U.S. Sales Force Increased to 400 Sales
Professionals for 2019 Following Unprecedented Positive Results of
Vascepa® Cardiovascular Outcomes Study Presented in November
2018
Amarin Corporation plc (NASDAQ:AMRN), today provided a business
update, including a preliminary estimate of 2018 revenue results
and 2019 revenue and spending guidance. Amarin plans to discuss
these results and expectations with investors in connection with
the 37th Annual J.P. Morgan Healthcare Conference in San Francisco,
California, at which Amarin will be presenting.
Preliminary (unaudited) 2018
Financial Results
Record Revenue Levels: Net
total revenue for 2018 are estimated to have reached between $224
and $228 million, including estimated net total revenue of $72 to
$76 million in Q4 2018. Both the full year and Q4 2018 results
represent record revenue levels for Amarin. These results, which
are subject to audit, represent increases of approximately $43 to
$47 million (approximately 24% to 26%) over full year 2017 results.
Both full year and Q4 2018 net total revenue consist predominantly
of U.S. sales driven by increased prescriptions for Vascepa®
(icosapent ethyl) capsules (less than $1 million in estimated
ex-U.S. derived net revenue in 2018). Wholesaler inventory levels
of Vascepa were within normal industry ranges at the end of
2018.
Current Assets: Amarin ended
2018 with approximately $249 million in cash, approximately $72
million in net accounts receivable and approximately $56 million in
inventory.
No Debt, Except Remaining Balance of
Royalty-Bearing Instrument: Amarin ended 2018 with no debt
except the remaining balance on its royalty-bearing instrument
which is repaid at a rate of 10% of Vascepa revenues; aggregate
repayment of less than $90 million remains until this royalty-like
obligation is fully extinguished.
2019 Financial and Operational
Guidance
In November 2018, results of the REDUCE-ITTM
cardiovascular outcomes study of Vascepa were presented and
published1. These unprecedented placebo-controlled results were
headlined by achieving the study’s primary endpoint with a 25%
reduction in major adverse cardiovascular events and a number
needed to treat of 21, as well as achieving multiple prespecified
secondary endpoints, including a 20% reduction in
cardiovascular-related death. In connection with these results, the
company expressed its priorities as follows:
- Aggressively grow U.S. revenues through promotion and education
of healthcare professionals;
- Pursue label expansion for Vascepa through a supplemental new
drug application (sNDA) to the FDA in the U.S. seeking a label
which reflects the cardioprotective effects of Vascepa demonstrated
in the REDUCE-IT study;
- Leverage data from the sNDA through third-party relationships
to expand Vascepa regulatory approvals and sales internationally;
and
- Operate in a cost-effective, opportunistic manner.
Preliminary feedback from physicians, payers and
other healthcare professionals regarding REDUCE-IT results have
been broadly positive. The New England Journal of Medicine on
December 26, 2018 designated the REDUCE-IT study as a top story of
2018 in the NEJM Journal Watch Cardiology section. Similarly, the
American College of Cardiology included REDUCE-IT results in its
top 10 list for 2018.
While such initial feedback is encouraging, the
REDUCE-IT results remain new and unknown in detail to most
healthcare professionals and payers. Also unknown in detail by most
healthcare professionals and payers are the failures of
prior-generation therapies to demonstrate cardiovascular benefit
and the important differentiation of Vascepa from these other
products. While the potential need for Vascepa is estimated to be
millions of patients, and while Vascepa is the first therapy for
its targeted population to demonstrate positive results in a
robust, globally-conducted cardiovascular outcomes study, Vascepa
is creating a new paradigm in preventative cardiovascular care.
Significant advancement in preventative cardiovascular care has
been infrequent. Statin therapy, the standard of care for treating
cholesterol related cardiovascular risk, was introduced
approximately three decades ago and grew tremendously over many
years. There is no historical revenue analog for a cardiovascular
drug that is directly comparable to the current market dynamic in
which Vascepa operates with its status as an increasingly
recognized preferred add-on to statin therapy in select patients
and its favorable efficacy, safety and cost profile. However, usage
rates of new drugs for chronic needs have shown more pronounced
growth following label expansion than following positive outcomes
study results. This is likely due in part to expanded consumer
promotion and greater payer acceptance following label expansion;
recent examples include Repatha® and Jardiance®, neither of which
are competitors to Vascepa, nor is Vascepa seeking to replace
statin therapy. Rather, Vascepa is seeking to address
cardiovascular risk not fully addressed by other available
therapies.
2019 Revenue Guidance: While we
are optimistic that Vascepa will reach billions of dollars in
revenues, history of other therapies for chronic conditions
suggests that growth occurs over many years. Forecasting Vascepa
revenues at this early stage is difficult as feedback from
physicians and payers remains preliminary and the timing of an
expanded U.S. label for Vascepa is not yet known. Fortunately,
managed care coverage for Vascepa is already generally good. While
such coverage may improve further following label expansion, we do
not expect Vascepa coverage by most payers to change dramatically
in 2019 compared to current coverage. Amarin begins 2019
anticipating that its 2019 net total revenue will increase by more
than 50% over 2018 results to approximately $350 million, mostly
from sales of Vascepa in the U.S.
