0001520262FalseAlkermes plc.00015202622023-10-252023-10-25

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): October 25, 2023

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland		001-35299				98-1007018
(State or other jurisdiction		(Commission				(IRS Employer
of incorporation)		File Number)				Identification No.)
Connaught House, 1 Burlington Road
Dublin 4, Ireland D04 C5Y6
(Address of principal executive offices)

 

Registrant's telephone number, including area code: + 353-1-772-8000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐		Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐		Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐		Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐		Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, $0.01 par value		ALKS		Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

		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. ☐

 

 

 

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Item 2.02 Results of Operations and Financial Condition.

 

On October 25, 2023, Alkermes plc (the “Company”) announced financial results for the three and nine months ended September 30, 2023. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on October 25, 2023 discussing such financial results are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release issued by Alkermes plc on October 25, 2023 announcing financial results for the three and nine months ended September 30, 2023.
99.2		Investor presentation to be displayed by Alkermes plc on October 25, 2023.
104		Cover page interactive data file (embedded within the Inline XBRL document).

 

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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.

 

	ALKERMES PLC
Date: October 25, 2023	By:		/s/ Iain M. Brown
			Iain M. Brown
			Senior Vice President, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

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Exhibit 99.1

	Alkermes Contacts:
	For Investors:	Sandy Coombs +1 781 609 6377
	For Media:	Katie Joyce +1 781 249 8927

 

Alkermes plc Reports Third Quarter 2023 Financial Results

— Third Quarter Revenues of $380.9 Million; Net Sales of Proprietary Products Increased Approximately 16% Year-Over-Year —

— GAAP Net Income of $47.8 Million and Non-GAAP Net Income of $109.5 Million —

— Company Reiterates Financial Expectations for Full-Year 2023 —

— Separation of Oncology Business Expected to be Completed in November 2023 —

 

DUBLIN, Oct. 25, 2023 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the third quarter of 2023.

 

“With solid performance across our proprietary commercial portfolio, the successful settlement of the VIVITROL® patent litigation, and progress toward completion of the separation of our oncology business, we have made significant strides to evolve the business into a pure-play neuroscience company with the potential to generate strong profitability and cash flow,” said Richard Pops, Chief Executive Officer of Alkermes. “Our presentation at this week’s World Sleep Congress of the first-in-human safety and tolerability data and initial proof-of-concept data for ALKS 2680, our investigational, orexin 2 receptor agonist for the treatment of narcolepsy, represents an important milestone for that development program. We look forward to sharing additional data from the phase 1 study and advancing ALKS 2680 into a planned phase 2 program next year.”

 

“Our third quarter results demonstrate the financial strength of the business, driven by top-line year-over-year growth, strategic capital allocation and our focus on delivering value to shareholders,” commented Iain Brown, Chief Financial Officer of Alkermes. “Upon planned completion of the separation of the oncology business in the coming weeks, the remaining neuroscience business will be positioned to deliver enhanced profitability as we focus on growing our proprietary commercial products and advancing the key programs that we believe will drive future growth.”

 

Quarter Ended Sept. 30, 2023 Financial Results

Revenues

 

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Costs and Expenses

 

Profitability

 

Balance Sheet

 

Financial Expectations for 2023

Alkermes reiterated its financial expectations for full-year 2023, as set forth in its press release dated June 6, 2023.

 

Separation of Oncology Business

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Recent Events

Neuroscience

Corporate

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, Oct. 25, 2023, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

 

About Alkermes plc

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer. 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.

 

Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net income and non-GAAP basic and diluted earnings per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense;

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change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

The company’s management and board of directors utilize these non-GAAP financial measures to evaluate the company’s performance. The company provides these non-GAAP financial measures of the company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and non-GAAP basic and diluted earnings per share are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and non-GAAP basic and diluted earnings per share should not be considered measures of the company’s liquidity.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.

