Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the second quarter and six months ended June 30,
2021 and provided an update on company operations.
Recent Key Amarin Highlights:
- Second
Quarter Revenue: Net total revenue in the second quarter of 2021
was $154.5 million, an increase of 14% when compared with $135.3
million in total net revenue during the prior year period. Net
product revenue for the three months ended June 30, 2021 was
$153.8 million, an increase of 15% when compared with the net
product revenue in the prior year's second quarter. In the U.S.,
based on data from Symphony Health, Amarin retained approximately
89% of the icosapent ethyl market in the first half of 2021, with
approximately eight months of generic presence in the market.
- On Track
for European Launch: Amarin plans to launch VAZKEPA in Germany in
September and has filed several market access dossiers in Europe
with proposed pricing of approximately €200 per month.
- Received
Marketing Authorization for VAZKEPA in Great Britain: Amarin
received market authorization from the Medicines and Healthcare
Products Regulatory Agency (MHRA) for VAZKEPA in Great Britain as a
treatment to reduce the risk of cardiovascular (CV) events in high
CV risk statin-treated adult patients.
- Executing
Global Expansion Strategy: Amarin plans to initiate regulatory
approval processes in approximately 20 additional countries in
order to reach the top 50 cardiometabolic markets in the
world.
-
VASCEPA®/VAZKEPA Added to Four Medical Societies’ Clinical
Treatment Guidelines or Position Statements: VASCEPA is now
included in 19 medical societies’ clinical treatment guidelines or
position statements, including the recent addition of VASCEPA to
the "2021 Expert Consensus Decision Pathway on the Management of
Patients with Persistent Hypertriglyceridemia for Atherosclerotic
Cardiovascular Disease (ASCVD) Risk Reduction" issued by the
American College of Cardiology. Click here for more information on
the guidelines.
- New
Senior Leadership to Support Further Growth: As of August 1, 2021,
Karim Mikhail succeeded to the president and chief executive
officer position following the planned retirement of his
predecessor, John F. Thero. In addition, the company appointed
Laurent Abuaf as senior vice president, president of Europe.
- Strong Balance Sheet: Ended second
quarter 2021 with $523.1 million in total cash and investments and
no debt.
Management Commentary
“Amarin enters the second half of 2021 well
positioned to deliver on our goals to reignite growth of branded
VASCEPA in the U.S., to successfully launch VAZKEPA in Europe and
to undertake initiatives to expand its growth in other important
geographies,” stated Karim Mikhail, president and chief executive
officer of Amarin. “We believe that this additional expansion
represents an incremental market potential in excess of $1 billion
that we are confident we can access as there are millions of
at-risk patients who could benefit from VASCEPA/VAZKEPA.”
“There continues to be a steady flow of
scientific and clinical evidence in support of the cardioprotective
benefits of VASCEPA/VAZKEPA presented at key global medical
meetings. Later this month, we look forward to the European
Society of Cardiology, where VAZKEPA will be featured in a series
of oral and poster presentations by key opinion leaders before an
audience of leading cardiologists. We are particularly pleased that
our product launch in Germany will take place shortly after this
important congress.
“Our strategy for reducing the occurrence of the
debilitating and deadly effects of cardiovascular disease is sound
and we are executing our global plans to efficiently reach
physicians, payors, pharmacists and patients. We are transforming
our go-to-market model to enhance customer engagement while
executing a variety of promotional and educational programs to
increase awareness of the cardiovascular risk reduction benefits of
our unique therapy. We expect these efforts will build demand for
and drive adoption of VASCEPA/VAZKEPA in the U.S. and Europe,”
concluded Mr. Mikhail.
U.S. Prescription Growth
Normalized prescriptions for VASCEPA
(prescription of 120 grams of VASCEPA representing a one-month
supply) in the United States were flat according to data from
Symphony Health and increased by approximately 2% during the second
quarter 2021 compared to the same period in 2020 based on data from
IQVIA. Estimated normalized VASCEPA prescriptions, based on data
from Symphony Health and IQVIA, totaled approximately 1,086,000 and
1,015,000 in the second quarter of 2021, respectively, compared
with 1,089,000 and 998,000 in the second quarter of 2020,
respectively. The icosapent ethyl market in aggregate, consisting
of branded and generic product, increased for the three months
ended June 30, 2021 by approximately 13% as compared to the
three months ended June 30, 2020, based on data from Symphony
Health. Revenue recognition, which is based on control of the
product transferring to customers, and levels of prescriptions as
estimated by third parties, often do not directly correlate,
particularly over relatively short periods of time such as a fiscal
quarter.
