Esperion (NASDAQ: ESPR) today reported financial results for the
second quarter ended June 30, 2024, and provided a business update.
“Throughout the second quarter, we continued to execute our
strategy across all key areas of our business that are important
for long-term success and value creation,” stated Sheldon Koenig,
President and CEO of Esperion. “In addition to achieving notable
growth in U.S. product revenue, we made great inroads updating
utilization management criteria across multiple payers, which
underscores their recognition of the potential clinical benefits
for patients who are unable to achieve their LDL-C goals or reduce
their cardiovascular risk with current therapies and paves the way
for further prescription growth and increasing product revenue. In
collaboration with our global partners, we made great strides
expanding our international reach, which we believe will be a
meaningful revenue driver over time.”
“Importantly, we also monetized our European royalties and used
the proceeds for the early, discounted payoff and termination of
the Oberland revenue interest facility. This transformational
transaction provides us with increased operational and financial
flexibility and strategically unencumbers our balance sheet from
senior secured liens by leveraging what we believe is an
undervalued asset that has not been fully recognized in the
market,” added Koenig.
Second Quarter 2024 Key Accomplishments and Recent
Highlights
Monetized European Royalties
- Entered into a Royalty Purchase
Agreement with OMERS Life Sciences (OMERS), under which Esperion
received approximately $304.7 million in cash from OMERS in
exchange for 100% interest, subject to a cap, of Esperion’s
expected royalty entitlement on Daiichi Sankyo Europe’s (DSE)
net sales of bempedoic acid products in the European territories.
OMERS will receive a tiered royalty ranging from 15-25% of net
bempedoic acid product sales in Europe, until it has received an
aggregate amount equal to 1.7x its investment. Thereafter, all
future royalty payments from DSE royalties will revert back to
Esperion.
- Proceeds from the Royalty Purchase Agreement facilitated early
payout and termination of the Oberland secured facility, removing
all liens and covenants associated with that agreement.
- Esperion will continue to receive any earned sales-based
milestone payments following the first achievement of defined net
sales under the DSE agreement, which could cumulatively amount to
up to $300 million in potential future payments.
- This transaction enhances Esperion’s operational and financial
flexibility, strengthens its balance sheet, and better positions
the Company to focus on optimizing its U.S. commercialization
efforts.
Advanced US Commercialization Initiatives
- Partnered with major payers to improve the quantity and quality
of coverage for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic
acid and ezetimibe).
- Now more than 80% of payers previously covering the products
have updated their utilization management (UM) criteria to include
the recent label expansion.
- Increased preferred commercial coverage to 92% and Medicare
preferred coverage to greater than 50%.
- The Company expects this expanded payer coverage to drive
further increases in physician confidence to prescribe NEXLETOL and
NEXLIZET, ultimately leading to higher product sales in the
upcoming quarters and beyond.
- Made significant advances in prescription growth and sales
performance through innovative commercial initiatives, which
included targeted in-person and digital sales and marketing
campaigns, driving the adoption and revenue growth of NEXLETOL and
NEXLIZET.
- Expanded sales force targeted specific subsets of primary care
physicians and cardiologists with in-person detailing.
- Increased digital campaign tactics to include a full-scale
approach across eight channels to reach physicians, including
search, email, peer-to-peer, EHR, point of care, banners and social
media, to reach over 90% of the targeted healthcare providers.
- As a result of these combined initiatives, the Company now has
more than 21,000 healthcare practitioners writing scripts for
NEXLETOL and NEXLIZET, and total retail prescription equivalents
increased 11% during the four weeks of June compared to the prior
four weeks in May.
- Received a five-year patent extension for bempedoic acid,
contained in NEXLETOL and NEXLIZET, through December 3, 2030.
Significant International Progress
- NILEMDO® and NUSTENDI® received label expansion approval from
the European Commission as treatments to reduce cardiovascular risk
by lowering LDL-C levels.
- Otsuka Pharmaceutical, Esperion’s collaborator in the Japanese
market, announced that the primary endpoint of LDL-C reduction from
baseline at Week 12 was achieved with statistical significance in
the Phase 3 clinical trial in Japan for bempedoic acid as a
treatment for hypercholesterolemia. Otsuka plans to file a New Drug
Application (NDA) in Japan in the second half of 2024, with
expected approval and National Health Insurance (NHI) pricing
anticipated in 2025.
- New Drug Applications in Canada, Australia and Israel are on
track for submission by the end of this year.
