Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter and year ended December 31, 2021 and
provided an update on company operations.
“2021 was a year of significant progress, during
which we laid the foundation to support our long-term growth
strategy including greater geographic reach for VASCEPA®, expanded
operations and pipeline diversification, including a fixed-dose
combination portfolio,” stated Karim Mikhail, president, and chief
executive officer of Amarin. “We have an ambitious set of
objectives for 2022 and are keenly focused on executing our
strategy throughout the balance of the year and beyond.”
“In the U.S., our Go-To-Market strategy is
demonstrating encouraging results and industry data show that while
the icosapent ethyl (IPE) market is increasing, it remains
underpenetrated, which offers a continued growth opportunity for
VASCEPA. In Europe, launch activities are well underway in multiple
markets, closely connected with the progress of our reimbursement
discussions with the local authorities, and we are on track to
deliver on our commitments of additional submissions, reimbursement
decisions and launches in key European markets. Our International
strategy is also taking shape, with additional regulatory filings
completed in several key countries including Australia, New Zealand
and Israel, with recent receipt of acceptances for review in
Australia and Israel.”
“2022 is slated to be a year of execution for
Amarin. We are fully dedicated to maximizing our asset,
VASCEPA/VAZKEPA, intend to build on our important cardiovascular
outcomes data and progress on our diversification strategy
including further development of our fixed-dose combination
portfolio. Underlying these initiatives is our commitment to
operational excellence including flexible and profitable
investments in growth, while maintaining a strong balance sheet. We
will continue to enhance our leadership team and board with the
right talent to support the company’s next steps. The achievement
of these objectives is our highest priority as we seek to attain
our bold vision to stop heart disease from being the leading cause
of death, worldwide.”
United States
U.S. net product net revenue was $577.9 million
in full year 2021 amidst the ongoing challenges of the COVID-19
pandemic and the impact of additional generic icosapent ethyl
market entrants.
U.S. commercial operations remain positive
supporting investments to expand into new markets.
The Go-To-Market strategy is demonstrating
progress across all three initiatives:
Continued to Expand Provider Engagement
- Enhanced awareness and use of
VASCEPA with optimized sales force and expanded reach to
approximately 150,000 healthcare providers.
- Continue evaluating all resources
and encouraging pay-for-performance partnerships, such as BlinkRx,
elements of Omnichannel and other initiatives
Managed Care Access Remains a Focus
- In December 2021, Amarin had
approximately 40% of total commercial and Medicare Part D lives on
a weighted average basis with VASCEPA as the exclusive IP product.
Additional anticipated decisions could positively impact our
exclusive coverage level in 2022 beyond the 40%.
- Improved access for VASCEPA for 25%
of all commercial lives.
Optimizing Fulfillment of VASCEPA Prescriptions
for Cardiovascular (CV) Risk Reduction
- Launched new VASCEPA campaign
focused on prior myocardial infarction and stroke patients at a
heightened risk of a subsequent event to generate immediate growth
acceleration.
- Partnered with BlinkRx to support
fulfillment process across the continuum of care, to ensure
patients can start and remain on VASCEPA.
Europe
- Received market approval of VAZKEPA by
the European Commission (EC) and the UK Medicines and Healthcare
products regulatory agency (MHRA) as the first and only treatment
to reduced CV risk in high-risk, statin-treated adult patients who
have elevated triglycerides (≥150 mg/dL) and other risk
characteristics.
- Submitted market access and
reimbursement dossiers in ten European countries (namely Germany,
UK, Italy, France, Spain, Denmark, Sweden, Finland, Norway, and the
Netherlands) ahead of plan.
- Clinical and Health Technology
Assessments processes and reimbursement discussions are progressing
in all targeted markets.
- Launched VAZKEPA in Germany despite
resurging COVID-19 disruptions. Progressing commercial launch plans
of VAZKEPA in up to six countries as expected, with preparations
underway in several key markets.
- Actively negotiating partnerships to
bring VAZKEPA to Central and Eastern European markets via marketing
and distribution agreements with partners who have established
infrastructure in such markets
International
- Expects regulatory filings, approvals
and potential launches of VASCEPA, via partners, in up to six new
countries, including Australia, New Zealand, and certain
Asia-Pacific markets in 2022.
- Received acceptances of VASCEPA for regulatory review in
Australia and Israel, and has embarked on initiatives to engage a
commercial partner to market/distribute the product in this
region.
- The National Medical Products
Administration, or NMPA, has accepted for review the new drug
application for VASCEPA submitted by Edding, Amarin’s partner in
China.
