Amarin Corporation plc (NASDAQ:AMRN) today announced financial
results for the quarter ended September 30, 2023 and provided an
update on company operations.
“As we focus on demonstrating results that will
drive shareholder value, there are reasons to be optimistic about
the future of Amarin,” said Patrick Holt, President & CEO of
Amarin. “We have a strong balance sheet, with $321 million in cash,
including five consecutive quarters of positive cash flow and no
debt, proving that we can manage our cash effectively. In the US,
we continue to extend the lifecycle and retain market leadership
with branded VASCEPA® which provides meaningful profit and cash
flow for the overall business. We have more work to do to
accelerate revenues in Europe, but I am encouraged by the impact of
new leadership and our team, delivering early results in recently
launched countries. We have also seen early progress made by
partners in the rest of the world, particularly our opportunity in
China.”
“For our team moving forward, our path forward
is simple -- to maximize the number of patients on our product,
which will accelerate operational momentum and drive shareholder
value,” said Holt.
Europe
Amarin has continued to make progress with both
commercial and pricing and reimbursement efforts in Europe.
Amarin has early launches of VAZKEPA underway in
several European countries, including the UK (England, Wales &
Scotland), Spain and the Netherlands, with initial positive
progress driven by launch efforts being implemented under new
leadership.
In addition to these launch activities, the team
in Europe is continuing to advance various Health Technology
Assessment (HTA) processes and pricing & reimbursement
discussions in all markets where Amarin has submitted market access
dossiers. In July and August 2023, Amarin announced the following
positive pricing and reimbursement milestones:
- The Spanish Drug Pricing Committee recommended the national
reimbursement of VAZKEPA® (icosapent ethyl) to reduce the risk of
cardiovascular (CV) events in patients with high cardiovascular
risk.
- The Dutch Ministry of Health approved VAZKEPA for national
reimbursement in the Netherlands.
- The Scottish Medicines Consortium (SMC) accepted VAZKEPA for
reimbursement.
Although Italy's AIFA issued a negative
reimbursement decision for VAZKEPA in that country, Amarin has
finalized a new path forward to seek access to VAZKEPA for Italian
patients by the end of 2024. In France, Amarin continues to
progress its access strategy for VAZKEPA with the national health
authorities. The Company does not expect this process to conclude
in 2024. In Germany, Amarin is exploring new options to re-enter
the market, and the Company will update investors in the coming
quarters.
United States
U.S. product net revenue was $62.4 million in the
third quarter of 2023, a decline of $2.2 million versus the second
quarter of 2023, a decrease of 3% sequentially. The Company
maintains approximately 57% market share of IPE (icosapent ethyl)
prescriptions despite generic competition as the U.S. commercial
organization continues an efficient support of branded VASCEPA.
During the third quarter of 2023, Amarin
maintained its existing access for VASCEPA in exclusive accounts,
representing approximately 43% of all Commercial and Part D lives
on a weighted average basis.
The U.S. business continues to be profitable and
support our global operations. Amarin continues to actively monitor
key performance indicators in the U.S. market and is prepared to
execute multiple strategies to support the business moving
forward.
Rest of World
In China, Amarin’s partner Edding Pharm launched
VASCEPA in October to treat adult patients with severe
hypertriglyceridemia (≥ 500 mg/dL). Edding also announced that it
has submitted its regulatory filing with the National Medical
Products Administration (NMPA) for the Company’s new indication
marketing application for VASCEPA to potentially treat
cardiovascular risk reduction (CVRR). The Company is now awaiting
the agency’s acceptance of that filing.
Amarin is in the second year of a three-year plan
to submit and obtain regulatory approval in 20 or more additional
countries and regions around the world to ensure that patients in
the top 50 cardiometabolic markets worldwide can benefit from
VASCEPA/VAZKEPA.
In the third quarter of 2023, Amarin signed an
exclusive commercialization agreement with Lotus Pharmaceuticals to
distribute and commercialize VAZKEPA across 10 countries in
Southeast Asia and South Korea. Amarin also announced an exclusive
marketing and commercial agreement with Neopharm for VAZKEPA in
Israel.
