Amarin Corporation plc (NASDAQ:AMRN), today announced
financial results for the three and nine months ended September 30,
2020 and provided an update on company operations.
Key
Achievements in Third Quarter
2020 (and recent weeks)
-
Achieved record quarterly and nine-month revenue levels: Reported
$156.5 million in net total revenue in the third quarter of 2020,
an increase of 39% compared to the third quarter of 2019, resulting
in net total revenue for the first nine months of $446.8 million,
an increase of 56% compared to the same period in
2019.
-
Reaffirmed strategy to continue increasing U.S. promotion of
VASCEPA: As reported, the U.S. Court of Appeals for the Federal
Circuit upheld the March 2020 U.S. District Court ruling in favor
of two generic companies in connection with their abbreviated new
drug applications, or ANDAs, related to VASCEPA capsules in its
initial triglyceride lowering indication. While generic competition
could potentially launch in the United States at any time, Amarin
continues to expect that with enhanced education and promotional
initiatives there is an opportunity to meaningfully grow revenue
for VASCEPA in the United States. These incremental initiatives
include direct-to-consumer advertisement, which launched for the
new cardiovascular risk reduction indication in the third quarter
of 2020. Such promotion builds on the important outreach to
healthcare professionals made by our direct sales team, the size of
which doubled near the start of 2020. Amarin’s strategy and
initiatives to further expand the market despite likely generic
competition reflect the large number of at-risk patients who could
potentially benefit from VASCEPA and survey data indicating that
most healthcare professionals and at-risk patients are not yet
aware of the benefits of VASCEPA in the cardiovascular risk
reduction indication, which launched in early 2020. Amarin’s
decision to continue to invest in expanding the market for VASCEPA
also reflects its confidence in its manufacturing processes, which
the company has built over a decade to achieve consistent,
high-quality, stable supply to support anticipated global
demand.
-
Progressed European regulatory review and commercial preparations:
Continued to support regulatory review of VASCEPA by the European
Medicines Agency (EMA) with the expectation of an early 2021
approval of VASCEPA for commercial sale in Europe. In the process
of hiring select people with extensive commercial experience in
Europe and preparing for post-approval market access
negotiations.
-
Expanded medical society recommendations in support of the efficacy
and safety of VASCEPA: The European Society of Cardiology expanded
their guidelines to recommend use of VASCEPA in treating acute
coronary syndrome patients. Previously they had recommended use of
VASCEPA for treating patients with established cardiovascular
disease.
-
Reported additional VASCEPA clinical results and other data that
further define VASCEPA’s multifactorial mechanisms of action,
clinical need and effects in reducing cardiovascular risk:
EVAPORATE study results reported in August 2020 showed a 17%
reduction in coronary plaque over 18 months in patients with
established coronary plaque. REDUCE-IT® PCI results presented in
October 2020 showed through post hoc subgroup analyses that
patients in the REDUCE-IT study who had stenting, bypass or other
forms of percutaneous cardiovascular intervention (PCI) experienced
significantly reduced rates of ischemic events when treated with
VASCEPA. REDUCE-IT RENAL results presented in October 2020 showed,
through prespecified and post hoc subgroup analyses, that patients
in the REDUCE-IT study who had compromised renal function at
baseline prior to treatment with VASCEPA or placebo, experienced
higher rates of cardiovascular events than the overall population
studied in REDUCE-IT. Additionally, VASCEPA use in the treatment of
such patients with baseline decreased renal function resulted in
similarly favorable relative risk reductions and numerically
greater absolute risk reductions versus placebo in comparison with
the overall patient population.
-
Reaffirmed clinical trial results from study of VASCEPA in China
are expected by year end 2020: Assuming positive results from this
study conducted by Amarin’s commercial partner for VASCEPA in
China, regulatory submission in China could follow promptly
thereafter.
-
Advanced enrollment in three COVID-19 related pilot studies:
Clinical studies of VASCEPA in Argentina, Canada and the United
States each reported substantial patient enrollment. These are
investigator-initiated studies which Amarin supports but does not
manage, and the clinical data being collected from these studies
are blinded. Final results from these studies are expected to be
available some time in 2021. Mechanistic data continues to provide
reasons to believe that VASCEPA could potentially be beneficial to
lessen the impact of COVID-19.
