Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the third quarter and nine months ended
September 30, 2021 and provided an update on Company
operations.
Recent Key Amarin Highlights:
- Topline
Financial Results: Total net revenue for the three and nine months
ended September 30, 2021 were $142.0 million and $438.7
million, respectively, compared to $156.5 million and $446.8
million in the corresponding periods of 2020, respectively,
indicating decreases of 9% and 2%, respectively. Net product
revenue for the three and nine months ended September 30, 2021
were $141.4 million and $436.6 million, respectively, compared to
$155.2 million and $441.1 million in the corresponding periods of
2020, respectively, indicating decreases of 9% and 1%,
respectively. In the U.S., based on data from Symphony Health,
Amarin retained approximately 83% and 87% of the icosapent ethyl
market in the three and nine months ended September 30, 2021,
respectively, with approximately one year of generic presence in
the market.
- Launched
VAZKEPA (icosapent ethyl) in Europe: Amarin launched VAZKEPA in
Germany as a treatment to reduce the risk of cardiovascular events
in statin-treated adult patients at high cardiovascular risk who
have elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and either
established cardiovascular disease or diabetes and at least one
additional cardiovascular risk factor.i Amarin is deploying a
distinct digitally native omnichannel approach to marketing VAZKEPA
in Europe, which is supported by an approximately 150-person
commercial field force in Germany and further Medical and
Commercial teams in all major markets. In addition, the Company
today announced the successful submission of market access dossiers
for reimbursement in ten major countries in Europe.
-
Introduced new Go-to-Market Strategy for VASCEPA® (icosapent ethyl)
in U.S.: The new Go-to-Market strategy is designed to accelerate
growth of VASCEPA in the U.S., with plans focused on expanding
healthcare professional reach and engagement through a new digital
omnichannel platform, driving further enhancements in managed care
access and optimizing VASCEPA prescriptions for cardiovascular (CV)
risk reduction.
- Executing
International Expansion Strategy: Amarin announced plans to
initiate regulatory filing and review processes and obtain
approvals in several additional countries in 2022 as part of its
global growth strategy to reach the top 50 cardiometabolic markets
in the world.
-
VASCEPA/VAZKEPA Added to Two Additional Medical Societies’ Clinical
Treatment Guidelines or Position Statements: VASCEPA/VAZKEPA is now
included in more than 20 medical societies’ clinical treatment
guidelines or position statements. Click here for more information
on the guidelines.
- New Senior Executive Further Strengthens Leadership Team: As of
August 19, 2021, Jason Marks was appointed senior vice president,
chief legal officer & corporate secretary, succeeding Joseph
Kennedy who retired as general counsel, effective August
2021.
-
Strong Balance Sheet: Ended third quarter 2021 with $517.9 million
in total cash and investments and no debt.
Management Commentary
“During the third quarter we made important
strides toward our goal to bring the CV risk reduction benefits of
VASCEPA/VAZKEPA to at-risk patients around the world,” stated Karim
Mikhail, president and chief executive officer of Amarin. “We are
delighted with the launch of VAZKEPA in Germany in mid-September
and to report that we have submitted market access dossiers for
VAZKEPA in ten major countries in Europe ahead of our year end
timeline. These filings form the foundation for pricing
negotiations and, ultimately, for the launch of VAZKEPA in multiple
other European countries throughout 2022.
“Importantly, we introduced a new Go-to-Market
strategy in the U.S. that is designed to significantly expand reach
and engagement with our target audiences through multiple digital
omnichannels in order to increase awareness of and drive demand for
VASCEPA in its CV risk reduction indication. In tandem, we are
optimizing VASCEPA prescriptions in this indication by addressing
factual errors by certain stakeholders in the prescribing ecosystem
to reduce generic substitution for non-indicated uses. We have
secured significant, positive managed care access for VASCEPA, but
we continue working to enhance that access by further removing
barriers and reducing patient out-of-pocket costs for VASCEPA
prescriptions.
“Our global growth strategy in the near-term
remains steadfast: expand the markets for VASCEPA/VAZKEPA in Europe
and around the world and grow the U.S. market for VASCEPA through
our new Go-to-Market initiatives. We are well positioned to deliver
on our commitment to reduce the occurrence of the debilitating and
deadly effects of cardiovascular disease by bringing the CV risk
reduction benefits of VASCEPA/VAZKEPA to patients globally, while
building value for our stakeholders,” concluded Mr.
Mikhail.
Europe
In September 2021, Amarin launched VAZKEPA in
Germany with a scientific conference that was led by eleven
internationally renowned cardiovascular specialists and was
attended by more than 200 healthcare professionals from Germany,
with a live stream to many more physicians across the
continent. The commercial team has made great strides
introducing the cardioprotective benefits of VAZKEPA to the German
market with 60 events hosted to date and more than 50 events
approved and ready to execute before year-end. As Germany is
the largest economy in Europe, and there are more than
300,000 deaths due to cardiovascular disease (CVD) in Germany every
yearii, it represents both a significant market need and
opportunity.
