Total Revenue Increased 67% to $73.3 Million in
First Quarter 2019 Compared to Prior Year
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced
financial results for the quarter ended March 31, 2019 (Q1 2019)
and provided an update on company operations.
Key Amarin achievements in Q1 2019 include:
- Revenue growth: Net total revenue of $73.3 million in Q1 2019
as compared to $43.9 in Q1 2018, an increase of approximately 67%
primarily reflecting increased Vascepa prescription growth.
- sNDA submission: On March 28, 2019, Amarin submitted a
supplemental new drug application (sNDA) to the U.S. Food and Drug
Administration (FDA) seeking an expanded indication for Vascepa®
(icosapent ethyl) capsules, based on the positive results of the
landmark REDUCE-IT™ cardiovascular outcomes study which, assuming
approval, will facilitate considerably broader promotion of Vascepa
in the United States.
- Total events analysis presented from REDUCE-IT study: New data
presented in March 2019 at the American College of Cardiology 68th
Annual Scientific Session showed that Vascepa provided a
statistically significant 30% risk reduction in total (first and
subsequent) cardiovascular events compared to placebo in the
statin-treated patient population studied in REDUCE-IT
demonstrating approximately one fewer major adverse cardiovascular
events (MACE) per six patients treated with Vascepa (or 159 fewer
MACE per 1000 patients) over a five year period. This new data was
concurrently published in the Journal of the American College of
Cardiology1.
- American Diabetes Association® guidelines updated: The American
Diabetes Association (ADA) updated its 2019 Standards of Medical
Care in Diabetes2 to incorporate findings from REDUCE-IT
recommending that “in patients with ASCVD (atherosclerotic
cardiovascular disease) or other cardiac risk factors on a statin
with controlled low-density cholesterol (LDL-C), but elevated
triglycerides (135-499), the addition of icosapent ethyl should be
considered to reduce cardiovascular risk.”
“Initial reaction from the medical community to
REDUCE-IT results has been very encouraging, including the updated
guidelines from the ADA. Our expanded sales team is off to a good
start and we are optimistic regarding the potential results of
pharmacoeconomic analysis expected later this year,” commented John
Thero, Amarin’s president and chief executive officer. “We remain
very early in the process of introducing Vascepa to healthcare
professionals and we remain limited in what we can say about
Vascepa, particularly to consumers, until the label for Vascepa is
expanded. We are confident in the robust results of the REDUCE-IT
study and we look forward to interacting with regulatory
authorities in their review of these Vascepa clinical results in
conjunction with the expanded labeling we seek for Vascepa.”
Commercialization Progressing Well in Second Phase of
Four Phase Plan
Following positive clinical results from the
REDUCE-IT cardiovascular outcomes study, Amarin commenced what it
described previously as the second of four phases of its commercial
evolution. In this second phase, Amarin more than doubled the size
of its U.S. sales force to begin 2019 with approximately 400 sales
representatives plus their managers in the U.S. while in parallel
not renewing its prior co-promotion agreement for Vascepa. The new
sales representatives were fully trained and deployed by
mid-January 2019. Amarin also significantly expanded the number of
healthcare professionals it calls on for Vascepa education to
approximately 55,000 healthcare professionals and expanded various
other marketing and medical education programs.
Amarin reported that there was encouraging
evidence of commercial progress in the first quarter despite the
majority of Amarin’s sales representatives being new and despite
the label for Vascepa not referencing the results of the REDUCE-IT
study. During the first quarter of 2019, shipments of Vascepa to
customers increased, driven by increased levels of Vascepa
prescriptions. Such increased prescriptions were derived from both
past prescribers and new prescribers of Vascepa. Many of the new
sales representatives hired by Amarin have already demonstrated
positive contributions.
