Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter ended September 30, 2022 and provided an
update on the Company’s operations.
“In the third quarter of 2022, Amarin made
important progress on meeting its key priorities and long-term
growth strategy highlighted by improvement in the Company’s cash
position, reporting a cash positive quarter excluding restructuring
charges. We remain confident in the opportunities that lie
ahead and our direction for the remainder of 2022 and into 2023,”
said Karim Mikhail, President and Chief Executive Officer of
Amarin.
"In Europe, we are on-track to deliver on our
commitment to obtain pricing and reimbursement approval in up to
eight European markets and to launch in up to six European markets
this year, and we remain confident in our $1 billion plus revenue
opportunity across the region. We are pleased with the progress we
are making in key markets, and in the third quarter of 2022, we
were successful in securing overall pricing and reimbursement in
Finland, as well as individual pricing and reimbursement in
Austria. This adds to the reimbursements obtained in England &
Wales, Northern Ireland and Sweden, the individual reimbursement in
Denmark, and the positive scientific assessments in France, Italy
and the Netherlands. We also expect potential reimbursement
decisions by year-end and into early 2023 in Spain, Italy, Norway,
the Netherlands and France.
"In the U.S., we are pleased with the continuing
stabilization of our VASCEPA® business and our performance in the
market. This represents our third consecutive quarter where we have
seen stable U.S. revenues, which have been achieved through our
team’s focus on branded promotion of VASCEPA. In the U.S., steps
were also taken earlier in 2022 to reduce our costs and improve our
cash position. The implementation of a comprehensive cost savings
plan began to materialize in the third quarter and is on-track to
deliver $100 million in cost savings* through mid-2023. In
addition, we continued to make progress on renegotiating our supply
purchase agreements.
"We also continue our efforts to expand
awareness and understanding around the science behind
VASCEPA/VAZKEPA, and the tremendous clinical value that our product
provides in reducing cardiovascular (CV) risk in high and very
high-risk patients. With respect to thought leadership, we are
actively establishing a presence and educating the healthcare
community at key cardiovascular meetings and congresses across the
world, including a major presence at the European Society of
Cardiology Congress in August, the Canadian Cardiovascular Congress
in October and American Heart Association Scientific Sessions
coming up in November. We also continue to make progress on the
development of our fixed-dose combination of VASCEPA with a statin
and enhance and expand our leadership team to support the company’s
long-term strategy.
"As we consider our achievements in the third
quarter and move into the fourth quarter of the year, we remain
steadfast and confident in our long-term strategy and the
opportunities ahead to execute against a BOLD vision to stop heart
disease from being the leading cause of death for patients
worldwide,” concluded Mr. Mikhail.
Europe
Amarin has commenced the launch of VAZKEPA in the U.K. To date,
Amarin is making excellent progress securing VAZKEPA patient access
through local formulary negotiations, and those negotiations will
continue to progress throughout the remainder of 2022 and into
2023. Launch activities also continue to progress in Sweden.
- Secured pricing and reimbursement for VAZKEPA in Finland and
Northern Ireland, with broad access to patients, similar to
England/Wales and Sweden.
In addition, Amarin obtained individual reimbursement for
VAZKEPA in Austria, adding to the individual reimbursement in
Denmark obtained earlier this year; the Company plans to resubmit
for broader pricing and reimbursement access in those countries in
the months ahead. Clinical and Health Technology Assessment
processes and reimbursement discussions are progressing across all
targeted markets in Europe where Amarin has submitted market access
dossiers, including Spain, France, Italy, Norway, the Netherlands,
Portugal, Scotland, Switzerland and Israel.
- Price negotiations are nearing conclusion with Spain’s Ministry
of Health, which could allow for a possible pricing and
reimbursement decision before the end of 2022.
- In Italy, our dossier has advanced from the scientific
assessment phase of negotiations into the pricing and reimbursement
phase of discussions with the regulators in that market.
- In the Netherlands we received a positive recommendation by the
National Health Care Institute (ZIN) for reimbursement and expect
to begin pricing negotiations with the Dutch Ministry of
Health.