Amarin has filed market access dossiers for
reimbursement in ten European countries, including Germany, the
United Kingdom, France, Italy, Spain, Denmark, Sweden, Finland,
Norway and the Netherlands. Amarin expects to file several
additional dossiers in various other European countries throughout
2022. The submitted filings include health economic 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 or U.S. $240 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 adverse
cardiovascular events, the risk of which VAZKEPA is proven to
reduce.
U.S. Icosapent Ethyl Market
The icosapent ethyl market in aggregate,
consisting of branded and generic product, increased for the three
months ended September 30, 2021 by approximately 11% as compared to
the same period in 2020, based on data from Symphony Health. Based
on data from Symphony Health, VASCEPA captured approximately 83% of
the total icosapent ethyl normalized prescriptions for the three
months ended September 30, 2021.
Two generic versions of VASCEPA have launched in
the U.S., 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 Amarin
believes has likewise infringed on its rights.
The COVID-19 Delta Variant caused a resurgence
of positive COVID cases, which peaked in the third quarter of 2021.
According to IQVIA, this resulted in a decrease in patient office
visits of approximately 6% and lab tests of approximately 7% as
compared with the same period of 2020. We expect that continued
recovery from COVID-19 will further contribute to future market
growth.
International Market
Expansion
Amarin is gaining traction in its goal to unlock
the potential of VASCEPA/VAZKEPA internationally. The Company
plans to file three waves of regulatory submissions for approval of
VASCEPA/VAZKEPA in 20 additional countries in order to ensure that
patients in the top 50 cardiometabolic markets worldwide can
benefit from VASCEPA/VAZKEPA. Amarin today announced plans to
initiate the first wave of regulatory filings in several countries
in 2022, including Australia, New Zealand and Israel. With
approvals in the U.S. and Europe, and backed by the results from
the global REDUCE-IT® long-term CV outcomes study, Amarin has
significant clinical data to support these filings. In total, this
expansion across an additional 20 markets 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.1
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 atherosclerotic cardiovascular
disease 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 use based on VASCEPA’s demonstrated clinical
results.
In August 2021, Amarin’s partner in Canada, HLS
Therapeutics (HLS), announced a promotional agreement with Pfizer,
which addresses the expansion of VASCEPA promotion to the primary
care physician (PCP) audience in Canada. HLS will retain
responsibility over VASCEPA's commercialization and will continue
to record all revenue related to VASCEPA sales in Canada.
Financial Update
Total net revenue for the three and nine months
ended September 30, 2021 were $142.0 million and $438.7
million, respectively, compared to $156.5 million and $446.8
million in the corresponding periods of 2020, respectively,
indicating decreases of 9% and 2%, respectively. Net product
revenue for the three and nine months ended September 30, 2021
were $141.4 million and $436.6 million, respectively, compared to
$155.2 million and $441.1 million in the corresponding periods of
2020, respectively, indicating decreases of 9% and 1%,
respectively. The decrease in net product revenue and total net
revenue for the three months ended September 30, 2021 was driven
primarily by decreased volume of VASCEPA sales to customers in the
U.S.
In addition, total net revenue includes
licensing and royalty revenue of approximately $0.6 million and
$2.1 million in the three and nine months ended September 30,
2021, which compares with licensing and royalty revenue of
approximately $1.3 million and $5.7 million in the three and nine
months ended September 30, 2020, respectively, under
agreements for the commercialization of VASCEPA outside the
U.S.
Cost of goods sold for the three and nine months
ended September 30, 2021 was $30.2 million and $90.7 million,
respectively, compared to $33.1 million and $96.7 million in the
corresponding periods of 2020, respectively. Amarin’s overall gross
margin on net product revenue for both the three and nine months
ended September 30, 2021 was 79%, compared to 79% and 78% for
the three and nine months ended September 30, 2020,
respectively.
Selling, general and administrative (SG&A)
expense for the three and nine months ended September 30, 2021
were $103.0 million and $316.0 million, respectively, compared to
$120.2 million and $346.5 million, respectively, in the
corresponding periods of 2020, representing a decrease of 14% and
9% for the same three and nine month periods one year ago. The
decreases were due primarily to reduced promotional initiatives
when compared to the same periods in the prior year.
Research and development (R&D) expense for
the three and nine months ended September 30, 2021 were $7.8
million and $23.6 million, respectively, compared to $10.2 million
and $30.5 million, respectively, in the corresponding periods of
2020, representing decreases of 23%, respectively. These decreases
were primarily driven by the completion of certain activities
related to 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 a net loss of
$13.2 million in the three months ended September 30, 2021, or
basic and diluted loss per share of $0.03, which included $10.4
million in non-cash stock-based compensation expense and $14.1
million in restructuring expense. In comparison, Amarin reported a
net loss of $6.8 million in the three months ended
September 30, 2020, or basic and diluted loss per share of
$0.02, which included $11.6 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 and into 2022.
