Activities Underway to Support Planned Commercial
Expansion
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on the commercialization and development of therapeutics to
improve cardiovascular health, today announced financial
results for the three and nine months ended September 30, 2018, and
provided an update on company operations.
Key Amarin achievements since its last quarterly
report include:
- R&D progress: The Vascepa®
(icosapent ethyl) cardiovascular outcomes study, REDUCE-IT™,
reported topline results on September 24, 2018. REDUCE-IT met its
primary endpoint demonstrating an approximately 25% relative risk
reduction, to a high degree of statistical significance
(p<0.001), in major adverse cardiovascular events (MACE) in the
intent-to-treat patient population with use of Vascepa 4 grams/day
as compared to placebo. Additional details regarding these
important results are scheduled for presentation on November 10th
at the 2018 Scientific Sessions of the American Heart Association
(AHA) in Chicago, Illinois.
- Commercial expansion: Through
hiring and internal promotion, in late September, Amarin expanded
its sales management team and accelerated actions to expand its
U.S. direct sales force from approximately 150 to approximately 400
sales representatives. The company is on-track for having these new
representatives hired and trained before the start of 2019 while in
parallel working to expand other Vascepa related promotional
activities, market education programs and further increase Vascepa
supply capacity.
- Q3 revenue and prescription growth:
Recognized $55.0 million in net product revenue from U.S. sales of
Vascepa in Q3 2018 compared to $47.1 million in Q3 2017, an
increase of 17%. Increased normalized prescriptions for Vascepa in
the U.S. by 19% and 22% compared to Q3 2017 based on data from
Symphony Health Solutions and IQVIA, respectively. Amarin does not
believe that these results for the quarter ended September 30, 2018
were impacted by announcement in the last week of September 2018 of
the topline results of the REDUCE-IT study.
- Capital resources: As of September
30, 2018, Amarin reported $81.9 million in cash, $47.6 million in
net accounts receivable, $25.7 million in other receivables and
$43.7 million in inventory.
- Debt eliminated: Pursuant to a debt
exchange announced on October 19, 2018, effective November 2, 2018,
the company will no longer have any debt obligation with a fixed
maturity date and will no longer have interest payments associated
with such debt. The company’s royalty-like obligation remains
to be paid at a rate of 10% of Vascepa revenues until the aggregate
remaining obligation of $94.1 million is satisfied.
“The landmark results of the REDUCE-IT study
present an important opportunity to improve the practice of
medicine with respect to preventative cardiovascular care. We
believe that these outcomes study results position Vascepa to
address a significant unmet medical need and could be considered
the most significant breakthrough in preventative cardiovascular
care since the advent of statin therapy decades ago. We are
very excited about the potential for Vascepa to help millions of
patients and we are acting accordingly to expand on our established
commercial foundation, including existing broad managed care
coverage and extensive key opinion leader support,” stated John F.
Thero, president and chief executive officer. “Amarin looks forward
to the primary REDUCE-IT outcomes study results being presented at
AHA and to working towards the future publication of these results
in a major medical journal within 2018.”
REDUCE-IT Cardiovascular Outcomes
Study
As previously announced, the REDUCE-IT outcomes
study was designed to assess the putative cardiovascular effects of
the prescription drug Vascepa at 4 grams/day in lowering the risk
of cardiovascular events beyond LDL (“bad”) cholesterol management
in patients with cardiovascular risk factors including elevated
triglycerides. While the study enrolled patients with elevated
triglyceride levels (≥135 mg/dL, median baseline 216 mg/dL),
REDUCE-IT was a cardiovascular outcomes study and not a
lipid-focused study.
Various prior therapies have sought to address
the residual cardiovascular risk beyond bad cholesterol management
and have failed, including CETP inhibitors, fibrates, nicotinic
acid and omega-3 mixtures. Many of these therapies lower
triglyceride levels but failed to demonstrate cardiovascular risk
reduction in studied populations. The molecular structure and
clinical effects and profile of Vascepa are unique.
