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 six months ended June 30, 2019,
and provided an update on company operations.
Key Amarin achievements since its last quarterly
report include:
- U.S. regulatory review progressing: The Priority Review of
Amarin’s supplemental new drug application (sNDA) seeking to expand
the indication for Vascepa® (icosapent ethyl) appears to be
progressing in an orderly and timely manner toward the September
28, 2019 PDUFA goal date.
- Second quarter net product revenue growth increased by 91%:
Recognized $100.8 million in total revenue and $100.4 million in
net product revenue from Vascepa sales in Q2 2019 compared to $52.5
million in Q2 2018, an increase of 91%. The total revenue result is
at the upper end of the company’s previously estimated revenue of
between $97 and $101 million announced on July 2, 2019.
- U.S. prescriptions grew by more than 70%: Increased normalized
prescriptions for Vascepa by 76% and 73% compared to Q2 2018 based
on data from Symphony Health Solutions and IQVIA,
respectively.
- Commercial expansion preparation under way: Actively hiring
additional sales managers and sales representatives to double the
size of Amarin’s U.S. sales force to approximately 800 sales
representatives by October 2019, while also executing on other
plans to effectively educate healthcare professionals and consumers
regarding the cardiovascular risk reduction profile of Vascepa and
the significant unmet need for this disease, following an
anticipated label expansion in late September.
- International plans on track: Progressing through Amarin’s
licensee, HLS Therapeutics Inc. (TSX:HLS), towards anticipated
approval of Vascepa in Canada in the fourth quarter of 2019. As
previously disclosed, the application for Vascepa was granted a
priority review designation by Health Canada. Other international
progress is continuing, including Amarin’s plans to submit an
application seeking approval for Vascepa in Europe before the end
of 2019.
- Increased cash balance to ensure robust launch of Vascepa: As
of June 30, 2019, Amarin had a cash balance of $221.8 million. In
July 2019, Amarin completed a $460.0 million equity offering
resulting in an increase in Amarin’s cash balance to more than $600
million on a pro forma basis.
“Amarin made tremendous progress in the first
half of 2019, including achieving $100 million in quarterly revenue
which is a record for Vascepa sales,” stated John F. Thero,
president and chief executive officer, Amarin. “We believe this is
just the start of realizing the significant commercial opportunity
for Vascepa, which will be driven by our passion to potentially
help millions of at-risk patients and our ability to broadly
communicate to healthcare professionals and patients the
cost-effective value of Vascepa based on the FDA-approved expanded
indication we’re anticipating in September. Our focus right now is
ensuring we are prepared to robustly launch Vascepa based on that
expanded indication.”
Regulatory Update
As previously announced, Amarin submitted an
sNDA to the FDA on March 28, 2019, seeking to expand the indication
for Vascepa. The sNDA was based on the positive results of the
landmark REDUCE-IT™ cardiovascular outcomes study. If approved, the
expanded label is anticipated to allow for considerably broader
promotion of Vascepa in the United States. As announced in May
2019, the FDA accepted the sNDA for filing and granted Priority
Review designation with an assigned PDUFA goal date of September
28, 2019.
To date, the FDA has not informed Amarin as to
whether it plans to convene an Advisory Committee (AdCom) to review
the sNDA. The FDA is not required to inform sponsor companies that
it does not intend to hold an AdCom. While it remains possible that
the FDA may elect to convene an AdCom, with less than two months
remaining prior to the PDUFA date Amarin is now assuming that an
AdCom is unlikely. If Amarin is informed definitively that there
will or will not be an AdCom, the company plans to update investors
accordingly.
Label negotiations in the sNDA process could
commence as early as one month prior to the PDUFA date under FDA’s
typical processes. As such, a final version of the updated Vascepa
label is not available at this time. It would therefore be
unproductive for Amarin to speculate on the wording of such a label
before a final determination by the FDA except to express that
Amarin is seeking a cardiovascular risk reduction label for Vascepa
which is consistent with the results of the REDUCE-IT study.
