Amarin Corporation plc (NASDAQ:AMRN), today announced
financial results for the three and six months ended June 30, 2020,
and provided an update on company operations. Key Amarin
achievements since its last quarterly report include:
- Maintaining favorable revenue progress amid COVID-19
challenges: Reported $135.3 million in net total revenue in Q2
2020, an increase of 34% over Q2 2019, resulting in H1 2020 net
total revenue of $290.3 million, an increase of 67% over H1
2019.
- Progressing VASCEPA® development in Europe towards expected
approval in early 2021: Continued to support review of VASCEPA by
the European Medicines Agency in anticipation of expected approval
of VASCEPA for commercial sale in Europe in early 2021 while
advancing commercial plans for VASCEPA reimbursement and related
commercial launch in Europe.
- Decision made on commercialization in Europe: As announced
separately today, Amarin plans to maximize the blockbuster
potential of VASCEPA in Europe through its own dedicated European
commercial organization. Amarin’s plan retains for shareholders
substantially all of the economic upside to participate in the
multi-billion-dollar cardiovascular risk reduction market in Europe
while preserving strategic optionality and enabling later
partnering of VASCEPA in smaller countries in Europe. To help
execute on this European strategy Amarin appointed industry
veteran, Mr. Karim Mikhail, as senior vice president, commercial
head Europe. As detailed in today’s separate press release, Mr.
Mikhail has extensive cardiovascular and international experience
and a track-record of success to rely on in building
multi-billion-dollar brands.
- Results of VASCEPA clinical trial in China nearing reporting:
VASCEPA clinical trial results on-track to be reported by Amarin’s
partner in China before end of 2020.
- Patent appeal progressing: Substantive briefing completed with
two supporting amicus briefs submitted and September 2, 2020
hearing date scheduled in Amarin’s appeal to the U.S. Court of
Appeals for the Federal Circuit of the March 30, 2020 adverse
district court decision on patents covering the first FDA-approved
indication for VASCEPA.
- Strong cash and investments balance: As of June 30, 2020,
Amarin reported total cash and investments of $611.3 million with
its only debt remaining to be paid being a maximum of $23.0 million
on its royalty-like instrument.
“The second quarter of 2020 was a challenging
but productive quarter for Amarin. Despite headwinds brought on by
the adverse patent judgment and the onset of COVID-19 related
societal restrictions at the end of the first quarter, the Amarin
team continues to be productive with an increasingly positive
outlook. We recently resumed a substantial level of in-person
interactions with healthcare professionals in various geographies
to build on the January launch of VASCEPA for its new and
differentiated cardiovascular risk reduction indication. Amarin’s
employees are working diligently to succeed driven by our mission
to bring the promise of VASCEPA to millions of cardiovascular
disease patients in need in the United States and internationally,”
stated John F. Thero, president and chief executive officer,
Amarin.
Prescription Growth
Normalized prescriptions for VASCEPA
(prescription of 120 grams of VASCEPA representing a one-month
supply) increased by approximately 44% and 47% in Q2 2020 compared
to Q2 2019 based on data from Symphony Health and IQVIA,
respectively. Estimated normalized VASCEPA prescriptions, based on
data from Symphony Health and IQVIA, totaled approximately
1,090,000 and 1,007,000 in the second quarter of 2020. Year to
date, estimated normalized prescriptions for VASCEPA increased by
approximately 57% and 59%, compared to the first half 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 2,151,000 and
1,969,000 in the first half of 2020, respectively. As is typically
true, prescription and net revenue growth values are rarely the
same in any quarter. In Q2 2020, the estimates of prescriptions
made by these third parties reflected slightly stronger growth than
Amarin experienced in shipments of product to customers upon which
revenues are recognized. Such differences are likely due to the
estimated nature of these prescription growth numbers and the
timing of purchases by customers. In Q1 2020, the inverse was true
with the rate of growth in net revenue exceeding the third-party
estimates of prescription growth.
VASCEPA revenue and prescription growth in Q2
2020 were adversely impacted by actions taken to slow the spread of
COVID-19 infections. 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.
Further impacting VASCEPA growth in Q2 2020, for safety reasons
Amarin reduced face-to-face interactions between Amarin sales
personnel and healthcare professionals. While Amarin’s field team
utilized various means to virtually interact with healthcare
professionals in Q2 2020, such interactions were less frequent and
potentially less impactful than in-person communications, in
particular as VASCEPA is being newly introduced to many healthcare
professionals.
