Avadel deal pushes Alkermes (NASDAQ: ALKS) to H1 2026 net loss
Rhea-AI Filing Summary
Alkermes plc reported strong top-line growth for the quarter ended June 30, 2026, with total revenues of 496,009 thousand, up from 390,657 thousand a year earlier, but net income declined to 501 thousand from 87,098 thousand as expenses and interest rose.
For the first six months of 2026, revenues grew to 888,920 thousand from 697,167 thousand, while results swung to a net loss of 65,979 thousand, compared with net income of 109,562 thousand in 2025, largely reflecting the February 2026 acquisition of Avadel Pharmaceuticals.
The Avadel transaction carried preliminary consideration of 2,306,920 thousand, added 1,794,900 thousand of identifiable intangibles and 511,246 thousand of goodwill, and was financed with new term loans totaling 1,525,000 thousand, driving interest expense of 46,817 thousand and negative operating cash flow of 20,560 thousand year to date.
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AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
For the quarterly period ended
OR
Commission File Number
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Accelerated filer ☐ |
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Non-accelerated filer ☐ |
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Smaller reporting company |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of the registrant’s ordinary shares, $0.01 par value, outstanding as of July 23, 2026 was
ALKERMES PLC AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2026
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Page No. |
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PART I - FINANCIAL INFORMATION |
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Item 1. |
Condensed Consolidated Financial Statements (unaudited): |
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Condensed Consolidated Balance Sheets — June 30, 2026 and December 31, 2025 |
5 |
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Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income — For the Three and Six Months Ended June 30, 2026 and 2025 |
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Condensed Consolidated Statements of Cash Flows — For the Six Months Ended June 30, 2026 and 2025 |
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Condensed Consolidated Statements of Shareholders’ Equity — For the Three and Six Months Ended June 30, 2026 and 2025 |
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Notes to Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
30 |
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk |
43 |
Item 4. |
Controls and Procedures |
43 |
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PART II - OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
44 |
Item 1A. |
Risk Factors |
44 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
44 |
Item 5. |
Other Information |
44 |
Item 6. |
Exhibits |
45 |
Signatures |
46 |
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2
Cautionary Note Concerning Forward-Looking Statements
This document contains and incorporates by reference “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In some cases, these statements can be identified by the use of forward-looking terminology such as “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,” “continue,” “believe,” “plan,” “estimate,” “intend” or other similar words. These statements discuss future expectations and contain projections of results of operations or of financial condition, or state trends and known uncertainties or other forward-looking information. Forward-looking statements in this Quarterly Report on Form 10-Q (this “Form 10-Q”) may include, without limitation, statements regarding:
Actual results might differ materially from those expressed or implied by these forward-looking statements because these forward-looking statements are subject to risks, assumptions and uncertainties. In light of these risks, assumptions and uncertainties, the forward-looking expectations discussed in this Form 10-Q might not occur. You are cautioned not to place undue reliance on the forward-looking statements in this Form 10-Q, which speak only as of the date of this Form 10-Q. All subsequent written and oral forward-looking statements concerning the matters addressed in this Form 10-Q and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Except as required by applicable law or regulation, we do not undertake any obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For information about the risks, assumptions and uncertainties of our business,
3
see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) on February 25, 2026 (our “Annual Report”).
This Form 10-Q may include data that we obtained from industry publications and third-party research, surveys and studies. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that any industry publications and third-party research, surveys and studies from which data is included in this Form 10-Q are reliable, we have not independently verified any such data. This Form 10-Q may also include data based on our own internal estimates and research. Our internal estimates and research have not been verified by any independent source and are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Part I, Item 1A—Risk Factors” in our Annual Report. These and other factors could cause our results to differ materially from those expressed or implied in this Form 10-Q.
Note Regarding Company and Product References
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including late-stage candidates in narcolepsy and idiopathic hypersomnia, and early-stage candidates in attention-deficit hyperactivity disorder (“ADHD”) and fatigue associated with multiple sclerosis and Parkinson’s disease. Use of terms such as “us,” “we,” “our,” “Alkermes” or the “Company” in this Form 10-Q is meant to refer to Alkermes plc and its consolidated subsidiaries. Except as otherwise suggested by the context, (a) references to “products” or “our products” in this Form 10-Q include our marketed products, marketed products using our proprietary technologies, our licensed products, our product candidates and product candidates using our proprietary technologies, (b) references to the “biopharmaceutical industry” in this Form 10-Q are intended to include reference to the “biotechnology industry” and/or the “pharmaceutical industry” and (c) references to “licensees” in this Form 10-Q are used interchangeably with references to “partners.”
Note Regarding Trademarks
We are the owner of various U.S. federal trademark registrations (“®”) and other trademarks (“TM”) and service marks, including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LUMRYZ®, LYBALVI®, MICROPUMP®, NANOCRYSTAL®, REVITALYZSM and VIVITROL®.
The following are trademarks of the respective companies listed: BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, RISPERDAL CONSTA®, TREVICTA®, and XEPLION®—Johnson & Johnson or its affiliated companies; and VUMERITY®—Biogen MA Inc. (together with its affiliates, “Biogen”). Other trademarks, trade names and service marks appearing in this Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Form 10-Q may be referred to without the ® or TM symbol, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
4
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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June 30, 2026 |
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December 31, 2025 |
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(In thousands, except share and per share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Investments—short-term |
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Receivables, net |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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INVESTMENTS—LONG-TERM |
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RIGHT-OF-USE ASSETS |
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INTANGIBLE ASSETS, NET |
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GOODWILL |
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DEFERRED TAX ASSETS |
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OTHER ASSETS |
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TOTAL ASSETS |
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$ |
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$ |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Accrued sales discounts, allowances and reserves |
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Operating lease liabilities—short-term |
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Current portion of long-term debt |
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Total current liabilities |
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OPERATING LEASE LIABILITIES—LONG-TERM |
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CONTINGENT CONSIDERATION |
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LONG-TERM DEBT |
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DEFERRED TAX LIABILITIES |
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OTHER LONG-TERM LIABILITIES |
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Total liabilities |
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SHAREHOLDERS’ EQUITY: |
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Preferred shares, par value, $ |
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Ordinary shares, par value, $ |
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Treasury shares, at cost ( |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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Accumulated deficit |
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( |
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( |
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Total shareholders’ equity |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
(unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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(In thousands, except per share amounts) |
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REVENUES: |
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Product sales, net |
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$ |
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$ |
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$ |
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$ |
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Manufacturing and royalty revenues |
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Total revenues |
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EXPENSES: |
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Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) |
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Research and development |
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Selling, general and administrative |
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Change in fair value of contingent consideration |
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Amortization of acquired intangible assets |
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Total expenses |
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OPERATING (LOSS) INCOME |
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( |
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OTHER (EXPENSE) INCOME, NET: |
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Interest income |
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Interest expense |
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( |
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( |
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Other (expense) income, net |
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( |
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Total other (expense) income, net |
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( |
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( |
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(LOSS) INCOME BEFORE INCOME TAXES |
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( |
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( |
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INCOME TAX PROVISION (BENEFIT) |
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( |
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NET (LOSS) INCOME |
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$ |
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$ |
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$ |
( |
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$ |
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(LOSS) EARNINGS PER ORDINARY SHARE: |
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(Loss) earnings per ordinary share—basic |
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$ |
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$ |
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$ |
( |
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$ |
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(Loss) earnings per ordinary share—diluted |
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$ |
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$ |
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$ |
( |
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$ |
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WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES OUTSTANDING: |
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Basic |
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Diluted |
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COMPREHENSIVE (LOSS) INCOME: |
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Net (loss) income |
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$ |
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$ |
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$ |
( |
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$ |
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Holding (loss) gain, net of a tax (benefit) provision of $ |
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( |
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( |
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Foreign currency translation gain |
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COMPREHENSIVE (LOSS) INCOME: |
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$ |
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$ |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
ALKERMES PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Six Months Ended |
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June 30, |
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2026 |
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2025 |
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(In thousands) |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net (loss) income |
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$ |
( |
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$ |
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Adjustments to reconcile net income to cash flows from operating activities: |
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Depreciation and amortization |
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Amortization of inventory step-up |
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Share-based compensation expense |
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Change in fair value of contingent consideration |
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Deferred income taxes |
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( |
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Other non-cash charges |
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Changes in assets and liabilities: |
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Receivables |
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( |
) |
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Contract assets |
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( |
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Inventory |
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( |
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Prepaid expenses and other assets |
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( |
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Right-of-use assets |
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Accounts payable and accrued expenses |
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( |
) |
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Accrued sales discounts, allowances and reserves |
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( |
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Contract liabilities |
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( |
) |
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Operating lease liabilities |
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( |
) |
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( |
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Other long-term liabilities |
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Cash flows (used in) provided by operating activities |
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( |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Additions of property, plant and equipment |
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( |
) |
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( |
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Proceeds from the sale of property, plant and equipment |
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Proceeds from the sale of the Athlone facility |
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Business combination, net of cash acquired |
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( |
) |
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Purchases of investments |
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( |
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( |
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Sales and maturities of investments |
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Cash flows used in investing activities |
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( |
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( |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from the issuance of ordinary shares under share-based compensation arrangements |
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Proceeds from the issuance of debt, net |
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Deferred financing costs paid to third parties |
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( |
) |
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Employee taxes paid related to net share settlement of equity awards |
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( |
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( |
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Payment for the repurchase of ordinary shares |
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( |
) |
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Principal payments of long-term debt |
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( |
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Cash flows provided by financing activities |
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NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
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( |
) |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH—Beginning of period |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH—End of period |
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$ |
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$ |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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Cash paid for taxes |
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$ |
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$ |
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Non-cash investing and financing activities: |
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Purchased capital expenditures included in accounts payable and accrued expenses |
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$ |
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$ |
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Unpaid contingent consideration |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
ALKERMES PLC AND SUBSIDIARIES
(unaudited)
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Ordinary Shares |
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Additional |
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Accumulated Other Comprehensive |
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Accumulated |
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Treasury Stock |
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Shares |
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Amount |
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Capital |
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(Loss) Income |
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Deficit |
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Shares |
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Amount |
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Total |
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(In thousands, except share data) |
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BALANCE — December 31, 2025 |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Repurchase of Alkermes' ordinary shares |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized loss on marketable securities, net of tax benefit of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Foreign currency translation loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
BALANCE — March 31, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Repurchase of Alkermes' ordinary shares |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized loss on marketable securities, net of tax benefit of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
Foreign currency translation gain |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — June 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
|
|
Ordinary Shares |
|
|
Additional |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Treasury Stock |
|
|
|
|
||||||||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Loss) Income |
|
|
Deficit |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
||||||||
|
|
(In thousands, except share data) |
|
|||||||||||||||||||||||||||||
BALANCE — December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gain on marketable securities, net of tax provision of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of ordinary shares under employee stock plans |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||||
Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Share-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Unrealized gain on marketable securities, net of tax provision of $ |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
BALANCE — June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
9
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited)
1. THE COMPANY
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including late-stage candidates in narcolepsy and idiopathic hypersomnia (“IH”), and early-stage candidates in ADHD and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of the Company for the three and six months ended June 30, 2026 and 2025 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2025. The year-end consolidated balance sheet data, which is presented for comparative purposes, was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the U.S. (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments of a normal recurring nature that are necessary to state fairly the results of operations for the reported periods.
