Amarin Corporation plc (NASDAQ:AMRN) today provided a business
update, including preliminary unaudited full-year 2020 revenue
results. Amarin plans to discuss these results and expectations
with investors in connection with the 39th Annual J.P. Morgan
Healthcare Conference at which Amarin is scheduled to present on
Tuesday, January 12, 2020, at 2:00 pm Eastern time.
Preliminary (unaudited) 2020 Financial
Results
Record Revenue Levels: Full-year 2020 total
net revenue, subject to audit, are expected to be approximately
$610 million. Despite the impact of COVID-19, this estimated 2020
net revenue expectation represents an increase of approximately 42%
compared with full-year 2019 results. This growth was primarily
driven by increased prescription levels of VASCEPA® in the United
States.
Liquid Assets: Amarin ended 2020 with more
than $550 million in cash and investments, approximately $150
million in net accounts receivable and approximately $180 million
in inventory.
No Debt: At year-end 2020, Amarin had no debt,
having fully repaid its prior royalty-like debt instrument in the
fourth quarter of 2020, which from 2013 through most of 2020
required approximately 10% of net revenue to be paid against this
prior obligation.
Management Commentary“Amarin
has the people, product and resources to expand globally starting
with anticipated 2021 VASCEPA regulatory approval and commercial
launch in Europe. Our expected growth in Europe and elsewhere
overseas will build on our growth and experience in the United
States,” commented John F. Thero, president and chief executive
officer. “We intend to build on our strong scientific foundation
and medical experience. As patients begin to return for medical
care beyond the COVID-19 era, we aim to ensure that VASCEPA is
increasingly prescribed to help at-risk patients. While 2020 was a
challenging year, I am thankful to our employees for the progress
they made in countless areas. Their hard work and passion provide a
strong foundation from which we will further launch VASCEPA to
reduce persistent cardiovascular risk in appropriate patients, or
P-CVR, in the United States, Europe and around the world.”
Highlights from 2020 and
Outlook
U.S. Commercial
Amarin achieved a number of important commercial
milestones in 2020, despite the challenges Amarin faced with
COVID-19 and the November launch of generic icosapent ethyl in the
United States.
U.S. commercial highlights from 2020
include:
- Record levels of VASCEPA revenues,
prescriptions, prescribers and patients
- Faster prescription growth for
VASCEPA as compared to most other cardiovascular drugs that
reported positive outcomes studies in recent years, despite VASCEPA
having a lower level of promotional spend than many such drugs
- VASCEPA growth in 2020 due to
COVID-19 was slower than initially expected but compares well with
the growth in 2020 of peer drugs
- The P-CVR indication has quickly
garnered the largest part of the market as approximately 93% of
VASCEPA prescriptions based on the most recent data reported to us
by IQVIA were for patients with triglyceride (TG) levels below 500
mg/dL
- Further expanded managed care
coverage for VASCEPA during 2020 with additional improvements
agreed for 2021
- Such increases are consistent with
third-party analysis, which found VASCEPA to be cost effective, and
with medical guidelines or recommendations from six leading U.S.
medical societies
- Doubled size of sales force
(training for this expanded group was completed in March 2020 just
before Amarin’s customer-facing team was temporarily prohibited
from conducting in-person meetings due to COVID-19)
- Adapted to COVID-19 protocols with
various tele-sales, tele-marketing and virtual education
initiatives as well as training representatives to safely interact
with healthcare professionals where possible
U.S. commercial outlook includes:
- Confidence that millions of at-risk
patients remain untreated for P-CVR and could benefit from
VASCEPA
- Recognition that many at-risk
patients ceased doctor visits for ordinary care in 2020 but are
likely to return to their doctors for needed care as COVID-19 risk
recedes
- According to IQVIA, patient visits
to medical offices for non-emergency medical care were down
approximately 70% in April 2020 during the height of COVID-19, with
visits steadily increasing thereafter. In December 2020, as a
result of a spike in COVID-19 cases, patient visits have decreased
approximately 50% compared to pre-COVID levels
- Following a resurgence of COVID-19
in recent months, Amarin intends to reduce spending levels for
certain forms of promotion (e.g., television advertisements) in
early 2021
- U.S. promotional spending likely to
be variable with adjustments upward or downward in response to the
changing impact from COVID-19 and generic competition
- As COVID-19 vaccine progress is
made, along with other mitigating approaches, Amarin plans to
increasingly resume its promotion of VASCEPA for P-CVR while
continuing to adapt to market changes
- Generic competition launched in
November 2020 only for the original indication (TG >500 mg/dL)
and is expected to continue to face supply limits, despite
stockpiles of generic product likely created prior to launch
- Variability is expected as
patients, pharmacies and payers adjust to the availability, pricing
and label of this generic competition
- Due to the uncertainties regarding
COVID-19 and potential generic supply, Amarin will continue to
withhold 2021 revenue guidance for VASCEPA in the U.S. until there
is greater clarity on the impact of these issues