Amarin remains confident that the patient need
for VASCEPA in the United States remains high and that, as the
negative impact of COVID-19 on patient visits and lab tests
recedes, VASCEPA growth will be positioned to accelerate as more
patients seek routine doctor visits and lab tests and as our
promotional activities become less restricted.
Two generic versions of VASCEPA have launched in
the United States, both of which are indicated only as an adjunct
to diet for lowering triglyceride levels in adult patients with
severe hypertriglyceridemia (TG ≥500 mg/dL), which represents a
limited patient population. Amarin has filed a lawsuit to defend
its cardiovascular risk reduction patent rights against what it
believes to be unlawful infringement by a company sponsoring a
generic product and a healthcare insurance company that the Company
believes has likewise infringed on its rights. Based on data from
Symphony Health, VASCEPA captured approximately 88% of the total
icosapent ethyl normalized prescriptions for the three months ended
June 30, 2021.
Europe
After receiving marketing authorization for
VAZKEPA in Europe by the European Commission and in Great Britain
by the MHRA, Amarin has filed market access dossiers in four out of
ten planned first wave European country submissions. The dossiers
were filed in the United Kingdom, France, Italy and Denmark. The
German dossier is ready for submission just prior to the launch
date in September 2021. These dossiers are an important component
for successful product launch as they support pricing and
reimbursement, a key determining factor in market penetration. The
submitted filings include data demonstrating the uniqueness of
VAZKEPA from a scientific perspective, various country-specific
demographic data sets to define the eligible patient population
based on the drug's approved label, and proposed pricing of
approximately €200 per month. Amarin is seeking pricing it believes
is well justified based on the demonstrated clinical effectiveness
of VAZKEPA and the high economic burden of heart attacks, strokes
and other cardiovascular events, which VAZKEPA can help avoid.
Global Market Expansion
Amarin’s goal is to unlock the potential of
VASCEPA by bringing the cardioprotective benefits of
VASCEPA/VAZKEPA to patients worldwide. The Company plans to
access 20 additional countries to ensure that patients in the top
50 cardiometabolic markets worldwide can benefit from VASCEPA. In
these territories which include Australia, New Zealand, key Latin
American markets, and select Asian markets, Amarin will initiate
regulatory filing processes in the coming months and
year. With approvals in the U.S. and Europe and backed by the
global REDUCE-IT study outcomes, Amarin has the clinical data to
support these filings and expects regulatory submissions and
approval decision times to range from six to eighteen months
depending on the region. This expansion has the potential to add a
significant number of patients who can benefit from VASCEPA, which
Amarin believes represents a market opportunity in excess of $1
billion.
In early 2021, in Mainland China, the Chinese
National Medical Products Administration (NMPA) accepted for review
the New Drug Application (NDA) for VASCEPA. In addition, the
medical guidelines of the Chinese Society of Cardiology were
updated to recommend use of icosapent ethyl in China as a treatment
consideration to further lower ASCVD in the appropriate patient
population. Edding, Amarin's marketing partner in China, expects to
receive a decision on the NDA in Mainland China and separately, in
Hong Kong, near the end of 2021. Following approval, Edding will
undertake the process to ensure that this unique therapy is
reimbursed in the major provinces of Mainland China as the first
and only drug for its important potential indication for use based
on VASCEPA’s demonstrated clinical results.
New Leadership to Support Further
Growth
Amarin significantly enhanced its senior
leadership team with the promotion of Mr. Mikhail to president and
chief executive officer on August 1, 2021. Mr. Mikhail has a
successful track-record of leading significant growth of
cardiovascular and other franchises with Merck for 22 years, where
he served in leadership roles in seven countries across three
continents and where he led Merck's multibillion-dollar lipid
franchise among other senior management positions.
