Alkermes plc 8-K, filed Dec 14, 2023
Alkermes plc. (ALKS)
About this 8-K
Alkermes plc filed this 8-K on December 14, 2023, reporting on events of December 13, 2023.
Items reported
- Item 1.01: Entered into a material agreement
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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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. ☐
Item 1.01 Entry into a Material Definitive Agreement.
On December 13, 2023, Alkermes Pharma Ireland Limited (the “Seller”), an indirect wholly-owned subsidiary of Alkermes plc (together with its subsidiaries, the “Company”), entered into an asset purchase agreement (the “Purchase Agreement”) with Novo Nordisk Production Ireland Limited (the “Purchaser”) and Novo Nordisk A/S (the “Purchaser Guarantor” and, collectively with the Seller and the Purchaser, the “Parties”). Under the Purchase Agreement, the Seller agreed to sell and transfer to the Purchaser, and the Purchaser agreed to purchase and assume liabilities related to, the Company’s development and manufacturing facility located in Athlone, Ireland (the “Athlone Facility”) and certain assets used in the operation or functioning of the Athlone Facility for an aggregate cash purchase price of $92.5 million (subject to adjustment in accordance with the terms of the Purchase Agreement, the “Purchase Price,” and the purchase and sale transactions under the Purchase Agreement collectively, the “Transaction”). Pursuant to the terms of the Purchase Agreement, the Purchaser Guarantor has agreed to guarantee the Purchaser’s obligations to pay the Purchase Price.
In connection with the Transaction, approximately 400 employees of the Seller will transfer to the Purchaser upon the closing of the Transaction (the “Closing”).
Pursuant to the Purchase Agreement, the Parties and/or certain of their affiliates, as applicable, will enter into, in connection with the Closing, certain ancillary agreements, including, among others, a land sale contract, a transitional services agreement, and agreements under which the Purchaser will continue certain development and manufacturing work currently performed at the Athlone Facility for a period of time after the Closing, which work may continue through the end of 2025.
The Purchase Agreement contains customary warranties and covenants by and to the Parties, including indemnification obligations for, among other matters, breaches or failure to perform warranties or covenants and for certain liabilities or claims, in each case subject to the terms set forth in the Purchase Agreement.
The Closing, expected to occur in mid-2024, is subject to certain closing conditions set forth in the Purchase Agreement.
The warranties and covenants contained in the Purchase Agreement were made only for the purposes of the Purchase Agreement and the transactions contemplated thereby and solely for the benefit of the Parties, and may be subject to qualifications or limitations agreed by the Parties in connection with negotiating the terms of the Purchase Agreement. In addition, certain warranties were made as of a specific date, may be subject to a contractual standard of materiality different from those generally applicable to investors, or may have been used for the purposes of allocating risk between the Parties rather than establishing matters as facts. Accordingly, the foregoing description of the Purchase Agreement is only intended to provide investors with information regarding the terms of the Purchase Agreement, and investors should not rely on the warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or the condition of the Seller and should read the foregoing description of the Purchase Agreement, including such warranties and covenants or any descriptions thereof, in conjunction with the disclosures in the Company’s periodic reports and other filings with the U.S. Securities and Exchange Commission (the “SEC”).
The foregoing description of the Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the Purchase Agreement, a copy of which the Company intends to file as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2023.
Item 7.01 Regulation FD Disclosure.
On December 14, 2023, the Company issued a press release announcing entry into the Purchase Agreement. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated by reference in this Item 7.01.
The information in this Item 7.01, and in Exhibit 99.1 furnished herewith, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933, as amended, (the “Securities Act”) or the Exchange Act except as expressly set forth by specific reference in such a filing.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
EXHIBIT INDEX
Exhibit No. |
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Description |
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99.1 |
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Press release issued by Alkermes plc dated December 14, 2023. |
104 |
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Cover page interactive data file (embedded within the Inline XBRL document). |
Note Regarding Forward-Looking Statements
Certain statements set forth or incorporated by reference in Item 1.01 above constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, including, but not limited to, statements regarding the Company’s expectations related to the Closing, including the anticipated timing thereof, the ancillary agreements to be entered into and other conditions to consummation of the Closing. Investors are cautioned that forward-looking statements are inherently subject to risks and uncertainties that could cause actual events to differ materially from those expressed or implied in such statements, including, among others, that the Transaction may involve unexpected costs, liabilities or delays; that a condition to the Closing may not be satisfied or waived in a timely manner or at all and may result in the Closing being delayed or not occurring; that a Party may terminate the Purchase Agreement prior to the Closing; and those risks and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and in subsequent filings made by the Company with the SEC, which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained or incorporated by reference in Item 1.01.
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SIGNATURE
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 hereunto duly authorized.
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ALKERMES PLC |
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Date: December 14, 2023 |
By: |
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/s/ David J. Gaffin |
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David J. Gaffin |
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Secretary |
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Exhibit 99.1
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Alkermes Contacts: |
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For Investors: |
Sandy Coombs +1 781 609 6377 |
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For Media: |
Katie Joyce +1 781 609 6806 |
Alkermes plc Announces Agreement to Sell Athlone, Ireland Facility to Novo Nordisk
DUBLIN, Dec. 14, 2023—Alkermes plc (Nasdaq: ALKS) today announced that it has entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk, a leading global healthcare company. Under the terms of the agreement, upon the closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions.
“As we prepare to enter 2024 as a pure-play neuroscience company, we have continued our focus on aligning our infrastructure and cost structure with the projected needs of the business. Upon closing, we expect this transaction to drive operational efficiencies and enhance profitability over the long term,” said Richard Pops, Chief Executive Officer of Alkermes. “I am particularly pleased to enter this agreement with Novo Nordisk as it offers our employees at this world-class, state-of-the-art GMP manufacturing facility in Athlone an exciting opportunity for growth.”
“The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” said Thilde G. Hummel Bøgebjerg, Senior Vice President, Product Supply Emerging Technologies, Novo Nordisk. “With this acquisition, we are excited to soon welcome approximately 400 highly skilled colleagues currently employed by Alkermes with valuable capabilities within oral drug development and manufacturing who will play a key role in serving even more patients with oral products.”
Alkermes and Novo Nordisk also plan to enter into subcontracting arrangements to continue certain work currently performed at the facility for a period of time after closing of the transaction, which may continue through the end of 2025. This transaction is expected to be operating cost-neutral to Alkermes over the subcontracting period and thereafter, the transaction
is expected to yield significant operating cost benefit and contribute to enhanced profitability. Alkermes will continue to retain all royalty revenues associated with products currently manufactured at the facility.
Alkermes will continue to manufacture its proprietary commercial products, VIVITROL®, ARISTADA®, ARISTADA INITIO® and LYBALVI®, at its Wilmington, Ohio manufacturing facility.
About Alkermes plc
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the expected timeline, structure, impacts and anticipated financial and operational benefits of the transaction, including details relating to the closing of the transaction and expectations regarding the company’s plans to enter into subcontracting arrangements with Novo Nordisk; and the company’s expectations regarding its future financial plans, expectations and prospects, including anticipated royalty revenues and profitability. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: that the transaction may involve unexpected costs, liabilities or delays; that a condition to the closing of the transaction may not be satisfied
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or waived in a timely manner or at all and may result in closing being delayed or not occurring; that a party may terminate the definitive agreement relating to the transaction prior to its consummation; the company may not realize the anticipated financial or operational benefits of the transaction; the unfavorable outcome of arbitration or litigation, including so-called "Paragraph IV" litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company's products or products using the company's proprietary technologies; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company’s financial obligations to government payers; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license.
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