Amarin Corporation plc (NASDAQ:AMRN) today announced financial
results for the quarter ended June 30, 2023 and provided an update
on company operations.
“I am honored to have joined Amarin and to lead
the Company at this time,” said Patrick Holt, President & CEO
of Amarin. Mr. Holt continued, “Amarin’s second quarter performance
was marked by continued revenue generation in the U.S. and a cash
positive quarter. While it is early in my tenure as President and
CEO, it is clear to me the decisive and deliberate actions taken
put us on the right path for the future. Those actions are now
underway, and we are focused on managing our U.S. business to
enhance profitability, redesigning our commercial infrastructure in
Europe to better align with current and future commercial
potential, and working to generate revenue from partnerships in key
international markets. We believe these steps will place us on the
right path to support continued efforts to bring VASCEPA/VAZKEPA to
patients globally while enhancing value for shareholders.”
“We remain steadfast in our conviction on the
depth and breadth of our clinical data for VASCEPA/VAZKEPA based on
REDUCE-IT®, the definitive, large, long-term outcomes study of
icosapent ethyl with gold standard cardiovascular clinical
endpoints. Further, we remain committed to maximizing the value of
VASCEPA/VAZKEPA and its impact for patients,” Holt concluded.
Europe
Amarin has early launches of VAZKEPA underway in
several European countries, including the U.K. (England &
Wales). 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
2023, Amarin announced that 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.
United States
U.S. product net revenue was $64.6 million in
the second quarter of 2023, a decline of $17.7 million versus the
first quarter of 2023, a decrease of 22% sequentially. The Company
maintains approximately 57% market share of IPE prescriptions
despite generic competition as the U.S. commercial organization
continues an efficient support of branded VASCEPA.
During the second quarter of 2023, Amarin
maintained its existing access for VASCEPA in exclusive accounts,
representing approximately 45% of all Commercial and Part D lives
on a weighted average basis.
The U.S. business continues to support
investments in Europe. Amarin continues to actively monitor key
performance indicators in the U.S. market to support its strategy
moving forward.
International
Amarin is in the process of filing regulatory
submissions for approval in 20 additional countries to ensure that
patients in these markets can benefit from VASCEPA/VAZKEPA. In the
second quarter of 2023, Amarin secured regulatory approval for
VASCEPA in China and the Kingdom of Saudi Arabia. Amarin is
continuing to explore additional partnership opportunities in key
markets around the world.
Financial Update
Total net revenue for the three months ended
June 30, 2023, was $80.2 million, compared to $94.4 million in the
corresponding period of 2022, a decrease of 15%. Total net revenue
in the quarter includes $65.2 million in net product revenue and
approximately $15.0 million in licensing and royalty revenue.
Net product revenue for the three months ended
June 30, 2023, was $65.2 million, compared to $93.8 million in the
corresponding period of 2022, a decrease of 31%. This decrease was
driven by generic competition resulting in lower volume, as well as
increased net pricing pressure in the U.S., versus the second
quarter of 2022. In Europe revenue was $0.6 million in the second
quarter of 2023.
Amarin recognized licensing and royalty revenue
of $15.0 million, which includes $11.1 million of non-cash payment
related to previously received partnership milestones and receipt
of a cash milestone payment received in the quarter related to the
VHTG regulatory approval in China. The majority of the $11.1
million non-cash payment is the result of a change in accounting
estimate arising from a change in the performance period to
complete the performance obligations, which led to an acceleration
of revenue recognition.
Cost of goods sold for the three months ended
June 30, 2023, was $37.5 million, compared to $50.8 million in the
corresponding period of 2022. Amarin’s overall gross margin on net
product revenue for the three months ended June 30, 2023 was 42%,
compared with 46% for the corresponding period of 2022. During the
three months ended June 30, 2023, Amarin amended a supplier
agreement resulting in a charge of $14.3 million. During the three
months ended June 30, 2022, Amarin also amended a supplier
agreement resulting in a charge of $15.0 million and had a charge
of $9.6 million related to unsellable inventory not related to
product dating. Excluding the impact of these one-time items, gross
margin was 64% and 72% for the three months ended June 30, 2023 and
2022, respectively.
Selling, general and administrative expenses for
the three months ended June 30, 2023, was $51.0 million, compared
to $86.9 million in the corresponding period of the prior year.