-
Maintained strong cash balance and reduced debt: As of September
30, 2020, Amarin reported total cash and investments of $608.0
million and $9.5 million remaining debt on its royalty-like
instrument, which Amarin plans to pay in full during the fourth
quarter of 2020.
Management Commentary
“The third quarter was a productive but
challenging quarter for Amarin as total net revenue grew to record
levels reflecting increased prescription levels for VASCEPA,
despite many patients not yet returning to their doctors’ offices
for preventative healthcare due to the global pandemic,” stated
John F. Thero, president and chief executive officer. “We believe
the key court decisions regarding VASCEPA patents related to the
triglyceride lowering indication have been wrong and we plan to
continue to pursue this matter to the highest level. Moreover, we
believe that because of numerous factors, including that VASCEPA
was only recently launched as the first and only drug for its
cardiovascular risk reduction indication, that continued investment
is justified in market expansion with the expectation that
increased revenue and profit can accumulate for Amarin by doing so.
We remain focused on bringing this potentially life-saving drug to
at-risk patients in the United States, Europe and elsewhere in the
world.”
“We are excited to be nearing the EMA’s
regulatory decision on VASCEPA and are busy preparing for our
anticipated commercial launch in Europe, where there is a large and
growing opportunity for Amarin to bring this proven effective
therapy to the millions of patients at high risk for cardiovascular
events. Launching on our own in major markets in Europe allows us
to create the greatest value as Amarin would not have to share
profits with a partner. Importantly, we can leverage the knowledge
and experience gained from the tremendous progress made by our U.S.
commercial team.
“In the coming months, we expect to achieve a
number of key milestones including the topline data readout from
the Phase 3 clinical trial of VASCEPA in China with our partner,
Eddingpharm; a recommendation from the Committee for Medicinal
Products for Human Use (CHMP) relating to our European regulatory
review and approval process; and presentation of numerous data in
support of VASCEPA in the cardiovascular risk reduction indication
at the upcoming Annual Scientific Sessions of the American Heart
Association,” added Mr. Thero.
Prescription Growth
Normalized prescriptions for VASCEPA
(prescription of 120 grams of VASCEPA representing a one-month
supply) increased by approximately 36% and 37% in the third quarter
of 2020 compared to the same period in 2019 based on data from
Symphony Health and IQVIA, respectively. Estimated normalized
VASCEPA prescriptions, based on data from Symphony Health and
IQVIA, totaled approximately 1,174,000 and 1,081,000 in the third
quarter of 2020. Year to date, estimated normalized prescriptions
for VASCEPA increased by approximately 49% and 51%, compared
to the first nine months of 2019 based on data from Symphony Health
and IQVIA, respectively. Estimated normalized VASCEPA
prescriptions, based on data from Symphony Health and IQVIA,
totaled approximately 3,325,000 and 3,050,000 in the first nine
months of 2020, respectively.
As with much of the pharmaceutical industry,
VASCEPA revenue and prescription growth have been adversely
impacted by the COVID-19 pandemic. Amarin temporarily suspended
in-person promotional activities in March 2020 and beginning in
June 2020 in a phased approach, resumed face-to-face interactions
with healthcare providers, to the extent such healthcare providers
allow, and recently substantially all sales force personnel are
permitted to resume face-to-face interaction. This has been done in
a manner consistent with guidelines from local, state and
government health officials in the United States, although such
permission may be further restricted if geographies continue to
experience a resurgence of the pandemic. Due to various state and
local shelter in place and other travel restrictions, reports from
IQVIA indicated that patient visits to medical offices in April
were down approximately 70% compared to pre-COVID-19 levels.
Similarly, IQVIA reported a significant drop in the number of
routine lab tests, including blood tests, being conducted.
Physicians typically require office visits, including physical
examinations and blood tests, prior to prescribing new medications
such as VASCEPA.
Commencing in September 2020, weekly normalized
prescriptions reached levels consistent with, or slightly higher
than, pre-COVID-19 levels. According to IQVIA data, in September
2020 the number of patient visits to health care providers
increased meaningfully over the lows of April 2020 but remained
below the volume levels reported prior to mid-March 2020 when the
impact of COVID-19 began to significantly affect the United States.