Per IQVIA data, patient visits to physicians
increased in June compared to the lows of April indicating
encouraging signs of recovery. However, per data from IQVIA for the
week ending July 3, 2020, patient visits to physicians remained
approximately 35% below pre-COVID-19 levels1. Similarly, the number
of lab tests in June also remained well below pre-COVID-19 levels.
This data is independent of VASCEPA and reflects continued patient
cautiousness in the COVID-19 era.
In June, Amarin initiated a phased redeployment
of sales representatives in a manner consistent with federal,
Centers for Disease Control and Prevention, and state and local
regulations. Amarin’s redeployment expanded in July although not
all healthcare professionals will currently allow sales
representatives into their offices, particularly in some of the
densely populated areas including New York City and Los Angeles
where VASCEPA is best known, and historically most highly
prescribed. Amarin intends to remain flexible and responsible in
its promotion of VASCEPA while seeking effective ways to ensure
that prescribers and at-risk patients are increasingly aware of the
demonstrated positive efficacy and safety of VASCEPA.
Increasing Promotion in the United
States
As society begins to emerge from COVID-19
restrictions, albeit partially and inconsistently, Amarin views the
need for VASCEPA to be greater than ever. Cardiovascular disease is
among the most significant underlying conditions that could lead to
less favorable outcomes in patients infected by COVID-19.
Therefore, patients’ need for preventative cardiovascular care is
greater than ever. Amarin is confident that its branded commercial
launch activities, medical education, and other efforts will help
patients and healthcare providers understand the value of VASCEPA
for cardiovascular protection in appropriate patients.
Amarin’s launch of VASCEPA for its new
cardiovascular risk reduction indication remains in its infancy.
Based on a recent survey of approximately 300 randomly sampled
cardiologists, endocrinologists and primary care physicians,
unaided awareness of VASCEPA for cardiovascular risk was just 32%.
And among 302 statin-treated patients with triglycerides above 150
mg/dL and other relevant factors, unaided awareness was less than
1%.
To augment Amarin’s ongoing activities to
educate healthcare professionals and in parallel with our sales
team getting back into the field, in mid-July Amarin began to
launch its first ever direct-to-consumer campaign for VASCEPA
focused on the use of VASCEPA for cardiovascular risk reduction in
indicated patients. The campaign focuses on 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,
which informs healthcare professionals as well as consumers,
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
of COVID-19 recovery and the unprecedented nature and limited
history of VASCEPA’s approved indication.
International Update
In Europe, EMA review of Amarin’s application
remains active. Based on the pace of the review, Amarin anticipates
the timing of completion of EMA’s review to support early 2021
European Community approval of VASCEPA for marketing and sale in
Europe. Amarin is rapidly preparing for the commercial launch of
VASCEPA in Europe with an emphasis on pursuing reasonable
reimbursement for VASCEPA on a country-by-country basis. Amarin is
confident that it has the resources to be successful in launching
VASCEPA in Europe without having to share a significant portion of
the economics from such launch with a commercial partner, except
perhaps in certain of the smaller countries of Europe. Notably, the
physician targets to be educated about VASCEPA in Europe tend to be
more concentrated than in the United States as high-risk patients
in Europe are more likely to be treated by a specialist. Therefore,
targeting European physicians for education should be a more
efficient process than in the United States where primary care
physicians continue to manage most statin-treated patients. While
Amarin has been preparing for an extended period of time for
certain aspects of commercializing VASCEPA in Europe, Amarin
recently began to expand its commercialization team for Europe
including hiring an experienced head of commercialization for
Europe with a core group of other key hires anticipated to be added
before the end of 2020.
In Canada, Amarin’s partner appears to have had
early success in getting VASCEPA recommended for reimbursement for
a significant patient population, patients with established
cardiovascular disease consistent with VASCEPA’s approved label,
and aims to pursue further expansion of such reimbursement to other
at-risk patient groups over time. VASCEPA was launched in Canada in
February 2020. Receiving a positive reimbursement recommendation
this quickly is a credit to Amarin’s partner and to the
demonstrated clinical effectiveness of VASCEPA.
In China, results of the study of VASCEPA in
treating patients with severe hypertriglyceridemia (TG >500
mg/dL) is anticipated to be reported by Amarin’s partner before the
end of 2020. Based on the results of this study, Amarin and its
partner in China will evaluate how to best proceed toward
regulatory approval of VASCEPA in China.
