Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter ended March 31, 2021 and provided an
update on company operations.
Recent Key Amarin Highlights:
- Q1 net total revenue: Net total
revenue in the first quarter of 2021 was $142.2 million, consisting
of $140.8 million in net product revenue from the United States,
$0.5 million in net product revenue from outside the United States
and $0.8 million in licensing and royalty revenue. Net product
revenue from the United States declined $4.7 million, or 3% in the
first quarter of 2021 compared to the first quarter of 2020.
Results in the first quarter of 2021 were significantly impacted by
COVID-19 and by severe winter storms and power outages in various
areas of the country such as Texas. In addition, while generic
supply has been limited with generic icosapent ethyl (IPE)
accounting for 9% of icosapent ethyl normalized prescriptions in
the first quarter of 2021, as reported by Symphony Health, the
generic introduction created disruption to VASCEPA growth.
Moreover, as reported in conjunction with first quarter 2020
results, net product revenue in the first quarter of 2020 included
$10.8 million from a shipment timing anomaly which effectively
provided an added week of revenue shipments. This anomaly did not
reoccur in the first quarter of 2021.
- Q1 bottom line improvement:
Operating expenses were reduced by $29.0 million in the first three
months of 2021 compared to the prior year, primarily as a result of
lower sales and marketing expenditures incurred as the company
worked to efficiently manage expenses in light of COVID-19 related
limitations impacting physicians, patients and the level of our
promotions. These savings resulted in a reported net loss of $1.6
million ($0.00 per share) in the first quarter of 2021 compared to
a net loss of $20.6 million ($0.06 per share) in the first quarter
of 2020. On a pro forma non-GAAP basis, excluding reported non-cash
expenses, net operating results were profitable in the first
quarter of 2021.
- Received European marketing
authorization for VAZKEPA and commenced pre-launch commercial
initiatives in Europe: Received market authorization from the
European Commission (EC) for icosapent ethyl (brand name VAZKEPA in
Europe) to reduce the risk of cardiovascular events in high-risk,
statin-treated adult patients who have elevated triglycerides (≥150
mg/dL) and either established cardiovascular disease or diabetes
and at least one additional cardiovascular risk factor. Commenced
pre-launch disease and brand awareness campaigns in preparation for
the planned commercial launch of VAZKEPA in Germany, anticipated to
commence before the end of the third quarter of 2021. Similar to
the United States, cardiovascular disease is the number one cause
of death in Europe and, subject to upcoming market access
negotiations, millions of at-risk patients could potentially
benefit from this marketing authorization.
- Received Great Britain marketing
authorization for VAZKEPA from the Medicines and Healthcare
Products Regulatory Agency (MHRA): Received market authorization
from MHRA for icosapent ethyl (brand name VAZKEPA in Great Britain)
as a treatment to reduce the risk of cardiovascular events in high
cardiovascular risk statin-treated adult patients who have elevated
triglycerides (≥150 mg/dL) and either established cardiovascular
disease or diabetes and at least one additional cardiovascular risk
factor. The Great Britain Marketing Authorization for VAZKEPA
applies to England, Scotland and Wales. Under the Brexit Northern
Ireland agreement, the European centralized marketing authorization
for the European Union covers Northern Ireland.
- Mainland China and Hong Kong
approval expected near the end of 2021: As submitted by the
company’s 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. In addition,
medical guidelines of the Chinese Society of Cardiology (CSC) were
updated to recommend use of icosapent ethyl in China.
- Icosapent ethyl use now included in
clinical treatment guidelines or position statements from 15
medical societies: Among these, most directly relevant to Amarin’s
commercialization plans in Europe and China, are medical treatment
guidelines from both the European Society of Cardiology (ESC) and
the European Atherosclerosis Society (EAS) as well as a
recommendation from the Chinese Society of Cardiology (CSC).
- Management succession plans: John
Thero, Amarin’s president and chief executive officer announced
plans to retire effective August 1, 2021 with a planned
transitional support period thereafter. Karim Mikhail, Amarin’s
senior vice president and head of commercial for Europe, has been
appointed as his successor. Joseph Kennedy, Amarin’s executive vice
president, general counsel, another of the small number of senior
management members at Amarin who have been with the company since
before VASCEPA was originally approved in 2012, also announced his
plans to retire from Amarin, as disclosed separately. A search has
commenced to hire a new general counsel with Mr. Kennedy also
intending to support his transition, including continued support of
certain legal matters.