The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto of the Company, which are contained in the Annual Report. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for any full fiscal year.
Principles of Consolidation
The accompanying condensed consolidated financial statements include the accounts of Alkermes plc and its wholly-owned subsidiaries as disclosed in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” accompanying the Annual Report. Intercompany accounts and transactions have been eliminated. Columns and rows within tables may not sum due to rounding.
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements in accordance with GAAP requires that Company management make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies, including, but not limited to, those related to revenue from contracts with its customers and related allowances, impairment and amortization of intangibles and long-lived assets, inventory, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of the Avadel Acquisition (as defined below), investments, contingent consideration and litigation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different conditions or using different assumptions.
Business Combinations
In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 805, Business Combinations (“Topic 805”), acquisitions that meet the definition of a business are recorded using the acquisition method of accounting. The Company recognizes and measures the identifiable assets acquired, liabilities assumed and any non-controlling interest as of the acquisition date at fair value. The excess, if any, of the fair value of total consideration transferred in a business combination over the fair value of identifiable assets acquired, liabilities assumed and any non-controlling interest is recognized as goodwill. Transaction costs incurred as a result of a business combination other than costs related to the issuance of debt or equity securities are recorded in the period the costs are incurred.
10
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Contingent Consideration
Contingent consideration in a business combination may consist of development, regulatory and/or commercial milestone payments and is included as part of the acquisition cost and recognized at fair value as of the acquisition date. Fair value is generally estimated using a probability-weighted discounted cash flow (“DCF”) approach resulting from contingent consideration and is re-measured at each reporting date until the contingency is resolved. Changes in fair value are recognized within “Operating (loss) income” in the accompanying condensed consolidated statements of operations and comprehensive (loss) income. Changes in the fair value of contingent consideration can result from changes to one or multiple assumptions, including adjustments to discount rates, changes in the assumed achievement and timing of specified milestones and changes in the assumed probability associated with such milestones.
The period over which the Company discounts its contingent consideration is based on the current development stage of the product candidate associated with the milestone, the specific development plan for that product candidate adjusted for the probability of completing the development step, and the date on which contingent payments may be triggered. In estimating the probability of success, the Company utilizes data regarding similar milestone events from several sources, including industry studies and its own experience. These fair value measurements are based on significant inputs not observable in the market. Significant judgment is employed in determining the appropriateness of these assumptions at the acquisition date and for each subsequent reporting period. Accordingly, changes in assumptions described above could have a material impact on the increase or decrease in the fair value of contingent consideration recorded in any given period.
Reclassification
The Company reclassified certain prior year amounts on the consolidated balance sheet to conform to the current year presentation. These reclassifications had no impact on the previously reported total assets, liabilities or shareholders’ equity.
Goodwill
Goodwill represents the excess of the purchase price of acquired businesses over the fair value of the identifiable net assets acquired. Goodwill is not amortized but is tested for impairment at least annually and more frequently if events or changes in circumstances indicate that the carrying value of a reporting unit may exceed its fair value. Goodwill is not deductible for tax purposes.
The Company has the option to first assess qualitative factors to determine whether it is necessary to perform the quantitative impairment test. If the Company elects this option and believes, as a result of the qualitative assessment, that it is more-likely-than-not that the fair value of its reporting unit is less than its carrying amount, the quantitative impairment test is required; otherwise, no further testing is required. Alternatively, the Company may elect to not first assess qualitative factors and immediately perform the quantitative impairment test. In the quantitative impairment test, the Company compares the fair value of its reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of the reporting unit, then the Company would record an impairment loss equal to the difference.
Intangible Assets
Intangible assets acquired in business combinations, including developed technology, product rights, licenses, and in-process research and development (“IPR&D”), are recorded at fair value as of the acquisition date. Definite-lived identifiable intangible assets are amortized based on the proportion of expected excess earnings over their estimated economic useful life. This method reflects the pattern in which the economic benefits of the intangible assets are expected to be realized.
Acquired IPR&D projects that have not yet received regulatory approval are considered indefinite-lived intangible assets and are required to be capitalized as indefinite-lived intangible assets until completion of the IPR&D project or abandonment. IPR&D projects are not amortized but are tested annually for impairment or more frequently if indicators arise. Upon completion of the development project, an impairment assessment is performed prior to amortizing the asset over its estimated useful life. IPR&D assets related to abandoned IPR&D projects are fully impaired.
11
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Segment Information
Operating segments are defined as components of an enterprise engaging in business activities for which separate financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company has utilized the management approach to determine that the Company is managed as
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard-setting bodies that are adopted by the Company on or prior to the specified effective date. Unless otherwise described in this Form 10-Q, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement—Reporting Comprehensive Income-Expense Disaggregation Disclosures, to improve disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization and depletion) in commonly-presented expense captions, such as cost of sales, selling, general and administrative expenses, and research and development. All disclosure requirements under this guidance are required for public business entities and effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted and the amendments in this guidance will be applied prospectively to financial statements for periods after the effective dates. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software. This ASU updates the requirements for capitalization of internal-use software, removing all reference to prescriptive and sequential software development stages (referred to as “project stages”). This ASU is effective for annual periods beginning after December 15, 2027, and for interim periods within those fiscal years. The Company is currently assessing the impact this ASU will have on its consolidated financial statements and related disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting. The amendments in this update clarify current interim disclosure requirements and provide a comprehensive list of required interim disclosures. The update also incorporates a disclosure principle that requires entities to disclose events that occur after the end of the reporting period. This update is effective for interim periods within annual periods beginning after December 15, 2027, though early adoption is permitted. The Company is currently assessing the impact this ASU will have on its consolidated financial statements and related disclosures.
3. BUSINESS COMBINATION
Acquisition of Avadel Pharmaceuticals plc
On February 12, 2026 (the “Closing Date”), the Company completed the acquisition of Avadel Pharmaceuticals plc (now operating as Avadel Pharmaceuticals Limited) (“Avadel”), pursuant to the definitive transaction agreement entered into in October 2025 and subsequently amended in November 2025 (the “Transaction Agreement”), adding both LUMRYZ to the Company’s portfolio of proprietary commercial products and a commercial organization with experience in narcolepsy. Pursuant to the Transaction Agreement, the Company acquired the entire issued and to be issued ordinary share capital of Avadel (the “Avadel Acquisition”) for consideration of (i) $
12
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The Avadel Acquisition has been accounted for as a business combination, using the acquisition method of accounting in accordance with Topic 805. The acquisition method requires, among other things, that assets acquired and liabilities assumed in a business combination be recognized at their fair values as of the acquisition date.
The Company’s purchase price allocation is preliminary and based on the information available as of the reporting date. The Company’s estimates and assumptions are subject to refinement as the Company continues to review information related to the Avadel Acquisition. The Company remains in the process of reviewing and finalizing the measurement of certain assets acquired and liabilities assumed, including but not limited to: tax positions, and other tax-related matters, and the estimated fair values of acquired intangible assets and inventory. Adjustments to the valuation of assets acquired and liabilities assumed will result in a corresponding adjustment to goodwill. The Company expects to complete the purchase price allocation as soon as practicable, but no later than one year from the Closing Date.
The total preliminary purchase consideration related to the Avadel Acquisition was as follows:
(In thousands) |
|
Amount |
|
|
Cash consideration paid for Avadel’s ordinary shares |
|
$ |
|
|
Cash consideration paid for cash settlement of Avadel equity awards |
|
|
|
|
Fair value of CVR contingent consideration |
|
|
|
|
Total preliminary purchase consideration |
|
$ |
|
|
The following table summarizes the preliminary estimates of the fair value of assets acquired and liabilities assumed as of the Closing Date:
(In thousands) |
|
February 12, 2026 |
|
|
Acquired Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
Receivables |
|
|
|
|
Inventory |
|
|
|
|
Prepaid expenses and other current assets |
|
|
|
|
Property, plant and equipment |
|
|
|
|
Right-of-use assets |
|
|
|
|
Intangible assets |
|
|
|
|
Deferred tax assets(1) |
|
|
|
|
Other assets |
|
|
|
|
Total fair value of assets acquired |
|
$ |
|
|
Assumed Liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
|
|
Accrued sales discounts, allowances and reserves |
|
|
|
|
Operating lease liabilities |
|
|
|
|
Deferred tax liability |
|
|
|
|
Other long-term liabilities(2) |
|
|
— |
|
Total recognized identifiable net assets acquired and liabilities assumed |
|
$ |
|
|
Goodwill(1)(2) |
|
|
|
|
Preliminary fair value of total consideration |
|
$ |
|
|
Contingent consideration |
|
|
|
|
Total Cash Consideration Paid |
|
$ |
|
|
13
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Contingent Consideration
In connection with the Avadel Acquisition, the vesting of certain outstanding Avadel equity awards was accelerated as of the Closing Date and each vested Avadel equity award became entitled to receive cash consideration and the right to receive one CVR per Avadel Share. The purchase price for the Avadel Acquisition includes $
Contingent payments of up to $
The estimated fair value of the contingent consideration was determined under an income approach using a DCF model. The key assumptions considered include probability of milestone achievement and estimated discount rates. At each reporting period after the Avadel Acquisition, the Company will revalue the contingent consideration liability and will record increases or decreases in the fair value of the liability in its condensed consolidated statements of operations and comprehensive (loss) income. Please refer to Note 18, Commitments and Contingent Liabilities, in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for information related to changes in the fair value of the contingent consideration.
Acquired Inventory
The fair value of the acquired inventory was estimated using the comparative sales method, which estimated the expected sales price of the product, reduced by all costs expected to be incurred to complete or to dispose of the inventory, as well as a market-participant profit allowance.
Acquired Intangible Assets
The identifiable intangible assets acquired included the following:
(In thousands) |
|
|
|
|
LUMRYZ |
|
$ |
|
|
In-process research and development |
|
|
|
|
Total identifiable intangible assets |
|
$ |
|
|
The fair value of LUMRYZ was estimated based on a multi-period excess earnings method which calculates the present value of the estimated revenues and net cash flows derived from LUMRYZ. Amortization of LUMRYZ is calculated using the percentage of excess earnings over the economic useful life method. The IPR&D relates to the product candidate acquired in the Avadel Acquisition, valiloxybate. Due to the early stage of development of this asset, and given the proximity to the Closing Date of a license agreement entered into by Avadel related to valiloxybate and the lack of suitable market comparables, the valuation was prepared utilizing a cost approach consisting of the upfront payment under the license agreement, together with additional development costs incurred by Avadel through prior to the Closing Date in respect of valiloxybate.