- As a reminder, Amarin received a positive reimbursement
assessment from HAS – the French National Authority for Health –
and price negotiations continue to progress.
United States
U.S. product net revenue was $87.9 million in
the third quarter of 2022, a decrease of $2.8 million versus the
second quarter of 2022, reflecting minimal impact on price and
volume. The Company continues to maintain more than 60% market
share of the IPE molecule despite generic competition as the U.S.
commercial organization continues to maintain targeted support of
branded VASCEPA. This revenue continues to support investments in
Europe and expansion into new markets.
Amarin continues to actively monitor key
performance indicators in the U.S. market to support its strategy
moving forward.
International
Amarin continues to advance towards its goal to
unlock the potential of VASCEPA internationally. The company is in
the process of filing regulatory submissions for approval in 20
additional countries to ensure that patients in the top 50
cardiometabolic markets worldwide can benefit from VASCEPA.
Amarin's marketing authorization submissions for VASCEPA in
Australia and New Zealand are continuing to advance per local
procedures.
In addition, Amarin continues to make progress
in these efforts with our partners, including:
- Eddingpharm (Asia) Macao Commercial Offshore Limited (Edding),
Amarin’s partner in China, recently received confirmation that the
Chinese government has completed product testing and has initiated
the final review period prior to approval. Our partner has
communicated that they still anticipate an approval could be
achieved before year-end.
- In Canada, HLS Therapeutics, Inc. has obtained reimbursement
from all major public payors and continues to launch in the public
sector.
Financial Update
Total net revenue for the three months ended
September 30, 2022 was $89.9 million, compared to $142.0 million in
the corresponding period of 2021, a decrease of 37%. Net product
revenue for the three months ended September 30, 2022 was $89.2
million, compared to $141.4 million in the corresponding period of
2021, a decrease of 37%. This decrease was driven by a decline in
volume and net selling price due to the impact of an increase in
generic competition in the U.S. As a reminder, during the three
months ended September 30, 2022 there were three or more generic
competitors in the U.S. market as compared to two generic
competitors in the U.S. market during the three months ended
September 30, 2021.
Amarin recognized licensing and royalty revenue
of approximately $0.7 million and $0.6 million during the three
months ended September 30, 2022 and 2021, respectively, from
VASCEPA-related commercial sales from our partners in Canada, the
China region and the Middle East.
Cost of goods sold for the three months ended
September 30, 2022 was $27.0 million, compared to $30.2 million in
the corresponding period of 2021. Amarin’s overall gross margin on
net product revenue for the three months ended September 30, 2022
was 70%, compared with 79% for the corresponding period of 2021.
During the three months ended September 30, 2022, Amarin took steps
to amend supplier agreements to align supply arrangements with
current and future market demand resulting in a charge of $3.1
million. Excluding the impact of this item, gross margin was 73%
for the three months ended September 30, 2022.
Selling, general and administrative expenses for
the three months ended September 30, 2022 was $58.7 million,
compared to $103.0 million in the corresponding period of the prior
year. This decrease was primarily due to the implementation of our
cost reduction plan announced in June and was partially offset by
investments to support commercial operations in Europe.
Research and development expenses for the three
months ended September 30, 2022 were $5.8 million, compared to $7.8
million in the corresponding period of the prior year. This
decrease was primarily driven by the implementation of our cost
reduction plan announced in June and was partially offset by costs
incurred related to the development of a fixed-dose combination of
VASCEPA with a statin.
In August 2022, the company announced the
discontinuation of the German operations as a result of not being
able to reach a viable agreement on the reimbursement price of
VAZKEPA in Germany. As a result, the company incurred a total of
$4.4 million in restructuring charges, substantially all of which
were cash expenditures incurred during the third quarter 2022.
