Form 8-K - Current report

False0001520262Alkermes plc.00015202622025-02-122025-02-12

 

 

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 12, 2025

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 12, 2025, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2024 and financial expectations for the year ending December 31, 2025. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 12, 2025 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 12, 2025 announcing financial results for the three months and year ended December 31, 2024 and financial expectations for the year ending December 31, 2025.
99.2		Investor presentation to be displayed by Alkermes plc on February 12, 2025.
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 12, 2025	By:		/s/ Blair C. Jackson
			Blair C. Jackson
			Executive Vice President, Chief Operating Officer (Interim Principal Financial Officer)

 

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Exhibit 99.1

	Alkermes Contacts:
	For Investors:	Sandy Coombs [phone]
	For Media:	Katie Joyce [phone]

 

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025

— Total Revenues of $1.56 Billion in 2024; Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year —

— GAAP Net Income from Continuing Operations of $372 Million and Diluted GAAP Earnings per Share from Continuing Operations of $2.20 for 2024 —

— ALKS 2680 Phase 2 Studies in Narcolepsy Type 1 and Type 2 Ongoing With Data Expected in H2 2025 —

 

DUBLIN, Feb. 12, 2025 — Alkermes plc (Nasdaq: ALKS) today reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025.

 

“2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience,” said Richard Pops, Chief Executive Officer of Alkermes. “Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category.”

 

“2024 was Alkermes’ strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company’s ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline,” said Blair Jackson, Chief Operating Officer of Alkermes. “We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company’s next phase of growth.”

 

Key Financial Highlights

Revenues

	Three Months Ended December 31,					Twelve Months Ended December 31,
(In millions)	2024		2023			2024		2023
Total Revenues	$	430.0	$	377.5		$	1,557.6	$	1,663.4*
Total Proprietary Net Sales	$	307.7	$	242.0		$	1,083.5	$	920.0
VIVITROL®	$	134.1	$	102.4		$	457.3	$	400.4
ARISTADA®i	$	96.6	$	83.4		$	346.2	$	327.7
LYBALVI®	$	77.0	$	56.2		$	280.0	$	191.9

 

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Profitability

	Three Months Ended December 31,					Twelve Months Ended December 31,
(In millions)	2024		2023			2024		2023*
GAAP Net Income From Continuing Operations	$	145.7	$	160.6		$	372.1	$	519.2
GAAP Net Income (Loss) From Discontinued Operations	$	0.8	$	(47.8)		$	(5.1)	$	(163.4)
GAAP Net Income	$	146.5	$	112.8		$	367.1	$	355.8
Non-GAAP Net Income From Continuing Operations	$	173.4	$	81.8		$	494.4	$	396.5
Non-GAAP Net Income (Loss) From Discontinued Operations	$	0.8	$	(44.4)		$	(5.1)	$	(152.9)
Non-GAAP Net Income	$	174.2	$	37.4		$	489.3	$	243.7
EBITDA From Continuing Operations	$	170.0	$	72.8		$	452.4	$	486.3
EBITDA From Discontinued Operations	$	1.1	$	(40.5)		$	(5.8)	$	(162.5)
EBITDA	$	171.1	$	32.3		$	446.6	$	323.8

 

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA® products that would ordinarily have been recognized in prior periods.

 

Revenue Highlights

LYBALVI

•

Revenues for the fourth quarter were $77.0 million.

•

Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023.

•

During the quarter, the company recorded LYBALVI® revenue of approximately $4 million related to year-end inventory fluctuations.

ARISTADAi

•

Revenues for the fourth quarter were $96.6 million.

•

Fourth quarter revenues grew 16% compared to the fourth quarter of 2023.

•

During the quarter, the company recorded ARISTADA® revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.

VIVITROL

•

Revenues for the fourth quarter were $134.1 million.

•

Fourth quarter revenues grew 31% compared to the fourth quarter of 2023.

•

During the quarter, the company recorded VIVITROL® revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.

Manufacturing & Royalty Revenues

•

Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter were $36.5 million.

