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 April 26, 2024 was
ALKERMES PLC AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024
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Page No. |
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Item 1. |
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Condensed Consolidated Balance Sheets — March 31, 2024 and December 31, 2023 |
5 |
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6 |
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Condensed Consolidated Statements of Cash Flows — For the Three Months Ended March 31, 2024 and 2023 |
7 |
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8 |
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9 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
23 |
Item 3. |
34 |
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Item 4. |
34 |
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Item 1. |
35 |
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Item 1A. |
35 |
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Item 2. |
35 |
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Item 5. |
35 |
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Item 6. |
36 |
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37 |
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, see “Part I, Item 1A—Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the United States (“U.S.”) Securities and Exchange Commission (the “SEC”) on February 21, 2024 (our “Annual Report”).
3
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 and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. 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”), including ALKERMES®, ARISTADA®, ARISTADA INITIO®, LinkeRx®, LYBALVI®, NanoCrystal® and VIVITROL®.
The following are trademarks of the respective companies listed: BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, 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 ® and TM symbols, 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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March 31, 2024 |
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December 31, 2023 |
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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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Receivables, net |
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Investments—short-term |
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Inventory |
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Contract assets |
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Prepaid expenses and other current assets |
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Assets held for sale |
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Total current assets |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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RIGHT-OF-USE ASSETS |
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INVESTMENTS—LONG-TERM |
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GOODWILL |
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INTANGIBLE ASSETS, NET |
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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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Contract liabilities—short-term |
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Current portion of long-term debt |
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Liabilities related to discontinued operations |
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— |
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Total current liabilities |
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LONG-TERM DEBT |
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OPERATING LEASE LIABILITIES—LONG-TERM |
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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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( |
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( |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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( |
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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 INCOME (LOSS)
(unaudited)
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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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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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Manufacturing and royalty revenues |
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Research and development revenue |
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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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Amortization of acquired intangible assets |
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Total expenses |
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OPERATING INCOME (LOSS) FROM CONTINUING OPERATIONS |
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( |
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OTHER INCOME (EXPENSE), 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 income (expense), net |
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( |
) |
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Total other income (expense), net |
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( |
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INCOME (LOSS) BEFORE INCOME TAXES |
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( |
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INCOME TAX PROVISION |
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NET INCOME (LOSS) FROM CONTINUING OPERATIONS |
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( |
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LOSS FROM DISCONTINUED OPERATIONS, NET OF TAX |
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( |
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( |
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NET INCOME (LOSS) |
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$ |
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$ |
( |
) |
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EARNINGS (LOSS) PER ORDINARY SHARE: |
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Earnings (loss) per share from continuing operations - basic |
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$ |
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$ |
( |
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Loss per share from discontinued operations - basic |
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$ |
( |
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$ |
( |
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Earnings (loss) per share - basic |
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$ |
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$ |
( |
) |
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Earnings (loss) per share from continuing operations - diluted |
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$ |
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$ |
( |
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Loss per share from discontinued operations - diluted |
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$ |
( |
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$ |
( |
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Earnings (loss) per share - diluted |
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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 INCOME (LOSS): |
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Net income (loss) |
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$ |
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$ |
( |
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Holding (loss) gain, net of a tax (benefit) provision of $( |
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( |
) |
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COMPREHENSIVE INCOME (LOSS) |
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$ |
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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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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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(In thousands) |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income (loss) |
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$ |
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$ |
( |
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Adjustments to reconcile net income (loss) to cash flows from operating activities: |
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Depreciation and amortization |
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Share-based compensation expense |
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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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Contract assets |
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( |
) |
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Inventory |
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( |
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( |
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Prepaid expenses and other assets |
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( |
) |
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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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( |
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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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( |
) |
Other long-term liabilities |
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( |
) |
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Cash flows provided by (used in) 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 equipment |
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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) provided by investing activities |
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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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Employee taxes paid related to net share settlement of equity awards |
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( |
) |
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( |
) |
Principal payments of long-term debt |
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( |
) |
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( |
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Cash flows used in financing activities |
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( |
) |
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( |
) |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
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( |
) |
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CASH AND CASH EQUIVALENTS—Beginning of period |
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CASH AND CASH EQUIVALENTS—End of period |
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$ |
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$ |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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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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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 |
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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, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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( |
) |
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$ |
( |
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$ |
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Issuance of ordinary shares under employee stock plans |
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— |
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— |
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— |
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— |
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Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Share-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized gain on marketable securities, net of tax benefit of $ |
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— |
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— |
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— |
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( |
) |
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— |
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— |
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— |
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( |
) |
Net income |
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— |
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— |
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— |
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— |
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— |
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— |
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BALANCE — March 31, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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( |
) |
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$ |
( |
) |
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$ |
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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 |
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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, 2022 |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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( |
) |
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$ |
( |
) |
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$ |
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Issuance of ordinary shares under employee stock plans |
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— |
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— |
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— |
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— |
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Receipt of Alkermes' ordinary shares for the exercise of stock options or to satisfy minimum tax withholding obligations related to share-based awards |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Share-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized gain on marketable securities, net of tax provision of $ |
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— |
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— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
|
|
( |
) |
BALANCE — March 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
$ |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
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 and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. Headquartered in Ireland, Alkermes also has a corporate office and research and development (“R&D”) center in Massachusetts and a manufacturing facility in Ohio.
On May 1, 2024, the Company completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland (the “Athlone Facility”) to Novo Nordisk (“Novo”). The Company and Novo also entered into subcontracting arrangements to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction; these activities may continue through the end of 2025. At March 31, 2024 and December 31, 2023, the Company classified the assets described under the related asset purchase agreement as “Assets held for sale” within the accompanying condensed consolidated balance sheets.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of the Company for the three months ended March 31, 2024 and 2023 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended December 31, 2023. The year-end condensed 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.
These 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.
Reclassification
The Company has presented its former oncology business as discontinued operations in its accompanying condensed consolidated statement of operations and comprehensive income (loss) for the three months ended March 31, 2023. See Note 3, Discontinued Operations in these “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for additional information.
Discontinued Operations
The Company determined that the separation of its oncology business in November 2023 met the criteria for classification of the oncology business as discontinued operations in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Discontinued Operations (“Topic 205”). Accordingly, the financial statements have been updated to present the results of the oncology business as discontinued operations for the three months ended March 31, 2023 in the accompanying condensed consolidated statement of operations and comprehensive income (loss).
9
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Assets Held for Sale
In connection with the sale of the Athlone Facility, the Company reviewed FASB ASC 805, Business Combinations and, based on the definitions therein, determined that the Athlone Facility constitutes a business. Accordingly, the assets associated with the sale of the Athlone Facility were classified as “Assets held for sale” within the accompanying condensed consolidated balance sheets as of March 31, 2024 and December 31, 2023.
