alks-8k_20230216.htm
false Alkermes plc. 0001520262 0001520262 2023-02-16 2023-02-16

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

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

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): February 16, 2023

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-35299

 

98-1007018

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

 

Connaught House, 1 Burlington Road

Dublin 4, Ireland D04 C5Y6

(Address of principal executive offices)

 

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

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

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

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

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Ordinary shares, $0.01 par value

 

ALKS

 

Nasdaq Global Select Market

 

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

 

 

 

Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 


 

 

Item 2.02 Results of Operations and Financial Condition.

 

On February 16, 2023, Alkermes plc (the “Company”) announced financial results for the three months and year ended December 31, 2022 and financial expectations for the year ending December 31, 2023. Copies of the related press release and the investor presentation to be displayed during the Company’s conference call on February 16, 2023 discussing such financial results and expectations are furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively. This information, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release issued by Alkermes plc dated February 16, 2023 announcing financial results for the three months and year ended December 31, 2022 and financial expectations for the year ending December 31, 2023.

99.2

 

Investor presentation to be displayed by Alkermes plc on February 16, 2023.

104

 

Cover page interactive data file (embedded within the Inline XBRL document).

 

2


 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ALKERMES PLC

 

 

Date: February 16, 2023

By:

 

/s/ Iain M. Brown

 

 

 

Iain M. Brown

 

 

 

Senior Vice President, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

3

alks-ex991_7.htm

Exhibit 99.1

alex

 

 

 

Alkermes Contacts:

 

 

For Investors:

Sandy Coombs     +1 781 609 6377

 

For Media:  

Katie Joyce         +1 781 249 8927

 

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

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

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

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

 

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

 

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

 

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

 

Quarter Ended Dec. 31, 2022 Financial Results

 

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

 

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

 

o

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

 

o

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

 

o

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


 

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

 

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

 

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

 

Year Ended Dec. 31, 2022 Financial Results

Revenues

 

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

 

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

 

o

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

 

o

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

 

o

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

 

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

 

o

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

 

o

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

Costs and Expenses

 

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

 

o

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

 

o

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

 

o

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

2

 


Profitability

 

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

 

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

Balance Sheet

 

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

 

Financial Expectations for 2023

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

 

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

 

In millions (except per share amounts)

 

2023 Expectations

Total Revenue

 

$1,130 – $1,250

VIVITROL Net Sales

 

$380 – $410

ARISTADA Net Sales

 

$315 – $345

LYBALVI Net Sales

 

$180 – $205

INVEGA Franchise Royalties*

 

$25 – $30

Other Revenues

 

$230 – $260

Cost of Goods Sold

 

$230 – $250

R&D Expenses

 

$370 – $400

SG&A Expenses

 

$695 – $725

Amortization of Intangible Assets

 

~$35

Interest Expense, Net

 

$5 – $10

Income Tax Benefit

 

$5 – $10

GAAP Net Loss

 

($160) – ($200)

GAAP Net Loss per Share+

 

($0.96) – ($1.20)

Non-GAAP Net Income

 

$0 – $40

Non-GAAP Net Earnings Per Share (Diluted)+

 

$0.00 – $0.23

Capital Expenditures

 

$35 – $40

3

 


 

 

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

 

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

 

Profitability Targets

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

 

The company is committed to achieving:

 

 

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

 

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

 

Recent Events:

 

Corporate

 

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

 

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

Neuroscience

 

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

4

 


Oncology

 

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

 

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

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 16, 2023, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

 

About Alkermes plc

Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

 

Non-GAAP Financial Measures

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

 

Non-GAAP net (loss) income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

 

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

5

 


 

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

 

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

 

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including expectations of continued growth of its proprietary products, investment in commercial activities, continued focus on operational efficiency, and expected costs and other impacts of the planned separation of the oncology business, and assumptions regarding royalty payments on sales of the long-acting INVEGA products; the company’s commitment to, and plans to drive, growth, long-term profitability and shareholder value, and its ability to achieve its accelerated long-term profitability targets; the company’s plans to  separate its neuroscience and oncology businesses, including the anticipated timing, structure and benefits of a potential separation; expectations concerning the ongoing arbitration proceedings with Janssen; and the potential therapeutic and commercial value of the company’s products. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the company may not be able to achieve long-term profitability or its profitability targets in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic on the company’s business, results of operations or financial condition, including impacts on healthcare systems and on patient and healthcare provider access to the company’s marketed products; the company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect a potential separation of the company’s neuroscience and oncology businesses; disruption to the company’s operations resulting from the potential separation;  the planned separation may adversely impact the company’s ability to attract or retain key personnel; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies, including the arbitration proceedings with Janssen; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company’s regulatory approval strategies or components of the company’s marketing applications; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the