•

VUMERITY® manufacturing and royalty revenues for the fourth quarter were $35.0 million.

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•

FAMPYRA® manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward.

•

RISPERDAL CONSTA® manufacturing revenues for the fourth quarter were $14.7 million.

 

Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

 

	Three Months Ended December 31,					Twelve Months Ended December 31,
(In millions)	2024		2023			2024		2023
R&D Expense – Continuing Operations	$	58.2	$	73.9		$	245.3	$	270.8
R&D Expense – Discontinued Operations	$	(1.1)	$	21.5		$	5.8	$	116.2
SG&A Expense – Continuing Operations	$	147.0	$	169.8		$	645.2	$	689.8
SG&A Expense – Discontinued Operations	$	—	$	19.4		$	—	$	48.6

 

Balance Sheet

•

At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023.

•

In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million.

Financial Expectations for 2025

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

In millions		2025 Expectations
Total Revenues		$1,340 – $1,430
VIVITROL Net Sales		$440 – $460
ARISTADAi Net Sales		$335 – $355
LYBALVI Net Sales		$320 – $340
Cost of Goods Sold		$185 – $205
R&D Expenses		$305 – $335
SG&A Expenses		$655 – $685
GAAP Net Income a		$175 – $205
EBITDA		$215 – $245
Adjusted EBITDA		$310 – $340
Effective Tax Rate		~17%

a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding.

Notes and Explanations

1.

The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and twelve months ended Dec. 31, 2023.

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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 Wednesday, Feb. 12, 2025, 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 [phone] for U.S. callers and [phone] 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, including narcolepsy and idiopathic hypersomnia. 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, EBITDA and Adjusted 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. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings.

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, EBITDA and Adjusted 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, EBITDA and Adjusted 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 expected drivers of growth, value creation and profitability; and the company’s expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, ALKS 2680 and the company’s other orexin portfolio candidates. The company cautions that forward-looking statements are inherently uncertain. The

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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 achieve its financial expectations, including those related to profitability; 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 unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company’s products or products using the company’s proprietary technologies; 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 most recent Annual Report on Form 10-K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

 

VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA®, INVEGA HAFYERA®, INVEGA TRINZA®, RISPERDAL CONSTA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; FAMPYRATM is a trademark of Merz Pharmaceuticals, LLC; 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, 2024				December 31, 2023
Revenues:
Product sales, net		$	307,726			$	241,972
Manufacturing and royalty revenues			122,260				135,500
Research and development revenue			—				3
Total Revenues			429,986				377,475
Expenses:
Cost of goods manufactured and sold			62,116				70,126
Research and development			58,174				73,933
Selling, general and administrative			146,994				169,789
Amortization of acquired intangible assets			14				8,996
Total Expenses			267,298				322,844
Operating Income			162,688				54,631
Other Income, net:
Interest income			11,400				9,749
Interest expense			(4,648	)			(6,054	)
Other income (expense), net			449				(10	)
Total Other Income, net			7,201				3,685
Income Before Income Taxes			169,889				58,316
Income Tax Provision (Benefit)			24,152				(102,236	)
Net Income From Continuing Operations			145,737				160,552
Income (Loss) From Discontinued Operations — Net of Tax			766				(47,773	)
Net Income — GAAP		$	146,503			$	112,779
GAAP Earnings (Loss) Per Ordinary Share - Basic:
From continuing operations		$	0.90			$	0.96
From discontinued operations		$	0.00			$	(0.29	)
From net income		$	0.90			$	0.68
GAAP Earnings (Loss) Per Ordinary Share - Diluted:
From continuing operations		$	0.88			$	0.94
From discontinued operations		$	0.00			$	(0.28	)
From net income		$	0.88			$	0.66
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			161,956				166,898
Diluted — GAAP and Non-GAAP			166,554				170,138

 

 

 