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 long-lived assets, share-based compensation, income taxes including the valuation allowance for deferred tax assets, valuation of investments 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.
Segment Information
The Company operates 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 as of the specified effective date. Unless otherwise discussed, 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 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure, which requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the Company’s chief operating decision maker. The amendments in this guidance also expand the interim segment disclosure requirements. All disclosure requirements under this guidance are required for public entities with a single reportable segment. This ASU became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this guidance are required to be applied on a retrospective basis. The Company elected to early adopt this guidance and determined this ASU did not have an impact on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures in order to provide information to assist key stakeholders in better assessing how the Company’s operations and related tax risks and tax planning and operational opportunities affect the Company’s tax rate and prospects for future cash flows. This ASU becomes effective for public companies for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. This guidance will be applied on a prospective basis. The Company is currently evaluating the impact this ASU will have on its consolidated financial statements and related disclosures.
10
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
3. DISCONTINUED OPERATIONS
Mural Oncology Separation
On November 15, 2023 (the “Separation Date”), the Company completed the separation of its oncology business into Mural Oncology plc (“Mural”), a new, independent, publicly-traded company (the “Separation”). The Separation was effected by means of a distribution of all of the outstanding ordinary shares of Mural to the Company’s shareholders (the “Distribution”), in which each of the Company’s shareholders received one ordinary share, nominal value $
In connection with the Separation, the Company entered into a separation agreement with Mural, dated as of November 13, 2023 (the “Separation Agreement”), that, among other things, sets forth the Company’s agreements with Mural regarding the principal actions taken or to be taken in connection with the Separation, including the Distribution. The Separation Agreement identified those assets to be transferred to, liabilities to be assumed by, and contracts to be assigned to Mural, including the operating lease for the office and laboratory space at 852 Winter Street in Waltham, Massachusetts, and it provided for when and how such transfers, assumptions and assignments were to occur. The purpose of the Separation Agreement was to provide Mural and the Company with those assets necessary to operate their respective businesses and to retain or assume the respective liabilities related to those assets.
Under the terms of the Separation Agreement, the Company granted Mural a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to certain IP controlled by the Company as of the date of the Distribution to allow Mural to use such IP for the oncology business, and Mural granted the Company a perpetual, worldwide, non-exclusive, royalty-free, fully paid-up license (or, as the case may be, sublicense) to the IP transferred to Mural as part of the Separation for the Company’s use outside of the oncology business.
Each of Mural and the Company agreed to releases with respect to pre-Distribution claims, and cross-indemnities with respect to post-Distribution claims, that are principally designed to place financial responsibility for the obligations and liabilities allocated to Mural under the Separation Agreement, and financial responsibility for the obligations and liabilities allocated to the Company under the Separation Agreement. The Company and Mural are also each subject to mutual six-month employee non-solicitation and non-hire restrictions, subject to certain customary exceptions, and certain confidentiality restrictions and information sharing obligations.
The transfer of assets and liabilities to Mural was effected through a contribution in accordance with the Separation Agreement, as summarized below:
(In thousands) |
|
November 15, 2023 |
|
|
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
Total current assets |
|
|
|
|
Property, plant and equipment, net |
|
|
|
|
Right-of-use assets |
|
|
|
|
Goodwill |
|
|
|
|
Deferred tax asset |
|
|
|
|
Total assets |
|
$ |
|
|
LIABILITIES |
|
|
|
|
Current Liabilities |
|
|
|
|
Operating lease liabilities—short-term |
|
$ |
|
|
Total current liabilities |
|
|
|
|
Operating lease liabilities—long-term |
|
|
|
|
Total liabilities |
|
|
|
|
Net assets transferred to Mural |
|
$ |
|
11
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The Company determined that the Separation and related Distribution qualified as tax-free for U.S. federal income tax purposes, which required significant judgment by management. In making such determination, the Company applied U.S. federal tax law to relevant facts and circumstances and obtained: (i) a favorable private letter ruling from the Internal Revenue Service; (ii) a tax opinion; and (iii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for U.S. federal income tax purposes, the Company and/or its shareholders could be subject to significant liabilities, which could have material adverse impacts on the Company’s business, financial condition, results of operations and cash flows in future reporting periods. Furthermore, other than taxes recorded on the transfer of IP, the Company determined that the Separation and related Distribution qualified as tax-free for Irish tax purposes, which required significant judgment by management. In making such determination, the Company applied Irish tax law to relevant facts and circumstances and obtained: (i) a tax opinion; and (ii) other external tax advice related to the concluded tax treatment. If the Separation and Distribution were to ultimately fail to qualify for tax-free treatment for Irish tax purposes, the Company and/or its shareholders could be subject to significant liabilities, which could have material adverse impacts on the Company’s business, financial condition, results of operations and cash flows in future reporting periods.
In connection with the Separation, the Company also entered into a tax matters agreement with Mural, dated as of
In connection with the Separation, the Company also entered into an employee matters agreement with Mural, dated as of November 13, 2023 (as amended, the “Employee Matters Agreement”). The Employee Matters Agreement governs the Company’s, Mural’s and their respective subsidiaries’ and affiliates’ rights, responsibilities and obligations after the Separation with respect to, employment, benefits and compensation matters relating to employees and former employees (and their respective dependents and beneficiaries) who are or were associated with the Company, including those who became employees of Mural in connection with the Separation; the allocation of assets and liabilities generally relating to employees, employment or service-related matters and employee benefit plans; other human resources, employment and employee benefits matters; and the treatment of equity-based awards granted by the Company prior to the Separation.
The Company entered into
Discontinued Operations
The Company determined that the Separation met the criteria for classification of the oncology business as discontinued operations in accordance with Topic 205.
