Esperion (NASDAQ: ESPR) today reported financial results for the
third quarter ended September 30, 2023, and provided a business
update.
“We continued to deliver on our commitments during the third
quarter of 2023, posting strong revenue growth, prudently managing
expenses, and executing on our strategic plan to maximize the
blockbuster potential of NEXLETOL and NEXLIZET,” said Sheldon
Koenig, President and CEO. “We built upon the momentum we generated
in the first half of the year, continuing to deliver prescription
growth even with our narrow indication and promotional footprint.
We made progress toward label expansion, receiving FDA acceptance
of our cardiovascular risk reduction indication submissions in the
U.S. and with the EMA review process on track in Europe. We
anticipate approval in the U.S. by March 31 and in Europe in the
first half of 2024. We now have an organization-wide focus on
preparation for our new labels, and are laying the groundwork to
make changes to our sales organization so that we can hit the
ground running the moment we receive approval. We are proud of our
first-in-class therapies and look forward to bringing these
life-saving medications to millions more patients early next
year.”
Third Quarter 2023 Key Accomplishments and Recent
Highlights
- Announced the acceptance by the U.S. Food and Drug
Administration (FDA) of its Supplemental New Drug Applications
(sNDAs) submissions for NEXLETOL and NEXLIZET with a PDUFA, or
action, date of March 31, 2024. The review process by the European
Medicines Agency (EMA) for expanded indications for NILEMDO®
(bempedoic acid) and NUSTENDI® (bempedoic acid and ezetimibe) also
remains on track. Both applications for label expansion 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 approval in the U.S. in the first
quarter of 2024 and in Europe in the first half of 2024.
- Presented additional pre-specified analyses from landmark trial
at ESC 2023. The CLEAR Outcomes Total Events Analysis demonstrated
that bempedoic acid reduces total major adverse cardiovascular
events including non-fatal myocardial infarction, non-fatal stroke,
coronary revascularizations and cardiovascular death by 20%,
reinforcing the value of long-term bempedoic acid use in reducing
not just the first, but multiple events over time. Results also
demonstrated a risk reduction of 17% in a composite of major
adverse cardiovascular events including non-fatal myocardial
infarction, non-fatal stroke, and cardiovascular death, 31% in
total myocardial infarctions, and 22% in total coronary
revascularizations. The CLEAR Outcomes Analysis by Glycemic Status
also demonstrated that bempedoic acid reduces time to first major
adverse cardiovascular events including non-fatal myocardial
infarction, non-fatal stroke and cardiovascular death by 20% in
patients with diabetes and does not increase rates of new onset
diabetes, a key differentiating feature compared to statins, and
which further supports the safety and efficacy of bempedoic acid
compared to placebo in patients with and without diabetes. Patients
with diabetes constitute a large proportion of the primary
prevention population at risk for cardiovascular events. These
analyses further differentiate bempedoic acid from existing LDL-C
lowering therapies.
- Daiichi Sankyo Europe gained approvals in three new countries
during the third quarter: the Netherlands, Slovakia, and
Spain.
- Announced a strategic collaboration with the American College
of Cardiology and Amgen to launch a new quality improvement
campaign called “Driving Urgency in LDL Screening,” with the aim of
increasing the rate of diagnostic LDL cholesterol screening in
patients without a prior cardiac event, as well as those with known
cardiovascular disease, in order to help clinicians identify those
who need treatment in accordance with medical guidelines.
Third Quarter and YTD 2023 Financial
Results
Total revenue was $34.0 million for the three months ended
September 30, 2023, and $84.1 million for the nine months ended
September 30, 2023, compared to $19.0 million and $56.7 million for
the comparable periods in 2022, an increase of 79% and 48%,
respectively.
U.S. net product revenue was $20.3 million for the three months
ended September 30, 2023, and $57.6 million for the nine months
ended September 30, 2023, compared to $14.0 million and $40.9
million for the comparable periods in 2022, an increase of 45% and
41%, respectively, driven by retail prescription growth of 33% and
25%.
Collaboration revenue was $13.7 million for the three months
ended September 30, 2023, and $26.5 million for the nine months
ended September 30, 2023, compared to $5.0 million and $15.8
million for the comparable periods in 2022, an increase of
approximately 174% and 68%, respectively, driven by increased
royalty revenue and tablet shipments to international partners.
Research and development expense was $14.9 million for the three
months ended September 30, 2023, and $68.4 million for the nine
months ended September 30, 2023, compared to $29.1 million and
$85.9 million for the comparable periods in 2022, a decrease of 49%
and 20%, respectively. The decrease is primarily related to the
close-out of our CLEAR Outcomes study.