Amarin is optimistic that the worst period of impact from COVID-19
on the levels of patients seeking ordinary course doctor visits and
lab tests may be behind it. Amarin expects, however, that the
COVID-19 dynamic will continue to have an unfavorable impact on
revenue, at least in the near term. Accordingly, the degree and
timing for potential reacceleration of VASCEPA revenue growth is
uncertain, particularly if there are resurgences in the spread of
the infection in various geographies and a reinforcement of social
distancing and other protocols.
While Amarin’s field team continues to utilize,
as necessary, various means to interact with healthcare
professionals virtually, such interactions tend to be less frequent
and potentially less impactful than in-person communications. This
is particularly the case because VASCEPA is being newly introduced
to many healthcare professionals as a treatment for cardiovascular
risk reduction based on its second FDA indication, launched in
January 2020.
Increasing Promotion in
the United
States
To augment Amarin’s ongoing activities to
educate healthcare professionals and in parallel with the sales
team getting back into the field, Amarin launched its first ever
direct-to-consumer campaign focused on the use of VASCEPA for
cardiovascular risk reduction in indicated patients in mid-July
2020. The campaign highlights persistent cardiovascular risk and
the benefit of VASCEPA to reduce risk of a heart attack or stroke
by 25% when added to a statin. The campaign is intended to raise
awareness of VASCEPA among both healthcare professionals and
consumers and encourages patients to ask their providers about
VASCEPA. As healthcare professionals and patients learn more about
VASCEPA, Amarin anticipates expanded VASCEPA prescriptions and
revenue. However, the timing and magnitude of such increases remain
difficult to predict due to the challenges of quantifying the pace
and stability of COVID-19 recovery and the unprecedented nature and
limited history of VASCEPA’s approved indication.
Financial Update
Net total revenue for the three and nine months
ended September 30, 2020 were $156.5 million and $446.8 million,
respectively, compared to $112.4 million and $286.5 million in the
corresponding periods of 2019, respectively, indicating increases
of 39% and 56%, respectively. Net product revenue for the three and
nine months ended September 30, 2020 were $155.2 million and $441.1
million, respectively, compared to $112.3 million and $285.3
million in the corresponding periods of 2019, respectively,
indicating increases of 38% and 55%, respectively. The increase in
net product revenue was driven primarily by increased volume of
VASCEPA sales to customers in the United States, as well as a
modest increase in VASCEPA’s net selling price in the United
States, reflecting various factors including managed care coverage
improvements. The increase was also driven by VASCEPA sales outside
of the United States of approximately $0.5 million and $8.9 million
during the three and nine months ended September 30, 2020 as
compared to nil and $0.3 million during the three and nine months
ended September 30, 2019, primarily as a result of an initial order
in the first half of 2020 to ensure adequate product supply for
Amarin’s commercial partner’s launch of VASCEPA in Canada
(recognized upon shipment by Amarin to that partner).
In addition, Amarin recognized licensing and
royalty revenue of approximately $1.3 million and $5.7 million in
the three and nine months ended September 30, 2020, respectively,
under agreements for the commercialization of VASCEPA outside the
United States. This compares with licensing and royalty revenue of
$0.2 million and $1.1 million in the same periods of 2019,
respectively.
Cost of goods sold for the three and nine months
ended September 30, 2020 was $33.1 million and $96.7 million,
respectively, compared to $25.4 million and $65.4 million in the
corresponding periods of 2019, respectively. Amarin’s overall gross
margin on net product revenue for the three and nine months ended
September 30, 2020 was 79% and 78%, respectively, compared to 77%
for the three and nine months ended in 2019. This increase in gross
margin on net product sales is driven by gross margin on U.S.
product sales of 79% for the three and nine months ended September
30, 2020, partially offset by the gross margin on product sales to
Amarin’s partners outside the United States to which, under
contractual agreements, we generally sell product on a cost-plus
basis with licensing and royalty revenue separately recorded.
Selling, general and administrative (SG&A)
expense for the three and nine months ended September 30, 2020 were
$120.2 million and $346.5 million, respectively, compared to $82.6
million and $227.6 million, respectively, in the corresponding
periods of 2019, representing increases of 46% and 52%. This
increase is primarily due to personnel costs related to the sales
force expansion as well as an increase in promotional activity
following the launch of VASCEPA, including consumer-focused
promotion which was augmented in July 2020 when Amarin launched its
first television advertisement of VASCEPA focused on cardiovascular
risk reduction based on the product’s new label.