- Strong balance sheet: Ended first
quarter 2021 with $538.7 million in total cash and investments and
no debt.
Management Commentary
“Results in the first quarter of 2021 reflect a
mixture of positive accomplishments and continued headwinds,
particularly from COVID-19, the effects of which continued to be
more persistent than was hoped,” stated John Thero, president and
chief executive officer of Amarin. “A clear highlight of the
quarter was the broad label for VAZKEPA which is now authorized for
marketing in Europe. The opportunity for VAZKEPA in Europe is large
and our team in Europe is making tremendous progress.”
Mr. Thero added, “In the United States, while we
ended the first quarter of 2021 with some early signs of potential
recovery from the effects of COVID-19, such as increased rates of
patients new to the brand and more prescribers of VASCEPA, such
signs are based on limited data, inconsistent, and vary by
geography. Awareness and understanding of VASCEPA remain low and
many at-risk patients are using alternative products that have
failed to demonstrate benefit in cardiovascular outcomes studies.
As we witness greater evidence that the effects of COVID-19 are
receding, we plan to increase what we believe to be our most
cost-effective marketing initiatives to continue the launch of this
important product for the cardiovascular risk reduction indication
that we pulled-back due to COVID-19. We believe that millions of
at-risk patients in the United States could benefit from VASCEPA if
they become better informed regarding the risks of cardiovascular
disease and the proven efficacy and safety profile of VASCEPA.”
“We have an immense opportunity to reduce
occurrences of the often debilitating and deadly effects of
cardiovascular disease and the economic and societal burdens
associated with it globally,” stated Karim Mikhail, who will be
succeeding to the roles of president and chief executive officer of
Amarin upon Mr. Thero’s retirement. “We believe that we have
multi-billion dollar opportunities in the United States, Europe and
potentially in the rest of the world. Regarding Europe, we are
pleased with the label for VAZKEPA authorized for marketing and
sale in the European Union. We have commenced product awareness
initiatives, particularly in Germany where at a recent cardiology
meeting our product was broadly discussed and well received. While
key opinion leaders in Germany are aware of VAZKEPA, between now
and our anticipated product launch in Germany we will work to
increase product awareness more broadly with our greatest priority
on pursuing approved product pricing and related market access
across Europe. We anticipate that any successes in Europe will aid
our plans to expand use of this important product globally.”
Mr. Mikhail added, “I am thankful for the
support that I am getting from John and everyone at Amarin in
preparation for our planned transition on August 1st. With the
effectiveness of our product, and the talent and experience of our
teams globally, I am confident we will achieve every milestone on
our roadmap to success.”
U.S. Prescription Growth
Normalized prescriptions for VASCEPA
(prescription of 120 grams of VASCEPA representing a one-month
supply) in the United States was relatively flat based on Symphony
Health data and increased by approximately 4% based on IQVIA data,
during the first quarter 2021 compared to the same period in 2020.
Estimated normalized VASCEPA prescriptions, based on data from
Symphony Health and IQVIA, totaled approximately 1,064,000 and
989,000 in the first quarter of 2021, respectively, compared with
1,061,000 and 955,000 in the first quarter of 2020, respectively.
The icosapent ethyl market in aggregate, consisting of branded and
generic product, increased for the three months ended March 31,
2021 by approximately 11% as compared to the three months ended
March 31, 2020, based on data from Symphony Health. Unlike product
shipments, upon which revenue is recognized, prescription data
tends not to be lumped primarily into one day each week and
therefore the anomaly which effectively resulted in an added
shipment week for VASCEPA in the first three months of 2020, but
not in the first three months of 2021, is not believed to have
impacted reported prescription levels.
The resurgence of COVID-19 experienced in late
2020 continued throughout the first quarter of 2021, particularly
in certain parts of the United States where VASCEPA usages have
historically been most robust. Based on prescription data reported
by Symphony Health, in the first quarter of 2021 there was a
slowing in prescription growth for major categories of lipid
lowering drugs and the 11% growth of icosapent ethyl prescriptions
was second only to PCSK9s for which prescriptions reportedly grew,
based on data from Symphony Health, albeit against a much smaller
denominator for prescription volume.
