PR Newswire
— Total Revenues of $1.56 Billion in 2024; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year —
— GAAP Net Income from Continuing Operations of $372 Million and Diluted GAAP Earnings per Share from Continuing Operations of $2.20 for 2024 —
— ALKS 2680 Phase 2 Studies in Narcolepsy Type 1 and Type 2 Ongoing With Data Expected in H2 2025 —
DUBLIN
, Feb. 12, 2025 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025.
“2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience,” said Richard Pops, Chief Executive Officer of Alkermes. “Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category.”
“2024 was Alkermes’ strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company’s ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline,” said Blair Jackson, Chief Operating Officer of Alkermes. “We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company’s next phase of growth.”
Key Financial Highlights
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Total Revenues |
$ |
430.0 |
$ |
377.5 |
$ |
1,557.6 |
$ |
1,663.4* |
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Total Proprietary Net Sales |
$ |
307.7 |
$ |
242.0 |
$ |
1,083.5 |
$ |
920.0 |
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VIVITROL® |
$ |
134.1 |
$ |
102.4 |
$ |
457.3 |
$ |
400.4 |
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ARISTADA®i |
$ |
96.6 |
$ |
83.4 |
$ |
346.2 |
$ |
327.7 |
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LYBALVI® |
$ |
77.0 |
$ |
56.2 |
$ |
280.0 |
$ |
191.9 |
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GAAP Net Income From Continuing Operations |
$ |
145.7 |
$ |
160.6 |
$ |
372.1 |
$ |
519.2 |
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GAAP Net Income |
$ |
146.5 |
$ |
112.8 |
$ |
367.1 |
$ |
355.8 |
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Non-GAAP Net Income From Continuing Operations |
$ |
173.4 |
$ |
81.8 |
$ |
494.4 |
$ |
396.5 |
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Non-GAAP Net Income |
$ |
174.2 |
$ |
37.4 |
$ |
489.3 |
$ |
243.7 |
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EBITDA From Continuing Operations |
$ |
170.0 |
$ |
72.8 |
$ |
452.4 |
$ |
486.3 |
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EBITDA |
$ |
171.1 |
$ |
32.3 |
$ |
446.6 |
$ |
323.8 |
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*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods.
Revenue Highlights
LYBALVI
- Revenues for the fourth quarter were $77.0 million.
- Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023.
- During the quarter, the company recorded LYBALVI® revenue of approximately $4 million related to year-end inventory fluctuations.
ARISTADAi
- Revenues for the fourth quarter were $96.6 million.
- Fourth quarter revenues grew 16% compared to the fourth quarter of 2023.
- During the quarter, the company recorded ARISTADA® revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL
- Revenues for the fourth quarter were $134.1 million.
- Fourth quarter revenues grew 31% compared to the fourth quarter of 2023.
- During the quarter, the company recorded VIVITROL® revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues
- Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter were $36.5 million.
- VUMERITY® manufacturing and royalty revenues for the fourth quarter were $35.0 million.
- FAMPYRA® manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward.
- RISPERDAL CONSTA® manufacturing revenues for the fourth quarter were $14.7 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
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R&D Expense – Continuing Operations |
$ |
58.2 |
$ |
73.9 |
$ |
245.3 |
$ |
270.8 |
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SG&A Expense – Continuing Operations |
$ |
147.0 |
$ |
169.8 |
$ |
645.2 |
$ |
689.8 |
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Balance Sheet
- At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023.
- In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million.
Financial Expectations for 2025
All line items are according to GAAP, except as otherwise noted.
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Total Revenues |
$1,340 – $1,430 |
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VIVITROL Net Sales |
$440 – $460 |
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ARISTADAi Net Sales |
$335 – $355 |
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LYBALVI Net Sales |
$320 – $340 |
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Cost of Goods Sold |
$185 – $205 |
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R&D Expenses |
$305 – $335 |
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SG&A Expenses |
$655 – $685 |
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GAAP Net Income a |
$175 – $205 |
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EBITDA |
$215 – $245 |
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Adjusted EBITDA |
$310 – $340 |
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Effective Tax Rate |
~17% |
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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 and twelve months ended Dec. 31, 2023.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 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 U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.