In addition, the Company announced the
appointment of Laurent Abuaf as the new senior vice president and
president of Europe to fill the opening left by Mr. Mikhail’s
promotion to president and chief executive officer. He will join
Amarin and assume the role on August 23, 2021. Mr. Abuaf joins
Amarin with nearly 20 years of global pharmaceutical
commercialization experience, primarily with AstraZeneca, where he
most recently served as President, United Kingdom. He brings a
wealth of European marketing management experience across small,
medium and large markets. Mr. Abuaf has significant
cardiometabolic launch experience having contributed to the
successful launch of Crestor® and Farxiga®. He also has significant
entrepreneurial and strategic project management experience, having
led and managed commercial activities in multiple countries in
Asia. Prior to his career in pharmaceuticals, Mr. Abuaf spent
nearly five years with Boston Consulting Group.
Financial Update
Net total revenue for the three and six months
ended June 30, 2021 were $154.5 million and $296.7 million,
respectively, compared to $135.3 million and $290.3 million in the
corresponding periods of 2020, respectively, indicating increases
of 14% and 2%, respectively. Net product revenue for the three and
six months ended June 30, 2021 were $153.8 million and $295.2
million, respectively, compared to $133.7 million and $285.9
million in the corresponding periods of 2020, respectively,
indicating increases of 15% and 3%, respectively. The increase in
net product revenue and net total revenue was driven primarily by
increased volume of VASCEPA sales to customers in the United
States.
In addition, net total revenue includes
licensing and royalty revenue of approximately $1.5 million and
$4.4 million in the six months ended June 30, 2021 and 2020,
respectively, under agreements for the commercialization of VASCEPA
outside the United States.
Cost of goods sold for the three and six months
ended June 30, 2021 was $32.2 million and $60.5 million,
respectively, compared to $28.8 million and $63.6 million in the
corresponding periods of 2020, respectively. Amarin’s overall gross
margin on net product revenue for the three and six months ended
June 30, 2021 and was 79% and 80%, respectively, compared to
78% for both the three and six months ended June 30, 2020.
Selling, general and administrative (SG&A)
expense for the three and six months ended June 30, 2021 were
$107.2 million and $213.0 million, respectively, compared to $92.4
million and $226.3 million, respectively, in the corresponding
periods of 2020, representing an increase of 16% for the same three
month period and a decrease of 6% for the same six month period.
The increase for the same three month period in 2021 and 2020, was
due primarily to personnel costs related to preparation for
expansion into the European market as well as increased promotional
activity in connection with the resumption of marketing and
direct-to-consumer promotions. The decrease for the same six month
period in 2021 and 2020, was due primarily to a decrease in
promotional activity as a result of the COVID-19 pandemic, which
included reduced marketing and direct-to-consumer promotions,
travel, and a slower hiring process to replace open positions due
to ordinary turnover.
Research and development (R&D) expense for
the three and six months ended June 30, 2021 were $6.4 million
and $15.7 million, respectively, compared to $10.0 million and
$20.2 million, respectively, in the corresponding periods of 2020,
representing decreases of 36% and 22%, respectively. These
decreases were primarily driven by the completion of certain
analyses performed beyond the REDUCE-IT cardiovascular outcomes
trial and the reversal of expense for certain performance-based
awards that were no longer deemed probable.
Under U.S. GAAP, Amarin reported net income of
$7.8 million in the three months ended June 30, 2021, or basic
and diluted earnings per share of $0.02. This net income included
$2.5 million in non-cash stock-based compensation expense. Amarin
reported net income of $4.4 million in the second quarter of 2020,
or basic and diluted earnings per share of $0.01. This net income
included $12.1 million in non-cash stock-based compensation
expense. The company expects financial results regarding net income
or net loss to be variable through the balance of 2021.
Under U.S. GAAP, Amarin reported net income of
$6.2 million in the six months ended June 30, 2021, or basic
and diluted earnings per share of $0.02. This net income included
$16.4 million in non-cash stock-based compensation expense. For the
six months ended June 30, 2020, Amarin reported a net loss of
$16.1 million, or basic and diluted loss per share of $0.04. This
net loss included $22.7 million in non-cash stock-based
compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $10.3
million for the second quarter of 2021, or non-GAAP adjusted basic
and diluted earnings per share of $0.03, compared to non-GAAP
adjusted net income of $16.5 million for the second quarter of
2020, or non-GAAP adjusted basic and diluted earnings per share of
$0.04.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $22.6
million for the six months ended June 30, 2021, or non-GAAP
adjusted basic and diluted earnings per share of $0.06, compared to
non-GAAP adjusted net income of $6.6 million for the six months
ended June 30, 2020, or non-GAAP adjusted basic and diluted
earnings per share of $0.02.