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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, 2024				December 31, 2023
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income from Continuing Operations		$	145,737			$	160,552
Adjustments:
Depreciation expense			6,833				9,225
Amortization expense			14				8,996
Interest income			(11,400	)			(9,749	)
Interest expense			4,648				6,054
Income tax provision (benefit)			24,152				(102,236	)
EBITDA from Continuing Operations			169,984				72,842
EBITDA from Discontinued Operations			1,120				(40,537	)
EBITDA		$	171,104			$	32,305
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		$	145,737			$	160,552
Adjustments:
Share-based compensation expense			20,747				22,776
Depreciation expense			6,833				9,225
Amortization expense			14				8,996
Loss on debt extinguishment			719				—
Income tax effect related to reconciling items			(629	)			22,011
Separation expense			—				19,084
Non-cash net interest expense			—				115
Deferred tax valuation release			—				(160,953	)
Non-GAAP Net Income from Continuing Operations			173,421				81,806
Non-GAAP Net Income (Loss) from Discontinued Operations			766				(44,383	)
Non-GAAP Net Income		$	174,187			$	37,423
Non-GAAP diluted earnings per ordinary share from continuing operations		$	1.04			$	0.48
Non-GAAP diluted loss per ordinary share from discontinued operations		$	0.00			$	(0.26	)
Non-GAAP diluted earnings per ordinary share from net income		$	1.05			$	0.22

 

 

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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, 2024				December 31, 2023
Revenues:
Product sales, net		$	1,083,534			$	919,998
Manufacturing and royalty revenues			474,095				743,388
Research and development revenue			3				19
Total Revenues			1,557,632				1,663,405
Expenses:
Cost of goods manufactured and sold			245,331				253,037
Research and development			245,326				270,806
Selling, general and administrative			645,238				689,751
Amortization of acquired intangible assets			1,101				35,689
Total Expenses			1,136,996				1,249,283
Operating Income			420,636				414,122
Other Income, net:
Interest income			42,450				30,854
Interest expense			(22,578	)			(23,032	)
Other income (expense), net			3,242				(425	)
Total Other Income, net			23,114				7,397
Income Before Income Taxes			443,750				421,519
Income Tax Provision (Benefit)			71,612				(97,638	)
Net Income From Continuing Operations			372,138				519,157
Loss From Discontinued Operations — Net of Tax			(5,068	)			(163,400	)
Net Income — GAAP		$	367,070			$	355,757
GAAP Earnings (Loss) Per Ordinary Share - Basic:
From continuing operations		$	2.25			$	3.12
From discontinued operations		$	(0.03	)		$	(0.98	)
From net income		$	2.22			$	2.14
GAAP Earnings (Loss) Per Ordinary Share - Diluted:
From continuing operations		$	2.20			$	3.06
From discontinued operations		$	(0.03	)		$	(0.96	)
From net income		$	2.17			$	2.10
Weighted Average Number of Ordinary Shares Outstanding:
Basic — GAAP and Non-GAAP			165,392				166,223
Diluted — GAAP and Non-GAAP			169,198				169,730

 

 

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Condensed Consolidated Statements of Operations - GAAP (Continued)		Year Ended				Year Ended
(In thousands, except per share data)		December 31, 2024				December 31, 2023
An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:
Net Income from Continuing Operations		$	372,138			$	519,157
Adjustments:
Depreciation expense			27,432				36,921
Amortization expense			1,101				35,689
Interest income			(42,450	)			(30,854	)
Interest expense			22,578				23,032
Income tax provision (benefit)			71,612				(97,638	)
EBITDA from Continuing Operations			452,411				486,307
EBITDA from Discontinued Operations			(5,790	)			(162,484	)
EBITDA		$	446,621			$	323,823
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		$	372,138			$	519,157
Adjustments:
Share-based compensation expense			96,636				92,719
Depreciation expense			27,432				36,921
Amortization expense			1,101				35,689
Separation expense			1,446				38,364
Loss on debt extinguishment			719				—
Gain on sale of Athlone manufacturing facility			(1,462	)			—
Income tax effect related to reconciling items			(3,945	)			25,343
Deferred tax valuation release			—				(160,953	)
Restructuring expense			—				5,938
Final award in the Janssen arbitration (2022 back royalties and interest)			—				(197,092	)
Non-cash net interest expense			342				461
Non-GAAP Net Income from Continuing Operations			494,407				396,547
Non-GAAP Net Loss from Discontinued Operations			(5,068	)			(152,894	)
Non-GAAP Net Income		$	489,339			$	243,653
Non-GAAP diluted earnings per ordinary share from continuing operations		$	2.92			$	2.34
Non-GAAP diluted loss per ordinary share from discontinued operations		$	(0.03	)		$	(0.90	)
Non-GAAP diluted earnings per ordinary share from net income		$	2.89			$	1.44

