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): July 24, 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 July 24, 2024, Alkermes plc (the “Company”) announced financial results for the three and six months ended June 30, 2024. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on July 24, 2024 discussing such financial results are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.		Description
99.1		Press release issued by Alkermes plc on July 24, 2024 announcing financial results for the three and six months ended June 30, 2024.
99.2		Investor presentation to be displayed by Alkermes plc on July 24, 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: July 24, 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 Second Quarter 2024 Financial Results

— Second Quarter Revenues of $399.1 Million —

— Net Sales of Proprietary Products Increased Approximately 16% Year-Over-Year —

— GAAP Net Income from Continuing Operations of $94.7 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.55 —

— Company Reiterates 2024 Financial Expectations —

 

DUBLIN, July 24, 2024 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2024.

 

“Our second quarter results reflect solid execution across our business, delivering double-digit, year-over-year growth for our proprietary commercial product portfolio and robust profitability. We enter the second half of the year in a strong financial position with clear operational priorities to drive the performance of our commercial portfolio and advance our neuroscience development pipeline, including the phase 2 program for ALKS 2680 in narcolepsy type 1 and type 2,” said Richard Pops, Chief Executive Officer of Alkermes. “As a profitable, smid-cap biotech growth company with multiple commercial products and a development pipeline with significant value potential, we are executing our plan to become a leader in the field of neuroscience.”

 

Key Financial Highlights

Revenues

	Three Months Ended June 30,					Six Months Ended June 30,
(In millions)	2024		2023			2024		2023
Total Revenues	$	399.1	$	617.4*		$	749.5	$	905.0*
Total Proprietary Net Sales	$	269.3	$	231.5		$	502.8	$	446.2
VIVITROL®	$	111.9	$	102.1		$	209.5	$	198.7
ARISTADA®i	$	86.0	$	82.4		$	164.9	$	162.5
LYBALVI®	$	71.4	$	47.0		$	128.4	$	85.0

Profitability

	Three Months Ended June 30,					Six Months Ended June 30,
(In millions)	2024		2023			2024		2023
GAAP Net Income From Continuing Operations	$	94.7	$	279.1		$	133.6	$	267.1
GAAP Net Loss From Discontinued Operations	$	(3.3)	$	(42.0)		$	(5.4)	$	(71.8)
GAAP Net Income	$	91.4	$	237.1*		$	128.2	$	195.2*
Non-GAAP Net Income From Continuing Operations	$	123.4	$	134.3		$	199.6	$	164.4
Non-GAAP Net Loss From Discontinued Operations	$	(3.3)	$	(40.0)		$	(5.4)	$	(67.7)
Non-GAAP Net Income	$	120.1	$	94.3		$	194.2	$	96.7
EBITDA From Continuing Operations	$	118.6	$	299.1		$	170.1	$	306.2
EBITDA From Discontinued Operations	$	(3.9)	$	(41.4)		$	(6.4)	$	(77.4)
EBITDA	$	114.7	$	257.7*		$	163.7	$	228.9*

 

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*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products (consisting of $195.4 million for 2022 and $50.1 million for the first quarter of 2023) that would ordinarily have been recognized in prior periods.

 

Revenue Highlights

LYBALVI

ARISTADAi

VIVITROL

Manufacturing & Royalty Revenues

 

Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

 

	Three Months Ended June 30,					Six Months Ended June 30,
(In millions)	2024		2023			2024		2023
R&D Expense – Continuing Operations	$	59.6	$	68.2		$	127.3	$	132.0
R&D Expense – Discontinued Operations	$	3.9	$	32.6		$	6.4	$	62.4
SG&A Expense – Continuing Operations	$	168.1	$	195.8		$	347.9	$	363.6
SG&A Expense – Discontinued Operations	$	—	$	9.5		$	—	$	16.1

 

Balance Sheet

At June 30, 2024, the company recorded cash, cash equivalents and total investments of $962.5 million, compared to $807.8 million at March 31, 2024. The company’s total debt outstanding as of June 30, 2024 was $289.5 million.

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Share Repurchase Program

During the second quarter of 2024, the company repurchased approximately 3.5 million of the company’s ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $84.7 million. As of June 30, 2024, the company had $315.3 million (exclusive of any fees, commissions or other expenses related to such repurchases) remaining under the program.

Financial Expectations for 2024

Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024.