Deferred Tax Liabilities
The deferred tax liability of $
14
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
As of the Closing Date, Avadel recorded an uncertain tax position of $
Goodwill
The excess of the estimated fair value of the purchase price consideration over the fair value amounts assigned to the assets acquired and liabilities assumed represents the goodwill amount resulting from the Avadel Acquisition. The factors that contributed to the recognition of goodwill included the synergies that are specific to the Company’s business and not available to market participants, including the acquisition of a commercial organization with experience in narcolepsy which accelerates the Company’s commercial entry into the sleep medicine market and provides a strong foundation for the potential launch of alixorexton, the Company’s lead orexin development candidate.
Revenues and Net (Loss) Income of Avadel
The operations of Avadel for the period of the Closing Date through June 30, 2026 have been included in the Company’s condensed consolidated statements of operations and comprehensive (loss) income. During the three and six months ended June 30, 2026, the Company recorded total revenues of $
Transaction Costs
In conjunction with the Avadel Acquisition, the Company incurred approximately $
Pro forma financial information (unaudited)
The following unaudited pro forma information presents the combined results of operations for the three and six months ended June 30, 2026 and 2025 as if the Avadel Acquisition had been completed on January 1, 2025. The unaudited pro forma financial information is based on the historical financial information for the Company and Avadel, along with certain pro forma adjustments described below. The unaudited pro forma information for the three and six months ended June 30, 2026 reflects revenues and net loss of Avadel from January 1, 2026 through the Closing Date, and excludes approximately $
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Net (loss) income |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
||
The unaudited pro forma financial information includes, where applicable, adjustments primarily for:
15
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The unaudited pro forma information does not reflect the cost of any integration activities, benefits from any synergies that may be derived from the Avadel Acquisition or revenue growth that may be anticipated.
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. The Company recognizes revenue following the five-step model prescribed in accordance with FASB ASC 606, Revenue from Contracts with Customers: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies the performance obligations.
Product Sales, Net
The Company’s product sales, net consist of sales in the U.S. of ARISTADA and ARISTADA INITIO, LYBALVI, VIVITROL, and, following the completion of the Avadel Acquisition on February 12, 2026, LUMRYZ, primarily to wholesalers, specialty distributors and specialty pharmacies. Product sales, net are recognized when the customer obtains control of the product, which is when the product has been received by the customer.
During the three and six months ended June 30, 2026 and 2025, the Company recorded product sales, net, as follows:
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
VIVITROL |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
ARISTADA and ARISTADA INITIO |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LYBALVI |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LUMRYZ |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total product sales, net |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with the Company’s customers, healthcare providers or payers. The Company’s process for estimating reserves established for these variable consideration components does not differ materially from historical practices. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from the Company’s estimates. If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment. See the “Revenue from Contracts with Customers” section in Note 2, Summary of Significant Accounting Policies in the “Notes to Consolidated Financial Statements” in the Annual Report for information with respect to the Company’s significant categories of sales discounts and allowances.
The decrease in Medicaid rebates as a percentage of sales was primarily due to gross-to-net favorability, as actual Medicaid rebates related to VIVITROL and ARISTADA/ARISTADA INITIO were lower than original estimates during the six months ended June 30, 2026 by approximately $
16
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
A rollforward of the Company’s provisions for sales discounts and allowances is as follows:
|
|
Six Months Ended June 30, 2026 |
|
|||||||||||||||||
(In thousands) |
|
Contractual Adjustments(2) |
|
|
Discounts(3) |
|
|
Product Returns |
|
|
Other |
|
|
Total |
|
|||||
Beginning balance — December 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Avadel beginning balance as of February 12, 2026 (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Current provisions relating to sales in current year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Adjustments relating to prior years |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
Payments relating to sales in current year |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Payments relating to sales in prior years |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Ending balance — June 30, 2026 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|||||
Total revenue-related reserves as of June 30, 2026 and December 31, 2025 included in the accompanying consolidated balance sheets are summarized as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Reduction of accounts receivable |
|
$ |
|
|
$ |
|
||
Components of accrued sales discounts, allowances and reserves |
|
|
|
|
|
|
||
Components of other long-term liabilities |
|
|
|
|
|
|
||
Total revenue-related reserves |
|
$ |
|
|
$ |
|
||
Manufacturing and Royalty Revenues
During the three and six months ended June 30, 2026 and 2025, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:
|
|
Three Months Ended June 30, 2026 |
|
|
Six Months Ended June 30, 2026 |
|
||||||||||||||||||
(In thousands) |
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
||||||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||||
VUMERITY |
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
||||
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
|
|
Three Months Ended June 30, 2025 |
|
|
Six Months Ended June 30, 2025 |
|
||||||||||||||||||
(In thousands) |
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
|
Manufacturing |
|
|
Royalty |
|
|
Total |
|
||||||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||||
VUMERITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
17
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
5. INVESTMENTS
Investments consist of the following (in thousands):
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|||||||||||
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
||||||||
|
|
Amortized |
|
|
|
|
|
Less than |
|
|
Greater than |
|
|
Estimated |
|
|||||
June 30, 2026 |
|
Cost |
|
|
Gains |
|
|
One Year |
|
|
One Year |
|
|
Fair Value |
|
|||||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
|
|||
Total short-term investments |
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
|
|||
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
||
|
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
||
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total long-term investments |
|
|
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
|
||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
December 31, 2025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Total short-term investments |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|||
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Certificates of deposit |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total long-term investments |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total investments |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|||
At June 30, 2026, the Company’s investments in corporate debt securities had a minimum rating of A3 (Moody’s)/A (Standard and Poor’s), and
Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows:
|
|
Six Months Ended June 30, |
|
|||||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Proceeds from the sales and maturities of investments |
|
$ |
|
|
$ |
|
||
Realized gains |
|
$ |
|
|
$ |
|
||
Realized losses |
|
$ |
|
|
$ |
|
||
18
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The Company’s available-for-sale and held-to-maturity securities at June 30, 2026 had contractual maturities in the following periods:
|
|
Available-for-sale |
|
|
Held-to-maturity |
|
||||||||||
|
|
Amortized |
|
|
Estimated |
|
|
Amortized |
|
|
Estimated |
|
||||
(In thousands) |
|
Cost |
|
|
Fair Value |
|
|
Cost |
|
|
Fair Value |
|
||||
Within 1 year |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
After 1 year through 5 years |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
6. FAIR VALUE
The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis and indicates the fair value hierarchy and the valuation techniques that the Company utilized to determine such fair value:
|
|
June 30, |
|
|
|
|
|
|
|
|
|
|
||||
(In thousands) |
|
2026 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. government and agency debt securities |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent consideration |
|
$ |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
||||
|
|
2025 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. government and agency debt securities |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
The Company transfers its financial assets and liabilities, measured at fair value on a recurring basis, between the fair value hierarchies at the end of each reporting period. There were
The Company’s investments classified as Level 2 within the fair value hierarchy were initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing market-observable data. The market-observable data included reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validated the prices developed using the market-observable data by obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active.
At June 30, 2026, the fair value of the contingent consideration resulting from the Avadel Acquisition was $
19
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
During the three months ended June 30, 2026, the fair value of the contingent consideration increased by $
The change in fair value of contingent consideration during each of the three and six months ended June 30, 2026 was $
The following table is a rollforward of the fair value of the Company’s assets with fair values that were determined using Level 3 inputs at June 30, 2026:
|
|
Fair Value |
|
|||||
(In thousands) |
|
Assets |
|
|
Liabilities |
|
||
Balance, January 1, 2026 |
|
$ |
|
|
$ |
— |
|
|
Addition of contingent consideration attributable to consideration transferred |
|
|
— |
|
|
|
|
|
Change in fair value of contingent consideration attributable to consideration transferred |
|
|
— |
|
|
|
|
|
Addition of contingent consideration attributable to post-combination expense |
|
|
— |
|
|
|
|
|
Change in fair value of contingent consideration attributable to post-combination expense |
|
|
— |
|
|
|
|
|
Impairment of corporate debt security |
|
|
( |
) |
|
|
— |
|
Balance, June 30, 2026 |
|
$ |
— |
|
|
$ |
|
|
The carrying amounts reflected in the accompanying condensed consolidated balance sheets for cash and cash equivalents, accounts receivable, contract assets, other current assets, accounts payable and accrued expenses, sales discounts, allowances and reserves approximate fair value due to their short-term nature.
The estimated fair value of the Company’s long-term debt under its Facilities (as defined in Note 12, Long-Term Debt in these “Notes to Condensed Consolidated Financial Statements”), which was based on quoted market price indications (Level 2 in the fair value hierarchy) and which may not be representative of actual values that could have been, or will be, realized in the future, was $
7. INVENTORY
Inventory is stated at the lower of cost and net realizable value. Cost is determined using the first-in, first-out method. Inventory consists of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods(1) |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
||
20
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
In connection with the Avadel Acquisition, the Company recorded a fair value step-up adjustment to inventory of $
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Land |
|
$ |
|
|
$ |
|
||
Building and improvements |
|
|
|
|
|
|
||
Furniture, fixtures and equipment |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
Subtotal |
|
|
|
|
|
|
||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property, plant and equipment, net |
|
$ |
|
|
$ |
|
||
9. GOODWILL AND INTANGIBLE ASSETS
Goodwill and intangible assets consist of the following:
|
|
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||||||||||||||||||
(In thousands) |
|
Weighted Amortizable Life (Years) |
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
||||||
Goodwill |
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||||
Definite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
LUMRYZ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|||
Capitalized IP |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||||
Indefinite-lived intangible asset: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
IPR&D |
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Based on its most recent analysis, the Company expects to amortize approximately $
In connection with the Avadel Acquisition, the Company recorded the excess of the estimated fair value of the purchase price consideration over the fair value amounts assigned to the assets acquired and liabilities assumed as goodwill. For additional information related to the estimated purchase price consideration see Note 3, Business Combination in these “Notes to Condensed Consolidated Financial Statements”.
