Amarin Corporation plc (NASDAQ:AMRN), today announced
financial results for the quarter ended March 31, 2020 (Q1 2020)
and provided an update on company operations.
Key recent Amarin achievements include:
- Record revenue: Net total revenue reached a record high of
$155.0 million in Q1 2020 as compared to $73.3 in Q1 2019, an
increase of approximately 112% primarily reflecting increased
VASCEPA® (icosapent ethyl) prescription growth in the United States
augmented by $6.7 million net product revenue from VASCEPA sales
outside of the United States.
- Commercial expansion: Increased size of U.S. sales force for
VASCEPA in Q1 2020 to approximately 800 sales representatives plus
their managers representing a doubling in size compared to most of
2019. All such new hires have now completed training and are
interacting with healthcare providers, which interactions,
commencing in mid-March, were transitioned to telephonic or other
forms consistent with social distancing practices amidst the
COVID-19 pandemic.
- International progress: In Canada, Amarin’s commercial partner
began promotion of VASCEPA in mid Q1 2020. As planned, Amarin’s
commercial partner for Canada purchased VASCEPA capsules from
Amarin to support their launch of VASCEPA. These purchases for
Canada represented the majority of Amarin’s net product revenue
from outside the United States in Q1 2020. In China, Amarin’s
partner is nearing completion of their clinical trial of VASCEPA,
the results of which are expected to be reported later this year
based on our partner’s assumption of continued limited impact from
COVID-19 on study completion. In Europe, the marketing
authorization application for VASCEPA with the European Medicines
Agency, or EMA, is undergoing review with an approval
recommendation anticipated by Amarin near the end of 2020 and
associated European Community, or EC, approval expected promptly
thereafter, assuming continued limited impact of COVID-19 on the
review. As previously disclosed, Amarin is taking a parallel path
of evaluating whether it is best for long-term shareholder value to
launch VASCEPA directly, in whole or in part, in Europe or to
contract with a potential pan-European partner for VASCEPA
promotion and sales. Amarin is targeting Q3 2020 for making this
decision.
- ANDA litigation update: As previously disclosed, Amarin and the
defendants in the patent litigation pertaining to the initial
indication for VASCEPA in the United States have agreed to expedite
proceedings for the appeal of the district court decision. The
parties have requested the U.S. Court of Appeals for the Federal
Circuit approve an expedited schedule including requested briefing
in Q2 2020 and an expedited hearing. This proposed timing should
facilitate a hearing in Q3 2020 (or perhaps early Q4 2020) and
position the court to rule thereafter potentially in 2020 or in
early 2021. Amarin believes that it has a strong basis for appeal,
which will be set out in its opening brief proposed for filing on
May 12th.
“Amarin’s record revenue in Q1 2020 further
confirms the value of VASCEPA’s new cardiovascular risk reduction
indication and reflects that our commercial launch got off to a
good start,” commented John Thero, Amarin’s president and chief
executive officer. “We are regularly receiving positive responses
from physicians about VASCEPA and witnessing further improvements
in already good managed care coverage for VASCEPA supporting the
large opportunity for this unique product. With strong science,
great employees and wonderful collaborators, we are highly
motivated to improve patient care for the millions of people
worldwide who might benefit from VASCEPA while aggressively working
to overcome challenges caused by COVID-19 restrictions and patent
litigation.”
Commercialization Progress for Unique Drug
In mid-December 2019, the FDA approved VASCEPA
as the first and only therapy for lowering persistent
cardiovascular risk as studied in the landmark REDUCE-IT®
cardiovascular outcomes study. Such approval reflects the results
of over a decade of research and development which validated
Amarin’s insights regarding the unique effects of the active
ingredient in VASCEPA and the interaction of such effects on lipid
management and cardiovascular health. This R&D program included
three successful Phase 3 studies (MARINE, ANCHOR and REDUCE-IT).
Amarin’s success over the development period faced many naysayers
as multiple other companies and therapies fail to achieve similar
results with other products.