ANDA Update
Substantive legal briefs have been filed with
the U.S. Court of Appeals for the Federal Circuit in Amarin’s
appeal of the previously announced district court’s decision in
favor of two filers of abbreviated new drug applications, or ANDAs,
for Amarin’s VASCEPA capsules in the United States based on the
MARINE indication. The oral hearing date for this appeal is
September 2, 2020. More information regarding this appeal can be
found in this FAQ on the Amarin website.
Amarin believes strongly that the lower court
judgment was seriously flawed and that it has strong arguments on
appeal that could result in a victory for Amarin. If generic
companies ultimately succeed at this effort, Amarin anticipates
that for an extended period of time a significant portion of the
icosapent ethyl market may remain branded due to potential supply
volume constraints for high quality, generic versions of VASCEPA.
At this time, Amarin is increasing promotion of VASCEPA with the
expectation that Amarin will benefit from such promotion under
these conditions with or without the launch of generic VASCEPA.
Financial Update
Net total revenue for the three and six months
ended June 30, 2020 were $135.3 million and $290.3 million,
respectively, compared to $100.8 million and $174.1 million in the
corresponding periods of 2019, respectively, indicating increases
of 34% and 67%, respectively. Net product revenue for the three and
six months ended June 30, 2020 were $133.7 million and $285.9
million, respectively, compared to $100.4 million and $173.1
million in the corresponding periods of 2019, respectively,
indicating increases of 33% and 65%, 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. In addition, the increase was also driven by VASCEPA
sales outside of the United States of approximately $1.8 million
and $8.5 million during the three and six months ended June 30,
2020 as compared to nil and $0.3 million during the three and six
months ended June 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 $4.4 million and $1.0 million in
the six months ended June 30, 2020 and 2019, respectively, under
agreements for the commercialization of VASCEPA outside the United
States.
Cost of goods sold for the three and six months
ended June 30, 2020 was $28.8 million and $63.6 million,
respectively, compared to $22.8 million and $39.9 million in the
corresponding periods of 2019, respectively. Amarin’s overall gross
margin on net product revenue for the three and six months ended
June 30, 2020 and 2019 was 78% and 77%, respectively. This increase
in gross margin on net product sales is driven by gross margin on
U.S. product sales of 79% and 80% for the three and six months
ended June 30, 2020, partially offset by the gross margin on
product sales to Amarin’s partners outside the United States as per
contractual arrangements. Net product revenue to Amarin’s partners
does not include licensing and royalty revenue.
Selling, general and administrative (SG&A)
expense for the three and six months ended June 30, 2020 were $92.4
million and $226.3 million, respectively, compared to $73.4 million
and $145.0 million, respectively, in the corresponding periods of
2019, representing increases of 26% and 56%. This increase is due
primarily to personnel costs related to the sales force expansion.
This increase was offset during the three months ended June 30,
2020 compared to the corresponding period in 2019 by a decrease in
consumer-focused promotion. Such consumer-focused promotion 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. While there was a decrease in
promotional activities in the second quarter of 2020, in early 2020
there was an increase in promotional activities to support the
launch of VASCEPA for its new cardiovascular risk reduction
indication resulting in an increase in year-to-date costs for such
promotional activities compared to the same prior year period.
Primarily driven by the increase in educational and marketing
initiatives described above, Amarin anticipates SG&A expense to
be approximately $10 million to $20 million higher in the second
half of 2020 compared to the first half of 2020.
Research and development (R&D) expense for
the three and six months ended June 30, 2020 were $10.0 million and
$20.2 million, respectively, compared to $7.1 million and $14.4
million, respectively, in the corresponding periods of 2019,
representing increases of 40% and 41%, 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 net income of
$4.4 million in the three months ended June 30, 2020, or basic and
diluted earnings per share of $0.01. This net income included $12.1
million in non-cash stock-based compensation expense. Amarin
reported a net loss of $1.8 million in the second quarter of 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.