Recent Events

 

Notes and Explanations

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 24, 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

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and preclinical candidates in development for neurological disorders, including narcolepsy. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in 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 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 profitability; and the potential therapeutic and commercial value of ALKS 2680 and the company’s development pipeline. 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 make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023

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and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

 

VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; 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)		June 30, 2024				June 30, 2023
Revenues:
Product sales, net		$	269,273			$	231,477
Manufacturing and royalty revenues			129,858				385,913
Research and development revenue			—				7
Total Revenues			399,131				617,397
Expenses:
Cost of goods manufactured and sold			61,472				63,249
Research and development			59,649				68,225
Selling, general and administrative			168,113				195,756
Amortization of acquired intangible assets			14				8,898
Total Expenses			289,248				336,128
Operating Income			109,883				281,269
Other Income, net:
Interest income			10,735				6,769
Interest expense			(5,952	)			(5,684	)
Other income (expense), net			2,053				(525	)
Total Other Income, net			6,836				560
Income Before Income Taxes			116,719				281,829
Income Tax Provision			22,061				2,728
Net Income From Continuing Operations			94,658				279,101
Loss From Discontinued Operations — Net of Tax			(3,300	)			(42,036	)
Net Income — GAAP		$	91,358			$	237,065
GAAP Earnings (Loss) Per Ordinary Share - Basic:
From continuing operations		$	0.56			$	1.68
From discontinued operations		$	(0.02	)		$	(0.25	)
From net income		$	0.54			$	1.43
GAAP Earnings (Loss) Per Ordinary Share - Diluted:
From continuing operations		$	0.55			$	1.63
From discontinued operations		$	(0.02	)		$	(0.25	)
From net income		$	0.53			$	1.38
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			168,321				166,279
Diluted — GAAP and Non-GAAP			170,977				171,553

 

 

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Condensed Consolidated Statements of Operations - GAAP (Continued)		Three Months Ended				Three Months Ended
(In thousands, except per share data)		June 30, 2024				June 30, 2023
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income from Continuing Operations		$	94,658			$	279,101
Adjustments:
Depreciation expense			6,644				9,426
Amortization expense			14				8,898
Interest income			(10,735	)			(6,769	)
Interest expense			5,952				5,684
Income tax provision			22,061				2,728
EBITDA from Continuing Operations			118,594				299,068
EBITDA from Discontinued Operations			(3,913	)			(41,388	)
EBITDA		$	114,681			$	257,680
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		$	94,658			$	279,101
Adjustments:
Share-based compensation expense			20,601				27,187
Depreciation expense			6,644				9,426
Amortization expense			14				8,898
Non-cash net interest expense			114				115
Separation expense			813				5,857
Income tax effect related to reconciling items			2,060				816
Gain on sale of Athlone manufacturing facility			(1,462	)			—
Final award in the Janssen arbitration (2022 back royalties and interest)			—				(197,092	)
Non-GAAP Net Income from Continuing Operations			123,442				134,308
Non-GAAP Net Loss from Discontinued Operations			(3,300	)			(40,031	)
Non-GAAP Net Income		$	120,142			$	94,277
Non-GAAP diluted earnings per ordinary share from continuing operations		$	0.72			$	0.78
Non-GAAP diluted loss per ordinary share from discontinued operations		$	(0.02	)		$	(0.23	)
Non-GAAP diluted earnings per ordinary share from net income		$	0.70			$	0.55

 

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Statements of Operations - GAAP		Six Months Ended				Six Months Ended
(In thousands, except per share data)		June 30, 2024				June 30, 2023
Revenues:
Product sales, net		$	502,809			$	446,204
Manufacturing and royalty revenues			246,691				458,775
Research and development revenue			3				13
Total Revenues			749,503				904,992
Expenses:
Cost of goods manufactured and sold			120,116				121,413
Research and development			127,260				131,995
Selling, general and administrative			347,862				363,589
Amortization of acquired intangible assets			1,073				17,698
Total Expenses			596,311				634,695
Operating Income			153,192				270,297
Other Income, net:
Interest income			20,134				11,735
Interest expense			(11,930	)			(10,972	)
Other income (expense), net			2,235				(564	)
Total Other Income, net			10,439				199
Income Before Income Taxes			163,631				270,496
Income Tax Provision			30,025				3,445
Net Income From Continuing Operations			133,606				267,051
Loss From Discontinued Operations — Net of Tax			(5,420	)			(71,831	)
Net Income — GAAP		$	128,186			$	195,220
GAAP Earnings (Loss) Per Ordinary Share - Basic:
From continuing operations		$	0.79			$	1.61
From discontinued operations		$	(0.03	)		$	(0.43	)
From net income		$	0.76			$	1.18
GAAP Earnings (Loss) Per Ordinary Share - Diluted:
From continuing operations		$	0.78			$	1.56
From discontinued operations		$	(0.03	)		$	(0.42	)
From net income		$	0.75			$	1.14
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			168,152				165,686
Diluted — GAAP and Non-GAAP			171,960				170,747

 

 

 