Research and development (R&D) expense for
the three and nine months ended September 30, 2020 were $10.2
million and $30.5 million, respectively, compared to $8.9 million
and $23.3 million, respectively, in the corresponding periods of
2019, representing increases of 14% and 31%, respectively. The
increase in expense was primarily driven by costs beyond the
conduct of the REDUCE-IT study to further analyze samples collected
from REDUCE-IT patients as well as costs associated with the
achievement of certain milestones under Amarin’s strategic
collaboration agreement with Mochida and costs to support various
publications and pilot studies.
Under U.S. GAAP, Amarin reported a net loss of
$6.8 million in the three months ended September 30, 2020, or basic
and diluted loss per share of $0.02, which included $11.6 million
in non-cash stock-based compensation expense. In comparison, Amarin
reported a net loss of $3.5 million for the third quarter of 2019,
or basic and diluted loss per share of $0.01, which included $8.0
million in non-cash stock-based compensation expense.
Under U.S. GAAP, Amarin reported a net loss of
$22.9 million for the nine months ended September 30, 2020, or
basic and diluted loss per share of $0.06, which included $34.3
million in non-cash stock-based compensation expense. In
comparison, Amarin reported a net loss of $29.7 million, or basic
and diluted loss per share of $0.09 for the nine months ended
September 30, 2019, which included $22.7 million in non-cash
stock-based compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $4.8
million for the third quarter of 2020, or non-GAAP adjusted basic
and diluted earnings per share of $0.01, compared to non-GAAP
adjusted net income of $4.5 million for the third quarter of 2019,
or non-GAAP adjusted basic and diluted earnings per share of
$0.01.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $11.4
million for the nine months ended September 30, 2020, or non-GAAP
adjusted basic and diluted earnings per share of $0.03, compared to
non-GAAP adjusted net loss of $7.0 million for the nine months
ended September 30, 2019, or non-GAAP adjusted basic and diluted
loss per share of $0.02.
As of September 30, 2020, Amarin reported
aggregate cash and investments of $608.0 million, consisting of
cash and cash equivalents of $207.2 million and liquid short-term
and long-term investments of $354.7 and $46.1 million,
respectively. As of September 30, 2020, Amarin reported $147.3
million in net accounts receivable ($223.6 million in gross
accounts receivable before allowances and reserves) and $148.5
million in inventory. Further, Amarin plans to pay the remaining
$9.5 million of its debt during the fourth quarter of 2020. Once
repaid, Amarin will have no debt obligations.
As previously expressed, until uncertainties
regarding the effects and duration of the COVID-19 pandemic and the
scope of potential generic competition are better understood,
Amarin is not providing an estimate of expected 2020 revenue
results. Based on its current plans and expectations, Amarin
believes that its current capital resources are sufficient to
achieve sustained positive cash flows from VASCEPA, including
commercial launch of VASCEPA in Europe. Results are anticipated to
vary significantly on a quarterly basis including some likely
negative net cash flow periods. Factors that are expected to
contribute to this variability include the cost and response to,
Amarin’s educational and promotional initiatives to advance its
launch in the United States of VASCEPA in its new cardiovascular
risk reduction indication; the continued and varied impact of the
COVID-19 pandemic on Amarin’s business and society; the potential
launch of generic versions of VASCEPA in the United States; and the
cost and response to Amarin’s efforts toward the further
development and launch of VASCEPA in Europe. While Amarin believes
that it has adequate supply to support likely near-term sales
demand, the company intends to continue to purchase supply as
needed to support anticipated VASCEPA growth in the United States
and globally.
As of September 30, 2020, Amarin had
approximately 388.8 million American Depository Shares (ADSs) and
ordinary shares outstanding, 2.4 million common share equivalents
of Series A Convertible Preferred Shares outstanding, approximately
17.5 million equivalent shares underlying stock options at a
weighted-average exercise price of $7.84, and 7.7 million
equivalent shares underlying restricted or deferred stock
units.