As an industry benchmark, it is generally
accepted that it requires at least 5 sales calls before most
physicians change prescribing behaviors. For Vascepa, this may
require fewer visits to some doctors due to the robustly positive
REDUCE-IT results and the lack of an alternative proven treatment
option to address the risk evaluated in REDUCE-IT. Conversely, it
may also take more visits to some doctors for them to begin
prescribing Vascepa as the label for Vascepa has not yet expanded,
and because prescribers have not had a practice changing new
therapy for preventative cardiovascular care in many years beyond
cholesterol management and diabetes therapies. As of the end of
March 2019, consistent with previously communicated projections,
Amarin sales representatives called on approximately 75% of our
target physicians two or more times with the published results of
the REDUCE-IT study. However, only slightly greater than half of
these physicians had been called on three or more times.
The first quarter of each year historically was
difficult for Vascepa prescription growth due to seasonal factors
such as beginning of the year deductibles under patient insurance
coverages. These factors are independent of Vascepa. In the first
quarter of 2019, such seasonal factors, which curtail patient
refill prescriptions, were largely offset by new prescriptions.
Based on data from Symphony Health, new prescriptions (NRx) of
Vascepa increased by approximately 80% in the first quarter of 2019
compared to the same period of the prior year. In addition, refill
prescription rates were approximately 3% to 5% higher in the first
quarter of 2019 compared to the same period of the prior year.
These increases in the first quarter of 2019 were partially offset
by a decline in Vascepa inventory levels reported by independent
commercial wholesalers. Such channel inventory levels at
wholesalers were in the normal industry range. Calculated on a
days-of-sales outstanding basis, channel inventory levels also
declined in the first quarter of 2018.
Prescription Growth
Normalized prescriptions for Vascepa
(prescription of 120 grams of Vascepa representing a one-month
supply) increased by approximately 58% and 55% in Q1 2019 compared
to Q1 2018 based on data from Symphony Health and IQVIA,
respectively. Estimated normalized Vascepa prescriptions, based on
data from Symphony Health and IQVIA, totaled approximately 618,000
and 553,000 in the first quarter of 2019.
As described more fully in Amarin’s Quarterly
Report on Form 10-Q, Amarin recognizes product revenue when its
customers, consisting mostly of independent commercial
distributors, take possession of the product which they order from
us and we ship to them. Amarin revenue is not recognized when
individual patients fill prescriptions. In each of the three months
ended March 31, 2019 and 2018, based on product shipment
information available to Amarin, it appears that Symphony Health
and IQVIA may have understated the rate of growth in Vascepa
prescription levels.
Symphony Health and IQVIA collect and report
estimates of prescription information. There is a limited amount of
information available to such companies to determine the actual
number of total prescriptions for prescription products like
Vascepa during such periods. Data reported by Symphony Health and
IQVIA is rarely identical. Their estimates are based on a
combination of data received from pharmacies and other
distributors, and historical data when actual data is unavailable.
Their calculations of changes in prescription levels between
periods can be significantly affected by lags in data reporting
from various sources or by changes in how pharmacies and other
distributors provide data. Such methods can from time to time
result in significant inaccuracies in information when ultimately
compared with actual results. These inaccuracies have historically
been most prevalent and pronounced during periods of time of
inflections upward or downward in rates of use and less prevalent
and pronounced over longer periods of time such as annually.
As such, the resulting conclusions from such sources should be
viewed with caution. Amarin cites such third-party information as a
courtesy to its investors and because Amarin does not have direct
access to prescription information.
The prescription levels and changes in
prescription levels reported above are based on information made
available to us from third-party resources and may be subject to
adjustment and may overstate or understate actual prescriptions.
For example, it is Amarin’s understanding that in March and April
2019 Symphony Health had been working to fill gaps in data sources
and that they may issue “corrected” data at some point in the near
future. Amarin is not directly aware of the details related to such
source issues, or the precise timeline for corrective data or the
degree to which estimated Vascepa prescriptions, as reported by
Symphony Health, may change upward or downward if such corrections
are implemented.