(In thousands) |
|
Goodwill |
|
|
Goodwill at December 31, 2025 |
|
|
|
|
Additions in connection with the Avadel Acquisition |
|
|
|
|
Goodwill at June 30, 2026 |
|
|
|
|
21
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
10. LEASES
Future lease payments under non-cancelable leases at June 30, 2026 consist of the following:
|
|
June 30, |
|
|
(In thousands) |
|
2026 |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total operating lease payments |
|
$ |
|
|
Less: imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
|
At June 30, 2026, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were
In July 2026, the Company entered into a lease agreement for approximately
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Accrued other |
|
|
|
|
|
|
||
Total accounts payable and accrued expenses |
|
$ |
|
|
$ |
|
||
A summary of the Company’s current provision for sales discounts, allowances and reserves was as follows:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Medicaid rebates |
|
$ |
|
|
$ |
|
||
Product discounts |
|
|
|
|
|
|
||
Medicare Part D |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued sales discounts, allowances and reserves |
|
$ |
|
|
$ |
|
||
Included in accounts payable was approximately $
22
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
12. LONG-TERM DEBT
Long-term debt consisted of the following:
|
|
June 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2026 |
|
|
2025 |
|
||
Term Loan A Facility, due February 12, 2031 |
|
$ |
|
|
$ |
|
||
Term Loan B Facility, due August 12, 2031 |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Less: current portion |
|
|
( |
) |
|
|
|
|
Long-term debt |
|
$ |
|
|
$ |
|
||
On the Closing Date, the Company entered into a credit agreement (the “Credit Agreement”), by and among Alkermes plc, as the TopCo Borrower, Alkermes, Inc., as the U.S. Borrower, Alkermes Finance LLC, as the U.S. Co-Borrower, JPMorgan Chase Bank, N.A., as Administrative Agent, Joint Lead Arranger and Joint Bookrunner, BofA Securities, Inc., as Joint Lead Arranger and Joint Bookrunner, and the lenders party thereto. The Credit Agreement provides for (i) a senior secured term loan A facility in an aggregate principal amount of up to $
Borrowings under the TLA Facility bear interest at an annual rate of, at the Company’s option, either (i) the Term SOFR Rate (as defined in the Credit Agreement) plus a Secured Net Leverage Ratio-(as defined in the Credit Agreement)-based margin, which will initially be
The Credit Agreement (other than with respect to the TLB Facility) requires the maintenance of a maximum Secured Net Leverage Ratio and a minimum Consolidated Interest Coverage Ratio (as defined in the Credit Agreement), in each case, with the levels set forth in the Credit Agreement, as of the last day of any fiscal quarter of the Company ending after the Closing Date. In addition, the Credit Agreement contains customary affirmative and negative covenants that apply after the Closing Date, including limitations on indebtedness, liens, mergers, consolidations, sales of assets, investments, transactions with affiliates, restricted payments and sales and leasebacks. The Credit Agreement also contains certain customary events of default, including upon a change of control.
The Credit Agreement is guaranteed by subsidiary guarantors and secured by a lien on substantially all of the assets of the borrowers and the subsidiary guarantors, whether owned as of the Closing Date or thereafter acquired.
In November 2025, the Company entered into an amended and restated bridge term credit agreement, which provided for a senior secured bridge term loan facility in an aggregate amount of up to approximately $
23
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Scheduled maturities with respect to the Facilities are as follows (in thousands):
Year Ending December 31: |
|
|
|
|
2026 |
|
$ |
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
|
At June 30, 2026, the Company’s balance of unamortized deferred financing costs and unamortized original issue discount costs were $
13. SHAREHOLDERS’ EQUITY
In February 2024, the Company’s board of directors approved a share repurchase program authorizing the Company to repurchase ordinary shares of the Company in an aggregate amount of up to $
During the three months ended March 31, 2026, the Company repurchased approximately
14. SHARE-BASED COMPENSATION
The following table presents share-based compensation expense included in the accompanying condensed consolidated statements of operations and comprehensive (loss) income:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Cost of goods manufactured and sold |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Selling, general and administrative |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Share-based compensation expense for acceleration of Avadel Shares |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
24
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
At June 30, 2026 and December 31, 2025, $
During the three and six months ended June 30, 2026, share-based compensation expense included: $
15. (LOSS) EARNINGS PER ORDINARY SHARE
Basic (loss) earnings per ordinary share is calculated based upon net (loss) income available to holders of ordinary shares, divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted (loss) earnings per ordinary share, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the potential dilutive effect of outstanding ordinary share equivalents such as stock options and restricted stock unit awards.
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net (loss) income |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average number of ordinary shares outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Stock options |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Restricted stock unit awards |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Dilutive ordinary share equivalents |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Shares used in calculating diluted (loss) earnings per ordinary share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The following potential ordinary share equivalents were not included in the net (loss) earnings per ordinary share calculation because the effect would have been anti-dilutive:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Stock options |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Restricted stock unit awards |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
||||
25
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
16. INCOME TAXES
The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. In determining future taxable income, the Company is responsible for assumptions that it utilizes, including the amount of Irish and non-Irish pre-tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company uses to manage the underlying business.
As of June 30, 2026, the Company has recognized $
The Company recorded an income tax benefit of $
The income tax benefit in the three months ended June 30, 2026 primarily relates to a lower estimated annual effective tax rate. The income tax provision during the six months ended June 30, 2026 was primarily attributable to taxes on income earned in the U.S. The income tax provisions during the three and six months ended June 30, 2025 were primarily attributable to taxes on income earned in Ireland.
The Company’s effective tax rates during the six months ended June 30, 2026 and 2025 were (
In March 2026, the Company was notified by the U.S. Internal Revenue Service (“IRS”) that Alkermes US Holdings, Inc. (“Alkermes US Holdings”), a wholly-owned subsidiary of the Company, and subsidiaries of Alkermes US Holdings had been selected for examination for the year ended December 31, 2023. The Company is cooperating with the IRS by responding to inquiries and providing requested documentation. As of the date of this report, no adjustments have been proposed by the IRS as a result of this examination.
26
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
17. SEGMENT REPORTING
Segment Information
The Company’s significant segment expenses that are regularly provided to the Company’s CODM are as follows:
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
June 30, |
|
|
June 30, |
|
||||||||||
(In thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenue |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of goods manufactured and sold (exclusive of amortization of acquired intangible assets shown below) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
External R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Development programs: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Alixorexton |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LYBALVI |
|
|
|
|
|
|
|
|
|
|
|
|
||||
LUMRYZ |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other orexin programs |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other external R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total external R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Internal R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Employee-related |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Occupancy |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Depreciation |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other internal R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total internal R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
R&D expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling and marketing expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total selling, general and administrative expense |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other segment (expense) income (1) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
NET (LOSS) INCOME |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
27
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
18. COMMITMENTS AND CONTINGENT LIABILITIES
Contingent Consideration
At June 30, 2026, the Company’s contingent consideration related to the CVR Milestone issued as part of consideration for the Avadel Acquisition. Holders of Avadel Shares as of the Closing Date are entitled to receive a potential aggregate cash payment of $
Litigation
From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. If the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated, the Company would accrue a liability for the estimated loss. Because of uncertainties related to claims and litigation, accruals are based on the Company’s best estimates, utilizing all available information. On a periodic basis, as additional information becomes available, or based on specific events such as the outcome of litigation or settlement of claims, the Company may reassess the potential liability related to these matters and may revise these estimates, which could result in material adverse adjustments to the Company’s operating results. At June 30, 2026, there were
LYBALVI ANDA Litigation
In August 2025, Alkermes Pharma Ireland Limited (“APIL”) and Alkermes, Inc., two wholly-owned subsidiaries of the Company, filed a patent infringement lawsuit against Teva (as defined herein) in the U.S. District Court for the District of New Jersey (the “NJ District Court”) and a patent infringement lawsuit against Apotex in each of the NJ District Court and the U.S. District Court for the District of Delaware (the “DE District Court”). In September 2025, APIL and Alkermes, Inc. filed a patent infringement lawsuit against MSN (as defined herein) in the NJ District Court. On June 18, 2026, APIL and Alkermes, Inc. filed an additional patent infringement lawsuit against Apotex in the NJ District Court, which was consolidated on July 23, 2026 with the previously filed lawsuit in the NJ District Court. As used herein, Teva refers to Teva Pharmaceuticals, Inc., Apotex refers to Apotex Inc. and Apotex Corp., and MSN refers to MSN Laboratories Private Limited (“MSN Labs”), MSN Pharmaceuticals, Inc. and Novadoz Pharmaceuticals LLC. These lawsuits were filed following receipt of “paragraph IV certification” notices from each of Teva, Apotex and MSN Labs regarding their respective filings of an abbreviated new drug application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to engage in the commercial manufacture, use or sale of a generic version of LYBALVI (olanzapine and samidorphan tablets, 5mg/10mg, 10mg/10mg, 15mg/10mg and 20mg/10mg) in the U.S. prior to the expiration of certain of the Company’s U.S. patents. The notices alleged that certain of the Company’s patents related to LYBALVI are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed generic products. The Company intends to vigorously defend its intellectual property. The filing of each lawsuit within 45 days of receipt of each of the respective notices triggered stays of FDA approval of each of the respective ANDAs for up to 30 months in accordance with the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”).
Antitrust Class Action Litigation
In October 2025, Value Drug Company filed a complaint asserting antitrust claims against Alkermes, Inc. and APIL in the U.S. District Court for the District of Massachusetts (the “MA District Court”). The complaint was filed on behalf of a putative class of direct purchasers of VIVITROL and alleges that the Company’s U.S. Patent No. 7,919,499 related to VIVITROL was fraudulently obtained, improperly listed in the Orange Book, and wrongfully enforced, resulting in delayed market entry for generic forms of VIVITROL. The lawsuit seeks, among other things, unspecified money damages plus interest, reasonable attorneys’ fees and other costs. The Company intends to vigorously defend itself in this matter. In December 2025, Alkermes, Inc. and APIL filed a motion to dismiss the complaint with the MA District Court.
28
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Government Matters
The Company has received a civil investigative demand from a U.S. state governmental authority. The Company is cooperating with the investigation.
Other Legal Proceedings
The Company is involved in litigation and other legal proceedings incidental to its normal business activities. The Company intends to vigorously defend itself in these matters.
In addition, in January 2023, Acorda Therapeutics, Inc. (“Acorda”) filed a petition with the U.S. District Court for the Southern District of New York (the “NY Southern District Court”) asking the court to confirm in part and modify in part the final arbitral award rendered by an arbitration panel in October 2022 and, as part of the requested modification, seeking an additional approximately $
29
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with the accompanying condensed consolidated financial statements and related notes beginning on page 5 in this Form 10-Q, and “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the audited financial statements and notes thereto accompanying our Annual Report.
Executive Summary
Net income was $0.5 million or $0.00 per ordinary share—basic and diluted, for the three months ended June 30, 2026 and net loss was $66.0 million or $0.40 per ordinary share—basic and diluted, for the six months ended June 30, 2026, compared to net income of $87.1 million and $109.6 million or $0.53 and $0.67 per ordinary share—basic and $0.52 and $0.65 per ordinary share—diluted, for the three and six months ended June 30, 2025, respectively.
The decrease in net income of $86.6 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to increases in total operating expenses and interest expense of $180.0 million and $25.9, respectively. These increases were primarily related to the Avadel Acquisition. The increase in total revenues of $105.4 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to the addition of LUMRYZ to our proprietary product portfolio.
The change in net loss of $175.5 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to increases in total operating expenses and interest expense of $328.5 million and $46.8 million, respectively, primarily related to the Avadel Acquisition. The increase in total revenues of $191.8 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to an increase in LYBALVI product sales, net and the addition of LUMRYZ, as previously noted.
These items are discussed in greater detail later in the “Results of Operations” section in this “Part I, Item 2—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q.
Products
Marketed Products
The key marketed products discussed below have generated, or are expected to generate, significant revenues for us. See the descriptions of the marketed products below and “Part I, Item 1A—Risk Factors” in our Annual Report for important factors that could adversely affect our marketed products. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for these marketed products.