- Expects final decisions from the NMPA in Mainland China and
from the regulatory authority in Hong Kong in the second half of
2022.
- Expanded VASCEPA commercialization in
several Middle Eastern countries including Lebanon, UAE, and Qatar
through partners.
- Continued execution of international
expansion strategy that features plans to bring the CV reduction
benefits of VASCEPA/VAZKEPA to approximately 20 additional
countries over the course of the next three years through a series
of distribution agreements and partnerships1.
- Amarin’s partner in Canada, HLS
Therapeutics, announced a co-promotional agreement for VASCEPA with
Pfizer in Canada.
Financial Update
Total net revenue for the full year ended
December 31, 2021 was $583.2 million, compared to $614.1
million in the corresponding period of 2020, a decrease of 5%. Net
product revenue for the full year ended December 31, 2021 was
$580.3 million compared to $607.0 million in the corresponding
period of 2020, a decrease of 4%. This decrease was driven
primarily by volume of VASCEPA sales to Amarin’s customers in the
United States, which were adversely impacted by generic
availability in the United States. The decrease was also driven by
VASCEPA sales to our partners outside of the United States of
approximately $2.4 million for the full year ended
December 31, 2021 as compared to $8.9 million for the full
year ended December 31, 2020, primarily as a result of an
initial order to ensure availability of 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 $2.9 million and $7.0 million for the full year
ended December 31, 2021 and 2020, respectively, from
VASCEPA-related commercial sales of our partners in Canada, the
China region and the Middle East.
Cost of goods sold for the full year ended
December 31, 2021 was $121.3 million, compared to $131.4
million in the corresponding period of 2020. Amarin’s overall gross
margin on net product revenue for the quarter and year ended
December 31, 2021 was 79%, compared with 79% and 78% for the
quarter and year ended December 31, 2020.
Selling, general and administrative expenses for
the full year ended December 31, 2021 was $408.3 million
compared to $463.3 million in the prior year. This decrease was
primarily due to a decrease in marketing and direct to consumer
promotions in 2021, as a result of the impact of COVID-19 and the
company’s focus on improving the profitability of operations in the
United States. The decrease also includes a reduction in costs
associated with the company’s Go-To-Market strategy resulting in
decreased promotional initiatives, reduced travel and a decrease in
sales force.
Research and development expenses for the full
year ended December 31, 2021 was $29.3 million compared to
$39.0 million in the prior year. This decrease was primarily driven
by the completion of certain analyses performed beyond the
REDUCE-IT cardiovascular outcomes trial.
Under U.S. GAAP, Amarin reported net income of
$7.7 million for the full year ended December 31, 2021, or
basic and diluted earnings per share of $0.02. This net income
includes $36.6 million in non-cash stock-based compensation. For
the full year ended December 31, 2020, Amarin reported a net
loss of $18.0 million, or basic and diluted loss per share of
$0.05. This net loss included $45.8 million in non-cash stock-based
compensation expense.
Excluding non-cash stock-based compensation
expense and restructuring expense, non-GAAP adjusted net income was
$58.1 million for the full year ended December 31, 2021, or
non-GAAP adjusted basic earnings per share of $0.15 and diluted
earnings per share of $0.14, compared with non-GAAP adjusted net
income of $27.8 million for the full year ended December 31,
2020, or non-GAAP adjusted basic and diluted earnings per share of
$0.07.
As of December 31, 2021, Amarin reported
aggregate cash and investments of $489.1 million, consisting of
cash and cash equivalents of $219.5 million and liquid short-term
and long-term investments of $234.7 million and $35.0 million,
respectively. As of December 31, 2021, Amarin reported $163.7
million in net accounts receivable ($262.9 million in gross
accounts receivable before allowances and reserves) and $355.9
million in total inventory. Furthermore, Amarin has no debt as the
final royalty-like debt payment was made during the fourth quarter
of 2020, which previously had been 10% of net product revenue
generated from VASCEPA.
As of December 31, 2021, Amarin had
approximately 396.6 million American Depository Shares ADSs and
ordinary shares outstanding, nil common share equivalents of Series
A Convertible Preferred Shares outstanding and approximately 18.5
million equivalent shares underlying stock options at a
weighted-average exercise price of $7.32, as well as 9.3 million
equivalent shares underlying restricted or deferred stock
units.
Strengthening our Leadership Team and
Board of Directors
Amarin expanded its leadership team with the
addition of four new executive members.