Regulatory Update
On March 28, 2019 Amarin submitted a
supplemental new drug application (sNDA) to the U.S. Food and Drug
Administration (FDA) seeking an expanded indication for Vascepa®
(icosapent ethyl) capsules, based on the positive results of the
REDUCE-IT™ cardiovascular outcomes study. The FDA has a 60-day
review period to determine whether the sNDA is complete and
acceptable for filing. Pending such acceptance for filing, Amarin,
unless and until it learns otherwise in communications from the
FDA, is operating under the assumption that the sNDA will be
reviewed on a standard review clock of ten months resulting in a
PDUFA date near the end of January 2020. While Amarin is not
relying on priority review for the sNDA, if the FDA were to decide
that the sNDA will be subject to priority review this would
typically be communicated within 60 to 74 days of the FDA’s receipt
of the sNDA.
Amarin continues to expect that there will be an
Advisory Committee (AdCom) meeting organized by the FDA in
conjunction with its review of the expanded label for Vascepa
sought in its sNDA, reflecting that Vascepa is positioned to become
the first drug approved to treat the large patient population
studied in the REDUCE-IT trial. However, the FDA determination as
to whether or not there will be an AdCom has not yet been
communicated to Amarin. Typically, the FDA does not communicate
such a decision until it has had the opportunity to substantially
review the sNDA.
In the event that Amarin receives a definitive
communication from FDA regarding the scheduling of a PDUFA date for
the sNDA or the scheduling of an AdCom, Amarin will seek to provide
public update on such matters.
Health Canada has communicated to Amarin’s
Canadian partner that priority review status was granted for its
New Drug Submission (NDS) for Vascepa in Canada. The NDS for
Vascepa was submitted to Health Canada on April 26, 2019 seeking
approval to market and sell Vascepa in Canada to reduce the risk of
ischemic cardiovascular events in statin-treated patients with
elevated triglycerides and other risk factors. The FDA operates
independently of Health Canada.
Financial Update
Net product revenue, the largest component of
net total revenue, for the three months ended March 31, 2019 and
2018 was approximately $72.7 million and $43.8 million,
respectively, primarily reflecting increased Vascepa prescriptions
in the United States. The net selling price of Vascepa declined
modestly in this period of 2019 compared to 2018 primarily due to
an increased portion of Vascepa prescriptions in 2019 derived from
prescriptions to patients with lower net paying Medicare insurance
coverage.
In addition, Amarin recognized licensing revenue
of approximately $0.5 million and $0.1 million for the quarters
ended March 31, 2019 and 2018, respectively, under agreements for
the commercialization of Vascepa outside the U.S.
Cost of goods sold for the three months ended
March 31, 2019 and 2018 was $17.1 million and $10.6 million,
respectively. Gross margin on net product revenue was 76% for each
of the three months ended March 31, 2019 and 2018.
Selling, general and administrative (SG&A)
expenses in the three months ended March 31, 2019 and 2018 were
$71.6 million and $43.4 million, respectively. This increase is due
primarily to increased promotional activities, including commercial
spend for expansion, including increased sales force expansion
following successful REDUCE-IT results, partially offset by
elimination of expenses associated with the company’s prior
co-promotion partner. This 65% increase in SG&A expenses
supported a 67% increase in net total revenue and is intended to
help support future revenue growth consistent with the company’s
previously expressed guidance that 2019 revenue levels will grow at
least 50% over 2018 levels to approximately $350 million in
2019.
Research and development expenses in the three
months ended March 31, 2019 and 2018 were $7.2 and $11.8 million,
respectively. This decrease in expense was primarily driven by a
decline in REDUCE-IT related costs after the successful completion
of the REDUCE-IT study. Following the reporting of REDUCE-IT
results, R&D costs consisted primarily of clinical trial
wrap-up activities, costs related to scientific publications and
preparing for sNDA submission based on the results of the study,
which occurred in March 2019.