Under U.S. GAAP, Amarin reported a net loss of
$7.0 million in the nine months ended September 30, 2021, or
basic and diluted loss per share of $0.02, which included $26.8
million in non-cash stock-based compensation expense and
$14.1 million in restructuring expense. For the nine months
ended September 30, 2020, Amarin reported a net loss of $22.9
million, or basic and diluted loss per share of $0.06, which
included $34.3 million in non-cash stock-based compensation
expense.
Excluding non-cash gains or losses for
stock-based compensation and restructuring expense, non-GAAP
adjusted net income was $11.4 million for the third quarter of
2021, or non-GAAP adjusted basic and diluted earnings per share of
$0.03, compared to non-GAAP adjusted net income of $4.8 million for
the third quarter of 2020, or non-GAAP adjusted basic and diluted
earnings per share of $0.01.
Excluding non-cash gains or losses for
stock-based compensation and restructuring expense, non-GAAP
adjusted net income was $34.0 million for the nine months ended
September 30, 2021, or non-GAAP adjusted basic and diluted
earnings per share of $0.09 and $0.08, respectively, compared to
non-GAAP adjusted net income of $11.4 million for the nine months
ended September 30, 2020, or non-GAAP adjusted basic and
diluted earnings per share of $0.03.
As of September 30, 2021, Amarin reported
aggregate cash and investments of $517.9 million, consisting of
cash and cash equivalents of $222.9 million and liquid short-term
and long-term investments of $256.3 million and $38.8 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 September 30, 2021, Amarin had
approximately 395.6 million American Depository Shares (ADSs) and
ordinary shares outstanding approximately 19.1 million equivalent
shares underlying stock options at a weighted-average exercise
price of $7.38 and 10.3 million equivalent shares underlying
restricted or deferred stock units.
Conference Call and Webcast
Information:
Amarin will host a conference call today,
November 3, 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 877-545-0523 within the United States, 973-528-0016 from
outside the United States, and referencing conference ID 527493. 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: 43234. 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.iii 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%.iv 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.
v,vi,vii
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.viii The primary results of REDUCE-IT were published in
The New England Journal of Medicine in November 2018.ix The total
events results of REDUCE-IT were published in the Journal of the
American College of Cardiology in March 2019.x 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 September 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.
CONSOLIDATED BALANCE SHEET DATA |
|
(U.S. GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
|
(in
thousands) |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
222,875 |
|
|
$ |
186,964 |
|
Restricted cash |
|
3,917 |
|
|
|
3,915 |
|
Short-term investments |
|
256,267 |
|
|
|
313,969 |
|
Accounts receivable, net |
|
149,361 |
|
|
|
154,574 |
|
Inventory |
|
309,268 |
|
|
|
188,864 |
|
Prepaid and other current assets |
|
21,345 |
|
|
|
30,947 |
|
Total current assets |
|
963,033 |
|
|
|
879,233 |
|
Property, plant and equipment, net |
|
1,569 |
|
|
|
2,016 |
|
Long-term investments |
|
38,802 |
|
|
|
62,469 |
|
Operating lease right-of-use asset |
|
7,762 |
|
|
|
8,054 |
|
Other long-term assets |
|
456 |
|
|
|
432 |
|
Intangible asset, net |
|
24,183 |
|
|
|
13,817 |
|
TOTAL ASSETS |
$ |
1,035,805 |
|
|
$ |
966,021 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
$ |
72,415 |
|
|
$ |
105,876 |
|
Accrued expenses and other current liabilities |
|
289,684 |
|
|
|
198,641 |
|
Current deferred revenue |
|
2,646 |
|
|
|
2,926 |
|
Total current liabilities |
|
364,745 |
|
|
|
307,443 |
|
Long-Term Liabilities: |
|
|
|
|
|
Long-term deferred revenue |
|
14,486 |
|
|
|
15,706 |
|
Long-term operating lease liability |
|
8,729 |
|
|
|
9,153 |
|
Other long-term liabilities |
|
5,350 |
|
|
|
6,214 |
|
Total liabilities |
|
393,310 |
|
|
|
338,516 |
|
Stockholders’ Equity: |
|
|
|
|
|
Common stock |
|
293,140 |
|
|
|
290,115 |
|
Additional paid-in capital |