Prescription Growth
Vascepa prescription growth in Q2 2019 stemmed
from both prior prescribers and new prescribers. Normalized
prescriptions for Vascepa (prescription of 120 grams of Vascepa
representing a one-month supply) increased by approximately 76% and
73% in Q2 2019 compared to Q2 2018 based on data from Symphony
Health and IQVIA, respectively. Estimated normalized Vascepa
prescriptions, based on data from Symphony Health and IQVIA,
totaled approximately 756,000 and 683,000 in the second quarter of
2019.
As there has been a trend of an increasing
number of 90-day prescriptions (or scripts) vs. 30-day
prescriptions, reporting from Symphony and IQVIA on prescription
counts may not reflect the true demand for the product. Script
counts from these services do not account for whether a script is
for 90 days or 30 days as both are counted as one script.
Accordingly, Amarin believes that pill counts reported as extended
units by Symphony and IQVIA show a more accurate reflection of the
demand for Vascepa. Normalized prescriptions, as referenced
above, take this into account by using the extended unit number and
dividing by the pill count in the bottle. Nonetheless, even when
normalized, estimates from these independent sources for Vascepa
and other drugs have historically been most accurate over longer
periods of time, such as annually, while directionally informative
over shorter periods of time.
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 they order and Amarin
ships to them. Amarin revenue is not recognized when individual
patients fill prescriptions.
Commercial Update
Upon FDA approval of an expanded indication for
Vascepa, Amarin’s goal is to be ready to launch a robust
educational and promotional campaign aimed at healthcare
professionals and consumers on the efficacy and safety profile of
Vascepa as well as on the significant unmet need to help patients
with underlying cardiovascular risks beyond cholesterol
management.
When physicians become knowledgeable about the
results of the REDUCE-IT study, it has been Amarin’s experience
that they appreciate the importance of Vascepa and how it can be
used to help the health of their patients. However, the vast
majority of healthcare professionals have little knowledge of
Vascepa. Amarin views this as an opportunity to be improved through
expanded Vascepa promotion supported by an expanded label.
With the benefit of funds from recent financing,
the company plans to create “surround sound” in its promotion of
Vascepa. This surround sound will include more sales
representatives, various forms of digital outreach, medical
education, scientific presentations at industry meetings,
direct-to-consumer advertising and other means of effective and
responsible communications.
Most of the sales representatives hired at the
start of 2019 are performing well and showing promise for greater
contribution in the future. Their progress, together with the
anticipated value of the expanded label for Vascepa, gives Amarin
the confidence to double the size of its sales force.
To date, Amarin has hired most of the additional
sales managers required for this expansion and is confident that it
will have approximately 400 new sales representatives hired,
trained and in the field promoting Vascepa by early October.
While the expanded sales team will reach a
larger number of healthcare professionals, it is equally important
to achieve more frequent interactions with targeted healthcare
professionals. The current sales team calls on approximately 50,000
healthcare professionals. With the doubling of the sales force,
Amarin expects to reach approximately 70,000 to 80,000 healthcare
professionals. As of the end of June 2019, consistent with
previously communicated projections, Amarin sales representatives
called on approximately half of its current target physicians five
or more times with the published results of the REDUCE-IT
study.
Direct-to-consumer (DTC) promotion is likely to
be a phased process. Upon label expansion, Amarin plans to increase
promotion through more placement of Vascepa advertisement in
platforms currently used. In parallel, new messaging for branded
promotion based on the anticipated expanded label for Vascepa will
be submitted to the FDA for review. Such submission for promotional
review cannot be made until after the label is expanded. Subject to
FDA review, Amarin anticipates launching that DTC campaign in the
second quarter of 2020.
Managed care coverage for Vascepa continues to
be favorable overall. Amarin anticipates marginal further
improvement to such coverage in Q3 2019, prior to label expansion,
and plans to pursue even broader managed care coverage following
assumed label expansion.