Under U.S. GAAP, Amarin reported a net loss of
$24.4 million in the first quarter of 2019, or basic and diluted
loss per share of $0.07. This net loss included $6.9 million in
non-cash stock-based compensation expense. Amarin reported a net
loss of $24.1 million in the first quarter of 2018, or basic and
diluted loss per share of $0.08. This net loss included $3.8
million in non-cash stock-based compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $17.5
million for the first quarter of 2019, or non-GAAP adjusted basic
and diluted loss per share of $0.05, compared to non-GAAP adjusted
net loss of $20.3 million for the first quarter of 2018, or
non-GAAP adjusted basic and diluted loss per share of $0.07.
As of March 31, 2019, Amarin reported cash and
cash equivalents of $211.1 million, $79.5 million in net accounts
receivable ($104.0 million in gross accounts receivable before
allowances and reserves) and $57.9 million in inventory. In
connection with the recently adopted lease standard, ASC 842, the
company recorded an operating lease right-of-use asset and
corresponding operating lease liability of approximately $9.0
million.
As of March 31, 2019, Amarin had approximately
330.6 million American Depository Shares (ADSs) and ordinary shares
outstanding, 28.9 million common share equivalents of Series A
Convertible Preferred Shares outstanding and approximately 16.8
million equivalent shares underlying stock options at a
weighted-average exercise price of $5.51, as well as 9.3 million
equivalent shares underlying restricted or deferred stock
units.
Conference Call and Webcast Information
The conference call can be heard live on the
investor relations section of the company's website at
www.amarincorp.com, or via telephone by dialing 877-407-8033 within
the United States or 201-689-8033 from outside the United States. 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, PIN: 46060. A replay of the call will also be
available through the company's website shortly after the call.
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
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 REDUCE-IT
REDUCE-IT3, an 8,179-patient cardiovascular
outcomes study, was completed in 2018. REDUCE-IT was the first
multinational cardiovascular outcomes study that evaluated the
effect of prescription pure EPA therapy as an add-on to statins in
patients with high cardiovascular risk who, despite stable statin
therapy, had elevated triglyceride levels (at least 135 mg/dL). A
large portion of the male and female patients enrolled in this
outcomes study were diagnosed with type 2 diabetes.
More information on the REDUCE-IT study results
can be found at 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.4,
5
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. 6
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. 7-10
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.
Important Safety Information for Vascepa based on REDUCE-IT, as
previously reported in The New England Journal of Medicine3
publication of the primary results of the REDUCE-IT study:
- Excluding the major adverse cardiovascular events (MACE)
results described above, overall adverse event rates in REDUCE-IT
were similar across the statin plus Vascepa and the statin plus
placebo treatment groups.
- There were no significant differences between treatments in the
overall rate of treatment emergent adverse events or serious
adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a
frequency of >2% which occurred at a numerically higher rate in
the statin plus Vascepa treatment group than in the statin plus
placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and
more frequently with Vascepa than placebo were:
- peripheral edema (6.5% Vascepa patients versus 5.0% placebo
patients), although there was no increase in the rate of heart
failure in Vascepa patients
- constipation (5.4% Vascepa patients versus 3.6% placebo
patients), although mineral oil, as used as placebo, is known to
lower constipation, and
- atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo
patients), although there were reductions in rates of cardiac
arrest, sudden death and myocardial infarctions observed in Vascepa
patients
- There were numerically more SAEs related to bleeding in the
statin plus Vascepa treatment group although overall rates were low
with no fatal bleeding observed in either group and no significant
difference in adjudicated hemorrhagic stroke or serious central
nervous system or gastrointestinal bleeding events between
treatments.
- In summary, Vascepa was well tolerated with a safety profile
generally consistent with clinical experience associated with
omega-3 fatty acids and current FDA-approved labeling of such
products.