- Laurent Abuaf, Senior Vice
President, President Europe
- Jason Marks, Chief Legal Officer
and Corporate Secretary
- Alan Wills, Executive Vice
President, Corporate Business Development
- Lisa DeFrancesco, Senior Vice
President Investor Relations and Corporate Affairs
The Company also enhanced its board of directors
with the appointment of Per Wold-Olsen, who joined the Amarin Board
of Directors on January 10, 2022.
2022 Financial Outlook
Given the uncertainty primarily related to the
continued global impact of COVID-19 as well as the uncertainty
resulting from the impact of generic availability in the U.S.,
Amarin is unable to provide 2022 revenue guidance; however, the
company will continue to evaluate its ability to provide as the
year progresses.
As noted above, U.S. commercial operations are
expected to continue to operate on a contribution margin positive
basis. Amarin will continue to invest in building the appropriate
infrastructure and foundation in Europe for successful commercial
launches and advance necessary actions to support regulatory
activities in other international markets. Amarin will also
progress lifecycle management (LCM) opportunities as described. The
company will continue to evaluate its planned spend in 2022 and
adjust if assumptions warrant adjustments.
Amarin reiterates its belief that current cash
and investments and other assets are adequate to support continued
operations, including European launch activities.
Conference Call and Webcast
Information:
Amarin will host a conference call on March 1,
2022, at 8:00 a.m. ET to discuss this information. The conference
call can be accessed 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 424818. A
replay of the call will be made available for a period of two weeks
following the conference call. To listen to a replay of the call,
dial 877-481-4010 from within the United States and 919-882-2331
from outside of the United States, and reference conference ID
44616. 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 and adjusting it for non-cash stock-based
compensation expense and restructuring 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 has offices in Bridgewater, New Jersey in the
United States, Dublin in Ireland, Zug in Switzerland, and other
countries in Europe 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.i 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%.ii 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.
iii,iv,v
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.vi The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.vii The total
events results of REDUCE-IT were published in the Journal of the
American College of Cardiology in March 2019.viii 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 annual report on Form
10-K for the year ended December 31, 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:Lisa DeFrancescoInvestor
Relations Amarin Corporation plcinvestor.relations@amarincorp.com
(investor inquiries)
CONSOLIDATED BALANCE SHEET DATA |
|
(U.S. GAAP) |
|
Unaudited * |
|
|
|
|
|
|
|
|
|
|
December 31, 2021 |
|
|
December 31, 2020 |
|
|
|
(in thousands) |
|
ASSETS |
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
219,454 |
|
|
$ |
186,964 |
|
Restricted cash |
|
|
3,918 |
|
|
|
3,915 |
|
Short-term investments |
|
|
234,674 |
|
|
|
313,969 |
|
Accounts receivable, net |
|
|
163,653 |
|
|
|
154,574 |
|
Inventory |
|
|
234,676 |
|
|
|
188,864 |
|
Prepaid and other current assets |
|
|
22,352 |
|
|
|
30,947 |
|
Total current assets |
|
|
878,727 |
|
|
|
879,233 |
|
Property, plant and equipment, net |
|
|
1,425 |
|
|
|
2,016 |
|
Long-term investments |
|
|
34,996 |
|
|
|
62,469 |
|
Long-term inventory |
|
|
121,254 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
|
7,660 |
|
|
|
8,054 |
|
Other long-term assets |
|
|
456 |
|
|
|
432 |
|
Intangible asset, net |
|
|
23,547 |
|
|
|
13,817 |
|
TOTAL ASSETS |
|
$ |
1,068,065 |
|
|
$ |
966,021 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
114,922 |
|
|
$ |
105,876 |
|
Accrued expenses and other current liabilities |
|
|
253,111 |
|
|
|
198,641 |
|
Current deferred revenue |
|
|
2,649 |
|
|
|
2,926 |
|
Total current liabilities |
|
|
370,682 |
|
|
|
307,443 |
|
Long-Term Liabilities: |
|
|
|
|
|
|
Long-term deferred revenue |
|
|
14,060 |
|
|
|
15,706 |
|
Long-term operating lease liability |
|
|
8,576 |
|
|
|
9,153 |
|