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Operating expenses from discontinued operations |
|
|
|
|
|
|
||
Cost of goods manufactured |
|
$ |
— |
|
|
$ |
|
|
Research and development |
|
|
|
|
|
|
||
Selling, general and administrative |
|
|
— |
|
|
|
|
|
Total operating expenses from discontinued operations |
|
|
|
|
|
|
||
Operating loss from discontinued operations |
|
|
( |
) |
|
|
( |
) |
Income tax benefit from discontinued operations |
|
|
( |
) |
|
|
( |
) |
Net loss and comprehensive loss from discontinued operations |
|
$ |
( |
) |
|
$ |
( |
) |
12
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
There were
The following table summarizes the significant non-cash items and capital expenditures of the discontinued operations that are included in the accompanying condensed consolidated statements of cash flows for the three months ended March 31, 2023:
|
|
Three Months Ended |
|
|
(In thousands) |
|
March 31, 2023 |
|
|
OPERATING ACTIVITIES: |
|
|
|
|
Depreciation |
|
$ |
|
|
Share-based compensation expense |
|
|
|
|
Right-of-use assets |
|
|
|
|
Operating lease liabilities |
|
|
( |
) |
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
Additions of property, plant and equipment |
|
$ |
( |
) |
4. REVENUE FROM CONTRACTS WITH CUSTOMERS
Product Sales, Net
During the three months ended March 31, 2024 and 2023, the Company recorded product sales, net, as follows:
|
|
Three Months Ended March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
VIVITROL |
|
$ |
|
|
$ |
|
||
ARISTADA and ARISTADA INITIO |
|
|
|
|
|
|
||
LYBALVI |
|
|
|
|
|
|
||
Total product sales, net |
|
$ |
|
|
$ |
|
Manufacturing and Royalty Revenues
During the three months ended March 31, 2024 and 2023, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:
|
|
Three Months Ended March 31, 2024 |
|
|||||||||
(In thousands) |
|
Manufacturing Revenue |
|
|
Royalty Revenue |
|
|
Total |
|
|||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
VUMERITY |
|
|
|
|
|
|
|
|
|
|||
Other |
|
|
|
|
|
|
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
|
Three Months Ended March 31, 2023 |
|
|||||||||
(In thousands) |
|
Manufacturing Revenue |
|
|
Royalty Revenue |
|
|
Total |
|
|||
Long-acting INVEGA products(1) |
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
VUMERITY |
|
|
|
|
|
|
|
|
|
|||
Other |
|
|
|
|
|
|
|
|
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
13
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
In November 2021, the Company received notice of partial termination of an exclusive license agreement with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson (“Janssen Pharmaceutica”). Under this license agreement, the Company provided Janssen Pharmaceutica with rights to, and know-how, training and technical assistance in respect of, the Company’s small particle pharmaceutical compound technology, known as NanoCrystal technology, which was used to develop the long-acting INVEGA products. When the partial termination became effective in February 2022, Janssen Pharmaceutica ceased paying royalties related to sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. Accordingly, the Company ceased recognizing royalty revenue related to sales of these products in February 2022. In April 2022, the Company commenced binding arbitration proceedings related to, among other things, Janssen Pharmaceutica’s partial termination of this license agreement and Janssen Pharmaceutica’s royalty and other obligations under the agreement. In May 2023, the arbitral tribunal (the “Tribunal”) in the arbitration proceedings issued a final award (the “Final Award”) which concluded the arbitration proceedings. The Final Award provided, among other things, that the Company was due back royalties and late-payment interest related to 2022 U.S. net sales of the long-acting INVEGA products, which payments were received from Janssen Pharmaceutica in the second quarter of 2023, and is entitled to 2023 and future royalty revenues from Janssen Pharmaceutica related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires).
Following issuance of the Final Award, the Company recognized royalty revenues related to the back royalties and resumed recognizing royalty revenue related to ongoing U.S. sales of the long-acting INVEGA products.
Contract Assets
Contract assets include unbilled amounts related to the manufacture of a product that, once complete, will be sold under certain of the Company’s manufacturing contracts. The amounts included in the contract assets table below are classified as “Current assets” in the accompanying condensed consolidated balance sheets, as they relate to manufacturing processes that are completed in
Total contract assets at March 31, 2024 were as follows:
(In thousands) |
|
Contract Assets |
|
|
Contract assets at December 31, 2023 |
|
$ |
|
|
Additions |
|
|
|
|
Transferred to receivables, net |
|
|
( |
) |
Contract assets at March 31, 2024 |
|
$ |
|
Contract Liabilities
Contract liabilities consist of contractual obligations related to deferred revenue. At March 31, 2024 and December 31, 2023, $
Total contract liabilities at March 31, 2024 were as follows:
(In thousands) |
|
Contract Liabilities |
|
|
Contract liabilities at December 31, 2023 |
|
$ |
|
|
Additions |
|
|
— |
|
Amounts recognized into revenue |
|
|
( |
) |
Contract liabilities at March 31, 2024 |
|
$ |
|
14
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
5
Investments consisted of the following (in thousands):
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|||||||||||
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
||||||||
|
|
Amortized |
|
|
|
|
|
Less than |
|
|
Greater than |
|
|
Estimated |
|
|||||
March 31, 2024 |
|
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, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|||
Non-U.S. government 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 |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
At March 31, 2024, the Company reviewed its investment portfolio to assess whether the unrealized losses on its available-for-sale investments were temporary. Investments with unrealized losses consisted of corporate debt securities and debt securities issued and backed by U.S. agencies and the U.S. government. At March 31, 2024,
15
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
Realized gains and losses on the sales and maturities of investments, which were identified using the specific identification method, were as follows:
|
|
Three Months Ended March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Proceeds from the sales and maturities of investments |
|
$ |
|
|
$ |
|
||
Realized gains |
|
$ |
— |
|
|
$ |
— |
|
Realized losses |
|
$ |
— |
|
|
$ |
— |
|
The Company’s available-for-sale and held-to-maturity securities at March 31, 2024 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:
|
|
March 31, |
|
|
|
|
|
|
|
|
|
|
||||
(In thousands) |
|
2024 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. government and agency debt securities |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
||||
|
|
2023 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. government and agency debt securities |
|
|
|
|
|
|
|
|
|
|
|
— |
|
|||
Corporate debt securities |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
||
Non-U.S. government 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.
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.