Financial Update
Total net revenue for the three months ended
September 30, 2023, was $66.1 million, compared to $89.9 million in
the corresponding period of 2022, a decrease of 27%. Total net
revenue in the quarter includes $64.9 million in net product
revenue and approximately $1.2 million in licensing and royalty
revenue.
Net product revenue for the three months ended
September 30, 2023, was $64.9 million, compared to $89.2 million in
the corresponding period of 2022, a decrease of 27%. This decrease
was driven by generic competition resulting in lower volume, as
well as increased net pricing pressure offset primarily by a
one-time Medicaid rebate adjustment of $6.5 million, versus the
third quarter of 2022. In Europe revenue was $0.8 million in the
third quarter of 2023.
Amarin recognized licensing and royalty revenue
of $1.2 million and $0.7 million during the three months ended
September 30, 2023 and 2022, respectively, from VASCEPA-related
commercial sales from our partners in Canada, the China region and
the Middle East, as well as an upfront licensing fee from our
partner in South Korea and ASEAN.
Cost of goods sold for the three months ended
September 30, 2023, was $36.2 million, compared to $27.0 million in
the corresponding period of 2022. Amarin’s overall gross margin on
net product revenue for the three months ended September 30, 2023
was 44%, compared with 70% for the corresponding period of 2022. As
a result of amended supplier agreements Amarin recognized a charge
of $12.7 million during the three months ended September 30, 2023.
During the three months ended September 30, 2022, Amarin also
amended a supplier agreement resulting in a charge of $3.1 million.
Excluding the impact of these one-time items, gross margin was 64%
and 73% for the three months ended September 30, 2023 and 2022,
respectively.
Selling, general and administrative expenses for
the three months ended September 30, 2023, was $45.5 million,
compared to $58.7 million in the corresponding period of the prior
year. This decrease was primarily due to the implementation of our
previously announced cost reduction plan.
Research and development expenses for the three
months ended September 30, 2023, were $5.1 million, compared to
$5.8 million in the corresponding period of the prior year. This
decrease was primarily driven by the implementation of our
previously announced cost reduction plan.
Restructuring expense for the three months ended
September 30, 2023 was $0.7 million compared to $3.5 million in the
corresponding period of the prior year. The charge in the current
year is due to the implementation of the Organizational
Restructuring Plan which was approved during the second quarter of
2023 and announced on July 18, 2023, which resulted in a reduction
of our entire U.S. sales field force, while maintaining our managed
care and trade organization to support U.S. commercial efforts, as
well as a reduction of approximately 30% of non-sales positions.
The prior year charge was primarily the result of the
discontinuation of the German operations as a result of not being
able to reach a viable agreement on the reimbursement price for
VAZKEPA in Germany.
Under U.S. GAAP, Amarin reported a net loss of
$19.3 million for the three months ended September 30, 2023, or
basic and diluted loss per share of $0.05. For the three months
ended September 30, 2022, Amarin reported a net loss of $5.1
million, or basic and diluted loss per share of $0.01. Amarin
reported aggregate cash and investments of $321 million as of
September 30, 2023 compared to $306 million as of September 30,
2022.
2023 Financial Outlook
Amarin continues to make progress on reducing
operating expenses and managing its cash position and on-track to
deliver $40 million of annual savings based on the reduction in
force announced in July 2023. With the recent cash preservation
initiatives, Amarin reiterates its belief that 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 November
1, 2023, 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 877-545-0523 within the United States, 973-528-0016 from
outside the United States, and referencing conference ID 991868. 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
49172. A replay of the call will also be available through the
company's website shortly after the call.
Use of Non-GAAP Adjusted Financial
Information
Included in this press release are non-GAAP
adjusted financial information as defined by U.S. Securities and
Exchange Commission Regulation G. The GAAP financial measure most
directly comparable to each non-GAAP adjusted financial measure
used or discussed, and a reconciliation of the differences between
each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, is included in this press release after the
condensed consolidated financial statements.
Non-GAAP adjusted net income (loss) was derived
by taking GAAP net loss and adjusting it for non-cash stock-based
compensation expense, restructuring expense and other one-time
expenses. 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. We are
committed to increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk for patients worldwide. 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.