6

 


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

 

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

 

(tables follow)

 

 

 

1 

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

2 

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

 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Three Months Ended

 

 

Three Months Ended

 

(In thousands, except per share data)

 

December 31, 2022

 

 

December 31, 2021

 

Revenues:

 

 

 

 

 

 

 

 

Product sales, net

 

$

216,117

 

 

$

178,916

 

Manufacturing and royalty revenues

 

 

88,546

 

 

 

143,372

 

License revenue

 

 

 

 

 

2,000

 

Research and development revenue

 

 

11

 

 

 

175

 

Total Revenues

 

 

304,674

 

 

 

324,463

 

Expenses:

 

 

 

 

 

 

 

 

Cost of goods manufactured and sold

 

 

53,964

 

 

 

53,682

 

Research and development

 

 

104,586

 

 

 

98,374

 

Selling, general and administrative

 

 

157,541

 

 

 

160,408

 

Amortization of acquired intangible assets

 

 

9,165

 

 

 

9,616

 

Total Expenses

 

 

325,256

 

 

 

322,080

 

Operating (Loss) Income

 

 

(20,582

)

 

 

2,383

 

Other Expense, net:

 

 

 

 

 

 

 

 

Interest income

 

 

3,921

 

 

 

453

 

Interest expense

 

 

(4,769

)

 

 

(2,405

)

Change in the fair value of contingent consideration

 

 

 

 

 

(750

)

Other (expense) income, net

 

 

(258

)

 

 

546

 

Total Other Expense, net

 

 

(1,106

)

 

 

(2,156

)

(Loss) Income Before Income Taxes

 

 

(21,688

)

 

 

227

 

Provision (Benefit) for Income Taxes

 

 

6,566

 

 

 

(646

)

Net (Loss) Income — GAAP

 

$

(28,254

)

 

$

873

 

 

 

 

 

 

 

 

 

 

(Loss) Earnings Per Share:

 

 

 

 

 

 

 

 

GAAP (loss) earnings per share — basic and diluted

 

$

(0.17

)

 

$

0.01

 

Non-GAAP earnings per share — basic

 

$

0.15

 

 

$

0.24

 

Non-GAAP earnings per share — diluted

 

$

0.14

 

 

$

0.23

 

 

 

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

 

 

Basic  — GAAP and Non-GAAP

 

 

164,336

 

 

 

161,833

 

Diluted — GAAP

 

 

164,336

 

 

 

166,803

 

Diluted — Non-GAAP

 

 

169,304

 

 

 

166,803

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net income is as follows:

 

Net (Loss) Income — GAAP

 

$

(28,254

)

 

$

873

 

Adjustments:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

26,482

 

 

 

19,020

 

Depreciation expense

 

 

10,510

 

 

 

11,527

 

Amortization expense

 

 

9,165

 

 

 

9,616

 

Separation expense

 

 

1,355

 

 

 

 

Income tax effect related to reconciling items

 

 

4,847

 

 

 

(3,355

)

Non-cash net interest expense

 

 

116

 

 

 

117

 

Change in the fair value of contingent consideration and other related assets

 

 

 

 

 

750

 

Non-GAAP Net Income

 

$

24,221

 

 

$

38,548

 

 

 

 

 

7

 


 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Year Ended

 

 

Year Ended

 

(In thousands, except per share data)

 

December 31, 2022

 

 

December 31, 2021

 

Revenues:

 

 

 

 

 

 

 

 

Product sales, net

 

$

777,552

 

 

$

627,424

 

Manufacturing and royalty revenues

 

 

331,983

 

 

 

541,807

 

License revenue

 

 

2,000

 

 

 

3,500

 

Research and development revenue

 

 

260

 

 

 

1,020

 

Total Revenues

 

 

1,111,795

 

 

 

1,173,751

 

Expenses:

 

 

 

 

 

 

 

 

Cost of goods manufactured and sold

 

 

218,108

 

 

 

197,387

 

Research and development

 