16
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
The estimated fair value of the Company’s long-term debt under its amended and restated credit agreement (such debt, the “2026 Term Loans”), 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 consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work in process |
|
|
|
|
|
|
||
Finished goods(1) |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
8. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 (1) |
|
|
2023 (1) |
|
||
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 consisted of the following:
|
|
|
|
March 31, 2024 |
|
|||||||||
(In thousands) |
|
Weighted Amortizable Life (Years) |
|
Gross Carrying Amount |
|
|
Accumulated Amortization |
|
|
Net Carrying Amount |
|
|||
Goodwill |
|
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
||
Finite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|||
Collaboration agreements |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
— |
|
||
Capitalized IP |
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total |
|
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
17
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
10. LEASES
Future lease payments under non-cancelable leases at March 31, 2024 consisted of the following:
|
|
March 31, |
|
|
(In thousands) |
|
2024 |
|
|
2024 |
|
$ |
|
|
2025 |
|
|
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Thereafter |
|
|
|
|
Total operating lease payments |
|
$ |
|
|
Less: imputed interest |
|
|
( |
) |
Total operating lease liabilities |
|
$ |
|
At March 31, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for all operating leases held by the Company were
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
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:
|
|
March 31, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Medicaid rebates |
|
$ |
|
|
$ |
|
||
Product discounts |
|
|
|
|
|
|
||
Medicare Part D |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued sales discounts, allowances and reserves |
|
$ |
|
|
$ |
|
Included in accounts payable was approximately $
18
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
12. LONG-TERM DEBT
Long-term debt consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
2026 Term Loans, due March 12, 2026 |
|
$ |
|
|
$ |
|
||
Less: current portion |
|
|
( |
) |
|
|
( |
) |
Long-term debt |
|
$ |
|
|
$ |
|
The 2026 Term Loans mature on
The 2026 Term Loans have an incremental facility capacity in the amount of $
13. SHARE-BASED COMPENSATION
The following table presents share-based compensation expense from continuing and discontinued operations included in the accompanying condensed consolidated statements of operations and comprehensive income (loss):
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Cost of goods manufactured and sold |
|
$ |
|
|
$ |
|
||
Research and development |
|
|
|
|
|
|
||
Selling, general and administrative |
|
|
|
|
|
|
||
Share-based compensation expense from continuing operations |
|
|
|
|
|
|
||
Cost of goods manufactured and sold |
|
|
— |
|
|
|
— |
|
Research and development |
|
|
— |
|
|
|
|
|
Selling, general and administrative |
|
|
— |
|
|
|
|
|
Share-based compensation expense from discontinued operations |
|
|
— |
|
|
|
|
|
Total share-based compensation expense |
|
$ |
|
|
$ |
|
At March 31, 2024 and December 31, 2023, $
In February 2021, the compensation committee of the Company’s board of directors approved the grant of performance-based restricted stock units to employees of the Company at the Senior Vice President level and above, in each case subject to vesting based on the achievement of certain financial, commercial and R&D performance criteria to be assessed over a performance period of three years from the date of the grant, and subject, at the end of such three-year performance period, to upward or downward adjustment based on a market condition tied to relative share price performance over the three-year performance period. On February 8, 2024, the compensation committee of the Company’s board of directors determined that the Company partially achieved the financial performance criteria. This was considered a modification in accordance with FASB ASC 718, Compensation—Stock Compensation (“Topic 718”) and resulted in a modification charge of approximately $
19
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
14. EARNINGS (LOSS) PER SHARE
Basic earnings (loss) per ordinary share is calculated based upon net income (loss) available to holders of ordinary shares divided by the weighted average number of ordinary shares outstanding. For the calculation of diluted earnings (loss) per ordinary share, the Company utilizes the treasury stock method and adjusts the weighted average number of ordinary shares outstanding for the effect of outstanding ordinary share equivalents such as stock options and restricted stock unit awards.
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 (1) |
|
||
Numerator: |
|
|
|
|
|
|
||
Net income (loss) from continuing operations |
|
$ |
|
|
$ |
( |
) |
|
Net loss from discontinued operations |
|
|
( |
) |
|
|
( |
) |
Net income (loss) |
|
$ |
|
|
$ |
( |
) |
|
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 earnings (loss) per ordinary share |
|
|
|
|
|
|
The following potential ordinary share equivalents were not included in the net earnings (loss) per ordinary share calculation because the effect would have been anti-dilutive:
|
|
Three Months Ended |
|
|||||
|
|
March 31, |
|
|||||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
Stock options |
|
|
|
|
|
|
||
Restricted stock unit awards |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
15. 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.
The Company recorded income tax provisions of $
The Company’s effective tax rate during the three months ended March 31, 2024 was
20
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
multinational companies with consolidated annual revenue of at least €
16. COMMITMENTS AND CONTINGENT LIABILITIES
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 March 31, 2024, there were
INVEGA SUSTENNA ANDA Litigation
Janssen Pharmaceutica and Janssen Pharmaceuticals, Inc. initiated patent infringement lawsuits in the U.S. District Court for the District of New Jersey (the “NJ District Court”) in January 2018 against Teva Pharmaceuticals USA, Inc. (“Teva”) and Teva Pharmaceuticals Industries, Ltd. (“Teva PI”) (such lawsuit, the “Teva Lawsuit”), in August 2019 against Mylan Laboratories Limited (“Mylan Labs”) and other Mylan entities (the “Mylan Lawsuit”), in December 2019 against Pharmascience, Inc. (“Pharmascience”), Mallinckrodt plc, and SpecGX LLC (the “Pharmascience Lawsuit”), and in February 2022 against Accord Healthcare, Inc., Accord Healthcare, Ltd. and Intas Pharmaceuticals, Ltd (“Accord” and such lawsuit, the “Accord Lawsuit”), and in the U.S. District Court for the District of Delaware (the “DE District Court”) in December 2021 against Tolmar Holding, Inc., Tolmar Pharmaceuticals, Inc., Tolmar Therapeutics, Inc., and Tolmar, Inc. (“Tolmar” and such lawsuit, the “Tolmar Lawsuit”), following the respective filings by each of Teva, Mylan Labs, Pharmascience, Accord and Tolmar of an Abbreviated New Drug Application (“ANDA”) seeking approval from the FDA to market a generic version of INVEGA SUSTENNA before the expiration of U.S. Patent No. 9,439,906. In October 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Teva Lawsuit. In December 2021, the NJ District Court entered a judgment in favor of the Janssen entities in the Mylan Lawsuit, based on the parties’ prior stipulation to be bound by the judgment in the Teva Lawsuit. The Teva entities and Mylan Labs each filed notices of appeal of their respective judgments with the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit Court”), which were consolidated in January 2022 (the “Teva Appeal”). The Pharmascience Lawsuit and the Accord Lawsuit were administratively terminated in July 2022, pending the outcome of the Teva Appeal. The Company is not a party to any of these proceedings. On April 1, 2024, the Federal Circuit Court issued a decision affirming in part and vacating and remanding in part the NJ District Court’s judgment. A trial was held in the Tolmar Lawsuit in October 2023 and on March 13, 2024, the DE District Court issued a decision, following which a notice of appeal and certain post-trial motions were filed in April 2024.
INVEGA TRINZA ANDA Litigation
In September 2020, Janssen Pharmaceutica, Janssen Pharmaceuticals, Inc., and Janssen Research & Development, LLC initiated a patent infringement lawsuit in the NJ District Court against Mylan Labs, Mylan, and Mylan Institutional LLC following the filing by Mylan Labs of an ANDA seeking approval from the FDA to market a generic version of INVEGA TRINZA before the expiration of U.S. Patent No. 10,143,693 (the “’693 Patent”). Requested judicial remedies include recovery of litigation costs and injunctive relief. In May 2023, the NJ District Court issued an opinion in favor of the Janssen entities on the issues of infringement and validity of the ’693 Patent and the Mylan entities filed a notice of appeal of the decision. The Company is not a party to this proceeding.