- Amarin intends to continue to
manage its U.S. commercial operations to expand patient care and
enhance profits from U.S. operations
Europe
Europe highlights from 2020 include:
- Reached Day 180 of the European
Medicines Agency, or EMA, centralized regulatory review of VASCEPA
assuring that the United Kingdom is grandfathered into a
facilitated review process despite its withdrawal from the European
Union
- An expanded recommendation was
issued by the European Society of Cardiology regarding use of
icosapent ethyl (U.S. brand name VASCEPA)
- Increased the size of the Amarin
team in Europe to approximately 50 experienced professionals to
support pre-approval and pre-launch preparations for VASCEPA in
select countries
- Commenced interactions with
authorities in select countries regarding VASCEPA market access
assuming approval, noting that more formal proceedings cannot
progress until after the product is approved and the label is
established
- Made major advances in expanding
company-wide systems to support expected commercial launch of
VASCEPA in Europe in 2021
Europe outlook includes:
- Millions of at-risk patients could
benefit from VASCEPA in Europe
- There are more patients on statins
in Europe in aggregate compared to the U.S. and the rate of death
from cardiovascular disease is higher
- Regulatory approval expected in
early 2021
- CHMP opinion expected in late
January or February 2021
- EMA approval decision expected
within 67 days of CHMP decision
- Market access negotiations
anticipated on a country-by-country basis promptly after approval
- Seeking net pricing that equals or
exceeds U.S. net pricing with focus on P-CVR indication based on
outcomes data in Europe, whereas pricing in the U.S was based on
original TG lowering indication
- Launch timing by country dependent
on market access (i.e., insurance coverage)
- At a minimum, launch expected in
Germany in 2021 after initial product awareness campaign
- Launch in Germany and other
countries is anticipated to give priority to specialists (e.g.,
cardiologists) and to also include substantial digital educational
and promotional initiatives
- Target of approximately 200
employees (or contractors) in the European commercial team by end
of 2021
Rest of World
Rest of world, or ROW, highlights from 2020
include:
- China positive clinical study
results reported
- Canada commercial launch of VASCEPA
initiated (just prior to slowdown from COVID-19)
- Canada reimbursement levels for
VASCEPA established within six months of product regulatory
approval to facilitate treating patients with established
cardiovascular disease
ROW outlook includes:
- Large at-risk patient opportunities
- In China 290 million people are
reported to have cardiovascular disease, a number which has been
increasing rapidly in recent years, including approximately 52
million reported to have high TG levels, a substantial portion of
whom might be able to benefit from VASCEPA
- Plans to submit application for
regulatory approval through Amarin’s commercial partner in the
People's Republic of China
- Anticipate inclusion of VASCEPA in
the treatment guidelines in Chinese medical societies
- Pursue opportunities for VASCEPA in
untapped countries after approval and market access in Europe is
secured, with such approval and market access expected to enhance
ROW positioning
R&D and Medical Advancement
R&D and medical advancement highlights from
2020 include:
- EVAPORATE exploratory study
results, as previously reported, reported 17% reduction in plaque
volume in patients with coronary atherosclerosis treated with
VASCEPA
- Numerous other studies presented in
support of the potential unique mechanism of action of VASCEPA
- In aggregate, Amarin supported over
40 scientific publications and presentations in 2020
- CardioLink-19 exploratory study
results, as previously reported, evaluated a higher initial dose of
VASCEPA and suggested VASCEPA could potentially have utility as a
therapeutic option for mitigating COVID-19 effects in an
out-patient setting
- This pilot study was rapidly
commenced and completed with results that exceeded
expectations
- Additional COVID-19 investigational
studies of VASCEPA were also commenced in 2020
- Witnessed an increase to twelve
(12) the number of medical societies globally that now include
icosapent ethyl in their guidelines or have otherwise recommended
its use
R&D and medical outlook includes:
- Supporting approval of VASCEPA in
Europe and regulatory review processes initiated by Amarin’s
commercial partner in the People's Republic of China
- Supporting cost-effectiveness
studies and market access for VASCEPA wherever it is approved
- Support completion of COVID-19
investigational studies and, based on the results, decide on
appropriate next steps
- Continue to study and differentiate
the unique clinical and biological effects of VASCEPA
- In concert with Amarin’s business
development and other efforts, prioritize and execute on potential
opportunities to expand indications for VASCEPA or develop new
products
Financial Resources
Amarin reiterates that it believes its current
cash resources are adequate to support the European launch and its
planned operations and priorities in the United States and
globally. Such guidance included anticipated resources likely
needed to further expand its VASCEPA supply capacity in
anticipation of launches of VASCEPA in Europe, China and other
countries as well as the opportunity to continue to grow
prescription levels in the United States after COVID-19 recedes,
continuing the launch of VASCEPA for P-CVR as commenced in
2020.