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. FDA has not reviewed and opined on a
supplemental new drug application related to REDUCE-IT. FDA has not
reviewed the information herein or determined whether to approve
Vascepa for use to reduce the risk of MACE. 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.
Important Cautionary Information About These
Data
Further REDUCE-IT data assessment and data
release could yield additional useful information to inform greater
understanding of the trial outcome. Further detailed data
assessment by Amarin and regulatory authorities will
continue and take several months to complete and record. The final
evaluation of the totality of the efficacy and safety data from
REDUCE-IT may include some or all of the following, as well as
other considerations: new information affecting the degree of
treatment benefit on studied endpoints; study conduct and data
robustness, quality, integrity and consistency; additional safety
data considerations and risk/benefit considerations; consideration
of REDUCE-IT results in the context of other clinical studies.
Recurrent event analyses for the total primary
endpoint events and for the total key secondary endpoint in
REDUCE-IT as published in the Journal of the American College of
Cardiology9 were conducted using a series of statistical models.
These analyses were tertiary or exploratory endpoints; most of the
models used were prespecified and one was post hoc. Each recurrent
event statistical model has inherent strengths and weaknesses, with
no single model considered definitive or outperforming the other
models, and this is an evolving field of science. Nonetheless,
results from the total primary and total key secondary endpoint
events analyses are consistent across the various recurrent event
statistical models and are also consistent with the original
primary and secondary endpoint results. Together, the REDUCE-IT
recurrent event analyses and the original primary and key secondary
endpoint analyses support the robustness of the clinical benefit of
Vascepa therapy in reducing cardiovascular risk.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding regulatory review and
related timing thereof; and expectations regarding further
advancement, commercial expansion and revenue growth. 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 (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin’s investor
relations website and may include social media channels. The
contents of Amarin’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
References
1 Bhatt DL, Steg PG, Miller
M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From
REDUCE-IT. J Am Coll Cardiol 2019. epub ahead of
print. https://doi.org/10.1016/j.jacc.2019.02.0322
American Diabetes Association. Diabetes Care
2019 Jan; 42 (Supplement 1): S103-S123.
https://doi.org/10.2337/dc19-S0103 Bhatt
DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with
Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med
2019;380:11-22.4 American Heart
Association. 2018. Disease and Stroke Statistics-2018
Update.5 American Heart Association.
2017. Cardiovascular disease: A costly burden for America
projections through 2035.6 Ganda OP,
Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia
therapy in hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.7 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.8 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):e008740.9 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.10 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 Solebury Trout In U.S.: +1 (646)
378-2992lstern@soleburytrout.com
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
March 31, 2019 |
|
December 31, 2018 |
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
211,089 |
|
|
$ |
249,227 |
|
Restricted cash |
|