|
1,845,103 |
|
|
|
1,817,649 |
|
Treasury stock |
|
(59,602 |
) |
|
|
(51,082 |
) |
Accumulated deficit |
|
(1,436,146 |
) |
|
|
(1,429,177 |
) |
Total stockholders’ equity |
|
642,495 |
|
|
|
627,505 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
1,035,805 |
|
|
$ |
966,021 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
(U.S. GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Product revenue, net |
$ |
141,442 |
|
|
$ |
155,190 |
|
|
$ |
436,598 |
|
|
$ |
441,118 |
|
Licensing and royalty
revenue |
|
596 |
|
|
|
1,309 |
|
|
|
2,098 |
|
|
|
5,691 |
|
Total revenue, net |
|
142,038 |
|
|
|
156,499 |
|
|
|
438,696 |
|
|
|
446,809 |
|
Less: Cost of goods sold |
|
30,211 |
|
|
|
33,071 |
|
|
|
90,692 |
|
|
|
96,676 |
|
Gross margin |
|
111,827 |
|
|
|
123,428 |
|
|
|
348,004 |
|
|
|
350,133 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
102,965 |
|
|
|
120,164 |
|
|
|
315,966 |
|
|
|
346,496 |
|
Research and development (1) |
|
7,820 |
|
|
|
10,204 |
|
|
|
23,554 |
|
|
|
30,450 |
|
Restructuring |
|
14,115 |
|
|
|
— |
|
|
|
14,115 |
|
|
|
— |
|
Total operating expenses |
|
124,900 |
|
|
|
130,368 |
|
|
|
353,635 |
|
|
|
376,946 |
|
Operating loss |
|
(13,073 |
) |
|
|
(6,940 |
) |
|
|
(5,631 |
) |
|
|
(26,813 |
) |
Interest income, net |
|
163 |
|
|
|
549 |
|
|
|
919 |
|
|
|
1,908 |
|
Other (expense) income, net |
|
(57 |
) |
|
|
33 |
|
|
|
(390 |
) |
|
|
50 |
|
Loss from operations before
taxes |
|
(12,967 |
) |
|
|
(6,358 |
) |
|
|
(5,102 |
) |
|
|
(24,855 |
) |
Income tax (provision)
benefit |
|
(184 |
) |
|
|
(430 |
) |
|
|
(1,867 |
) |
|
|
1,929 |
|
Net loss |
$ |
(13,151 |
) |
|
$ |
(6,788 |
) |
|
$ |
(6,969 |
) |
|
$ |
(22,926 |
) |
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.06 |
) |
Diluted |
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.06 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
396,618 |
|
|
|
389,699 |
|
|
|
395,681 |
|
|
|
378,770 |
|
Diluted |
|
396,618 |
|
|
|
389,699 |
|
|
|
395,681 |
|
|
|
378,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $93,723 and $110,241 for the three
months ended September 30, 2021 and 2020, respectively, and
research and development expenses were $6,630 and $8,544,
respectively, for the same periods. |
|
RECONCILIATION OF NON-GAAP NET INCOME |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended September 30, |
|
|
Nine months
ended September 30, |
|
|
(in thousands, except per share amounts) |
|
|
(in thousands, except per share amounts) |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net loss for EPS1 - GAAP |
|
(13,151 |
) |
|
|
(6,788 |
) |
|
|
(6,969 |
) |
|
|
(22,926 |
) |
Non-cash stock-based compensation expense |
|
10,432 |
|
|
|
11,583 |
|
|
|
26,836 |
|
|
|
34,306 |
|
Restructuring expense |
|
14,115 |
|
|
|
— |
|
|
|
14,115 |
|
|
|
— |
|
Adjusted net income for EPS1 -
non-GAAP |
$ |
11,396 |
|
|
$ |
4,795 |
|
|
$ |
33,982 |
|
|
$ |
11,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic - non-GAAP |
$ |
0.03 |
|
|
$ |
0.01 |
|
|
$ |
0.09 |
|
|
$ |
0.03 |
|
Diluted - non-GAAP |
$ |
0.03 |
|
|
$ |
0.01 |
|
|
$ |
0.08 |
|
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
396,618 |
|
|
|
389,699 |
|
|
|
395,681 |
|
|
|
378,770 |
|
Diluted |
|
402,657 |
|
|
|
399,400 |
|
|
|
402,787 |
|
|
|
401,454 |
|
i Summary of Product Characteristics Vazkepa – April
2021 https://ec.europa.eu/health/documents/community-register/2021/20210326150935/anx_150935_en.pdf.
Accessed August 2021ii Destatis: Federal Statistical Office: Causes
of death - the number of deaths fell by 1.6% in 2019. (last
accessed on January 6, 2021)iii American Heart Association. Heart
Disease and Stroke Statistics—2020 Update: A Report From the
American Heart
Association. Circulation. 2020;141:e139-e596iv Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am Coll
Cardiol. 2018;72(3):330-343v Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145vi
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):e008740vii
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology, genetics,
and biology. Circ Res. 2016;118:547-563viii 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.ix 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.x 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.
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