The FDA approval of VASCEPA’s new cardiovascular
risk indication allowed Amarin to launch VASCEPA in early 2020 with
education and promotion to healthcare professionals. Review of
educational and promotional messaging for patients has been
undergoing separate FDA review. As previously communicated, Amarin
intends to create a launch program for patient education and
promotion in mid-2020. At the start of 2020, survey data supports
that recognition and understanding of the unique effects of VASCEPA
was relatively low among healthcare professionals and patients.
This is not surprising as over the past decade Amarin spent the
majority of its resources on research and development. VASCEPA
promotion expanded in 2019. Acceleration of such promotion is a
priority for 2020, including launch of VASCEPA’s new indication for
cardiovascular risk reduction, the indication Amarin pursued for
the past decade with the aim of helping millions of high-risk
patients.
Regarding education and promotion of VASCEPA to
healthcare professionals, in early 2019 Amarin increased the size
of its direct sales force in the United States to approximately 400
sales representatives (plus their managers) representing an
approximate doubling of the sales force size from the prior year.
By Q3 2019, over 90% of the newly hired sales representatives were
contributing positively (i.e., new contributions exceeded their
cost). In early 2020, Amarin completed another round of expansion
of its direct sales force in the United States. Amarin did so with
the expectation that these new additions would contribute and more
than cover their costs quickly. At the end of Q1 2020, Amarin had
approximately 800 sales representatives (plus their managers).
These new sales representatives were trained in waves which
commenced in 2019 and accelerated in early 2020. It is too early to
fully assess the performance of these newly hired sales
representatives, but initial signs are encouraging although these
expectations for new sales representative productivity in 2020
compared to 2019 are now tempered due to restrictions on in-person
interactions pursuant to COVID-19.
The role of these sales representatives is to
help educate healthcare professionals regarding how VASCEPA might
be used to help their patients. During Q1 2020, we heard many
positive anecdotes from the promotion of VASCEPA for cardiovascular
risk reduction. The anecdotes came from prior prescribers and new
prescribers of VASCEPA. We witnessed prescription growth among
prior prescribers and new prescribers, including prescription
growth in areas of the United States where we previously had no
sales representation.
The sales growth in Q1 2020 was supported by
broad managed care coverage across the United States. This coverage
was good at the start of 2020 and improved during the quarter. Such
improved managed care coverage reflects: 1) the FDA approval of a
broad indication for VASCEPA (which approval did not include any
special post-approval commitments reflecting the strength of
VASCEPA’s robust and consistent clinical results); 2) ten esteemed
medical societies that have already changed their guidelines to
recommend icosapent ethyl (VASCEPA ) use or issued favorable
statements for using our drug to care for at-risk patients; 3)
multiple analyses presented in scientific forums showing that
VASCEPA is highly cost effective with such analysis further
suggesting that the preventative care solution demonstrated in
REDUCE-IT holds the potential in most scenarios to save society
money by preventing the high cost of cardiovascular events due to
heart attacks, stroke, revascularization and death; and 4) the
effective education of managed care providers and key opinion
leaders regarding VASCEPA.
COVID-19 presents unique challenges for the
launch of VASCEPA, particularly because many areas of the United
States where reports of COVID-19 infection are most pronounced
(e.g., metropolitan areas) are areas on which Amarin was relying
for sales growth in 2020. During late March 2020, when Amarin
suspended in-person sales calls due to COVID-19 social distancing
priorities, we witnessed a decline in the rate of new prescriptions
for VASCEPA. Our direct sales team has been finding new ways to
interact with healthcare professionals and we continue to receive
positive feedback from physicians regarding VASCEPA. However, many
patients are not coming to physicians’ offices for routine visits
due to risks of COVID-19 infection and the need for social
distancing. While this environment may slow VASCEPA sales growth,
we anticipate that most patients who currently take VASCEPA will
continue to fill their prescriptions.
