Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter ended March 31, 2022 and provided an update
on company operations.
“In the first quarter of 2022, we made important
progress across all three pillars of our long-term growth strategy
while working through the impact to VASCEPA in the U.S. as we faced
a third generic entrant to the market during the quarter,” said
Karim Mikhail, president and chief executive officer of Amarin.
“In the U.S., we are continuing to execute on
our go-to-market strategy to help drive VASCEPA revenue with this
focused approach, while also maintaining our focus on profitability
and contribution margin. In Europe, we received the first national
reimbursement for VAZKEPA in Sweden, which marked the first step in
the next phase of our geographic expansion strategy. This
reimbursement acknowledges the value VAZKEPA provides to
cardiovascular care. Looking ahead, we continue to advance
reimbursement discussions in multiple markets and have initial
launch activities underway as we remain on track to deliver on our
commitment to obtain reimbursement status and launch in up to six
key European markets this year. Our global expansion strategy is
continuing to take shape, with additional regulatory filings
completed in several key geographies and active partnership
discussions underway in specific countries.”
“We are also focused on maximizing the value of
VASCEPA/VAZKEPA and continue to benefit from the REDUCE-IT study,
which continues to produce compelling and impactful analyses of
this landmark outcomes trial. This includes the PRIOR-MI
sub-analysis recently published in the Journal of the American
College of Cardiology. In parallel, we are accelerating our efforts
toward greater diversification as we advance the development of our
fixed-dose combination of VASCEPA with a statin. We also remain
committed to operational excellence where we enhanced our
leadership team with the right talent to support the company’s next
steps as we execute against a BOLD vision to stop heart disease
from being the leading cause of death, worldwide.”
“In summary, during the first quarter, we made
meaningful advances toward achieving greater geographic reach for
VASCEPA®/VAZKEPA in key markets, advanced our U.S. go-to-market
strategy and made progress on our fixed-dose combination portfolio.
We remain focused on accomplishing the objectives we set for 2022
and look forward to making significant progress throughout the
balance of this year and beyond.”
Europe
- Achieved the first national
reimbursement decision for VAZKEPA in Sweden, which marks the
beginning of the next phase of the company’s growth and expansion
effort outside of the U.S.
- Clinical and Health Technology
Assessment processes and reimbursement discussions are progressing
across all of the targeted markets in Europe where Amarin has
submitted market access dossiers, including Norway, Finland,
Germany, the United Kingdom (UK), France, Italy, Spain, Denmark and
the Netherlands, and have:
- Ongoing work underway with the United Kingdom’s National
Institute for Health and Care Excellence (NICE), where Amarin
received a second Appraisal Consultation Document (ACD).
- Initiated the first of several rounds of price negotiations in
Germany. This is the first of five rounds of price negotiations,
while we continue to receive temporary reimbursement for VAZKEPA in
the meantime.
- Received a positive reimbursement assessment from Haute
Autorité de Santé (HAS) - the French National Authority for Health
– and we have initiated the price negotiation process in that
country.
- Advanced continued partnership discussions in Greece, a key
market in the region, despite discussions in Central and Eastern
Europe being impacted by local political conditions.
- Remained on track to receive
reimbursement decisions in up to eight countries with plans to
launch VAZKEPA in up to six European countries this year.
United States
U.S. commercial operations continue to support
investments in Europe and to expand into new markets. Amarin
continues to actively monitor key performance indicators in the
U.S. market to support steps forward.
U.S. product net revenue was $93.5 million in
first quarter 2022, amidst the ongoing challenges of the COVID-19
pandemic and the impact of additional generic IPE market entrants.
Importantly, during the first quarter, three generic entrants were
in the market versus one generic entrant in the prior year
period.
This revenue decline was driven primarily by a
33% decrease in VASCEPA sales in the United States. This decrease
was approximately evenly divided between a decrease in volume due
to the impact of generics and a decrease in net selling price due
to an increase in rebates offered to certain customers. In
addition, compared with other quarters of the year, deductibles
reset under patient insurance plans at the beginning of each year,
which is not unique to VASCEPA. This deductible reset can cause
some patients to not fill prescriptions at the start of the year,
particularly for asymptomatic medical conditions.
U.S.
