Amarin Corporation plc (NASDAQ:AMRN) today provided a business
update, including preliminary unaudited full-year 2021 revenue
results. Amarin plans to discuss these results and expectations
with investors in connection with the 40th Annual J.P. Morgan
Healthcare Conference at which Amarin is scheduled to present
virtually on Tuesday, January 11, 2022, at 8:15 am Eastern time.
Preliminary (Unaudited) 2021 Financial
Results
Revenue Levels: Full-year 2021 total net revenue, subject
to audit, are estimated to be approximately $580 million, despite
continued impact of global COVID-19 pandemic and generic
competition in the United States. Fourth quarter 2021 total revenue
is estimated to be approximately $140 million, which is at a
similar level as the third quarter of 2021 and stabilizing the 8%
decline experienced in Q3 2021 as compared to Q2 2021.
Liquid Assets: Amarin ended 2021 with approximately $490
million in cash and investments, approximately $145 million in net
accounts receivable, all of which are current, and with no
debt.
Management Commentary
“With the approval of VAZKEPA by EMA at the end of the first
quarter of 2021, our expeditious reimbursement dossier submission
in ten countries in Europe and the recognition by key
cardiovascular societies of the value that icosapent ethyl brings
to patients with residual cardiovascular risk, Amarin has the
unique opportunity to lead a new paradigm in cardiovascular disease
management worldwide,” said Karim Mikhail, Amarin’s president and
chief executive officer. “Today, we are also delighted to announce
an expansion of our portfolio with our plans to develop a fixed
dose combination of VASCEPA® and a statin.”
“Our vision to stop heart disease from being a leading cause of
death globally is a large undertaking that motivates us every day
to deliver for patients with cardiovascular risk. We remain
committed to achieving our goals, confident that Amarin has the
passion, the science, the strategic planning and the people to
realize our vision,” concluded Mr. Mikhail.
Highlights from 2021 and Outlook for 2022
Europe
Highlights of Amarin’s progress in Europe during 2021
include:
- Approval of VAZKEPA by the European Commission and the
Medicines and Healthcare Products Regulatory Agency as the
first and only treatment to reduce cardiovascular risk in
high-risk, statin-treated adult patients who have elevated
triglycerides (≥150 mg/dL) and other risk characteristics;
- The successful build out of the European commercial
organization, which now has 16 legal entities and branches, and a
commercial hub in Zug, Switzerland;
- Reimbursement discussions proceeding as planned with the
submission of market access dossiers in ten European countries
namely Germany, UK, Italy, France, Spain, Denmark, Sweden, Finland,
Norway, and the Netherlands; and
- Launch of VAZKEPA in mid-September 2021, which is tracking well
relative to other recent cardiometabolic launches, despite the
significant, ongoing and resurging COVID-19 disruptions.
Amarin’s outlook for achievement in Europe in 2022 includes:
- Ongoing education and awareness campaigns across Germany to
build market adoption and grow prescriptions for VAZKEPA;
- Outcome of market access (reimbursement) decisions in up to
eight countries;
- The launch of VAZKEPA in up to six countries;
- Submission of market access dossiers in an additional five
European countries; and
- Execution of several agreements in Central and Eastern European
markets with partners who already have established infrastructure
in such markets.
United States
U.S. commercial highlights from 2021 include:
- U.S. product net revenue expected to approximate $575 million
in 2021 amidst the ongoing challenges of the COVID-19 pandemic and
the impact of two generic icosapent ethyl products;
- The U.S. commercial operation continues to operate on a
positive contribution margin basis and, along with a strong balance
sheet, helps support Amarin’s global growth initiatives; and
- Confirmation that the new Go-to-Market strategy has been
successfully implemented in the fourth quarter 2021, and is
starting to show early results:
- We have reached more than 150,000 HCPs through our sales force
and omnichannel initiatives which are driven by a targeted HCP
segmentation strategy and marketing channel optimization;
- Amarin continues to work closely with payers to ensure that
VASCEPA maintains a net cost advantage compared to generic
icosapent ethyl products. As a result, many payers are covering
VASCEPA as the exclusive icosapent ethyl (IPE) product on their
formularies. As of December 2021, approximately 40% of total
Commercial and Medicare Part D lives estimated to have VASCEPA
covered as the exclusive IPE product on a weighted average basis;
and
- Amarin has partnered with BlinkRx, a unique patient access
solution, to provide an enhanced, digital-first prescription
fulfillment channel, that eliminates the challenges for patients in
starting and remaining on VASCEPA. Patients benefit from
transparent low prices, free home delivery, and world-class
support.
U.S. commercial outlook in 2022 is expected to feature:
- Continued amplification and expansion of sales force reach
through orchestrated omnichannel engagement to enhance customer
reach, coverage, share of voice and prescriptions;
- Emphasis to all stakeholders that VASCEPA is the only
prescription IPE product FDA approved for cardiovascular risk
reduction based on the landmark REDUCE-IT trial; and
- Consistent effort to grow existing awareness and adoption to
ensure VASCEPA revenue in the U.S. is stabilized in the short term,
until future life cycle management initiatives deliver their
intended growth contribution.
Amarin does not typically comment on ongoing litigation.
However, with regards to the District Court’s decision in
the Amarin Pharma, Inc. et. al. v. Hikma Pharma, Inc. et.
al. matter, we are pleased that the Court found that there
exists sufficient basis and factual questions concerning inducement
of infringement for the litigation to proceed against Health Net.
Amarin will continue to vigorously pursue its case against Health
Net. While we are disappointed in the ruling on Hikma’s Motion to
Dismiss, we recognize that this is an evolving area of law. Amarin
is currently assessing its options, including seeking leave to file
an amended complaint or file an appeal of the District Court’s
decision. Amarin believes that its patents are being infringed upon
and will continue to fight to protect the company’s intellectual
property.