 

 

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Alkermes plc and Subsidiaries
Selected Financial Information (Unaudited)
Condensed Consolidated Balance Sheets		December 31,				December 31,
(In thousands)		2024				2023
Cash, cash equivalents and total investments		$	824,816			$	813,378
Receivables			389,733				332,477
Inventory			182,887				186,406
Contract assets			4,990				706
Prepaid expenses and other current assets			86,077				98,166
Property, plant and equipment, net			227,564				226,943
Intangible assets, net and goodwill			83,917				85,018
Assets held for sale			—				94,260
Deferred tax assets			154,835				195,888
Other assets			100,748				102,981
Total Assets		$	2,055,567			$	2,136,223
Long-term debt — current portion		$	—			$	3,000
Other current liabilities			465,199				512,678
Long-term debt			—				287,730
Liabilities from discontinued operations			—				4,542
Other long-term liabilities			125,391				125,587
Total shareholders' equity			1,464,977				1,202,686
Total Liabilities and Shareholders' Equity		$	2,055,567			$	2,136,223
Ordinary shares outstanding (in thousands)			162,177				166,980
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, 2024, which the company intends to file in February 2025.

 

 

 

 

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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				Three Months Ended September 30, 2024				Three Months Ended December 31, 2024				Year Ended December 31, 2024
Cost of goods manufactured and sold		$	—			$	—			$	—			$	—			$	-
Research and development			2,516				3,913				481				(1,120	)			5,790
Selling, general and administrative			—				—				—				—				-
Income tax (benefit) provision			(396	)			(613	)			(67	)			354				(722	)
(Income) Loss from discontinued operations, net of tax		$	2,120			$	3,300			$	414			$	(766	)		$	5,068
(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

 

 

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Alkermes plc and Subsidiaries
Revenues for Calendar Year 2024 and 2023
(In thousands)		Three Months Ended March 31, 2024				Three Months Ended June 30, 2024				Three Months Ended September 30, 2024				Three Months Ended December 31, 2024				Year Ended December 31, 2024
Revenues:
VIVITROL		$	97,659			$	111,873			$	113,650			$	134,133			$	457,315
ARISTADA			78,870				86,049				84,652				96,616				346,187
LYBALVI			57,007				71,351				74,697				76,977				280,032
Total Proprietary Sales			233,536				269,273				272,999				307,726				1,083,534
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)			65,391				82,297				60,876				51,267				259,831
VUMERITY			31,254				35,234				32,574				34,985				134,047
Key Commercial Product Revenues			330,181				386,804				366,449				393,978				1,477,412
Legacy Product Revenues			20,188				12,327				11,694				36,008				80,217
Research and Development Revenues			3				—				—				—				3
Total Revenues		$	350,372			$	399,131			$	378,143			$	429,986			$	1,557,632
(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
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI.

 

 

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Alkermes plc and Subsidiaries
2025 Guidance — GAAP to EBITDA and Adjusted EBITDA
An itemized reconciliation between projected net income on a GAAP basis, EBITDA and Adjusted EBITDA is as follows:
(In millions)		Amount
Projected Net Income — GAAP		$	190.0
Adjustments:
Interest income			(30.0	)
Depreciation and amortization expense			30.0
Provision for income taxes			40.0
Projected EBITDA		$	230.0
Share-based compensation expense			95.0
Projected Adjusted EBITDA		$	325.0
Projected Net Income on a GAAP basis and Projected EBITDA and Projected Adjusted EBITDA reflect mid-points within ranges of estimated guidance.