Go-To-Market Strategy Update:
Continued to Expand
Provider Engagement
- Utilizing digital efforts to
increase branded VASCEPA prescriptions for those patients
prescribed icosapent ethyl for cardiovascular risk reduction.
Managed Care Access
Remains a Focus
- As of March 31, 2022, Amarin expanded coverage to approximately
45 percent of total commercial and Medicare Part D lives on a
weighted average basis with VASCEPA as the exclusive IPE
product.
Optimizing
Fulfillment of VASCEPA Prescriptions for Cardiovascular (CV) Risk
Reduction
- New VASCEPA campaign focused on
prior myocardial infarction and stroke patients at a heightened
risk of a subsequent event continues to generate traction.
- Ongoing evaluation of all resources
and expansion of pay-for-performance partnerships, such as BlinkRx,
elements of digital omnichannel efforts and other
initiatives.
- Following the discontinuation of
another fibrate clinical trial to reduce CV risk, plans are
underway to expand outreach to the 2 million patients in the U.S.
taking fenofibrates – most in combination with a statin for CV risk
reduction - and the physicians who prescribe them to encourage a
switch to VASCEPA with its proven CV risk reduction as established
by the landmark REDUCE-IT study.
International Expansion with
Partners
Amarin is gaining traction with its goal to
unlock the potential of VASCEPA internationally. The company plans
to file three waves of regulatory submissions for approval of
VASCEPA in 20 additional countries to ensure that patients in the
top 50 cardiometabolic markets worldwide can benefit from VASCEPA.
Toward that end, Amarin continues to make meaningful progress in
these first wave efforts with our partners.
- Expects regulatory filings,
approvals and potential launches of VASCEPA, through partners, in
up to six new countries.
- Received acceptance of the
regulatory review of the VASCEPA market authorization submission in
Australia, New Zealand and Israel, with the filing advancing as per
local protocols.
- Biologix, Amarin’s partner in the
Middle East and North Africa (MENA), received the official
registration certificate for VASCEPA from the Kingdom of Saudi
Arabia (KSA) regulatory authority for the treatment of severe
hypertriglyceridemia. This first approval in KSA enables the
preparation and submission of a variation to seek review and
approval for the CV risk reduction indication.
- In Canada, HLS Therapeutics, Inc.
completed negotiations with Canada’s pan-Canadian Pharmaceutical
Alliance (pCPA) for the terms and conditions under which VASCEPA
would qualify for public market reimbursement in Canada.
- Eddingpharm (Asia) Macao Commercial
Offshore Limited (Edding), Amarin’s partner in China, received
approval in Hong Kong and is planning a launch by the end of the
year. In addition, Edding expects to receive approval in China this
year.
Strengthened Leadership
Team
Amarin expanded its leadership team with the
addition of the following new executive members.
- Dr. Nabil Abadir, Senior Vice President, Chief Medical
Officer
- David Keenan, Senior Vice President, Technical Operations
Financial Update
Total net revenue for the first quarter ended
March 31, 2022 was $94.6 million, compared to $142.2 million in the
corresponding period of 2021, a decrease of 33%. Net product
revenue for the first quarter ended March 31, 2022 was $94.0
million compared to $141.4 million in the corresponding period of
2021, a decrease of 34%. Approximately half of this decrease was
driven by a decline in volume. The balance of the decrease was a
result of selling initiatives focused on certain customers to
maximize prescription fulfillment. As a reminder, during the three
months ended March 31, 2022 there were three generic competitors in
the market as compared to one generic competitor in the market
during the three months ended March 31, 2021. In addition, compared
with other quarters of the year, beginning of the year deductibles
under patient insurance plans, which are not unique to VASCEPA,
tend to cause some patients to not fill prescriptions particularly
for asymptomatic medical conditions.
Amarin recognized licensing and royalty revenue
of approximately $0.6 million and $0.8 million during the first
quarters ended March 31, 2022 and 2021, respectively, from
VASCEPA-related commercial sales of our partners in Canada, the
China region and the Middle East.
Cost of goods sold for the first quarter ended
March 31, 2022 was $22.2 million, compared to $28.3 million in the
corresponding period of 2021. Amarin’s overall gross margin on net
product revenue for the quarter ended March 31, 2022 was 76%,
compared with 80% for the quarter ended March 31, 2021.
