8-K

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): February 16, 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. ☐

Item 2.02 Results of Operations and Financial Condition.

On February 16, 2023, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2022 and financial expectations for the year ending December 31, 2023. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 16, 2023 discussing such financial results and expectations 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 dated February 16, 2023 announcing financial results for the three months and year ended December 31, 2022 and financial expectations for the year ending December 31, 2023.
99.2	Investor presentation to be displayed by Alkermes plc on February 16, 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: February 16, 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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EX-99.1

Exhibit 99.1

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

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2022 and Provides Financial Expectations for 2023

— Revenues of $1.11 Billion in 2022, GAAP Loss per Share of $0.97 and Diluted Non-GAAP Earnings per Share of $0.34 —

— Achieved LYBALVI^® Net Sales of $96.0 Million in First Full Year of Commercial Launch —

— Accelerated Long-Term Profitability Targets Reflect Enhanced Profitability Driven by Planned Separation of Oncology Business —

DUBLIN, Feb. 16, 2023 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2022 and provided financial expectations for 2023.

“2022 was a productive year for Alkermes as we delivered strong results for the first full year of the commercial launch of LYBALVI^®, achieved double-digit revenue growth for VIVITROL^® and ARISTADA^®, and continued to advance our R&D portfolio, including ongoing enrollment of the potential registration-enabling studies for nemvaleukin in oncology and initiation of the first-in-human studies for our orexin 2 receptor agonist program,” said Richard Pops, Chief Executive Officer of Alkermes. “Looking ahead, this year we are focused on three key areas: driving the ongoing launch of LYBALVI, advancing our orexin program in narcolepsy and other sleep disorders, and executing on the planned separation of our oncology businesses. Through these initiatives, we believe we can unlock significant value for our shareholders and establish a compelling investment thesis for both the neuroscience and oncology businesses.”

“We exceeded our financial expectations for 2022, driven by the strong performance of our proprietary products and our focus on disciplined management of our cost structure. The launch of LYBALVI represents a significant growth opportunity for the company in the oral antipsychotic market and leverages our established commercial capabilities,” commented Iain Brown, Chief Financial Officer of Alkermes. “We believe that the anticipated growth of LYBALVI and our proprietary commercial product portfolio, together with our expected decrease in R&D expenditures following the planned separation of the oncology business, will position the company to achieve the updated long-term profitability targets we are providing today and drive shareholder value.”

Quarter Ended Dec. 31, 2022 Financial Results

• Total revenues for the quarter were $304.7 million, compared to $324.5 million for the same period in the prior year.

• Net sales of proprietary products for the quarter were $216.1 million, compared to $178.9 million for the same period in the prior year.

o Net sales of VIVITROL were $102.0 million, compared to $92.0 million for the same period in the prior year, representing an increase of approximately 11%.

o Net sales of ARISTADA¹ were $79.2 million, compared to $78.7 million for the same period in the prior year, representing an increase of approximately 1%.

o Net sales of LYBALVI were $34.9 million, compared to $8.2 million for the same period in the prior year, following commercial launch in October 2021.

• Total operating expenses for the quarter were $325.3 million, compared to $322.1 million for the same period in the prior year.

• Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $28.3 million for the quarter, or a basic and diluted GAAP loss per share of $0.17. This compared to GAAP net income of $0.9 million, or a basic and diluted GAAP earnings per share of $0.01, for the same period in the prior year.

• Non-GAAP net income was $24.2 million for the quarter, or a non-GAAP basic earnings per share of $0.15 and non-GAAP diluted earnings per share of $0.14. This compared to non-GAAP net income of $38.5 million, or a non-GAAP basic earnings per share of $0.24 and non-GAAP diluted earnings per share of $0.23, for the same period in the prior year.

Year Ended Dec. 31, 2022 Financial Results

Revenues

• Total revenues for the year were $1.11 billion. This compared to $1.17 billion in the prior year.

• Net sales of proprietary products for the year were $777.6 million, compared to $627.4 million in the prior year.

o Net sales of VIVITROL were $379.5 million, compared to $343.9 million in the prior year, representing an increase of approximately 10%.

o Net sales of ARISTADA were $302.1 million, compared to $275.4 million in the prior year, representing an increase of approximately 10%.

o Net sales of LYBALVI were $96.0 million, compared to $8.2 million in the prior year, following commercial launch in October 2021.