The Institute for Clinical and Economic Review
(ICER), an independent non-profit organization, released its draft
evidence report regarding clinical effectiveness and economic
impacts of Vascepa on July 24, 2019. ICER’s draft report concluded
that Vascepa is cost effectiveness across all the non-profit
organization’s analyses, based on its quality-adjusted life year
(QALY) metrics Despite the draft report’s positive conclusion
regarding cost effectiveness, Amarin believes that ICER understates
the value of Vascepa. For example, the ICER base-case analyses
reflect only the costs of heart attack, stroke and cardiovascular
death and appear to exclude high costs associated with other
cardiovascular events that were demonstrated to be lowered by
Vascepa in the REDUCE-IT cardiovascular outcomes study (e.g.,
revascularization procedures and hospitalizations for unstable
angina). Amarin believes this draft report, while not perfect in
its value assessment, provides additional support for why medical
insurance should broadly cover Vascepa for the population of
patients studied in REDUCE-IT. While many payors already broadly
cover Vascepa, upon anticipated label expansion, Amarin plans to
use the results of the REDUCE-IT study, pharmaco-economic analysis,
such as presented by ICER, and other medical information and data
in negotiations with payers seeking expanded Vascepa insurance
coverage.
Financial Update
Total revenue for the three months ended June
30, 2019 and 2018 was $100.8 million and $52.6 million,
respectively. Net product revenue for the three months ended June
30, 2019 and 2018 was $100.4 million and $52.5 million,
respectively. Total revenue for the six months ended June 30, 2019
and 2018, was $174.1 million and $96.6 million, respectively. Net
product revenue for the six months ended June 30, 2019 and 2018 was
$173.1 million and $96.3 million, respectively. The increase in net
product revenue was primarily attributable to increases in new and
recurring prescriptions of Vascepa as net selling price remained
relatively unchanged for the six months ended June 30, 2019 as
compared to the same period in 2018.
During the second quarter, based on data from
Symphony Health Solutions and IQVIA, Amarin experienced continued
prescription growth and an increase in Vascepa market share,
particularly among physicians called on by Amarin’s sales
professionals. Symphony Health Solutions and IQVIA reported
estimated normalized total Vascepa prescriptions of approximately
756,000 and 683,000, respectfully, for the three months ended June
30, 2019, representing growth of approximately 76% and 73%,
respectively, over levels estimated by these sources for the same
three months of the prior year.
Licensing revenues recognized by the company
were $1.0 million and $0.2 million in the six months ended June 30,
2019 and 2018, 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 for the three months ended
June 30, 2019 and 2018 was $22.8 million and $12.8 million,
respectively. Cost of goods sold for the six months ended June 30,
2019 and 2018 was $39.9 million and $23.5 million, respectively.
Gross margin on net product revenue for the three and six months
ended June 30, 2019 and 2018 was 77% and 76%, respectively.
Selling, general and administrative (SG&A)
expenses in the six months ended June 30, 2019 and 2018 were $145.0
and $97.4 million, respectively, an increase of 49%. This increase
is due primarily to increased promotional activities, including
commercial spend for expansion following successful REDUCE-IT
results, as well as costs for sales force expansion, partially
offset by elimination of expenses associated with the company’s
prior co-promotion partner. As previously disclosed, the level of
anticipated SG&A spending will increase as Amarin doubles the
size of its sales force and increases its promotional and
educational spending for Vascepa in conjunction with the
anticipated label expansion.
Research and development (R&D) expenses in
the six months ended June 30, 2019 and 2018 were $14.4 and $29.9
million, respectively, a decrease of 52%. This decrease in expense
is primarily driven by a decline in REDUCE-IT related
costs. Following the completion of the REDUCE-IT trial, costs
consisted primarily of the clinical study’s wrap-up activities,
regulatory support and publications. As previously disclosed,
Amarin anticipates the level of spending on R&D will continue
to decline as it has completed the REDUCE-IT study and initial
publication of results from this important study.
