ALKS Alkermes PLC

 

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 15, 2024

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 February 15, 2024, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2023 and financial expectations for the year ending December 31, 2024. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 15, 2024 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 on February 15, 2024 announcing financial results for the three months and year ended December 31, 2023 and financial expectations for the year ending December 31, 2024.
99.2		Investor presentation to be displayed by Alkermes plc on February 15, 2024.
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 15, 2024	By:		/s/ Blair C. Jackson
			Blair C. Jackson
			Executive Vice President, Chief Operating Officer (Interim Principal Financial Officer)

 

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	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, 2023 and Provides Financial Expectations for 2024

— Total Revenues of $1.66 Billion in 2023; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year —

— GAAP Net Income of $356 Million and Diluted GAAP Earnings per Share of $2.10 for 2023 —

— Company Expects to Generate 30% EBITDA Margin in 2024 —

 

DUBLIN, Feb. 15, 2024 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2023 and provided financial expectations for 2024.

 

“We entered 2024 as a pure-play neuroscience company and are well positioned to deliver on our strategic priorities to drive growth of our proprietary commercial products, advance the clinical development of ALKS 2680 for the treatment of narcolepsy, and generate significant cash flow,” said Richard Pops, Chief Executive Officer of Alkermes. “Our financial expectations for 2024 reflect our sharpened strategic focus and our work to position the business for sustained profitability and growth. As we look ahead, 2024 will be an important year as we focus on maintaining strong momentum in the launch of LYBALVI® and advancing and expanding our development pipeline. We look forward to sharing our progress.”

 

Key Financial Highlights

Revenues

(In millions)	Three Months Ended December 31,					Twelve Months Ended December 31,
	2023		2022			2023		2022
Total Revenues	$	377.5	$	304.7		$	1,663.4	$	1,111.8
Total Proprietary Net Sales	$	242.0	$	216.1		$	920.0	$	777.6
VIVITROL®	$	102.4	$	102.0		$	400.4	$	379.5
ARISTADA®[i]	$	83.4	$	79.2		$	327.7	$	302.1
LYBALVI®	$	56.2	$	34.9		$	191.9	$	96.0

 

Profitability

(In millions)	Three Months Ended December 31,					Twelve Months Ended December 31,
	2023		2022			2023		2022
GAAP Net Income (Loss)	$	112.8	$	(28.3)		$	355.8	$	(158.3)
GAAP Net Income (Loss) From Continuing Operations	$	160.6	$	17.2		$	519.2	$	(33.2)
Non-GAAP Net Income	$	37.4	$	24.2		$	243.7	$	57.9
Non-GAAP Net Income From Continuing Operations	$	81.8	$	67.4		$	396.5	$	174.9
EBITDA	$	32.3	$	(1.2)		$	323.8	$	(84.0)
EBITDA From Continuing Operations	$	72.8	$	34.6		$	486.3	$	50.6

Please refer to Note 2 below for details related to certain tax provisions recorded during the quarter ended Dec. 31, 2023 which impacted GAAP Net Income and Non-GAAP Net Income during the quarter.

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Revenue Highlights

LYBALVI

ARISTADAi

VIVITROL

Manufacturing & Royalties

 

Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

 

(In millions)	Three Months Ended December 31,					Twelve Months Ended December 31,
	2023		2022			2023		2022
R&D Expense – Continuing Operations	$	73.9	$	73.0		$	270.8	$	272.7
R&D Expense – Discontinued Operations	$	21.5	$	31.6		$	116.2	$	121.1
SG&A Expense – Continuing Operations	$	169.8	$	152.9		$	689.8	$	590.8
SG&A Expense – Discontinued Operations	$	19.4	$	4.7		$	48.6	$	15.0

 

Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and certain one-time expenses related to the successful resolution of legal proceedings including the Janssen arbitration and VIVITROL patent litigation.

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Balance Sheet

At Dec. 31, 2023, the company recorded cash, cash equivalents and total investments of $813.4 million, compared to $740.1 million at Dec. 31, 2022. The company’s total debt outstanding as of Dec. 31, 2023 was $290.7 million.

