Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter ended March 31, 2023 and provided an update
on the Company’s operations.
“I am truly honored to lead Amarin during this
time of transition,” said Aaron Berg, Amarin’s Interim President
and CEO. Mr. Berg continued, “Amarin’s first quarter performance
was marked by solid revenue generation in the U.S. and a stable
cash position. However, we are not where we need to be in Europe.
While we will continue to work to optimally manage the U.S.
business, I am focused with the team on ways to accelerate patient
access and revenue in Europe. Amarin’s objectives remain to bring
the benefits of VASCEPA®/VAZKEPA® to patients around the globe and
to maximize value for shareholders.”
United States
U.S. product net revenue was $82.3 million in
the first quarter of 2023, compared to $88.0 million in the fourth
quarter of 2022, a decrease of seven percent. The Company maintains
approximately 57% market share of the IPE molecule despite generic
competition as the U.S. commercial organization continues an
efficient support of branded VASCEPA.
Amarin continues to actively monitor key
performance indicators in the U.S. market to thoughtfully support
its strategy.
Europe
Amarin has early launches underway of VAZKEPA in
the U.K. (England & Wales), Sweden and Finland. To date in the
U.K., Amarin is working to secure VAZKEPA patient access through
local formulary negotiations, and we expect those negotiations will
continue to progress throughout 2023.
In addition to these launch activities, the team
in Europe further advances the various Health Technology Assessment
(HTA) processes and pricing & reimbursement discussions in all
markets where Amarin has submitted market access dossiers.
International
The company 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 first quarter of 2023, Amarin secured
regulatory approval for VAZKEPA in New Zealand and Israel.
In addition, Amarin continues to make progress
in international markets with our partners and recently announced a
new partnership. In February 2023, Amarin and CSL Seqirus announced
that the two companies entered into an exclusive license and
distribution agreement under which Amarin will license exclusive
rights to VAZKEPA to CSL Seqirus to secure pricing and
reimbursement and commercialize VAZKEPA across Australia and New
Zealand.
Financial Update
“We continue to make progress on our financial
initiatives and our pursuit of operational excellence, beyond our
initial $100 million cost savings target,” said Tom Reilly,
Amarin’s CFO. “We have been working to renegotiate our supply
agreements including the most recent settlement this quarter. With
these efforts, we reduced operating expense guidance for 2023,”
said Mr. Reilly.
Total net revenue for the three months ended
March 31, 2023, was $86.0 million, compared to $94.6 million in the
corresponding period of 2022, a decrease of 9%. Net product revenue
for the three months ended March 31, 2023, was $84.7 million,
compared to $94.0 million in the corresponding period of 2022, a
decrease of 10%. This decrease was driven by a decline in volume
and net selling price due to the impact of generic competition in
the U.S. In Europe revenue was $0.4 million in the first quarter of
2023.
Amarin recognized licensing and royalty revenue
of approximately $1.3 million and $0.6 million during the three
months ended March 31, 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 Australia and New Zealand.
Cost of goods sold for the three months ended
March 31, 2023, was $38.0 million, compared to $22.2 million in the
corresponding period of 2022. Amarin’s overall gross margin on net
product revenue for the three months ended March 31, 2023 was 55%,
compared with 76% for the corresponding period of 2022. During the
three months ended March 31, 2023, Amarin amended a supplier
agreement resulting in a charge of $12.3 million. Excluding the
impact of this item, gross margin was 70% for the three months
ended March 31, 2023. The remaining decrease in gross margin is
primarily a result of a decrease in net selling price.
Selling, general and administrative expenses for
the three months ended March 31, 2023, was $59.6 million, compared
to $90.6 million in the corresponding period of the prior year.
This decrease was primarily due to the implementation of our
ongoing cost reduction plan.
Research and development expenses for the three
months ended March 31, 2023, were $5.7 million, compared to $10.1
million in the corresponding period of the prior year. This
decrease was primarily driven by the implementation of our ongoing
cost reduction plan.
Under U.S. GAAP, Amarin reported a net loss of
$16.5 million for the three months ended March 31, 2023, or basic
and diluted loss per share of $0.04. For the three months ended
March 31, 2022, Amarin reported a net loss of $31.6 million, or
basic and diluted loss per share of $0.08. Non-GAAP adjusted net
income was $7.6 million for the first quarter ended March 31, 2023,
or non-GAAP adjusted basic and diluted earnings per share of $0.02,
compared with non-GAAP adjusted net loss of $25.5 million for the
three months ended March 31, 2022, or non-GAAP adjusted basic and
diluted loss per share of $0.06. As of March 31, 2023, Amarin
reported aggregate cash and investments of $304.9 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 $270 million to $285 million from $290 to $305
million, reflecting additional identified cost savings along with
timing of reimbursements. With the recent stable U.S. business
revenues and 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 May 3,
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 888-506-0062 within the United States, 973-528-0011 from
outside the United States, and referencing conference ID 368360. 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
47933. 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.