30
The following provides summary information regarding our proprietary products that we commercialize:
Proprietary Products
|
|
|
|
|
|
Product |
|
Indicated Disease State |
|
|
Territory |
|
|
|
|
|
|
|
|
Schizophrenia (Initiation or re-initiation of ARISTADA) |
|
|
U.S. |
|
Schizophrenia |
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Narcolepsy |
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schizophrenia; Bipolar I disorder
|
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alcohol dependence; Opioid dependence |
|
|
U.S. |
31
The following provides summary information regarding certain key third-party products using our proprietary technologies under license and our key licensed product, that are commercialized by our licensees:
Key Third-Party Products Using Our Proprietary Technologies
Product |
|
Indicated Disease State |
|
Licensee |
|
Licensed Territory |
|
|
|
|
|
|
|
INVEGA SUSTENNA / XEPLION |
|
INVEGA SUSTENNA: Schizophrenia; Schizoaffective disorder
XEPLION: Schizophrenia |
|
Janssen Pharmaceutica (together with Janssen Pharmaceuticals, Inc., Janssen International and their affiliates “Janssen”) |
|
Worldwide |
INVEGA TRINZA / TREVICTA |
|
Schizophrenia |
|
Janssen |
|
Worldwide |
INVEGA HAFYERA / BYANNLI |
|
Schizophrenia |
|
Janssen |
|
Worldwide |
Our Key Licensed Product
Product |
|
Indicated Disease State |
|
Licensee |
|
Licensed Territory |
|
|
|
|
|
|
|
VUMERITY |
|
Multiple sclerosis |
|
Biogen |
|
Worldwide |
Proprietary Products
We have developed and now commercialize products designed to help address the unmet needs of people living with opioid dependence, alcohol dependence, schizophrenia, bipolar I disorder and narcolepsy. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our proprietary products.
ARISTADA and ARISTADA INITIO
ARISTADA (aripiprazole lauroxil) is an extended-release intramuscular injectable suspension approved in the U.S. for the treatment of schizophrenia. ARISTADA utilizes our proprietary LINKERX technology. ARISTADA is a prodrug; once in the body, ARISTADA is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. ARISTADA is available in four dose strengths with once-monthly dosing options (441 mg, 662 mg and 882 mg), a six-week dosing option (882 mg) and a two-month dosing option (1064 mg). ARISTADA is packaged in a ready-to-use, pre-filled syringe product format. We exclusively manufacture and commercialize ARISTADA in the U.S.
In May 2026 and June 2026, respectively, U.S. Patent No. 12,629,366 and U.S. Patent No. 12,653,822 relating to ARISTADA were granted. U.S. Patent No. 12,629,366 has claims to the pharmaceutical composition of ARISTADA and expires in 2032. U.S. Patent No. 12,653,822 has claims to the treatment of schizophrenia by rapid and continuous intramuscular injection and expires in 2035.
ARISTADA INITIO (aripiprazole lauroxil) leverages our proprietary LINKERX and NANOCRYSTAL technologies and provides an extended-release formulation of aripiprazole lauroxil in a smaller particle size compared to ARISTADA, thereby enabling faster dissolution and more rapid achievement of relevant levels of aripiprazole in the body. ARISTADA INITIO, combined with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter. We exclusively manufacture and commercialize ARISTADA INITIO in the U.S.
32
In June 2026, U.S. Patent No. 12,642,798 relating to ARISTADA INITIO was granted. The patent has claims to the manufacturing process and expires in 2035.
LUMRYZ
LUMRYZ (sodium oxybate) is an extended-release oral suspension product approved by the FDA in May 2023 and October 2024 as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy and in pediatric patients seven years of age and older with narcolepsy, respectively. The FDA has granted seven years of orphan drug exclusivity (“ODE”) to LUMRYZ for the adult and pediatric narcolepsy patient populations through May 1, 2030 and October 16, 2031, respectively. We exclusively commercialize LUMRYZ in the U.S. Pursuant to the settlement and license agreement entered into between Jazz Pharmaceuticals entities and Avadel entities in October 2025 (the “Avadel Settlement Agreement”), from October 1, 2025, Jazz receives a royalty of 3.85% (subject to certain adjustments set forth in the Avadel Settlement Agreement) on net sales of LUMRYZ sold for narcolepsy and additional royalties on net sales of LUMRYZ sold for any other non-narcolepsy indications. For more information about the Avadel Settlement Agreement and underlying royalty obligations, see “Patents and Proprietary Rights – LUMRYZ” in “Item 1—Business” in our Annual Report.
LUMRYZ employs a version of our MICROPUMP technology. LUMRYZ is manufactured by third parties. The FDA has required implementation of a risk evaluation and mitigation strategy (“REMS”) for LUMRYZ to help ensure the benefits of the drug outweigh any risks of serious adverse outcomes that may result from inappropriate prescribing, misuse, abuse or diversion of the product. Under the LUMRYZ REMS, healthcare providers who prescribe the drug must be specially certified, pharmacies that dispense the drug must be specially certified, and the drug must be dispensed only to patients who have enrolled in the LUMRYZ REMS and completed all REMS requirements, including documentation of safe use conditions.
LYBALVI
LYBALVI (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. We exclusively manufacture and commercialize LYBALVI in the U.S.
For a discussion of legal proceedings related to LYBALVI, see Note 18, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the section entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we and our licensees have previously and may in the future face claims against IP rights covering our products and competition from generic drug manufacturers.”
VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly, non-narcotic, injectable medication approved in the U.S. for the treatment of alcohol dependence in patients able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL and for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL uses our polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through one intramuscular injection every four weeks. We exclusively manufacture and commercialize VIVITROL in the U.S.
For a discussion of legal proceedings related to VIVITROL, see Note 18, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to such legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report and specifically the sections entitled “Uncertainty over IP in the biopharmaceutical industry has been the source of litigation and other legal proceedings, and we and our licensees have previously and may in the future face claims against IP rights covering our products and competition from generic drug manufacturers” and “Litigation or arbitration filed against Alkermes, including securities litigation, or actions (such as citizens petitions) filed against regulatory agencies in respect of our products, may result in financial losses, harm our reputation, divert management resources, negatively impact the approval of our products, or otherwise negatively impact our business.”
33
Products Using Our Proprietary Technologies and Licensed Product
We have licensed products to third parties for commercialization and have licensed our proprietary technologies to third parties to enable them to develop, commercialize and/or manufacture products. See the “Proprietary Technology Platforms” and “Patents and Proprietary Rights” sections in “Part I, Item 1—Business” in our Annual Report for information with respect to our proprietary technologies and the IP protection for these products. We receive royalties and/or manufacturing and other revenues from the commercialization of these products under our collaborative arrangements with these third parties. Such arrangements, among others, include the following:
Products Using Our Proprietary Technologies
INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI
The long-acting INVEGA products are long-acting atypical antipsychotics owned and commercialized worldwide by Janssen. We believe that these products incorporate our technologies.
INVEGA SUSTENNA is approved in the U.S. for the treatment of schizophrenia and for the treatment of schizoaffective disorder as either a monotherapy or adjunctive therapy. Paliperidone palmitate extended-release injectable suspension is approved in the European Union (“EU”) and other countries outside of the U.S. for the treatment of schizophrenia and is marketed and sold under the trade name XEPLION. INVEGA SUSTENNA/XEPLION is manufactured by Janssen.
INVEGA TRINZA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months. TREVICTA is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION. INVEGA TRINZA/TREVICTA is manufactured by Janssen.
INVEGA HAFYERA is approved in the U.S. for the treatment of schizophrenia in patients who have been adequately treated with INVEGA SUSTENNA for at least four months or INVEGA TRINZA for at least three months. BYANNLI is approved in the EU for the maintenance treatment of schizophrenia in adult patients who are clinically stable on XEPLION or TREVICTA. INVEGA HAFYERA/BYANNLI is manufactured by Janssen.
Licensed Product
VUMERITY
VUMERITY (diroximel fumarate) is a novel, oral fumarate with a distinct chemical structure that is approved in the U.S., the EU and several other countries for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Under our license and collaboration agreement with Biogen, Biogen holds the exclusive, worldwide license to develop and commercialize VUMERITY. For more information about the license and collaboration agreement with Biogen, see the “Collaborative Arrangements—Biogen” section in “Part I, Item 1—Business” in our Annual Report.
34
Key Development Programs
Our R&D is focused on the development of innovative medicines in the field of neuroscience that are designed to address unmet patient needs. As part of our ongoing R&D efforts, we have devoted, and will continue to devote, significant resources to conducting preclinical work and clinical studies to advance the development of new pharmaceutical products. The discussion below highlights our current key development programs. Drug development involves a high degree of risk and investment, and the status, timing and scope of our development programs are subject to change. Important factors that could adversely affect our drug development efforts are discussed in “Part I, Item 1A—Risk Factors” in our Annual Report. See the “Patents and Proprietary Rights” section in “Part I, Item 1—Business” in our Annual Report for information with respect to the IP protection for our key development programs.
Alixorexton
Alixorexton is a novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1 (“NT1”), narcolepsy type 2 (“NT2”) and IH. Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address EDS across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH and in Vibrance-1 and Vibrance-2, phase 2 studies in patients with NT1 and NT2, respectively. On April 1, 2026, we announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with NT1 and NT2. Alixorexton is also currently being evaluated in Vibrance-3, a phase 2 study in patients with IH. The FDA has granted alixorexton Breakthrough Therapy designation for the treatment of NT1 and Orphan Drug Designation (“ODD”) for the treatment of IH. The European Commission has granted ODD to alixorexton for the treatment of narcolepsy.
LUMRYZ (sodium oxybate)
On May 12, 2026, the Company announced positive topline results from REVITALYZ, a double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study evaluating the investigational use of LUMRYZ (sodium oxybate) extended-release oral suspension compared to placebo in adults with IH.