Forward-Looking Statements
This press release contains forward-looking
statements, within the meaning of U.S. securities laws, including,
but not limited to, expectations regarding Amarin’s financial
performance, metrics, and initiatives, including its 2023 revenues,
operating expenses, supply purchases, negotiations and settlements,
product prescriptions and managed care coverage, continued savings
from cost-cutting initiatives that is currently exceeding initial
targets, and Amarin’s overall ability to continue to deliver stable
revenues and cash position from its U.S. business; beliefs about
the timing and outcome of international commercial partnerships,
regulatory filings, reviews, recommendations, approvals, and
related reimbursement decisions and commercial launches of
VASCEPA/VAZKEPA outside of the U.S.; beliefs that Amarin's current
resources are sufficient to fund projected operations; and beliefs
about the overall world-wide market potential and success of
VASCEPA/VAZKEPA generally. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. A 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, 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: Jordan Zwick Amarin
Corporation plc IR@amarincorp.com Media Inquiries:
Mark Marmur Amarin Corporation plc PR@amarincorp.com
|
|
|
|
|
CONSOLIDATED
BALANCE SHEET DATA |
(U.S.
GAAP) |
Unaudited |
|
|
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
|
(in
thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
270,814 |
|
|
$ |
217,666 |
|
Restricted cash |
|
|
524 |
|
|
|
523 |
|
Short-term investments |
|
|
49,848 |
|
|
|
91,695 |
|
Accounts receivable, net |
|
|
122,400 |
|
|
|
130,990 |
|
Inventory |
|
|
254,461 |
|
|
|
228,732 |
|
Prepaid and other current assets |
|
|
19,464 |
|
|
|
19,492 |
|
Total current assets |
|
|
717,511 |
|
|
|
689,098 |
|
Property, plant and equipment, net |
|
|
147 |
|
|
|
874 |
|
Long-term investments |
|
|
— |
|
|
|
1,275 |
|
Long-term inventory |
|
|
91,792 |
|
|
|
163,620 |
|
Operating lease right-of-use asset |
|
|
8,510 |
|
|
|
9,074 |
|
Other long-term assets |
|
|
1,395 |
|
|
|
458 |
|
Intangible asset, net |
|
|
19,676 |
|
|
|
21,780 |
|
TOTAL ASSETS |
|
$ |
839,031 |
|
|
$ |
886,179 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
53,362 |
|
|
$ |
64,602 |
|
Accrued expenses and other current liabilities |
|
|
211,304 |
|
|
|
192,678 |
|
Current deferred revenue |
|
|
2,025 |
|
|
|
2,199 |
|
Total current liabilities |
|
|
266,691 |
|
|
|
259,479 |
|
Long-Term Liabilities: |
|
|
|
|
Long-term deferred revenue |
|
|
2,949 |
|
|
|
13,147 |
|
Long-term operating lease liability |
|
|
8,970 |
|
|
|
10,015 |
|
Other long-term liabilities |
|
|
7,273 |
|
|
|
8,205 |
|
Total liabilities |
|
|
285,883 |
|
|
|
290,846 |
|
Stockholders’ Equity: |
|
|
|
|
Common stock |
|
|
302,318 |
|
|
|
299,002 |
|
Additional paid-in capital |
|
|
1,895,155 |
|
|
|
1,885,352 |
|
Treasury stock |
|
|
(63,743 |
) |
|
|
(61,770 |
) |
Accumulated deficit |
|
|
(1,580,582 |
) |
|
|
(1,527,251 |
) |
Total stockholders’
equity |
|
|
553,148 |
|
|
|
595,333 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
839,031 |
|
|
$ |
886,179 |
|
|
|
|
|
|
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) |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Product
revenue, net |
$ |
64,903 |
|
|
$ |
89,222 |
|
|
$ |
214,744 |
|
|
$ |
277,004 |
|
