Alkermes plc Reports First Quarter 2025 Financial Results
- LYBALVI revenues grew 23% year-over-year to $70.0 million
- Strong cash position with $916.2 million in cash and investments, up from $824.8 million in December 2024
- Completed enrollment in Vibrance-1 phase 2 study for ALKS 2680 in narcolepsy type 1
- Maintained profitability with $22.5 million in GAAP net income
- Total revenues declined 12.5% year-over-year from $350.4 million to $306.5 million
- ARISTADA revenues decreased to $73.5 million from $78.9 million in Q1 2024
- GAAP net income decreased from $36.8 million in Q1 2024 to $22.5 million in Q1 2025
- Adjusted EBITDA declined to $45.6 million from $81.8 million in Q1 2024
Insights
Mixed Q1 results: proprietary product sales up 5%, but major EBITDA decline of 44% despite maintained 2025 guidance.
Alkermes delivered Q1 2025 total revenues of $306.5 million, a 12.5% decrease from $350.4 million in Q1 2024. The company's proprietary product portfolio grew 5% to $244.5 million, demonstrating continued commercial momentum despite the broader revenue decline.
LYBALVI emerged as the standout performer with $70 million in revenue, representing strong 23% year-over-year growth. VIVITROL contributed $101 million (up 3.4%), while ARISTADA declined to $73.5 million (down 6.8%).
The substantial revenue decline stemmed from manufacturing and royalty revenues, which fell 47% to $62 million from $116.8 million in Q1 2024. This drop significantly impacted profitability metrics, with GAAP net income decreasing to $22.5 million ($0.13 per share) from $38.9 million in the prior year period – a 42% reduction. More concerning, Adjusted EBITDA fell 44% to $45.6 million from $81.8 million.
On the positive side, Alkermes strengthened its financial position with cash and investments increasing to $916.2 million from $824.8 million at year-end 2024. The company also demonstrated expense management with SG&A costs decreasing to $171.7 million from $179.7 million year-over-year.
Despite the significant year-over-year profitability decline, management reiterated their 2025 financial guidance, suggesting confidence that upcoming quarters will align with their full-year expectations.
ALKS 2680 orexin agonist program advances with three Phase 2 trials in sleep disorders; topline data coming Q3 2025.
Alkermes reported significant progress in their ALKS 2680 development program, a novel oral orexin 2 receptor agonist targeting central disorders of hypersomnolence. The company has completed enrollment in the Vibrance-1 Phase 2 study for narcolepsy type 1, with topline results expected early in Q3 2025.
The broader clinical program is advancing steadily, with enrollment in Vibrance-2 (for narcolepsy type 2) expected to complete mid-year and topline data anticipated in fall 2025. Additionally, Vibrance-3 enrollment for idiopathic hypersomnia is now underway.
Orexin 2 receptor agonists represent a novel mechanism for treating sleep disorders. Rather than inducing sleep like traditional treatments, these compounds target the brain's arousal system, potentially addressing the underlying pathophysiology of narcolepsy and related conditions.
While still in mid-stage development, Alkermes is already preparing for Phase 3 clinical trials, indicating confidence in the program's potential. The company positions orexin 2 receptor agonists as "one of the most exciting new therapeutic categories in development" with transformative potential for patients suffering from these chronic, debilitating conditions.
This pipeline advancement comes as Alkermes continues to diversify beyond its established portfolio of CNS products for alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder. The sleep disorder market represents a significant commercial opportunity with substantial unmet needs for more effective treatments.