 

393,842

 

 

 

406,526

 

Selling, general and administrative

 

 

605,747

 

 

 

560,977

 

Amortization of acquired intangible assets

 

 

36,363

 

 

 

38,148

 

Total Expenses

 

 

1,254,060

 

 

 

1,203,038

 

Operating Loss

 

 

(142,265

)

 

 

(29,287

)

Other Expense, net:

 

 

 

 

 

 

 

 

  Interest income

 

 

7,629

 

 

 

2,408

 

  Interest expense

 

 

(13,040

)

 

 

(11,219

)

  Change in the fair value of contingent consideration

 

 

(21,750

)

 

 

(1,427

)

  Other income, net

 

 

2,122

 

 

 

219

 

Total Other Expense, net

 

 

(25,039

)

 

 

(10,019

)

Loss Before Income Taxes

 

 

(167,304

)

 

 

(39,306

)

(Benefit) Provision for Income Taxes

 

 

(9,037

)

 

 

8,863

 

Net Loss — GAAP

 

$

(158,267

)

 

$

(48,169

)

 

 

 

 

 

 

 

 

 

(Loss) Earnings Per Share:

 

 

 

 

 

 

 

 

GAAP loss per share — basic and diluted

 

$

(0.97

)

 

$

(0.30

)

Non-GAAP earnings per share — basic

 

$

0.35

 

 

$

0.80

 

Non-GAAP earnings per share — diluted

 

$

0.34

 

 

$

0.78

 

 

 

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

 

 

Basic and diluted — GAAP

 

 

163,742

 

 

 

160,492

 

Basic — Non-GAAP

 

 

163,742

 

 

 

160,492

 

Diluted — Non-GAAP

 

 

168,362

 

 

 

164,753

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:

 

Net Loss — GAAP

 

$

(158,267

)

 

$

(48,169

)

Adjustments:

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

94,253

 

 

 

87,623

 

Depreciation expense

 

 

41,498

 

 

 

40,505

 

Amortization expense

 

 

36,363

 

 

 

38,148

 

Legal settlement

 

 

15,905

 

 

 

 

Separation expense

 

 

1,355

 

 

 

 

Income tax effect related to reconciling items

 

 

2,254

 

 

 

6,994

 

Non-cash net interest expense

 

 

466

 

 

 

469

 

Reduction in the fair value of contingent consideration and other related assets

 

 

24,032

 

 

 

1,427

 

Debt refinancing charge

 

 

 

 

 

2,109

 

Non-GAAP Net Income

 

$

57,859

 

 

$

129,106

 

 

 


 

 


 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

December 31,

 

 

December 31,

 

(In thousands)

 

2022

 

 

2021

 

Cash, cash equivalents and total investments

 

$

740,075

 

 

$

765,741

 

Receivables

 

 

287,967

 

 

 

313,193

 

Inventory

 

 

181,418

 

 

 

150,335

 

Contract assets

 

 

8,929

 

 

 

13,363

 

Prepaid expenses and other current assets

 

 

43,527

 

 

 

48,967

 

Property, plant and equipment, net

 

 

325,361

 

 

 

341,054

 

Intangible assets, net and goodwill

 

 

130,553

 

 

 

166,916

 

Other assets

 

 

246,148

 

 

 

224,915

 

Total Assets

 

$

1,963,978

 

 

$

2,024,484

 

Long-term debt — current portion

 

$

3,000

 

 

$

3,000

 

Other current liabilities

 

 

494,742

 

 

 

468,286

 

Long-term debt

 

 

290,270

 

 

 

292,804

 

Other long-term liabilities

 

 

132,213

 

 

 

147,810

 

Total shareholders' equity

 

 

1,043,753

 

 

 

1,112,584

 

Total Liabilities and Shareholders' Equity

 

$

1,963,978

 

 

$

2,024,484

 

 

 

 

 

 

 

 

 

 

Ordinary shares outstanding (in thousands)

 

 

164,303

 

 

 

161,937

 

 

 

 

 

 

 

 

 

 

This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2022, which the company intends to file in February 2023.