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 twenty 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,
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: 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, 2023 |
|
December 31, 2022 |
|
|
|
|
(in thousands) |
|
|
ASSETS |
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
191,412 |
|
|
$ |
217,666 |
|
|
|
Restricted cash |
|
|
523 |
|
|
|
523 |
|
|
|
Short-term investments |
|
|
112,959 |
|
|
|
91,695 |
|
|
|
Accounts receivable, net |
|
|
133,236 |
|
|
|
130,990 |
|
|
|
Inventory |
|
|
225,813 |
|
|
|
228,732 |
|
|
|
Prepaid and other current assets |
|
|
19,878 |
|
|
|
19,492 |
|
|
|
Total current assets |
|
|
683,821 |
|
|
|
689,098 |
|
|
|
Property, plant and equipment, net |
|
|
187 |
|
|
|
874 |
|
|
|
Long-term investments |
|
|
544 |
|
|
|
1,275 |
|
|
|
Long-term inventory |
|
|
143,730 |
|
|
|
163,620 |
|
|
|
Operating lease right-of-use asset |
|
|
9,190 |
|
|
|
9,074 |
|
|
|
Other long-term assets |
|
|
1,638 |
|
|
|
458 |
|
|
|
Intangible asset, net |
|
|
21,078 |
|
|
|
21,780 |
|
|
|
TOTAL ASSETS |
|
$ |
860,188 |
|
|
$ |
886,179 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
58,779 |
|
|
$ |
64,602 |
|
|
|
Accrued expenses and other current liabilities |
|
|
183,264 |
|
|
|
192,678 |
|
|
|
Current deferred revenue |
|
|
2,199 |
|
|
|
2,199 |
|
|
|
Total current liabilities |
|
|
244,242 |
|
|
|
259,479 |
|
|
|
Long-Term Liabilities: |
|
|
|
|
|
|
Long-term deferred revenue |
|
|
12,702 |
|
|
|
13,147 |
|
|
|
Long-term operating lease liability |
|
|
9,841 |
|
|
|
10,015 |
|
|
|
Other long-term liabilities |
|
|
8,610 |
|
|
|
8,205 |
|
|
|
Total liabilities |
|
|
275,395 |
|
|
|
290,846 |
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
Common stock |
|
|
301,285 |
|
|
|
299,002 |
|
|
|
Additional paid-in capital |
|
|
1,890,496 |
|
|
|
1,885,352 |
|
|
|
Treasury stock |
|
|
(63,277 |
) |
|
|
(61,770 |
) |
|
|
Accumulated deficit |
|
|
(1,543,711 |
) |
|
|
(1,527,251 |
) |
|
|
Total stockholders’ equity |
|
|
584,793 |
|
|
|
595,333 |
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
860,188 |
|
|
$ |
886,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Product revenue, net |
$ |
84,654 |
|
|
$ |
93,986 |
|
|
|
Licensing and royalty revenue |
|
1,321 |
|
|
|
644 |
|
|
|
Total revenue, net |
|
85,975 |
|
|
|
94,630 |
|
|
|
Less: Cost of goods sold |
|
25,794 |
|
|
|
22,239 |
|
|
|
Less: Cost of goods sold - restructuring inventory |
|
12,254 |
|
|
|
— |
|
|
|
Gross margin |
|
47,927 |
|
|
|
72,391 |
|
|
|
Operating expenses: |
|
|
|
|
|
Selling, general and administrative (1) |
|
59,587 |
|
|
|
90,647 |
|
|
|
Research and development (1) |
|
5,681 |
|
|
|
10,051 |
|
|
|
Total operating expenses |
|
65,268 |
|
|
|
100,698 |
|
|
|
Operating loss |
|
(17,341 |
) |
|
|
(28,307 |
) |
|
|
Interest income, net |
|
2,221 |
|
|
|
203 |
|
|
|
Other income (expense), net |
|
624 |
|
|
|
(246 |
) |
|
|
Loss from operations before taxes |
|
(14,496 |
) |
|
|
(28,350 |
) |
|
|
Income tax provision |
|
(1,964 |
) |
|
|
(3,213 |
) |
|
|
Net loss |
$ |
(16,460 |
) |
|
$ |
(31,563 |
) |
|
|
Loss per share: |
|
|
|
|
|
Basic |
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
|
Diluted |
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
|
Weighted average shares: |
|
|
|
|
|
Basic |
|
406,177 |
|
|
|
397,805 |
|
|
|
Diluted |
|
406,177 |
|
|
|
397,805 |
|
|
|
|
|
|
|
|
|
(1) - Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $55,244 and $86,018 for the three
months ended March 31, 2023 and 2022, respectively, and research
and development expenses were $4,468 and $8,602, respectively, for
the same periods. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
2023 |
|
|
2022 |
|
|
|
Net loss for EPS1 - GAAP |
|
(16,460 |
) |
|
|
|
(31,563 |
) |
|
|
Non-cash stock-based compensation expense |
|
|
5,557 |
|
|
|
|
6,078 |
|
|
|
Restructuring inventory |
|
|
12,254 |
|
|
|
|
— |
|
|
|
Advisor fees |
|
|
6,270 |
|
|
|
|
— |
|
|
|
Adjusted net income (loss) for EPS1 - non-GAAP |
|
$ |
7,621 |
|
|
|
$ |
(25,485 |
) |
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
Basic - non-GAAP |
|
$ |
0.02 |
|
|
|
$ |
(0.06 |
) |
|
|
Diluted - non-GAAP |
|
$ |
0.02 |
|
|
|
$ |
(0.06 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
|
406,177 |
|
|
|
|
397,805 |
|
|
|
Diluted |
|
|
408,932 |
|
|
|
|
397,805 |
|
|
|
|
|
|
|
|
|
|
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