• Manufacturing and royalty revenues for the year were $332.0 million, compared to $541.8 million in the prior year.

o Royalty revenues from INVEGA SUSTENNA^®/XEPLION^®, INVEGA TRINZA^®/TREVICTA^® and INVEGA HAFYERA^®/BYANNLI^® (the “long-acting INVEGA products”) were $115.7 million, compared to $303.1 million in the prior year. This decrease was driven primarily by Janssen Pharmaceutica N.V.’s (Janssen) partial termination of the license agreement related to sales of the long-acting INVEGA products in the United States (U.S.), effective Feb. 2, 2022.

o Manufacturing and royalty revenues from VUMERITY^® were $115.5 million, compared to $87.4 million in the prior year.

Costs and Expenses

• Total operating expenses for the year were $1.25 billion, compared to $1.20 billion in the prior year.

o Cost of Goods Manufactured and Sold were $218.1 million, compared to $197.4 million in the prior year.

o R&D expenses were $393.8 million, compared to $406.5 million in the prior year. R&D expenses in 2021 included the accrual of a $25.0 million development milestone payment.

o Selling, General and Administrative (SG&A) expenses were $605.7 million, compared to $561.0 million in the prior year, primarily reflecting increased investment to support the launch of LYBALVI.

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Profitability

• GAAP net loss for the year was $158.3 million, or a basic and diluted GAAP loss per share of $0.97. This compared to GAAP net loss of $48.2 million, or a basic and diluted GAAP loss per share of $0.30, in the prior year, which included the $25.0 million development milestone payment.

• Non-GAAP net income for the year was $57.9 million, or a non-GAAP basic earnings per share of $0.35 and non-GAAP diluted earnings per share of $0.34. This compared to non-GAAP net income of $129.1 million, or a non-GAAP basic earnings per share of $0.80 and non-GAAP diluted earnings per share of $0.78, in the prior year.

Balance Sheet

• At Dec. 31, 2022, the company recorded cash, cash equivalents and total investments of $740.1 million, compared to $765.7 million at Dec. 31, 2021. The company’s total debt outstanding as of Dec. 31, 2022 was $293.3 million.

Financial Expectations for 2023

The following financial expectations for 2023 reflect the combined neuroscience and oncology business for the full year, as the company works toward the planned separation of the oncology business, which it currently expects to complete in the second half of the year. These financial expectations also reflect anticipated continued growth of the company’s proprietary products, investment in a direct-to-consumer campaign to support the launch of LYBALVI, continued focus on operational efficiency, and expected costs related to the potential separation of the company’s oncology business. In addition, these expectations reflect the company’s assumption that it will continue to receive royalty payments related to sales of the long-acting INVEGA products outside the U.S. through the end of May 2023. These financial expectations do not include any royalty payments related to sales of the long-acting INVEGA products in the U.S., as arbitration proceedings with Janssen related to these royalty payments remain ongoing.

All line items are according to GAAP, except as otherwise noted.

In millions(except per share amounts)	2023 Expectations
Total Revenue	$1,130 – $1,250
VIVITROL Net Sales	$380 – $410
ARISTADA Net Sales	$315 – $345
LYBALVI Net Sales	$180 – $205
INVEGA Franchise Royalties*	$25 – $30
Other Revenues	$230 – $260
Cost of Goods Sold	$230 – $250
R&D Expenses	$370 – $400
SG&A Expenses	$695 – $725
Amortization of Intangible Assets	~$35
Interest Expense, Net	$5 – $10
Income Tax Benefit	$5 – $10
GAAP Net Loss	($160) – ($200)
GAAP Net Loss per Share+	($0.96) – ($1.20)
Non-GAAP Net Income	$0 – $40
Non-GAAP Net Earnings Per Share (Diluted)+	$0.00 – $0.23
Capital Expenditures	$35 – $40

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*Reflects royalties related to sales of XEPLION/TREVICTA/BYANNLI outside of the U.S. through the end of May 2023.