Results of Operations
Product Sales, Net
Our product sales, net, consist of sales of ARISTADA and ARISTADA INITIO, LYBALVI, VIVITROL, and, following the completion of the Avadel Acquisition on February 12, 2026, LUMRYZ, primarily to wholesalers, specialty distributors and specialty pharmacies. The following table presents the adjustments deducted from product sales, gross, to arrive at product sales, net, for sales of ARISTADA and ARISTADA INITIO, LUMRYZ, LYBALVI and VIVITROL during the three and six months ended June 30, 2026 and 2025:
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
||||||||||||||||||||||||||||
|
June 30, |
|
|
|
June 30, |
|
|
||||||||||||||||||||||||||||
(In millions, except for % of Sales) |
2026(1) |
|
|
% of |
|
|
|
2025 |
|
|
% of |
|
|
|
2026(1) |
|
|
% of |
|
|
|
2025 |
|
|
% of |
|
|
||||||||
Product sales, gross |
$ |
762.7 |
|
|
|
100.0 |
|
% |
|
$ |
564.8 |
|
|
|
100.0 |
|
% |
|
$ |
1,389.3 |
|
|
|
100.0 |
|
% |
|
$ |
1,037.6 |
|
|
|
100.0 |
|
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Medicaid rebates |
|
(125.2 |
) |
|
|
(16.4 |
) |
% |
|
|
(105.2 |
) |
|
|
(18.6 |
) |
% |
|
|
(240.3 |
) |
|
|
(17.3 |
) |
% |
|
|
(199.5 |
) |
|
|
(19.2 |
) |
% |
Chargebacks |
|
(75.6 |
) |
|
|
(9.9 |
) |
% |
|
|
(64.4 |
) |
|
|
(11.4 |
) |
% |
|
|
(136.3 |
) |
|
|
(9.8 |
) |
% |
|
|
(118.3 |
) |
|
|
(11.4 |
) |
% |
Product discounts |
|
(73.5 |
) |
|
|
(9.6 |
) |
% |
|
|
(41.4 |
) |
|
|
(7.3 |
) |
% |
|
|
(126.9 |
) |
|
|
(9.1 |
) |
% |
|
|
(78.7 |
) |
|
|
(7.6 |
) |
% |
Medicare Part D |
|
(30.4 |
) |
|
|
(4.0 |
) |
% |
|
|
(21.3 |
) |
|
|
(3.9 |
) |
% |
|
|
(52.7 |
) |
|
|
(3.7 |
) |
% |
|
|
(39.7 |
) |
|
|
(3.8 |
) |
% |
Other |
|
(46.3 |
) |
|
|
(6.1 |
) |
% |
|
|
(25.3 |
) |
|
|
(4.5 |
) |
% |
|
|
(83.3 |
) |
|
|
(6.0 |
) |
% |
|
|
(49.7 |
) |
|
|
(4.9 |
) |
% |
Total adjustments |
|
(351.0 |
) |
|
|
(46.0 |
) |
% |
|
|
(257.6 |
) |
|
|
(45.6 |
) |
% |
|
|
(639.5 |
) |
|
|
(45.9 |
) |
% |
|
|
(485.9 |
) |
|
|
(46.8 |
) |
% |
Product sales, net |
$ |
411.7 |
|
|
|
54.0 |
|
% |
|
$ |
307.2 |
|
|
|
54.4 |
|
% |
|
$ |
749.8 |
|
|
|
54.1 |
|
% |
|
$ |
551.7 |
|
|
|
53.2 |
|
% |
35
The increases in product sales, gross, during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to the addition of LUMRYZ and an 18% and 23% increase, respectively, in the number of units sold for LYBALVI. During the six months ended June 30, 2026, there was also an increase of 7% in the number of units sold for ARISTADA/ARISTADA INITIO. In addition, there was a 6% price increase that went into effect on January 1, 2026 for each of LYBALVI, ARISTADA/ARISTADA INITIO and VIVITROL.
The decreases in Medicaid rebates as a percentage of sales during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to gross-to-net favorability, as actual Medicaid rebates were lower than original estimates by approximately $3.5 million and $8.9 million, respectively, for VIVITROL and $5.3 million and $8.1 million, respectively, for ARISTADA/ARISTADA INITIO. In addition, LUMRYZ does not participate in a Medicaid rebate program. The increases in Other adjustments during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily related to the addition of certain gross-to-net deductions related to LUMRYZ.
The following table compares product sales, net earned during the three and six months ended June 30, 2026 and 2025:
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
VIVITROL |
$ |
124.5 |
|
|
$ |
121.7 |
|
|
$ |
2.8 |
|
|
$ |
236.9 |
|
|
$ |
222.7 |
|
|
$ |
14.2 |
|
ARISTADA and ARISTADA INITIO |
|
96.7 |
|
|
|
101.3 |
|
|
|
(4.6 |
) |
|
|
190.5 |
|
|
|
174.8 |
|
|
|
15.7 |
|
LYBALVI |
|
93.9 |
|
|
|
84.3 |
|
|
|
9.6 |
|
|
|
186.3 |
|
|
|
154.3 |
|
|
|
32.0 |
|
LUMRYZ |
|
96.6 |
|
|
|
— |
|
|
|
96.6 |
|
|
|
136.1 |
|
|
|
— |
|
|
|
136.1 |
|
Product sales, net |
$ |
411.7 |
|
|
$ |
307.2 |
|
|
$ |
104.4 |
|
|
$ |
749.8 |
|
|
$ |
551.7 |
|
|
$ |
198.0 |
|
Manufacturing and Royalty Revenues
The following table compares manufacturing and royalty revenues earned during the three and six months ended June 30, 2026 and 2025:
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Manufacturing and royalty revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Long-acting INVEGA products |
$ |
27.4 |
|
|
$ |
30.3 |
|
|
$ |
(2.9 |
) |
|
$ |
45.4 |
|
|
$ |
48.1 |
|
|
$ |
(2.7 |
) |
VUMERITY |
|
30.6 |
|
|
|
39.4 |
|
|
|
(8.8 |
) |
|
|
57.9 |
|
|
|
67.2 |
|
|
|
(9.3 |
) |
Other |
|
26.3 |
|
|
|
13.7 |
|
|
|
12.6 |
|
|
|
35.8 |
|
|
|
30.1 |
|
|
|
5.7 |
|
Manufacturing and royalty revenues |
$ |
84.3 |
|
|
$ |
83.4 |
|
|
$ |
0.9 |
|
|
$ |
139.1 |
|
|
$ |
145.4 |
|
|
$ |
(6.3 |
) |
The decrease in VUMERITY revenue during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was due to decreases in manufacturing revenues of $7.4 million and royalty revenue of $1.4 million. The decrease in VUMERITY revenue during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was due to a decrease in manufacturing revenues of $13.4 million, partially offset by an increase in royalty revenue of $4.1 million. The decreases in VUMERITY manufacturing revenue were related to the conclusion of our VUMERITY manufacturing subcontracting obligations for Biogen in August 2025. The decrease in VUMERITY royalty revenue during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, and the increase in VUMERITY royalty revenue during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, were due to a decrease and an increase, respectively, in end-market net sales of the product.
The increases in Other manufacturing and royalty revenue during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to increases of $17.1 million and $12.0 million, respectively, in RISPERDAL CONSTA manufacturing revenue, primarily due to increases in the number of batches made available to Janssen for sale in the U.S., which has a higher selling price than product sold outside of the U.S., partially offset by decreases in revenues related to certain of our other legacy products.
36
Costs and Expenses
Cost of Goods Manufactured and Sold
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Cost of goods manufactured and sold |
$ |
98.1 |
|
|
$ |
49.5 |
|
|
$ |
48.6 |
|
|
$ |
159.7 |
|
|
$ |
98.7 |
|
|
$ |
61.0 |
|
In connection with the Avadel Acquisition, we acquired LUMRYZ inventory at its estimated fair value, resulting in a step-up of approximately $121.6 million above its cost. The inventory step-up is recognized in cost of goods manufactured and sold as the underlying inventory is sold. See Note 7, Inventory in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information related to purchase accounting adjustments. The increases in the cost of goods manufactured and sold during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily related to the addition of LUMRYZ and the amortization of such inventory step-up of approximately $31.0 million and $43.7 million, respectively. In addition, the cost of goods sold for ARISTADA/ARISTADA INITIO and VIVITROL increased due to increases in costs related to out-of-specification batches and investigation costs. These increases were partially offset by decreases of $5.1 million and $14.0 million, respectively, in the cost of goods manufactured for certain legacy products following the completion of our subcontracting arrangements for the manufacture of such products by the end of 2025.
Research and Development Expenses
For each of our R&D programs, we incur both external and internal expenses. External R&D expenses include fees for clinical and preclinical activities performed by contract research organizations, consulting fees, and costs related to laboratory services, the purchase of drug product materials and third-party manufacturing development activities. Internal R&D expenses include employee-related expenses, occupancy costs, depreciation and general overhead. We track external R&D expenses for each of our development programs; however, internal R&D expenses are not tracked by individual program as they can benefit multiple development programs or our products or technologies in general.
The following table sets forth our external R&D expenses for the three and six months ended June 30, 2026 and 2025 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
External R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Development programs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Alixorexton |
$ |
28.8 |
|
|
$ |
23.8 |
|
|
$ |
5.0 |
|
|
$ |
54.3 |
|
|
$ |
41.6 |
|
|
$ |
12.7 |
|
LYBALVI |
|
4.9 |
|
|
|
5.0 |
|
|
|
(0.1 |
) |
|
|
9.4 |
|
|
|
8.9 |
|
|
|
0.5 |
|
LUMRYZ |
|
4.7 |
|
|
|
— |
|
|
|
4.7 |
|
|
|
7.6 |
|
|
|
— |
|
|
|
7.6 |
|
Other orexin programs |
|
15.1 |
|
|
|
2.7 |
|
|
|
12.4 |
|
|
|
21.9 |
|
|
|
6.2 |
|
|
|
15.7 |
|
Other external R&D expenses |
|
13.8 |
|
|
|
7.9 |
|
|
|
5.9 |
|
|
|
25.0 |
|
|
|
15.4 |
|
|
|
9.6 |
|
Total external R&D expenses |
|
67.3 |
|
|
|
39.4 |
|
|
|
27.9 |
|
|
|
118.2 |
|
|
|
72.1 |
|
|
|
46.1 |
|
Internal R&D expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Employee-related |
|
37.0 |
|
|
|
30.6 |
|
|
|
6.4 |
|
|
|
80.6 |
|
|
|
62.0 |
|
|
|
18.6 |
|
Occupancy |
|
3.3 |
|
|
|
3.3 |
|
|
|
— |
|
|
|
6.6 |
|
|
|
6.4 |
|
|
|
0.2 |
|
Depreciation |
|
1.8 |
|
|
|
1.5 |
|
|
|
0.3 |
|
|
|
3.5 |
|
|
|
2.9 |
|
|
|
0.6 |
|
Other |
|
3.5 |
|
|
|
2.6 |
|
|
|
0.9 |
|
|
|
7.4 |
|
|
|
5.8 |
|
|
|
1.6 |
|
Total internal R&D expenses |
|
45.6 |
|
|
|
38.0 |
|
|
|
7.6 |
|
|
|
98.1 |
|
|
|
77.1 |
|
|
|
21.0 |
|
Research and development expenses |
$ |
112.9 |
|
|
$ |
77.4 |
|
|
$ |
35.5 |
|
|
$ |
216.3 |
|
|
$ |
149.2 |
|
|
$ |
67.1 |
|
These amounts are not necessarily predictive of future R&D expenses. In an effort to allocate our spending most effectively, we continually evaluate our products under development based on the performance of such products in preclinical and/or clinical trials, our expectations regarding the likelihood of their regulatory approval and our view of their future potential commercial viability, among other factors.