Share Repurchase Program

On Feb. 15, 2024, the company’s board of directors approved a new share repurchase program, authorizing the company to repurchase up to $400 million of the company’s ordinary shares (exclusive of any fees, commissions or other expenses related to such repurchases). The program does not have an expiration date and can be discontinued at any time. Please refer to Note 3 below for further details.

Financial Expectations for 2024

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

In millions		2024 Expectations
Total Revenues a		$1,500 – $1,600
VIVITROL Net Sales		$410 – $430
ARISTADAi Net Sales		$340 – $360
LYBALVI Net Sales		$275– $295
Cost of Goods Sold		$230 – $250
R&D Expenses		$225 – $255
SG&A Expenses		$625 – $655
GAAP Net Income b		$350 – $390
Non-GAAP Net Income b		$465 – $505
EBITDA		$445 – $485
Effective Tax Rate		~17%

a Expected Total Revenues reflect expiration of the U.S. royalty related to INVEGA SUSTENNA in August 2024.

b Expected 2024 weighted average basic share count of approximately 169.0 million shares outstanding and a weighted average diluted share count of approximately 173.0 million shares outstanding.

Recent Events

 

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Notes and Explanations

 

The tax benefit related to the release of the valuation allowance was excluded from non-GAAP net income due to the one-time nature of the benefit.

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Thursday, Feb. 15, 2024, 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 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.

 

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Non-GAAP Financial Measures

This press release 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 EBITDA. 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; 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. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense.

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 EBITDA 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 EBITDA 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 grow its proprietary commercial products, generate cash and sustain profitability; the company’s expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program, including initiation of the phase 2 study; the company’s expectations regarding its share repurchase program; and the company’s expectations regarding the sale of its development and manufacturing facility in Athlone, Ireland. 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: whether the company is able to sustain profitability; 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; 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 and in subsequent filings made by

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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; 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)		December 31, 2023				December 31, 2022
Revenues:
Product sales, net		$	241,972			$	216,117
Manufacturing and royalty revenues			135,500				88,546
Research and development revenue			3				11
Total Revenues			377,475				304,674
Expenses:
Cost of goods manufactured and sold			70,126				53,954
Research and development			73,933				73,011
Selling, general and administrative			169,789				152,852
Amortization of acquired intangible assets			8,996				9,165
Total Expenses			322,844				288,982
Operating Income			54,631				15,692
Other Income (Expense), net:
Interest income			9,749				3,921
Interest expense			(6,054	)			(4,769	)
Other expense, net			(10	)			(258	)
Total Other Income (Expense), net			3,685				(1,106	)
Income Before Income Taxes			58,316				14,586
Income Tax Benefit			(102,236	)			(2,589	)
Net Income From Continuing Operations			160,552				17,175
Loss from Discontinued Operations — Net of Tax		$	(47,773	)		$	(45,429	)
Net Income (Loss) — GAAP		$	112,779			$	(28,254	)
GAAP Earnings (Loss) Per Share - Basic:
From continuing operations		$	0.96			$	0.10
From discontinued operations		$	(0.29	)		$	(0.28	)
Earnings (loss) per share		$	0.68			$	(0.17	)
GAAP Earnings (Loss) Per Share - Diluted:
From continuing operations		$	0.94			$	0.10
From discontinued operations		$	(0.28	)		$	(0.27	)
Earnings (loss) per share		$	0.66			$	(0.17	)
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			166,898				164,336
Diluted — GAAP and Non-GAAP			170,138				169,304

 

 