Conference Call and Webcast
Information
Amarin will host a conference call November 5,
2020, at 7:30 a.m. ET to discuss this 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, 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: 38230. 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 income (loss) was derived
by taking GAAP net income (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 and
commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent
ethyl), is available by prescription in the United States, Canada,
Lebanon and the United Arab Emirates. VASCEPA is not yet approved
and available in any other countries. Amarin, on its own or
together with its commercial partners in select geographies, is
pursuing additional regulatory approvals for VASCEPA in China,
Europe and the Middle East. For more information about Amarin,
visit www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States
attributed to cardiovascular disease continues to rise. There are
605,000 new and 200,000 recurrent heart attacks per year
(approximately 1 every 40 seconds), in the United States. Stroke
rates are 795,000 per year (approximately 1 every 40 seconds),
accounting for 1 of every 19 U.S. deaths. Cardiovascular disease
results in 859,000 deaths per year in the United States.1 In
aggregate, there are more than 2.4 million major adverse
cardiovascular events per year from cardiovascular disease or, on
average, one every 13 seconds in the United States alone.
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with elevated triglycerides. Statin
therapy has been shown to control LDL-C, thereby reducing the risk
of cardiovascular events by 25-35%.2 Significant cardiovascular
risk remains after statin therapy. People with elevated
triglycerides have 35% more cardiovascular events compared to
people with normal (in range) triglycerides taking
statins.3,4,5
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes
study designed to evaluate the effect of VASCEPA 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 triglycerides between 135-499 mg/dL
(median baseline 216 mg/dL) and either established cardiovascular
disease (secondary prevention cohort) or diabetes mellitus and at
least one other cardiovascular risk factor (primary prevention
cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical
Cardiology.6 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.7 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.8 These and other publications
can be found in the R&D section on the company’s website at
www.amarincorp.com.
About VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. VASCEPA was initially launched in
the United States in 2013 based on the drug’s initial FDA approved
indication for use as an adjunct therapy to diet to reduce
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Since launch, VASCEPA has been prescribed
over eight million times. VASCEPA is covered by most major medical
insurance plans. The new, cardiovascular risk indication for
VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of UseVASCEPA is
indicated:
- As an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease
or
- diabetes mellitus and two or more
additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia.
The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions
occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
Key clinical effects of VASCEPA on major adverse
cardiovascular events are included in the Clinical Studies section
of the prescribing information for VASCEPA as set forth below:
Effect of VASCEPA on Time to First
Occurrence of Cardiovascular Events in Patients with
Elevated Triglyceride levels and Other Risk Factors for
Cardiovascular Disease in REDUCE-IT
|
VASCEPA |
Placebo |
VASCEPA vs Placebo |
N = 4089n (%) |
Incidence Rate (per 100 patient
years) |
N = 4090n (%) |
Incidence Rate (per 100 patient
years) |
Hazard Ratio (95% CI) |
Primary composite endpoint |
Cardiovascular death, myocardial infarction, stroke, coronary
revascularization, hospitalization for unstable angina (5-point
MACE) |
705(17.2) |
4.3 |
901(22.0) |
5.7 |
0.75(0.68, 0.83) |
Key secondary composite endpoint |
Cardiovascular death, myocardial infarction, stroke (3-point
MACE) |
459(11.2) |
2.7 |
606(14.8) |
3.7 |
0.74(0.65, 0.83) |
Other secondary endpoints |
Fatal or non-fatal myocardial infarction |
250(6.1) |
1.5 |
355(8.7) |
2.1 |
0.69(0.58, 0.81) |
Emergent or urgent coronary revascularization |
216(5.3) |
1.3 |
321(7.8) |
1.9 |
0.65(0.55, 0.78) |
Cardiovascular death [1] |
174(4.3) |
1.0 |
213(5.2) |
1.2 |
0.80(0.66, 0.98) |
Hospitalization for unstable angina [2] |
108(2.6) |
0.6 |
157(3.8) |
0.9 |
0.68(0.53, 0.87) |
Fatal or non-fatal stroke |
98(2.4) |
0.6 |
134(3.3) |
0.8 |
0.72(0.55, 0.93) |
[1] Includes adjudicated cardiovascular deaths and deaths of
undetermined causality.[2] Determined to be caused by myocardial
ischemia by invasive/non-invasive testing and requiring emergent
hospitalization. |
FULL VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding financial metrics and
performance such as prescription growth, revenue growth, operating
expenses, inventory purchases, and managed care coverage for
VASCEPA, including the impact of the COVID-19 pandemic, the outcome
of patent litigation and the launch of generic competition on these
metrics; the timing and outcome of regulatory reviews,
recommendations and approvals and related reimbursement decisions
in China, Europe and elsewhere; the timing and outcome of the
clinical trial in China; the timing and outcome of Amarin’s
decision to launch VASCEPA directly in major markets in Europe and
with a partner potentially in some markets in Europe; the timing
and outcome of Amarin’s patent litigation efforts; the timing and
outcome of promotion activities, including patient-oriented
campaigns and education of healthcare professionals; commercial and
international expansion, prescription growth and revenue growth and
future revenue levels, including the contributions of recently
hired sales representatives; the sufficiency of current capital
resources to achieve sustained positive cash flows; ability of
commercial supply to generic companies and Amarin; creditworthiness
of its largest customers; expectations related to exclusivity in
various jurisdictions and ongoing patent litigation appeal efforts
and associated business plans in various scenarios; and the impact
of the COVID-19 pandemic on all of the forgoing. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA will depend in part on its
ability to continue to effectively finance its business, efforts of
third parties, its ability to create market demand for VASCEPA
through education, marketing and sales activities, to achieve broad
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 secure and 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 be determined to not be infringed or not be valid 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.