— First Quarter Revenues of
— GAAP Net Income of
— Company Reiterates 2025 Financial Expectations —
"Our first quarter financial performance provides a solid foundation to deliver on our financial guidance for the year. We are in a strong position in this dynamic macroeconomic environment and remain focused on executing on the strategic objectives that we believe will drive the future value of the company," said Richard Pops, Chief Executive Officer of Alkermes. "We recently achieved an important milestone in the program for ALKS 2680, our novel, investigational, oral orexin 2 receptor agonist, completing enrollment in our first phase 2 study in the program, Vibrance-1, in narcolepsy type 1. We now expect topline results from Vibrance-1 early in the third quarter. We expect to complete enrollment in the Vibrance-2 phase 2 study, in narcolepsy type 2, mid-year, with topline data from that study expected in the fall. Enrollment in Vibrance-3, our phase 2 study in idiopathic hypersomnia, is now also underway. Across the ALKS 2680 development program, we have strong momentum and are preparing for the phase 3 program. With the potential to transform the treatment of central disorders of hypersomnolence, orexin 2 receptor agonists are one of the most exciting new therapeutic categories in development."
Key Financial Highlights
Revenues | ||||
(In millions) | Three Months Ended | |||
2025 | 2024 | |||
Total Revenues | $ | 306.5 | $ | 350.4 |
Total Proprietary Net Sales | $ | 244.5 | $ | 233.5 |
VIVITROL® | $ | 101.0 | $ | 97.7 |
ARISTADA®i | $ | 73.5 | $ | 78.9 |
LYBALVI® | $ | 70.0 | $ | 57.0 |
Profitability | ||||
(In millions) | Three Months Ended | |||
2025 | 2024 | |||
GAAP Net Income From Continuing Operations | $ | 22.5 | $ | 38.9 |
GAAP Net Income (Loss) From Discontinued Operations | $ | -- | $ | (2.1) |
GAAP Net Income | $ | 22.5 | $ | 36.8 |
EBITDA From Continuing Operations | $ | 22.8 | $ | 51.5 |
EBITDA From Discontinued Operations | $ | -- | $ | (2.5) |
EBITDA | $ | 22.8 | $ | 49.0 |
Adjusted EBITDA | $ | 45.6 | $ | 81.8 |
Revenue Highlights
LYBALVI
- Revenues for the quarter were
$70.0 million - Revenues and total prescriptions for the quarter grew
23% and22% , respectively, compared to the first quarter of 2024.
ARISTADAi
- Revenues for the quarter were
$73.5 million
VIVITROL
- Revenues for the quarter were
$101.0 million
Manufacturing & Royalty Revenues
- VUMERITY® manufacturing and royalty revenues for the quarter were
$27.8 million - Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were
$17.7 million
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
(In millions) | Three Months Ended | ||||||||||||
2025 | 2024 | ||||||||||||
R&D Expense – Continuing Operations | $ | 71.8 | $ | 67.6 | |||||||||
R&D Expense – Discontinued Operations | $ | -- | $ | 2.5 | |||||||||
SG&A Expense – Continuing Operations | $ | 171.7 | $ | 179.7 | |||||||||
SG&A Expense – Discontinued Operations | $ | -- | $ | -- | |||||||||
Balance Sheet
- At March 31, 2025, the company recorded cash, cash equivalents and total investments of
$916.2 million $824.8 million
Financial Expectations for 2025
Alkermes reiterates its financial expectations for 2025, as set forth in its press release dated Feb. 12, 2025.
Notes and Explanations
1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three months ended March 31, 2024.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, May 1, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for
About Alkermes plc
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.
EBITDA represents earnings before interest, tax, depreciation and amortization. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings.
The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, EBITDA and Adjusted EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, EBITDA and Adjusted EBITDA should not be considered measures of the company's liquidity.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects, including expected value drivers; and the company's expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the
VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA HAFYERA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license.