 

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including its ability to drive profitability and cash flow and to create value for shareholders; the company’s plans and expected timelines for the clinical development activities for ALKS 2680, including initiation of the phase 2 study and presentation of additional data; and the company’s expectations regarding the timing for completion, capitalization, structure, and anticipated benefits of the planned separation of its oncology business. 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: the company may not ultimately separate its oncology business on the anticipated timeline or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect the planned separation of the company’s oncology business; the planned separation may adversely impact the company’s ability to attract or retain key personnel; 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; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company’s regulatory approval strategies or components of the company’s marketing applications; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2022 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.

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VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license.

 

(tables follow)

i	The term “ARISTADA” as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise.

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP		Three Months Ended				Three Months Ended
(In thousands, except per share data)		September 30, 2023				September 30, 2022
Revenues:
Product sales, net		$	231,822			$	199,380
Manufacturing and royalty revenues			149,113				52,941
Research and development revenue			3				36
Total Revenues			380,938				252,357
Expenses:
Cost of goods manufactured and sold			61,509				50,625
Research and development			97,140				100,430
Selling, general and administrative			169,446				152,777
Amortization of acquired intangible assets			8,995				9,166
Total Expenses			337,090				312,998
Operating Income (Loss)			43,848				(60,641	)
Other Income (Expense), net:
Interest income			9,370				2,239
Interest expense			(6,006	)			(3,552	)
Other income (expense) , net			149				(1,861	)
Change in the fair value of contingent consideration			—				(3,553	)
Total Other Income (Expense), net			3,513				(6,727	)
Income (Loss) Before Income Taxes			47,361				(67,368	)
Income Tax Benefit			(397	)			(3,394	)
Net Income (Loss) — GAAP		$	47,758			$	(63,974	)
Earnings (Loss) Per Share:
GAAP earnings (loss) per share — basic		$	0.29			$	(0.39	)
GAAP earnings (loss) per share — diluted		$	0.28			$	(0.39	)
Non-GAAP earnings per share — basic		$	0.66			$	0.02
Non-GAAP earnings per share — diluted		$	0.64			$	0.02
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			166,607				164,282
Diluted — GAAP			171,903				164,282
Diluted — Non-GAAP			171,903				168,762
An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows:
Net Income (Loss) — GAAP		$	47,758			$	(63,974	)
Adjustments:
Share-based compensation expense			23,915				26,051
Depreciation expense			9,665				10,431
Amortization expense			8,995				9,166
Separation expense			9,640				—
Restructuring expense			5,938				—
Income tax effect related to reconciling items			3,511				(17	)
Non-cash net interest expense			115				116
Legal settlement			—				15,905
Change in the fair value of contingent consideration and other related assets			—				5,835
Non-GAAP Net Income		$	109,537			$	3,513

 

 

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP		Nine Months Ended				Nine Months Ended
(In thousands, except per share data)		September 30, 2023				September 30, 2022
Revenues:
Product sales, net		$	678,026			$	561,435
Manufacturing and royalty revenues			607,888				243,437
Research and development revenue			16				249
License revenue			—				2,000
Total Revenues			1,285,930				807,121
Expenses:
Cost of goods manufactured and sold			182,944				164,144
Research and development			291,565				289,256
Selling, general and administrative			549,181				448,206
Amortization of acquired intangible assets			26,693				27,198
Total Expenses			1,050,383				928,804
Operating Income (Loss)			235,547				(121,683	)
Other Income (Expense), net:
Interest income			21,105				3,708
Interest expense			(16,978	)			(8,271	)
Other (expense) income, net			(415	)			2,380
Change in the fair value of contingent consideration			—				(21,750	)
Total Other Income (Expense), net			3,712				(23,933	)
Income (Loss) Before Income Taxes			239,259				(145,616	)
Income Tax Benefit			(3,719	)			(15,603	)
Net Income (Loss) — GAAP		$	242,978			$	(130,013	)
Earnings (Loss) Per Share:
GAAP earnings (loss) per share — basic		$	1.46			$	(0.79	)
GAAP earnings (loss) per share — diluted		$	1.42			$	(0.79	)
Non-GAAP earnings per share — basic		$	1.24			$	0.21
Non-GAAP earnings per share — diluted		$	1.21			$	0.20
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			165,996				163,541
Diluted — GAAP			170,981				163,541
Diluted — Non-GAAP			170,981				167,687
An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows:
Net Income (Loss) — GAAP		$	242,978			$	(130,013	)
Adjustments:
Share-based compensation expense			75,062				67,771
Depreciation expense			29,693				30,988
Amortization expense			26,693				27,198
Separation expense			19,280				—
Restructuring expense			5,938				—
Income tax effect related to reconciling items			3,332				(2,593	)
Non-cash net interest expense			346				350
Final award in the Janssen arbitration (2022 back royalties and interest)			(197,092	)			—
Legal settlement			—				15,905
Reduction in the fair value of contingent consideration and other related assets			—				24,032
Non-GAAP Net Income		$	206,230			$	33,638

