our strategic plan,” said Sheldon
Koenig, President and Chief Executive Officer of Esperion.
“Following the presentation of our CLEAR Outcomes results in March,
we subsequently filed regulatory applications in both the U.S. and
Europe to meaningfully expand the current indications and remove
restrictions for use of NEXLETOL® (bempedoic acid) and NEXLIZET®
(bempedoic acid and ezetimibe). This was a significant
accomplishment and one that positions us for regulatory approval of
label expansion in both jurisdictions in the first half of next
year, which we believe will serve as a catalyst for further growth
and ultimately result in blockbuster status for our novel
therapies.”
“In addition, we presented new and meaningful data from our
landmark trial at several medical conferences during the quarter.
Of note, an unprecedented analysis highlighting significant
cardiovascular risk reduction in a primary prevention patient
population from CLEAR Outcomes was featured at the American
Diabetes Association (ADA) Meeting and simultaneously published by
the Journal of the American Medical Association (JAMA). Many
patients without ASCVD but who are at high risk for ASCVD events
have not had a new lipid-lowering option proven to lower
cardiovascular risk since statins. Our impressive outcomes data
clearly demonstrate the effectiveness of bempedoic acid not only in
secondary prevention patients, but also in the primary prevention
population, meaningfully expanding the number of patients who could
benefit from NEXLETOL and NEXLIZET to achieve their LDL-C goals and
reduce their cardiovascular risk. These results continue to
demonstrate the significant benefits of our therapies as the clear
next step in treatment after statins,” he concluded.
Second Quarter 2023 Key Accomplishments and Recent
Highlights
- Announced the submission of its Supplemental New Drug
Applications (sNDAs) for NEXLETOL and NEXLIZET to the Food and Drug
Administration (FDA), and the submission of an application for
expanded indication for NILEMDO® (bempedoic acid) and NUSTENDI®
(bempedoic acid and ezetimibe) to the European Medicines Agency
(EMA). Both applications seek the addition of bempedoic acid for
use in cardiovascular risk reduction in patients with or at high
risk for atherosclerotic cardiovascular disease. The Company
anticipates approvals in both the U.S. and Europe in the first half
of 2024.
- Presented key results from CLEAR Outcomes primary prevention
analysis at the 83rd American Diabetes Association (ADA) Scientific
Sessions, with simultaneous publication of the data in the renowned
peer-reviewed Journal of the American Medical Association (JAMA).
Bempedoic acid is the first LDL-lowering therapy since statins
to demonstrate cardiovascular risk reduction in a primary
prevention population, patients who have not yet had a
cardiovascular event, but who are at high risk for one. This data
expands the Company’s addressable market to 70 million patients in
the U.S. alone.
- Presented additional data from CLEAR Outcomes comparing the
cardiovascular risk reduction benefits of bempedoic acid treatment
with statins at the Endocrine Society Meeting (ENDO 2023). Results
demonstrated that the cardiovascular risk reduction benefit of
bempedoic acid treatment is comparable to that of statins based on
an analysis of per unit decrease in LDL-C, using the Cholesterol
Treatment Trialists’ (CTT) methodology.
- Acceptance of two late-breaker presentations at the European
Society of Cardiology (ESC) Congress 2023 in August: Clear Outcomes
Total Events Analysis, presented by Stephen J Nicholls, and Clear
Outcomes Analysis by Glycaemic Status, presented by Kausik K
Ray.
Second Quarter and YTD 2023 Financial
Results
Total revenue for the second quarter ended June 30, 2023, was
$25.8 million and $50.1 million for the six months ended June 30,
2023, compared to $18.8 million and $37.7 million for the
comparable periods in 2022, an increase of 37% and 33%,
respectively.
U.S. net product revenue for the second quarter ended June 30,
2023, was $20.3 million and $37.3 million for the six months ended
June 30, 2023, compared to $13.6 million and $26.9 million for the
comparable periods in 2022, an increase of 49% and 39%,
respectively, driven by retail prescription growth of 26% and
21%.