This decrease was primarily due to the implementation of our
previously announced cost reduction plan and commercial withdrawal
from Germany.
Research and development expenses for the three
months ended June 30, 2023, were $5.6 million, compared to $9.4
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
June 30, 2023 was $10.0 million compared to $10.2 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
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 the result of the implementation of the
Comprehensive Cost Reduction Plan announced on June 6, 2022, which
primarily related to the reduction of our U.S. field force from
approximately 300 sales representatives to approximately 75 sales
representatives.
Under U.S. GAAP, Amarin reported a net loss of
$17.6 million for the three months ended June 30, 2023, or basic
and diluted loss per share of $0.04. For the three months ended
June 30, 2022, Amarin reported a net loss of $70.0 million, or
basic and diluted loss per share of $0.18. Non-GAAP adjusted net
income was $8.6 million for the second quarter ended June 30, 2023,
or non-GAAP adjusted basic and diluted earnings per share of $0.02,
compared with non-GAAP adjusted net loss of $35.6 million for the
three months ended June 30, 2022, or non-GAAP adjusted basic and
diluted loss per share of $0.09. As of June 30, 2023, Amarin
reported aggregate cash and investments of $313 million.
2023 Financial Outlook
Amarin continues to make progress on reducing
operating expenses and managing its cash position. The Company is
now lowering operating expense guidance for the full year 2023 to
the range of $240 million to $250 million from $270 million to $285
million, reflecting additional identified cost savings along with
timing of reimbursements as well as savings from restructuring.
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.
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 plcIR@amarincorp.com
Media Inquiries:Mark MarmurAmarin Corporation
plcPR@amarincorp.com
|
|
|
|
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(in thousands) |
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
232,995 |
|
|
$ |
217,666 |
|
Restricted cash |
|
524 |
|
|
|
523 |
|
Short-term investments |
|
79,919 |
|
|
|
91,695 |
|
Accounts receivable, net |
|
122,730 |
|
|
|
130,990 |
|
Inventory |
|
227,021 |
|
|
|
228,732 |
|
Prepaid and other current assets |
|
43,306 |
|
|
|
19,492 |
|
Total current assets |
|
706,495 |
|
|
|
689,098 |
|
Property, plant and equipment, net |
|
179 |
|
|
|
874 |
|
Long-term investments |
|
67 |
|
|
|
1,275 |
|
Long-term inventory |
|
122,318 |
|
|
|
163,620 |
|
Operating lease right-of-use asset |
|
8,978 |
|
|
|
9,074 |
|
Other long-term assets |
|
1,604 |
|
|
|
458 |
|
Intangible asset, net |
|
20,377 |
|
|
|
21,780 |
|
TOTAL ASSETS |
$ |
860,018 |
|
|
$ |
886,179 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
54,309 |
|
|
$ |
64,602 |
|
Accrued expenses and other current liabilities |
|
214,598 |
|
|
|
192,678 |
|
Current deferred revenue |
|
2,025 |
|
|
|
2,199 |
|
Total current liabilities |
|
270,932 |
|
|
|
259,479 |
|
Long-Term Liabilities: |
|
|
|
Long-term deferred revenue |
|
3,331 |
|
|
|
13,147 |
|
Long-term operating lease liability |
|
9,472 |
|
|
|
10,015 |
|
Other long-term liabilities |
|
7,155 |
|
|
|
8,205 |
|
Total liabilities |
|
290,890 |
|
|
|
290,846 |
|
Stockholders’ Equity: |
|
|
|
Common stock |
|
301,906 |
|
|
|
299,002 |
|
Additional paid-in capital |
|
1,891,957 |
|
|
|
1,885,352 |
