Unaudited Full-Year 2016 Net Product Revenue
Estimated to Modestly Exceed Upper End of $112 to $125 Million
Previously Guided Range
Amarin Corporation plc (NASDAQ:AMRN), today provided a business
update, including an update on 2016 revenue guidance and 2017
revenue forecast. Amarin plans to discuss these results and
expectations with investors in conjunction with the 35th Annual
J.P. Morgan Healthcare Conference in San Francisco, California.
2016 Operational Progress
Product Revenue: Continued growth in both new
and recurring Vascepa prescriptions in Q4 2016 resulted in
increased market share and directly supported record revenue levels
for Q4 and full-year 2016. The company estimates full-year
2016 product revenues, on a GAAP basis subject to audit, modestly
exceeded $125 million, representing growth of more than 50% over
reported 2015 net product revenue of $81 million. As reported
in the past, inventory levels at wholesalers tend to fluctuate
based on seasonal factors, prescribing trends and other
factors. During 2016, predominantly in Q2, wholesaler
inventory levels increased based on estimated days of inventory on
hand. In addition, regional stocking of Vascepa expanded at certain
retail pharmacies, likely due to higher volume sales of Vascepa.
Amarin estimates that these changes in channel inventory increased
net product revenues by approximately $3 to $6 million during 2016
and that without these increases full-year 2016 net product
revenues would have been in the upper end of the company’s
previously provided guidance of $112 to $125 million.
Estimated prescriptions of Vascepa, based on data from Symphony
Health Solutions, increased more than 50% in 2016 over 2015 with
Vascepa market share for both total prescriptions (TRx) and new
prescriptions (NRx) exceeding 20% of the prescription omega-3
market.
REDUCE-IT: Five years of the six-year estimated
duration for this 8,175 patient cardiovascular outcomes study are
now complete. Cardiovascular risk, despite LDL-cholesterol
management via statin therapy, remains high. REDUCE-IT is the first
multi-national prospective cardiovascular outcomes study ever
conducted to evaluate the effect of treating patients who despite
statin use have elevated triglyceride levels with a therapy that
significantly lowers triglycerides. REDUCE-IT is also the
first cardiovascular outcomes study to test a high, 4-gram per day
dose of a pure-EPA omega-3 product. REDUCE-IT results,
assuming success, are intended to support significantly expanded
promotion and use of Vascepa to treat at-risk patients to lower the
rates of major adverse cardiovascular events. Tens of millions of
people in the United States alone have elevated triglycerides.
REDUCE-IT is a cardiovascular events driven study designed to
provide 90% power to detect a 15% relative risk reduction between
the patient arm treated with Vascepa added to well-controlled
statin therapy compared to the patient arm treated with placebo
added to well-controlled statin therapy. The study is
designed to be completed upon reaching 1,612 primary cardiovascular
events which Amarin estimates will occur near the end of 2017 with
results expected to be reported and published in 2018. The study is
being conducted under a special protocol assessment (SPA) agreement
with the FDA which was amended and re-affirmed with the FDA in 2016
along with finalization of the study’s statistical plan. A
pre-specified interim efficacy and safety analysis is scheduled to
be conducted by the independent data monitoring committee (DMC) at
approximately 80% of the total 1,612 primary cardiovascular events
targeted for completion of the study. Amarin anticipates that
onset of 80% of the target events will be reached in the first half
of 2017 and that the interim analysis will be conducted before the
end of Q3 2017. Consistent with the trial design, Amarin
continues to believe that the REDUCE-IT study is most likely to
continue to completion of 100% of the target events as the
requirements for early stoppage for overwhelming efficacy are
high.
Balance Sheet: Amarin ended 2016 with
approximately $98 million in cash and approximately $20 million in
net accounts receivable. The company also has $15.1 million of
outstanding exchangeable debt which, as previously disclosed, may
be put to the company on January 19, 2017. The company is
positioned to be cash flow positive for 2017 from commercial
operations excluding costs for REDUCE-IT, interest and
royalties.
“We are very pleased with the progress Amarin made in 2016 with
revenue growth, execution on REDUCE-IT, expense management,
increased productivity, lowered product cost and improved gross
margins, strengthening of our management team, securing new
chemical entity designation, publication of scientific findings,
expanded managed care coverage, international expansion and
numerous other advances that individually and collectively position
Amarin for continued growth and positive execution,” commented John
F. Thero, president and chief executive officer. “We expect
2017 to be an exciting year for Amarin as we build upon this
progress and prepare for results of the REDUCE-IT study.”
2017 Objectives and Financial Outlook
Amarin’s core strategy remains unchanged. Our primary
objectives are to:1) Continue to aggressively grow revenues;2)
Complete the REDUCE-IT study on a timely basis while maximizing the
likelihood of success; and3) Operate in a cost effective,
opportunistic manner.
The company begins 2017 expecting to achieve the following
results:
U.S. Product Revenues: Estimated to reach
between $155 and $165 million with quarterly variability continuing
based on seasonal factors.
International Expansion: Clarification expected
from China FDA regarding the clinical and regulatory path for
Vascepa approval in China. First country approval for
marketing Vascepa in the Middle East expected before the end of
2017.