In the United States, public reports from IQVIA
showed patient visits, on average, during the three months ended
March 31, 2021 were down to approximately 78% of the first quarter
2020 pre-COVID levels, which tempered the ability to grow new
VASCEPA prescriptions. As a likely consequence of fewer doctors’
visits, fewer lab tests and prioritization of COVID-19 safety,
there have been reports during the COVID-19 era of increased 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 the impact of COVID-19 on
patient visits and lab tests 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.
As previously disclosed, in November 2020, a
generic version of VASCEPA was launched in the United States, which
is indicated only as an adjunct to diet for lowering triglyceride
levels in adult patients with severe hypertriglyceridemia (TG ≥500
mg/dL). The population related to this indication is limited. We
have filed a lawsuit to defend our cardiovascular risk reduction
patent rights against what we believe is unlawful infringement by
the company sponsoring the generic product and a healthcare
insurance company that we believe is likewise representative. The
generic version of VASCEPA captured approximately 9% of the total
icosapent ethyl normalized prescriptions for the three months ended
March 31, 2021, based on data from Symphony Health. In addition,
based on available information we believe that a significant number
of icosapent ethyl prescriptions have gone unfilled in the three
months ended March 31, 2021, due to general market disruption of
order fulfillment processes caused by the launch of the generic
product. Thus far, growth of the generic product has been limited
by lack of qualified supply capacity. While other generic versions
of VASCEPA have regulatory approval to launch in the United States,
they have not yet done so. The extent to which generics companies
are making investments in supply capacity expansion is unclear.
Support for manufacturing capacity expansion and efficiency
improvements have been centerpieces of our development efforts for
the past decade and continue to be key to enable supply to meet our
commercialization plans in the United States, Europe and
globally.
Since the generic product launched in November
2020, 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 which have 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, this
opportunity is expected to be more readily achieved as impacts of
COVID-19 recede. Amarin intends to continue to vigorously defend
its intellectual property rights.
Global Market Expansion
Europe
After receiving marketing authorization for
VAZKEPA in Europe by the EC in late March 2021, Amarin commenced
training sales representatives in Germany to advance pre-launch
disease and brand awareness initiatives in preparation for the
planned commercial launch of VAZKEPA in Germany before the end of
the third quarter 2021. In the coming weeks, Amarin expects to have
approximately 150 sales representatives deployed for pre-launch
product and disease state awareness programs in Germany. Similar
outreach in other countries is being planned with timing linked to
negotiation of product pricing on a country-by-country basis as is
the norm for drug launches in Europe.
In seeking market access, Amarin expects to file
dossiers in 10 European countries in the coming months, including
the largest countries of Europe. After this first wave of dossiers
is advanced, additional dossier filings are planned. These dossiers
include data demonstrating the uniqueness of VAZKEPA from a
scientific perspective, various country-specific demographic data
sets to define the eligible patient population based on the label,
and proposed pricing. Amarin is seeking pricing it believes is well
justified based on the demonstrated clinical effectiveness of
VAZKEPA and the high economic burden of heart attacks, strokes and
other cardiovascular events, which VAZKEPA can help avoid along
with the associated pain and suffering for at-risk patients and
their families caused by such events.
China
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. In addition, the
medical guidelines of the CSC were updated to recommend use of
icosapent ethyl in China. Edding currently anticipates receiving a
decision in Mainland China and separately, 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.
Financial Update
Net total revenue for the three months ended
March 31, 2021 and 2020 were $142.2 million and $155.0 million,
respectively. The $12.8 million decrease in net total revenue
consisted of a $6.2 million decrease in net product revenue from
outside the United States (results in the first quarter of 2020, as
previously reported, including an initial stocking order for
Canada), a $4.6 million decrease in net product sales in the United
States, and a $2.0 million decline in license and royalty revenue
associated with the timing of commercial partners achieving various
pre-defined milestones. Net product revenue from the United States
for the three months ended March 31, 2021 and 2020 were $140.8
million and $145.5 million, respectively, a decrease of 3%. This
decrease was driven primarily by the effects of 1) COVID-19; 2)
severe weather and related power outages; 3) generic competition;
and 4) effectively one fewer week of shipments in the first quarter
of 2021 as compared to the first quarter of 2020, which (as
reported in 2020) added $10.8 million to net product revenue in the
first quarter of 2020. This anomaly, as expected, was not repeated
in 2021. Net product revenue in the first quarter of 2021 was
likely also impacted by our decision to reduce our level of
promotional activities. This expense savings we deemed appropriate
due to limited physician access and fewer patients visits to
doctors as a result COVID-19, as well as regional weather issues
which closed offices for numerous healthcare professionals.