 

 


 

 


 

 

Alkermes plc and Subsidiaries

 

Revenues for Calendar Year 2022 and 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months

 

 

Three Months

 

 

Three Months

 

 

Three Months

 

 

Year

 

 

 

Ended

 

 

Ended

 

 

Ended

 

 

Ended

 

 

Ended

 

 

 

March 31,

 

 

June 30,

 

 

September 30,

 

 

December 31,

 

 

December 31,

 

(In thousands)

 

 

2022

 

 

 

2022

 

 

 

2022

 

 

 

2022

 

 

 

2022

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

VIVITROL

 

$

84,854

 

 

$

96,105

 

 

$

96,534

 

 

$

101,985

 

 

$

379,478

 

ARISTADA

 

 

72,485

 

 

 

74,622

 

 

 

75,719

 

 

 

79,226

 

 

 

302,052

 

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

 

54,480

 

 

 

37,039

 

 

 

36,965

 

 

 

37,085

 

 

 

165,569

 

LYBALVI

 

 

13,929

 

 

 

20,060

 

 

 

27,127

 

 

 

34,906

 

 

 

96,022

 

VUMERITY

 

 

30,595

 

 

 

26,170

 

 

 

26,250

 

 

 

32,481

 

 

 

115,496

 

Key Commercial Product Revenues

 

 

256,343

 

 

 

253,996

 

 

 

262,595

 

 

 

285,683

 

 

 

1,058,617

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Legacy Product Revenues

 

 

20,095

 

 

 

22,117

 

 

 

(10,274

)

 

 

18,980

 

 

 

50,918

 

License Revenue

 

 

2,000

 

 

 

 

 

 

 

 

 

 

 

 

2,000

 

Research and Development Revenues

 

 

107

 

 

 

106

 

 

 

36

 

 

 

11

 

 

 

260

 

Total Revenues

 

$

278,545

 

 

$

276,219

 

 

$

252,357

 

 

$

304,674

 

 

$

1,111,795

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months

 

 

Three Months

 

 

Three Months

 

 

Three Months

 

 

Year

 

 

 

Ended

 

 

Ended

 

 

Ended

 

 

Ended

 

 

Ended

 

 

 

March 31,

 

 

June 30,

 

 

September 30,

 

 

December 31,

 

 

December 31,

 

(In thousands)

 

 

2021

 

 

 

2021

 

 

 

2021

 

 

 

2021

 

 

 

2021

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

$

75,732

 

 

$

95,522

 

 

$

90,293

 

 

$

92,427

 

 

$

353,974

 

VIVITROL

 

 

74,534

 

 

 

88,417

 

 

 

88,865

 

 

 

92,038

 

 

 

343,854

 

ARISTADA

 

 

55,429

 

 

 

72,391

 

 

 

68,872

 

 

 

78,663

 

 

 

275,355

 

LYBALVI

 

 

 

 

 

 

 

 

 

 

 

8,215

 

 

 

8,215

 

VUMERITY

 

 

13,440

 

 

 

20,348

 

 

 

26,749

 

 

 

26,885

 

 

 

87,422

 

Key Commercial Product Revenues

 

 

219,135

 

 

 

276,678

 

 

 

274,779

 

 

 

298,228

 

 

 

1,068,820

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Legacy Product Revenues

 

 

30,675

 

 

 

26,424

 

 

 

19,252

 

 

 

24,060

 

 

 

100,411

 

License Revenue

 

 

1,500

 

 

 

 

 

 

 

 

 

2,000

 

 

 

3,500

 

Research and Development Revenues

 

 

120

 

 

 

615

 

 

 

110

 

 

 

175

 

 

 

1,020

 

Total Revenues

 

$

251,430

 

 

$

303,717

 

 

$

294,141

 

 

$

324,463

 

 

$

1,173,751

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI.

 

 

 

 


 

 


 

 

Alkermes plc and Subsidiaries

 

2023 Guidance — GAAP to Non-GAAP Adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In millions, except per share data)

 

Amount

 

 

Shares

 

 

(Loss) Earnings Per Share

 

Projected Net Loss — GAAP

 

$

(180.0

)

 

 

166.5

 

 

$

(1.08

)

   Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

97.5

 

 

 

 

 

 

 

 

 

Depreciation expense

 

 

42.5

 

 

 

 

 

 

 

 

 

Amortization expense

 

 

35.0

 

 

 

 

 

 

 

 

 

Separation expense

 

 

21.0

 

 

 

 

 

 

 

 

 

Income tax effect related to reconciling items

 

 

3.5

 

 

 

 

 

 

 

 

 

Non-cash net interest expense

 

