Amarin Reports Second Quarter 2023 Financial Results
- Total net revenues of $80 million in Q2 2023
- Positive cash flow of $9 million
- Cost reduction plan implemented with expected savings of $40 million
- Positive recommendation from Spanish Drug Pricing Committee for national reimbursement of VAZKEPA® in Spain
- U.S. product net revenue declined by 22% sequentially to $64.6 million
-- Company Reported Total Net Revenues of
-- Delivered Positive Cash Flow of
-- Comprehensive Cost Reduction Plan Implemented in July with Expected Savings of
-- Received Positive Recommendation from Spanish Drug Pricing Committee for National Reimbursement of VAZKEPA® (icosapent ethyl) in Spain --
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 02, 2023 (GLOBE NEWSWIRE) -- 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
During the second quarter of 2023, Amarin maintained its existing access for VASCEPA in exclusive accounts, representing approximately
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
Net product revenue for the three months ended June 30, 2023, was
Amarin recognized licensing and royalty revenue of
Cost of goods sold for the three months ended June 30, 2023, was
Selling, general and administrative expenses for the three months ended June 30, 2023, was
Research and development expenses for the three months ended June 30, 2023, were
Restructuring expense for the three months ended June 30, 2023 was
Under U.S. GAAP, Amarin reported a net loss of
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
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 | |||||||
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 | |||||||||||||||
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 | |||||||||||
FAQ
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