International
Amarin’s progress toward achieving its goal of expanding the
global reach of VASCEPA/VAZKEPA during 2021 was highlighted by:
- Acceptance by the Chinese National Medical Products
Administration and the Hong Kong Department of Health to review the
new drug applications for VASCEPA filed by the company’s partner,
Edding;
- Development and announcement of an international expansion
strategy, through partnerships, that highlights plans to bring the
cardiovascular risk reduction benefits of VASCEPA/VAZKEPA to
approximately 20 additional countries over the course of the next
three years; and
- Announcement of VASCEPA co-promotional agreement for Amarin’s
partner in Canada, HLS Therapeutics, with Pfizer in Canada.
Outlook and plans for international expansion in 2022 to
include:
- Final regulatory actions on VASCEPA in Mainland China and in
Hong Kong in second half of 2022; and
- Regulatory filings, approvals and potential launches of
VASCEPA, via partners, in up to six new countries, including
Australia, New Zealand, and some Asia-Pacific markets.
Life Cycle Management (LCM)
Highlights of Amarin’s progress in LCM during 2021 and outlook
for 2022:
Building on the results of the landmark REDUCE-IT study of
VASCEPA on top of statin therapy, the Amarin team dedicated
substantial effort in 2021 to exploring opportunities for enhancing
our offering to patients in need of reducing their residual
cardiovascular risk. As a result of this effort, Amarin has
initiated development of a fixed dose combination product that has
both icosapent ethyl and a statin. “VASCEPA’s indication for
cardiovascular risk reduction provides for the use of the product
on top of statin therapy. Our plans to develop and produce a
product that has the two components in one has the potential to be
a more convenient product for HCPs and patients,” commented Steve
Ketchum, Amarin’s executive vice president, president of R&D
and chief scientific officer.
New Member of Amarin’s Board of Directors:
We are pleased to announce that Per Wold-Olsen will join the
Board of Directors on January 10, 2022, bringing a wealth of global
Life Science commercialization and healthcare experience to the
Board.
Mr. Wold-Olsen now serves as Chairman of the Board of GN Store
Nord A/S, a global top 20 listed Hearing Aid company based in
Denmark. He also serves as Chairman of Oncopeptides AB, a Swedish
based biotech company. He is past Chairman of Lundbeck A/S, past
Chairman of the Medicines for Malaria Ventures, past board member
of Gilead Sciences and past board member and now Chair of the
Advisory Committee of Novo Holdings - A world leader in Life
Science investing.
During his 30-year tenure at Merck & Co. Inc. in Europe and
in the US, Mr. Wold-Olsen served as a member of Merck’s Executive
Committee between 1994 and 2006. He retired from Merck at the end
of 2006 as the President of the Intercontinental Region. At Merck,
he was widely seen as the architect of many of the company’s
landmark cardiovascular outcome studies - some of the key drivers
of Merck’s cardiovascular strategies to demonstrate value, stay
competitive and deliver shareholder value.
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 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.
About Amarin Amarin is an innovative
pharmaceutical company leading a new paradigm in cardiovascular
disease management. From our foundation in scientific research 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 increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
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 yeari 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)
CapsulesVASCEPA (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 StatementsThis 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 (marketed as VAZKEPA in Europe); beliefs that
Amarin has the unique opportunity to lead a new paradigm in
cardiovascular disease management worldwide; plans to develop a
fixed dose combination of VASCEPA® and a statin; plans to stop
heart disease from being a leading cause of death globally; beliefs
that Amarin has the passion, the science, the strategic planning
and the people to realize the Amarin vision; beliefs about the
launch of VAZKEPA, including as compared to other recent
cardiometabolic launches; plans for ongoing education and awareness
campaigns; expectations for market access (reimbursement)
decisions, dossier submissions, partnering and launch in various
countries; beliefs that the new Go-to-Market strategy has been
successfully implemented and expectations for such initiatives;
plans to expand sales force reach, and expected benefits, and plans
to grow existing awareness and adoption of VASCEPA; plans for
future LCM initiatives; belief and plans for ongoing litigation
matters; plans for VASCEPA beyond the EU and the United States,
including expected timelines for final regulatory actions in
Mainland China and in Hong Kong in second half of 2022, and other
regulatory and commercial activities; plans regarding a fixed dose
combination product that has both icosapent ethyl and a statin and
its potential to be a more convenient product for HCPs and
patients; expectations for Mr. Wold-Olsen; Amarin’s 2022 outlook,
including the impact of the uncertainties resulting from the impact
of COVID-19 and generic availability in the U.S. and expectations
that U.S. commercial operations will continue to operate on a
contribution margin positive basis; plans to 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; goals
of progressing LCM opportunities; the commitment to evaluate its
planned spend in 2022 and adjust if assumptions warrant adjustments
and Amarin’s belief that current cash and investments and other
assets are adequate to support continued operations, including
European launch activities. 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. 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 communicates with its investors and the
public using the company website (www.amarincorp.com) and the
investor relations website (investor.amarincorp.com), including but
not limited to investor presentations and 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 Information
Investor Inquiries: Investor Relations Amarin Corporation plc In
U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries)
Solebury Trout In U.S.: +1 (646) 378-2992
amarinir@troutgroup.com
Media Inquiries: Communications Amarin Corporation plc In U.S.:
+1 (908) 892-2028 PR@amarincorp.com (media inquiries)
i American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American Heart
Association. Circulation. 2020;141:e139-e596. ii 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.iii Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145. iv 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. v 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.
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