Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter and year ended December 31, 2020 and
provided an update on company operations.
Recent Key Amarin Achievements:
- Record
revenue led by increased VASCEPA® (icosapent ethyl) use in the
United States: Annual net total revenue of $614.1 million
in 2020, an increase of 43% compared with 2019, consistent with
guidance provided at the beginning of 2021. Fourth quarter of 2020
net total revenue was $167.3 million, an increase of 17% compared
with the fourth quarter of 2019 and the highest quarterly net total
revenue to date.
-
Europe launch on-track for 2021: Received a
positive opinion from the Committee on Human Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA)
recommending market authorization in Europe for icosapent ethyl
(brand name VAZKEPA® in Europe) for cardiovascular risk
reduction.
-
Mainland China and Hong Kong approval expected near the end
of 2021: As submitted by our partner, Edding, in Mainland
China the Chinese National Medical Products Administration (NMPA)
has accepted for review icosapent ethyl. On a separate track, in
Hong Kong, the Hong Kong Department of Health is evaluating
icosapent ethyl. Medical guidelines of the Chinese Society of
Cardiology (CSC) updated to recommend use of icosapent ethyl in
China.
-
Strong balance sheet: Ended 2020 with $563.4
million in total cash and investments and no debt.
Management Commentary
“We entered 2021 well positioned to further grow
VASCEPA revenue in the U.S. while expanding internationally as we
continue to lead the creating of an important new paradigm in
preventative cardiovascular care beyond cholesterol management for
at-risk patients,” stated John F. Thero, president and chief
executive officer. “Our record revenue for the fourth quarter and
full year of 2020, despite the headwinds we faced from the COVID-19
pandemic, underscores the large, untapped market need for VASCEPA
in its new indication of persistent cardiovascular risk (P-CVR)
reduction in the United States. We continue to focus our efforts on
increasing awareness and education of P-CVR and VASCEPA’s
demonstrated benefits in reducing that risk as proven in the
landmark REDUCE-IT® study.”
“The positive CHMP opinion, as recently
announced, leads us to expect the European Commission to render its
formal approval of VAZKEPA in April 2021. The CHMP opinion and
anticipated approval are significant milestones for Amarin that
brings us closer to making this important drug available in Europe
to millions of patients at high risk of cardiovascular events such
as heart attacks and strokes. Our growing commercial team in Europe
is advancing commercial launch plans with unbranded engagement, and
preliminary market access discussions are underway in certain key
markets.”
“Our global expansion plans are being further
advanced by the progress of our partner in the China region,
Edding, which includes Mainland China, Hong Kong, Macau and Taiwan.
Edding is making tremendous progress across several key initiatives
critical to the successful approval and launch of VASCEPA in the
region, including the positive readout from their pivotal Phase 3
clinical study, inclusion of icosapent ethyl in the treatment
guidelines of the CSC, the acceptance of the regulatory filing
related to Mainland China with the NMPA and the introduction of
VASCEPA in the Hainan Boao Lecheng International Medical Tourism
Pilot Zone program. The China region represents a very significant
market opportunity and we continue to work closely with Edding in
support of their efforts to bring this important therapeutic to the
millions of patients in the China region with high triglycerides
who are at risk of cardiovascular events.”
“Amarin has a very dynamic year ahead and we
expect to achieve a number of potentially value-creating milestones
and to advance our leadership in cardiovascular risk reduction,”
concluded Mr. Thero.
U.S. Prescription Growth
Normalized prescriptions for VASCEPA
(prescription of 120 grams of VASCEPA representing a one-month
supply) in the United States increased by approximately 39% and 41%
in 2020 compared to the same period in 2019 based on data from
Symphony Health and IQVIA, respectively, and increased by 17% and
18% in the fourth quarter of 2020 compared to the same period in
2019, respectively. Estimated normalized VASCEPA prescriptions,
based on data from Symphony Health and IQVIA, totaled approximately
1,159,000 and 1,076,000 in the fourth quarter of 2020,
respectively. Estimated normalized VASCEPA prescriptions, based on
data from Symphony Health and IQVIA, totaled approximately
4,484,000 and 4,126,000 in 2020, respectively. While there is no
other drug which has the same labeled clinical effects as VASCEPA,
prescription growth of VASCEPA in 2020 compared well to the other
branded cardiovascular drugs which reported positive cardiovascular
outcomes study results in recent years.