________________________________ |
i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. |
Alkermes plc and Subsidiaries | ||||
Selected Financial Information (Unaudited) | ||||
Condensed Consolidated Statements of Operations - GAAP | Three Months Ended | Three Months Ended | ||
(In thousands, except per share data) | March 31, 2025 | March 31, 2024 | ||
Revenues: | ||||
Product sales, net | $ 244,493 | $ 233,536 | ||
Manufacturing and royalty revenues | 62,017 | 116,833 | ||
Research and development revenue | — | 3 | ||
Total Revenues | 306,510 | 350,372 | ||
Expenses: | ||||
Cost of goods manufactured and sold | 49,197 | 58,644 | ||
Research and development | 71,817 | 67,611 | ||
Selling, general and administrative | 171,704 | 179,749 | ||
Amortization of acquired intangible assets | — | 1,059 | ||
Total Expenses | 292,718 | 307,063 | ||
Operating Income | 13,792 | 43,309 | ||
Other Income, net: | ||||
Interest income | 10,141 | 9,399 | ||
Interest expense | — | (5,978) | ||
Other income, net | 1,556 | 182 | ||
Total Other Income, net | 11,697 | 3,603 | ||
Income Before Income Taxes | 25,489 | 46,912 | ||
Income Tax Provision | 3,025 | 7,964 | ||
Net Income From Continuing Operations | 22,464 | 38,948 | ||
Loss from Discontinued Operations — Net of Tax | — | (2,120) | ||
Net Income — GAAP | $ 22,464 | $ 36,828 | ||
GAAP Earnings (Loss) Per Share - Basic: | ||||
From continuing operations | $ 0.14 | $ 0.23 | ||
From discontinued operations | — | (0.01) | ||
Earnings per share | $ 0.14 | $ 0.22 | ||
GAAP Earnings (Loss) Per Share - Diluted: | ||||
From continuing operations | $ 0.13 | $ 0.23 | ||
From discontinued operations | — | (0.01) | ||
Earnings per share | $ 0.13 | $ 0.21 | ||
Weighted Average Number of Ordinary Shares Outstanding: | ||||
Basic — GAAP | 163,407 | 167,984 | ||
Diluted — GAAP | 168,737 | 172,981 | ||
Condensed Consolidated Statements of Operations - GAAP (Continued) | Three Months Ended | Three Months Ended | ||
(In thousands, except per share data) | March 31, 2025 | March 31, 2024 | ||
An itemized reconciliation between net income from continuing operations on a GAAP basis and Adjusted EBITDA is as follows: | ||||
Net Income from Continuing Operations | $ 22,464 | $ 38,948 | ||
Adjustments: | ||||
Depreciation and amortization expense | 7,421 | 8,056 | ||
Interest income | (10,141) | (9,399) | ||
Interest expense | — | 5,978 | ||
Income tax provision | 3,025 | 7,964 | ||
EBITDA from Continuing Operations | 22,769 | 51,547 | ||
EBITDA from Discontinued Operations | — | (2,516) | ||
EBITDA | 22,769 | 49,031 | ||
Share-based compensation | 22,810 | 32,755 | ||
Adjusted EBITDA | $ 45,579 | $ 81,786 | ||
Alkermes plc and Subsidiaries | ||||
Selected Financial Information (Unaudited) | ||||
Condensed Consolidated Balance Sheets | March 31, | December 31, | ||
(In thousands) | 2025 | 2024 | ||
Cash, cash equivalents and total investments | $ 916,206 | $ 824,816 | ||
Receivables | 318,703 | 389,733 | ||
Inventory | 183,438 | 182,887 | ||
Contract assets | 3,049 | 4,990 | ||
Prepaid expenses and other current assets | 89,843 | 86,077 | ||
Property, plant and equipment, net | 233,920 | 227,564 | ||
Intangible assets, net and goodwill | 83,899 | 83,917 | ||
Deferred tax assets | 152,144 | 154,835 | ||
Other assets | 100,775 | 100,748 | ||
Total Assets | $ 2,081,977 | $ 2,055,567 | ||
Accrued sales discounts, allowances and reserves | $ 249,795 | $ 272,452 | ||
Other current liabilities | 193,935 | 192,747 | ||
Other long-term liabilities | 126,664 | 125,391 | ||
Total shareholders' equity | 1,511,583 | 1,464,977 | ||
Total Liabilities and Shareholders' Equity | $ 2,081,977 | $ 2,055,567 | ||
Ordinary shares outstanding (in thousands) | 164,853 | 162,177 | ||
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in | ||||
Alkermes Contacts: | ||
For Investors: | Sandy Coombs | +1 781 609 6377 |
For Media: | Katie Joyce | +1 781 249 8927 |
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SOURCE Alkermes plc
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