While we continue to experiment with new ways to
interact with healthcare professionals during these challenging
times, we are also preparing for the time when our sales team can
begin to interact directly again with healthcare professionals. We
believe that such interactions are important since VASCEPA has a
new FDA-approved label and unique potential to help patients of
which most healthcare professionals are not yet aware. Also, while
VASCEPA has not been shown to reduce COVID-19 infections, patients
at risk for cardiovascular disease appear to be at particularly
high risk for COVID-19 related complications and we want to give
healthcare professionals knowledge about VASCEPA which may be
useful in lowering such cardiovascular risk in their patients.
Regarding education of consumers and patients
about the cardioprotective effects of VASCEPA, we anticipate
incorporating feedback from the FDA to potentially launch a
patient-oriented campaign in mid-2020. Due to uncertainties
stemming from COVID-19 and ANDA litigation, compared to what Amarin
was planning at the start of 2020, Amarin currently intends to
limit the extent of our patient-oriented campaign and focus
primarily on education of and promotion to healthcare
professionals. In particular, we intend to defer most or all of our
planned television campaign because it is expensive and most of its
value in providing education on the cardiovascular risk reduction
effects of VASCEPA are likely not to be near-term. Such campaign
will be readied for launch when and if we are successful in the
appeal of the ANDA litigation assuming patients have resumed
regular visits to their physicians by that time.
Prescription Growth in the
U.S.
Based on monthly compilations of U.S. data
provided by a third party, Symphony Health, the estimated number of
normalized total VASCEPA prescriptions for the three months ended
March 31, 2020 and 2019 was approximately 1,061,000 and 618,000,
respectively, reflecting growth of 72%. According to data from
another third party, IQVIA, the estimated number of normalized
total VASCEPA prescriptions for the three months ended March 31,
2020 and 2019 was approximately 962,000 and 553,000, respectively,
reflecting growth of 74%. Normalized total prescriptions represent
the estimated total number of VASCEPA prescriptions dispensed to
patients, calculated on a normalized basis (i.e., one month’s
supply, or total capsules dispensed multiplied by the number of
grams per capsule divided by 120 grams). Inventory levels at
wholesalers tend to fluctuate based on seasonal factors,
prescription trends and other factors; however, such inventory
levels remained within normal industry range.
In Q1 2020, we saw prescription growth lag in
January and February compared to trends in Q4 2019. We believe that
such lag, similar to prior years, was due to high beginning of the
year insurance deductibles as are increasingly prevalent in managed
care coverage. Such deductibles are not product specific but
do, as previously reported, impact whether patients can afford to
fill prescriptions for all drugs at the beginning of the year.
Historically this has led to prescriptions of drugs for
asymptomatic chronic conditions such as cardiovascular disease not
being filled. Throughout March 2020, prescription levels and
related shipments of product increased over levels experienced in
the first two months of Q1 2020 likely reflecting that some
patients had overcome their insurance deductibles and that
healthcare professionals were writing more prescriptions for
VASCEPA and urging their high-risk patients to fill their VASCEPA
prescriptions.
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
in the U.S., take possession of the product which they order from
Amarin and Amarin ships to these customers. Amarin revenue is not
recognized when individual patients fill prescriptions.
Shipments to the largest of Amarin’s customers,
large wholesalers, tend to occur at the beginning of each week. The
timing of the weekly calendar for Q1 2020 was such that shipments
made to customers on Monday, March 30, 2020 were received by
certain customers on March 31, 2020. As a result, for these
customers there was effectively an added week of revenue shipments
in Q1 2020 that did not exist in Q1 2019 when March 30th was on a
weekend. While both reported revenue levels and reported
prescription levels grew significantly in Q1 2020, this added week
of shipments to certain customers, together with shipments of
product to Canada (which don’t show up in data from Symphony Health
or IQVIA) combined with a modest increase in VASCEPA’s net selling
price (after rebates to managed care and other customary
adjustments) in Q1 2020 explain the majority of the greater rate of
increase in net product revenue reported for Q1 2020 compared to
the rate of increase in prescription levels. Overall, inventory
levels reported by wholesalers were within the normal industry
range at the end of Q1 2020.