Following a temporary suspension of in-person
promotional activities in March 2020 due to the COVID-19 pandemic
and quarantine in the United States, in June 2020 Amarin resumed
field-based, face-to-face interactions with healthcare providers,
to the extent such healthcare providers allow. For the second half
of 2020, substantially all of the company’s field force personnel
had the ability to resume face-to-face customer interactions,
though such interactions became more challenging in the fourth
quarter of 2020 with the resurgence of COVID-19. While Amarin
utilizes various means to interact with healthcare professionals
virtually and digitally, such interactions tend to be less
impactful than frequent in-person communications. This is
particularly true for VASCEPA, as it is being newly introduced to
many healthcare professionals as a treatment for cardiovascular
risk reduction based on its second FDA indication, which had
launched in January 2020.
Complications in 2020 from COVID-19 were
exacerbated as many at-risk patients in 2020 delayed doctors’
visits and blood tests. In the United States, public reports from
IQVIA showed patient visits to medical offices for non-emergency
medical care were down approximately 70% in April 2020 during the
height of the COVID-19 quarantine, with visits increasing
thereafter until the resurgence of COVID-19 in the fourth quarter
of 2020 when, for example, patient visits in December 2020 again
decreased to approximately 50% of pre-COVID-19 levels. As a result
of fewer doctors’ visits, fewer lab tests and prioritization of
COVID-19 safety, reports in 2020 showed an increase in heart
attacks and other urgent cardiovascular events which might have
been avoided through preventative cardiovascular risk management.
Amarin remains confident that the patient need for VASCEPA in the
United States remains high and that as COVID-19 begins to recede,
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.
In November 2020, a generic version of VASCEPA
was launched in the United States, and that generic drug is
indicated only as an adjunct to diet for lowering triglyceride
levels in adult patients with severe hypertriglyceridemia (TG ≥500
mg/dL), which based on industry data, represents no more than
approximately 7% of recent VASCEPA usage and a smaller proportion
of the overall market opportunity for VASCEPA. The “skinny label”
of this generic product represents no more than approximately $40
million of Amarin’s net product revenue at 2020 prescription
levels. The indication for this generic product is limited and we
have filed a lawsuit to protect our cardiovascular risk reduction
patent rights against what we believe is unlawful infringement by
Hikma Pharmaceuticals PLC and a representative healthcare insurance
company. Thus far, growth of the generic product has reportedly
been limited by lack of qualified supply capacity. Other generic
versions of VASCEPA have FDA approval to launch in the United
States but have thus far not done so.
In late 2020 and early 2021, various managed
care companies improved their insurance coverage of branded
VASCEPA. In addition, many insurance companies and patients have
reported that branded VASCEPA is less expensive to them than the
generic version and the wholesale acquisition cost of branded
VASCEPA continues to be lower than that of other branded drugs with
positive outcomes study results. In these and other ways, this is
an atypical generic launch in the United States. Amarin believes
the untapped market opportunity in the cardiovascular risk
reduction indication is large and that more patients will be helped
by VASCEPA with continued investment in market education regarding
its benefits. Amarin’s goal is to grow the market faster than
generic competition can take share. Amarin intends to vigorously
defend its intellectual property rights.
European Market Expansion
Amarin is seeking to commence commercial sale of
VAZKEPA in one or more countries of Europe before the end of 2021.
On January 28, 2021, Amarin received a positive CHMP opinion, which
recommended marketing authorization be granted for icosapent ethyl
in the European Union for cardiovascular risk reduction under the
brand name VAZKEPA. Approval of VAZKEPA for marketing and sale by
the European Commission is expected in April 2021. The need for
preventative cardiovascular care beyond cholesterol management is
potentially as large or larger in Europe than the United
States.
Market access in Europe is managed on a
country-by-country basis and, consequently, the timing for
receiving market access for each European country will vary
significantly. Amarin is planning a staged launch in Europe,
including likely launch in 2021 in Germany, Europe’s largest
market. In preparation for commercial launch, Amarin’s team in
Europe has increased to approximately 50 experienced professionals
and is targeted to increase to approximately 200 employees by the
end of 2021. Additional information regarding securing market
access in Europe and Amarin’s commercialization plans in Europe can
be found in the FAQ section under investor relations at
www.amarincorp.com.