VUMERITY ANDA Litigation
In July 2023, Biogen Inc., Biogen Swiss Manufacturing GmbH and Alkermes Pharma Ireland Limited filed a patent infringement lawsuit in the DE District Court against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc. and Zydus Lifesciences Limited (collectively, “Zydus”) following the filing by Zydus of an ANDA seeking approval from the FDA to engage in the commercial manufacture, use or sale of a generic version of VUMERITY (diroximel fumarate) delayed-release capsules for oral use, 231 mg, before expiration of the Company’s U.S. Patent Nos. 8,669,281;
21
ALKERMES PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Unaudited) (Continued)
9,090,558; and 10,080,733. The filing of the lawsuit triggered a stay of FDA approval of the ANDA 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”). A bench trial is scheduled to begin on July 28, 2025.
Government Matters
The Company has received a subpoena and civil investigative demands from U.S. state and federal governmental authorities for documents related to VIVITROL. The Company is cooperating with the investigations.
Product Liability and Other Legal Proceedings
The Company is involved in litigation and other legal proceedings incidental to its normal business activities, including product liability cases alleging that the FDA-approved VIVITROL labeling was inadequate and caused the users of the product to suffer from opioid overdose and death. The Company intends to vigorously defend itself in these matters.
In addition, in January 2023, 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 $
While the outcome of any of these proceedings cannot be accurately predicted, the Company does not believe the ultimate resolution of any of these existing proceedings would have a material adverse effect on the Company’s business or financial condition.
Guarantees
In connection with the Separation, the Company entered into the Assignment related to the 852 Winter Street Lease, which is described in more detail in Note 10, Leases in the “Notes to Consolidated Financial Statements” in the Annual Report. Although the Assignment transferred all of the rights, title and interest in, to and under the 852 Winter Street Lease to Mural US as of November 15, 2023, the Company ratified and reaffirmed for the remainder of the lease term its guarantor obligations under that certain Guaranty dated as of
22
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 from continuing operations was $38.9 million or $0.23 per ordinary share—basic and diluted, for the three months ended March 31, 2024, compared to net loss from continuing operations of $12.1 million or $0.07 per ordinary share—basic and diluted, for the three months ended March 31, 2023.
The net income from continuing operations during the three months ended March 31, 2024, as compared to the net loss from continuing operations during the three months ended March 31, 2023, was primarily due to an increase of $44.0 million in manufacturing and royalty revenues, an increase of $18.8 million in product sales, net and a decrease of $7.7 million in amortization of acquired intangible assets, partially offset by an increase of $11.9 million in selling, general and administrative expense, and an increase of $6.4 million in R&D expense.
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.
Business Update
On May 1, 2024, we completed the previously announced sale of the Athlone Facility to Novo. We also entered into subcontracting arrangements with Novo to continue certain development and manufacturing activities currently performed at the Athlone Facility for a period of time after the closing of the transaction; these activities may continue through the end of 2025.
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.
23
The following provides summary information regarding our proprietary products that we commercialize:
Proprietary Products
Product |
|
Indication(s) |
|
|
Territory |
|
|
|
|
|
|
|
|
Initiation or re-initiation of ARISTADA for the treatment of Schizophrenia |
|
|
U.S. |
|
Schizophrenia
|
|
|
U.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Schizophrenia; Bipolar I disorder
|
|
|
U.S. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alcohol dependence; Opioid dependence |
|
|
U.S. |
24
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 |
|
Indication(s) |
|
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 |
|
Indication(s) |
|
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 and bipolar I disorder. 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
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 April 2024, U.S. Patent No. 11,969,469 relating to ARISTADA was granted. This patent has claims to pharmaceutical compositions that confer long-term stability of the ARISTADA formulation and expires in 2033.
ARISTADA INITIO
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.
25
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.
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.
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.
For a discussion of legal proceedings related to certain of the patents covering INVEGA SUSTENNA and INVEGA TRINZA, see Note 16, 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 “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
26
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. For a discussion of legal proceedings related to certain of the patents covering VUMERITY, see Note 16, 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 “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
Key Development Program
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 program. 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 program.
ALKS 2680
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (“OX2R”) agonist in development as a once-daily treatment for narcolepsy. Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy. ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goal of improving duration of wakefulness and providing cataplexy control. ALKS 2680 was evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia and is currently being evaluated in a phase 2 study in patients with narcolepsy type 1. We expect to initiate a planned phase 2 study in patients with narcolepsy type 2 in the second half of 2024.
27
Results of Operations
As a result of the Separation, the historical results of our oncology business have been reflected as discontinued operations in our consolidated financial statements through the Separation Date. Prior period results of operations and balance sheet information have been recast to reflect this presentation.
Product Sales, Net
Our product sales, net, consist of sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI, primarily to wholesalers, specialty distributors and pharmacies. The following table presents the adjustments deducted from product sales, gross to arrive at product sales, net, for sales of VIVITROL, ARISTADA and ARISTADA INITIO, and LYBALVI during the three months ended March 31, 2024 and 2023:
|
Three Months Ended |
|
|
||||||||||||||
|
March 31, |
|
|
||||||||||||||
(In millions, except for % of Sales) |
2024 |
|
|
% of Sales |
|
|
|
2023 |
|
|
% of Sales |
|
|
||||
Product sales, gross |
$ |
467.3 |
|
|
|
100.0 |
|
% |
|
$ |
433.9 |
|
|
|
100.0 |
|
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Medicaid rebates |
|
(105.0 |
) |
|
|
(22.5 |
) |
% |
|
|
(97.9 |
) |
|
|
(22.6 |
) |
% |
Chargebacks |
|
(50.5 |
) |
|
|
(10.8 |
) |
% |
|
|
(45.4 |
) |
|
|
(10.5 |
) |
% |
Product discounts |
|
(34.3 |
) |
|
|
(7.3 |
) |
% |
|
|
(34.5 |
) |
|
|
(8.0 |
) |
% |
Medicare Part D |
|
(17.4 |
) |
|
|
(3.7 |
) |
% |
|
|
(18.9 |
) |
|
|
(4.4 |
) |
% |
Other |
|
(26.6 |
) |
|
|
(5.7 |
) |
% |
|
|
(22.5 |
) |
|
|
(5.1 |
) |
% |
Total adjustments |
|
(233.8 |
) |
|
|
(50.0 |
) |
% |
|
|
(219.2 |
) |
|
|
(50.5 |
) |
% |
Product sales, net |
$ |
233.5 |
|
|
|
50.0 |
|
% |
|
$ |
214.7 |
|
|
|
49.5 |
|
% |
VIVITROL product sales, gross, increased by 2% during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, primarily due to a 3.2% increase in the selling price that went into effect in January 2024, partially offset by a 1% decrease in the number of units sold. ARISTADA and ARISTADA INITIO product sales, gross, were relatively flat during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, due to a 3.0% increase in the selling price that went into effect in January 2024, partially offset by a 3% decrease in the number of units sold. LYBALVI product sales, gross, increased by 56% during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, primarily due to a 50% increase in the number of units sold and 3% and 3.8% increases in the selling price that went into effect in July 2023 and January 2024, respectively.