Other long-term liabilities |
|
|
7,648 |
|
|
|
6,214 |
|
Total liabilities |
|
|
400,966 |
|
|
|
338,516 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Common stock |
|
|
294,027 |
|
|
|
290,115 |
|
Additional paid-in capital |
|
|
1,855,246 |
|
|
|
1,817,649 |
|
Treasury stock |
|
|
(60,726 |
) |
|
|
(51,082 |
) |
Accumulated deficit |
|
|
(1,421,448 |
) |
|
|
(1,429,177 |
) |
Total stockholders’ equity |
|
|
667,099 |
|
|
|
627,505 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
1,068,065 |
|
|
$ |
966,021 |
|
|
|
|
|
|
|
|
* 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) |
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
143,722 |
|
|
$ |
165,907 |
|
|
$ |
580,320 |
|
|
$ |
607,025 |
|
Licensing
and royalty revenue |
|
|
769 |
|
|
|
1,344 |
|
|
|
2,867 |
|
|
|
7,035 |
|
Total revenue, net |
|
|
144,491 |
|
|
|
167,251 |
|
|
|
583,187 |
|
|
|
614,060 |
|
Less: Cost of
goods sold |
|
|
30,635 |
|
|
|
34,769 |
|
|
|
121,327 |
|
|
|
131,444 |
|
Gross margin |
|
|
113,856 |
|
|
|
132,482 |
|
|
|
461,860 |
|
|
|
482,616 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
|
92,368 |
|
|
|
116,816 |
|
|
|
408,334 |
|
|
|
463,312 |
|
Research and development (1) |
|
|
5,753 |
|
|
|
8,508 |
|
|
|
29,307 |
|
|
|
38,959 |
|
Restructuring |
|
|
(398 |
) |
|
|
— |
|
|
|
13,717 |
|
|
|
— |
|
Total operating expenses |
|
|
97,723 |
|
|
|
125,324 |
|
|
|
451,358 |
|
|
|
502,271 |
|
Operating income
(loss) |
|
|
16,133 |
|
|
|
7,158 |
|
|
|
10,502 |
|
|
|
(19,655 |
) |
Interest
income |
|
|
195 |
|
|
|
551 |
|
|
|
1,220 |
|
|
|
4,901 |
|
Interest
expense |
|
|
(23 |
) |
|
|
(163 |
) |
|
|
(129 |
) |
|
|
(2,605 |
) |
Other income
(expense), net |
|
|
88 |
|
|
|
54 |
|
|
|
(302 |
) |
|
|
104 |
|
Income (loss) from
operations before taxes |
|
|
16,393 |
|
|
|
7,600 |
|
|
|
11,291 |
|
|
|
(17,255 |
) |
Provision for
income taxes |
|
|
(1,695 |
) |
|
|
(2,674 |
) |
|
|
(3,562 |
) |
|
|
(745 |
) |
Net income
(loss) |
|
|
14,698 |
|
|
|
4,926 |
|
|
|
7,729 |
|
|
|
(18,000 |
) |
Earnings (loss)
per share |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.04 |
|
|
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.05 |
) |
Diluted |
|
$ |
0.04 |
|
|
$ |
0.01 |
|
|
$ |
0.02 |
|
|
$ |
(0.05 |
) |
Weighted average
shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
397,049 |
|
|
|
390,661 |
|
|
|
395,992 |
|
|
|
381,759 |
|
Diluted |
|
|
401,768 |
|
|
|
398,963 |
|
|
|
402,480 |
|
|
|
381,759 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
Unaudited as a standalone schedule; copied from consolidated
financial statements |
|
(1) Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $376,029 and $424,067 for 2021 and
2020, respectively, and research and development expenses were
$24,980 and $32,391, 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) |
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
for EPS - GAAP |
|
|
14,698 |
|
|
|
4,926 |
|
|
|
7,729 |
|
|
|
(18,000 |
) |
|
Stock-based compensation expense |
|
|
9,796 |
|
|
|
11,508 |
|
|
|
36,632 |
|
|
|
45,814 |
|
|
Restructuring expense |
|
|
(398 |
) |
|
|
— |
|
|
|
13,717 |
|
|
|
- |
|
Adjusted net
income for EPS - non-GAAP |
|
$ |
24,096 |
|
|
$ |
16,434 |
|
|
$ |
58,078 |
|
|
$ |
27,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic -
non-GAAP |
|
$ |
0.06 |
|
|
$ |
0.04 |
|
|
$ |
0.15 |
|
|
$ |
0.07 |
|
Diluted -
non-GAAP |
|
$ |
0.06 |
|
|
$ |
0.04 |
|
|
$ |
0.14 |
|
|
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
397,049 |
|
|
|
390,661 |
|
|
|
395,992 |
|
|
|
381,759 |
|
Diluted |
|
|
403,752 |
|
|
|
398,963 |
|
|
|
403,980 |
|
|
|
401,195 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
i American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596ii Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am Coll
Cardiol. 2018;72(3):330-343iii Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145iv
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):e008740v Nordestgaard
BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563
vi 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.vii 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.viii 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;74:1159-1161.1 The company is pursuing expansion into
these various additional markets and the status of regulatory
and/or patent approval will vary between market to market.
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024