Selling, general and administrative expense was $33.2 million
for the three months ended September 30, 2023, and $97.1 million
for the nine months ended September 30, 2023, compared to $25.0
million and $84.9 million for the comparable periods in 2022, an
increase of 33% and 14%, respectively. The increase is related to
higher legal and promotional costs.
The Company had net losses of $41.3 million for the three months
ended September 30, 2023, and $152.9 million for the nine months
ended September 30, 2023, compared to net losses of $55.1 million
and $178.2 million for the comparable periods in 2022,
respectively.
Basic and diluted net losses per share was $0.37 for the three
months ended September 30, 2023, and $1.53 for the nine months
ended September 30, 2023, compared to basic and diluted net losses
per share of $0.81 and $2.78, for the comparable periods in 2022,
respectively.
As of September 30, 2023, cash, cash equivalents, and investment
securities available-for-sale totaled $114.8 million, compared with
$166.9 million as of December 31, 2022.
The Company ended the quarter with approximately 112.1 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 OutlookThe 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.
INDICATIONNEXLIZET or NEXLETOL are 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 NEXLIZET or NEXLETOL on
cardiovascular morbidity and mortality has not been determined.
IMPORTANT SAFETY INFORMATIONNEXLIZET is
contraindicated in patients with a known hypersensitivity to
ezetimibe tablets. Hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been reported
with ezetimibe, a component of NEXLIZET.
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, 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, a component of NEXLIZET and
NEXLETOL, is associated with an increased risk of tendon rupture or
injury. Tendon rupture occurred within weeks to months of starting
NEXLIZET or 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 NEXLIZET or NEXLETOL at
the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in clinical 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 clinical trials of NEXLIZET, the most commonly reported
adverse reactions (incidence ≥3% and greater than placebo) observed
that not observed in clinical trials of bempedoic acid or
ezetimibe, were urinary tract infection, nasopharyngitis, and
constipation.
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 the
Esperion Therapeutics, Inc. Adverse Event reporting line at
1-833-377-7633.
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, es, 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)
|
September 30, 2023 |
|
December 31, 2022 |
Cash and cash equivalents |
$ |
114,833 |
|
|
$ |
124,775 |
|
Investments |
|
— |
|
|
|
42,086 |
|
Working
capital |
|
80,519 |
|
|
|
154,375 |
|
Total
assets |
|
221,305 |
|
|
|
247,939 |
|
Revenue
interest liability |
|
267,400 |
|
|
|
243,605 |
|
Convertible notes, net of issuance costs |
|
261,165 |
|
|
|
259,899 |
|
Common
stock |
|
112 |
|
|
|
75 |
|
Accumulated deficit |
|
(1,492,940 |
) |
|
|
(1,340,036 |
) |
Total
stockholders' deficit |
|
(410,004 |
) |
|
|
(323,778 |
) |
|
|
|
|
|
|
|
|
Esperion Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
20,251 |
|
|
$ |
13,964 |
|
|
$ |
57,575 |
|
|
$ |
40,896 |
|
Collaboration revenue |
|
13,718 |
|
|
|
5,016 |
|
|
|
26,509 |
|
|
|
15,761 |
|
Total Revenues |
|
33,969 |
|
|
|
18,980 |
|
|
|
84,084 |
|
|
|
56,657 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
|
13,377 |
|
|
|
6,506 |
|
|
|
31,815 |
|
|
|
22,807 |
|
Research and development |
|
14,885 |
|
|
|
29,143 |
|
|
|
68,365 |
|
|
|
85,894 |
|
Selling, general and administrative |
|
33,240 |
|
|
|
24,954 |
|
|
|
97,100 |
|
|
|
84,944 |
|
Total operating expenses |
|
61,502 |
|
|
|
60,603 |
|
|
|
197,280 |
|
|
|
193,645 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(27,533 |
) |
|
|
(41,623 |
) |
|
|
(113,196 |
) |
|
|
(136,988 |
) |
|
|
|
|
|
|
|
|
Interest expense |
|
(14,995 |
) |
|
|
(14,153 |
) |
|
|
(43,919 |
) |
|
|
(42,481 |
) |
Other income, net |
|
1,278 |
|
|
|
659 |
|
|
|
4,211 |
|
|
|
1,297 |
|
Net loss |
$ |
(41,250 |
) |
|
$ |
(55,117 |
) |
|
$ |
(152,904 |
) |
|
$ |
(178,172 |
) |
|
|
|
|
|
|
|
|
Net loss per common share -
basic and diluted |
$ |
(0.37 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.53 |
) |
|
$ |
(2.78 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding - basic and diluted |
|
111,869,478 |
|
|
|
67,806,292 |
|
|
|
99,973,647 |
|
|
|
64,021,248 |
|
|
|
|
|
|
|
|
|
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