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Condensed Consolidated Statements of Operations - GAAP (Continued)		Six Months Ended				Six Months Ended
(In thousands, except per share data)		June 30, 2024				June 30, 2023
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income from Continuing Operations		$	133,606			$	267,051
Adjustments:
Depreciation expense			13,641				18,810
Amortization expense			1,073				17,698
Interest income			(20,134	)			(11,735	)
Interest expense			11,930				10,972
Income tax provision			30,025				3,445
EBITDA from Continuing Operations			170,141				306,241
EBITDA from Discontinued Operations			(6,429	)			(77,380	)
EBITDA		$	163,712			$	228,861
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		$	133,606			$	267,051
Adjustments:
Share-based compensation expense			53,356				48,210
Depreciation expense			13,641				18,810
Amortization expense			1,073				17,698
Separation expense			1,240				9,640
Income tax effect related to reconciling items			(2,061	)			(179	)
Gain on sale of Athlone manufacturing facility			(1,462	)			—
Final award in the Janssen arbitration (2022 back royalties and interest)			—				(197,092	)
Non-cash net interest expense			228				231
Non-GAAP Net Income from Continuing Operations			199,621				164,369
Non-GAAP Net Loss from Discontinued Operations			(5,420	)			(67,676	)
Non-GAAP Net Income		$	194,201			$	96,693
Non-GAAP diluted earnings per ordinary share from continuing operations		$	1.16			$	0.96
Non-GAAP diluted loss per ordinary share from discontinued operations		$	(0.03	)		$	(0.40	)
Non-GAAP diluted earnings per ordinary share from net income		$	1.13			$	0.57

 

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets		June 30,				December 31,
(In thousands)		2024				2023
Cash, cash equivalents and total investments		$	962,520			$	813,378
Receivables			366,415				332,477
Inventory			194,731				186,406
Contract assets			3,492				706
Prepaid expenses and other current assets			101,435				98,166
Property, plant and equipment, net			222,738				226,943
Intangible assets, net and goodwill			83,945				85,018
Assets held for sale			—				94,260
Deferred tax assets			167,382				195,888
Other assets			104,184				102,981
Total Assets		$	2,206,842			$	2,136,223
Long-term debt — current portion		$	3,000			$	3,000
Other current liabilities			512,548				512,678
Long-term debt			286,459				287,730
Liabilities from discontinued operations			—				4,542
Other long-term liabilities			120,830				125,587
Total shareholders' equity			1,284,005				1,202,686
Total Liabilities and Shareholders' Equity		$	2,206,842			$	2,136,223
Ordinary shares outstanding (in thousands)			165,887				166,980
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, which the company intends to file in July 2024.

 

 

 

 

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Alkermes plc and Subsidiaries
Amounts Included in Discontinued Operations
(In thousands)		Three Months Ended March 31, 2024				Three Months Ended June 30, 2024				Six Months Ended June 30, 2024
Cost of goods manufactured and sold		$	—			$	—			$	-
Research and development			2,516				3,913				6,429
Selling, general and administrative			—				—				-
Income tax benefit			(396	)			(613	)			(1,009	)
Loss from discontinued operations, net of tax		$	2,120			$	3,300			$	5,420
(In thousands)		Three Months Ended March 31, 2023				Three Months Ended June 30, 2023				Six Months Ended June 30, 2023
Cost of goods manufactured and sold		$	11			$	11			$	22
Research and development			29,867				32,563				62,430
Selling, general and administrative			6,644				9,502				16,146
Income tax benefit			(6,727	)			(40	)			(6,767	)
Loss from discontinued operations, net of tax		$	29,795			$	42,036			$	71,831

 

 

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Second Quarter 2024 Financial Results & Business Update July 24, 2024 Exhibit 99.2

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Forward-Looking Statements and Non-GAAP Financial Information Certain statements set forth in this presentation constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: Alkermes plc’s (the “Company”) expectations with respect to its current and future financial, commercial and operating performance, business plans or prospects, including its expected cash and revenue generation and expectations of profitability. 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 and the results of such activities 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; the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities 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 for the year ended Dec. 31, 2023 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®. INVEGA® is a registered trademark of Johnson & Johnson or its affiliated companies. 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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Q2 2024 Financial and Operational Performance

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In millions Q2 2024 Financial Results Summary Total Revenue In millions GAAP Net Income GAAP Earnings Per Share Diluted * Results for the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products in 2022 and the first quarter of 2023 that ordinarily would have been recognized in prior periods, following the successful outcome of the Company’s arbitration with Janssen Pharmaceutica N.V. (“Janssen”), a subsidiary of Johnson & Johnson. * * * $617.4 Janssen back royalties and related interest