|
Treasury stock |
|
(63,464 |
) |
|
|
(61,770 |
) |
Accumulated deficit |
|
(1,561,271 |
) |
|
|
(1,527,251 |
) |
Total stockholders’ equity |
|
569,128 |
|
|
|
595,333 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
860,018 |
|
|
$ |
886,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Product revenue, net |
$ |
65,187 |
|
|
$ |
93,796 |
|
|
$ |
149,841 |
|
|
$ |
187,782 |
|
Licensing and royalty revenue |
|
14,980 |
|
|
|
644 |
|
|
|
16,301 |
|
|
|
1,288 |
|
Total revenue, net |
|
80,167 |
|
|
|
94,440 |
|
|
|
166,142 |
|
|
|
189,070 |
|
Less: Cost of goods sold |
|
23,199 |
|
|
|
35,810 |
|
|
|
48,993 |
|
|
|
58,049 |
|
Less: Cost of goods sold - restructuring inventory |
|
14,300 |
|
|
|
15,000 |
|
|
|
26,554 |
|
|
|
15,000 |
|
Gross margin |
|
42,668 |
|
|
|
43,630 |
|
|
|
90,595 |
|
|
|
116,021 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
50,953 |
|
|
|
86,893 |
|
|
|
110,540 |
|
|
|
177,540 |
|
Research and development (1) |
|
5,642 |
|
|
|
9,356 |
|
|
|
11,323 |
|
|
|
19,407 |
|
Restructuring |
|
10,032 |
|
|
|
10,213 |
|
|
|
10,032 |
|
|
|
10,213 |
|
Total operating expenses |
|
66,627 |
|
|
|
106,462 |
|
|
|
131,895 |
|
|
|
207,160 |
|
Operating loss |
|
(23,959 |
) |
|
|
(62,832 |
) |
|
|
(41,300 |
) |
|
|
(91,139 |
) |
Interest income, net |
|
3,001 |
|
|
|
288 |
|
|
|
5,222 |
|
|
|
491 |
|
Other income (expense), net |
|
3,043 |
|
|
|
(2,255 |
) |
|
|
3,667 |
|
|
|
(2,501 |
) |
Loss from operations before taxes |
|
(17,915 |
) |
|
|
(64,799 |
) |
|
|
(32,411 |
) |
|
|
(93,149 |
) |
Income tax benefit (provision) |
|
355 |
|
|
|
(5,157 |
) |
|
|
(1,609 |
) |
|
|
(8,370 |
) |
Net loss |
$ |
(17,560 |
) |
|
$ |
(69,956 |
) |
|
$ |
(34,020 |
) |
|
$ |
(101,519 |
) |
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.04 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.26 |
) |
Diluted |
$ |
(0.04 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.26 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
407,848 |
|
|
|
398,187 |
|
|
|
407,017 |
|
|
|
397,997 |
|
Diluted |
|
407,848 |
|
|
|
398,187 |
|
|
|
407,017 |
|
|
|
397,997 |
|
|
|
|
|
|
|
|
|
(1) - Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $50,002 and $79,244 for the three
months ended June 30, 2023 and 2022, respectively, and research and
development expenses were $4,758 and $7,905, respectively, for the
same periods. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
Unaudited |
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net loss for EPS1 - GAAP |
|
(17,560 |
) |
|
|
(69,956 |
) |
|
|
(34,020 |
) |
|
|
(101,519 |
) |
Non-cash stock-based compensation expense |
|
1,835 |
|
|
|
9,100 |
|
|
|
7,391 |
|
|
|
15,178 |
|
Restructuring inventory |
|
14,300 |
|
|
|
15,000 |
|
|
|
26,554 |
|
|
|
15,000 |
|
Restructuring expense |
|
10,032 |
|
|
|
10,213 |
|
|
|
10,032 |
|
|
|
10,213 |
|
Advisor fees |
|
— |
|
|
|
— |
|
|
|
6,270 |
|
|
|
— |
|
Adjusted
net income (loss) for EPS1 - non-GAAP |
$ |
8,607 |
|
|
$ |
(35,643 |
) |
|
$ |
16,227 |
|
|
$ |
(61,128 |
) |
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
Basic -
non-GAAP |
$ |
0.02 |
|
|
$ |
(0.09 |
) |
|
$ |
0.04 |
|
|
$ |
(0.15 |
) |
Diluted
- non-GAAP |
$ |
0.02 |
|
|
$ |
(0.09 |
) |
|
$ |
0.04 |
|
|
$ |
(0.15 |
) |
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
Basic |
|
407,848 |
|
|
|
398,187 |
|
|
|
407,017 |
|
|
|
397,997 |
|
Diluted |
|
408,148 |
|
|
|
398,187 |
|
|
|
409,547 |
|
|
|
397,997 |
|
|
|
|
|
|
|
|
|
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