Selling, general and administrative expenses for
the first quarter ended March 31, 2022 was $90.6 million compared
to $105.8 million in the prior year. This decrease was primarily
due to a decrease in marketing and direct-to-consumer promotions in
2022, as a result of the impact of COVID-19 and the company’s focus
on improving the profitability of operations in the United States.
The decrease also includes a reduction in costs associated with the
company’s Go-To-Market strategy resulting in decreased promotional
initiatives, reduced travel and a decrease in the U.S. sales
force.
Research and development expenses for the first
quarter ended March 31, 2022 were $10.1 million compared to $9.4
million in the prior year. This increase was primarily driven by
costs incurred related to the development of a fixed-dose
combination of VASCEPA with a statin.
Under U.S. GAAP, Amarin reported a net loss of
$31.6 million for the first quarter ended March 31, 2022, or basic
and diluted loss per share of $0.08. This net loss includes $6.1
million in non-cash stock-based compensation. For the first quarter
ended March 31, 2021, Amarin reported a net loss of $1.6
million, or basic and diluted loss per share of $0.00. This net
loss included $13.9 million in non-cash stock-based compensation
expense.
Excluding non-cash stock-based compensation
expense, non-GAAP adjusted net loss was $25.5 million for the first
quarter ended March 31, 2022 or non-GAAP adjusted basic and diluted
loss per share of $0.06, compared with non-GAAP adjusted net income
of $12.3 million for the first quarter ended March 31, 2021,
or non-GAAP adjusted basic and diluted earnings per share of
$0.03.
As of March 31, 2022, Amarin reported aggregate
cash and investments of $389.3 million, consisting of cash and cash
equivalents of $219.2 million and liquid short-term and long-term
investments of $143.4 million and $26.7 million, respectively. As
of March 31, 2022, Amarin reported $110.2 million in net accounts
receivable ($217.8 million in gross accounts receivable before
allowances and reserves) and $408.9 million in total inventory. As
a reminder, the first quarter typically has a higher use of cash as
a result of the timing of rebates and other payments.
As of March 31, 2022, Amarin had approximately
396.9 million American Depository Shares ADSs and ordinary shares
outstanding, approximately 19.6 million equivalent shares
underlying stock options at a weighted-average exercise price of
$6.77, as well as 15.4 million equivalent shares underlying
restricted or deferred stock units.
2022 Financial Outlook
Given the ongoing global impact of COVID-19, as
well as the uncertainty resulting from the impact of generic IPE
availability in the U.S. and challenges for most drugs seeking
market access in Europe, Amarin will continue to suspend 2022
revenue guidance; however, the company will continue to evaluate
its ability to provide greater financial outlook insight as the
year progresses.
U.S. commercial operations are expected to
continue to operate on a contribution margin positive basis. Amarin
will continue to invest in building the appropriate infrastructure
and foundation in Europe for successful commercial launches and to
advance necessary actions to support regulatory activities in other
international markets. Amarin will also progress lifecycle
management (LCM) opportunities as described. The company will
continue to evaluate its planned operational spend in 2022 and
adjust if assumptions warrant it.
Amarin reiterates its belief that current cash
and investments and other assets are adequate to support continued
operations, including European launch activities for at least the
next twelve months.
Conference Call and Webcast
Information:
Amarin will host a conference call on May 4,
2022, at 8:00 a.m. ET to discuss this information. The conference
call can be accessed on the investor relations section of the
company's website at www.amarincorp.com, or via telephone by
dialing 888-506-0062 within the United States, 973-528-0011 from
outside the United States, and referencing conference ID 930259. A
replay of the call will be made available for a period of two weeks
following the conference call. To listen to a replay of the call,
dial 877-481-4010 from within the United States and 919-882-2331
from outside of the United States, and reference conference ID
45008. 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) income 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 is an innovative pharmaceutical company
leading a new paradigm in cardiovascular disease management. From
our scientific research foundation to our focus on clinical trials,
and now our global commercial expansion, we are evolving and
growing rapidly. Amarin has offices in Bridgewater, New Jersey in
the United States, Dublin, in Ireland, Zug in Switzerland, and
other countries in Europe as well as commercial partners and
suppliers around the world. We are committed to rethinking
cardiovascular risk through the advancement of scientific
understanding of the impact on society of significant residual risk
that exists beyond traditional therapies, such as statins for
cholesterol management.
About VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. 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 ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)
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.
FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements , within the meaning of U.S. securities laws, including,
but not limited to, including beliefs about the world-wide market
potential for VASCEPA; 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
disappointing outcome of patent litigation and the launch of
generic competition on these metrics; beliefs that Amarin is well
positioned to deliver on its goals to grow VASCEPA in the U.S. and
beyond; beliefs about patient needs for VASCEPA; effects of the
COVID-19 pandemic on Amarin's operations and on the healthcare
industry more broadly, which effects continue to be fluid; beliefs
that Amarin's strategy for reducing the effects of cardiovascular
disease is sound and that Amarin is efficiently reaching
physicians, payors, pharmacists and patients; plans for Amarin's
go-to-market model; the timing and outcome of regulatory filings
and reviews, recommendations and approvals and related
reimbursement decisions and commercial launches in Europe, the
China region and elsewhere; plans for Amarin's expected launch of
VASCEPA directly in major markets in Europe, directly and
indirectly; beliefs about the cardioprotective and other benefits
of VASCEPA; beliefs about the strength of data in market access
dossiers and other reports; expectations for the timing,
effectiveness and outcome of promotional activities, including
patient-oriented campaigns, conference and posted presentations and
education of healthcare professionals; commercial and international
expansion, prescription growth and revenue growth and future
revenue levels, including the contributions of sales
representatives and the new leadership team; beliefs that Amarin's
current resources are sufficient to fund projected operations; and
the impact of the COVID-19 pandemic on all of the foregoing. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA and maintain or grow market share
will depend in part on Amarin’s ability to continue to effectively
finance its business, VASCEPA approval in geographies outside the
U.S., efforts of third parties, Amarin’s ability to create and
increase 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, maintain and defend its patent protection for
VASCEPA. Among the factors that could cause actual results to
differ materially from those described or projected herein include
the following: the possibility that VASCEPA may not receive
regulatory approval in the China region or other geographies on the
expected timelines or at all; the risk that additional generic
versions of VASCEPA will enter the market and that generic versions
of VASCEPA will achieve greater market share and more commercial
supply than anticipated, particularly in light of the disappointing
outcome of Amarin's litigation against two generic drug companies
and subsequent requests for appeal; the risk that the scope and
duration of the COVID-19 pandemic will continue to impact access to
and sales of VASCEPA; the risk that Amarin has overestimated the
market potential for VASCEPA in the U.S., Europe and other
geographies; risks associated with Amarin's expanded enterprise;
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; and 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 Amarin’s annual report on Form
10-K for the year ended December 31, 2021, and quarterly
report on Form 10-Q for the quarter ended March 31, 2022. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date they are made. Amarin undertakes no obligation to update or
revise the information contained in its forward-looking statements,
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, U.S. 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: Lisa DeFrancesco Investor Relations Amarin
Corporation plc investor.relations@amarincorp.com (investor
inquiries)
Media Inquiries: Mark Marmur Corporate
Communications, Amarin Corporation plc PR@amarincorp.com (media
inquiries)
-Tables to Follow-
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CONSOLIDATED
BALANCE SHEET DATA |
|
(U.S.
GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
|
(in
thousands) |
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
219,151 |
|
|
$ |
219,454 |
|
|
Restricted cash |
|
|
3,918 |
|
|
|
3,918 |
|
|
Short-term investments |
|
|
143,406 |
|
|
|
234,674 |
|
|
Accounts receivable, net |
|
|
110,234 |
|
|
|
163,653 |
|
|
Inventory |
|
|
267,818 |
|
|
|
234,676 |
|
|
Prepaid and other current assets |
|
|
28,092 |
|
|
|
22,352 |
|
|
Total current assets |
|
|
772,619 |
|
|
|
878,727 |
|
|
Property, plant and equipment, net |
|
|
1,281 |
|
|
|
1,425 |
|
|
Long-term investments |
|
|
26,701 |
|
|
|
34,996 |
|
|
Long-term inventory |
|
|
141,052 |
|
|
|
121,254 |
|
|
Operating lease right-of-use asset |
|
|
8,689 |
|
|
|
7,660 |
|
|
Other long-term assets |
|
|
456 |
|
|
|
456 |
|
|
Intangible asset, net |
|
|
22,911 |
|
|
|
23,547 |
|
|
TOTAL ASSETS |
|
$ |
973,709 |
|
|
$ |
1,068,065 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
90,753 |
|
|
$ |
114,922 |
|
|
Accrued expenses and other current liabilities |
|
|
207,622 |
|
|
|
253,111 |
|
|
Current deferred revenue |
|
|
2,198 |
|
|
|
2,649 |
|
|
Total current liabilities |
|
|
300,573 |
|
|
|
370,682 |
|
|
Long-Term Liabilities: |
|
|
|
|
|
Long-term deferred revenue |
|
|
14,139 |
|
|
|
14,060 |
|
|
Long-term operating lease liability |
|
|
10,398 |
|
|
|
8,576 |
|
|
Other long-term liabilities |
|
|
7,490 |
|
|
|
7,648 |
|
|
Total liabilities |
|
|
332,600 |
|
|
|
400,966 |
|
|
Stockholders’ Equity: |
|
|
|
|
|
Common stock |
|
|
294,364 |
|
|
|
294,027 |
|
|
Additional paid-in capital |
|
|
1,861,017 |
|
|
|
1,855,246 |
|
|
Treasury stock |
|
|
(61,261 |
) |
|
|
(60,726 |
) |
|
Accumulated deficit |
|
|
(1,453,011 |
) |
|
|
(1,421,448 |
) |
|
Total stockholders’ equity |
|
|
641,109 |
|
|
|
667,099 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
973,709 |
|
|
$ |
1,068,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS DATA |
|
(U.S.
GAAP) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
Product
revenue, net |
$ |
93,986 |
|
|
$ |
141,383 |
|
|
|
Licensing
and royalty revenue |
|
644 |
|
|
|
787 |
|
|
|
Total revenue, net |
|
94,630 |
|
|
|
142,170 |
|
|
|
Less: Cost
of goods sold |
|
22,239 |
|
|
|
28,326 |
|
|
|
Gross
margin |
|
72,391 |
|
|
|
113,844 |
|
|
|
Operating
expenses: |
|
|
|
|
|
Selling, general and administrative (1) |
|
90,647 |
|
|
|
105,798 |
|
|
|
Research and development (1) |
|
10,051 |
|
|
|
9,377 |
|
|
|
Total operating expenses |
|
100,698 |
|
|
|
115,175 |
|
|
|
Operating
loss |
|
(28,307 |
) |
|
|
(1,331 |
) |
|
|
Interest
income, net |
|
203 |
|
|
|
471 |
|
|
|
Other
expense, net |
|
(246 |
) |
|
|
(142 |
) |
|
|
Loss from
operations before taxes |
|
(28,350 |
) |
|
|
(1,002 |
) |
|
|
Income tax
provision |
|
(3,213 |
) |
|
|
(624 |
) |
|
|
Net
loss |
$ |
(31,563 |
) |
|
$ |
(1,626 |
) |
|
|
Loss per
share: |
|
|
|
|
|
Basic |
$ |
(0.08 |
) |
|
$ |
(0.00 |
) |
|
|
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.00 |
) |
|
|
Weighted
average shares: |
|
|
|
|
|
Basic |
|
397,805 |
|
|
|
394,638 |
|
|
|
Diluted |
|
397,805 |
|
|
|
394,638 |
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $86,018 and $93,727 for the three
months ended March 31, 2022 and 2021, respectively, and research
and development expenses were $8,602 and $7,523, respectively, for
the same periods. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET (LOSS) INCOME |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
Three months
ended March 31, |
|
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
Net loss for
EPS1 - GAAP |
|
|
(31,563 |
) |
|
|
(1,626 |
) |
|
|
Non-cash stock-based compensation expense |
|
|
6,078 |
|
|
|
13,925 |
|
|
|
Adjusted net
(loss) income for EPS1 - non-GAAP |
|
$ |
(25,485 |
) |
|
$ |
12,299 |
|
|
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)
earnings per share: |
|
|
|
|
|
|
Basic -
non-GAAP |
|
$ |
(0.06 |
) |
|
$ |
0.03 |
|
|
|
Diluted -
non-GAAP |
|
$ |
(0.06 |
) |
|
$ |
0.03 |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
Basic |
|
|
397,805 |
|
|
|
394,638 |
|
|
|
Diluted |
|
|
397,805 |
|
|
|
403,650 |
|
|
|
|
|
|
|
|
|
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