Partially offsetting the effects of reduced promotional activities
were improvements in insurance coverage at various payers which
improved overall throughout 2020 with some continued improvements
in 2021.
Cost of goods sold for the three months ended
March 31, 2021 and 2020 was $28.3 million and $34.8 million,
respectively. Amarin’s overall gross margin on net product revenue
for the three months ended March 31, 2021 and 2020 was 80% and
77%, respectively, in part reflecting the mix of net product
revenue between sales in the United States and sales to our
commercial partners (gross margins are generally lower for sales to
commercial partners the resell the product and are responsible for
promotional costs in their agreed territories).
Selling, general and administrative (SG&A)
expenses for the three months ended March 31, 2021 and 2020
was $105.8 million and $133.9 million, respectively, representing a
decrease of 21%. This decrease was primarily due to a decrease in
marketing and direct-to-consumer promotions in 2021, as our partial
response to limitations imposed by COVID-19 and our focus on
improving the profitability of our operations in the United States.
Additionally, due to COVID-19, the company intentionally slowed the
hiring of replacements for open positions in the United States
resulting from ordinary turnover, partially offset by increased
personnel costs related to preparing for the launch of VAZKEPA in
Europe. The decrease in SG&A expenses also reflects lower legal
fees associated with the timing of prior ANDA patent litigation in
the United States.
Research and development expenses for the three
months ended March 31, 2021 and 2020 were $9.4 million and
$10.3 million, respectively. This decrease primarily reflects
completion of certain analyses performed beyond the REDUCE-IT
cardiovascular outcomes trial primary results. Included in such
expenses for the three months ended March 31, 2021 were certain
costs to support ongoing studies of VASCEPA regarding its potential
to help prevent or mitigate the clinical effects of COVID-19. The
results of such ongoing studies are blinded to Amarin.
Under U.S. GAAP, Amarin reported a net loss of
$1.6 million in the first quarter of 2021, or basic and diluted
loss per share of $0.00. This net loss included $13.9 million in
non-cash stock-based compensation expense. Amarin reported a net
loss of $20.6 million in the first quarter of 2020, or basic and
diluted loss per share of $0.06 . This net loss included $10.6
million in non-cash stock-based compensation expense.
Excluding non-cash stock-based compensation
expense, non-GAAP adjusted net income was $12.3 million for the
three months ended March 31, 2021, or non-GAAP adjusted basic
and diluted earnings per share of $0.03, compared to non-GAAP
adjusted net loss of $10.0 million for the three months ended
March 31, 2020, or non-GAAP adjusted basic and diluted loss
per share of $0.03.
As of March 31, 2021, Amarin reported
aggregate cash and investments of $538.7 million, consisting of
cash and cash equivalents of $291.0 million and liquid short-term
and long-term investments of $223.7 million and $24.0 million,
respectively. As of March 31, 2021, Amarin reported $151.3
million in net accounts receivable ($220.2 million in gross
accounts receivable before allowances and reserves) and $230.9
million in inventory. Amarin reiterates that, based on the current
plans, we believe that our existing resources are sufficient to
fund VAZKEPA’s launch in Europe and to support our ongoing US
promotion.
As of March 31, 2021, Amarin had
approximately 394.8 million ADSs and ordinary shares outstanding
and approximately 19.4 million equivalent shares underlying stock
options at a weighted-average exercise price of $7.68, as well as
10.3 million equivalent shares underlying restricted or deferred
stock units.