Data supporting the unique effects of Vascepa
was accentuated during Q3 2018 when the report of the successful
topline results of the REDUCE-IT cardiovascular outcomes study with
Vascepa were announced shortly after cardiovascular outcomes study
results were reported for prescription drug Lovaza® (named Omacor
in Europe) from the ASCEND study. In the ASCEND study Lovaza at a
low dose of 1 gram/day failed to demonstrate cardioprotective
benefit. The REDUCE-IT topline results were also on the heels of a
report in Q3 2018 by the independent Cochrane Foundation which
reviewed available outcomes data for omega-3 products, including
dietary supplements, showing that except for the successful study
of a purified prescription EPA product in Japan (the JELIS study),
omega-3 products have a consistent pattern of showing negligible
cardioprotective effects. Note that omega-3 products containing DHA
have been shown to increase bad cholesterol levels in relevant
patient populations.
Vascepa, as a single molecule active ingredient
drug, does not contain DHA and has been shown in prior studies to
not increase bad cholesterol in relevant patient populations.
Patients in the REDUCE-IT study were enrolled with baseline median
LDL cholesterol of 75 mg/dL controlled by statin therapy. In
addition, omega-3 molecules are fragile and highly prone to
oxidation (spoilage typically evidenced by a fishy smell) or other
forms of degradation that can impact their effect and safety.
Vascepa is manufactured through a stringent and complex
FDA-regulated process designed to effectively eliminate impurities
and isolate and protect the single molecule active ingredient
against degradation.
Amarin is eager to share REDUCE-IT data in
greater detail with both the medical community and regulatory
authorities. As previously reported, REDUCE-IT results have been
accepted for presentation at the 2018 Scientific Sessions of the
American Heart Association (AHA) on November 10, 2018 in Chicago,
Illinois. The presentation, classified as late breaking clinical
trial results, is scheduled to commence at 2:18 pm Central Time and
listed as Main Event 1 for the time frame.
Until the AHA presentation, as agreed with AHA,
Amarin does not plan to share any further details regarding the
results of the REDUCE-IT study. Key topline results from the
REDUCE-IT study as reported on September 24, 2018 include:
- Efficacy: Approximately 25%
relative risk reduction, demonstrated to a high degree of
statistical significance (p<0.001), in the primary endpoint
composite of the first occurrence of MACE, including cardiovascular
death, nonfatal myocardial infarction (MI), nonfatal stroke,
coronary revascularization, or unstable angina requiring
hospitalization. This result was supported by robust demonstrations
of efficacy across multiple secondary endpoints. No further
information regarding the secondary endpoint results will be
provided until the AHA presentation.
- Safety: Vascepa was well
tolerated with a safety profile consistent with clinical experience
associated with omega-3 fatty acids and current FDA-approved
labeling. The proportions of patients experiencing adverse events
and serious adverse events in REDUCE-IT were similar between the
active and placebo treatment groups. Median follow-up time in
REDUCE-IT was 4.9 years.
Commercial Update
The REDUCE-IT cardiovascular outcomes study
started in 2011. Prior to knowing the results of this
important study, Amarin devoted a majority of its resources to
research and development. The aggregate cost of supporting
the REDUCE-IT clinical outcomes study plus more than 20 scientific
publications and presentations per year is approximately $50
million or more annually. As a result, resources available to
support Vascepa marketing and sales have been limited. Over the
past five years, Amarin has grown Vascepa revenues, based on an
important but niche biomarker-based indication, with a
professional, well-trained and productive sales team which for most
of this period consisted of approximately 135 sales
representatives.