|
1,502 |
|
|
|
1,500 |
|
Accounts receivable, net |
|
|
79,485 |
|
|
|
66,523 |
|
Inventory |
|
|
57,909 |
|
|
|
57,802 |
|
Prepaid and other current assets |
|
|
5,334 |
|
|
|
2,945 |
|
Total current
assets |
|
|
355,319 |
|
|
|
377,997 |
|
Property, plant and equipment, net |
|
|
57 |
|
|
|
63 |
|
Operating lease right-of-use asset |
|
|
8,900 |
|
|
|
— |
|
Other long-term assets |
|
|
643 |
|
|
|
174 |
|
Intangible asset, net |
|
|
7,319 |
|
|
|
7,480 |
|
TOTAL ASSETS |
|
$ |
372,238 |
|
|
$ |
385,714 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
26,776 |
|
|
$ |
37,632 |
|
Accrued expenses and other current liabilities |
|
|
94,170 |
|
|
|
84,171 |
|
Current portion of long-term debt from royalty-bearing
instrument |
|
|
38,960 |
|
|
|
34,240 |
|
Deferred revenue, current |
|
|
1,898 |
|
|
|
1,220 |
|
Total current
liabilities |
|
|
161,804 |
|
|
|
157,263 |
|
Long-Term Liabilities: |
|
|
|
|
Long-term debt from royalty-bearing instrument |
|
|
35,338 |
|
|
|
46,108 |
|
Deferred revenue, long-term |
|
|
18,265 |
|
|
|
19,490 |
|
Long-term operating lease liability |
|
|
7,930 |
|
|
|
— |
|
Other long-term liabilities |
|
|
8,030 |
|
|
|
10,523 |
|
Total
liabilities |
|
|
231,367 |
|
|
|
233,384 |
|
Stockholders’ Equity: |
|
|
|
|
Preferred Stock |
|
|
21,850 |
|
|
|
21,850 |
|
Common stock |
|
|
250,088 |
|
|
|
246,663 |
|
Additional paid-in capital |
|
|
1,301,389 |
|
|
|
1,282,762 |
|
Treasury stock |
|
|
(19,493 |
) |
|
|
(10,413 |
) |
Accumulated deficit |
|
|
(1,412,963 |
) |
|
|
(1,388,532 |
) |
Total stockholders’
equity |
|
|
140,871 |
|
|
|
152,330 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
$ |
372,238 |
|
|
$ |
385,714 |
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
(in thousands, except per share
amounts) |
|
|
|
2019 |
|
|
|
2018 |
|
Product revenue, net |
$ |
72,731 |
|
|
$ |
43,777 |
|
Licensing revenue |
|
547 |
|
|
|
142 |
|
Total revenue, net |
|
73,278 |
|
|
|
43,919 |
|
Less: Cost of goods sold |
|
17,140 |
|
|
|
10,648 |
|
Gross margin |
|
56,138 |
|
|
|
33,271 |
|
Operating expenses: |
|
|
|
Selling, general and administrative (1) |
|
71,633 |
|
|
|
43,407 |
|
Research and development (1) |
|
7,242 |
|
|
|
11,762 |
|
Total operating expenses |
|
78,875 |
|
|
|
55,169 |
|
Operating loss |
|
(22,737 |
) |
|
|
(21,898 |
) |
Interest expense, net |
|
(1,697 |
) |
|
|
(2,252 |
) |
Other income, net |
|
3 |
|
|
|
55 |
|
Loss from operations before taxes |
|
(24,431 |
) |
|
|
(24,095 |
) |
(Provision for) benefit from income taxes |
|
— |
|
|
|
— |
|
Net loss |
$ |
(24,431 |
) |
|
$ |
(24,095 |
) |
Loss per share: |
|
|
|
Basic |
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
Diluted |
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
Weighted average shares: |
|
|
|
Basic |
|
328,712 |
|
|
|
285,207 |
|
Diluted |
|
328,712 |
|
|
|
285,207 |
|
|
|
|
|
|
(1 |
) |
Excluding non-cash stock-based compensation, selling,
general and administrative expenses were $66,027 and $40,205 for
the three months ended March 31, 2019 and 2018, respectively, and
research and development expenses were $5,964 and $11,202,
respectively, for the same periods. |
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET
LOSS |
Unaudited |
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
(in thousands, except per share
amounts) |
|
|
|
2019 |
|
|
|
2018 |
|
Net loss for EPS1 - GAAP |
$ |
(24,431 |
) |
|
$ |
(24,095 |
) |
|
Non-cash stock-based compensation expense |
|
6,884 |
|
|
|
3,762 |
|
Adjusted net loss for EPS1 - non-GAAP |
$ |
(17,547 |
) |
|
$ |
(20,333 |
) |
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
Basic and diluted - non-GAAP |
$ |
(0.05 |
) |
|
$ |
(0.07 |
) |
|
|
|
|
|
Weighted average shares: |
|
|
|
Basic and diluted |
|
328,712 |
|
|
|
285,207 |
|
|
|
|
|
|
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