 

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets		September 30,				December 31,
(In thousands)		2023				2022
Cash, cash equivalents and total investments		$	995,581			$	740,075
Receivables			337,697				287,967
Inventory			192,186				181,418
Contract assets			2,766				8,929
Prepaid expenses and other current assets			42,982				43,527
Property, plant and equipment, net			327,517				325,361
Intangible assets, net and goodwill			103,860				130,553
Deferred tax assets			162,184				115,602
Other assets			114,458				130,546
Total Assets		$	2,279,231			$	1,963,978
Accounts payable and accrued expenses		$	481,587			$	472,204
Long-term debt — current portion			3,000				3,000
Other current liabilities			18,520				22,538
Long-term debt			288,366				290,270
Other long-term liabilities			132,175				132,213
Total shareholders' equity			1,355,583				1,043,753
Total Liabilities and Shareholders' Equity		$	2,279,231			$	1,963,978
Ordinary shares outstanding (in thousands)			166,714				164,377
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2023, which the company intends to file in October 2023.

 

 

 

 

 

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Third Quarter 2023 Financial Results & Business Update October 25, 2023 Exhibit 99.2

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Forward-Looking Statements and Non-GAAP Financial Information Certain statements set forth in this presentation 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: Alkermes plc’s (the “Company”) expectations concerning its future financial, commercial and operating performance, business plans or prospects; the Company’s expectations regarding the timing of the planned separation of its oncology business; the potential therapeutic and commercial value of ALKS 2680 for the treatment of narcolepsy; and the Company’s expectations regarding plans and timelines for further clinical development activities for ALKS 2680, including study design and dose selection. The Company cautions that forward-looking statements are inherently uncertain. The forward-looking statements contained in this presentation 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, assumptions and uncertainties. These risks, assumptions and uncertainties include, among others: the Company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties may delay or otherwise negatively affect the planned separation of the Company’s oncology business; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation or 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; clinical development activities may not be completed on time or at all; the results of the Company’s development activities, including those related to ALKS 2680, may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; potential changes in the cost, scope, design or duration of the Company’s development activities, including the ALKS 2680 development program; the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities may not agree with the Company’s regulatory approval strategies or components of the Company’s marketing applications and may make adverse decisions regarding the Company’s products; the Company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the Company’s products or an increase in the Company’s financial obligations to government payers; the Company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks, assumptions and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended Dec. 31, 2022 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, and on the Company’s website at www.alkermes.com in the ‘Investors – SEC filings’ section. 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 presentation. Non-GAAP Financial Measures: This presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”), including non-GAAP net income and non-GAAP earnings per share. The Company provides these non-GAAP financial measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures, to the extent reasonably determinable, can be found in the Appendix of this presentation. Note Regarding Trademarks: The Company and its affiliates are the owners of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO® , LYBALVI® and VIVITROL®. VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto.

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Q3 2023 Financial Performance

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In millions Q3 2023 Financial Results Summary Total Revenue* In millions GAAP Net Income (Loss) In millions Non-GAAP Net Income** *Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson (“Janssen”), announced in June 2023. **Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation.