At the start of 2018, preparing for REDUCE-IT
success, Amarin took select steps to prepare for anticipated
commercial expansion following REDUCE-IT results. These steps
included modestly increasing the number of Vascepa sales
representatives to 150 while continuing to maintain its commercial
business (excluding R&D, financing and other costs described
below) positive from a cash flow perspective; training leading
sales representative to become managers; piloting consumer
awareness initiatives; increasing levels of supply on hand while
working with third-party suppliers to increase capacity;
contracting with managed care for Vascepa insurance coverage well
into 2019; soliciting resumes from experienced sales candidates;
expanding relationships with key opinion leaders (KOLs),
professional societies and patient advocacy groups; and making
other selective preparations to strengthen Amarin’s foundation to
support future commercial growth.
Following Amarin learning in late Q3 2018 that
the results of the REDUCE-IT study were positive, Amarin expanded
its sales management and began hiring additional sales
representatives. Nearly all of the new sales management
positions the company sought to fill are now filled. The company is
pleased to have ample experienced applicants to fill its open sales
representative positions. The company is on track to have a
sales force of 400 sales representatives in the United States to
start 2019. New sales representatives are being hired with
starting dates throughout Q4 and slotted for group training with
the aim of having all new hires trained by year-end. This
broadened sales team will call on more than double the number of
physicians targeted historically by Amarin’s sales team. They
will be supported in doing so by other promotional and market
education programs. Amarin believes that presentation and
future publication of results from the REDUCE-IT study will be
helpful as part of this education process with healthcare
professionals.
Amarin plans to submit a supplemental new drug
application (sNDA) in early 2019 seeking an expanded indication for
Vascepa in the United States.
Financial Update
Net product revenue for the three months ended
September 30, 2018 and 2017 was $55.0 million and $47.1 million,
respectively. Net product revenue for the nine months ended
September 30, 2018 and 2017 was $151.3 million and $126.3 million,
respectively. Increased revenue is mainly attributed to
increased Vascepa prescriptions. Amarin does not believe that
these results were impacted by news of REDUCE-IT topline results or
by steps taken to expand promotion of Vascepa after such
results.
During the third quarter, based on data from
Symphony Health Solutions and IQVIA, Amarin experienced continued
prescription growth and an increase in Vascepa market share,
particularly among detailed physicians. Symphony Health Solutions
and IQVIA estimated normalized total Vascepa prescriptions of
approximately 458,000 and 457,000, respectively, for the three
months ended September 30, 2018, representing growth of
approximately 19% and 22%, respectively, over levels estimated by
these sources for the same three months of the prior
year.
Net pricing of Vascepa in the third quarter of
2018 was relatively consistent with the prior year and channel
inventory levels remain in the ordinary range.
Licensing revenue during the three months ended
September 30, 2018 and 2017 was $0.4 million and $0.3 million,
respectively, related to timing of milestones and other factors
impacting revenue recognition for licensing fees under agreements
for the commercialization of Vascepa outside the United States.
Cost of goods sold during the nine months ended
September 30, 2018 and 2017 was $37.0 million and $31.5 million,
respectively. Gross margin on net product revenue for the nine
months ended September 30, 2018 and 2017 were 76% and 75%,
respectively.
Selling, general and administrative (SG&A)
expense for the nine months ended September 30, 2018 and 2017 was
$147.3 million and $98.9 million, respectively, an increase of
$48.4 million, or 49%. This increase is due primarily to increased
promotional activities, including commercial spend for anticipated
expansion following successful REDUCE-IT results, including a pilot
consumer promotion program, and increased co-promotion fees
calculated on increased gross profit resulting from higher net
product revenue, including an accrual of $10.7 million for
co-promotion tail payments. The tail co-promotion fees, which are
calculated as a percentage of the 2018 co-promotion fee, are
payable in 2019 through 2021. Such co-promotion fee costs are
currently scheduled to end on December 31, 2018. For the nine
months ended September 30, 2018, the aggregate cost of the
co-promotion fee, including the tail payment accrual, was $30.5
million.