Amarin’s forward-looking statements do not reflect the potential
impact of significant transactions the company may enter into, such
as mergers, acquisitions, dispositions, joint ventures or any
material agreements that Amarin may enter into, amend or
terminate.
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.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315IR@amarincorp.com (investor inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028PR@amarincorp.com (media inquiries)
|
|
|
|
|
|
|
CONSOLIDATED
BALANCE SHEET DATA |
|
(U.S.
GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
|
|
(in
thousands) |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
207,207 |
|
|
$ |
644,588 |
|
|
Restricted cash |
|
|
3,915 |
|
|
|
3,907 |
|
|
Short-term investments |
|
|
354,655 |
|
|
|
— |
|
|
Accounts receivable, net |
|
|
147,292 |
|
|
|
116,430 |
|
|
Inventory |
|
|
148,531 |
|
|
|
76,769 |
|
|
Prepaid and other current assets |
|
|
26,945 |
|
|
|
13,311 |
|
|
Total current assets |
|
|
888,545 |
|
|
|
855,005 |
|
|
Property, plant and equipment, net |
|
|
2,166 |
|
|
|
2,361 |
|
|
Long-term investments |
|
|
46,092 |
|
|
|
— |
|
|
Operating lease right-of-use asset |
|
|
8,149 |
|
|
|
8,511 |
|
|
Other long-term assets |
|
|
1,074 |
|
|
|
1,074 |
|
|
Intangible asset, net |
|
|
14,177 |
|
|
|
15,258 |
|
|
TOTAL ASSETS |
|
$ |
960,203 |
|
|
$ |
882,209 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
121,366 |
|
|
$ |
49,950 |
|
|
Accrued expenses and other current liabilities |
|
|
189,650 |
|
|
|
139,826 |
|
|
Debt from royalty-bearing instrument |
|
|
9,467 |
|
|
|
50,130 |
|
|
Deferred revenue, current |
|
|
5,706 |
|
|
|
2,342 |
|
|
Total current liabilities |
|
|
326,189 |
|
|
|
242,248 |
|
|
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
|
Deferred revenue, long-term |
|
|
13,199 |
|
|
|
18,504 |
|
|
Long-term operating lease liability |
|
|
9,255 |
|
|
|
9,443 |
|
|
Other long-term liabilities |
|
|
4,303 |
|
|
|
3,751 |
|
|
Total liabilities |
|
|
352,946 |
|
|
|
273,946 |
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
Preferred stock |
|
|
5,434 |
|
|
|
21,850 |
|
|
Common stock |
|
|
287,585 |
|
|
|
269,173 |
|
|
Additional paid-in capital |
|
|
1,799,069 |
|
|
|
1,764,317 |
|
|
Treasury stock |
|
|
(50,728 |
) |
|
|
(35,900 |
) |
|
Accumulated deficit |
|
|
(1,434,103 |
) |
|
|
(1,411,177 |
) |
|
Total stockholders’ equity |
|
|
607,257 |
|
|
|
608,263 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
960,203 |
|
|
$ |
882,209 |
|
|
|
|
|
|
|
|
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) |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
155,190 |
|
|
$ |
112,250 |
|
|
$ |
441,118 |
|
|
$ |
285,347 |
|
|
Licensing
and royalty revenue |
|
1,309 |
|
|
|
158 |
|
|
|
5,691 |
|
|
|
1,131 |
|
|
Total revenue, net |
|
156,499 |
|
|
|
112,408 |
|
|
|
446,809 |
|
|
|
286,478 |
|
|
Less: Cost
of goods sold |
|
33,071 |
|
|
|
25,444 |
|
|
|
96,676 |
|
|
|
65,354 |
|
|
Gross
margin |
|
123,428 |
|
|
|
86,964 |
|
|
|
350,133 |
|
|
|
221,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
120,164 |
|
|
|
82,559 |
|
|
|
346,496 |
|
|
|
227,598 |
|
|
Research and development (1) |
|
10,204 |
|
|
|
8,923 |
|
|
|
30,450 |
|
|
|
23,295 |
|