Further, as described previously, both Symphony
Health and IQVIA collect and report estimates of prescription
information. There is a limited amount of information available to
such companies to determine the actual number of total
prescriptions for prescription products like VASCEPA during such
periods. Data reported by Symphony Health and IQVIA is rarely
identical. Their estimates are based on a combination of data
received from pharmacies that report such data and other
distributors, and historical data when actual data is
unavailable. Their calculations of changes in prescription
levels between periods can be significantly affected by lags in
data reporting from various sources or by changes in how pharmacies
and other distributors provide data. Such methods can from
time to time result in significant inaccuracies in information when
ultimately compared with actual results. These inaccuracies
have historically been most prevalent and pronounced during periods
of time of inflections upward or downward in rates of use and less
prevalent and pronounced over longer periods of time such as
annually. As such, the resulting conclusions from such
sources should be viewed with caution. Amarin cites such
third-party information as a courtesy to its investors and because
Amarin does not have direct access to prescription
information. The prescription levels and changes in
prescription levels reported above are based on information made
available to Amarin from third-party resources and may be subject
to adjustment and may overstate or understate actual
prescriptions.
International Update
Amarin has expanded VASCEPA commercialization
activities outside of the United States through several contractual
arrangements in territories including China, the Middle East, North
Africa and Canada. Amarin continues to assess other opportunities
to develop VASCEPA commercialization outside of the United States
through similar arrangements.
Amarin’s partner in China is conducting a
clinical trial for VASCEPA which should report results later this
year. Amarin has been informed by its partner that COVID-19 is not
expected to have a significant impact on the clinical trial
results in China or on the timing of such results. Assuming
clinical trial success, this will position VASCEPA to be first in
class in China.
Amarin continues to pursue a parallel process in
Europe of evaluating whether to launch VASCEPA by itself in select
countries, and partner other countries, or to enter into a
pan-European partnership for the launch of VASCEPA. As
previously reported, in Q4 2019 our regulatory submission for
VASCEPA in Europe was accepted for review by the EMA. While we
anticipate some impact on this review due to COVID-19, we do not
expect this impact to shift the likely timing of the anticipated
EMA recommendation for approval of VASCEPA in Europe from our
estimate of near the end of 2020 and associated EC approval
expected promptly thereafter. We seek a cardiovascular risk
reduction indication in Europe.
In late 2019, Health Canada awarded approval, and in early 2020
granted extended regulatory exclusivity, to Amarin’s partner in
Canada to market VASCEPA. Sales of VASCEPA have begun in the
Canadian market.
Financial Update
Net product revenue for the three months ended
March 31, 2020 and 2019 was approximately $152.2 million and $72.7
million, respectively. This $79.5 million increase in net product
revenue was driven primarily by increased volume of sales for
VASCEPA in the United States, which includes an additional week of
revenue in the first quarter of 2020 of $10.8 million due to timing
of orders placed by customers and related receipt, as well as a
modest increase in VASCEPA’s net selling price 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 $6.7 million during the three months ended
March 31, 2020 as compared to $0.3 million during the three months
ended March 31, 2019 primarily 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 $2.8 million and $0.5 million for
the three months ended March 31, 2020 and 2019, respectively, under
agreements for the commercialization of VASCEPA outside the
U.S.
Cost of goods sold for the three months ended
March 31, 2020 and 2019 was $34.8 million and $17.1 million,
respectively. Amarin’s overall gross margin on net product revenue
was 77% and 76% for the three months ended March 31, 2020 and 2019,
respectively. This increase in gross margin on product sales is
driven by gross margin on U.S. product sales of 80%, partially
offset by the gross margin on product sales to our partners outside
the U.S. as per contractual arrangements. Net product revenue to
our partners does not include licensing and royalty revenue.
Selling, general and administrative (SG&A)
expenses during the three months ended March 31, 2020 and 2019 were
$133.9 million and $71.6 million, respectively. This increase is
due primarily to increased personnel costs related to the sales
force expansion and an increase in promotional activities and
direct to consumer promotion following the launch of VASCEPA in
early 2020 for the new indication and expanded label approved by
FDA.