37
The increases in expenses related to alixorexton during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to increased spend related to the advancement of the development program, including initiation of our phase 3 Brilliance Studies in narcolepsy and costs related to our long-term extension study. The increases in expenses related to LUMRYZ during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were due to the addition, in connection with the Avadel Acquisition, of the REVITALYZ phase 3 development program. The increases in other orexin programs and other external R&D expenses during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to activities associated with our preclinical and clinical development programs.
The increases in employee-related expenses during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to increases in share-based compensation expense of $1.7 million and $10.0 million, respectively, and increases in labor and benefits expense related to a 16% increase in R&D-related headcount, primarily in connection with the Avadel Acquisition. The increase in share-based compensation expense during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to expense of $6.7 million related to Avadel Shares that were accelerated and settled by us in connection with the Avadel Acquisition. See Note 3, Business Combination in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information related to purchase accounting adjustments.
Selling, General and Administrative Expense
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Selling and marketing expense |
|
$ |
154.3 |
|
|
$ |
121.2 |
|
|
$ |
33.1 |
|
|
$ |
309.3 |
|
|
$ |
244.1 |
|
|
$ |
65.2 |
|
General and administrative expense |
|
|
63.3 |
|
|
|
49.6 |
|
|
|
13.7 |
|
|
|
172.9 |
|
|
|
98.5 |
|
|
|
74.4 |
|
Selling, general and administrative expense |
|
$ |
217.6 |
|
|
$ |
170.8 |
|
|
$ |
46.8 |
|
|
$ |
482.2 |
|
|
$ |
342.6 |
|
|
$ |
139.6 |
|
The increases in selling and marketing expense during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to increases in employee-related expenses of $18.0 million and $45.8 million, respectively, and marketing expense of $15.1 million and $19.4 million, respectively. The increases in employee-related expenses were primarily due to a 16% increase in sales and marketing-related headcount due to the addition of the LUMRYZ commercial organization. Also, during the six months ended June 30, 2026, we recorded share-based compensation expense of $13.3 million related to Avadel Shares that were accelerated and settled by us in connection with the Avadel Acquisition. See Note 3, Business Combination in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information related to purchase accounting adjustments. The increases in marketing expense during the three and six months ended June 30, 2026, as compared to the three and six months ended June 30, 2025, were primarily due to the addition of marketing costs for LUMRYZ of $13.7 million and $24.2 million, respectively, partially offset by decreases of $4.4 million and $8.3 million, respectively, in direct marketing spend for ARISTADA/ARISTADA INITIO, LYBALVI and VIVITROL.
The increase in general and administrative expense during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to increases of $7.0 million and $3.9 million in employee-related expenses and professional service fees, respectively. The increase in labor and benefits expense was primarily due to an 11% increase in general and administrative-related headcount. The increase in professional service fees was primarily due to increases in legal fees and consulting fees.
The increase in general and administrative expense during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, was primarily due to increases of $32.8 million, $26.3 million and $9.1 million in expenses related to the Avadel Acquisition, employee-related expenses and professional service fees, respectively. Expenses related to the Avadel Acquisition included stamp duty and transaction-related advisory fees. The increase in employee-related expenses was primarily due to increases of $12.9 million and $9.7 million in labor and benefits expense and share-based compensation expense, respectively. The increase in labor and benefits expense was primarily due to an increase in severance expense of $5.6 million related to the Avadel Acquisition, and the 11% increase in general and administrative-related headcount noted above. The increase in share-based compensation expense was primarily due to the recognition of incremental share-based compensation expense following the modification of certain equity awards and due to Avadel Shares that were accelerated and settled by us in connection with the Avadel Acquisition. The increase in professional service fees was primarily due to an increase in legal fees and expenses incurred in connection with the Avadel Acquisition.
38
Amortization of Acquired Intangible Assets
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Amortization of acquired intangible assets |
|
$ |
22.6 |
|
|
$ |
— |
|
|
$ |
22.6 |
|
|
$ |
34.3 |
|
|
$ |
— |
|
|
$ |
34.3 |
|
We amortize our amortizable intangible assets using the economic-use method, which reflects the pattern that the economic benefits of the intangible assets are consumed as revenue is generated from the underlying patent or contract. Based on our most recent analysis, amortization of intangible assets included within our consolidated balance sheet at June 30, 2026 is expected to be approximately $79.9 million, $103.8 million, $125.6 million, $118.1 million and $115.7 million in the years ending December 31, 2026 through 2030, respectively.
Contingent Consideration
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Change in fair value of contingent consideration |
|
|
26.4 |
|
|
$ |
— |
|
|
$ |
26.4 |
|
|
|
26.4 |
|
|
$ |
— |
|
|
$ |
26.4 |
|
The changes in fair value of contingent consideration during the three and six months ended June 30, 2026 related to an increase in probability of success of achieving the CVR Milestone following receipt of positive topline results from the REVITALYZ phase 3 clinical study of LUMRYZ in IH announced in May 2026. See Note 6, Fair Value, in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information regarding the valuation approach used to determine the fair value of the contingent consideration.
Other (Expense) Income, Net
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Interest income |
|
$ |
5.3 |
|
|
$ |
11.1 |
|
|
$ |
(5.8 |
) |
|
$ |
13.8 |
|
|
$ |
21.2 |
|
|
$ |
(7.4 |
) |
Interest expense |
|
|
(25.9 |
) |
|
|
— |
|
|
|
(25.9 |
) |
|
|
(46.8 |
) |
|
|
— |
|
|
|
(46.8 |
) |
Other (expense) income, net |
|
|
0.4 |
|
|
|
0.8 |
|
|
|
(0.4 |
) |
|
|
(0.9 |
) |
|
|
2.4 |
|
|
|
(3.3 |
) |
Total other (expense) income, net |
|
$ |
(20.2 |
) |
|
$ |
11.9 |
|
|
$ |
(32.1 |
) |
|
$ |
(33.9 |
) |
|
$ |
23.6 |
|
|
$ |
(57.5 |
) |
Interest income consists of interest earned on our cash and available-for-sale investments. The increase in interest expense in both periods is due to financing costs related to the Bridge Credit Agreement through the Closing Date of the Avadel Acquisition and interest incurred on the Facilities. See Note 12, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information regarding the Bridge Credit Agreement and the Facilities.
Income Tax Provision (Benefit)
|
|
Three Months Ended |
|
|
|
|
|
Six Months Ended |
|
|
|
|
||||||||||||
|
|
June 30, |
|
|
|
|
|
June 30, |
|
|
|
|
||||||||||||
(In millions) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
2026 |
|
|
2025 |
|
|
Change |
|
||||||
Income tax provision (benefit) |
|
$ |
(2.4 |
) |
|
|
17.7 |
|
|
$ |
(20.1 |
) |
|
$ |
2.2 |
|
|
$ |
20.8 |
|
|
$ |
(18.6 |
) |
The income tax benefit in the three months ended June 30, 2026 primarily related to a lower estimated annual effective tax rate. The income tax provision during the six months ended June 30, 2026 was primarily attributable to taxes on income earned in the U.S. The income tax provisions during the three and six months ended June 30, 2025 were primarily attributable to taxes on income earned in Ireland.
39
Liquidity and Financial Condition
Our financial condition is summarized as follows:
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||||||||||||||||||
(In millions) |
|
U.S. |
|
|
Ireland |
|
|
Total |
|
|
U.S. |
|
|
Ireland |
|
|
Total |
|
||||||
Cash and cash equivalents |
|
$ |
194.6 |
|
|
$ |
316.9 |
|
|
$ |
511.5 |
|
|
$ |
129.1 |
|
|
$ |
259.5 |
|
|
$ |
388.6 |
|
Restricted cash |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
731.2 |
|
|
|
731.2 |
|
Investments—short-term |
|
|
145.0 |
|
|
|
— |
|
|
|
145.0 |
|
|
|
199.1 |
|
|
|
0.5 |
|
|
|
199.6 |
|
Investments—long-term |
|
|
35.1 |
|
|
|
— |
|
|
|
35.1 |
|
|
|
0.1 |
|
|
|
— |
|
|
|
0.1 |
|
Total cash, restricted cash and investments |
|
$ |
374.7 |
|
|
$ |
316.9 |
|
|
$ |
691.6 |
|
|
$ |
328.3 |
|
|
$ |
991.2 |
|
|
$ |
1,319.5 |
|
At June 30, 2026 our investments consisted of the following:
|
|
|
|
|
Gross |
|
|
|
|
|
|
|
||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Allowance for |
|
|
Estimated |
|
||||||||
(In millions) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Credit Losses |
|
|
Fair Value |
|
|||||
Investments—short-term available-for-sale |
|
$ |
145.1 |
|
|
$ |
0.1 |
|
|
$ |
(0.2 |
) |
|
$ |
— |
|
|
$ |
145.0 |
|
Investments—long-term available-for-sale |
|
|
35.1 |
|
|
|
— |
|
|
|
(0.1 |
) |
|
|
— |
|
|
|
35.0 |
|
Investments—long-term held-to-maturity |
|
|
0.1 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
0.1 |
|
Total |
|
$ |
180.3 |
|
|
$ |
0.1 |
|
|
$ |
(0.3 |
) |
|
$ |
— |
|
|
$ |
180.1 |
|
Sources and Uses of Cash
We used $20.6 million and generated $249.0 million of cash from operating activities during the six months ended June 30, 2026 and 2025, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, including debt service and capital expenditures, for at least the twelve months following the date from which our financial statements were issued. Subject to market conditions, interest rates and other factors, we may pursue opportunities to obtain financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures.
Our investment objectives are, first, to preserve liquidity and conserve capital and, second, to generate investment income. We mitigate credit risk in our cash reserves by maintaining a well-diversified portfolio that limits the amount of investment exposure as to institution, maturity and investment type. Our available-for-sale investments consist primarily of short and long-term U.S. government and agency debt securities and corporate debt securities. Our held-to-maturity investments consist of investments that are held as collateral under certain letters of credit related to certain of our lease agreements.
We classify available-for-sale investments in an unrealized loss position that do not mature within 12 months as long-term investments. We have the intent and ability to hold these investments until recovery, which may be at maturity, and it is more-likely-than-not that we would not be required to sell these securities before recovery of their amortized cost.
We have no off-balance sheet arrangements that are reasonably likely to have a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources in the next 12 months.
Information about our cash flows, by category, is presented in the accompanying condensed consolidated statements of cash flows. The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
|
|
|
|
|
|
|
||
|
|
Six Months Ended June 30, |
|
|||||
(In millions) |
|
2026 |
|
|
2025 |
|
||
Cash, cash equivalents and restricted cash, beginning of period |
|
$ |
1,119.8 |
|
|
$ |
291.1 |
|
Cash flows (used in) provided by operating activities |
|
|
(20.6 |
) |
|
|
249.0 |
|
Cash flows used in investing activities |
|
|
(2,079.4 |
) |
|
|
(20.1 |
) |
Cash flows provided by financing activities |
|
|
1,491.7 |
|
|
|
1.2 |
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
511.5 |
|
|
$ |
521.2 |
|
40
Operating Activities
Cash flows provided by operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting our net income for non-cash operating items such as depreciation, amortization and share-based compensation and changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in our results of operations.