 

 

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Fourth Quarter and Year-End 2024 Financial Results & Business Update February 12, 2025 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 revenue and 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 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 unfavorable outcome of arbitration, litigation, including so-called “Paragraph IV” litigation, or other proceedings or other disputes related to the Company’s products or products using the Company’s proprietary technologies; the U.S. Food and Drug Administration 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 most recent 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 Adjusted EBITDA, which excludes from earnings share-based compensation expense in addition to the components of EBITDA. 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 SUSTENNA® is a registered trademark of Johnson & Johnson or its affiliated companies. 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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Highly Profitable, Self-Funding Business With Strong Balance Sheet EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense.* Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. ** Retired ~$290M of long-term debt and repurchased $200M of the company’s shares in 2024. >$1B of proprietary product net sales expected in 2025 Non-dilutive funding for development pipeline >$200M of EBITDA* expected in 2025 Ongoing commitment to efficiency ~$825M in cash and investments at 12/31/24 Strong financial position and clean balance sheet**

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Q4 & FY 2024 Financial and Operational Performance

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In millions FY 2024 Financial Results Summary Total Revenue In millions GAAP Net Income GAAP Earnings Per Share Diluted FY 2024 results reflect expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024. FY 2023 results reflect reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen Pharmaceutica N.V. (“Janssen”) announced in June 2023.

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In millions FY 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 EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense.*Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation. FY 2024 results reflect expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024. FY 2023 results reflect reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen announced in June 2023.

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Q4 2024 Revenue Summary In millions Q4’24 Q4’23 Total Proprietary Net Sales $307.7 $242.0 VIVITROL® $134.1 $102.4 ARISTADA®* $96.6 $83.4 LYBALVI® $77.0 $56.2 Manufacturing & Royalty Revenue $122.3 $135.5 Total Revenue $430.0 $377.5 *Inclusive of ARISTADA INITIO® **Reflects expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024. ** **

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FY 2024 Revenue Summary In millions FY’24 FY’23 Total Proprietary Net Sales $1,083.5 $920.0 VIVITROL® $457.3 $400.4 ARISTADA®* $346.2 $327.7 LYBALVI® $280.0 $191.9 Manufacturing & Royalty Revenue $474.1 $743.4*** Total Revenue $1,557.6 $1,663.4*** *Inclusive of ARISTADA INITIO® **Reflects expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024. ***Reflects reinstatement of certain U.S. royalties following the successful outcome of the Company’s arbitration with Janssen announced in June 2023. ** **

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Alkermes: 2025 Financial Expectations* *These expectations are provided by the Company on Feb. 12, 2025 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. ‡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 millions) Financial Expectations for Year Ending Dec. 31, 2025 Total Revenues $1,340 – $1,430 COGS $185 – $205 R&D Expense $305 – $335 SG&A Expense $655 – $685 GAAP Net Income $175 – $205 EBITDA‡ $215 – $245 Adjusted EBITDA‡ $310 – $340 Effective Tax Rate ~17% Expected net sales of proprietary products: VIVITROL® net sales of $440M – $460M ARISTADA® net sales of $335M – $355M LYBALVI® net sales of $320M – $340M EBITDA represents earnings before interest, tax, depreciation and amortization. Adjusted EBITDA excludes from earnings share-based compensation expense in addition to the components of EBITDA.