Research and development (R&D) expense for
the nine months ended September 30, 2018 and 2017 was $44.0 million
and $35.2 million, respectively, an increase of $8.8 million, or
25%. This increase in expense is primarily driven by the timing of
REDUCE-IT and related costs and the recording of $2.7 million in
expense related to the company’s previously announced strategic
collaboration with Mochida Pharmaceutical Co., Ltd. We
continue to anticipate that our level of spending on R&D will
begin to decline following publication of results of the REDUCE-IT
study; however, the company will continue to incur expenses related
to seeking approval of an expanded indication for Vascepa based on
submission of an sNDA as well as costs associated with the other
R&D activities.
Under U.S. GAAP, Amarin reported a net loss of $24.5 million in the
three months ended September 30, 2018, or basic and diluted loss
per share of $0.08. This net loss included $6.7 million in non-cash
stock-based compensation expense. Amarin reported a net loss of
$10.8 million in the third quarter of 2017, or basic and diluted
loss per share of $0.04. This net loss included $3.5 million in
non-cash stock-based compensation expense.
Under U.S. GAAP, Amarin reported a net loss of
$82.8 million in the nine months ended September 30, 2018, or basic
and diluted loss per share of $0.28. This net loss included $14.0
million in non-cash stock-based compensation expense. For the nine
months ended September 30, 2017, Amarin reported a net loss of
$45.4 million, or basic and diluted loss per share of $0.17. This
net loss included $10.5 million in non-cash stock-based
compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $17.8
million for the third quarter of 2018, or non-GAAP adjusted basic
and diluted loss per share of $0.06, compared to non-GAAP adjusted
net loss of $7.3 million for the third quarter of 2017, or non-GAAP
adjusted basic and diluted loss per share of $0.03.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $68.7
million for the nine months ended September 30, 2018, or non-GAAP
adjusted basic and diluted loss per share of $0.24, compared to
non-GAAP adjusted net loss of $34.9 million for the nine months
ended September 30, 2017, or non-GAAP adjusted basic and diluted
loss per share of $0.13.
Amarin reported cash and cash equivalents of
$81.9 million as of September 30, 2018. Net cash flows for the nine
months ended September 30, 2018, excluding the $70.0 million in net
proceeds from the equity offering completed in the first quarter,
was negative $61.8 million. Net cash flows for the same period was
positive $20.9 million excluding cash flows associated with
financing activities and REDUCE-IT. More specifically, net
cash flow was positive for this period excluding finance related
proceeds and expenses (interest and royalty), excluding research
and development payments (most of which relates to the REDUCE-IT
study), excluding payments made in preparation for expansion upon
positive REDUCE-IT results such as increasing Vascepa inventory
levels, and excluding the one-time payment made related to the
company’s previously announced agreement with Teva Pharmaceuticals
USA, Inc.
As of September 30, 2018, the company had $47.6
million in net accounts receivable ($62.7 million in gross accounts
receivable before allowances and reserves), $25.7 million in other
receivables due primarily from financial institutions resulting
from the timing of stock option exercises in late September which
amounts were collected in early October and $43.7 million in
inventory.
As of September 30, 2018, Amarin had
approximately 304.1 million American Depository Shares (ADSs) and
ordinary shares outstanding, 28.9 million common share equivalents
of Series A Convertible Preferred Shares outstanding and
approximately 21.0 million equivalent shares underlying stock
options at a weighted-average exercise price of $3.36, as well as
9.6 million equivalent shares underlying restricted or deferred
stock units. On October 19, 2018, the company announced the forced
exchange of its then outstanding $30.0 million in exchangeable
notes. Pursuant to such exchange, the company will issue
approximately 7.7 million ADSs and eliminate its $30.0 million debt
and related interest obligations. Following this exchange,
Amarin will have no outstanding debt. The company continues to have
an obligation under a royalty-like arrangement which is paid off at
a rate equal to 10% of net product revenue up to an aggregate
payment of $94.1 million. There is no maturity date related to this
royalty-like arrangement.