Cash flows used in operating activities for the six months ended June 30, 2026 were $20.6 million and primarily consisted of net loss of $66.0 million, adjusted for non-cash items, including share-based compensation of $67.5 million, depreciation and amortization of $49.7 million, amortization of inventory step-up of $43.7 million, the change in fair value of contingent consideration of $26.4 million and changes in working capital of $147.8 million.
Cash flows provided by operating activities for the six months ended June 30, 2025 primarily consisted of $109.6 million of net income, adjusted for non-cash items, including $47.8 million of share-based compensation, $15.2 million of depreciation and amortization and changes of $74.1 million in working capital.
Investing Activities
Cash flows used in investing activities for the six months ended June 30, 2026 were primarily used to complete the Avadel Acquisition and purchase $12.2 million of property, plant and equipment, partially offset by $17.9 million in net sales of investments. Total cash consideration paid on the Closing Date was $2,199.2 million, which was accounted for as a business combination, and we recognized $2,085.1 million of assets acquired, net of liabilities assumed and cash transferred as an investing activity during the six months ended June 30, 2026.
Cash flows used in investing activities for the six months ended June 30, 2025 were primarily due to the purchase of $23.1 million of property, plant and equipment, partially offset by $1.3 million in net sales of investments.
Financing Activities
Cash flows provided by financing activities for the six months ended June 30, 2026 primarily consisted of $1,511.6 million in net proceeds from borrowings under the Facilities in connection with the Avadel Acquisition and $42.0 million of cash that we received upon exercises of employee stock options. These increases were partially offset by $27.7 million (exclusive of any fees, commissions or other related expenses) used to repurchase our ordinary shares under the Repurchase Program and $24.5 million of employee taxes paid related to the net share settlement of equity awards.
Cash flows provided by financing activities for the six months ended June 30, 2025 were due to $31.6 million of cash that we received upon exercises of employee stock options, offset by $30.4 million of employee taxes paid related to the net share settlement of equity awards.
Debt
On February 12, 2026, in connection with the Avadel Acquisition, we entered into the Credit Agreement, which provides for (i) a TLA Facility in an aggregate principal amount of up to $750.0 million and (ii) a TLB Facility in an aggregate principal amount of up to $775.0 million. The TLA Facility matures on February 12, 2031, and the TLB Facility matures on August 12, 2031. On the Closing Date, we borrowed the full $1.525 billion available to us under the Facilities.
For additional details regarding our outstanding indebtedness, see Note 12, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.
On February 12, 2026, in connection with completion of the Avadel Acquisition and our entry into the Credit Agreement, we terminated the Bridge Credit Agreement originally entered into in order to fund the Avadel Acquisition, as the commitments under the Credit Agreement, together with our cash on hand as of the Closing Date, were sufficient to fund the Avadel Acquisition.
41
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates under different conditions or using different assumptions.
See the “Critical Accounting Estimates” section in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report for a discussion of our critical accounting estimates. See below for a discussion of additions to our critical accounting estimates since December 31, 2025.
Contingent Consideration
We record contingent consideration we may owe related to a business combination at fair value on the acquisition date. We estimate the fair value of contingent consideration through valuation models that incorporate a DCF model related to the achievement of a certain specified milestone. We revalue our contingent consideration each reporting period, with changes in the fair value of contingent consideration recognized within the consolidated statements of operations and comprehensive (loss) income. Changes in the fair value of contingent consideration can result from changes to one or multiple assumptions, including adjustments to the discount rates, changes in the assumed achievement and timing of any such specified milestone and changes in the assumed probability associated with regulatory approval.
The period over which we discount contingent consideration is based on the current development stage of the product candidate, the specific development plan for such product candidate adjusted for the probability of completing the development step, and the date on which contingent payments may be triggered. In estimating the probability of success, we utilize data regarding similar milestone events from several sources, including industry studies and our own experience. These fair value measurements are based on significant inputs not observable in the market. Significant judgment is employed in determining the appropriateness of these assumptions at the acquisition date and for each subsequent reporting period. Accordingly, changes in assumptions described above could have a material impact on the increase or decrease in the fair value of contingent consideration recorded in any given period.
At June 30, 2026, our contingent consideration related to the CVR Milestone issued in connection with the Avadel Acquisition. The fair value of the contingent consideration was determined as follows:
In accordance with the accounting standard for fair value measurements, the fair value of the contingent consideration has been classified as a Level 3 liability as its fair value is based on significant inputs not observable in the market.
Valuation of Intangible Assets
Our intangible assets consist primarily of IP related to the existing commercial product and IPR&D product candidates that we acquired as part of the Avadel Acquisition. When significant identifiable intangible assets are acquired, we engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date. Discounted cash flow models are typically used in these valuations, which require the use of significant estimates and assumptions, including but not limited to:
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We believe the fair values assigned to the intangible assets acquired are based upon reasonable estimates and assumptions given available facts and circumstances as of the acquisition date. If these projects are not successfully developed, the sales and profitability of the Company may be adversely affected in future periods. Additionally, the value of the acquired intangible assets may become impaired. We believe that the foregoing assumptions used in the IPR&D analysis were reasonable as of the acquisition date. No assurance can be given, however, that the underlying assumptions used to estimate expected product sales, development costs or profitability, or the events associated with such products, will transpire as estimated.
New Accounting Standards
See the “New Accounting Pronouncements” section in Note 2, Summary of Significant Accounting Policies in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for discussion of certain recent accounting standards applicable to us.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Market risks related to our investment portfolio, and the ways we manage such risks, are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. We regularly review our marketable securities holdings and shift our investment holdings to those that best meet our investment objectives, which are to preserve capital, provide sufficient liquidity to satisfy operating requirements and generate investment income. Apart from such adjustments to our investment portfolio, there have been no material changes to our market risks since December 31, 2025, and we do not anticipate any near-term changes in the nature of our market risk exposures or in our management’s objectives and strategies with respect to managing such exposures.
We are exposed to non-U.S. currency exchange risk related primarily to royalty revenues that we receive on certain of our products, partially offset by certain operating costs arising from expenses and payables in connection with our Irish operations that are settled predominantly in euro. These non-U.S. currency exchange rate risks are summarized in “Part II, Item 7A—Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report. There has been no material change in our assessment of our sensitivity to non-U.S. currency exchange rate risk since December 31, 2025.
At June 30, 2026, our borrowings consisted of $1.525 billion outstanding under the Facilities. The TLA Facility matures on February 12, 2031; the TLB Facility matures on August 12, 2031. The Facilities bear interest at the one-, three- or six-month SOFR rate of our choosing plus a credit spread adjustment applicable to the interest period and an applicable margin of 2.75%. We are currently using the three-month SOFR rate, which was 3.70% at June 30, 2026. A 10% increase in this rate would increase the amount of interest we would expect to pay from July 1, 2026 through December 31, 2026 by $2.9 million. See Note 12, Long-Term Debt in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information related to the Facilities.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management has evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of June 30, 2026. Based upon that evaluation, our principal executive officer and principal financial officer each concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to provide reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
b) Change in Internal Control Over Financial Reporting
During the three months ended June 30, 2026, there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For information regarding legal proceedings, see the discussion of legal proceedings in Note 18, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, which discussion is incorporated into this Part II, Item 1 by reference.
Item 1A. Risk Factors
For a discussion of our risk factors, see “Part I, Item 1A—Risk Factors” in our Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following table summarizes purchases of our ordinary shares made by or on behalf of us or any of our affiliated purchasers, as defined in Rule 10b-18(a)(3) under the Exchange Act, during the three months ended June 30, 2026:
Period |
|
Total Number of Ordinary Shares Purchased |
|
|
Average Price Paid per Ordinary Share |
|
|
Total Number of Ordinary Shares Purchased as Part of Publicly Announced Program |
|
|
Approximate Dollar Value (in millions) of Ordinary Shares that May Yet Be Purchased Under the Program |
|
||||
April 1, 2026 – April 30, 2026 |
|
|
6,455 |
|
|
$ |
34.59 |
|
|
|
— |
|
|
$ |
172.3 |
|
May 1, 2026 – May 31, 2026 |
|
|
18,797 |
|
|
|
36.39 |
|
|
|
— |
|
|
|
172.3 |
|
June 1, 2026 – June 30, 2026 |
|
|
3,699 |
|
|
|
42.99 |
|
|
|
— |
|
|
|
172.3 |
|
Totals |
|
|
28,951 |
|
|
$ |
36.83 |
|
|
|
— |
|
|
|
|
|
Item 5. Other Information
During the three months ended June 30, 2026, the following contracts, instructions or written plans for the purchase or sale of the Company’s securities that are or were intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (each, a “Rule 10b5-1 plan”) were adopted by officers (as defined in Rule 16a-1(f) under the Exchange Act) and directors of the Company: (i) on
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Item 6. Exhibits
The following exhibits are filed or furnished as part of this Form 10-Q:
EXHIBIT INDEX
Exhibit No. |
|
Description of Exhibit |
2.1 § |
|
Transaction Agreement, dated as of October 22, 2025 by and among Alkermes plc and Avadel Pharmaceuticals plc (incorporated by reference to Exhibit 2.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299) filed on October 22, 2025). |
2.1A |
|
Amendment No. 1 to the Transaction Agreement, dated as of November 18, 2025, by and between Alkermes plc and Avadel Pharmaceuticals plc (incorporated by reference to Exhibit 2.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299) filed on November 19, 2025). |
2.1B |
|
Appendix III to the Rule 2.7 Announcement, dated as of October 22, 2025 (Conditions Appendix) (incorporated by reference to Exhibit 2.2 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299) filed on October 22, 2025). |
10.1 † |
|
Alkermes plc 2018 Stock Option and Incentive Plan, as amended (incorporated by reference from Exhibit 10.1 to the Alkermes plc Current Report on Form 8-K (File No. 001-35299) filed on May 20, 2026). |
31.1 # |
|
Rule 13a-14(a)/15d-14(a) Certification. |
31.2 # |
|
Rule 13a-14(a)/15d-14(a) Certification. |
32.1 ‡ |
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.SCH # |
|
Inline XBRL Taxonomy Extension Schema Document with Embedded Linkbase Documents. |
104 # |
|
Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibit 101). |
# Filed herewith.
‡ Furnished herewith.
† Indicates a management contract or any compensatory plan, contract or arrangement.
§ Schedules and similar attachments to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company undertakes to furnish copies of any omitted schedules and similar attachments upon request by the SEC.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
ALKERMES PLC |
|
|
|
|
|
|
|
(Registrant) |
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ Richard F. Pops |
|
|
|
Richard F. Pops |
|
|
|
Chairman and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|||
|
|
|
|
|
By: |
/s/ Joshua Reed |
|
|
|
Joshua Reed |
|
|
|
Senior Vice President, Chief Financial Officer |
|
|
|
(Principal Financial Officer) |
|
Date: July 28, 2026 |
|
|
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