Currently, Amarin anticipates 2021 operating
expenses of approximately $550 million to $600 million which
represents an increase of approximately 10% to 20%, compared with
2020 levels. Included in these anticipated expenses are increased
costs associated with Amarin’s commercial launch preparations and
initial launch in Europe as well as continued U.S. promotional
activities, including increased face to face interactions between
Amarin’s sales professionals and health care providers and
direct-to-consumer advertising in the U.S. after the impact of
COVID-19 becomes less pronounced and at-risk patients begin
returning to their doctors for non-urgent medical care. With
continued investment in consumer and in-person marketing, Amarin
expects VASCEPA revenue growth in the U.S. As described above,
these spending levels may vary from quarter to quarter. Further
these operating expense levels assume substantial societal recovery
in 2021 from COVID-19 and the continued limited availability of
supply to the generic companies. Amarin will re-evaluate its
planned spend in 2021 if any of these assumptions change.
More Information to Follow
Amarin expects to provide further details
regarding its 2020 results and perspective regarding its future
outlook in the company's annual report on Form 10-K.
About Amarin Amarin Corporation
plc is a rapidly growing, innovative pharmaceutical company focused
on developing and commercializing therapeutics to cost-effectively
improve cardiovascular health. Amarin’s lead product, VASCEPA®
(icosapent ethyl), is available by prescription in the United
States, Canada, Lebanon and the United Arab Emirates. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, Europe and the Middle East. For more information
about Amarin, visit www.amarincorp.com.
About Cardiovascular
RiskCardiovascular disease is an enormous and growing
public burden globally. In the United States alone there are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds), in the United States. Stroke
rates are 795,000 per year (approximately 1 every 40 seconds),
accounting for 1 of every 19 U.S. deaths. Cardiovascular disease
results in 859,000 deaths per year in the United States.1 In
aggregate, there are more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, one every 13 seconds in the United States alone.
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)
CapsulesVASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. 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 eight million times. VASCEPA is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of UseVASCEPA 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 VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements regarding revenue and prescription growth, the impacts
of COVID-19, including its future trajectory and effects on
non-urgent medical care, the impacts of generic competition,
including expected levels of generic supply, changes to U.S.
commercial operations, including to spending and promotional
levels, plans for commercial and international expansion, including
the timing and outcome of regulatory approvals, market access
negotiations and commercial launch, R&D and medical outlook,
including the timing and results of future studies, market access
efforts and indication expansion opportunities, the adequacy of its
current cash resources and its 2021 operating expenses. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA will depend in part on its
ability to continue to effectively finance its business, efforts of
third parties, its ability to create 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 and maintain patent
protection for VASCEPA. Among the factors that could cause actual
results to differ materially from those described or projected
herein include the following: uncertainties associated with the
COVID-19 pandemic and generic competition; factors outside of our
control may prevent VASCEPA from achieving market acceptance and
commercial success; the commercial value of VASCEPA outside the
United States may be smaller than we anticipate; uncertainties
associated generally with research and development, clinical trials
and related regulatory approvals; and sales may not meet
expectations and related costs may increase beyond expectations. 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 its most recent Quarterly Report on Form 10-Q. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof. Amarin undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise. Amarin’s forward-looking statements do not reflect the
potential impact of significant transactions the company may enter
into, such as mergers, acquisitions, dispositions, joint ventures
or any material agreements that Amarin may enter into, amend or
terminate.
Availability of Other Information About
AmarinInvestors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact
InformationInvestor Inquiries:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com
(investor inquiries)
Solebury TroutamarinIR@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media
inquiries)
________________________________ |
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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