+2023 per share expectations are calculated based on a weighted average basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

Profitability Targets

The company today accelerated its long-term profitability targets to reflect the planned separation of the company’s oncology business in the second half of 2023. The updated profitability targets continue to reflect the removal of all royalty revenues related to sales of the long-acting INVEGA products, as arbitration proceedings with Janssen related to these royalty payments remain ongoing. The company is not providing reconciliations of, or comparable GAAP measures for, the following non-GAAP profitability targets, as they are not determinable without unreasonable efforts.*

The company is committed to achieving:

• FY 2024 non-GAAP net income equal to 25% of the company’s total revenues and EBITDA² margin of 20% of total revenues

• FY 2025 non-GAAP net income equal to 30% of the company’s total revenues and EBITDA margin of 25% of total revenues

Recent Events:

Corporate

• In November 2022, the company announced its intent, as approved by its board of directors (the Board) to separate its neuroscience business and oncology business. The company plans to explore a separation of the oncology business into an independent, publicly-traded company as part of an ongoing review of strategic alternatives for the oncology business. The separation, if consummated, is expected to be completed in the second half of 2023.

• In December 2022, the company received an interim award (the Interim Award) in its arbitration proceedings with Janssen, a subsidiary of Johnson & Johnson, in respect of Janssen’s partial termination in the United States of two license agreements with the company. In the Interim Award, the arbitral tribunal (the Tribunal) agreed with the company’s position that, while Janssen may terminate the agreements, it may not continue to sell Products (as defined in the agreements) developed during the term of the agreements without paying royalties pursuant to the terms of the respective agreements. The company will engage with Janssen and the Tribunal in additional proceedings prior to the Tribunal’s issuance of a final award.

Neuroscience

• In November 2022, the company initiated a phase 1 single ascending dose study in healthy volunteers to advance the clinical development of its orexin 2 receptor agonist program for the treatment of narcolepsy and other sleep disorders.

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Oncology

• In December 2022, the Independent Data Monitoring Committee for the company’s ARTISTRY-6 phase 2 study evaluating nemvaleukin alfa (nemvaleukin), the company’s investigational, novel engineered interleukin-2 (IL-2) variant immunotherapy, as monotherapy in patients with advanced cutaneous melanoma or advanced mucosal melanoma, performed a risk-benefit assessment of the study and recommended that the trial continue without modifications.

• In January 2023, the company announced that nemvaleukin has been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the United Kingdom.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 16, 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, non-GAAP basic and diluted (loss) earnings per share, non-GAAP net income margin (non-GAAP net income/total revenue) and EBITDA margin (EBITDA/total revenue). 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 (loss) income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

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 (loss) income, non-GAAP basic and diluted (loss) earnings per share, non-GAAP net income margin and EBITDA margin 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 (loss) income, non-GAAP basic and diluted (loss) earnings per share, non-GAAP net income margin and EBITDA margin should not be considered measures of the company’s liquidity.

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

*The company has not provided full financial expectations for time periods after the year ending Dec. 31, 2023 and therefore is not providing reconciliations of, or comparable GAAP measures for, non-GAAP net income margins or EBITDA margins, for time periods after the year ending Dec. 31, 2023. Reconciliations of such forward-looking non-GAAP profitability measures to comparable GAAP measures are not determinable without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain future financial amounts necessary for such reconciliations, which amounts could have a significant impact on the company’s future financial results, including such non-GAAP profitability measures and the comparable GAAP financial measures.

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 expectations of continued growth of its proprietary products, investment in commercial activities, continued focus on operational efficiency, and expected costs and other impacts of the planned separation of the oncology business, and assumptions regarding royalty payments on sales of the long-acting INVEGA products; the company’s commitment to, and plans to drive, growth, long-term profitability and shareholder value, and its ability to achieve its accelerated long-term profitability targets; the company’s plans to  separate its neuroscience and oncology businesses, including the anticipated timing, structure and benefits of a potential separation; expectations concerning the ongoing arbitration proceedings with Janssen; and the potential therapeutic and commercial value of the company’s products. 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 be able to achieve long-term profitability or its profitability targets in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic on the company’s business, results of operations or financial condition, including impacts on healthcare systems and on patient and healthcare provider access to the company’s marketed products; the company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect a potential separation of the company’s neuroscience and oncology businesses; disruption to the company’s operations resulting from the potential separation;  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, including the arbitration proceedings with Janssen; 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

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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 atwww.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

VIVITROL^® is a registered trademark of Alkermes, Inc.; ARISTADA^®, ARISTADA INITIO^® and LYBALVI^® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI^®, INVEGA^®, INVEGA HAFYERA^®, INVEGA 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)

¹  The term “ARISTADA” as used in this press release refers to ARISTADA and ARISTADA INITIO^®, unless the context indicates otherwise.

