Esperion (NASDAQ: ESPR) today reported financial results for the
fourth quarter and full year ended December 31, 2023, and provided
a business update.
“We have recently made major strides as a company, which we
believe position us for sustained growth in the short, medium, and
long term,” said Sheldon Koenig, President and CEO. “First amongst
these was reaching agreement with our valued European partner, DSE,
to resolve the outstanding litigation and continue executing our
strategy to strengthen our global franchise over time. Our
agreement has had an immediate positive impact on our balance
sheet, promises substantial cost savings in the years to come, and
creates a roadmap for product lifecycle extension in Europe. We are
pleased with the near- and long-term value this brings to our
organization and look forward to DSE’s continued partnership and
strong execution in Europe. We also continue to progress our other
partnerships globally, including with Otsuka in Japan, and are on
track to making this the blockbuster franchise we expect it to
be.”
“We have continued to prioritize our commercial expansion based
on our anticipated cardiovascular risk reduction labels from the
FDA in March and the EMA in the second quarter. We are confident
that our prospective labels will have a material impact on
sales.”
“With the cash infusion from our settlement plus our recent
capital raise, we are now exceptionally well positioned to fund our
commercial launch, increase our coverage and market share, advance
our preclinical pipeline, and bring our first-in-class therapies to
millions of patients globally who need them. I am proud of our
entire organization and its commitment to our long-term vision and
look forward to updating you on our progress in the periods
ahead.”
Fourth Quarter and Full Year 2023 Key Accomplishments
and Recent Highlights
- Announced the resolution of pending litigation with Daiichi
Sankyo Europe (DSE) in January 2024, which included near-term cash
payments of $125 million and millions of dollars in anticipated
manufacturing cost savings and additional potential revenue
streams. The settlement provided for an amendment to the parties’
collaboration agreement and dismissal of their pending legal case.
In addition to the near-term cash payments, the settlement terms
provide for the transition of Esperion’s manufacturing and supply
responsibilities in Europe and other territories to DSE, resulting
in significant cost savings and efficiencies. The settlement
agreement also expanded the parties’ collaboration agreement to
include potential development and commercialization of a triple
combination therapy in Europe, which could potentially extend
patent exclusivity and corresponding revenue stream, to which
Esperion would be entitled tiered royalties.
- Closed on a follow-on equity offering in January 2024, raising
gross proceeds of $97.8 million. Proceeds will enable the Company
to fund the ongoing commercialization efforts for NEXLETOL®
(bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe),
research and clinical development of pipeline candidates, working
capital, capital expenditures, and general corporate purposes.
- Announced FDA approval of an updated LDL-cholesterol lowering
indication for NEXLETOL and NEXLIZET in December 2023, to include
the treatment of primary hyperlipidemia as a qualifier for existing
approved populations. In addition, the maximally tolerated
qualifier for statin use was removed, and the prior limitation of
use stating “the effect of NEXLIZET or NEXLETOL on cardiovascular
morbidity and mortality has not been determined” was also removed.
Of note, this labeling modification does not impact the full,
pending label approvals for cardiovascular risk reduction
indications for both drugs, which remain on track for anticipated
approval on or before March 31, 2024.
- A pre-specified, exploratory analysis of CLEAR Outcomes was
presented at the 2023 American Heart Association Scientific
Sessions. The exploratory analysis focused on vascular
inflammation, as measured by the inflammatory marker hsCRP as a
major determinant of atherosclerotic risk regardless of statin use.
In the exploratory analysis, participants with baseline hsCRP in
the top 25% of all participants were 43% more likely to experience
major adverse cardiovascular events (MACE), twice as likely to
experience cardiovascular death, and 121% more likely to experience
all-cause mortality compared to those in the lowest 25%. In CLEAR
Outcomes, patients who were randomized to bempedoic acid
experienced a 21.6% reduction in hsCRP compared to placebo at 6
months. This analysis further differentiates bempedoic acid from
other non-statin LDL-lowering therapies.
- Reported royalty revenue of $5.5 million in the fourth quarter,
representing a year-over-year increase of 139%. Daiichi Sankyo
Europe (DSE) launched in Spain and gained approval in the Czech
Republic during the fourth quarter of 2023. Daiichi Sankyo Asia and
South Central American (DS ASCA) launched in Hong Kong during the
fourth quarter of 2023, marking the first territory in that region
to launch.
- Our development program with Otsuka in Japan remains on track,
with anticipated Japan New Drug Application (JNDA) filing in 2024,
and approval and National Health Insurance (NHI) pricing in
2025.
- Preparing for regulatory filings in Canada and Australia.
Fourth Quarter and Fiscal Year 2023 Financial
Results
Total revenue was $32.3 million for the three months ended
December 31, 2023, and $116.3 million for the full year ended
December 31, 2023, compared to $18.8 million and $75.5 million for
the comparable periods in 2022, an increase of approximately 72%
and 54%, respectively.