Under U.S. GAAP, Amarin reported a net loss of
$16.1 million in the six months ended June 30, 2020, or basic and
diluted loss per share of $0.04. This net loss included $22.7
million in non-cash stock-based compensation expense. For the six
months ended June 30, 2019, Amarin reported a net loss of $26.3
million, or basic and diluted loss per share of $0.08. This net
loss included $14.8 million in non-cash stock-based compensation
expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $16.5
million for the second quarter of 2020, or non-GAAP adjusted basic
and diluted earnings per share of $0.04, compared to non-GAAP
adjusted net income of $6.1 million for the second quarter of 2019,
or non-GAAP adjusted basic and diluted earnings per share of
$0.02.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $6.6
million for the six months ended June 30, 2020, or non-GAAP
adjusted basic and diluted earnings per share of $0.02, compared to
non-GAAP adjusted net loss of $11.5 million for the six months
ended June 30, 2019, or non-GAAP adjusted basic and diluted loss
per share of $0.03.
As of June 30, 2020, Amarin reported aggregate
cash and investments of $611.3 million, consisting of cash and cash
equivalents of $214.0 million and liquid short-term investments and
long-term investments of $336.3 and $61.0 million, respectively. As
of June 30, 2020, Amarin reported $125.0 million in net accounts
receivable ($173.2 million in gross accounts receivable before
allowances and reserves) and $124.8 million in inventory. As
previously expressed, until uncertainties regarding the effects and
duration of the COVID-19 pandemic and patent litigation 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 Amarin’s efforts to continue
with a robust launch of VASCEPA in its new cardiovascular risk
reduction indication, further developments from the influence of
the COVID-19 pandemic on Amarin’s business and society, the
potential launch of generic versions of VASCEPA in the United
States and Amarin’s efforts toward the further development and
launch of VASCEPA in Europe.
As of June 30, 2020, Amarin had approximately
385.8 million American Depository Shares (ADSs) and ordinary shares
outstanding, 5.2 million common share equivalents of Series A
Convertible Preferred Shares outstanding, approximately 17.2
million equivalent shares underlying stock options at a
weighted-average exercise price of $7.87, and 7.6 million
equivalent shares underlying restricted or deferred stock
units.
Conference Call and Webcast
Information
Amarin will host a conference call August 4,
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 877-869-3847 within the United States, 201-689-8261 from
outside the United States, or by using the call back feature at
https://bit.ly/3j5aEDx. 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: 35819. 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. Amarin, 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.2 In
aggregate, this is 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%.3 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.4,5,6
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.7 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.8 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.9 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 Use
VASCEPA 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 = 4089 n (%) |
Incidence Rate (per 100 patient years) |
N = 4090 n (%) |
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 appeal of the patent litigation district
court decision; 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 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 |
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
(in
thousands) |
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
214,007 |
|
|
$ |
644,588 |
|
Restricted cash |
|
3,913 |
|
|
|
3,907 |
|
Short-term investments |
|
336,273 |
|
|
|
— |
|
Accounts receivable, net |
|
124,985 |
|
|
|
116,430 |
|
Inventory |
|
124,844 |
|
|
|
76,769 |
|
Prepaid and other current assets |
|
23,589 |
|
|
|
13,311 |
|
Total current assets |
|
827,611 |
|
|
|
855,005 |
|
Property, plant and equipment, net |
|
2,316 |
|
|
|
2,361 |
|
Long-term investments |
|
61,039 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
8,291 |
|
|
|
8,511 |
|
Other long-term assets |
|
1,074 |
|
|
|
1,074 |
|
Intangible asset, net |
|
14,538 |
|
|
|
15,258 |
|
TOTAL ASSETS |
$ |
914,869 |
|
|
$ |
882,209 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
86,757 |
|
|
$ |
49,950 |
|
Accrued expenses and other current liabilities |