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Condensed Consolidated Statements of Operations - GAAP (Continued)		Three Months Ended				Three Months Ended
(In thousands, except per share data)		December 31, 2023				December 31, 2022
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income from Continuing Operations		$	160,552			$	17,175
Adjustments:
Depreciation expense			9,225				10,013
Amortization expense			8,996				9,165
Interest income			(9,749	)			(3,921	)
Interest expense			6,054				4,769
Income tax (benefit) provision			(102,236	)			(2,589	)
EBITDA from Continuing Operations			72,842				34,612
EBITDA from Discontinued Operations			(40,537	)			(35,777	)
EBITDA		$	32,305			$	(1,165	)
An itemized reconciliation between net income from continuing operations on a GAAP basis and non-GAAP net income is as follows:
Net Income from Continuing Operations		$	160,552			$	17,175
Adjustments:
Share-based compensation expense			22,776				24,692
Depreciation expense			9,225				10,013
Amortization expense			8,996				9,165
Separation expense			19,084				1,355
Income tax effect related to reconciling items			22,011				4,847
Deferred tax valuation release			(160,953	)			—
Non-cash net interest expense			115				116
Non-GAAP Net Income from Continuing Operations			81,806				67,363
Non-GAAP Net Loss from Discontinued Operations			(44,383	)			(43,142	)
Non-GAAP Net Income		$	37,423			$	24,221
Non-GAAP diluted earnings per share from continuing operations		$	0.48			$	0.40
Non-GAAP diluted loss per share from discontinued operations		$	(0.26	)		$	(0.25	)
Non-GAAP diluted earnings per share		$	0.22			$	0.14

 

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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, 2023				December 31, 2022
Revenues:
Product sales, net		$	919,998			$	777,552
Manufacturing and royalty revenues			743,388				331,983
License revenue			—				2,000
Research and development revenue			19				260
Total Revenues			1,663,405				1,111,795
Expenses:
Cost of goods manufactured and sold			253,037				218,068
Research and development			270,806				272,702
Selling, general and administrative			689,751				590,751
Amortization of acquired intangible assets			35,689				36,363
Total Expenses			1,249,283				1,117,884
Operating Income (Loss)			414,122				(6,089	)
Other Income (Expense), net:
Interest income			30,854				7,629
Interest expense			(23,032	)			(13,040	)
Change in the fair value of contingent consideration			—				(21,750	)
Other (expense) income, net			(425	)			2,122
Total Other Income (Expense), net			7,397				(25,039	)
Income (Loss) Before Income Taxes			421,519				(31,128	)
Income Tax (Benefit) Provision			(97,638	)			2,024
Net Income (Loss) From Continuing Operations			519,157				(33,152	)
Discontinued Operations — Net of Tax			(163,400	)			(125,115	)
Net Income (Loss) — GAAP		$	355,757			$	(158,267	)
GAAP Earnings (Loss) Per Share - Basic:
From continuing operations		$	3.12			$	(0.20	)
From discontinued operations		$	(0.98	)		$	(0.76	)
Earnings (loss) per share		$	2.14			$	(0.97	)
GAAP Earnings (Loss) Per Share - Diluted:
From continuing operations		$	3.06			$	(0.20	)
From discontinued operations		$	(0.96	)		$	(0.76	)
Earnings (loss) per share		$	2.10			$	(0.97	)
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			166,223				163,742
Diluted — GAAP			169,730				163,742
Diluted — Non-GAAP			169,730				168,362
An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income (Loss) from Continuing Operations		$	519,157			$	(33,152	)
Adjustments:
Depreciation expense			36,921				39,959
Amortization expense			35,689				36,363
Interest income			(30,854	)			(7,629	)
Interest expense			23,032				13,040
Income tax (benefit) provision			(97,638	)			2,024
EBITDA from Continuing Operations			486,307				50,605
EBITDA from Discontinued Operations			(162,484	)			(134,637	)
EBITDA		$	323,823			$	(84,032	)

 

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Condensed Consolidated Statements of Operations - GAAP (Continued)		Year Ended				Year Ended
(In thousands, except per share data)		December 31, 2023				December 31, 2022
An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and non-GAAP net income is as follows:
Net Income (Loss) from Continuing Operations		$	519,157			$	(33,152	)
Adjustments:
Share-based compensation expense			92,719				87,676
Depreciation expense			36,921				39,959
Amortization expense			35,689				36,363
Separation expense			38,364				1,355
Income tax effect related to reconciling items			25,343				2,254
Final award in the Janssen arbitration (2022 back royalties and interest)			(197,092	)			—
Deferred tax valuation release			(160,953	)			—
Restructuring			5,938				—
Non-cash net interest expense			461				466
Reduction in the fair value of contingent consideration and other related assets			—				24,032
Legal settlement			—				15,905
Non-GAAP Net Income from Continuing Operations			396,547				174,858
Non-GAAP Net Loss from Discontinued Operations			(152,894	)			(116,999	)
Non-GAAP Net Income		$	243,653			$	57,859
Non-GAAP diluted earnings per share from continuing operations		$	2.34			$	1.04
Non-GAAP diluted loss per share from discontinued operations		$	(0.90	)		$	(0.69	)
Non-GAAP diluted earnings per share		$	1.44			$	0.34