Under U.S. GAAP, Amarin reported a net loss of
$5.1 million for the third quarter ended September 30, 2022, or
basic and diluted loss per share of $0.01. This net loss includes
$5.0 million in non-cash stock-based compensation and $6.6 million
in restructuring expenses. For the third quarter ended September
30, 2021, Amarin reported a net loss of $13.2 million, or basic and
diluted loss per share of $0.03. This net loss included $10.4
million in non-cash stock-based compensation expense and $14.1
million in restructuring expenses. Excluding non-cash stock-based
compensation expense and restructuring expense, non-GAAP adjusted
net income was $6.4 million for the third quarter ended September
30, 2022 or non-GAAP adjusted basic and diluted earnings per share
of $0.02, compared with non-GAAP adjusted net income of $11.4
million for the third quarter ended September 30 2021, or non-GAAP
adjusted basic and diluted earnings per share of $0.03. As of
September 30, 2022, Amarin reported aggregate cash and investments
of $306.0 million.
*Compared to 2021 full year GAAP operating
expenses and excludes restructuring charges.
2022 Financial Outlook
Given the uncertainty resulting from the impact
of generic IPE in the U.S. and challenges for most drugs seeking
market access in Europe, Amarin will continue to suspend 2022
revenue guidance.
The stabilization of the U.S. business revenues
and recent cash preservation initiatives have resulted in extended
cash runway for the Company. Amarin believes the current cash and
investments and other assets are adequate to support continued
operations, including European launch activities.
Conference Call and Webcast
Information:
Amarin will host a conference call on October
27, 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 367970. 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
46629. 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 and restructuring 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; 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 September 30, 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
InformationInvestor Inquiries:Lisa DeFrancescoInvestor
Relations Amarin Corporation
plcinvestor.relations@amarincorp.com (investor inquiries)
Media Inquiries:
Mark MarmurCorporate Communications, Amarin
Corporation plcPR@amarincorp.com (media inquiries)
-Tables to Follow-
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
240,498 |
|
|
$ |
219,454 |
|
Restricted cash |
|
|
3,920 |
|
|
|
3,918 |
|
Short-term investments |
|
|
63,203 |
|
|
|
234,674 |
|
Accounts receivable, net |
|
|
123,379 |
|
|
|
163,653 |
|
Inventory |
|
|
227,606 |
|
|
|
234,676 |
|
Prepaid and other current assets |
|
|
27,914 |
|
|
|
22,352 |
|
Total current assets |
|
|
686,520 |
|
|
|
878,727 |
|
Property, plant and equipment, net |
|
|
999 |
|
|
|
1,425 |
|
Long-term investments |
|
|
2,264 |
|
|
|
34,996 |
|
Long-term inventory |
|
|
187,964 |
|
|
|
121,254 |
|
Operating lease right-of-use asset |
|
|
8,462 |
|
|
|
7,660 |
|
Other long-term assets |
|
|
456 |
|
|
|
456 |
|
Intangible asset, net |
|
|
21,638 |
|
|
|
23,547 |
|
TOTAL ASSETS |
|
$ |
908,303 |
|
|
$ |
1,068,065 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
93,157 |
|
|
$ |
114,922 |
|
Accrued expenses and other current liabilities |
|
|
192,001 |
|
|
|
253,111 |
|
Current deferred revenue |
|
|
2,198 |
|
|
|
2,649 |
|
Total current liabilities |
|
|
287,356 |
|
|
|
370,682 |
|
Long-Term Liabilities: |
|
|
|
|
Long-term deferred revenue |
|
|
13,499 |
|
|
|
14,060 |
|
Long-term operating lease liability |
|
|
9,924 |
|
|
|
8,576 |
|