Under U.S. GAAP, Amarin reported a net loss of
$1.8 million in the three months ended June 30, 2019, or basic and
diluted loss per share of $0.01. This net loss included $7.9
million in non-cash stock-based compensation expense. Amarin
reported a net loss of $34.2 million in the second quarter of 2018,
or basic and diluted loss per share of $0.12. This net loss
included $3.6 million in non-cash stock-based compensation
expense.
Under GAAP, Amarin reported a net loss of $26.3
million in the six months ended June 30, 2019, or basic and diluted
loss per share of $0.08. This net loss included $14.8 million in
non-cash stock-based compensation expense. For the six months ended
June 30, 2018, Amarin reported a net loss of $58.3 million, or
basic and diluted loss per share of $0.20. This net loss included
$7.4 million in non-cash stock-based compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $6.1
million for the second quarter of 2019, or non-GAAP adjusted basic
and diluted earnings per share of $0.02, compared to non-GAAP
adjusted net loss of $30.6 million for the second quarter of 2018,
or non-GAAP adjusted basic and diluted loss per share of $0.10.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $11.5
million for the six months ended June 30, 2019, or non-GAAP
adjusted basic and diluted loss per share of $0.03, compared to
non-GAAP adjusted net loss of $50.9 million for the six months
ended June 30, 2018, or non-GAAP adjusted basic and diluted loss
per share of $0.18.
As of June 30, 2019, Amarin reported cash and
cash equivalents of $221.8 million, $95.4 million in net accounts
receivable ($116.3 million in gross accounts receivable before
allowances and reserves) and $46.3 million in inventory. As noted
above, the company completed an equity offering in July 2019 for
gross proceeds of approximately $460.0 million and issued
approximately 25.5 million ADSs, including the full exercise of the
underwriters’ 30-day over-allotment option to purchase up to an
additional 15% of the ADSs issued in the offering. Net proceeds
after fees and expenses from this financing were approximately
$439.5 million. While Amarin was net cash flow positive in the
three months ended June 30, 2019, the company expects net cash flow
to be negative in the second half of 2019 reflecting planning
increased spending for Vascepa promotion and anticipated increased
purchases of Vascepa inventory.
As of June 30, 2019, prior to the above
described financing, Amarin had approximately 331.3 million
American Depository Shares (ADSs) and ordinary shares outstanding,
28.9 million common share equivalents of Series A Convertible
Preferred Shares outstanding and approximately 16.6 million
equivalent shares underlying stock options at a weighted-average
exercise price of $5.86, as well as 9.3 million equivalent shares
underlying restricted or deferred stock units.
Conference Call and Webcast
Information
Amarin will host a conference call
at 7:30 a.m. ET today, July 31, 2019. 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 51652.
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-IT1 was an 8,179-patient multinational
cardiovascular outcomes study completed in 2018. REDUCE-IT
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.2,
3
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
levels.4
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease.5-8
About Vascepa® (icosapent
ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not
fish oil, but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient from degradation. Vascepa, known in
scientific literature as AMR101, has been designated a new chemical
entity by the FDA. Amarin has been issued multiple patents
internationally based on the unique clinical profile
of Vascepa, including the drug’s ability to lower triglyceride
levels in relevant patient populations without raising
LDL-cholesterol levels.
Indication and Usage Based on Current FDA-Approved Label (not
including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to
diet to reduce triglyceride (TG) levels in adult patients with
severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis
and cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on
Current FDA-Approved Label (not including REDUCE-IT
results) (Includes Data from Two 12-Week Studies (n=622)
(MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to
2000 mg/dL)
- Vascepa is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and
greater than placebo) was arthralgia (2.3% for Vascepa, 1.0%
for placebo). There was no reported adverse reaction >3% and
greater than placebo.