 

 

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets		December 31,				December 31,
(In thousands)		2023				2022
Cash, cash equivalents and total investments		$	813,378			$	740,075
Receivables			332,477				287,967
Inventory			186,406				181,418
Contract assets			706				8,929
Prepaid expenses and other current assets			98,166				41,203
Property, plant and equipment, net			226,943				222,919
Intangible assets, net and goodwill			85,018				120,707
Assets held for sale			94,260				93,871
Assets from discontinued operations			—				40,087
Other assets			298,869				226,802
Total Assets		$	2,136,223			$	1,963,978
Long-term debt — current portion		$	3,000			$	3,000
Other current liabilities			512,678				488,898
Long-term debt			287,730				290,270
Liabilities from discontinued operations			4,542				19,386
Other long-term liabilities			125,587				118,671
Total shareholders' equity			1,202,686				1,043,753
Total Liabilities and Shareholders' Equity		$	2,136,223			$	1,963,978
Ordinary shares outstanding (in thousands)			166,980				164,377
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, 2023, which the company intends to file in February 2024.

 

 

 

 

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Alkermes plc and Subsidiaries
Amounts included in Discontinued Operations
(In thousands)		Three Months Ended March 31, 2023				Three Months Ended June 30, 2023				Three Months Ended September 30, 2023				Three Months Ended December 31, 2023				Year Ended December 31, 2023
Cost of goods manufactured and sold		$	11			$	11			$	11			$	6			$	39
Research and development			29,867				32,563				32,262				21,485				116,177
Selling, general and administrative			6,644				9,502				13,073				19,368				48,587
Income tax (benefit) provision			(6,727	)			(40	)			(1,550	)			6,914				(1,403	)
Loss from discontinued operations, net of tax		$	29,795			$	42,036			$	43,796			$	47,773			$	163,400
(In thousands)		Three Months Ended March 31, 2022				Three Months Ended June 30, 2022				Three Months Ended September 30, 2022				Three Months Ended December 31, 2022				Year Ended December 31, 2022
Cost of goods manufactured and sold		$	10			$	10			$	10			$	10			$	40
Research and development			29,161				27,475				32,929				31,575				121,140
Selling, general and administrative			3,201				3,488				3,618				4,689				14,996
Income tax (benefit) provision			(22,883	)			1,374				1,293				9,155				(11,061	)
Loss from discontinued operations, net of tax		$	9,489			$	32,347			$	37,850			$	45,429			$	125,115

 

 

 

 

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Alkermes plc and Subsidiaries
Revenues for Calendar Year 2023 and 2022
(In thousands)		Three Months Ended March 31, 2023				Three Months Ended June 30, 2023				Three Months Ended September 30, 2023				Three Months Ended December 31, 2023				Year Ended December 31, 2023
Revenues:
VIVITROL		$	96,659			$	102,070			$	99,305			$	102,385			$	400,419
ARISTADA			80,077				82,410				81,834				83,369				327,690
LYBALVI			37,991				46,997				50,683				56,218				191,889
Total Proprietary Sales			214,727				231,477				231,822				241,972				919,998
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)			24,543				326,380				90,993				81,461				523,377
VUMERITY			28,874				32,295				34,561				33,596				129,326
Key Commercial Product Revenues			268,144				590,152				357,376				357,029				1,572,701
Legacy Product Revenues			19,445				27,238				23,559				20,443				90,685
Research and Development Revenues			6				7				3				3				19
Total Revenues		$	287,595			$	617,397			$	380,938			$	377,475			$	1,663,405
(In thousands)		Three Months Ended March 31, 2022				Three Months Ended June 30, 2022				Three Months Ended September 30, 2022				Three Months Ended December 31, 2022				Year Ended December 31, 2022
Revenues:
VIVITROL		$	84,854			$	96,105			$	96,534			$	101,985			$	379,478
ARISTADA			72,485				74,622				75,719				79,226				302,052
LYBALVI			13,929				20,060				27,127				34,906				96,022
Total Proprietary Sales			171,268				190,787				199,380				216,117				777,552
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)			54,480				37,039				36,965				37,085				165,569
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
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI.

