Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today announced
an update to its revenue guidance for the first quarter of 2018,
reiteration of full year revenue guidance, further progress towards
completing its potential landmark cardiovascular outcomes study,
REDUCE-IT, and initiation of previously announced Vascepa®
promotion initiatives.
Revenue Guidance
Based on lower than expected orders from
Amarin’s wholesaler customers attributed to seasonal factors
related primarily to patients’ beginning of the new year insurance
policy deductible amounts, Amarin estimates that net product
revenue for its first fiscal quarter, the quarter ended March 31,
2018, is likely to be approximately $43 million, which represents
an estimated increase of 25% to 30% over net product revenue in the
same period of the prior year. At the beginning of Q1 2018,
the company estimated net product revenue for the quarter would be
$45 to $48 million. With respect to full year 2018 net product
revenue expectations, Amarin continues to believe that it is on
track to achieve product revenue of at least $230 million, with
such guidance planned to be updated after REDUCE-IT results.
Historically, first quarter net product revenue
from Vascepa® sales are negatively impacted by seasonal factors
related to patient insurance deductibles. In 2018, Amarin
believes that increased beginning of the year insurance policy
deductible amounts at several payor plans made drug coverage more
difficult for a significant number of affected patients. The
company also believes that wholesaler customers, likely in response
to slower than fourth quarter of 2017 Vascepa demand due to these
seasonal effects, decreased their levels of Vascepa inventory.
Without such decreases in inventory levels at wholesalers,
estimated net product revenue for the quarter ended March 31, 2018
would have been approximately $2 million higher.
New prescriptions (NRx) of Vascepa reached
record levels in March 2018 based on data from Symphony Health and
IQVIA. The seasonal factors described above appear to most impact
prescription refills by patients with prior Vascepa prescriptions.
Although it appears to be taking longer on average than last year,
Amarin anticipates that most patients have largely worked through
their beginning of the year insurance deductibles late in the first
quarter and will begin to resume filling prescriptions for Vascepa.
Medical insurance coverage for Vascepa remains strong for most
patients with commercial or Medicare Part D insurance coverage.
Beginning of year deductibles under payor plans are not drug
specific. Based on prescription data from third-party sources,
Amarin believes that other branded therapies, particularly those
for asymptomatic conditions, also experienced prolonged seasonal
impact in the first quarter of 2018.
With respect to Q1 2018, the company noted that
total prescription (TRx) growth reported by third-party sources
reflect stronger growth than product shipments to wholesalers upon
which revenues are recognized. Historically prescription
growth reported by such third parties has been consistent with
growth in product shipments on an annual basis with some quarterly
variability observed in these estimates.
The company intends to provide further updates regarding its
operational progress and financial results including in connection
with its quarterly report on Form 10-Q anticipated in early
May.
REDUCE-IT Final Patient Visits Progressing as
Planned
Amarin reported that greater than 97% of
patients who are alive and active in the REDUCE-IT study have
either completed their final visit or are scheduled to complete
their final visit in the coming weeks with work ongoing to schedule
the remaining patients for their final study-related visits.
This progress is consistent with the company’s objective of
reporting top-line results from this important study before the end
of Q3 2018.
As separately reported today, Amarin estimates
that the onset of the 1,612th primary major adverse cardiovascular
event (MACE) has occurred in the REDUCE-IT study and anticipates
that MACE from the study will be adjudicated through Q2 2018. This
timing is also consistent with reporting top-line results before
the end of Q3 2018.
Amarin is intentionally blinded to the results
of the study and will remain blinded to such results until after
the study is completed and the database is locked.
Expanded Vascepa® Promotion and Disease
Awareness Initiatives on Track
Amarin recently commenced its previously
described pilot awareness initiative including an updated website
at www.vascepa.com and limited airings of a television commercial
based on the current indication for Vascepa. The company was
pleased by the participation of professional societies and patient
advocacy groups for the recent first annual National Triglycerides
Day on March 28th. Patients are encouraged to learn more
about their risks for cardiovascular disease, including learning
more about their triglyceride levels and to consult with their
healthcare professionals.
“We look forward to continuing to educate
healthcare professionals regarding Vascepa based on its current
label and supporting data while advancing REDUCE-IT to provide
broadly sought outcomes data,” stated John F. Thero, president and
chief executive officer. “Recent studies by other companies
highlight that significant cardiovascular risk remains beyond
well-controlled cholesterol management. I have great confidence in
the unique clinical attributes of Vascepa to potentially mitigate a
substantial portion of this residual cardiovascular risk.”
About AmarinAmarin 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. Vascepa® (icosapent
ethyl), Amarin's first FDA-approved product, is a highly-pure,
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.
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. 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.
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 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.
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.1,
2
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. 3, 4, 5, 6
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding net product revenue
from sales of Vascepa for the first quarter of 2018, for the year
ended December 31, 2018 and inclusive quarterly periods;
expectations related to seasonal trends thought to affect sales of
Vascepa and their anticipated impact on Vascepa sales in future
periods; expectations for continued final patient visits, estimated
event rates, results and related announcement timing associated
with Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the successful completion of the REDUCE-IT study; and
expectations regarding the ability to promote Vascepa and to
educate healthcare professionals regarding the efficacy and safety
of Vascepa. 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, 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 the sale of
pharmaceutical products, 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 Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for intended uses; 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 annual report on
Form 10-K. 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 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.
2 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
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 increase cardiovascular events, medical costs, and
resource utilization in a real-world analysis of statin-treated
patients with high cardiovascular risk and well-controlled
low-density lipoprotein cholesterol [abstract]. Circulation.
2017;136(suppl 1):A15187.
5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz 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) 378-2992lstern@troutgroup.com
Media Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
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