Conference Call and Webcast
Information
Amarin will host a conference call
at 7:30 a.m. ET today, November 1, 2018. The
call will be webcast live with slides and accessible through the
investor relations section of the company’s website at
www.amarincorp.com. The call can also be heard via telephone by
dialing 877-407-8033. A replay of the call will be made available
for a period of two weeks following the conference call. To hear a
replay of the call, dial 877-481-4010 (inside the United States) or
919-882-2331 (outside the United States). A replay of the call will
also be available through the company's website shortly after the
call. For both dial-in numbers please use conference ID 38108.
Use of Non-GAAP Adjusted Financial
Information
Included in this press release are non-GAAP
adjusted financial information as defined by U.S. Securities and
Exchange Commission Regulation G. The GAAP financial measure most
directly comparable to each non-GAAP adjusted financial measure
used or discussed, and a reconciliation of the differences between
each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, is included in this press release after the
condensed consolidated financial statements.
Non-GAAP adjusted net loss was derived by taking
GAAP net loss and adjusting it for non-cash stock-based
compensation expense. Management uses these non-GAAP adjusted
financial measures for internal reporting and forecasting purposes,
when publicly providing its business outlook, to evaluate the
company’s performance and to evaluate and compensate the company’s
executives. The company has provided these non-GAAP financial
measures in addition to GAAP financial results because it believes
that these non-GAAP adjusted financial measures provide investors
with a better understanding of the company’s historical results
from its core business operations.
While management believes that these non-GAAP
adjusted financial measures provide useful supplemental information
to investors regarding the underlying performance of the company’s
business operations, investors are reminded to consider these
non-GAAP measures in addition to, and not as a substitute for,
financial performance measures prepared in accordance with GAAP.
Non-GAAP measures have limitations in that they do not reflect all
of the amounts associated with the company’s results of operations
as determined in accordance with GAAP. In addition, it should be
noted that these non-GAAP financial measures may be different from
non-GAAP measures used by other companies, and management may
utilize other measures to illustrate performance in the future.
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 lipid
science and the potential therapeutic benefits of polyunsaturated
fatty acids. 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 REDUCE-IT
The REDUCE-IT cardiovascular outcomes study
commenced in 2011, enrolled and followed 8,179 randomized patients,
and was conducted based on a special protocol assessment agreement
with FDA.
REDUCE-IT is the first global cardiovascular
outcomes study to prospectively evaluate the effect of Vascepa, or
any therapy, 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
TGs between 150-499 mg/dL (median baseline 216 mg/dL) and either
established cardiovascular disease (secondary prevention cohort) or
diabetes mellitus and at least one other CV risk factor (primary
prevention cohort). The design of the REDUCE-IT cardiovascular
outcomes study was published in March 2017 in Clinical Cardiology1
and can be found in the R&D section on the company’s website at
www.amarincorp.com.
The REDUCE-IT hypothesis tested whether
additional cardiovascular risk reduction beyond LDL-C controlled
with statin therapy could be achieved in high risk patients with
the putative cardioprotective effects of Vascepa 4 grams/day.
Independent of REDUCE-IT, Amarin worked to support the REDUCE-IT
hypothesis with published scientific findings based on various
degrees of evidence that show EPA may interrupt the atherosclerotic
process (e.g., plaque formation and instability) by beneficially
affecting cellular functions thought to contribute to
atherosclerosis and cardiovascular events and by beneficially
affecting lipid, lipoprotein and inflammation biomarkers.2, 3, 4,
5, 6
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.