Collaboration revenue for the second quarter ended June 30,
2023, was $5.5 million and $12.8 million for the six months ended
June 30, 2023, compared to $5.3 million and $10.7 million for the
comparable periods in 2022, an increase of 4% and approximately
20%, respectively, driven by increased royalty revenue, partially
offset by timing of tablet shipments to international partners.
Research and development expenses for the second quarter ended
June 30, 2023, were $22.1 million and $53.5 million for the six
months ended June 30, 2023, compared to $32.4 million and $56.8
million for the comparable periods in 2022, a decrease of 32% and
6%, respectively. The decrease is primarily related to lower costs
related to our CLEAR Outcomes study following the announcement and
presentation of the full study results in March 2023.
Selling, general and administrative expenses for the second
quarter ended June 30, 2023, were $34.0 million and $63.9 million
for the six months ended June 30, 2023, compared to $29.6 million
and $60.0 million for the comparable periods in 2022, an increase
of 15% and approximately 7%, respectively, primarily related to
upfront training costs for our contract sales force and higher
legal costs.
The Company had net losses of $49.9 million for the second
quarter ended June 30, 2023, and $111.7 million for the six months
ended June 30, 2023, compared to net losses of $66.3 million and
$123.1 million for the comparable periods in 2022,
respectively.
Basic and diluted net losses per share was $0.46 for the second
quarter ended June 30, 2023, and $1.19 for the six months ended
June 30, 2023, compared to basic and diluted net losses per share
of $1.05 and $1.98, for the comparable periods in 2022,
respectively.
As of June 30, 2023, cash, cash equivalents, and investment
securities available-for-sale totaled $138.5 million, compared with
$166.9 million on December 31, 2022.
The Company ended the quarter with approximately 100.9 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.
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® (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 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) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Cash and cash equivalents |
|
$ |
138,470 |
|
|
$ |
124,775 |
|
Investments |
|
|
— |
|
|
|
42,086 |
|
Working capital |
|
|
124,952 |
|
|
|
154,375 |
|
Total assets |
|
|
234,626 |
|
|
|
247,939 |
|
Revenue interest
liability |
|
|
259,774 |
|
|
|
243,605 |
|
Convertible notes, net of
issuance costs |
|
|
260,738 |
|
|
|
259,899 |
|
Common stock |
|
|
101 |
|
|
|
75 |
|
Accumulated deficit |
|
|
(1,451,690 |
) |
|
|
(1,340,036 |
) |
Total stockholders'
deficit |
|
|
(371,978 |
) |
|
|
(323,778 |
) |
|
Esperion Therapeutics, Inc.Statement
of Operations(In thousands, except share and per
share data)(Unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
20,293 |
|
|
$ |
13,578 |
|
|
$ |
37,324 |
|
|
$ |
26,932 |
|
Collaboration revenue |
5,493 |
|
|
5,263 |
|
|
12,791 |
|
|
10,745 |
|
Total Revenues |
25,786 |
|
|
18,841 |
|
|
50,115 |
|
|
37,677 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
6,786 |
|
|
9,176 |
|
|
18,438 |
|
|
16,301 |
|
Research and development |
22,099 |
|
|
32,432 |
|
|
53,480 |
|
|
56,751 |
|
Selling, general and administrative |
33,959 |
|
|
29,609 |
|
|
63,860 |
|
|
59,990 |
|
Total operating expenses |
62,844 |
|
|
71,217 |
|
|
135,778 |
|
|
133,042 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
(37,058 |
) |
|
(52,376 |
) |
|
(85,663 |
) |
|
(95,365 |
) |
|
|
|
|
|
|
|
|
Interest expense |
(14,537 |
) |
|
(14,266 |
) |
|
(28,924 |
) |
|
(28,328 |
) |
Other income, net |
1,660 |
|
|
318 |
|
|
2,933 |
|
|
638 |
|
Net loss |
$ |
(49,935 |
) |
|
$ |
(66,324 |
) |
|
$ |
(111,654 |
) |
|
$ |
(123,055 |
) |
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(0.46 |
) |
|
$ |
(1.05 |
) |
|
$ |
(1.19 |
) |
|
$ |
(1.98 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
109,243,845 |
|
|
63,227,406 |
|
|
93,927,148 |
|
|
62,097,358 |
|
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