²  Calculated as earnings before interest, taxation, depreciation, amortization and one-time items, includes share-based compensation expenses.

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)	December 31, 2022			December 31, 2021
Revenues:
Product sales, net	$	216,117		$	178,916
Manufacturing and royalty revenues		88,546			143,372
License revenue		—			2,000
Research and development revenue		11			175
Total Revenues		304,674			324,463
Expenses:
Cost of goods manufactured and sold		53,964			53,682
Research and development		104,586			98,374
Selling, general and administrative		157,541			160,408
Amortization of acquired intangible assets		9,165			9,616
Total Expenses		325,256			322,080
Operating (Loss) Income		(20,582	)		2,383
Other Expense, net:
Interest income		3,921			453
Interest expense		(4,769	)		(2,405	)
Change in the fair value of contingent consideration		—			(750	)
Other (expense) income, net		(258	)		546
Total Other Expense, net		(1,106	)		(2,156	)
(Loss) Income Before Income Taxes		(21,688	)		227
Provision (Benefit) for Income Taxes		6,566			(646	)
Net (Loss) Income — GAAP	$	(28,254	)	$	873
(Loss) Earnings Per Share:
GAAP (loss) earnings per share — basic and diluted	$	(0.17	)	$	0.01
Non-GAAP earnings per share — basic	$	0.15		$	0.24
Non-GAAP earnings per share — diluted	$	0.14		$	0.23
Weighted Average Number of Ordinary Shares Outstanding:
Basic  — GAAP and Non-GAAP		164,336			161,833
Diluted — GAAP		164,336			166,803
Diluted — Non-GAAP		169,304			166,803
An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net income is as follows:
Net (Loss) Income — GAAP	$	(28,254	)	$	873
Adjustments:
Share-based compensation expense		26,482			19,020
Depreciation expense		10,510			11,527
Amortization expense		9,165			9,616
Separation expense		1,355			—
Income tax effect related to reconciling items		4,847			(3,355	)
Non-cash net interest expense		116			117
Change in the fair value of contingent consideration and other related assets		—			750
Non-GAAP Net Income	$	24,221		$	38,548

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP	Year Ended			Year Ended
(In thousands, except per share data)	December 31, 2022			December 31, 2021
Revenues:
Product sales, net	$	777,552		$	627,424
Manufacturing and royalty revenues		331,983			541,807
License revenue		2,000			3,500
Research and development revenue		260			1,020
Total Revenues		1,111,795			1,173,751
Expenses:
Cost of goods manufactured and sold		218,108			197,387
Research and development		393,842			406,526
Selling, general and administrative		605,747			560,977
Amortization of acquired intangible assets		36,363			38,148
Total Expenses		1,254,060			1,203,038
Operating Loss		(142,265	)		(29,287	)
Other Expense, net:
Interest income		7,629			2,408
Interest expense		(13,040	)		(11,219	)
Change in the fair value of contingent consideration		(21,750	)		(1,427	)
Other income, net		2,122			219
Total Other Expense, net		(25,039	)		(10,019	)
Loss Before Income Taxes		(167,304	)		(39,306	)
(Benefit) Provision for Income Taxes		(9,037	)		8,863
Net Loss — GAAP	$	(158,267	)	$	(48,169	)
(Loss) Earnings Per Share:
GAAP loss per share — basic and diluted	$	(0.97	)	$	(0.30	)
Non-GAAP earnings per share — basic	$	0.35		$	0.80
Non-GAAP earnings per share — diluted	$	0.34		$	0.78
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted — GAAP		163,742			160,492
Basic — Non-GAAP		163,742			160,492
Diluted — Non-GAAP		168,362			164,753
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:
Net Loss — GAAP	$	(158,267	)	$	(48,169	)
Adjustments:
Share-based compensation expense		94,253			87,623
Depreciation expense		41,498			40,505
Amortization expense		36,363			38,148
Legal settlement		15,905			—
Separation expense		1,355			—
Income tax effect related to reconciling items		2,254			6,994
Non-cash net interest expense		466			469
Reduction in the fair value of contingent consideration and other related assets		24,032			1,427
Debt refinancing charge		—			2,109
Non-GAAP Net Income	$	57,859		$	129,106

Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets	December 31,		December 31,
(In thousands)	2022		2021
Cash, cash equivalents and total investments	$	740,075	$	765,741
Receivables		287,967		313,193
Inventory		181,418		150,335
Contract assets		8,929		13,363
Prepaid expenses and other current assets		43,527		48,967
Property, plant and equipment, net		325,361		341,054
Intangible assets, net and goodwill		130,553		166,916
Other assets		246,148		224,915
Total Assets	$	1,963,978	$	2,024,484
Long-term debt — current portion	$	3,000	$	3,000
Other current liabilities		494,742		468,286
Long-term debt		290,270		292,804
Other long-term liabilities		132,213		147,810
Total shareholders' equity		1,043,753		1,112,584
Total Liabilities and Shareholders' Equity	$	1,963,978	$	2,024,484
Ordinary shares outstanding (in thousands)		164,303		161,937
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2022, which the company intends to file in February 2023.

Alkermes plc and Subsidiaries
Revenues for Calendar Year 2022 and 2021
	Three Months		Three Months		Three Months			Three Months		Year
	Ended		Ended		Ended			Ended		Ended
	March 31,		June 30,		September 30,			December 31,		December 31,
(In thousands)		2022		2022		2022			2022		2022
Revenues:
VIVITROL	$	84,854	$	96,105	$	96,534		$	101,985	$	379,478
ARISTADA		72,485		74,622		75,719			79,226		302,052
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)		54,480		37,039		36,965			37,085		165,569
LYBALVI		13,929		20,060		27,127			34,906		96,022
VUMERITY		30,595		26,170		26,250			32,481		115,496
Key Commercial Product Revenues		256,343		253,996		262,595			285,683		1,058,617
Legacy Product Revenues		20,095		22,117		(10,274	)		18,980		50,918
License Revenue		2,000		—		—			—		2,000
Research and Development Revenues		107		106		36			11		260
Total Revenues	$	278,545	$	276,219	$	252,357		$	304,674	$	1,111,795
	Three Months		Three Months		Three Months			Three Months		Year
	Ended		Ended		Ended			Ended		Ended
	March 31,		June 30,		September 30,			December 31,		December 31,
(In thousands)		2021		2021		2021			2021		2021
Revenues:
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)	$	75,732	$	95,522	$	90,293		$	92,427	$	353,974
VIVITROL		74,534		88,417		88,865			92,038		343,854
ARISTADA		55,429		72,391		68,872			78,663		275,355
LYBALVI		—		—		—			8,215		8,215
VUMERITY		13,440		20,348		26,749			26,885		87,422
Key Commercial Product Revenues		219,135		276,678		274,779			298,228		1,068,820
Legacy Product Revenues		30,675		26,424		19,252			24,060		100,411
License Revenue		1,500		—		—			2,000		3,500
Research and Development Revenues		120		615		110			175		1,020
Total Revenues	$	251,430	$	303,717	$	294,141		$	324,463	$	1,173,751
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI.

Alkermes plc and Subsidiaries
2023 Guidance — GAAP to Non-GAAP Adjustments
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows:
(In millions, except per share data)	Amount			Shares		(Loss) Earnings Per Share
Projected Net Loss — GAAP	$	(180.0	)		166.5	$	(1.08	)
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
Projected Net Income — Non-GAAP	$	20.0			171.5	$	0.12
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

EX-99.2

Fourth Quarter and Year-End 2022 Financial Results & Business Update February 16, 2023 Exhibit 99.2