|
168,549 |
|
|
|
139,826 |
|
Debt from royalty-bearing instrument |
|
22,455 |
|
|
|
50,130 |
|
Deferred revenue, current |
|
5,706 |
|
|
|
2,342 |
|
Total current liabilities |
|
283,467 |
|
|
|
242,248 |
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
Deferred revenue, long-term |
|
14,507 |
|
|
|
18,504 |
|
Long-term operating lease liability |
|
9,311 |
|
|
|
9,443 |
|
Other long-term liabilities |
|
4,821 |
|
|
|
3,751 |
|
Total liabilities |
|
312,106 |
|
|
|
273,946 |
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
Preferred stock |
|
7,166 |
|
|
|
21,850 |
|
Common stock |
|
285,672 |
|
|
|
269,173 |
|
Additional paid-in capital |
|
1,787,492 |
|
|
|
1,764,317 |
|
Treasury stock |
|
(50,252 |
) |
|
|
(35,900 |
) |
Accumulated deficit |
|
(1,427,315 |
) |
|
|
(1,411,177 |
) |
Total stockholders’ equity |
|
602,763 |
|
|
|
608,263 |
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
914,869 |
|
|
$ |
882,209 |
|
|
|
|
|
|
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) |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
133,724 |
|
$ |
100,366 |
|
|
$ |
285,928 |
|
|
$ |
173,097 |
|
Licensing
and royalty revenue |
|
1,593 |
|
|
426 |
|
|
|
4,382 |
|
|
|
973 |
|
Total revenue, net |
|
135,317 |
|
|
100,792 |
|
|
|
290,310 |
|
|
|
174,070 |
|
Less: Cost
of goods sold |
|
28,797 |
|
|
22,770 |
|
|
|
63,604 |
|
|
|
39,910 |
|
Gross
margin |
|
106,520 |
|
|
78,022 |
|
|
|
226,706 |
|
|
|
134,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
92,395 |
|
|
73,406 |
|
|
|
226,332 |
|
|
|
145,039 |
|
Research and development (1) |
|
9,969 |
|
|
7,130 |
|
|
|
20,247 |
|
|
|
14,372 |
|
Total operating expenses |
|
102,364 |
|
|
80,536 |
|
|
|
246,579 |
|
|
|
159,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income (loss) |
|
4,156 |
|
|
(2,514 |
) |
|
|
(19,873 |
) |
|
|
(25,251 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income (expense), net |
|
151 |
|
|
789 |
|
|
|
1,359 |
|
|
|
(908 |
) |
Other income
(expense), net |
|
108 |
|
|
(95 |
) |
|
|
17 |
|
|
|
(92 |
) |
Income
(loss) from operations before taxes |
|
4,415 |
|
|
(1,820 |
) |
|
|
(18,497 |
) |
|
|
(26,251 |
) |
Income tax
benefit |
|
— |
|
|
— |
|
|
|
2,359 |
|
|
|
— |
|
Net income
(loss) |
$ |
4,415 |
|
$ |
(1,820 |
) |
|
$ |
(16,138 |
) |
|
$ |
(26,251 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.01 |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
Diluted |
$ |
0.01 |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
384,663 |
|
|
330,863 |
|
|
|
373,300 |
|
|
|
329,793 |
|
Diluted |
|
399,664 |
|
|
330,863 |
|
|
|
373,300 |
|
|
|
329,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash
stock-based compensation, selling, general and administrative
expenses were $82,035 and $66,564 for the three months ended June
30, 2020 and 2019, respectively, and research and development
expenses were $8,198 and $6,089, respectively, for the same
periods. |
|
|
|
|
|
|
|
|
|
|
|
|
|
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) |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Net income (loss) for EPS1 - GAAP |
$ |
4,415 |
|
$ |
(1,820 |
) |
|
$ |
(16,138 |
) |
|
$ |
(26,251 |
) |
Non-cash stock-based compensation expense |
|
12,131 |
|
|
7,883 |
|
|
|
22,722 |
|
|
|
14,766 |
|
Adjusted net
income (loss) for EPS1 - non-GAAP |
$ |
16,546 |
|
$ |
6,063 |
|
|
$ |
6,584 |
|
|
$ |
(11,485 |
) |
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
Basic -
non-GAAP |
$ |
0.04 |
|
$ |
0.02 |
|
|
$ |
0.02 |
|
|
$ |
(0.03 |
) |
Diluted -
non-GAAP |
|
0.04 |
|
|
0.02 |
|
|
|
0.02 |
|
|
|
(0.03 |
) |
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
Basic |
|
384,663 |
|
|
330,863 |
|
|
|
373,300 |
|
|
|
329,793 |
|
Diluted |
|
399,664 |
|
|
373,238 |
|
|
|
402,033 |
|
|
|
329,793 |
|
|
|
|
|
|
|
|
|
References__________________________1
IQVIA. Monitoring the Impact of COVID-19 on the Pharmaceutical
Market. July 17, 2020. Data week ending July 3, 2020.2 American
Heart Association. Heart Disease and Stroke Statistics—2020 Update:
A Report From the American Heart Association. Circulation.
2020;141:e139–e596.3 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.4 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.5
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):e008740.6 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.7 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;40:138-148.8 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;380:11-22.9 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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