 

 

 

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Alkermes plc and Subsidiaries
2024 Guidance — GAAP to EBITDA
An itemized reconciliation between projected net income on a GAAP basis and EBITDA is as follows:
(In millions, except per share data)		Amount
Projected Net Income — GAAP		$	370.0
Adjustments:
Net interest income			(16.0	)
Depreciation expense			35.0
Amortization expense			1.0
Provision for income taxes			75.0
Projected EBITDA		$	465.0
Projected Net Income on a GAAP basis and Projected EBITDA reflect mid-points within ranges of estimated guidance.

 

 

 

 

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Alkermes plc and Subsidiaries
2024 Guidance — GAAP to Non-GAAP Adjustments
An itemized reconciliation between projected earnings 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				Earnings Per Share
Projected Net Income — GAAP		$	370.0				173.0			$	2.14
Adjustments:
Share-based compensation expense			86.0
Depreciation expense			35.0
Amortization expense			1.0
Non-cash net interest expense			0.5
Income tax effect related to reconciling items			(7.5	)
Projected Net Income — Non-GAAP		$	485.0				173.0			$	2.80
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

 

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Fourth Quarter and Year-End 2023 Financial Results & Business Update February 15, 2024 Exhibit 99.2

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Forward-Looking Statements 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 with respect to its current and future financial and operating performance, business plans or prospects, including its expected cash generation, revenue and growth drivers, expectations of profitability, potential return of capital to shareholders and potential transactions; the potential therapeutic and commercial value of the Company’s marketed products and development candidates; the Company’s expectations regarding plans and timelines for further clinical development activities, including for ALKS 2680; and the Company’s plans to advance and expand its neuroscience pipeline. The Company cautions that forward-looking statements are inherently uncertain. 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: whether the Company is able to sustain profitability; 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; the Company’s commercial activities may not result in the benefits that the Company anticipates; 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 or support growth of 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, assumptions 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, 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, EBITDA (earnings before interest, taxes, depreciation and amortization) 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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2023 Accomplishments Enabled Repositioning of Alkermes and Established Strong Foundation for Growth *Based on twelve months ended Dec. 31, 2023 compared to the prior year Generated ALKS 2680 initial clinical proof-of-concept data in patients with narcolepsy type 1 Completed separation of the oncology business Continued focus on operational efficiency, including recent agreement to divest Athlone, Ireland manufacturing facility Grew proprietary commercial product portfolio net sales by 18%* year-over-year Successfully settled VIVITROL® patent litigation Prevailed in Janssen arbitration; Raised 2023 financial expectations

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Alkermes 2024: Profitable, Pure-play Neuroscience Company >$1B commercial business driven primarily by 4 core products* Proven development capabilities with advancing neuroscience pipeline Positioned for sustained profitability and significant cash generation *Based on revenues from VIVITROL®, ARISTADA®, VUMERITY® and LYBALVI® for twelve months ended Dec. 31, 2023

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Q4 & FY 2023 Financial and Operational Performance

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In millions FY 2023 Financial Results Summary Total Revenue In millions GAAP Net Income (Loss) GAAP Earnings (Loss) Per Share (Diluted)

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In millions FY 2023 Profitability From Continuing Operations GAAP Net Income (Loss) From Continuing Operations In millions Non-GAAP Net Income From Continuing Operations* EBITDA From Continuing Operations* In millions *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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Q4 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **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 % Q4’23 Q4’22 ∆Q4’23 vs. Q4’22 Total Proprietary Net Sales $242.0 $216.1 12% VIVITROL® $102.4 $102.0 - ARISTADA®* $83.4 $79.2 5% LYBALVI® $56.2 $34.9 61% Manufacturing & Royalty Revenue** $135.5 $88.5 53% Research & Development Revenue $0.0 $0.0 - Total Revenue** $377.5 $304.7 24%