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, including its assumptions regarding royalty payments on sales of XEPLION®, TREVICTA® and BYANNLI® through May 2023, and expectations concerning revenue growth, value creation and profitability; the Company’s plans to separate its neuroscience and oncology businesses, including the anticipated timing, structure, costs and benefits of the proposed separation and expectations concerning the anticipated business profiles and future financial and operating performance, business plans or prospects of the two businesses if separated; and the potential therapeutic and commercial value of the Company’s products and product candidates. 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 be able to achieve its targeted financial and profitability metrics in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic on the Company’s business, results of operations or financial condition; the Company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect the planned separation of the Company’s neuroscience and oncology businesses; disruption to the Company’s operations resulting from the planned separation; the Company may be unable to make, on a timely or cost-effective basis, the changes necessary to separately operate its neuroscience and oncology businesses; 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 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, including the arbitration proceedings with Janssen Pharmaceutica N.V. (“Janssen”); 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 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 most recent annual report 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®. 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.

Agenda Introduction Sandy Coombs, SVP, Investor Relations & Corporate Affairs Q4 & FY 2022 Commercial Review Todd Nichols, Chief Commercial Officer Q4 & FY 2022 Financial Results; 2023 Financial Expectations; Updated Profitability Targets Iain Brown, Chief Financial Officer 2023 Outlook; Update on Proposed Separation of Oncology Business Richard Pops, Chief Executive Officer Q&A

2022 Commercial Review

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

LYBALVI® Prescription Growth Trends *Source: IQVIA NPA Weekly Q4’22 total TRx: ~28,400 reflecting 23% sequential growth compared to Q3’22 ~7,600 prescribers had written a prescription for LYBALVI (as of 12/31/22) since launch reflecting 27% increase since Q3’22 Post-Launch TRx by Week* (Through 2/3/23) TRx Week

LYBALVI® Performance and Expectations *These expectations are provided by the Company on Feb. 16, 2023 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. LYBALVI Quarterly Net Sales ($M) Q4’22 net sales of $34.9M reflect 29% sequential growth compared to Q3’22 Q4’22 gross-to-net deductions: ~25%, primarily reflecting the continuation of less restrictive initial commercial payer coverage FY’22 net sales of $96.0 million in first full year of launch Outlook: FY’23 net sales expected to range from $180M – $205M*

ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales ($M)* Q4’22 year-over-year net sales increased 1% to $79.2M FY’22 year-over-year net sales increased 10% to $302.1M Gross-to-net deductions: 54.2% in FY’22, compared to 53.7% in FY’21 Outlook: FY’23 net sales expected to range from $315M – $345M†* *Inclusive of ARISTADA INITIO® † These expectations are provided by the Company on Feb. 16, 2023 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.

ARISTADA® Prescription Growth Trends ARISTADA Quarterly TRx MOT* Q4’22 year-over-year growth of 7% on TRx months of therapy (MOT) basis Market Share: TRx MOT: 10% of atypical LAI market prescriptions in Q4’22 *Source: IQVIA NPA

VIVITROL® Performance and Expectations *These expectations are provided by the Company on Feb. 16, 2023 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. VIVITROL Quarterly Net Sales ($M) Q4’22 year-over-year net sales increased 11% to $102.0M FY’22 year-over-year net sales increased 10% to $379.5M Gross-to-net deductions: 50.0% in FY’22, compared to 51.5% in FY’21 Outlook: FY’23 net sales expected to range from $380M – $410M*

Q4 & FY 2022 Financial and Operational Performance

In millions FY 2022 Financial Results Summary** Total Revenue In millions GAAP Net Loss In millions Non-GAAP Net Income* *Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. **In FY22, royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® (the “long-acting INVEGA products”) were $115.7 million, compared to $303.1 million in FY21. This decrease was driven by Janssen’s partial termination of the license agreement related to sales of the long-acting INVEGA products in the U.S., effective Feb. 2, 2022. The Company and Janssen are engaged in ongoing arbitration proceedings related to, among other things, Janssen’s royalty and other obligations under the license agreement.

Q4 2022 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **In Q4'22, royalty revenues from long-acting INVEGA products were $25.2 million, compared to $81.1 million in Q4’21. This decrease was driven by Janssen’s partial termination of the license agreement related to sales of the long-acting INVEGA products in the U.S., effective Feb. 2, 2022. The Company and Janssen are engaged in ongoing arbitration proceedings related to, among other things, Janssen’s royalty and other obligations under the license agreement. †LYBALVI was commercially launched in October 2021.