|
Total operating expenses |
|
130,368 |
|
|
|
91,482 |
|
|
|
376,946 |
|
|
|
250,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(6,940 |
) |
|
|
(4,518 |
) |
|
|
(26,813 |
) |
|
|
(29,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income, net |
|
549 |
|
|
|
1,146 |
|
|
|
1,908 |
|
|
|
238 |
|
|
Other income
(expense), net |
|
33 |
|
|
|
(90 |
) |
|
|
50 |
|
|
|
(182 |
) |
|
Loss from
operations before taxes |
|
(6,358 |
) |
|
|
(3,462 |
) |
|
|
(24,855 |
) |
|
|
(29,713 |
) |
|
Income tax
(provision) benefit |
|
(430 |
) |
|
|
— |
|
|
|
1,929 |
|
|
|
— |
|
|
Net
loss |
$ |
(6,788 |
) |
|
$ |
(3,462 |
) |
|
$ |
(22,926 |
) |
|
$ |
(29,713 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
Diluted |
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
389,699 |
|
|
|
350,994 |
|
|
|
378,770 |
|
|
|
336,938 |
|
|
Diluted |
|
389,699 |
|
|
|
350,994 |
|
|
|
378,770 |
|
|
|
336,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash
stock-based compensation, selling, general and administrative
expenses were $110,241 and $75,803 for the three months ended
September 30, 2020 and 2019, respectively, and research and
development expenses were $8,544 and $7,716, respectively, for the
same periods. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended September 30, |
|
Nine months
ended September 30, |
|
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for
EPS1 - GAAP |
$ |
(6,788 |
) |
|
|
$ |
(3,462 |
) |
|
$ |
(22,926 |
) |
|
|
$ |
(29,713 |
) |
|
|
Non-cash stock-based compensation expense |
|
11,583 |
|
|
|
|
7,963 |
|
|
|
34,306 |
|
|
|
|
22,729 |
|
|
|
Adjusted net
income (loss) for EPS1 - non-GAAP |
$ |
4,795 |
|
|
|
$ |
4,501 |
|
|
$ |
11,380 |
|
|
|
$ |
(6,984 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic -
non-GAAP |
$ |
0.01 |
|
|
|
$ |
0.01 |
|
|
$ |
0.03 |
|
|
|
$ |
(0.02 |
) |
|
|
Diluted -
non-GAAP |
|
0.01 |
|
|
|
|
0.01 |
|
|
|
0.03 |
|
|
|
|
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
389,699 |
|
|
|
|
350,994 |
|
|
|
378,770 |
|
|
|
|
336,938 |
|
|
|
Diluted |
|
399,400 |
|
|
|
|
373,238 |
|
|
|
401,454 |
|
|
|
|
336,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
References
1 American Heart Association. Heart Disease and Stroke
Statistics—2020 Update: A Report From the American
Heart Association. Circulation.
2020;141:e139–e596.2 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 Budoff M. Triglycerides and
triglyceride-rich lipoproteins in the causal pathway of
cardiovascular disease. Am J Cardiol. 2016;118:138-145.4 Toth
PP, Granowitz C, Hull M, et al. High triglycerides 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):e008740.5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.6 Bhatt DL, Steg PG, Brinton E, et al., 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;40:138-148.7 Bhatt DL, Steg PG, Miller M, et al., on
behalf of the REDUCE-IT Investigators. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med. 2019;380:11-22.8 Bhatt DL, Steg PG, Miller M, et al., on
behalf of the REDUCE-IT Investigators. Reduction in first and total
ischemic events with icosapent ethyl across baseline triglyceride
tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
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