Rest of World
China
In November 2020, Amarin’s partner in the China
region, Edding, shared positive, statistically significant top line
results from their Phase 3 clinical trial of VASCEPA. In December
2020, the CSC included icosapent ethyl in its updated Guidelines
for Primary Prevention of Cardiovascular Diseases for 2021 as
published in the Chinese Journal of Cardiovascular Diseases. In
January 2021, VASCEPA was accepted for introduction into the Hainan
Boao Lecheng International Medical Tourism Pilot Zone program. Most
recently, in Mainland China, the Chinese National Medical Products
Administration (NMPA) accepted for review the New Drug Application
for VASCEPA. Edding currently anticipates receiving a decision in
Mainland China and, separately in Hong Kong, near the end of 2021,
followed by steps 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. With approximately 180.4 million
hypertriglyceridemia (HTG) patients in Mainland China in 2019,
representing approximately 20.2% of the adult population and broad
use of statin therapy in the country, the medical need for VASCEPA
in Mainland China is believed to be high creating a meaningful
market opportunity for Amarin and its partner, Edding.
Canada, Middle East and Other
Cardiovascular disease is a growing public
health burden globally. Amarin has elected to pursue VASCEPA
approval in limited countries initially with plans to seek
regulatory approvals in other geographies after the product is
launched and has market access in Europe. Limited exceptions are in
select countries of the Middle East and in Canada where promotion
of VASCEPA has commenced in a phased manner.
Financial Update
Net total revenue for the three and twelve
months ended December 31, 2020 were $167.3 million and $614.1
million, respectively, compared with $143.3 million and $429.8
million in the corresponding periods of 2019, indicating increases
of 17% and 43%, respectively. Net product revenue for the three and
twelve months ended December 31, 2020 were $165.9 million and
$607.0 million, respectively, compared to $142.0 million and $427.4
million in the corresponding periods of 2019, indicating increases
of 17% and 42%, respectively. The increases in net product revenue
were driven primarily by increased volume of VASCEPA sales to
customers in the United States, as well as a modest increase in
VASCEPA’s net selling price in the United States, reflecting
various factors including managed care coverage improvements. The
increase was also driven by VASCEPA sales outside of the United
States of approximately nil and $8.9 million during the three and
twelve months ended December 31, 2020 as compared to $0.4 million
and $0.7 million during the three and twelve months ended December
31, 2019, primarily as a result of an initial order in the first
half of 2020 to ensure adequate product supply for Amarin’s
commercial partner’s launch of VASCEPA in Canada (recognized upon
shipment by Amarin to our partner).
Amarin recognized licensing and royalty revenue
of approximately $7.0 million and $2.4 million for the years ended
December 31, 2020 and 2019, respectively, from VASCEPA-related
commercial progress of our partners in Canada, the China region and
the Middle East.
Cost of goods sold for the three and twelve
months ended December 31, 2020 was $34.8 million and $131.4
million, respectively, compared to $30.7 million and $96.0 million
in the corresponding periods of 2019. Amarin’s overall gross margin
on net product revenue for the quarter and year ended December 31,
2020 was 79% and 78%, respectively, compared to 78% in the quarter
and year ended December 31, 2019, respectively.
Selling, general and administrative expenses for
the year ended December 31, 2020 was $463.3 million compared with
$323.6 million, in the prior year. This increase was primarily due
to personnel costs related to the U.S. sales force expansion and
European commercial launch preparations. The increase also included
an increase in other promotional activities in the United States
focused on cardiovascular risk reduction based on VASCEPA’s new
label. The level of such promotional activities varied from
quarter-to-quarter in 2020 with decreases resulting when the impact
of COVID-19 was most pronounced.
Research and development expenses for the years
ended December 31, 2020 and 2019 were $39.0 million and $34.4
million, respectively. This increase reflects support of numerous
publications regarding results of the REDUCE-IT cardiovascular
outcomes study, costs and fees related to regulatory reviews of
VASCEPA, particularly in Europe, together with costs associated
with exploratory development, including costs of pilot studies of
VASCEPA for other potential uses such as the potential use of
VASCEPA as a therapy to help mitigate patient risks and symptoms of
COVID-19.
Under U.S. GAAP, Amarin reported a net loss of
$18.0 million for the year ended December 31, 2020, or basic and
diluted loss per share of $0.05. This net loss included $45.8
million in non-cash stock-based compensation expense. For the year
ended December 31, 2019, Amarin reported a net loss of $22.6
million, or basic and diluted loss per share of $0.07. This net
loss included $30.9 million in non-cash stock-based compensation
expense.
Excluding non-cash stock-based compensation
expense, non-GAAP adjusted net income was $27.8 million for the
year ended December 31, 2020, or non-GAAP adjusted basic and
diluted earnings per share of $0.07, compared to non-GAAP adjusted
net income of $8.3 million for the year ended December 31, 2019, or
non-GAAP adjusted basic and diluted earnings per share of
$0.02.