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 Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
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 non-GAAP net income, 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.
Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. 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, non-GAAP net income, 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, non-GAAP net income, 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 drivers of growth, value creation and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. 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, including those related to profitability; 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 unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company’s products or products using the company’s proprietary technologies; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s most recent Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
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®, INVEGA HAFYERA®, INVEGA TRINZA®, RISPERDAL CONSTA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; FAMPYRATM is a trademark of Merz Pharmaceuticals, LLC; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license.
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Revenues: |
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Product sales, net |
$ 307,726 |
$ 241,972 |
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Manufacturing and royalty revenues |
122,260 |
135,500 |
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Research and development revenue |
— |
3 |
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Total Revenues |
429,986 |
377,475 |
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Expenses: |
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Cost of goods manufactured and sold |
62,116 |
70,126 |
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Research and development |
58,174 |
73,933 |
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Selling, general and administrative |
146,994 |
169,789 |
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Amortization of acquired intangible assets |
14 |
8,996 |
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Total Expenses |
267,298 |
322,844 |
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Operating Income |
162,688 |
54,631 |
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Other Income, net: |
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Interest income |
11,400 |
9,749 |
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Interest expense |
(4,648) |
(6,054) |
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Other income (expense), net |
449 |
(10) |
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Total Other Income, net |
7,201 |
3,685 |
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Income Before Income Taxes |
169,889 |
58,316 |
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Income Tax Provision (Benefit) |
24,152 |
(102,236) |
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145,737 |
160,552 |
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766 |
(47,773) |
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$ 146,503 |
$ 112,779 |
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From continuing operations |
$ 0.90 |
$ 0.96 |
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From discontinued operations |
$ 0.00 |
$ (0.29) |
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From net income |
$ 0.90 |
$ 0.68 |
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From continuing operations |
$ 0.88 |
$ 0.94 |
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From discontinued operations |
$ 0.00 |
$ (0.28) |
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From net income |
$ 0.88 |
$ 0.66 |
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Basic — GAAP and Non-GAAP |
161,956 |
166,898 |
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Diluted — GAAP and Non-GAAP |
166,554 |
170,138 |
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An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows: |
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$ 145,737 |
$ 160,552 |
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Adjustments: |
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Depreciation expense |
6,833 |
9,225 |
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Amortization expense |
14 |
8,996 |
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Interest income |
(11,400) |
(9,749) |
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Interest expense |
4,648 |
6,054 |
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Income tax provision (benefit) |
24,152 |
(102,236) |
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169,984 |
72,842 |
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1,120 |
(40,537) |
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$ 171,104 |
$ 32,305 |
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An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows: |
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$ 145,737 |
$ 160,552 |
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Adjustments: |
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Share-based compensation expense |
20,747 |
22,776 |
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Depreciation expense |
6,833 |
9,225 |
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Amortization expense |
14 |
8,996 |
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Loss on debt extinguishment |
719 |
— |
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Income tax effect related to reconciling items |
(629) |
22,011 |
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Separation expense |