- Adverse events and product complaints may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving treatment with Vascepa and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush,
dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on
REDUCE-IT, as previously reported in The New England
Journal of Medicine1 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. For example, detailed data
assessment by regulatory authorities, such as the FDA and
Health Canada, will continue and take several months to complete
and announce. The final evaluation by regulatory authorities of the
totality of efficacy and safety data from REDUCE-IT may include
some or all of the following, as well as other considerations: new
information or analyses 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; and consideration of REDUCE-IT
results in the context of other clinical studies. Because
regulatory reviews are typically fluid and not definitive
interactions between sponsor and agency on individual elements of
an application and related information, Amarin does not plan to
update investors on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding revenue and
prescription growth, including updated revenue guidance for 2019;
sales force expansion and marketing initiatives expected in 2019
and beyond; FDA regulatory review, including the timing and outcome
of such review; the applicability and reliability of REDUCE-IT
results; the cost-effectiveness of Vascepa; the likelihood that
physicians will prescribe Vascepa after learning about the
REDUCE-IT results; and the expected outcome and timing of review
elements and market dynamics for Vascepa. 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 gain regulatory
approvals, 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 reviews and 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. Cardiovascular
Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.2 American Heart Association.
2018. Disease and Stroke Statistics-2018
Update.3 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.4 Ganda OP, Bhatt DL, Mason RP, et al.
Unmet need for adjunctive dyslipidemia therapy in
hypertriglyceridemia management. J Am Coll Cardiol.
2018;72(3):330-343.5 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol.
2016;118:138-145.6 Toth PP, Granowitz C, Hull M, et al.
High triglycerides are associated with increased cardiovascular
events, medical costs, and resource use: A real-world
administrative claims analysis of statin-treated patients with high
residual cardiovascular risk. J Am Heart
Assoc. 2018;7(15):e008740.7 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and
biology. Circ Res. 2016;118:547-563.8 Nordestgaard BG,
Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Inquiries: Elisabeth Schwartz Investor
Relations Amarin Corporation plc In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern Solebury Trout In U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries: Gwen Fisher Corporate
Communications Amarin Corporation plc In U.S.: +1 (908)
325-0735 pr@amarincorp.com
|
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
|
|
|
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
221,771 |
|
|
$ |
249,227 |
|
Restricted cash |
|
|
1,503 |
|
|
|
1,500 |
|
Accounts receivable, net |
|
|
95,398 |
|
|
|
66,523 |
|
Inventory |
|
|
46,268 |
|
|
|
57,802 |
|
Prepaid and other current assets |
|
|
7,103 |
|
|
|
2,945 |
|
Total current assets |
|
|
372,043 |
|
|
|
377,997 |
|
Property, plant and equipment, net |
|
|
858 |
|
|
|
63 |
|
Operating lease right-of-use asset |
|
|
8,762 |
|
|
|
— |
|
Other long-term assets |
|
|
1,102 |
|
|
|
174 |
|
Intangible asset, net |
|
|
7,157 |
|
|
|
7,480 |
|
TOTAL ASSETS |
|
$ |
389,922 |
|
|
$ |
385,714 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
34,018 |
|
|
$ |
37,632 |
|
Accrued expenses and other current liabilities |
|
|
103,495 |
|
|
|
84,171 |
|
