EX-99.1 2 alks-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

 

 

 

Alkermes Contacts:

 

 

For Investors:

Sandy Coombs +1 781 609 6377

 

For Media:

Katie Joyce +1 781 249 8927

 

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2023 and Provides Financial Expectations for 2024

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

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

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

 

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

 

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

 

Key Financial Highlights

Revenues

(In millions)

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

Total Revenues

$

377.5

$

304.7

$

1,663.4

$

1,111.8

Total Proprietary Net Sales

$

242.0

$

216.1

$

920.0

$

777.6

     VIVITROL®

$

102.4

$

102.0

$

400.4

$

379.5

     ARISTADA®[i]

$

83.4

$

79.2

$

327.7

$

302.1

     LYBALVI®

$

56.2

$

34.9

$

191.9

$

96.0

 

Profitability

(In millions)

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

GAAP Net Income (Loss)

$

112.8

$

(28.3)

$

355.8

$

(158.3)

GAAP Net Income (Loss) From Continuing Operations

$

160.6

$

17.2

$

519.2

$

(33.2)

Non-GAAP Net Income

$

37.4

$

24.2

$

243.7

$

57.9

Non-GAAP Net Income From Continuing Operations

$

81.8

$

67.4

$

396.5

$

174.9

EBITDA

$

32.3

$

(1.2)

 

$

323.8

$

(84.0)

EBITDA From Continuing Operations

$

72.8

$

34.6

 

$

486.3

$

50.6

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

1

 

 

Revenue Highlights

LYBALVI

•
Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $56.2 million and $191.9 million, respectively.
•
Fourth quarter revenues and total prescriptions grew 61% and 65%, respectively, compared to the fourth quarter of 2022.

ARISTADAi

•
Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $83.4 million and $327.7 million, respectively.
•
Fourth quarter revenues and total prescriptions (on a months of therapy basis) grew 5% and 4%, respectively, compared to the fourth quarter of 2022.

VIVITROL

•
Revenues for the fourth quarter and year-ended Dec. 31, 2023 were $102.4 million and $400.4 million, respectively.

Manufacturing & Royalties

•
Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the fourth quarter and year-ended Dec. 31, 2023 were $75.2 million and $486.1 million, respectively. 2023 royalty revenues included $195.4 million of back royalties and associated interest related to U.S. net sales of these products in 2022, following favorable resolution of the arbitration proceedings related to these products in the second quarter of 2023.
•
VUMERITY® revenues for the fourth quarter and year-ended Dec. 31, 2023 were $33.6 million and $129.3 million, respectively.

 

Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

 

(In millions)

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

R&D Expense – Continuing Operations

$

73.9

$

73.0

$

270.8

$

272.7

R&D Expense – Discontinued Operations

$

21.5

$

31.6

$

116.2

$

121.1

SG&A Expense – Continuing Operations

$

169.8

$

152.9

$

689.8

$

590.8

SG&A Expense – Discontinued Operations

$

19.4

$

4.7

$

48.6

$

15.0

 

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

2

 

 

Balance Sheet

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

Share Repurchase Program

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

Financial Expectations for 2024

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

In millions

 

2024 Expectations

Total Revenues a

 

$1,500 – $1,600

VIVITROL Net Sales

 

$410 – $430

ARISTADAi Net Sales

 

$340 – $360

LYBALVI Net Sales

$275– $295

Cost of Goods Sold

 

$230 – $250

R&D Expenses

 

$225 – $255

SG&A Expenses

 

$625 – $655

GAAP Net Income b

 

$350 – $390

Non-GAAP Net Income b

 

$465 – $505

EBITDA

 $445 – $485

Effective Tax Rate

~17%

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

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

Recent Events

•
In November 2023, the company completed the separation of its oncology business into Mural Oncology plc, a new, independent, publicly-traded company.
•
In December 2023, the company announced that it had entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Under the terms of the agreement, upon closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions.
•
In January 2024, the company announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment received in prior LYBALVI studies.
•
In January 2024, the company announced that it had completed the narcolepsy type 1 cohort in its phase 1b study of ALKS 2680, the company’s novel, investigational orexin 2 receptor agonist in development for the treatment of narcolepsy. The data supported dose selection of 4 mg, 6 mg, and 8 mg once daily for the planned phase 2 study in narcolepsy type 1, which the company plans to initiate in the first half of 2024.