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.7,
8
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. 9, 10, 11, 12
Forward-Looking
Statements
This press release contains forward-looking
statements, including expectations regarding planned scientific
presentation, publication, regulatory review and related timing
thereof, including plans to submit an sNDA in early 2019 seeking an
expanded indication for Vascepa in the United States; and expected
costs relating to the foregoing; statements regarding Vascepa’s
ability to address a significant unmet medical need and potentially
being the most significant breakthrough in preventative
cardiovascular care since the advent of statin therapy;
expectations that REDUCE-IT results could lead to a new treatment
paradigm in the patient population studied; plans for sales force,
international and insurance coverage expansion as well as sales
force training and deployment. 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, its ability to obtain an
expanded indication for Vascepa in the United States, 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, Brinton EA, Jacobson TA,
Miller M, Tardif J-C, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN,
Braeckman RA, Juliano RA, Ballantyne CM and 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;40:138-148.2 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 Borow KM,
Nelson JR, Mason RP. Biologic plausibility, cellular effects, and
molecular mechanisms of eicosapentaenoic acid (EPA) in
atherosclerosis. Atherosclerosis. 2015;242(1):357-366.4 Nelson JR,
Wani O, May HT, et al. Potential benefits of eicosapentaenoic acid
on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.5 Mason
RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acid improves
endothelial function and nitric oxide bioavailability in a manner
that is enhanced in combination with a statin. Biomed Pharmacother.
2018;103:1231-1237.6 Takamura M, Kurokawa K, Ootsuji H, et al.
Long-term administration of eicosapentaenoic acid improves
post-myocardial infarction cardiac remodeling in mice by regulating
macrophage polarization. J Am Heart Assoc. 2017;6(2). pii:
e004560. 7 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.8 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.9 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.10 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):A15187.11 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.12 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
Lee M. Stern Trout Group In U.S.: +1 (646)
378-2992lstern@troutgroup.com
Media Inquiries: Christy Maginn Burson-Marsteller In U.S.:
+1 (646) 280-5210 Christy.Maginn@bm.com
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|
|
|
|
|
|
|
September 30, 2018 |
|
December 31, 2017 |
|
|
|
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current
Assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
81,892 |
|
|
$ |
73,637 |
|
Restricted cash |
|
|
600 |
|
|
|
600 |
|
Accounts
receivable, net |
|
|
47,648 |
|
|
|
45,318 |
|
Other
receivables |
|
|
25,654 |
|
|
|
— |
|
Inventory, net |
|
|
43,673 |
|
|
|
30,260 |
|
Prepaid
and other current assets |
|
|
2,935 |
|
|
|
3,455 |
|
Total
current assets |
|
|
202,402 |
|
|
|
153,270 |
|
Property,
plant and equipment, net |
|
|
69 |
|
|
|
28 |
|
Other
long-term assets |
|
|
174 |
|
|
|
174 |
|
Intangible asset, net |
|
|
7,642 |
|
|
|
8,126 |
|
TOTAL ASSETS |
|
$ |
210,287 |
|
|
$ |
161,598 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
26,174 |
|
|
$ |
25,155 |
|
Accrued
expenses and other current liabilities |
|
|
93,899 |
|
|
|
58,902 |
|
Current
portion of exchangeable senior notes, net of discount |
|
|
219 |
|
|
|
481 |
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
30,130 |
|
|
|
22,348 |
|
Deferred
revenue, current |
|
|
1,220 |
|
|
|
1,644 |
|