Current portion of long-term debt from royalty-bearing
instrument |
|
|
45,410 |
|
|
|
34,240 |
|
Deferred revenue, current |
|
|
1,962 |
|
|
|
1,220 |
|
Total current liabilities |
|
|
184,885 |
|
|
|
157,263 |
|
Long-Term Liabilities: |
|
|
|
|
Long-term debt from royalty-bearing instrument |
|
|
23,202 |
|
|
|
46,108 |
|
Deferred revenue, long-term |
|
|
17,775 |
|
|
|
19,490 |
|
Long-term operating lease liability |
|
|
8,160 |
|
|
|
— |
|
Other long-term liabilities |
|
|
6,813 |
|
|
|
10,523 |
|
Total liabilities |
|
|
240,835 |
|
|
|
233,384 |
|
Stockholders’ Equity: |
|
|
|
|
Preferred Stock |
|
|
21,850 |
|
|
|
21,850 |
|
Common stock |
|
|
250,588 |
|
|
|
246,663 |
|
Additional paid-in capital |
|
|
1,311,965 |
|
|
|
1,282,762 |
|
Treasury stock |
|
|
(20,533 |
) |
|
|
(10,413 |
) |
Accumulated deficit |
|
|
(1,414,783 |
) |
|
|
(1,388,532 |
) |
Total stockholders’ equity |
|
|
149,087 |
|
|
|
152,330 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
389,922 |
|
|
$ |
385,714 |
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Product revenue, net |
$ |
100,366 |
|
|
$ |
52,537 |
|
|
$ |
173,097 |
|
|
$ |
96,313 |
|
Licensing revenue |
|
426 |
|
|
|
106 |
|
|
|
973 |
|
|
|
248 |
|
Total revenue, net |
|
100,792 |
|
|
|
52,643 |
|
|
|
174,070 |
|
|
|
96,561 |
|
Less: Cost of goods sold |
|
22,770 |
|
|
|
12,846 |
|
|
|
39,910 |
|
|
|
23,494 |
|
Gross margin |
|
78,022 |
|
|
|
39,797 |
|
|
|
134,160 |
|
|
|
73,067 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
73,406 |
|
|
|
53,944 |
|
|
|
145,039 |
|
|
|
97,350 |
|
Research and development (1) |
|
7,130 |
|
|
|
18,159 |
|
|
|
14,372 |
|
|
|
29,921 |
|
Total operating expenses |
|
80,536 |
|
|
|
72,103 |
|
|
|
159,411 |
|
|
|
127,271 |
|
Operating loss |
|
(2,514 |
) |
|
|
(32,306 |
) |
|
|
(25,251 |
) |
|
|
(54,204 |
) |
Interest income (expense), net |
|
789 |
|
|
|
(1,773 |
) |
|
|
(908 |
) |
|
|
(4,025 |
) |
Other expense, net |
|
(95 |
) |
|
|
(131 |
) |
|
|
(92 |
) |
|
|
(76 |
) |
Loss from operations before taxes |
|
(1,820 |
) |
|
|
(34,210 |
) |
|
|
(26,251 |
) |
|
|
(58,305 |
) |
(Provision for) benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(1,820 |
) |
|
$ |
(34,210 |
) |
|
$ |
(26,251 |
) |
|
$ |
(58,305 |
) |
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.01 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.20 |
) |
Diluted |
$ |
(0.01 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.20 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
330,863 |
|
|
|
293,662 |
|
|
|
329,793 |
|
|
|
289,458 |
|
Diluted |
|
330,863 |
|
|
|
293,662 |
|
|
|
329,793 |
|
|
|
289,458 |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Excluding non-cash stock-based compensation, selling, general and
administrative expenses were $66,564 and $50,878 for the three
months ended June 30, 2019 and 2018, respectively, and research and
development expenses were $6,089 and $17,607, 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 $66,564
and $40,594 for the three months ended June 30, 2019 and 2018,
respectively. |
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Net loss for EPS1 - GAAP |
|
$ |
(1,820 |
) |
|
$ |
(34,210 |
) |
|
$ |
(26,251 |
) |
|
$ |
(58,305 |
) |
Non-cash stock-based compensation expense |
|
|
7,883 |
|
|
|
3,618 |
|
|
|
14,766 |
|
|
|
7,381 |
|
Adjusted net income (loss) for EPS1 - non-GAAP |
|
$ |
6,063 |
|
|
$ |
(30,592 |
) |
|
$ |
(11,485 |
) |
|
$ |
(50,924 |
) |
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
|
Basic - non-GAAP |
|
$ |
0.02 |
|
|
$ |
(0.10 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.18 |
) |
Diluted - non-GAAP |
|
|
0.02 |
|
|
|
(0.10 |
) |
|
|
(0.03 |
) |
|
|
(0.18 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
330,863 |
|
|
|
293,662 |
|
|
|
329,793 |
|
|
|
289,458 |
|
Diluted |
|
|
373,238 |
|
|
|
293,662 |
|
|
|
329,793 |
|
|
|
289,458 |
|
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