The following table compares product sales, net earned during the three months ended March 31, 2024 and 2023:
|
Three Months Ended |
|
|
|
|
||||||
|
March 31, |
|
|
|
|
||||||
(In millions) |
2024 |
|
|
2023 |
|
|
Change |
|
|||
VIVITROL |
$ |
97.7 |
|
|
$ |
96.7 |
|
|
$ |
1.0 |
|
ARISTADA and ARISTADA INITIO |
|
78.9 |
|
|
|
80.1 |
|
|
|
(1.2 |
) |
LYBALVI |
|
57.0 |
|
|
|
37.9 |
|
|
|
19.1 |
|
Product sales, net |
$ |
233.5 |
|
|
$ |
214.7 |
|
|
$ |
18.9 |
|
Manufacturing and Royalty Revenues
The following table compares manufacturing and royalty revenues earned during the three months ended March 31, 2024 and 2023:
|
Three Months Ended |
|
|
|
|
||||||
|
March 31, |
|
|
|
|
||||||
(In millions) |
2024 |
|
|
2023 |
|
|
Change |
|
|||
Manufacturing and royalty revenues: |
|
|
|
|
|
|
|
|
|||
Long-acting INVEGA products |
$ |
62.7 |
|
|
$ |
13.6 |
|
|
$ |
49.1 |
|
VUMERITY |
|
31.3 |
|
|
|
28.9 |
|
|
|
2.4 |
|
Other |
|
22.8 |
|
|
|
30.4 |
|
|
|
(7.6 |
) |
Manufacturing and royalty revenues |
$ |
116.8 |
|
|
$ |
72.9 |
|
|
$ |
43.9 |
|
28
Our agreements with Janssen related to the long-acting INVEGA products provide for tiered royalty payments, which consist of a patent royalty and a know-how royalty, both of which are determined on a country-by-country basis. The patent royalty, which equals 1.5% of net sales, is payable in each country until the expiration of the last of the patents with valid claims applicable to the product in such country. The know-how royalty is a tiered royalty of 3.5% on calendar year net sales up to $250 million; 5.5% on calendar year net sales of between $250 million and $500 million; and 7.5% on calendar year net sales exceeding $500 million. The know-how royalty rate resets to 3.5% at the beginning of each calendar year and is payable until 15 years from the first commercial sale of a product in each individual country, subject to expiry of the agreement. For more information about the license agreement with Janssen in respect of the long-acting INVEGA products, see the “Collaborative Arrangements—Janssen” section in “Part I, Item 1—Business” in our Annual Report.
In November 2021, we received notice from Janssen of partial termination of our license agreement under which we provided Janssen with rights to, and know-how, training and technical assistance in respect of, our NanoCrystal technology, which was used to develop the long-acting INVEGA products. The partial termination became effective in February 2022, at which time Janssen ceased paying royalties related to sales of INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. Accordingly, we ceased recognizing royalty revenue related to sales of these products in February 2022. In April 2022, we commenced binding arbitration proceedings related to, among other things, Janssen’s partial termination of this license agreement and Janssen’s royalty and other obligations under the agreement. In May 2023, the Tribunal issued the Final Award, which concluded the arbitration proceedings. The Final Award provided that we were due back royalties and late-payment interest related to 2022 U.S. net sales of the long-acting INVEGA products, which we received from Janssen in the second quarter of 2023, and are entitled to 2023 and future royalty revenues from Janssen related to net sales of INVEGA SUSTENNA through August 20, 2024, INVEGA TRINZA through the second quarter of 2030 (but no later than May 2030 when the license agreement expires) and INVEGA HAFYERA through May 2030 (when the license agreement expires).
Following issuance of the Final Award, we recognized royalty revenues related to the back royalties and resumed recognizing royalty revenue related to U.S. sales of the long-acting INVEGA products. Royalty revenues related to the long-acting INVEGA products increased by $49.1 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, primarily due to the result of the arbitration proceedings in the second quarter of 2023 and the resumption of recognizing royalty revenue on U.S. net sales of the long-acting INVEGA products. During the three months ended March 31, 2024, Janssen’s worldwide net sales of the long-acting INVEGA products were $1,056.0 million, as compared to $1,044.0 million during the three months ended March 31, 2023.
We expect royalty revenues from net sales of the long-acting INVEGA products to decrease in the near-term, as the royalty revenues related to net sales of INVEGA SUSTENNA are expected to end on August 20, 2024, which we anticipate will have a significant impact on our INVEGA SUSTENNA royalty revenues during 2024. In addition, each of INVEGA SUSTENNA and INVEGA TRINZA are currently subject to Paragraph IV litigation in response to companies seeking to market generic versions of such products. Increased competition from new products or generic versions of these products may lead to reduced unit sales of such products and increased pricing pressure. For a discussion of these legal proceedings, see Note 16, Commitments and Contingent Liabilities in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, and for information about risks relating to these legal proceedings, see “Part I, Item 1A—Risk Factors” in our Annual Report, and specifically the section entitled “We or our licensees may face claims against IP rights covering our products and competition from generic drug manufacturers.”
We receive a 15% royalty on worldwide net sales of VUMERITY manufactured and packaged by us, subject to increases in such royalty rate for VUMERITY manufactured and/or packaged by Biogen or its designees, in the period that the end-market sales of VUMERITY occur. We also recognize manufacturing revenue related to VUMERITY at cost plus 15%, upon making available bulk batches of VUMERITY to Biogen and, to the extent we package such product, then also when packaged batches of VUMERITY are made available to Biogen. Manufacturing revenue from VUMERITY decreased by $0.5 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023. The decrease was primarily due to a reduction in the sales price, partially offset by increases in the number of packaged and bulk batches made available to Biogen. The reduction in the sales price related to our manufacturing revenue was primarily due to the removal of depreciation expense from the manufacturing cost base as the assets used to manufacture VUMERITY were classified as held for sale in the three months ended March 31, 2024. Royalty revenue related to VUMERITY increased by $2.9 million during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023. The increase in royalty revenue was due to an increase in end-market net sales of VUMERITY from $108.2 million during the three months ended March 31, 2023 to $127.5 million during the three months ended March 31, 2024.