As of June 30, 2021, Amarin reported
aggregate cash and investments of $523.1 million, consisting of
cash and cash equivalents of $327.0 million and liquid short-term
and long-term investments of $181.9 million and $14.2 million,
respectively. The Company believes its current resources are
sufficient to fund projected operations including ongoing promotion
of VASCEPA in the U.S. and a successful commercial launch of
VAZKEPA in Europe.
As of June 30, 2021, Amarin had
approximately 395.2 million American Depository Shares (ADSs) and
ordinary shares outstanding approximately 19.7 million equivalent
shares underlying stock options at a weighted-average exercise
price of $7.54 and 10.4 million equivalent shares underlying
restricted or deferred stock units.
Conference Call and Webcast
Information:
Amarin will host a conference call August 5,
2021, at 7:30 a.m. ET to discuss this information. The conference
call can be heard live on the investor relations section of the
company's website at www.amarincorp.com, or via telephone by
dialing 888-506-0062 within the United States, 973-528-0011 from
outside the United States, and referencing conference ID 401474. A
replay of the call will be made available for a period of two weeks
following the conference call. To hear a replay of the call, dial
877-481-4010, PIN: 42077. A replay of the call will also be
available through the company's website shortly after the call.
Use of Non-GAAP Adjusted Financial
Information
Included in this press release are non-GAAP
adjusted financial information as defined by U.S. Securities and
Exchange Commission Regulation G. The GAAP financial measure most
directly comparable to each non-GAAP adjusted financial measure
used or discussed, and a reconciliation of the differences between
each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, is included in this press release after the
condensed consolidated financial statements.
Non-GAAP adjusted net income was derived by
taking GAAP net income (loss) and adjusting it for non-cash
stock-based compensation expense. Management uses these non-GAAP
adjusted financial measures for internal reporting and forecasting
purposes, when publicly providing its business outlook, to evaluate
the company’s performance and to evaluate and compensate the
company’s executives. The company has provided these non-GAAP
financial measures in addition to GAAP financial results because it
believes that these non-GAAP adjusted financial measures provide
investors with a better understanding of the company’s historical
results from its core business operations.
While management believes that these non-GAAP
adjusted financial measures provide useful supplemental information
to investors regarding the underlying performance of the company’s
business operations, investors are reminded to consider these
non-GAAP measures in addition to, and not as a substitute for,
financial performance measures prepared in accordance with GAAP.
Non-GAAP measures have limitations in that they do not reflect all
of the amounts associated with the company’s results of operations
as determined in accordance with GAAP. In addition, it should be
noted that these non-GAAP financial measures may be different from
non-GAAP measures used by other companies, and management may
utilize other measures to illustrate performance in the future.
About Amarin
Amarin is an innovative pharmaceutical company
leading a new paradigm in cardiovascular disease management. From
our scientific research foundation to our focus on clinical trials,
and now our commercial expansion, we are evolving and growing
rapidly. Amarin primarily has offices in Bridgewater, New Jersey in
the United States, Dublin in Ireland, and Zug in Switzerland as
well as commercial partners and suppliers around the world. We are
committed to rethinking cardiovascular risk through the advancement
of scientific understanding of the impact on society of significant
residual risk that exists beyond traditional therapies, such as
statins for cholesterol management.
About Cardiovascular Risk
Cardiovascular disease is the number one cause
of death in the world. In the United States alone, cardiovascular
disease results in 859,000 deaths per year.2 And the number of
deaths in the United States attributed to cardiovascular disease
continues to rise. In addition, in the United States there are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds). Stroke rates are 795,000 per
year (approximately 1 every 40 seconds), accounting for 1 of every
19 U.S. deaths. In aggregate, in the United States alone, there are
more than 2.4 million major adverse cardiovascular events per year
from cardiovascular disease or, on average, 1 every 13 seconds.
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with elevated triglycerides. Statin
therapy has been shown to control LDL-C, thereby reducing the risk
of cardiovascular events by 25-35%.3 Significant cardiovascular
risk remains after statin therapy. People with elevated
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking statins.