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Q3 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® †LYBALVI was commercially launched in October 2021. **Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen announced in June 2023. In millions, except % Q3’23 Q3’22 ∆Q3’23 vs. Q3’22 Total Proprietary Net Sales $231.8 $199.4 16% VIVITROL® $99.3 $96.5 3% ARISTADA®* $81.8 $75.7 8% LYBALVI®† $50.7 $27.1 87% Manufacturing & Royalty Revenue** $149.1 $52.9 182% Research & Development Revenue $0.0 $0.0 - Total Revenue** $380.9 $252.4 51%

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Alkermes: 2023 Financial Expectations1 1 “Financial Expectations for Year Ending Dec. 31, 2023” and “Janssen royalty expectations”, on the one hand, and “Expected net sales of proprietary products”, on the other hand, were initially provided by the Company on June 6, 2023 and Feb. 16, 2023, respectively. The Company reiterates these expectations as of Oct. 25, 2023, and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations. ‡Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix of this presentation. (in millions, except per share amounts) Financial Expectations for Year Ending Dec. 31, 2023 Total Revenues $1,550 – $1,680 COGS $230 – $250 R&D Expense $370 – $400 SG&A Expense $695 – $725 Amortization of Intangible Assets ~$35 Interest Expense, net $5 – $10 Income Tax Benefit $5 – $10 GAAP Net Income $225 – $265 GAAP Earnings Per Share (Diluted) $1.31 – $1.54 Non-GAAP Net Income‡ $230 – $270 Non-GAAP Earnings Per Share (Diluted)‡ $1.34 – $1.57 The Company’s 2023 financial expectations continue to reflect Alkermes’ combined neuroscience and oncology business for the full year. The Company continues to work toward the planned separation of its oncology business, which it expects to complete in November 2023. Total Revenues Breakdown: Expected net sales of proprietary products: VIVITROL® net sales of $380M – $410M ARISTADA® net sales of $315M – $345M LYBALVI® net sales of $180M – $205M Janssen royalty expectations: Long-acting INVEGA® franchise back royalties and interest on late payments related to 2022: ~$197M INVEGA® franchise royalties related to 2023: $265M – $280M

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Q3 2023 Commercial Review

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Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) R12M = Rolling Twelve Months Key Product Revenues ($M)

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LYBALVI® Performance and Expectations *These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of Oct. 25, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations. LYBALVI Quarterly Net Sales ($M) Q3’23 net sales of $50.7M reflect 8% sequential growth compared to Q2’23 Q3’23 gross-to-net deductions: ~25% Outlook: FY’23 net sales expected to range from $180M – $205M*

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LYBALVI® Prescription Growth Trends Q3’23 total TRx: ~41,800 reflecting 10% sequential growth compared to Q2’23 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 10/13/23) TRx Week

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ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales ($M)* Q3’23 year-over-year net sales increased 8% to $81.8M Outlook: FY’23 net sales expected to range from $315M – $345M†* *Inclusive of ARISTADA INITIO® † These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of Oct. 25, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations.

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VIVITROL® Performance and Expectations *These expectations were initially provided by the Company on Feb. 16, 2023. The Company reiterates these expectations as of Oct. 25, 2023 and such expectations are effective only as of this date. The Company expressly disclaims any obligation to update or reaffirm these expectations. VIVITROL Quarterly Net Sales ($M) Q3’23 year-over-year net sales increased 3% to $99.3M Outlook: FY’23 net sales expected to range from $380M – $410M*

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Preliminary Results from a Phase 1 Study of ALKS 2680, an Orexin 2 Receptor Agonist, in Healthy Participants and Patients with Narcolepsy or Idiopathic Hypersomnia