Conference Call and Webcast
Information:
Amarin will host a conference call April 29,
2021, at 7:30 a.m. ET to discuss this information. The conference
call can be heard live on the investor relations section of the
company's website at www.amarincorp.com, or via telephone by
dialing 888-506-0062 within the United States, 973-528-0011 from
outside the United States, and referencing conference ID 942273. A
replay of the call will be made available for a period of four
weeks following the conference call. To hear a replay of the call,
dial 877-481-4010, PIN: 40926. 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 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, and Zug in Switzerland as well as
commercial partners and suppliers around the world. We are
committed to rethinking cardiovascular risk through the advancement
of scientific understanding of the impact on society of significant
residual risk that exists beyond traditional therapies, such as
statins for cholesterol management.
About Cardiovascular Risk
Cardiovascular disease is the number one cause
of death in the world. In the United States alone, cardiovascular
disease results in 859,000 deaths per year.1 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%.2 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.
3,4,5
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.6 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.7 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.8 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
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 and expectations that VASCEPA
growth is positioned to increase as the impact of COVID-19 recedes,
the timing and outcome of patent litigation and the impact of the
launch and future launches of generic competition on these metrics;
plans and expected timing to launch VAZKEPA in Europe and the
timing and outcome of other regulatory reviews, recommendations and
approvals and related reimbursement decisions and commercial
launches in the China region, Europe and elsewhere; beliefs about
the opportunity for VAZKEPA in Europe and that the team is making
tremendous progress; expectations for the executive succession; the
timing and outcome of promotion activities, including
patient-oriented campaigns and education of healthcare
professionals and plans to resume marketing initiatives and
increase product awareness; beliefs about the market opportunity
for VASCEPA in the U.S. and worldwide, including that millions of
at-risk patients in the U.S. could benefit from VASCEPA; the
expectation that any successes in Europe will aide plans to expand
globally; statements regarding 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; beliefs about the generic
market, including the availability of commercial supply to generic
companies and Amarin, the population addressable by the generic
version of VASCEPA and pricing dynamics; plans to grow the market
faster than generic competition can take share; expectations
related to exclusivity in various jurisdictions; beliefs about the
ongoing patent litigation efforts, including the lawsuit we filed
to defend our patent rights and plans to vigorously defend our
intellectual property rights; plans for our global market
expansion, including the sales teams, dossier filings, pricing
negotiations and other launch initiatives, and our belief that our
existing resources are sufficient to fund VAZKEPA’s launch in
Europe and to support our U.S. promotion; 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 the China region or other geographies on the
expected timelines or at all and that, even if VASCEPA does receive
regulatory approval, we might not be successful or timely in
launching and commercializing the product in a particular
geography, including Europe, particularly since we have no
experience commercializing a product internationally; 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; the risk that we have
overestimated U.S. and worldwide market opportunities and our
ability to successfully access them; 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 our annual report on Form 10-K for the year ended
December 31, 2020, filed on February 25, 2021 and Amarin’s
quarterly report on Form 10-Q for the quarter ended March 31, 2021,
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
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) 719-1315IR@amarincorp.com
(investor inquiries)
Solebury Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028PR@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 |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
|
|
|
|
|
|
(in
thousands) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
290,994 |
|
|
$ |
186,964 |
|
Restricted cash |
|
|
3,917 |
|
|
|
3,915 |
|
Short-term investments |