Other long-term liabilities |
|
|
9,697 |
|
|
|
7,648 |
|
Total liabilities |
|
|
320,476 |
|
|
|
400,966 |
|
Stockholders’ Equity: |
|
|
|
|
Common stock |
|
|
298,596 |
|
|
|
294,027 |
|
Additional paid-in capital |
|
|
1,878,923 |
|
|
|
1,855,246 |
|
Treasury stock |
|
|
(61,585 |
) |
|
|
(60,726 |
) |
Accumulated deficit |
|
|
(1,528,107 |
) |
|
|
(1,421,448 |
) |
Total stockholders’ equity |
|
|
587,827 |
|
|
|
667,099 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
908,303 |
|
|
$ |
1,068,065 |
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Product revenue, net |
$ |
89,222 |
|
|
$ |
141,442 |
|
|
$ |
277,004 |
|
|
$ |
436,598 |
|
Licensing and royalty revenue |
|
656 |
|
|
|
596 |
|
|
|
1,944 |
|
|
|
2,098 |
|
Total revenue, net |
|
89,878 |
|
|
|
142,038 |
|
|
|
278,948 |
|
|
|
438,696 |
|
Less: Cost of goods sold |
|
23,941 |
|
|
|
30,211 |
|
|
|
81,990 |
|
|
|
90,692 |
|
Less: Cost of goods sold - restructuring inventory |
|
3,078 |
|
|
|
— |
|
|
|
18,078 |
|
|
|
— |
|
Gross margin |
|
62,859 |
|
|
|
111,827 |
|
|
|
178,880 |
|
|
|
348,004 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
58,745 |
|
|
|
102,965 |
|
|
|
236,285 |
|
|
|
315,966 |
|
Research and development (1) |
|
5,765 |
|
|
|
7,820 |
|
|
|
25,172 |
|
|
|
23,554 |
|
Restructuring |
|
3,493 |
|
|
|
14,115 |
|
|
|
13,706 |
|
|
|
14,115 |
|
Total operating expenses |
|
68,003 |
|
|
|
124,900 |
|
|
|
275,163 |
|
|
|
353,635 |
|
Operating loss |
|
(5,144 |
) |
|
|
(13,073 |
) |
|
|
(96,283 |
) |
|
|
(5,631 |
) |
Interest income, net |
|
750 |
|
|
|
163 |
|
|
|
1,241 |
|
|
|
919 |
|
Other income (expense), net |
|
511 |
|
|
|
(57 |
) |
|
|
(1,990 |
) |
|
|
(390 |
) |
Loss from operations before taxes |
|
(3,883 |
) |
|
|
(12,967 |
) |
|
|
(97,032 |
) |
|
|
(5,102 |
) |
Income tax provision |
|
(1,257 |
) |
|
|
(184 |
) |
|
|
(9,627 |
) |
|
|
(1,867 |
) |
Net loss |
$ |
(5,140 |
) |
|
$ |
(13,151 |
) |
|
$ |
(106,659 |
) |
|
$ |
(6,969 |
) |
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.02 |
) |
Diluted |
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.02 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
404,614 |
|
|
|
396,618 |
|
|
|
399,944 |
|
|
|
395,681 |
|
Diluted |
|
404,614 |
|
|
|
396,618 |
|
|
|
399,944 |
|
|
|
395,681 |
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $54,358 and $93,723 for the three
months ended September 30, 2022 and 2021, respectively, and
research and development expenses were $5,138 and $6,630,
respectively, for the same periods. |
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
Unaudited |
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2022 |
|
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Net loss for EPS1 - GAAP |
|
(5,140 |
) |
|
|
(13,151 |
) |
|
|
(106,659 |
) |
|
|
(6,969 |
) |
Non-cash stock-based compensation expense |
|
5,015 |
|
|
|
10,432 |
|
|
|
20,192 |
|
|
|
26,836 |
|
Restructuring inventory |
|
3,078 |
|
|
|
— |
|
|
|
18,078 |
|
|
|
— |
|
Restructuring expense |
|
3,493 |
|
|
|
14,115 |
|
|
|
13,706 |
|
|
|
14,115 |
|
Adjusted net income (loss) for EPS1 - non-GAAP |
$ |
6,446 |
|
|
$ |
11,396 |
|
|
$ |
(54,683 |
) |
|
$ |
33,982 |
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
Basic - non-GAAP |
$ |
0.02 |
|
|
$ |
0.03 |
|
|
$ |
(0.14 |
) |
|
$ |
0.09 |
|
Diluted - non-GAAP |
$ |
0.02 |
|
|
$ |
0.03 |
|
|
$ |
(0.14 |
) |
|
$ |
0.08 |
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
404,614 |
|
|
|
396,618 |
|
|
|
399,944 |
|
|
|
395,681 |
|
Diluted |
|
405,541 |
|
|
|
402,657 |
|
|
|
399,944 |
|
|
|
402,657 |
|
|
|
|
|
|
|
|
|
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