— |
19,084 |
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Non-cash net interest expense |
— |
115 |
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Deferred tax valuation release |
— |
(160,953) |
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|
173,421 |
81,806 |
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|
766 |
(44,383) |
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$ 174,187 |
$ 37,423 |
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Non-GAAP diluted earnings per ordinary share from continuing operations |
$ 1.04 |
$ 0.48 |
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Non-GAAP diluted loss per ordinary share from discontinued operations |
$ 0.00 |
$ (0.26) |
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Non-GAAP diluted earnings per ordinary share from net income |
$ 1.05 |
$ 0.22 |
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Revenues: |
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Product sales, net |
$ 1,083,534 |
$ 919,998 |
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Manufacturing and royalty revenues |
474,095 |
743,388 |
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Research and development revenue |
3 |
19 |
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Total Revenues |
1,557,632 |
1,663,405 |
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Expenses: |
||||
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Cost of goods manufactured and sold |
245,331 |
253,037 |
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Research and development |
245,326 |
270,806 |
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Selling, general and administrative |
645,238 |
689,751 |
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Amortization of acquired intangible assets |
1,101 |
35,689 |
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Total Expenses |
1,136,996 |
1,249,283 |
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Operating Income |
420,636 |
414,122 |
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Other Income, net: |
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Interest income |
42,450 |
30,854 |
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Interest expense |
(22,578) |
(23,032) |
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Other income (expense), net |
3,242 |
(425) |
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Total Other Income, net |
23,114 |
7,397 |
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Income Before Income Taxes |
443,750 |
421,519 |
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Income Tax Provision (Benefit) |
71,612 |
(97,638) |
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|
372,138 |
519,157 |
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(5,068) |
(163,400) |
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$ 367,070 |
$ 355,757 |
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From continuing operations |
$ 2.25 |
$ 3.12 |
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From discontinued operations |
$ (0.03) |
$ (0.98) |
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From net income |
$ 2.22 |
$ 2.14 |
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From continuing operations |
$ 2.20 |
$ 3.06 |
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From discontinued operations |
$ (0.03) |
$ (0.96) |
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From net income |
$ 2.17 |
$ 2.10 |
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Basic — GAAP and Non-GAAP |
165,392 |
166,223 |
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Diluted — GAAP and Non-GAAP |
169,198 |
169,730 |
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An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows: |
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$ 372,138 |
$ 519,157 |
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Adjustments: |
||||
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Depreciation expense |
27,432 |
36,921 |
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Amortization expense |
1,101 |
35,689 |
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Interest income |
(42,450) |
(30,854) |
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Interest expense |
22,578 |
23,032 |
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Income tax provision (benefit) |
71,612 |
(97,638) |
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|
452,411 |
486,307 |
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|
(5,790) |
(162,484) |
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|
$ 446,621 |
$ 323,823 |
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An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows: |
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|
$ 372,138 |
$ 519,157 |
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Adjustments: |
||||
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Share-based compensation expense |
96,636 |
92,719 |
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Depreciation expense |
27,432 |
36,921 |
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Amortization expense |
1,101 |
35,689 |
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Separation expense |
1,446 |
38,364 |
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Loss on debt extinguishment |
719 |
— |
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Gain on sale of Athlone manufacturing facility |
(1,462) |
— |
||
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Income tax effect related to reconciling items |
(3,945) |
25,343 |
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Deferred tax valuation release |
— |
(160,953) |
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Restructuring expense |