REDUCE-IT: As per above, onset of 80% of
primary cardiovascular events to occur in the first half of 2017,
the pre-specified 80% interim look to be conducted by the DMC
before the end of Q3 2017 and targeted final primary cardiovascular
event (the 1,612th patient with a primary cardiovascular event) to
be reached near the end of 2017 with trial results presented and
published in 2018. A publication on the clinical design of
REDUCE-IT is anticipated in or before mid-2017. Amarin will remain
blinded to results of the REDUCE-IT study until after the study is
stopped and the database is locked at either the second interim
analysis or at the final analysis.
Spending: Excluding commercial spending for
anticipated expansion post successful REDUCE-IT results, sales,
general and administrative expenses, excluding non-cash costs, to
increase by less than 10% in 2017 compared with 2016 with the
exceptions of increased co-promotion fees anticipated to be paid to
Kowa associated primarily with anticipated increased revenue
growth. Amarin anticipates that R&D expenses in 2017,
excluding non-cash costs, will remain relatively consistent with
2016 levels with the majority of such spending devoted to the
ongoing REDUCE-IT trial.
Commercial Preparations for Expansion
Post-REDUCE-IT: Our intention is to significantly expand
promotion of Vascepa upon positive results from REDUCE-IT. However,
currently we do not intend to significantly expand the size of our
sales force until after the REDUCE-IT results are available.
Rather, as has been successful in the past two years, we intend to
continue to work to improve the productivity of our existing sales
team while planning and evaluating how to best expand Vascepa
promotion assuming positive REDUCE-IT results. We anticipate
that research and other activities to support such preparations
will cost $3 to $5 million in 2017. In addition, we
anticipate increasing purchases of supply for Vascepa in 2017 both
to support anticipated revenue growth in 2017 and to prepare for
REDUCE-IT success.
Cash Flow: Assuming projected revenue growth
and spending assumptions per above, we expect Amarin to be cash
flow positive from commercial operations for 2017, excluding
REDUCE-IT, interest and royalties.
Amarin plans to provide further details regarding its 2016
results and 2017 outlook in connection with the company’s annual
report on Form 10-K in late February 2017.
About Vascepa® (icosapent ethyl)
capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule
prescription product consisting of either 1 gram or 0.5 grams 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. Vascepa is known in scientific
literature as AMR101.
FDA-approved Indication and Usage
- 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
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- 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.
- Patients receiving treatment with Vascepa and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush,
dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by
calling 1‑855‑VASCEPA or the
FDA at 1‑800‑FDA‑1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the FDA as an
adjunct to diet to reduce triglyceride levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under
various stages of development for potential use in other
indications that have not been approved by the FDA. 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.
About Amarin
Amarin Corporation plc is a biopharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health. Amarin's product
development program leverages its extensive experience in lipid
science and the potential therapeutic benefits of polyunsaturated
fatty acids. Amarin's clinical program includes a
commitment to the ongoing REDUCE-IT cardiovascular outcomes
study. Vascepa® (icosapent
ethyl), Amarin's first FDA-approved product, is a
highly-pure, EPA-only, omega-3 fatty acid product available by
prescription. For more information about Vascepa, visit
www.vascepa.com. For more information about Amarin,
visit www.amarincorp.com.
Forward-looking statements
This press release contains forward-looking statements,
including statements about the future commercialization of Vascepa;
expectations regarding Vascepa sales and resulting revenue amounts
and company expenses for the fourth quarter of 2016 and for the
years ended December 31, 2016 and 2017; expectations related to
Amarin's 2017 financial outlook and potentially ending 2017 as cash
flow positive from commercial operations; including expectations
for continued event rates, interim data review and results
announcements in Amarin's REDUCE-IT cardiovascular outcomes study;
expectations regarding the continued effect and scope of the
court-expanded ability to promote Vascepa and to educate healthcare
professionals regarding the efficacy and safety of Vascepa;
expectations related to the interim and final outcome of the
REDUCE-IT study and the successful completion of the REDUCE-IT
study; statements regarding quarterly changes and seasonal effects
on Vascepa sales; and statements regarding the potential efficacy,
safety and therapeutic benefits of Vascepa, regulatory reviews and
approvals of Vascepa internationally and related commercial
potential. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. In
particular, as disclosed in its previous filings with the U.S.
Securities and Exchange Commission, Amarin's ability to effectively
commercialize Vascepa will depend in part on its ability to
continue to effectively finance its business (including the
REDUCE-IT study), 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 historical
REDUCE-IT clinical trial enrollment and randomization rates may not
be predictive of future results and related cost may increase
beyond expectations; the risk that Vascepa may not show clinically
meaningful effects in REDUCE-IT or support regulatory approvals for
intended uses; the risk associated with pending litigation; and the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents. 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 we communicate with our
investors and the public using our company website
(www.amarincorp.com), our investor relations website
(http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be
deemed to be material information. As a result, we encourage
investors, the media, and others interested in Amarin to
review the information that we post on these channels, including
our investor relations website, on a regular basis. This list of
channels may be updated from time to time on our investor relations
website and may include social media channels. The contents of our
website or these channels, or any other website that may be
accessed from our website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
Amarin Contact Information:
Investor Relations:
Gene Mack
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com
Media Inquiries:
Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
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