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FY 2023 Revenue Summary Amounts in the table above may not sum due to rounding. *Inclusive of ARISTADA INITIO® **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 % FY’23 FY’22 ∆FY’23 vs. FY’22 Total Proprietary Net Sales $920.0 $777.6 18% VIVITROL® $400.4 $379.5 6% ARISTADA®* $327.7 $302.1 8% LYBALVI® $191.9 $96.0 100% Manufacturing & Royalty Revenue** $743.4 $332.0 124% License Revenue - $2.0 (100%) Research & Development Revenue $0.0 $0.3 - Total Revenue** $1,663.4 $1,111.8 50%

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Alkermes: 2024 Financial Expectations* *These expectations are provided by the Company on Feb. 15, 2024 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. (in millions) Financial Expectations for Year Ending Dec. 31, 2024 Total Revenues $1,500 – $1,600 COGS $230 – $250 R&D Expense $225 – $255 SG&A Expense $625 – $655 GAAP Net Income $350 – $390 EBITDA‡ $445 – $485 Non-GAAP Net Income‡ $465 – $505 Effective Tax Rate ~17% Expected net sales of proprietary products: VIVITROL® net sales of $410M – $430M ARISTADA® net sales of $340M – $360M LYBALVI® net sales of $275M – $295M

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2023 Commercial Review

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Topline Growth and Diversification Reflect Evolving Business *Inclusive of ARISTADA INITIO® **Licensed product (royalty & manufacturing revenue) Key Product Revenues ($M) $574 $715 $893 $1,049

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LYBALVI® Performance and Expectations *These expectations are provided by the Company on Feb. 15, 2024 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) Q4’23 net sales of $56.2M reflect 11% sequential growth compared to Q3’23 Q4’23 gross-to-net deductions: ~29% Outlook: FY’24 net sales expected to range from $275M – $295M*

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LYBALVI® Prescription Growth Trends Q4’23 total TRx: ~46,700 reflecting 11% sequential growth compared to Q3’23 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 2/2/24) TRx Week

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ARISTADA® Performance and Expectations ARISTADA Annual Net Sales* ($M) *Inclusive of ARISTADA INITIO®† These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. $241 $275 $302 $328 Q4’23 year-over-year net sales increased 5% to $83.4M FY’23 year-over-year net sales increased 8% to $327.7M Outlook: FY’24 net sales expected to range from $340M – $360M†*

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VIVITROL® Performance and Expectations VIVITROL Annual Net Sales ($M) $311 $344 $380 $400 Q4’23 net sales of $102.4M were flat year-over-year FY’23 year-over-year net sales increased 6% to $400.4M Outlook: FY’24 net sales expected to range from $410M – $430M* *These expectations are provided by the Company on Feb. 15, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.

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2024 Outlook

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Capital Allocation Strategy Maximize the potential of proprietary commercial products with primary focus on LYBALVI® Pursue external opportunities to expand portfolio with assets that are a strong strategic fit Invest in internal development pipeline to advance new neuroscience candidates Return excess cash to shareholders

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2024 Strategic Priorities Driven by 4 core productsand streamlined operating structure Initiate phase 2 program Advance internal development candidates and explore external pipeline opportunities Deliver strong commercial growth and profitability Advance orexin 2 receptor agonist program Expand neuroscience pipeline Plan for significant cash generation Continue focus on capital allocation, including potential opportunities to return capital to shareholders