— |
5,938 |
||
|
Final award in the Janssen arbitration (2022 back royalties and interest) |
— |
(197,092) |
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Non-cash net interest expense |
342 |
461 |
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|
494,407 |
396,547 |
||
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|
(5,068) |
(152,894) |
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|
$ 489,339 |
$ 243,653 |
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Non-GAAP diluted earnings per ordinary share from continuing operations |
$ 2.92 |
$ 2.34 |
||
|
Non-GAAP diluted loss per ordinary share from discontinued operations |
$ (0.03) |
$ (0.90) |
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|
Non-GAAP diluted earnings per ordinary share from net income |
$ 2.89 |
$ 1.44 |
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||||
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Cash, cash equivalents and total investments |
$ 824,816 |
$ 813,378 |
||
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Receivables |
389,733 |
332,477 |
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Inventory |
182,887 |
186,406 |
||
|
Contract assets |
4,990 |
706 |
||
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Prepaid expenses and other current assets |
86,077 |
98,166 |
||
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Property, plant and equipment, net |
227,564 |
226,943 |
||
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Intangible assets, net and goodwill |
83,917 |
85,018 |
||
|
Assets held for sale |
— |
94,260 |
||
|
Deferred tax assets |
154,835 |
195,888 |
||
|
Other assets |
100,748 |
102,981 |
||
|
|
$ 2,055,567 |
$ 2,136,223 |
||
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Long-term debt — current portion |
$ — |
$ 3,000 |
||
|
Other current liabilities |
465,199 |
512,678 |
||
|
Long-term debt |
— |
287,730 |
||
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Liabilities from discontinued operations |
— |
4,542 |
||
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Other long-term liabilities |
125,391 |
125,587 |
||
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Total shareholders’ equity |
1,464,977 |
1,202,686 |
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|
|
$ 2,055,567 |
$ 2,136,223 |
||
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Ordinary shares outstanding (in thousands) |
162,177 |
166,980 |
||
|
This selected financial information should be read in conjunction with the consolidated financial statements and |
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|
|||||
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Cost of goods manufactured and sold |
$ — |
$ — |
$ — |
$ — |
|
|||||
|
Research and development |
2,516 |
3,913 |
481 |
(1,120) |
|
|||||
|
Selling, general and administrative |
— |
— |
— |
— |
|
|||||
|
Income tax (benefit) provision |
(396) |
(613) |
(67) |
354 |
|
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|
|||||
|
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|
|
|
|
|
|||||
|
Cost of goods manufactured and sold |
$ 11 |
$ 11 |
$ 11 |
$ 6 |
|
|||||
|
Research and development |
29,867 |
32,563 |
32,262 |
21,485 |
|
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|
Selling, general and administrative |
6,644 |
9,502 |
13,073 |
19,368 |
|
|||||
|
Income tax (benefit) provision |
(6,727) |
(40) |
(1,550) |
6,914 |
|
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|
|
|
|
|
|
|
|||||
|
|
||||||||||
|
|
||||||||||
|
|
Three Months |
Three Months |
Three Months |
Three Months |
|
|||||
|
Revenues: |
||||||||||
|
VIVITROL |
$ 97,659 |
$ 111,873 |
$ 113,650 |
$ 134,133 |
|
|||||
|
ARISTADA |
78,870 |
86,049 |
84,652 |
96,616 |
|
|||||
|
LYBALVI |
57,007 |
71,351 |
74,697 |
76,977 |
|
|||||
|
|
|
|
|
|
|
|||||
|
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
65,391 |
82,297 |
60,876 |
51,267 |
|
|||||
|
VUMERITY |
31,254 |
35,234 |
32,574 |
34,985 |
|
|||||
|
|
|
|
|
|
|
|||||
|
Legacy Product Revenues |
20,188 |
12,327 |
11,694 |
36,008 |
|
|||||
|
Research and Development Revenues |
3 |
— |
— |
— |
|
|||||
|
|
|
|
|
|
|
|||||
|
|
Three Months |
Three Months |
Three Months |
Three Months |
|
|||||
|
Revenues: |
||||||||||
|
VIVITROL |
$ 96,659 |
$ 102,070 |
$ 99,305 |
$ 102,385 |
|
|||||
|
ARISTADA |
80,077 |
82,410 |
81,834 |
83,369 |
|
|||||
|
LYBALVI |
37,991 |
46,997 |
50,683 |
56,218 |
|
|||||
|
|
|
|
|
|
|
|||||
|
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) |
24,543 |
326,380 |
90,993 |
81,461 |
|
|||||
|
VUMERITY |
28,874 |
32,295 |
34,561 |
33,596 |
|
|||||
|
|
|
|
|
|
|
|||||
|
Legacy Product Revenues |
19,445 |
27,238 |
23,559 |
20,443 |
|
|||||
|
Research and Development Revenues |
6 |
7 |
3 |
3 |
|
|||||
|
|
|
|
|
|
|
|||||
|
(1) – Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI. |
||||||||||
|
|
||
|
|
||
|
An itemized reconciliation between projected net income on a GAAP basis, EBITDA and Adjusted EBITDA is as follows: |
||
|
|
|
|
|
Projected Net Income — GAAP |
$ 190.0 |
|
|
Adjustments: |
||
|
Interest income |
(30.0) |
|
|
Depreciation and amortization expense |
30.0 |
|
|
Provision for income taxes |
40.0 |
|
|
Projected EBITDA |
$ 230.0 |
|
|
Share-based compensation expense |
95.0 |
|
|
Projected Adjusted EBITDA |
$ 325.0 |
|
|
Projected Net Income on a GAAP basis and Projected EBITDA and Projected Adjusted EBITDA reflect mid-points within ranges of estimated guidance. |
||
Alkermes Contacts:
For Investors: Sandy Coombs +1 781 609 6377
For Media: Katie Joyce +1 781 249 8927
View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-plc-reports-financial-results-for-the-fourth-quarter-and-year-ended-dec-31-2024-and-provides-financial-expectations-for-2025-302373897.html
SOURCE Alkermes plc