|
|
223,742 |
|
|
|
313,969 |
|
Accounts receivable, net |
|
|
151,275 |
|
|
|
154,574 |
|
Inventory |
|
|
230,892 |
|
|
|
188,864 |
|
Prepaid and other current assets |
|
|
29,696 |
|
|
|
30,947 |
|
Total current assets |
|
|
930,516 |
|
|
|
879,233 |
|
Property, plant and equipment, net |
|
|
1,862 |
|
|
|
2,016 |
|
Long-term investments |
|
|
24,004 |
|
|
|
62,469 |
|
Operating lease right-of-use asset |
|
|
7,958 |
|
|
|
8,054 |
|
Other long-term assets |
|
|
456 |
|
|
|
432 |
|
Intangible asset, net |
|
|
25,456 |
|
|
|
13,817 |
|
TOTAL ASSETS |
|
$ |
990,252 |
|
|
$ |
966,021 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
94,262 |
|
|
|
105,876 |
|
Accrued expenses and other current liabilities |
|
|
228,734 |
|
|
|
198,641 |
|
Current deferred revenue |
|
|
2,773 |
|
|
|
2,926 |
|
Total current liabilities |
|
325769 |
|
|
|
307,443 |
|
Long-Term Liabilities: |
|
|
|
|
|
|
|
|
Long-term deferred revenue |
|
|
15,197 |
|
|
|
15,706 |
|
Long-term operating lease liability |
|
|
9,015 |
|
|
|
9,153 |
|
Other long-term liabilities |
|
|
5,660 |
|
|
|
6,214 |
|
Total liabilities |
|
|
355,641 |
|
|
|
338,516 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
292,360 |
|
|
|
290,115 |
|
Additional paid-in capital |
|
|
1,831,388 |
|
|
|
1,817,649 |
|
Treasury stock |
|
|
(58,334 |
) |
|
|
(51,082 |
) |
Accumulated deficit |
|
|
(1,430,803 |
) |
|
|
(1,429,177 |
) |
Total stockholders’ equity |
|
|
634,611 |
|
|
|
627,505 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
990,252 |
|
|
$ |
966,021 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
(U.S. GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
(in thousands, except per share amounts) |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
141,383 |
|
|
$ |
152,204 |
|
Licensing and royalty
revenue |
|
787 |
|
|
|
2,789 |
|
Total revenue, net |
|
142,170 |
|
|
|
154,993 |
|
Less: Cost of goods sold |
|
28,326 |
|
|
|
34,807 |
|
Gross margin |
|
113,844 |
|
|
|
120,186 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
105,798 |
|
|
|
133,937 |
|
Research and development (1) |
|
9,377 |
|
|
|
10,278 |
|
Total operating expenses |
|
115,175 |
|
|
|
144,215 |
|
Operating loss |
|
(1,331 |
) |
|
|
(24,029 |
) |
Interest income, net |
|
471 |
|
|
|
1,208 |
|
Other expense, net |
|
(142 |
) |
|
|
(91 |
) |
Loss from operations before
taxes |
|
(1,002 |
) |
|
|
(22,912 |
) |
Income tax (provision)
benefit |
|
(624 |
) |
|
|
2,359 |
|
Net loss |
$ |
(1,626 |
) |
|
$ |
(20,553 |
) |
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.00 |
) |
|
$ |
(0.06 |
) |
Diluted |
$ |
(0.00 |
) |
|
$ |
(0.06 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
394,638 |
|
|
|
361,136 |
|
Diluted |
|
394,638 |
|
|
|
361,136 |
|
|
|
|
|
|
|
|
|
(1) Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $94,801 and $124,919 for the three
months ended March 31, 2021 and 2020, respectively, and research
and development expenses were $6,449 and $8,705, respectively, for
the same periods. |
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended March 31, |
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
2021 |
|
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
Net loss for
EPS1 - GAAP |
|
(1,626 |
) |
|
|
|
(20,553 |
) |
Non-cash stock-based compensation expense |
|
|
13,925 |
|
|
|
|
10,591 |
|
Adjusted net
income (loss) for EPS1 - non-GAAP |
$ |
12,299 |
|
|
|
$ |
(9,962 |
) |
|
|
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per
share: |
|
|
|
|
|
|
|
|
Basic - non-GAAP |
$ |
0.03 |
|
|
|
$ |
(0.03 |
) |
Diluted -
non-GAAP |
$ |
0.03 |
|
|
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
Basic |
|
394,638 |
|
|
|
|
361,136 |
|
Diluted |
|
403,650 |
|
|
|
|
373,238 |
|
_________________________________1 American Heart Association.
Heart Disease and Stroke Statistics—2020 Update: A Report From the
American Heart Association. Circulation. 2020;141:e139–e596.2
Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive
dyslipidemia therapy in hypertriglyceridemia management. J Am
Coll Cardiol. 2018;72(3):330-343.3 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth
PP, Granowitz C, Hull M, et al. High triglycerides are associated
with increased cardiovascular events, medical costs, and
resource use: A real-world administrative claims analysis of
statin-treated patients with high residual
cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.5
Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic
cardiovascular disease - New insights from epidemiology,
genetics, and biology. Circ Res. 2016;118:547-563.6 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;40:138-148.7 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;380:11-22.8 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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