29
Costs and Expenses
Cost of Goods Manufactured and Sold
|
Three Months Ended |
|
|
|
|
||||||
|
March 31, |
|
|
|
|
||||||
(In millions) |
2024 |
|
|
2023 (1) |
|
|
Change |
|
|||
Cost of goods manufactured and sold |
$ |
58.6 |
|
|
$ |
58.2 |
|
|
$ |
0.4 |
|
The increase in cost of goods manufactured and sold during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to an increase of $3.9 million in the cost of goods sold for VIVITROL, partially offset by decreases in the cost of goods manufactured for certain legacy products that we manufacture due to a decrease in sales of such products. The increase in the cost of goods sold for VIVITROL was primarily due to an increase in costs related to out-of-specification batches and investigation costs.
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 months ended March 31, 2024 and 2023 relating to our then-current development programs and our internal R&D expenses, listed by the nature of such expenses:
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
March 31, |
|
|
|
|
||||||
(In millions) |
|
2024 |
|
|
2023 (1) |
|
|
Change |
|
|||
External R&D expenses: |
|
|
|
|
|
|
|
|
|
|||
Development programs: |
|
|
|
|
|
|
|
|
|
|||
ALKS 2680 |
|
$ |
10.5 |
|
|
$ |
1.7 |
|
|
$ |
8.8 |
|
LYBALVI |
|
|
5.0 |
|
|
|
3.3 |
|
|
|
1.7 |
|
Other external R&D expenses |
|
|
8.8 |
|
|
|
14.4 |
|
|
|
(5.6 |
) |
Total external R&D expenses |
|
|
24.3 |
|
|
|
19.4 |
|
|
|
4.9 |
|
Internal R&D expenses: |
|
|
|
|
|
|
|
|
|
|||
Employee-related |
|
|
34.5 |
|
|
|
33.2 |
|
|
|
1.3 |
|
Occupancy |
|
|
3.0 |
|
|
|
2.9 |
|
|
|
0.1 |
|
Depreciation |
|
|
1.4 |
|
|
|
2.3 |
|
|
|
(0.9 |
) |
Other |
|
|
4.4 |
|
|
|
6.0 |
|
|
|
(1.6 |
) |
Total internal R&D expenses |
|
|
43.3 |
|
|
|
44.4 |
|
|
|
(1.1 |
) |
Research and development expenses |
|
$ |
67.6 |
|
|
$ |
63.8 |
|
|
$ |
3.8 |
|
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.
The increase in expenses related to ALKS 2680 during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to an increase in spend related to the advancement of the development program for the product, including completion of our phase 1b proof-of-concept study and activities to prepare for the initiation of our phase 2 clinical studies for the product, the first of which was announced in April 2024 in patients with narcolepsy type 1, and the second of which we expect to initiate in patients with narcolepsy type 2 in the second half of 2024.The increase in expenses related to LYBALVI during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to increased spend on the pediatric studies
30
related to the product, partially offset by decreased spend following the completion of the long-term safety and tolerability studies for the product. The decrease in other external R&D expenses during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to disciplined prioritization of R&D spend and activities associated with our research programs.
Selling, General and Administrative Expense
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
March 31, |
|
|
|
|
||||||
(In millions) |
|
2024 |
|
|
2023 (1) |
|
|
Change |
|
|||
Selling and marketing expense |
|
$ |
125.6 |
|
|
$ |
118.5 |
|
|
$ |
7.1 |
|
General and administrative expense |
|
|
54.1 |
|
|
|
49.3 |
|
|
|
4.8 |
|
Selling, general and administrative expense |
|
$ |
179.7 |
|
|
$ |
167.8 |
|
|
$ |
11.9 |
|
The increase in selling and marketing expense during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to a $4.7 million increase in marketing spend related to the direct-to-consumer campaign for LYBALVI. Employee-related expenses also increased by $2.0 million, primarily due to an increase in share-based compensation expense related to the vesting of certain performance-based restricted stock unit awards, as previously discussed in Note 13, Share-based Compensation within the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q.
The increase in general and administrative expense during the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, was primarily due to an increase in employee-related expenses of $4.8 million, primarily due to an increase in share-based compensation expense related to the vesting of certain performance-based restricted stock unit awards, as previously discussed in Note 13, Share-based Compensation within the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q, partially offset by a decrease in professional services fees of $1.9 million, primarily due to decreased legal expenses.
Other Income (Expense), Net
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
March 31, |
|
|
|
|
||||||
(In millions) |
|
2024 |
|
|
2023 |
|
|
Change |
|
|||
Interest income |
|
$ |
9.4 |
|
|
$ |
5.0 |
|
|
$ |
4.4 |
|
Interest expense |
|
|
(6.0 |
) |
|
|
(5.3 |
) |
|
|
(0.7 |
) |
Other income (expense), net |
|
|
0.2 |
|
|
|
(0.1 |
) |
|
|
0.3 |
|
Total other income (expense), net |
|
$ |
3.6 |
|
|
$ |
(0.4 |
) |
|
$ |
4.0 |
|
Interest income consists primarily of interest earned on our cash and available-for-sale investments. Interest expense consists of interest incurred on our 2026 Term Loans. The increases in interest income and interest expense in the three months ended March 31, 2024, as compared to the three months ended March 31, 2023, were primarily related to increases in interest rates, due to the rising interest rate environment.
Income Tax Provision
|
|
March 31, |
|
|
|
|
||||||
(In millions) |
|
2024 |
|
|
2023 (1) |
|
|
Change |
|
|||
Income tax provision |
|
|
8.0 |
|
|
|
0.7 |
|
|
$ |
7.3 |
|
The income tax provision in the three months ended March 31, 2024 was primarily attributable to taxes on income earned in Ireland. The income tax provision in the three months ended March 31, 2023 was primarily due to U.S. federal and state taxes on income earned in the U.S. and the tax impact of employee equity activity.