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ALKS 2680 Is an Investigational Oral Orexin 2 Receptor Agonist for the Treatment of Narcolepsy ALKS 2680 is a highly potent, orally bioavailable, selective OX2R agonist  ≥10 fold more potent than orexin Aa >5,000-fold selectivity relative to OX1Ra Designed to address underlying pathology of narcolepsy and achieve: Improved wakefulness duration and quality, with a PK/PD profile that mirrors natural sleep/wake cycle Cataplexy control Low therapeutic dose with once-daily oral dosing Acceptable safety profile with wide therapeutic window ALKS 2680 demonstrated dose-dependent improvements in wake duration and cataplexy control in a mouse model of narcolepsyb Initial data from the ongoing Phase 1 study, which includes innovative translational approaches, has shown: ALKS 2680 is generally well tolerated Proof of concept in patients with narcolepsy type 1 aData from preclinical studies using CHO cells. bOrexin DTA mice CHO: Chinese Hamster Ovary; DTA: diphtheria toxin subunit A; OX1R: orexin receptor type 1; OX2R: orexin receptor type 2; PD: pharmacodynamic; PK: pharmacokinetic

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Ongoing Randomized, Double-Blind, Placebo-Controlled First-in-Human Study of ALKS 2680: SAD and MAD Healthy Volunteers Each dose cohort in both SAD and MAD included 8 new participants 6 on ALKS 2680, 2 on placebo Objectives: Safety and tolerability Pharmacokinetics (PK) and pharmacodynamics (PD) *Denotes dynamic decision points for triggering subsequent cohorts aIn MAD, participants were dosed for 10 days once daily

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ALKS 2680 Was Generally Well Tolerated in Healthy Volunteers in Both SAD and MAD Maximum tolerated dose not reached Most AEs were mild and observed at doses ≥15 mg (SAD) and ≥8 mg (MAD)  No severe AEs or serious adverse events (SAEs) were reported Most AEs were transient and resolved without intervention or treatment interruption AEs observed in >1 participant (>5%) and deemed related to study drug were: SAD: dizziness, pollakiuria, nausea, and blurred vision MAD: insomnia, dizziness, pollakiuria, and visual disturbance (described as blurred or distorted vision, increased light sensitivity) No safety signal identified in vital signs, laboratory parameters, or ECGs One participant in MAD discontinued after taking a single 25 mg dose due to transient, non-serious, non-severe AEs that resolved without treatment AE: adverse event; ECG: electrocardiogram; MAD: multiple ascending dose; SAD: single ascending dose Healthy Volunteers

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ALKS 2680 Achieved Desired Pharmacokinetic Profile With Once-Daily Dosing Overall PK profile supports once-daily dosing Mimics natural sleep/wake cycle Half life = 8-10 hours Wide safety margin ~100-fold safety multiples for planned therapeutic doses relative to toxicology studiesa 2 metabolites measured Consistent with preclinical studies Neither contribute to pharmacologic activity No reactive metabolites have been identified Healthy Volunteers Systemic Exposure (AUC) 10000 1000 100 10 1 1 3 8 15 25 50 AUC ng*h/mL 100 1 1 3 8 15 25 50 Cmax ng/mL 10 Maximum Serum Concentration (Cmax) ALKS 2680, mg ALKS 2680, mg aToxicology studies in mice up to 28 days of dosing completed AUC: area under the curve; PK: pharmacokinetics Proportional increase with dose Lower-than-proportional increase with dose

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Ongoing Randomized, Double-Blind, Placebo-Controlled First-in-Human Study of ALKS 2680 in Patients With NT1 NT2 and IH patient cohorts are currently being evaluated at higher doses 1:1:1:1 randomization in a 4-way cross-over design Up to 8 patients per cohort First 4 patients in the NT1 cohort completed Objectives: Safety and tolerability Sleep latency (MWT) at each cross-over NT1 Patients IH: idiopathic hypersomnia; NT1: narcolepsy type 1; NT2: narcolepsy type 2; PBO: placebo; MWT: Maintenance of Wakefulness Test n=1 n=1 n=1 n=1 N=4