 

0.5

 

 

 

 

 

 

 

 

 

Projected Net Income — Non-GAAP

 

$

20.0

 

 

 

171.5

 

 

$

0.12

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

 

 

 

 

Slide 1

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

Slide 2

Forward-Looking Statements and Non-GAAP Financial Information Certain statements set forth in this presentation constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: Alkermes plc’s (the “Company”) expectations concerning its future financial, commercial and operating performance, business plans or prospects, including its assumptions regarding royalty payments on sales of XEPLION®, TREVICTA® and BYANNLI® through May 2023, and expectations concerning revenue growth, value creation and profitability; the Company’s plans to separate its neuroscience and oncology businesses, including the anticipated timing, structure, costs and benefits of the proposed separation and expectations concerning the anticipated business profiles and future financial and operating performance, business plans or prospects of the two businesses if separated; and the potential therapeutic and commercial value of the Company’s products and product candidates. The Company cautions that forward-looking statements are inherently uncertain. The forward-looking statements contained in this presentation are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks, assumptions and uncertainties. These risks, assumptions and uncertainties include, among others: the Company may not be able to achieve its targeted financial and profitability metrics in a timely manner or at all; the impacts of the ongoing COVID-19 pandemic on the Company’s business, results of operations or financial condition; the Company may not ultimately separate its oncology business during 2023 or at all; unanticipated developments, costs or difficulties that may delay or otherwise negatively affect the planned separation of the Company’s neuroscience and oncology businesses; disruption to the Company’s operations resulting from the planned separation; the Company may be unable to make, on a timely or cost-effective basis, the changes necessary to separately operate its neuroscience and oncology businesses; the planned separation may adversely impact the Company’s ability to attract or retain key personnel; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation or other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the Company’s products or products using the Company’s proprietary technologies, including the arbitration proceedings with Janssen Pharmaceutica N.V. (“Janssen”); clinical development activities may not be completed on time or at all; the results of the Company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities may not agree with the Company’s regulatory approval strategies or components of the Company’s marketing applications and may make adverse decisions regarding the Company’s products; the Company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the Company’s products or an increase in the Company’s financial obligations to government payers; the Company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks, assumptions and uncertainties described under the heading “Risk Factors” in the Company’s most recent annual report and in subsequent filings made by the Company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov, and on the Company’s website at www.alkermes.com in the ‘Investors – SEC filings’ section. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation. Non-GAAP Financial Measures: This presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”), including non-GAAP net income and non-GAAP earnings per share. The Company provides these non-GAAP financial measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures, to the extent reasonably determinable, can be found in the Appendix of this presentation. Note Regarding Trademarks: The Company and its affiliates are the owners of various U.S. federal trademark registrations (®) and other trademarks (TM), including ARISTADA®, ARISTADA INITIO® , LYBALVI® and VIVITROL®. Any other trademarks referred to in this presentation are the property of their respective owners. Appearances of such other trademarks herein should not be construed as any indicator that their respective owners will not assert their rights thereto.

Slide 3

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

Slide 4

2022 Commercial Review

Slide 5

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

Slide 6

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

Slide 7

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

Slide 8

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

Slide 9

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

Slide 10

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

Slide 11

Q4 & FY 2022 Financial and Operational Performance

Slide 12

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

Slide 13

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

Slide 14

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

Slide 15

Alkermes: 2023 Financial Expectations* *These expectations are provided by the Company on Feb. 16, 2023 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. ‡Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix of this presentation. Total Revenues Breakdown: Expected net sales of proprietary products: VIVITROL® net sales of $380M – $410M ARISTADA® net sales of $315M – $345M LYBALVI® net sales of $180M – $205M Assumes $25M – $30M of royalties related to sales of XEPLION®, TREVICTA® and BYANNLI® outside the U.S. through May 2023

Slide 16

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

Slide 17

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

Slide 18

2023 Outlook & Planned Separation Update

Slide 19

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

Slide 20

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

Slide 21

Appendix Confidential, Internal Use Only

Slide 22

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

Slide 23

Appendix: 2023 Guidance GAAP to Non-GAAP Adjustments Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges. +2023 per share expectations are calculated based on a weighted average basic share count of approximately 166.5 million shares outstanding and a weighted average diluted share count of approximately 171.5 million shares outstanding.

Slide 24

www.alkermes.com