4,5,6
About REDUCE-IT
REDUCE-IT was a global cardiovascular outcomes
study designed to evaluate the effect of VASCEPA in adult patients
with LDL-C controlled to between 41-100 mg/dL (median baseline 75
mg/dL) by statin therapy and various cardiovascular risk factors
including persistent elevated triglycerides between 135-499 mg/dL
(median baseline 216 mg/dL) and either established cardiovascular
disease (secondary prevention cohort) or diabetes mellitus and at
least one other cardiovascular risk factor (primary prevention
cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical
Cardiology.7 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.8 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.9 These and other publications
can be found in the R&D section on the company’s website at
www.amarincorp.com.
About VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed over ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)VASCEPA is indicated:
- As an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for
Cardiovascular Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089n (%) |
Incidence Rate (per 100 patient
years) |
N = 4090n (%) |
Incidence Rate (per 100 patient
years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705(17.2) |
4.3 |
901(22.0) |
5.7 |
0.75(0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459(11.2) |
2.7 |
606(14.8) |
3.7 |
0.74(0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250(6.1) |
1.5 |
355(8.7) |
2.1 |
0.69(0.58, 0.81) |
Emergent or urgent coronary revascularization |
216(5.3) |
1.3 |
321(7.8) |
1.9 |
0.65(0.55, 0.78) |
Cardiovascular death [1] |
174(4.3) |
1.0 |
213(5.2) |
1.2 |
0.80(0.66, 0.98) |
Hospitalization for unstable angina [2] |
108(2.6) |
0.6 |
157(3.8) |
0.9 |
0.68(0.53, 0.87) |
Fatal or non-fatal stroke |
98(2.4) |
0.6 |
134(3.3) |
0.8 |
0.72(0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality.[2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements which are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995, including
beliefs about the world-wide market potential for VASCEPA;
expectations regarding financial metrics and performance such as
prescription growth, revenue growth, operating expenses, inventory
purchases, and managed care coverage for VASCEPA, including the
impact of the COVID-19 pandemic, the disappointing outcome of
patent litigation and the launch of generic competition on these
metrics; beliefs that Amarin is well positioned to deliver on its
goals to grow VASCEPA in the U.S. and beyond; beliefs about patient
needs for VASCEPA; effects of the COVID-19 pandemic on Amarin's
operations and on the healthcare industry more broadly, which
effects continue to be fluid; beliefs that Amarin's strategy for
reducing the effects of cardiovascular disease is sound and that
Amarin is efficiently reaching physicians, payors, pharmacists and
patients; plans for Amarin's go-to-market model; the timing and
outcome of regulatory reviews, recommendations and approvals and
related reimbursement decisions and commercial launches in Europe,
the China region and elsewhere; plans for Amarin's expected launch
of VASCEPA directly in major markets in Europe, directly and
indirectly; beliefs about the cardioprotective and other benefits
of VASCEPA; beliefs about the strength of data in market access
dossiers and other reports; expectations for the timing,
effectiveness and outcome of promotional activities, including
patient-oriented campaigns, conference and posted presentations and
education of healthcare professionals; commercial and international
expansion, prescription growth and revenue growth and future
revenue levels, including the contributions of sales
representatives and the new leadership team; beliefs that Amarin's
current resources are sufficient to fund projected operations;
ongoing patent litigation efforts; and the impact of the COVID-19
pandemic on all of the forgoing. These forward-looking statements
are not promises or guarantees and involve substantial risks and
uncertainties. Amarin's ability to effectively commercialize
VASCEPA and maintain or grow market share will depend in part on
Amarin’s ability to continue to effectively finance its business,
VASCEPA approval in geographies outside the U.S., efforts of third
parties, Amarin’s ability to create and increase market demand for
VASCEPA through education, marketing and sales activities, to
achieve broad market acceptance of VASCEPA, to receive adequate
levels of reimbursement from third-party payers, to develop and
maintain a consistent source of commercial supply at a competitive
price, to comply with legal and regulatory requirements in
connection with the sale and promotion of VASCEPA and to secure,
maintain and defend its patent protection for VASCEPA. Among the
factors that could cause actual results to differ materially from
those described or projected herein include the following: the
possibility that VASCEPA may not receive regulatory approval in the
China region or other geographies on the expected timelines or at
all, the risk that additional generic versions of VASCEPA will
enter the market and that generic versions of VASCEPA will achieve
greater market share and more commercial supply than anticipated,
particularly in light of the recent and disappointing outcome of
Amarin's litigation against two generic drug companies and
subsequent requests for appeal; the risk that the scope and
duration of the COVID-19 pandemic will continue to impact access to
and sales of VASCEPA; the risk that Amarin has overestimated the
market potential for VASCEPA in the U.S., Europe and other
geographies; risks associated with Amarin's expanded enterprise;
uncertainties associated generally with research and development,
clinical trials and related regulatory approvals; the risk that
sales may not meet expectations and related cost may increase
beyond expectations; the risk that patents may be determined to not
be infringed or not be valid in patent litigation and applications
may not result in issued patents sufficient to protect the VASCEPA
franchise. A further list and description of these risks,
uncertainties and other risks associated with an investment in
Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including Amarin’s quarterly report on
Form 10-Q for the quarter ended June 30, 2021, filed on or about
the date hereof. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date they are made. Amarin undertakes no
obligation to update or revise the information contained in its
forward looking statements, whether as a result of new information,
future events or circumstances or otherwise. Amarin’s
forward-looking statements do not reflect the potential impact of
significant transactions the company may enter into, such as
mergers, acquisitions, dispositions, joint ventures or any material
agreements that Amarin may enter into, amend or terminate.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact
InformationInvestor Inquiries:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com (investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media
inquiries)
AMARIN, REDUCE-IT, VASCEPA and VAZKEPA are trademarks of Amarin
Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark
in Europe and other countries and regions and is pending
registration in the United States.