As of December 31, 2020, Amarin reported
aggregate cash and investments of $563.4 million, consisting of
cash and cash equivalents of $187.0 million and liquid short-term
and long-term investments of $314.0 million and $62.5 million,
respectively. As of December 31, 2020, Amarin reported $154.6
million in net accounts receivable ($203.9 million in gross
accounts receivable before allowances and reserves) and $188.9
million in inventory. Furthermore, the final royalty-like debt
payment was made during the fourth quarter of 2020, which
previously had been 10% of net product revenue since VASCEPA was
launched, resulting in Amarin having no debt.
As of December 31, 2020, Amarin had
approximately 392.5 million ADSs and ordinary shares outstanding,
nil common share equivalents of Series A Convertible Preferred
Shares outstanding and approximately 16.7 million equivalent shares
underlying stock options at a weighted-average exercise price of
$8.00, as well as 7.7 million equivalent shares underlying
restricted or deferred stock units.
Conference Call and Webcast
Information:
Amarin will host a conference call February 25,
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 877-545-0320 within the United States, 973-528-0016 from
outside the United States, and referencing conference ID 635842. 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: 40090. 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 (loss) income 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 a rapidly growing, 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. In 2009, Amarin had fewer than twenty
employees. Today, with offices in Bridgewater, New Jersey in the
United States, Dublin in Ireland, and Zug in Switzerland, Amarin
has approximately 1,000 employees and 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 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.1 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.2 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.3 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. 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, approval is anticipated in
April 2021 following the January 28, 2021 favorable opinion of the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommending that marketing
authorisation be 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
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 outcome of patent litigation
and the launch of generic competition on these metrics; the timing
and outcome of regulatory reviews, recommendations and approvals
and related reimbursement decisions and commercial launches in the
China region, Europe and elsewhere; plans for Amarin’s expected
launch of VASCEPA directly in major markets in Europe, directly and
indirectly; the timing and outcome of Amarin’s patent litigation
efforts; the timing and outcome of promotion activities, including
patient-oriented campaigns and education of healthcare
professionals; commercial and international expansion, prescription
growth and revenue growth and future revenue levels, including the
contributions of sales representatives; the sufficiency of current
capital resources to achieve sustained positive cash flows; the
availability of commercial supply to generic companies and Amarin;
expectations related to exclusivity in various jurisdictions and
ongoing patent litigation efforts and associated business plans in
various scenarios; 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, 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
Europe, 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, 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 annual
report on Form 10-K for the year ended December 31, 2020, filed on
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 hereof. Amarin undertakes no
obligation to update or revise the information contained in this
press release, 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
AmarinInvestors 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 IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
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inquiries)
CONSOLIDATED BALANCE SHEET DATA |
|
(U.S. GAAP) |
|
Unaudited * |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
|
|
December 31, 2019 |
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
186,964 |
|
|
$ |
644,588 |
|
Restricted cash |
|
|
3,915 |
|
|
|
3,907 |
|
Short-term investments |
|
|
313,969 |
|
|
|
— |
|
Accounts receivable, net |
|
|
154,574 |
|
|
|
116,430 |
|
Inventory |
|
|
188,864 |
|
|
|
76,769 |
|
Prepaid and other current assets |
|
|
30,947 |
|
|
|
13,311 |
|
Total current assets |
|
|
879,233 |
|
|
|
855,005 |
|
