Amarin Corporation plc (NASDAQ:AMRN), today provided a business
update, including an update of preliminary 2019 results and
additional 2020 financial guidance. Amarin plans to discuss
these results and expectations with investors in connection with
the 38th Annual J.P. Morgan Healthcare Conference in San Francisco,
California, at which Amarin is scheduled to present on Wednesday,
January 15, 2020, at 10:30 a.m. Pacific Time (PT) / 1:30 p.m.
Eastern Time (ET).
Preliminary (unaudited) 2019
Financial Results
Record Revenue Levels: 2019 net
total revenue, subject to audit, are expected to be at or
potentially slightly above the upper-end of the company’s
previously expressed guidance of $410 to $425 million, this upper
end representing an increase of ~85% over 2018 results. Net total
revenue consists predominantly of U.S. sales driven by increased
prescriptions for VASCEPA® (icosapent ethyl) capsules. Wholesaler
inventory levels of VASCEPA were within normal industry ranges at
the end of 2019.
Current Assets: Amarin ended
2019 with approximately $645 million in cash, approximately $117
million in net accounts receivable and approximately $76 million in
inventory.
No Debt, Except Remaining Balance of
Royalty-Bearing Instrument: Amarin ended 2019 with no debt
except the remaining balance on its royalty-bearing instrument
which is repaid at a rate of 10% of VASCEPA revenue until this
royalty-like obligation is fulfilled; aggregate repayment of less
than $55 million remained as of December 31, 2019.
2020 Financial and Operational
Guidance
On December 13, 2019, Amarin announced the
approval of VASCEPA as the first and only drug with an FDA-approved
indication for reducing cardiovascular risk in patients with
persistent high cardiovascular risk despite statin therapy as
studied in the REDUCE-IT® cardiovascular outcomes study. With this
new indication, Amarin aims to help millions of patients through
aggressively launching VASCEPA in the United States while exploring
additional international opportunities.
Amarin is increasing its United States sales
force to 800 sales representatives, up from 400 in most of 2019.
Health professional targets will be expanded from approximately
50,000 to a planned 75,000 physicians along with planned increased
frequency in the number of calls to these targets. The hiring of
the expanded sales team is well underway as more than two-thirds of
the new sales representatives are hired and in the process of being
trained. The remaining sales professionals are targeted to be hired
in January or early February 2020. While trained sales
representatives are already in the field with the new label for
VASCEPA, the company’s national sales launch meeting is scheduled
for next week, after which the sales team will be more fully
trained and more prepared for field promotion.
In addition, Amarin is training select
physicians to present VASCEPA to their peers and sponsoring various
medical education programs that cover VASCEPA starting this
month.
While Amarin anticipates revenue growth to be
stimulated by such activities, it is common for patients who are
candidates for VASCEPA to visit their physicians only once,
sometimes twice, annually. As a result, similar to the
experience of other therapies for treating chronic conditions, we
do not anticipate prescription rates for VASCEPA to spike upwardly
immediately. In addition, historically, the first calendar quarter
of each year has started relatively slowly due to a number of
recurring seasonal factors that have also affected similarly
situated prescription therapies.
Branded direct-to-consumer (DTC) promotion of
VASCEPA for cardiovascular risk reduction is subject to separate
FDA approval which Amarin anticipates receiving by mid-2020
(submission was not possible until after the new label for VASCEPA
was approved). Based on results shown for other products,
such DTC promotion when launched is anticipated to further
accelerate VASCEPA revenue growth. Until such branded DTC promotion
is permitted, the company anticipates various programs to increase
awareness and remind physicians and consumers that previously
approved therapies are insufficient to address persistent
cardiovascular risk for many patients.
2020 Revenue Guidance: Amarin
anticipates total net revenue in 2020 will be in a range of $650 to
$700 million, mostly from sales of VASCEPA in the United
States. The guidance remains unchanged from the total net
revenue guidance issued by the company on December 13, 2019.
Beyond 2020, Amarin reiterates that it believes
that VASCEPA total net revenue will grow to reach multiple billions
of dollars. The history of other therapies for chronic
conditions suggests that growth builds over multiple years.
At this time, the company is not providing guidance regarding
annual revenue levels beyond 2020.
Inventory Purchases: Because
the rate of VASCEPA revenue growth is difficult to predict, in 2020
Amarin intends to spend approximately $250 million on inventory
purchases, which is approximately twice the amount spent for
inventory purchases in 2019. Such planned purchases do not
change Amarin’s revenue guidance. Rather, the company believes they
prepare Amarin, together with existing inventory, for a situation
in which actual revenue turns out to be significantly higher than
the revenue guidance described above. One of the important
features of VASCEPA is the product’s stability achieved through the
expert manufacturing of its fragile single-active ingredient.
This stability achievement presents limited financial risk of
over-purchasing VASCEPA inventory as the product has demonstrated
stability supporting approved commercial expiry dating through four
years.
Spending and Net Cash Flow:
Currently, Amarin anticipates operating expenses in 2020 to
increase approximately $200 to $250 million over 2019 levels.
Included in these amounts are previously described increased costs
associated with the company’s planned expansion of its sales team
and REDUCE-IT promotional activities, including direct-to-consumer
advertising. In the event that net product revenue grows faster
than expected, selling, general and administrative (SG&A)
expenses may be higher than reflected in this operating expense
guidance.