U.S. net product revenue was $20.8 million for the three months
ended December 31, 2023, and $78.3 million for the full year ended
December 31, 2023, compared to $15.0 million and $55.9 million for
the comparable periods in 2022, an increase of 39% and 40%,
respectively, driven by retail prescription growth of 44% and
30%.
Collaboration revenue was $11.5 million for the three months
ended December 31, 2023, and $38.0 million for the full year ended
December 31, 2023, compared to $3.9 million and $19.6 million for
the comparable periods in 2022, an increase of approximately 195%
and 94%, respectively, driven by increased royalty revenue and
tablet shipments to international partners.
Research and development expense was $17.7 million for the three
months ended December 31, 2023, and $86.1 million for the full year
ended December 31, 2023, compared to $33.0 million and $118.9
million for the comparable periods in 2022, a decrease of 46% and
28%, respectively. The decrease is primarily related to the
close-out of our CLEAR Outcomes study.
Selling, general and administrative expense was $45.4 million
for the three months ended December 31, 2023, and $142.5 million
for the full year ended December 31, 2023, compared to $24.1
million and $109.1 million for the comparable periods in 2022, an
increase of 88% and 31%, respectively. The increase is related to
higher legal and promotional costs in addition to increases in
headcount. The Company incurred $13.1 million in legal litigation
expenses in the three months ended December 31, 2023, reflecting
one-time legal expenses related to litigation resolution.
The Company had net losses of $56.3 million for the three months
ended December 31, 2023, and $209.2 million for the full year ended
December 31, 2023, compared to net losses of $55.5 million and
$233.7 million for the comparable periods in 2022,
respectively.
Basic and diluted net losses per share was $0.50 for the three
months ended December 31, 2023, and $2.03 for the full year ended
December 31, 2023, compared to basic and diluted net losses per
share of $0.76 and $3.52, for the comparable periods in 2022,
respectively.
As of December 31, 2023, cash, cash equivalents, and investment
securities available-for-sale totaled $82.2 million, compared with
$166.9 million as of December 31, 2022. In addition, the Company
improved its cash position in January 2024, resulting significantly
from the cash proceeds of its follow-on equity offering, which
raised approximately $90.8 million in net proceeds, and the joint
settlement agreement with its European partner that resulted in a
$100 million cash payment.
The Company ended the quarter with approximately 118.2 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 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. 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 /NEXLIZET is indicated as an
adjunct to diet and statin therapy for the treatment of primary
hyperlipidemia in adults with heterozygous familial
hypercholesterolemia (HeFH) or atherosclerotic cardiovascular
disease, who require additional lowering of LDL-C.
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, 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: 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) |
|
|
|
December 31,2023 |
|
December 31,2022 |
Cash and cash equivalents |
|
$ |
82,248 |
|
|
$ |
124,775 |
|
Investments |
|
|
— |
|
|
|
42,086 |
|
Working capital |
|
|
44,841 |
|
|
|
154,375 |
|
Total assets |
|
|
205,796 |
|
|
|
247,939 |
|
Revenue interest liability |
|
|
274,778 |
|
|
|
243,605 |
|
Convertible notes, net of issuance costs |
|
|
261,596 |
|
|
|
259,899 |
|
Common stock |
|
|
118 |
|
|
|
75 |
|
Accumulated deficit |
|
|
(1,549,284 |
) |
|
|
(1,340,036 |
) |
Total stockholders' deficit |
|
|
(454,994 |
) |
|
|
(323,778 |
) |
Esperion Therapeutics, Inc. |
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
20,760 |
|
|
$ |
14,967 |
|
|
$ |
78,335 |
|
|
$ |
55,863 |
|
Collaboration revenue |
11,490 |
|
|
3,851 |
|
|
37,999 |
|
|
19,612 |
|
Total Revenues |
32,250 |
|
|
18,818 |
|
|
116,334 |
|
|
75,475 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
11,452 |
|
|
4,160 |
|
|
43,267 |
|
|
26,967 |
|
Research and development |
17,742 |
|
|
33,033 |
|
|
86,107 |
|
|
118,927 |
|
Selling, general and administrative |
45,423 |
|
|
24,138 |
|
|
142,523 |
|
|
109,082 |
|
Total operating expenses |
74,617 |
|
|
61,331 |
|
|
271,897 |
|
|
254,976 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
(42,367 |
) |
|
(42,513 |
) |
|
(155,563 |
) |
|
(179,501 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
(15,057 |
) |
|
(14,329 |
) |
|
(58,976 |
) |
|
(56,810 |
) |
Other income, net |
1,080 |
|
|
1,355 |
|
|
5,291 |
|
|
2,652 |
|
Net loss |
$ |
(56,344 |
) |
|
$ |
(55,487 |
) |
|
$ |
(209,248 |
) |
|
$ |
(233,659 |
) |
|
|
|
|
|
|
|
|
|
Net
loss per common share – basic and diluted |
$ |
(0.50 |
) |
|
$ |
(0.76 |
) |
|
$ |
(2.03 |
) |
|
$ |
(3.52 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding – basic and diluted |
112,403,358 |
|
|
73,487,416 |
|
|
103,106,616 |
|
|
66,407,242 |
|
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