Vascepa Label Expansion: Amarin
anticipates submitting a sNDA in the U.S. seeking an expanded
indication for Vascepa before the end of Q1 2019. Assuming a
standard 10-month review by the FDA, an expanded label for Vascepa
is not currently expected to impact 2019 Vascepa revenue levels.
After the sNDA is submitted, Amarin will seek clarification as to
whether priority review by the FDA is possible for this important
submission. The dataset from Vascepa, representing greater than
35,000 patient years of study, is large. Additionally, the list of
prespecified endpoints which the company intends to evaluate in
support of the sNDA is extensive. As a result, submission of the
sNDA is not anticipated until late in Q1 2019.
Inventory Purchases: Because
the rate of Vascepa revenue growth is difficult to predict,
including potentially significantly varied timing regarding FDA
review of the sNDA, Amarin intends to purchase inventory during
2019 at a rate which could support at least twice the 2019 net
total revenue guidance described above. Such purchases do not
change Amarin’s revenue guidance. Rather, they prepare Amarin for a
situation in which actual revenue turns out to be significantly
higher than the 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. The incremental cost of this inventory build is anticipated
to be between $50 and $75 million in 2019.
Quarterly Variability and Other
Considerations: As of the end of 2018, Amarin had promoted
REDUCE-IT published results, subject to various off-label related
disclosures and disclaimers, to approximately 25,000 of its
targeted 50,000 physicians. However, most of these 25,000
physicians have thus far met with Amarin sales reps only once since
the results were published in The New England Journal of Medicine
in November (see investor relations section of Amarin’s website for
link to this publication and discussion of frequently asked
investor questions regarding REDUCE-IT results). As Amarin
discussed when Vascepa was initially launched for its currently
approved niche indication as a treatment for adult patients with
very high triglyceride levels (TG >500 mg/dL), data from
promotion of other products by other companies suggests that target
audiences often need to see data multiple times (e.g. 5 – 7 times)
before usage patterns are significantly changed. Accordingly, while
we believe that a small portion of the increase in Q4 2018 revenues
reflects REDUCE-IT results, we anticipate that most of the upside
from these unprecedented clinical trial results will be realized in
the future. It is encouraging and important to note that
cardiologists who, while fewer in number, appear to be embracing
REDUCE-IT results rapidly. As a result, beginning in January we
increased the number of cardiologists to be targeted by our sales
representatives.
Amarin has increased its sales force to 400
sales representatives, up from 150 for most of 2018. More than 90%
of these sales representatives are now well trained and will be
meeting with healthcare professionals this week. The remainder,
fewer than 40 sales representatives, are scheduled to complete
their training and begin Vascepa promotion within two weeks. This
rapid hiring and training of these new sales representatives, which
more than doubles Amarin’s sales force, completed over a period of
approximately three months is an example of Amarin’s
execution-oriented approach. By the end of March 2019, we
anticipate that nearly all our 50,000 physician targets will be
called upon at least once regarding REDUCE-IT results with most of
these targets called upon two to three times.
Patients who are good candidates for Vascepa
tend to visit their physicians once, sometimes twice, a year. 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. Also, for context, note that
we do not anticipate broadly expanding consumer promotion of
Vascepa until the label for Vascepa is expanded. At that time, we
will also evaluate whether 400 sales representatives are sufficient
to support the multi-billion dollar potential of this important new
cardiovascular therapy.
While Amarin anticipates that net total revenue
will increase in each quarter of 2019 compared to the corresponding
quarter of 2018, at this time the company is not providing
quantified revenue guidance by quarter. The company anticipates
continued industry-wide seasonality regarding prescription growth
with, for example, Q1 impacted by headwinds caused by annual
beginning of the year deductibles under insurance plans for some
patients. This dynamic has historically caused some patients to
ration the number of prescriptions they fill until they satisfy
their deductibles and can better afford all of their prescriptions.
This beginning of the year challenge is not specific to Vascepa but
has historically most significantly impacted therapies such as
Vascepa which address chronic, asymptomatic medical conditions. In
addition, while 400 sales representatives giving Vascepa top
promotion priority is anticipated to grow revenues, Amarin, as
previously described, did not renew its agreement with its prior
co-promotion partner beyond the December 31, 2018 expiration date
of the co-promotion agreement. That partner was primarily promoting
Vascepa in a second position by its sales representatives. All
Amarin sales representatives will be promoting Vascepa in the first
and only position. A short adjustment period is expected between
the impact of ceasing the sales calls under that co-promotion
agreement and Amarin’s new sales representatives becoming fully
productive.