Amarin, after being cash flow positive in the
second and third quarters of 2019, had net cash outflow of
approximately $28 million in the fourth quarter of 2019 reflecting
the expansion of the company’s sales force and other costs
associated with the new FDA-approved label for VASCEPA and the U.S.
launch of this new label. Amarin anticipates starting 2020
with net cash outflows as it completes its sales force expansion
and as these sales representatives become productive and other
forms of expanded promotion take hold. On a steady-state basis,
including the expanded sales force size, but excluding incremental
purchases to build inventory and incremental spending for
launch-level DTC, Amarin estimates that it needs approximately $150
million in quarterly net revenue to collect adequate cash to
achieve cashflow breakeven. During the ramp-up phase,
including the estimated higher cash outflow levels for inventory
build and DTC launch of a new indication, Amarin estimates that
approximately $200 million in quarterly net revenue is required to
generate required cash collections to achieve cashflow breakeven.
Above these breakeven levels, additional cash inflows should be net
positive. Amarin reiterates that it believes that its current cash
resources are adequate to reach positive net cash flow based on
VASCEPA following its launch for its new FDA-approved
cardiovascular risk reduction indication and reiterated that such
spending levels are likely to vary quarterly. Amarin will
consider added promotion as well as further sales force expansion
if the pace of revenue growth exceeds expectations and if such
added promotion can be reasonably predicted to pay for itself on a
reasonably prompt basis.
International: Internationally,
Amarin currently has three partners for commercialization of
VASCEPA in select geographies and intends to consider potential
additional partners to commercialize VASCEPA in other parts of the
world. Amarin’s partner HLS received approval of VASCEPA from
Health Canada on December 31, 2019. In the Middle East,
Amarin’s partner Biologix, received approval for VASCEPA in two
countries, Lebanon and the United Arab Emirates, with additional
approvals in the region requested. In the Greater China region,
Amarin’s partner, Eddingpharm, continues to run the biomarker
focused clinical study of VASCEPA. The pace of patient enrollment
in this trial has been increasing, positioning that study for
potential completion in 2020, with the intention of making VASCEPA
the first approved prescription drug of its type in Mainland China
and other markets in that region. With respect to commercialization
partners for VASCEPA in other geographies, Amarin intends to
continue to be receptive to inquiries from qualified companies.
Comment from Amarin's President
and CEO
“Early feedback from physicians and medical
societies has been positive regarding the new indication for
VASCEPA,” commented John F. Thero, president and chief executive
officer. “Publications from both the AHA and ACC listed icosapent
ethyl in their top cardiovascular news lists for 2019, a
particularly major accomplishment as icosapent ethyl was on these
lists for 2018 as well. With extraordinary employees, broad support
from leading physicians, good payor coverage, a large patient need,
and the only approved indication to address this need, Amarin
commences 2020 with confidence and focus. Our aim is to make
VASCEPA a new standard of care for the benefit of millions of
patients.”
Amarin will provide further details regarding
its 2019 results and plans to provide further outlook for 2020 in
connection with the company's annual report on Form 10-K when filed
near the end of February 2020.
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, Lebanon and the United Arab
Emirates, and is expected to be available in Canada through an
anticipated February 2020 commercial launch. Amarin, together with
its commercial partners in select geographies, is pursuing
additional regulatory approvals for VASCEPA in China, the European
Union and the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular
Disease
Cardiovascular disease is an enormous and
growing medical issue worldwide.1,2 In the United States
alone, a heart attack, stroke, death or other major cardiovascular
event is experienced every 14 seconds.2,3
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk of experiencing a
cardiovascular event. However, even with the achievement of target
LDL-C levels, millions of patients still have significant and
persistent cardiovascular risk, especially those patients with high
triglycerides. Statin therapy has been shown to control LDL-C,
thereby reducing the risk of cardiovascular events by 25-35% – but
that still leaves 65-75% of risk remaining.4 People with high
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.5,6,7
About VASCEPA®
(icosapent ethyl) Capsules
VASCEPA (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 and 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 Use
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 º established
cardiovascular disease or º 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 for bleeding
should be monitored.
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 expectations regarding prescription growth
and revenue growth from sales of VASCEPA; expectations that
REDUCE-IT results could lead to a new treatment paradigm in the
patient population studied; expectations regarding managed care
coverage for VASCEPA; expectations regarding levels of operating
spending and levels of inventory purchases and plans for commercial
and international expansion. These forward-looking statements are
not promises or guarantees and involve substantial risks and
uncertainties. In addition, 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 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 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 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 not be
determined to be infringed or upheld 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 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.
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 Information
Investor Inquiries: Elisabeth Schwartz
Investor Relations Amarin Corporation plc In U.S.: +1 (908)
719-1315 investor.relations@amarincorp.com
Lee M. Stern Solebury Trout In U.S.: +1 (646)
378-2992 lstern@soleburytrout.com
Media Inquiries: Gwen Fisher Corporate
Communications Amarin Corporation plc In U.S.: +1 (908)
325-0735 pr@amarincorp.com
______________________________
References
1 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019. 2 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through
2035. 3 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance. 4 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. 5 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145. 6 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. 7 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
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