Crestor® and Farxiga® are registered trademarks of AstraZeneca
group of companies.
CONSOLIDATED BALANCE SHEET DATA |
|
(U.S. GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
June 30, 2021 |
|
|
December 31, 2020 |
|
|
(in thousands) |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
327,016 |
|
|
$ |
186,964 |
|
Restricted cash |
|
3,917 |
|
|
|
3,915 |
|
Short-term investments |
|
181,910 |
|
|
|
313,969 |
|
Accounts receivable, net |
|
182,259 |
|
|
|
154,574 |
|
Inventory |
|
272,455 |
|
|
|
188,864 |
|
Prepaid and other current assets |
|
28,426 |
|
|
|
30,947 |
|
Total current assets |
|
995,983 |
|
|
|
879,233 |
|
Property, plant and equipment, net |
|
1,713 |
|
|
|
2,016 |
|
Long-term investments |
|
14,158 |
|
|
|
62,469 |
|
Operating lease right-of-use asset |
|
7,861 |
|
|
|
8,054 |
|
Other long-term assets |
|
456 |
|
|
|
432 |
|
Intangible asset, net |
|
24,820 |
|
|
|
13,817 |
|
TOTAL ASSETS |
$ |
1,044,991 |
|
|
$ |
966,021 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
|
141,251 |
|
|
|
105,876 |
|
Accrued expenses and other current liabilities |
|
226,545 |
|
|
|
198,641 |
|
Current deferred revenue |
|
2,643 |
|
|
|
2,926 |
|
Total current liabilities |
|
370,439 |
|
|
|
307,443 |
|
Long-Term Liabilities: |
|
|
|
|
|
Long-term deferred revenue |
|
14,825 |
|
|
|
15,706 |
|
Long-term operating lease liability |
|
8,875 |
|
|
|
9,153 |
|
Other long-term liabilities |
|
5,528 |
|
|
|
6,214 |
|
Total liabilities |
|
399,667 |
|
|
|
338,516 |
|
Stockholders’ Equity: |
|
|
|
|
|
Common stock |
|
292,782 |
|
|
|
290,115 |
|
Additional paid-in capital |
|
1,834,548 |
|
|
|
1,817,649 |
|
Treasury stock |
|
(59,011 |
) |
|
|
(51,082 |
) |
Accumulated deficit |
|
(1,422,995 |
) |
|
|
(1,429,177 |
) |
Total stockholders’
equity |
|
645,324 |
|
|
|
627,505 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
1,044,991 |
|
|
$ |
966,021 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
(U.S. GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Product revenue, net |
$ |
153,773 |
|
|
$ |
133,724 |
|
|
$ |
295,156 |
|
|
$ |
285,928 |
|
Licensing and royalty
revenue |
|
715 |
|
|
|
1,593 |
|
|
|
1,502 |
|
|
|
4,382 |
|
Total revenue, net |
|
154,488 |
|
|
|
135,317 |
|
|
|
296,658 |
|
|
|
290,310 |
|
Less: Cost of goods sold |
|
32,155 |
|
|
|
28,797 |
|
|
|
60,481 |
|
|
|
63,604 |
|
Gross margin |
|
122,333 |
|
|
|
106,520 |
|
|
|
236,177 |
|
|
|
226,706 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
107,203 |
|
|
|
92,395 |
|
|
|
213,001 |
|
|
|
226,332 |
|
Research and development (1) |
|
6,357 |
|
|
|
9,969 |
|
|
|
15,734 |
|
|
|
20,247 |
|
Total operating expenses |
|
113,560 |
|
|
|
102,364 |
|
|
|
228,735 |
|
|
|
246,579 |
|
Operating income (loss) |
|
8,773 |
|
|
|
4,156 |
|
|
|
7,442 |
|
|
|
(19,873 |
) |
Interest income, net |
|
285 |
|
|
|
151 |
|
|
|
756 |
|
|
|
1,359 |
|
Other (expense) income, net |
|
(191 |
) |
|
|
108 |
|
|
|
(333 |
) |
|
|
17 |
|
Income (loss) from operations
before taxes |
|
8,867 |
|
|
|
4,415 |
|
|
|
7,865 |
|
|
|
(18,497 |
) |
Income tax (provision)
benefit |
|
(1,059 |
) |
|
|
- |
|
|
|
(1,683 |
) |