Research and development expenses during the
three months ended March 31, 2020 and 2019 were $10.3 million and
$7.2 million, 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 our strategic collaboration agreement with Mochida.
Under U.S. GAAP, Amarin reported a net loss of
$20.6 million in the first quarter of 2020, or basic and diluted
loss per share of $0.06. This net loss included $10.6 million in
non-cash stock-based compensation expense. Amarin reported a net
loss of $24.4 million in the first quarter of 2019, or basic and
diluted loss per share of $0.07. This net loss included $6.9
million in non-cash stock-based compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $10.0
million for the first quarter of 2020, or non-GAAP adjusted basic
and diluted loss per share of $0.03, compared to non-GAAP adjusted
net loss of $17.5 million for the first quarter of 2019, or
non-GAAP adjusted basic and diluted loss per share of $0.05.
As of March 31, 2020, Amarin reported aggregate
cash and investments of $623.7 million, consisting of cash and cash
equivalents of $329.0 million and liquid short-term investments and
long-term investments of $213.2 and $81.5 million, respectively.
Net cash flow from operations was positive in Q1 2020 of
approximately $4.1 million despite increases, as expected, in net
accounts receivable, all of which were then current, reflecting
revenue growth and inventory in preparation for anticipated future
growth. As of March 31, 2020, Amarin reported $158.3 million in net
accounts receivable ($189.6 million in gross accounts receivable
before allowances and reserves), and $92.1 million in
inventory. While, as previously expressed, until
uncertainties regarding the effects and duration of COVID-19 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 although results are anticipated to vary significantly
on a quarterly basis including some potential negative net cash
flow periods as Amarin works to launch VASCEPA based on its new
cardiovascular risk reduction indication and adjust for various
scenarios regarding the impacts of COVID-19 and potential launch of
generic versions of VASCEPA in the United States.
As of March 31, 2020, Amarin had approximately
361.7 million American Depository Shares (ADSs) and ordinary shares
outstanding, 28.9 million common share equivalents of Series A
Convertible Preferred Shares outstanding and approximately 17.2
million equivalent shares underlying stock options at a
weighted-average exercise price of $7.92, as well as 7.0 million
equivalent shares underlying restricted or deferred stock
units.
In light of logistics and financial difficulties
created on some companies by COVID-19, Amarin recently completed a
review of its supply chain to ensure continued supply and of its
largest customers to ensure creditworthiness. We are pleased
with the findings of this review. Regarding supply, the steps
that we have taken to geographically diversify our supply chain
together with steps we took to bolster inventory levels gives us
confidence that we have adequate VASCEPA supply to meet anticipated
demand for the foreseeable future. Regarding customers, we have
little concern about our large wholesaler customers being able to
continue to pay Amarin as and when amounts are due. As is done in
the ordinary course, Amarin intends to periodically conduct such
reviews and address new concerns, if any, as they arise.
Patent Litigation
As previously reported, the trial for the ANDA
patent litigation against defendants Dr. Reddy’s Laboratories,
Hikma Pharmaceuticals USA Inc. and certain of their respective
affiliates, or the Defendants, took place in January 2020. On March
30, 2020, the Court issued its ruling in favor of the Defendants.
Amarin is appealing the decision and may pursue additional
remedies, including seeking a preliminary injunction against a
generic product launch. If the generic version of VASCEPA proposed
by either Defendant is approved by the FDA and the sponsor has
qualified supply available and elects to launch at risk during the
appeal process, such a launch would be at risk of damages such as
lost profits to us should we prevail on appeal.
We intend to vigorously pursue appeal of the
district court decision and plan robust increased product education
and promotion if we win the appeal and plan various strategies for
seeking to profit if the appeal is unsuccessful.
The results of this litigation do not apply to
Canada, China, Europe or other international jurisdictions that
don’t rely on determinations in United States courts.