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2024 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 $1,218

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LYBALVI® Performance and Expectations *These expectations are provided by the Company on Feb. 12, 2025 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) Q4’24 LYBALVI net sales of $77.0M reflects 37% growth compared to Q4’23 Q4’24 gross-to-net deductions: ~30% FY’24 LYBALVI net sales were $280.0M Outlook: FY’25 net sales expected to range from $320M – $340M*

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LYBALVI® Prescription Growth Trends Q4’24 total TRx: ~60,300 reflecting 5% sequential growth compared to Q3’24 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 1/31/2025) TRx Week

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ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales* ($M) Q4’24 ARISTADA net sales were $96.6M FY’24 ARISTADA net sales were $346.2M Outlook: FY’25 net sales expected to range from $335M – $355M†* *Inclusive of ARISTADA INITIO®†These expectations are provided by the Company on Feb. 12, 2025 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 are provided by the Company on Feb. 12, 2025 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. Q4’24 VIVITROL net sales were $134.1M FY’24 VIVITROL net sales were $457.3M Outlook: FY’25 net sales expected to range from $440M – $460M*

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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 March 31, 2024 Three Months Ended June 30, 2024 Three Months Ended September 30, 2024 Three Months Ended December 31, 2024 Year Ended December 31, 2024 Cost of goods manufactured and sold $ --- $ --- $ --- $ --- $ --- Research and development 2.5 3.9 0.5 (1.1) 5.8 Selling, general and administrative --- --- --- --- --- Income tax (benefit) provision $ (0.4) $ (0.6) $ (0.1) $ 0.3 $ (0.7) Loss (profit) from discontinued operations, net of tax $ 2.1 $ 3.3 $ 0.4 $ (0.8) $ 5.1 (In millions) 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 $ 0.0 $ 0.0 $ 0.0 $ 0.0 $ 0.0 Research and development 29.9 32.6 32.3 21.5 116.2 Selling, general and administrative 6.6 9.5 13.1 19.4 48.6 Income tax (benefit) provision $ (6.7) $ (0.0) $ (1.6) $ 6.9 $ (1.4) Loss from discontinued operations, net of tax $ 29.8 $ 42.0 $ 43.8 $ 47.8 $ 163.4

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Appendix: Financial Results GAAP to EBITDA Adjustments (In millions) Year Ended December 31, 2024 Year Ended December 31, 2023 Net Income from Continuing Operations — GAAP $ 372.1 $ 519.2 Adjustments: Depreciation expense 27.4 36.9 Amortization expense 1.1 35.7 Interest income (42.5) (30.9) Interest expense 22.6 23.0 Income tax provision (benefit) 71.6 (97.6) EBITDA from Continuing Operations $ 452.4 $ 486.3 EBITDA from Discontinued Operations $ (5.8) $ (162.5) EBITDA $ 446.6 $ 323.8

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Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Year Ended December 31, 2024 Year Ended December 31, 2023 Net Income from Continuing Operations — GAAP $ 372.1 $ 519.2 Adjustments: Share-based compensation expense 96.6 92.7 Depreciation expense 27.4 36.9 Amortization expense 1.1 35.7 Separation expense 1.4 38.4 Loss on debt extinguishment 0.7 --- Gain on sale of Athlone manufacturing facility (1.5) --- Income tax effect related to reconciling items (3.9) 25.3 Deferred tax valuation release --- (161.0) Restructuring expense --- 5.9 Final award in the Janssen arbitration (2022 back royalties and interest) --- (197.1) Non-cash net interest expense 0.3 0.5 Non-GAAP Net Income from Continuing Operations $ 494.4 $ 396.5 Non-GAAP Net Loss from Discontinued Operations $ (5.1) $ (152.9) Non-GAAP Net Income $ 489.3 $ 243.7 Amounts in the table above may not sum due to rounding.

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Appendix: 2025 Guidance GAAP to EBITDA and Adjusted EBITDA Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges. (In millions) Year Ended December 31, 2023 Year Ending December 31, 2025 Projected Net Income — GAAP $ 190.0 Adjustments: Net interest income (30.0) Depreciation expense 30.0 Provision for income taxes 40.0 Projected EBTIDA $ 230.0 Shared-based compensation expense 95.0 Projected Adjusted EBITDA $ 325.0

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www.alkermes.com

Document and Entity Information	Feb. 12, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 12, 2025
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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