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In millions Q2 2024 Profitability From Continuing Operations GAAP Net Income 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; EBITDA (earnings before interest, taxes, depreciation and amortization) ** GAAP and EBITDA results for the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products in 2022 and the first quarter of 2023 that ordinarily would have been recognized in prior periods, following the successful outcome of the Company’s arbitration with Janssen. † Non-GAAP net income results for the three months ended June 30, 2023 included approximately $50.1 million of back royalties related to U.S. net sales of long-acting INVEGA products in the first quarter of 2023 that ordinarily would have been recognized in the first quarter of 2023, following the successful outcome of the Company’s arbitration with Janssen. †

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Q2 2024 Revenue Summary Amounts in the table above may not sum due to rounding. In millions Q2’24 Q2’23 Total Proprietary Net Sales $269.3 $231.5 VIVITROL® $111.9 $102.1 ARISTADA®* $86.0 $82.4 LYBALVI® $71.4 $47.0 Manufacturing & Royalty Revenue $129.9 $385.9** Total Revenue $399.1 $617.4** *Inclusive of ARISTADA INITIO® **Results for the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products in 2022 and the first quarter of 2023 that ordinarily would have been recognized in prior periods, following the successful outcome of the Company’s arbitration with Janssen.

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Alkermes: 2024 Financial Expectations* *These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on July 24, 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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Q2 2024 Commercial Review

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LYBALVI® Performance and Expectations *These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on July 24, 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) Q2’24 LYBALVI® net sales of $71.4M reflects 52% growth compared to Q2’23 Q2’24 gross-to-net deductions: ~28% Outlook: FY’24 net sales expected to range from $275M – $295M*

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LYBALVI® Prescription Growth Trends Q2’24 total TRx: ~55,300 reflecting 12% sequential growth compared to Q1’24 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 7/12/24) TRx Week

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ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales* ($M) Q2’24 ARISTADA® net sales were $86.0M Outlook: FY’24 net sales expected to range from $340M – $360M†* *Inclusive of ARISTADA INITIO®† These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on July 24, 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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VIVITROL® Performance and Expectations VIVITROL Quarterly Net Sales ($M) * These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on July 24, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. Q2’24 VIVITROL® net sales were $111.9M Outlook: FY’24 net sales expected to range from $410M – $430M*

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Appendix

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Appendix: Amounts Included in Discontinued Operations (In millions) Year Ended December 31, 2023 Three Months Ended June 30, 2024 Cost of goods manufactured and sold $ --- Research and development 3.9 Selling, general and administrative --- Income tax benefit $ (0.6) Loss from discontinued operations, net of tax $ 3.3 (In millions) Year Ended December 31, 2023 Three Months Ended June 30, 2023 Cost of goods manufactured and sold $ 0.0 Research and development 32.6 Selling, general and administrative 9.5 Income tax benefit $ (0.0) Loss from discontinued operations, net of tax $ 42.0

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Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Net Income from Continuing Operations — GAAP $ 94.7 $ 279.1 Adjustments: Share-based compensation expense 20.6 27.2 Depreciation expense 6.6 9.4 Amortization expense 0.0 8.9 Non-cash net interest expense 0.1 0.1 Separation expense 0.8 5.9 Income tax effect related to reconciling items 2.1 0.8 Gain on sale of Athlone manufacturing facility (1.5) --- Final award in the Janssen arbitration (2022 back royalties and interest) --- (197.1) Non-GAAP Net Income from Continuing Operations $ 123.4 $ 134.3 Non-GAAP Net Loss from Discontinued Operations $ (3.3) $ (40.0) Non-GAAP Net Income $ 120.1 $ 94.3 Amounts in the table above may not sum due to rounding.

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Appendix: Financial Results GAAP to EBITDA Adjustments (In millions) Three Months Ended June 30, 2024 Three Months Ended June 30, 2023 Net Income from Continuing Operations — GAAP $ 94.7 $ 279.1 Adjustments: Depreciation expense 6.6 9.4 Amortization expense 0.0 8.9 Interest income (10.7) (6.8) Interest expense 6.0 5.7 Income tax provision 22.1 2.3 EBITDA from Continuing Operations $ 118.6 $ 299.1 EBITDA from Discontinued Operations $ (3.9) $ (41.4) EBITDA $ 114.7 $ 257.7

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Appendix: 2024 Guidance GAAP to Non-GAAP Adjustments (In millions) Year Ended December 31, 2023 Year Ending December 31, 2024 Projected Net Income — GAAP $ 370.0 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 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges.

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Appendix: 2024 Guidance GAAP to EBITDA Adjustments (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

v3.24.2

Document and Entity Information	Jul. 24, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 24, 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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