Publications and Presentations
- Continued to accumulate a growing body of clinical and
scientific data published in support of the cardiovascular risk
reduction benefits of bempedoic acid.
- “Comparative Cardiovascular Benefits of Bempedoic Acid and
Statin Drugs” published in the Journal of the American College of
Cardiology. This analysis of CLEAR Outcomes data demonstrated the
cardiovascular risk reduction benefit of bempedoic acid treatment
predicted per unit decrease in LDL-C is comparable to that seen in
statin trials.
- “Impact of the COVID‐19 Pandemic on Conduct and Results of
CLEAR Outcomes Trial” published in the Journal of Clinical
Cardiology. This analysis confirms the benefit of bempedoic acid
and suggests that the global COVID-19 pandemic may have
underestimated the benefit of bempedoic acid on both MACE-4
(cardiovascular (CV) death, nonfatal myocardial infarction (MI),
nonfatal stroke, or coronary revascularization) and MACE-3
(cardiovascular (CV) death, nonfatal myocardial infarction (MI),
nonfatal stroke) based on the contribution of undetermined deaths
that likely represent COVID-19 infection or pandemic-related
fatalities.
Second Quarter and YTD 2024 Financial
Results
Revenue
- Total revenue for the three and six months ended June 30, 2024,
was $73.8 million and $211.6 million, respectively, compared to
$25.8 million and $50.1 million for the comparable periods in 2023,
an increase of 186% and 322%, respectively.
- U.S. net product revenue for the three and six months ended
June 30, 2024, was $28.3 million and $53.1 million, respectively,
compared to $20.3 million and $37.3 million for the comparable
periods in 2023, an increase of 39% and 42%, respectively, driven
by retail prescription growth of 41% and 42%.
- Collaboration revenue for the three and six months ended June
30, 2024, was $45.5 million and $158.5 million, compared to $5.5
million and $12.8 million for the comparable periods in 2023, an
increase of approximately 727% and 1138%, respectively, driven by
revenue recognized from our Settlement Agreement with DSE,
increased product sales to our international partners and sales
growth within partner territories.
R&D Expenses
- Research and development expenses for the three and six months
ended June 30, 2024, were $11.5 million and $24.9 million, compared
to $22.1 million and $53.5 million for the comparable periods in
2023, a decrease of 48% and approximately 53%, respectively.
- The decrease is primarily related to the close-out of our CLEAR
Outcomes study.
Selling, General and Administrative (SG&A) Expenses
- Selling, general and administrative expenses for the three and
six months ended June 30, 2024, were $44.2 million and $86.2
million, compared to $34.0 million and $63.9 million for the
comparable periods in 2023, an increase of 30% and 35%,
respectively.
- The increase is primarily related to the ramp up of our sales
force ahead of our commercial launch in addition to bonus payments
and promotional costs.
Loss on extinguishment of debt. The Company incurred a one-time
loss of $53.2 million for the three and six months ended June 30,
2024, related to the termination of the Oberland revenue interest
purchase agreement.
Net Loss. The Company had net losses of $61.9 million and $0.9
million for the three and six months ended June 30, 2024, compared
to net losses of $49.9 million and $111.7 million for the
comparable periods in 2023, respectively.
Earnings (Loss) Per Share. Basic and diluted net losses per
share was $0.33 for the second quarter ended June 30, 2024, and
$0.01 for the six months ended June 30, 2024, compared to basic and
diluted net losses per share of $0.46 and $1.19, for the comparable
periods in 2023, respectively.
Cash and Cash Equivalents. As of June 30, 2024, cash and cash
equivalents totaled $189.3 million compared to $82.2 million as of
December 31, 2023.
The Company ended the quarter with approximately 194.6 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 Outlook
The Company reiterates its full year 2024 operating expense
guidance, which is expected to be approximately $225 million to
$245 million, including $20 million in non-cash expenses related to
stock compensation.
Conference Call and Webcast Information
Esperion will host a conference call and 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.
A live audio webcast can be accessed on the investor and media
section of the Esperion website at
esperion.com/investor-relations/events. 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.
INDICATION NEXLIZET and NEXLETOL are
indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is
indicated to reduce the risk of myocardial infarction and coronary
revascularization in adults who are unable to take recommended
statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering
therapies, to reduce LDL-C in adults with primary hyperlipidemia,
including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies,
or alone when concomitant LDL-C lowering therapy is not possible,
to reduce LDL-C in adults with primary hyperlipidemia, including
HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a
prior hypersensitivity to bempedoic acid or ezetimibe or any of the
excipients. Serious hypersensitivity reactions including
anaphylaxis, angioedema, rash, and urticaria have been
reported.