Furthermore, the label being sought for VASCEPA in many of these
geographies are not for the triglyceride reduction indication at
issue in this patient litigation in the United States. In addition,
certain of the regulatory authorities in these geographies (e.g.,
Europe) provide added regulatory exclusivity that augments patent
protection.
Conference Call and Webcast
Information:
Amarin will host a conference call April 30,
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 877-407-8133 within the United States, 201-689-8040 from
outside the United States, or by using the call back feature at
https://bit.ly/2Knoe4L. 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: 34453. A replay of the
call will also be available through the company's website shortly
after the call.
Use of Non-GAAP Adjusted Financial
Information
Included in this press release are non-GAAP
adjusted financial information as defined by U.S. Securities and
Exchange Commission Regulation G. The GAAP financial measure most
directly comparable to each non-GAAP adjusted financial measure
used or discussed, and a reconciliation of the differences between
each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, is included in this press release after the
condensed consolidated financial statements.
Non-GAAP adjusted net loss was derived by taking
GAAP net loss and adjusting it for non-cash stock-based
compensation expense. Management uses these non-GAAP adjusted
financial measures for internal reporting and forecasting purposes,
when publicly providing its business outlook, to evaluate the
company’s performance and to evaluate and compensate the company’s
executives. The company has provided these non-GAAP financial
measures in addition to GAAP financial results because it believes
that these non-GAAP adjusted financial measures provide investors
with a better understanding of the company’s historical results
from its core business operations.
While management believes that these non-GAAP
adjusted financial measures provide useful supplemental information
to investors regarding the underlying performance of the company’s
business operations, investors are reminded to consider these
non-GAAP measures in addition to, and not as a substitute for,
financial performance measures prepared in accordance with GAAP.
Non-GAAP measures have limitations in that they do not reflect all
of the amounts associated with the company’s results of operations
as determined in accordance with GAAP. In addition, it should be
noted that these non-GAAP financial measures may be different from
non-GAAP measures used by other companies, and management may
utilize other measures to illustrate performance in the future.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing 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, the European Union 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.1,2 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 similar, accounting for 1 of every 19 U.S. deaths
(approximately 1 every 40 seconds).3
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% – but that still leaves a 65-75%
risk remaining.4 People with elevated triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.5,6,7
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 and 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 in China, Europe and elsewhere; the
timing and outcome of the clinical trial in China; the timing and
outcome of the decision on whether to launch VASCEPA directly or
with a partner on good terms in Europe; the timing and outcome of
Amarin’s appeal of the patent litigation district court decision;
the timing and status 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; 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 and Media Inquiries:Elisabeth
SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
CONSOLIDATED
BALANCE SHEET DATA |
(U.S.
GAAP) |
Unaudited |
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
(in
thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
329,045 |
|
|
$ |
644,588 |
|
Restricted cash |
|
|
3,910 |
|
|
|
3,907 |
|
Short-term investments |
|
|
213,190 |
|
|
|
— |
|
Accounts receivable, net |
|
|
158,288 |
|
|
|
116,430 |
|
Inventory |
|
|
92,121 |
|
|
|
76,769 |
|
Prepaid and other current assets |
|
|
20,760 |
|
|
|
13,311 |
|
Total current assets |
|
|
817,314 |
|
|
|
855,005 |
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
2,466 |
|
|
|
2,361 |
|
Long-term investments |
|
|
81,519 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
|
8,397 |
|
|
|
8,511 |
|
Other long-term assets |
|
|
1,074 |
|
|
|
1,074 |
|
Intangible asset, net |
|
|
14,898 |
|
|
|
15,258 |
|
TOTAL ASSETS |
|
$ |
925,668 |
|
|
$ |
882,209 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
98,330 |
|
|
$ |
49,950 |
|
Accrued expenses and other current liabilities |
|
|
170,731 |
|
|
|
139,826 |
|
Debt from royalty-bearing instrument |
|
|
36,978 |
|
|
|
50,130 |
|
Deferred revenue, current |
|
|
4,288 |
|
|
|
2,342 |
|
Total current liabilities |
|
|
310,327 |
|
|
|
242,248 |
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
Deferred revenue, long-term |
|
|
17,519 |
|
|
|
18,504 |
|
Long-term operating lease liability |
|
|
9,381 |
|
|
|
9,443 |
|
Other long-term liabilities |
|
|
2,665 |
|
|
|
3,751 |
|
Total liabilities |
|
|
339,892 |
|
|
|
273,946 |
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
Preferred stock |
|
|
21,850 |
|
|
|
21,850 |
|
Common stock |
|
|
270,716 |
|
|
|
269,173 |
|
Additional paid-in capital |
|
|
1,774,671 |
|
|
|
1,764,317 |
|
Treasury stock |
|
|
(49,731 |
) |
|
|
(35,900 |
) |
Accumulated deficit |
|
|
(1,431,730 |
) |
|
|
(1,411,177 |
) |
Total stockholders’ equity |
|
|
585,776 |
|
|
|
608,263 |
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
925,668 |
|
|
$ |
882,209 |
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS DATA |
(U.S.