|
|
2,359 |
|
Net income (loss) |
$ |
7,808 |
|
|
$ |
4,415 |
|
|
$ |
6,182 |
|
|
$ |
(16,138 |
) |
Earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.02 |
|
|
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.04 |
) |
Diluted |
$ |
0.02 |
|
|
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.04 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
395,899 |
|
|
|
384,663 |
|
|
|
395,272 |
|
|
|
373,300 |
|
Diluted |
|
401,767 |
|
|
|
399,664 |
|
|
|
402,778 |
|
|
|
373,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $104,550 and $82,035 for the three
months ended June 30, 2021 and 2020, respectively, and research and
development expenses were $6,531 and $8,198, respectively, for the
same periods. |
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
2021 |
|
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net income (loss) for EPS1 - GAAP |
|
7,808 |
|
|
|
4,415 |
|
|
|
6,182 |
|
|
|
(16,138 |
) |
Non-cash stock-based compensation expense |
|
2,479 |
|
|
|
12,131 |
|
|
|
16,403 |
|
|
|
22,722 |
|
Adjusted net income for EPS1 -
non-GAAP |
$ |
10,287 |
|
|
$ |
16,546 |
|
|
$ |
22,585 |
|
|
$ |
6,584 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic - non-GAAP |
$ |
0.03 |
|
|
$ |
0.04 |
|
|
$ |
0.06 |
|
|
$ |
0.02 |
|
Diluted - non-GAAP |
$ |
0.03 |
|
|
$ |
0.04 |
|
|
$ |
0.06 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
395,899 |
|
|
|
384,663 |
|
|
|
395,272 |
|
|
|
373,300 |
|
Diluted |
|
401,767 |
|
|
|
399,664 |
|
|
|
402,778 |
|
|
|
402,033 |
|
1 Cardiovascular Branch of Chinese Medical Association, Cardiac
Prevention and Rehabilitation Professional Committee of Chinese
Rehabilitation Medicine Association, Chinese Gerontology and
Elderly Cardiology Committee of the National Medical Association,
et al. Guidelines for Primary Prevention of Cardiovascular Diseases
in China. Chinese Journal of Cardiovascular Diseases.
2020;48(12):1000-1038.2 American Heart Association. Heart Disease
and Stroke Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139–e596.3 Ganda OP, Bhatt DL,
Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.4 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.5 Toth PP, Granowitz C, Hull M, et al.
High triglycerides are associated with increased cardiovascular
events, medical costs, and resource use: A real-world
administrative claims analysis of statin-treated patients with high
residual cardiovascular risk. J Am Heart Assoc.
2018;7(15):e008740.6 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.7 Bhatt DL, Steg PG, Brinton E, et al., on behalf
of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT:
Reduction of Cardiovascular Events with Icosapent
Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.8 Bhatt DL,
Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl
for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.9 Bhatt DL,
Steg PG, Miller M, et al., on behalf of the REDUCE-IT
Investigators. Reduction in first and total ischemic events with
icosapent ethyl across baseline triglyceride tertiles. J Am Coll
Cardiol. 2019;74:1159-1161.
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