Property, plant and equipment, net |
|
|
2,016 |
|
|
|
2,361 |
|
Long-term investments |
|
|
62,469 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
|
8,054 |
|
|
|
8,511 |
|
Other long-term assets |
|
|
432 |
|
|
|
1,074 |
|
Intangible asset, net |
|
|
13,817 |
|
|
|
15,258 |
|
TOTAL ASSETS |
|
$ |
966,021 |
|
|
$ |
882,209 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
105,876 |
|
|
$ |
49,950 |
|
Accrued expenses and other current liabilities |
|
|
198,641 |
|
|
|
139,826 |
|
Debt from royalty-bearing instrument |
|
|
— |
|
|
|
50,130 |
|
Current deferred revenue |
|
|
2,926 |
|
|
|
2,342 |
|
Total current liabilities |
|
|
307,443 |
|
|
|
242,248 |
|
Long-Term Liabilities: |
|
|
|
|
|
|
|
|
Long-term deferred revenue |
|
|
15,706 |
|
|
|
18,504 |
|
Long-term operating lease liability |
|
|
9,153 |
|
|
|
9,443 |
|
Other long-term liabilities |
|
|
6,214 |
|
|
|
3,751 |
|
Total liabilities |
|
|
338,516 |
|
|
|
273,946 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
21,850 |
|
Common stock |
|
|
290,115 |
|
|
|
269,173 |
|
Additional paid-in capital |
|
|
1,817,649 |
|
|
|
1,764,317 |
|
Treasury stock |
|
|
(51,082 |
) |
|
|
(35,900 |
) |
Accumulated deficit |
|
|
(1,429,177 |
) |
|
|
(1,411,177 |
) |
Total stockholders’ equity |
|
|
627,505 |
|
|
|
608,263 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
966,021 |
|
|
$ |
882,209 |
|
|
|
|
|
|
|
|
|
|
* Unaudited as a
standalone schedule; copied from consolidated financial
statements |
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
(U.S. GAAP) |
|
Unaudited * |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
|
2020 |
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue,
net |
$ |
165,907 |
|
|
$ |
142,044 |
|
|
$ |
607,025 |
|
|
$ |
427,391 |
|
Licensing and royalty
revenue |
|
1,344 |
|
|
|
1,233 |
|
|
|
7,035 |
|
|
|
2,364 |
|
Total revenue, net |
|
167,251 |
|
|
|
143,277 |
|
|
|
614,060 |
|
|
|
429,755 |
|
Less: Cost of goods
sold |
|
34,769 |
|
|
|
30,665 |
|
|
|
131,444 |
|
|
|
96,019 |
|
Gross margin |
|
132,482 |
|
|
|
112,612 |
|
|
|
482,616 |
|
|
|
333,736 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
116,816 |
|
|
|
96,025 |
|
|
|
463,312 |
|
|
|
323,623 |
|
Research and development (1) |
|
8,508 |
|
|
|
11,097 |
|
|
|
38,959 |
|
|
|
34,392 |
|
Total operating expenses |
|
125,324 |
|
|
|
107,122 |
|
|
|
502,271 |
|
|
|
358,015 |
|
Operating income
(loss) |
|
7,158 |
|
|
|
5,490 |
|
|
|
(19,655 |
) |
|
|
(24,279 |
) |
Interest income |
|
551 |
|
|
|
3,074 |
|
|
|
4,901 |
|
|
|
8,499 |
|
Interest expense |
|
(163 |
) |
|
|
(1,439 |
) |
|
|
(2,605 |
) |
|
|
(6,626 |
) |
Other income
(expense), net |
|
54 |
|
|
|
107 |
|
|
|
104 |
|
|
|
(75 |
) |
Income (loss) from
operations before taxes |
|
7,600 |
|
|
|
7,232 |
|
|
|
(17,255 |
) |
|
|
(22,481 |
) |
Provision for income
taxes |
|
(2,674 |
) |
|
|
(164 |
) |
|
|
(745 |
) |
|
|
(164 |
) |
Net income
(loss) |
|
4,926 |
|
|
|
7,068 |
|
|
|
(18,000 |
) |
|
|
(22,645 |
) |
Earnings (loss) per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
Diluted |
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
390,661 |
|
|
|
359,156 |
|
|
|
381,759 |
|
|
|
342,538 |
|
Diluted |
|
398,963 |
|
|
|
401,039 |
|
|
|
381,759 |
|
|
|
342,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Unaudited as a
standalone schedule; copied from consolidated financial
statements |
|
(1) Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $424,067 and $297,321 for 2020 and
2019, respectively, and research and development expenses were
$32,391 and $29,777, respectively, for the same periods. |
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
Year Ended December 31, |
|
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
|
2020 |
|
2019 |
|
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) for
EPS - GAAP |
|
|
4,926 |
|
|
|
7,068 |
|
|
|
|
(18,000 |
) |
|
|
(22,645 |
) |
Stock-based compensation expense |
|
|
11,508 |
|
|
|
8,188 |
|
|
|
|
45,814 |
|
|
|
30,917 |
|
Adjusted net income
for EPS - non-GAAP |
|
$ |
16,434 |
|
|
$ |
15,256 |
|
|
|
$ |
27,814 |
|
|
$ |
8,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic - non-GAAP |
|
$ |
0.04 |
|
|
$ |
0.04 |
|
|
|
$ |
0.07 |
|
|
$ |
0.02 |
|
Diluted -
non-GAAP |
|
$ |
0.04 |
|
|
$ |
0.04 |
|
|
|
$ |
0.07 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
390,661 |
|
|
|
359,156 |
|
|
|
|
381,759 |
|
|
|
342,538 |
|
Diluted |
|
|
398,963 |
|
|
|
401,039 |
|
|
|
|
401,195 |
|
|
|
386,797 |
|
1 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;40:138-148.2 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;380:11-22.3 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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