GAAP) |
Unaudited |
|
|
|
|
|
|
|
Three months
ended March 31, |
|
(in thousands, except per share amounts) |
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
Product
revenue, net |
$ |
152,204 |
|
|
$ |
72,731 |
|
Licensing
and royalty revenue |
|
2,789 |
|
|
|
547 |
|
Total revenue, net |
|
154,993 |
|
|
|
73,278 |
|
Less: Cost
of goods sold |
|
34,807 |
|
|
|
17,140 |
|
Gross
margin |
|
120,186 |
|
|
|
56,138 |
|
Operating
expenses: |
|
|
|
|
|
Selling, general and administrative (1) |
|
133,937 |
|
|
|
71,633 |
|
Research and development (1) |
|
10,278 |
|
|
|
7,242 |
|
Total operating expenses |
|
144,215 |
|
|
|
78,875 |
|
Operating
loss |
|
(24,029 |
) |
|
|
(22,737 |
) |
Interest
income (expense), net |
|
1,208 |
|
|
|
(1,697 |
) |
Other
(expense) income, net |
|
(91 |
) |
|
|
3 |
|
Loss from
operations before taxes |
|
(22,912 |
) |
|
|
(24,431 |
) |
Income tax
benefit |
|
2,359 |
|
|
|
— |
|
Net
loss |
$ |
(20,553 |
) |
|
$ |
(24,431 |
) |
Loss per
share: |
|
|
|
|
|
Basic |
$ |
(0.06 |
) |
|
$ |
(0.07 |
) |
Diluted |
$ |
(0.06 |
) |
|
$ |
(0.07 |
) |
Weighted
average shares: |
|
|
|
|
|
Basic |
|
361,136 |
|
|
|
328,712 |
|
Diluted |
|
361,136 |
|
|
|
328,712 |
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $124,919 and $66,027 for the three
months ended March 31, 2020 and 2019, respectively, and research
and development expenses were $8,705 and $5,964, respectively, for
the same periods. |
RECONCILIATION OF NON-GAAP NET LOSS |
|
Unaudited |
|
|
|
|
|
|
|
|
|
Three months
ended March 31, |
|
|
(in thousands, except per share amounts) |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Net loss for EPS1 - GAAP |
|
$ |
(20,553 |
) |
|
|
$ |
(24,431 |
) |
|
|
|
|
10,591 |
|
|
|
|
6,884 |
|
|
Adjusted net
loss for EPS1 - non-GAAP |
|
$ |
(9,962 |
) |
|
|
$ |
(17,547 |
) |
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share: |
|
|
|
|
|
|
Basic and
diluted - non-GAAP |
|
$ |
(0.03 |
) |
|
|
$ |
(0.05 |
) |
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
Basic and
diluted |
|
|
361,136 |
|
|
|
|
328,712 |
|
|
References
1 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.2 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through 2035.3
American Heart Association: Heart Disease and Stroke Statistics --
2019 At-a-Glance.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.
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