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Appendix

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Appendix: Amounts Included in Discontinued Operations (In thousands) Year Ended December 31, 2023 Three Months Ended March 31, 2023 Three Months Ended June 30, 2023 Three Months Ended September 30, 2023 Three Months Ended December 31, 2023 Year Ended December 31, 2023 Cost of goods manufactured and sold $ 11 $ 11 $ 11 $ 6 $ 39 Research and development 29,867 32,563 32,262 21,485 116,177 Selling, general and administrative 6,644 9,502 13,073 19,368 48,587 Income tax provision (benefit) $ (6,727) $ (40) $ (1,550) $ 6,914 $ (1,403) Loss from discontinued operations, net of tax $ 29,795 $ 42,036 $ 43,796 $ 47,773 $ 163,400 (In thousands) Year Ended December 31, 2023 Three Months Ended March 31, 2022 Three Months Ended June 30, 2022 Three Months Ended September 30, 2022 Three Months Ended December 31, 2022 Year Ended December 31, 2022 Cost of goods manufactured and sold $ 10 $ 10 $ 10 $ 10 $ 40 Research and development 29,161 27,475 32,929 31,575 121,140 Selling, general and administrative 3,201 3,488 3,618 4,689 14,996 Income tax provision (benefit) $ (22,883) $ 1,374 $ 1,293 $ 9,155 $ (11,061) Loss from discontinued operations, net of tax $ 9,489 $ 32,347 $ 37,850 $ 45,429 $ 125,115

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Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Year Ended December 31, 2023 Year Ended December 31, 2022 Net Income (Loss) from Continuing Operations — GAAP $ 519.2 $ (33.2) Adjustments: Share-based compensation expense 92.7 87.7 Depreciation expense 36.9 40.0 Amortization expense 35.7 36.4 Separation expense 38.4 1.4 Income tax effect related to reconciling items 25.3 2.3 Final award in the Janssen arbitration (2022 back royalties and interest) (197.1) -- Deferred tax valuation release (161.0) -- Restructuring 5.9 -- Non-cash net interest expense 0.5 0.5 Reduction in the fair value of contingent consideration and other related assets -- 24.0 Legal settlement -- 15.9 Non-GAAP Net Income from Continuing Operations $ 396.5 $ 174.9 Non-GAAP Net Loss from Discontinued Operations $ (152.9) $ (117.0) Non-GAAP Net Income $ 243.7 $ 57.9 Amounts in the table above may not sum due to rounding.

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Appendix: Financial Results GAAP to EBITDA (In millions) Year Ended December 31, 2023 Year Ended December 31, 2022 Net Income from Continuing Operations — GAAP $ 519.2 $ (33.2) Adjustments: Depreciation expense 36.9 40.0 Amortization expense 35.7 36.4 Interest income (30.9) (7.6) Interest expense 23.0 13.0 Income tax (benefit) provision (97.6) 2.0 EBITDA from Continuing Operations $ 486.3 $ 50.6 EBITDA from Discontinued Operations $ (162.5) $ (134.6) EBITDA $ 323.8 $ (84.0)

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Appendix: 2024 Guidance GAAP to Non-GAAP Adjustments (In millions, except per share data) Year Ended December 31, 2023 Year Ending December 31, 2024 Shares+ Earnings Per Share Projected Net Income — GAAP $ 370.0 173.0 $ 2.14 Adjustments: Share-based compensation expense 86.0 Depreciation expense 35.0 Amortization expense 1.0 Non-cash net interest expense 0.5 Income tax effect related to reconciling items (7.5) Projected Net Income — Non-GAAP $ 485.0 173.0 $ 2.80 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges. +2024 per share expectations are calculated based on a weighted average diluted share count of approximately 173.0 million shares outstanding.

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Appendix: 2024 Guidance GAAP to EBITDA (In millions) Year Ended December 31, 2023 Year Ending December 31, 2024 Projected Net Income — GAAP $ 370.0 Adjustments: Net interest income (16.0) Depreciation expense 35.0 Amortization expense 1.0 Provision for income taxes 75.0 Projected EBITDA $ 465.0 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges.

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www.alkermes.com

v3.24.0.1

Document and Entity Information	Feb. 15, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 15, 2024
Entity Registrant Name	Alkermes plc.
Entity Central Index Key	0001520262
Entity Emerging Growth Company	false
Entity File Number	001-35299
Entity Incorporation, State or 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
Title of 12(b) Security	Ordinary shares, $0.01 par value
Trading Symbol	ALKS
Security Exchange Name	NASDAQ

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