2022 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® ** In FY22, royalty revenues from long-acting INVEGA products were $115.7 million, compared to $303.1 million in FY21. This decrease was driven by Janssen’s partial termination of the license agreement related to sales of the long-acting INVEGA products in the U.S., effective Feb. 2, 2022. The Company and Janssen are engaged in ongoing arbitration proceedings related to, among other things, Janssen’s royalty and other obligations under the license agreement. †LYBALVI was commercially launched in October 2021.

Alkermes: 2023 Financial Expectations* *These expectations are provided by the Company on Feb. 16, 2023 and are effective only as of such 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. 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 Assumes $25M – $30M of royalties related to sales of XEPLION®, TREVICTA® and BYANNLI® outside the U.S. through May 2023

2023 Financial Expectations* Breakdown *These expectations, provided by the Company on Feb. 16, 2023 and effective only as of such date, reflect the mid-points within the ranges of 2023 guidance provided by the Company on Feb. 16, 2023 and are intended to provide a framework for understanding the costs associated with various elements of the business. The Company expressly disclaims any obligation to update or reaffirm these expectations.

Updated Profitability Targets Reflect One-Year Acceleration of Previously Provided Targets *The Company is not providing reconciliations of, or comparable GAAP measures for, forward-looking non-GAAP profitability targets because the comparable GAAP measures are not determinable without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain future financial amounts necessary for such reconciliations, which amounts could have a significant impact on the Company’s future financial results, including such non-GAAP profitability targets and the comparable GAAP financial measures. †Assuming separation of the Company’s oncology business is effected through a spin-off of the oncology business into an independent, publicly-traded company. NGNI: Non-GAAP net income; EBITDA: Earnings before interest, tax, depreciation, amortization; earnings include share-based compensation expense. Planned separation of oncology business is expected to enhance profitability of remaining neuroscience business† These financial expectations reflect removal of all royalties from worldwide sales of long-acting INVEGA products ~30% ~25% ~25% ~15-20% ~30% Accelerated Accelerated 2026E

2023 Outlook & Planned Separation Update

Clear Priorities to Unlock Value in 2023 2023 Business Priorities and Value Drivers Drive launch of LYBALVI® Continued execution of commercial strategy and investment in DTC campaign Advance orexin 2 receptor agonist Establish initial safety and tolerability profile and generate initial clinical proof-of-concept data for ALKS 2680 Separate oncology business Clarify value proposition for standalone neuroscience and oncology businesses DTC: Direct-to-consumer

Post-Separation Alkermes* Pure-Play, Commercial-Stage Neuroscience Company Separation expected to enhance profitability Builds on Alkermes’ innovation and excellence in neuroscience *Assuming separation of the Company’s oncology business is effected through a spin-off of the oncology business into an independent, publicly-traded company Proprietary Products Topline primarily driven by growth of proprietary commercial products in addiction and psychiatry Complex manufacturing capabilities Development Pipeline Early-stage neuroscience pipeline ALKS 2680, orexin 2 receptor agonist in phase 1 Portfolio of preclinical neuroscience assets Commercial Capabilities Established commercial capabilities in complex psychiatry and addiction markets Opportunity to capture further operating leverage

Appendix Confidential, Internal Use Only

Appendix: Financial Results GAAP to Non-GAAP Adjustments Amounts in the table above may not sum due to rounding.

Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments 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 basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

www.alkermes.com

XML

Document and Entity Information	Feb. 16, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 16, 2023
Entity Registrant Name	Alkermes plc.
Entity Central Index Key	0001520262
Entity Emerging Growth Company	false
Entity File Number	001-35299
Entity Incorporation State Country Code	L2
Entity Tax Identification Number	98-1007018
Entity Address, Address Line One	Connaught House
Entity Address, Address Line Two	1 Burlington Road
Entity Address, City or Town	Dublin 4
Entity Address, Country	IE
Entity Address, Postal Zip Code	D04 C5Y6
City Area Code	353
Local Phone Number	1-772-8000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Security 12b Title	Ordinary shares, $0.01 par value
Trading Symbol	ALKS
Security Exchange Name	NASDAQ