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, returning to baseline following
discontinuation of treatment. 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 may occur more frequently in patients over
60 years of age, in those taking corticosteroid or fluoroquinolone
drugs, in patients with renal failure, and in patients with
previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the
first sign of tendon rupture. Consider alternative therapy in
patients who have a history of tendon disorders or tendon
rupture.
The most common adverse reactions in the primary hyperlipidemia
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 the primary hyperlipidemia trials of NEXLIZET, the most
commonly reported adverse reactions (incidence ≥3% and greater than
placebo) observed with NEXLIZET, but not observed in clinical
trials of bempedoic acid or ezetimibe, were urinary tract
infection, nasopharyngitis, and constipation.
The most common adverse reactions in the cardiovascular outcomes
trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at
an incidence of ≥2% and 0.5% greater than placebo were
hyperuricemia, renal impairment, anemia, elevated liver enzymes,
muscle spasms, gout, and cholelithiasis.
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 Esperion Therapeutics, Inc. Adverse Event
reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and
NEXLETOL.
Esperion Therapeutics
At 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.
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 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: Alina
Veneziainvestorrelations@esperion.com (734) 887-3903
Media: Tiffany Aldrich corporateteam@esperion.com (616)
443-8438
|
ESPERION Therapeutics, Inc. |
|
Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
June 30,2024 |
|
December 31,2023 |
Cash and cash equivalents |
$ |
189,304 |
|
|
$ |
82,248 |
|
Working capital |
|
169,770 |
|
|
|
44,841 |
|
Total assets |
|
352,319 |
|
|
|
205,796 |
|
Royalty sale liability |
|
287,499 |
|
|
|
— |
|
Revenue interest
liability |
|
— |
|
|
|
274,778 |
|
Convertible notes, net of
issuance costs |
|
262,475 |
|
|
|
261,596 |
|
Common stock |
|
195 |
|
|
|
118 |
|
Accumulated deficit |
|
(1,550,187 |
) |
|
|
(1,549,284 |
) |
Total stockholders'
deficit |
|
(344,220 |
) |
|
|
(454,994 |
) |
ESPERION Therapeutics, Inc. |
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2024 |
|
|
2023 |
|
2024 |
2023 |
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
$ |
28,302 |
|
|
$ |
20,293 |
|
|
|
$ |
53,058 |
|
|
$ |
37,324 |
|
|
Collaboration revenue |
45,532 |
|
|
5,493 |
|
|
|
158,511 |
|
|
12,791 |
|
|
Total Revenues |
73,834 |
|
|
25,786 |
|
|
|
211,569 |
|
|
50,115 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Cost of goods sold |
15,609 |
|
|
6,786 |
|
|
|
25,684 |
|
|
18,438 |
|
|
Research and development |
11,461 |
|
|
22,099 |
|
|
|
24,864 |
|
|
53,480 |
|
|
Selling, general and administrative |
44,185 |
|
|
33,959 |
|
|
|
86,173 |
|
|
63,860 |
|
|
Total operating expenses |
71,255 |
|
|
62,844 |
|
|
|
136,721 |
|
|
135,778 |
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations |
2,579 |
|
|
(37,058 |
) |
|
|
74,848 |
|
|
(85,663 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
(13,723 |
) |
|
(14,537 |
) |
|
|
(27,747 |
) |
|
(28,924 |
) |
|
Loss on extinguishment of
debt |
(53,235 |
) |
|
— |
|
|
|
(53,235 |
) |
|
— |
|
|
Other income, net |
2,454 |
|
|
1,660 |
|
|
|
5,231 |
|
|
2,933 |
|
|
Net loss |
$ |
(61,925 |
) |
|
$ |
(49,935 |
) |
|
|
$ |
(903 |
) |
|
$ |
(111,654 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.46 |
) |
|
|
$ |
(0.01 |
) |
|
$ |
(1.19 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
188,793,816 |
|
|
109,243,845 |
|
|
|
179,026,191 |
|
|
93,927,148 |
|
|
Grafico Azioni Esperion Therapeutics (NASDAQ:ESPR)
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Da Feb 2025 a Mar 2025
Grafico Azioni Esperion Therapeutics (NASDAQ:ESPR)
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Da Mar 2024 a Mar 2025