31
Liquidity and Financial Condition
Our financial condition is summarized as follows:
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
||||||||||||||||||
(In millions) |
|
U.S. |
|
|
Ireland |
|
|
Total |
|
|
U.S. |
|
|
Ireland |
|
|
Total |
|
||||||
Cash and cash equivalents |
|
$ |
128.3 |
|
|
$ |
292.5 |
|
|
$ |
420.8 |
|
|
$ |
317.8 |
|
|
$ |
139.7 |
|
|
$ |
457.5 |
|
Investments—short-term |
|
|
209.8 |
|
|
|
114.5 |
|
|
|
324.3 |
|
|
|
187.6 |
|
|
|
128.4 |
|
|
|
316.0 |
|
Investments—long-term |
|
|
28.0 |
|
|
|
34.8 |
|
|
|
62.8 |
|
|
|
18.0 |
|
|
|
21.9 |
|
|
|
39.9 |
|
Total cash and investments |
|
$ |
366.1 |
|
|
$ |
441.8 |
|
|
$ |
807.9 |
|
|
$ |
523.4 |
|
|
$ |
290.0 |
|
|
$ |
813.4 |
|
Outstanding borrowings—short and long-term |
|
$ |
290.1 |
|
|
$ |
— |
|
|
$ |
290.1 |
|
|
$ |
290.7 |
|
|
$ |
— |
|
|
$ |
290.7 |
|
At March 31, 2024 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 |
|
$ |
324.6 |
|
|
$ |
0.5 |
|
|
$ |
(0.8 |
) |
|
$ |
— |
|
|
$ |
324.3 |
|
Investments—long-term available-for-sale |
|
|
61.6 |
|
|
|
— |
|
|
|
(0.6 |
) |
|
|
— |
|
|
|
61.0 |
|
Investments—long-term held-to-maturity |
|
|
1.8 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1.8 |
|
Total |
|
$ |
388.0 |
|
|
$ |
0.5 |
|
|
$ |
(1.4 |
) |
|
$ |
— |
|
|
$ |
387.1 |
|
Sources and Uses of Cash
We generated $21.1 million of cash from operating activities and used $21.3 million of cash in operating activities during the three months ended March 31, 2024 and 2023, respectively. We expect that our existing cash, cash equivalents and investments will be sufficient to finance our anticipated working capital and other cash requirements, such as capital expenditures and principal and interest payments on our long-term debt, 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 additional financing in the future, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures. In addition, the 2026 Term Loans have an incremental facility capacity in an amount of $175.0 million, plus additional potential amounts, provided that we meet certain conditions, including a specified leverage ratio.
Our investment objectives are, first, to preserve capital and provide sufficient liquidity to satisfy operating requirements 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, sector 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.
We classify available-for-sale investments in an unrealized loss position that do not mature within twelve 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 twelve months.
Information about our cash flows, by category, is presented in the accompanying consolidated statements of cash flows. The discussion of our cash flows that follows does not include the impact of any adjustments to remove discontinued operations and is stated on a total company consolidated basis. The following table summarizes our cash flows for the three months ended March 31, 2024 and 2023:
32
|
|
Three Months Ended March 31, |
|
|||||
(In millions) |
|
2024 |
|
|
2023 |
|
||
Cash and cash equivalents, beginning of period |
|
$ |
457.5 |
|
|
$ |
292.5 |
|
Cash flows provided by (used in) operating activities |
|
|
21.1 |
|
|
|
(21.3 |
) |
Cash flows (used in) provided by investing activities |
|
|
(39.9 |
) |
|
|
72.8 |
|
Cash flows used in financing activities |
|
|
(17.9 |
) |
|
|
(22.6 |
) |
Cash and cash equivalents, end of period |
|
$ |
420.8 |
|
|
$ |
321.4 |
|
Operating Activities
Cash flows from 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 (loss) 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 provided by operating activities for the three months ended March 31, 2024 were $21.1 million and primarily consisted of a net income of $38.9 million adjusted for non-cash items, including share-based compensation of $32.8 million, depreciation and amortization of $8.1 million and deferred income taxes of $7.5 million, partially offset by changes in working capital of $66.3 million.
Cash flows used in operating activities for the three months ended March 31, 2023 were $21.3 million and primarily consisted of a net loss of $41.8 million adjusted for non-cash items, including share-based compensation of $22.6 million, depreciation and amortization of $18.7 million and changes in working capital of $14.9 million, partially offset by deferred income taxes of $36.1 million.
Investing Activities
Cash flows used in investing activities for the three months ended March 31, 2024 were primarily due to $32.0 million in net purchase of investments and the purchase of $8.3 million of property, plant and equipment. Cash flows provided by investing activities for the three months ended March 31, 2023 were primarily due to a $79.7 million increase in net sales of investments, offset by the purchase of $6.9 million of property, plant and equipment.
Financing Activities
Cash flows used in financing activities for the three months ended March 31, 2024 and 2023 primarily related to $28.3 million and $24.7 million of employee taxes paid related to the net share settlement of equity awards, respectively, partially offset by $11.2 million and $2.9 million of cash that we received upon exercises of employee stock options, respectively.
Debt
At March 31, 2024, the principal balance of our borrowings consisted of $291.0 million outstanding under our 2026 Term Loans. See Note 12, Long-Term Debt, in the “Notes to Condensed Consolidated Financial Statements” in this Form 10-Q for further discussion of our 2026 Term Loans.
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.
33
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.
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, 2023, 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 to manufacturing and 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, 2023.
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 interim 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 March 31, 2024. Based upon that evaluation, our principal executive officer and interim 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 interim 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 March 31, 2024, 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.
34
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
For information regarding legal proceedings, see the discussion of legal proceedings in Note 16, 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. There have been no material changes from the risk factors disclosed in our Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On February 15, 2024, our board of directors authorized a share repurchase program to repurchase ordinary shares of the Company in an aggregate amount of up to $400.0 million (exclusive of any fees, commissions or other expenses related to such repurchases) from time to time (the “2024 Repurchase Program”). The timing and amount of any share repurchases under the 2024 Repurchase Program will be based on a variety of factors, including but not limited to ongoing assessments of our needs, alternative investment opportunities, the market price of our ordinary shares and general market conditions. The 2024 Repurchase Program has no set expiration date and may be suspended or discontinued at any time. The 2024 Repurchase Program terminates, and supersedes in its entirety, our prior share repurchase program authorized by our board of directors in September 2011. We did not purchase any shares under this program during the three months ended March 31, 2024.
During the three months ended March 31, 2024, we acquired 960,486 of our ordinary shares, at an average price of $29.52 per share, to satisfy withholding tax obligations related to the vesting of employee equity awards.
Item 5. Other Information
During the three months ended March 31, 2024, no officers (as defined in Rule 16a-1(f) under the Exchange Act) or directors of the Company
35
Item 6. Exhibits
The following exhibits are filed or furnished as part of this Form 10-Q:
EXHIBIT INDEX
Exhibit No. |
|
Description of Exhibit |
3.1 # |
|
Memorandum and Articles of Association of Alkermes plc (as amended and restated on May 13, 2022). |
31.1 # |
|
|
31.2 # |
|
|
32.1 ‡ |
|
|
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.
36
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/ Blair C. Jackson |
|
|
|
Blair C. Jackson |
|
|
|
Executive Vice President, Chief Operating Officer |
|
|
|
(Interim Principal Financial Officer) |
|
Date: May 1, 2024 |
|
|
|
37