Licensing
and royalty revenue |
|
1,153 |
|
|
|
656 |
|
|
|
17,454 |
|
|
|
1,944 |
|
Total revenue, net |
|
66,056 |
|
|
|
89,878 |
|
|
|
232,198 |
|
|
|
278,948 |
|
Less: Cost
of goods sold |
|
23,560 |
|
|
|
23,941 |
|
|
|
72,553 |
|
|
|
81,990 |
|
Less: Cost
of goods sold - restructuring inventory |
|
12,674 |
|
|
|
3,078 |
|
|
|
39,228 |
|
|
|
18,078 |
|
Gross
margin |
|
29,822 |
|
|
|
62,859 |
|
|
|
120,417 |
|
|
|
178,880 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
45,457 |
|
|
|
58,745 |
|
|
|
155,997 |
|
|
|
236,285 |
|
Research and development (1) |
|
5,105 |
|
|
|
5,765 |
|
|
|
16,428 |
|
|
|
25,172 |
|
Restructuring |
|
711 |
|
|
|
3,493 |
|
|
|
10,743 |
|
|
|
13,706 |
|
Total operating expenses |
|
51,273 |
|
|
|
68,003 |
|
|
|
183,168 |
|
|
|
275,163 |
|
Operating
loss |
|
(21,451 |
) |
|
|
(5,144 |
) |
|
|
(62,751 |
) |
|
|
(96,283 |
) |
Interest
income, net |
|
3,216 |
|
|
|
750 |
|
|
|
8,438 |
|
|
|
1,241 |
|
Other
(expense) income, net |
|
(575 |
) |
|
|
511 |
|
|
|
3,092 |
|
|
|
(1,990 |
) |
Loss from
operations before taxes |
|
(18,810 |
) |
|
|
(3,883 |
) |
|
|
(51,221 |
) |
|
|
(97,032 |
) |
Provision
for income taxes |
|
(501 |
) |
|
|
(1,257 |
) |
|
|
(2,110 |
) |
|
|
(9,627 |
) |
Net
loss |
$ |
(19,311 |
) |
|
$ |
(5,140 |
) |
|
$ |
(53,331 |
) |
|
$ |
(106,659 |
) |
Loss per
share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.05 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
Diluted |
$ |
(0.05 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.27 |
) |
Weighted
average shares: |
|
|
|
|
|
|
|
Basic |
|
408,417 |
|
|
|
404,614 |
|
|
|
407,489 |
|
|
|
399,944 |
|
Diluted |
|
408,417 |
|
|
|
404,614 |
|
|
|
407,489 |
|
|
|
399,944 |
|
|
|
|
|
|
|
|
|
(1) - Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $41,807 and $54,358 for the three
months ended September 30, 2023 and 2022, respectively, and
research and development expenses were $4,113 and $5,138,
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) |
|
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net loss for EPS1 - GAAP |
|
(19,311 |
) |
|
|
(5,140 |
) |
|
|
(53,331 |
) |
|
|
(106,659 |
) |
Non-cash stock-based compensation expense |
|
|
4,643 |
|
|
|
5,015 |
|
|
|
12,034 |
|
|
|
20,192 |
|
Restructuring inventory |
|
|
12,674 |
|
|
|
3,078 |
|
|
|
39,228 |
|
|
|
18,078 |
|
Restructuring expense |
|
|
711 |
|
|
|
3,493 |
|
|
|
10,743 |
|
|
|
13,706 |
|
Advisor fees |
|
|
— |
|
|
|
— |
|
|
|
6,270 |
|
|
|
— |
|
Adjusted net
(loss) income for EPS1 - non-GAAP |
|
$ |
(1,283 |
) |
|
$ |
6,446 |
|
|
$ |
14,944 |
|
|
$ |
(54,683 |
) |
|
|
|
|
|
|
|
|
|
1basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
Basic -
non-GAAP |
|
$ |
(0.00 |
) |
|
$ |
0.02 |
|
|
$ |
0.04 |
|
|
$ |
(0.14 |
) |
Diluted -
non-GAAP |
|
$ |
(0.00 |
) |
|
$ |
0.02 |
|
|
$ |
0.04 |
|
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
408,417 |
|
|
|
404,614 |
|
|
|
407,489 |
|
|
|
399,944 |
|
Diluted |
|
|
408,417 |
|
|
|
405,541 |
|
|
|
417,117 |
|
|
|
399,944 |
|
|
|
|
|
|
|
|
|
|
1 Excludes one-time supply restructuring payment of $25
million in third quarter 2022 and one-time supply restructuring
payment of $10 million in first quarter 2023.
Grafico Azioni Amarin (NASDAQ:AMRN)
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Da Apr 2024 a Mag 2024
Grafico Azioni Amarin (NASDAQ:AMRN)
Storico
Da Mag 2023 a Mag 2024