Total
current liabilities |
|
|
151,642 |
|
|
|
108,530 |
|
Long-Term
Liabilities: |
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
29,159 |
|
|
|
28,992 |
|
Long-term
debt from royalty-bearing instrument |
|
|
53,924 |
|
|
|
70,834 |
|
Deferred
revenue, long-term |
|
|
19,736 |
|
|
|
17,192 |
|
Other
long-term liabilities |
|
|
8,652 |
|
|
|
1,150 |
|
Total
liabilities |
|
|
263,113 |
|
|
|
226,698 |
|
Stockholders’ Deficit: |
|
|
|
|
Preferred
stock |
|
|
21,850 |
|
|
|
24,364 |
|
Common
stock |
|
|
232,646 |
|
|
|
208,768 |
|
Additional paid-in capital |
|
|
1,057,408 |
|
|
|
977,866 |
|
Treasury
stock |
|
|
(9,867 |
) |
|
|
(4,229 |
) |
Accumulated deficit |
|
|
(1,354,863 |
) |
|
|
(1,271,869 |
) |
Total
stockholders’ deficit |
|
|
(52,826 |
) |
|
|
(65,100 |
) |
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
$ |
210,287 |
|
|
$ |
161,598 |
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Product revenue,
net |
$ |
54,973 |
|
|
$ |
47,051 |
|
|
$ |
151,286 |
|
|
$ |
126,343 |
|
Licensing revenue |
|
350 |
|
|
|
309 |
|
|
|
598 |
|
|
|
895 |
|
Total
revenue, net |
|
55,323 |
|
|
|
47,360 |
|
|
|
151,884 |
|
|
|
127,238 |
|
Less: Cost of goods
sold |
|
13,541 |
|
|
|
11,921 |
|
|
|
37,035 |
|
|
|
31,520 |
|
Gross
margin |
|
41,782 |
|
|
|
35,439 |
|
|
|
114,849 |
|
|
|
95,718 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative (1) |
|
49,960 |
|
|
|
33,194 |
|
|
|
147,310 |
|
|
|
98,910 |
|
Research
and development (1) |
|
14,072 |
|
|
|
10,694 |
|
|
|
43,993 |
|
|
|
35,211 |
|
Total
operating expenses |
|
64,032 |
|
|
|
43,888 |
|
|
|
191,303 |
|
|
|
134,121 |
|
Operating loss |
|
(22,250 |
) |
|
|
(8,449 |
) |
|
|
(76,454 |
) |
|
|
(38,403 |
) |
Interest
expense, net |
|
(2,163 |
) |
|
|
(2,401 |
) |
|
|
(6,188 |
) |
|
|
(7,097 |
) |
Other
(expense) income, net |
|
(58 |
) |
|
|
25 |
|
|
|
(134 |
) |
|
|
100 |
|
Loss
from operations before taxes |
|
(24,471 |
) |
|
|
(10,825 |
) |
|
|
(82,776 |
) |
|
|
(45,400 |
) |
(Provision for) benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net
loss |
$ |
(24,471 |
) |
|
$ |
(10,825 |
) |
|
$ |
(82,776 |
) |
|
$ |
(45,400 |
) |
Loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.08 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.17 |
) |
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.17 |
) |
Weighted
average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
295,595 |
|
|
|
270,803 |
|
|
|
291,526 |
|
|
|
270,566 |
|
Diluted |
|
295,595 |
|
|
|
270,803 |
|
|
|
291,526 |
|
|
|
270,566 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation,
selling, general and administrative expenses were $44,357 and
$30,223 for the three months ended September 30, 2018 and 2017,
respectively, and research and development expenses were $13,024
and $10,170, respectively, for the same periods. Excluding non-cash
stock-based compensation as well as co-promotion fees paid to the
company's U.S. co-promotion partner, selling, general and
administrative expenses were $33,200 and $24,295 for the three
months ended September 30, 2018 and 2017, respectively. |
|
|
RECONCILIATION OF NON-GAAP NET
LOSS |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Net loss for EPS1 -
GAAP |
|
$ |
(24,471 |
) |
|
$ |
(10,825 |
) |
|
$ |
(82,776 |
) |
|
$ |
(45,400 |
) |
Non-cash
stock-based compensation expense |
|
|
6,651 |
|
|
|
3,495 |
|
|
|
14,032 |
|
|
|
10,471 |
|
Adjusted
net loss for EPS1 - non-GAAP |
|
$ |
(17,820 |
) |
|
$ |
(7,330 |
) |
|
$ |
(68,744 |
) |
|
$ |
(34,929 |
) |
|
|
|
|
|
|
|
|
|
1basic
and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share: |
|
|
|
|
|
|
|
|
Basic
and diluted - non-GAAP |
|
$ |
(0.06 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic
and diluted |
|
|
295,595 |
|
|
|
270,803 |
|
|
|
291,526 |
|
|
|
270,566 |
|
|
|
|
|
|
|
|
|
|
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