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Demographics and Baseline Characteristics Baseline Disease Severity Total (N=4) Narcolepsy Severity Scale, mean (SD) Severe 29-42, very severe 43-54 39.8 (3.50)  Epworth Sleepiness Scale, mean (SD) Score >10 suggests excessive daytime sleepiness 16.0 (2.83)  Weekly Cataplexy Rate, mean (SD) 9.0 (10.61)  NT1 Patients Demographic Characteristic Total (N=4) Age, years, mean (SD) 23.5 (6.40) Female, n (%) 1 (25) White Race, n (%) 4 (100) Body Mass Index, kg/m2, mean (SD) 30.5 (5.45)

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Placebo ALKS 2680 Preferred Term n=4 1 mgn=4 3 mgn=4 8 mgn=4 Adverse events (AEs) reported as related to study drug, n (%) 0 0 0 4 (100) Insomnia 0 0 0 3 (75) Pollakiuria 0 0 0 2 (50) Salivary hypersecretion 0 0 0 2 (50) Blood pressure increased 0 0 0 1 (25) Bruxism  0 0 0 1 (25) Dizziness 0 0 0 1 (25) Hyperhidrosis 0 0 0 1 (25) Single Doses of ALKS 2680 Were Generally Well Tolerated NT1 Patients All AEs were mild in severity; no serious AEs or AEs leading to discontinuation were reported No treatment-emergent, clinically meaningful changes in laboratory parameters or ECGs at any dose AE: adverse event; ECG: electrocardiogram

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ALKS 2680 Significantly Improved Sleep Latency With a Clear Dose Response NT1 Patients Change from Baseline in Average Sleep Latency on MWT Over 8 Hours, Least Squares Mean (95% CI), Minutes ALKS 2680 Dose P < 0.001 Average Sleep Latency on the Maintenance of Wakefulness Test (MWT) (N = 4 per dose) P < 0.01 P < 0.001

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ALKS 2680 Single Dose Time Course Suggests a Therapeutic Dose Between 3 mg and 8 mg in NT1 NT1 Patients Sleep Latency Mean ± SE, Minutes Maximum test duration = 40 min Day 1 (Post-dose), Hours Maintenance of Wakefulness Test (MWT) 2 4 6 8 Day -1 (Baseline), Hours Dosing 0 NT1: narcolepsy type 1

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Conclusions ALKS 2680 in Generally well tolerated up to doses of 50 mg Increased objective and subjective measures of alertness PK/PD profile supports once-daily oral dosing ALKS 2680 in Generally well tolerated at all doses tested; drug-related adverse events only observed at highest dose (8 mg) Statistically significant, clinically meaningful, and durable improvement of sleep latency Profile supportive of once-daily administration Improvement in sleep latency observed at a low therapeutic dose targeted between 3 and 8 mg in narcolepsy type 1 NT1 Patients Healthy Volunteers Initial benefit/risk profile supports continued clinical evaluation of ALKS 2680 (N = 80) (N = 4)

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Appendix

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Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Three Months Ended September 30, 2023 Net Income — GAAP $ 47.8 Adjustments: Share-based compensation expense 23.9 Depreciation expense 9.7 Amortization expense 9.0 Separation expense 9.6 Restructuring expense 5.9 Income tax effect related to reconciling items 3.5 Non-cash net interest expense 0.1 Non-GAAP Net Income $ 109.5

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Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments (In millions, except per share data) Year Ended December 31, 2023 Year Ending December 31, 2023 Shares+ Earnings Per Share Projected Net Income — GAAP $ 245.0 171.5 $ 1.43 Adjustments: Share-based compensation expense 97.5 Depreciation expense 42.5 Amortization expense 35.0 Separation expense 21.0 Income tax effect related to reconciling items 3.5 Non-cash net interest expense 0.5 Final award in the Janssen arbitration (2022 back royalties and interest on late payments)* (195.0) Projected Net Income — Non-GAAP $ 250.0 171.5 $ 1.46 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges. +2023 per share expectations are calculated based on a weighted average diluted share count of approximately 171.5 million shares outstanding. *Back royalties and interest on late payments related to 2022 pursuant to final award related to arbitration proceedings with Janssen.

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