Spending: Currently, Amarin
anticipates operating expenses for 2019 to increase $25 to $50
million over 2018 levels. Included in these amounts are increased
costs associated with Vascepa promotion partially offset by
elimination of expenses associated with the company’s prior
co-promotion partner, expense which is estimated to have exceeded
$40 million in 2018, and modestly lower R&D expenses as the
REDUCE-IT trial is complete. R&D expenses, while lower than
2018, are anticipated to remain relatively high to support the sNDA
submission, to support multiple potential additional publications
of REDUCE-IT results, to support partners with respect to
international submissions for Vascepa and to evaluate future
product opportunities on Amarin’s own and in collaboration with its
development partner, Mochida. Total R&D expenses for 2019 are
anticipated to be approximately $40 million and likely highest in
the first half of 2019. These expense estimates assume that Vascepa
label expansion is approved following an anticipated 10-month FDA
review cycle. In the event that the label is expanded earlier than
expected or product revenue grows faster than expected, selling,
general & administrative (SG&A) expenses may be higher than
reflected in this operating expense guidance.
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. In the Middle East, Amarin’s partner Biologix, in
2018, received approval for Vascepa in two countries, Lebanon and
the United Arab Emirates, with additional approvals in the region
requested. In Greater China, Amarin’s partner Eddingpharm began
enrolling patients in a clinical study for Vascepa, with the
intention of making Vascepa the first approved prescription drug of
its type in Mainland China and other markets in that region. In
Canada, Amarin and its newest partner HLS Therapeutics are hopeful
that REDUCE-IT results will support efforts to gain regulatory
approval to commercialize Vascepa although, similar to the pathway
in the U.S., the REDUCE-IT data package is still being prepared and
regulatory submission in Canada cannot be made until after that
data package is ready for submission in the U.S. With respect to
commercialization partners for Vascepa in other geographies, Amarin
intends to continue to be receptive to inquiries from qualified
companies. However, in the near-term, Amarin’s priority is the U.S.
sNDA submission and label expansion approval.
Comment from Amarin's President
and CEO
“We enter 2019 with great confidence that
Vascepa will lead to improved cardiovascular care for millions of
at-risk patients,” commented John F. Thero, president and chief
executive officer. He continued, “2018 was a landmark year for
Amarin as an unprecedented positive outcomes result from the use of
Vascepa was demonstrated in the REDUCE-IT study and, prior to
presenting REDUCE-IT results, we achieved record product revenues
from Vascepa. With the support of our investors, we are well
financed and positioned to increase Vascepa promotion. Amarin’s
dedicated team of employees and collaborators give me confidence
that we will successfully pursue Vascepa label expansion while
further accelerating Vascepa revenue growth in the U.S. and
advancing Vascepa internationally.”
Amarin will provide further details regarding
its 2018 results and plans to provide further outlook for 2019 in
connection with the company's annual report on Form 10-K when
issued near the end of February 2019.
About Amarin
Amarin Corporation plc. is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa® (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing additional
regulatory approvals for Vascepa in Canada, China and the Middle
East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular
Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.2,
3
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
levels.4
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease. 5, 6, 7, 8
About VASCEPA® (icosapent ethyl)
Capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient from degradation. Vascepa, known in scientific
literature as AMR101, has been designated a new chemical entity by
the FDA. Amarin has been issued multiple patents internationally
based on the unique clinical profile of Vascepa, including the
drug’s ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
Indication and Usage Based on Current
FDA-Approved Label (not including REDUCE-IT results)
- Vascepa (icosapent ethyl) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
determined.
Important Safety Information for Vascepa Based
on Current FDA-Approved Label (not including REDUCE-IT results)
(Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR)
of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence >2% and greater than placebo) was arthralgia
(2.3% for Vascepa, 1.0% for placebo). There was no reported adverse
reaction >3% and greater than placebo.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
- Patients receiving treatment
with Vascepa and other drugs affecting coagulation (e.g.,
anti-platelet agents) should be monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding planned regulatory
filings and the nature of FDA’s review and related timing thereof;
expectations regarding regulatory approvals outside the United
States; expectations that REDUCE-IT results could lead to a new
treatment paradigm in the patient population studied; expectations
concerning the extent and timing of any increase in usage rates
following the announcement of the REDUCE-IT results; expectations
regarding sales force expansion and medical education and marketing
initiatives expected in 2019 and beyond; expectations concerning
revenue and prescriptions growth, operating and R&D expenses,
inventory purchases and other financial metrics; expectations
concerning quarterly variability and general market trends; and
expectations regarding international and insurance coverage
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 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 (http://www.amarincorp.com/), the investor relations
website (http://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.
References
1 Bhatt DL, Steg PG, Miller M, Brinton EA,
Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C,
Tardif JC, Ballantyne CM. Cardiovascular Risk Reduction with
Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med
2019;380:11-22.2 American Heart Association. 2018. Disease
and Stroke Statistics-2018 Update.3 American Heart Association.
2017. Cardiovascular disease: A costly burden for America
projections through 2035.4 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;118:547-563.8 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor
Relations and Corporate CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 719-1315investor.relations@amarincorp.com
(investor inquiries)PR@amarincorp.com (media inquiries)
Lee M. Stern Trout Group In U.S.: +1
(646) 378-2992lstern@troutgroup.com
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