 

3

 

 

Notes and Explanations

1.
The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 205, Discontinued Operations. Accordingly, the accompanying consolidated financial statements for all periods presented have been updated to present the assets and liabilities associated with the oncology business as discontinued operations on the consolidated balance sheets, and the results of all discontinued operations reported as a separate component of loss in the consolidated statements of operations and comprehensive income (loss).
2.
During the quarter ended Dec. 31, 2023, the company recorded a $102.2 million net tax benefit from continuing operations and an income tax provision of $6.9 million from discontinued operations driven by a $161.0 million tax benefit related to the partial release of a valuation allowance against certain Irish deferred tax assets, partially offset by
i.
an income tax expense related to a reduced foreign derived intangible income deduction following the publication of new guidance on the application of Section 174 of the U.S. Internal Revenue Code of 1986, as amended, and
ii.
a one-time charge related to the transfer of certain intellectual property in connection with the separation of the company’s oncology business.

 

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

3.
Under the share repurchase program, the company may repurchase ordinary shares of the company from time to time in an aggregate amount of up to $400 million (exclusive of any fees, commissions or other expenses related to such repurchases), subject to general business and market conditions and other investment opportunities, through open market purchases, conducted through Rule 10b5-1 plans or 10b-18 plans pursuant to the Securities Exchange Act of 1934, as amended, or through other mechanisms permitted by the company’s constitution.

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Thursday, Feb. 15, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

 

About Alkermes plc

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

 

4

 

 

Non-GAAP Financial Measures

This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.

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

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

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

 

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning its future financial and operating performance, business plans or prospects, including its ability to grow its proprietary commercial products, generate cash and sustain profitability; the company’s expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program, including initiation of the phase 2 study; the company’s expectations regarding its share repurchase program; and the company’s expectations regarding the sale of its development and manufacturing facility in Athlone, Ireland. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to sustain profitability; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company’s regulatory approval strategies; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K and in subsequent filings made by

5

 

 

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

 

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

 

(tables follow)

i

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

 

 

6

 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Three Months Ended

 

 

Three Months Ended

 

(In thousands, except per share data)

 

December 31, 2023

 

 

December 31, 2022

 

Revenues:

 

 

 

 

Product sales, net

 

$

241,972

 

 

$

216,117

 

Manufacturing and royalty revenues

 

 

135,500

 

 

 

88,546

 

Research and development revenue

 

 

3

 

 

 

11

 

Total Revenues

 

 

377,475

 

 

 

304,674

 

Expenses:

 

 

 

 

Cost of goods manufactured and sold

 

 

70,126

 

 

 

53,954

 

Research and development

 

 

73,933

 

 

 

73,011

 

Selling, general and administrative

 

 

169,789

 

 

 

152,852

 

Amortization of acquired intangible assets

 

 

8,996

 

 

 

9,165

 

Total Expenses

 

 

322,844

 

 

 

288,982

 

Operating Income

 

 

54,631

 

 

 

15,692

 

Other Income (Expense), net:

 

 

 

 

 

 

Interest income

 

 

9,749

 

 

 

3,921

 

Interest expense

 

 

(6,054

)

 

 

(4,769

)

Other expense, net

 

 

(10

)

 

 

(258

)

Total Other Income (Expense), net

 

 

3,685

 

 

 

(1,106

)

Income Before Income Taxes

 

 

58,316

 

 

 

14,586

 

Income Tax Benefit

 

 

(102,236

)

 

 

(2,589

)

Net Income From Continuing Operations

 

 

160,552

 

 

 

17,175

 

Loss from Discontinued Operations — Net of Tax

 

$

(47,773

)

 

$

(45,429

)

Net Income (Loss) — GAAP

 

$

112,779

 

 

$

(28,254

)

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Share - Basic:

 

 

 

 

 

 

From continuing operations

 

$

0.96

 

 

$

0.10

 

From discontinued operations

 

$

(0.29

)

 

$

(0.28

)

Earnings (loss) per share

 

$

0.68

 

 

$

(0.17

)

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Share - Diluted:

 

 

 

 

 

 

From continuing operations

 

$

0.94

 

 

$

0.10

 

From discontinued operations

 

$

(0.28

)

 

$

(0.27

)

Earnings (loss) per share

 

$

0.66

 

 

$

(0.17

)

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

Basic — GAAP and Non-GAAP

 

 

166,898

 

 

 

164,336

 

Diluted — GAAP and Non-GAAP

 

 

170,138

 

 

 

169,304

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP (Continued)

 

Three Months Ended

 

 

Three Months Ended

 

(In thousands, except per share data)

 

December 31, 2023

 

 

December 31, 2022

 

 

 

 

 

 

 

 

An itemized reconciliation between net income from continuing operations on a GAAP basis and EBITDA is as follows:

 

 

 

 

 

 

Net Income from Continuing Operations

 

$

160,552

 

 

$

17,175

 

Adjustments:

 

 

 

 

 

 

Depreciation expense

 

 

9,225

 

 

 

10,013

 

Amortization expense

 

 

8,996

 

 

 

9,165

 

Interest income

 

 

(9,749

)

 

 

(3,921

)

Interest expense

 

 

6,054

 

 

 

4,769

 

Income tax (benefit) provision

 

 

(102,236

)

 

 

(2,589

)

EBITDA from Continuing Operations

 

 

72,842

 

 

 

34,612

 

EBITDA from Discontinued Operations

 

 

(40,537

)

 

 

(35,777

)

EBITDA

 

$

32,305

 

 

$

(1,165

)

 

 

 

 

 

 

 

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

 

 

 

 

 

 

Net Income from Continuing Operations

 

$

160,552

 

 

$

17,175

 

Adjustments:

 

 

 

 

 

 

Share-based compensation expense

 

 

22,776

 

 

 

24,692

 

Depreciation expense

 

 

9,225

 

 

 

10,013

 

Amortization expense

 

 

8,996

 

 

 

9,165

 

Separation expense

 

 

19,084

 

 

 

1,355

 

Income tax effect related to reconciling items

 

 

22,011

 

 

 

4,847

 

Deferred tax valuation release

 

 

(160,953

)

 

 

—

 

Non-cash net interest expense

 

 

115

 

 

 

116

 

Non-GAAP Net Income from Continuing Operations

 

 

81,806

 

 

 

67,363

 

Non-GAAP Net Loss from Discontinued Operations

 

 

(44,383

)

 

 

(43,142

)

Non-GAAP Net Income

 

$

37,423

 

 

$

24,221

 

 

 

 

 

 

 

 

Non-GAAP diluted earnings per share from continuing operations

 

$

0.48

 

 

$

0.40

 

Non-GAAP diluted loss per share from discontinued operations

 

$

(0.26

)

 

$

(0.25

)

Non-GAAP diluted earnings per share

 

$

0.22

 

 

$

0.14

 

 

 

 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Year Ended

 

 

Year Ended

 

(In thousands, except per share data)

 

December 31, 2023

 

 

December 31, 2022

 

Revenues:

 

 

 

 

Product sales, net

 

$

919,998

 

 

$

777,552

 

Manufacturing and royalty revenues

 

 

743,388

 

 

 

331,983

 

License revenue

 

 

—

 

 

 

2,000

 

Research and development revenue

 

 

19

 

 

 

260

 

Total Revenues

 

 

1,663,405

 

 

 

1,111,795

 

Expenses:

 

 

 

 

Cost of goods manufactured and sold

 

 

253,037

 

 

 

218,068

 

Research and development

 

 

270,806

 

 

 

272,702

 

Selling, general and administrative

 

 

689,751

 

 

 

590,751

 

Amortization of acquired intangible assets

 

 

35,689

 

 

 

36,363

 

Total Expenses

 

 

1,249,283

 

 

 

1,117,884

 

Operating Income (Loss)

 

 

414,122

 

 

 

(6,089

)

Other Income (Expense), net:

 

 

 

 

 

 

  Interest income

 

 

30,854

 

 

 

7,629

 

  Interest expense

 

 

(23,032

)

 

 

(13,040

)

  Change in the fair value of contingent consideration

 

 

—

 

 

 

(21,750

)

  Other (expense) income, net

 

 

(425

)

 

 

2,122

 

Total Other Income (Expense), net

 

 

7,397

 

 

 

(25,039

)

Income (Loss) Before Income Taxes

 

 

421,519

 

 

 

(31,128

)

Income Tax (Benefit) Provision

 

 

(97,638

)

 

 

2,024

 

Net Income (Loss) From Continuing Operations

 

 

519,157

 

 

 

(33,152

)

Discontinued Operations — Net of Tax

 

 

(163,400

)

 

 

(125,115

)

Net Income (Loss) — GAAP

 

$

355,757

 

 

$

(158,267

)

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Share - Basic:

 

 

 

 

 

 

From continuing operations

 

$

3.12

 

 

$

(0.20

)

From discontinued operations

 

$

(0.98

)

 

$

(0.76

)

Earnings (loss) per share

 

$

2.14

 

 

$

(0.97

)

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Share - Diluted:

 

 

 

 

 

 

From continuing operations

 

$

3.06

 

 

$

(0.20

)

From discontinued operations

 

$

(0.96

)

 

$

(0.76

)

Earnings (loss) per share

 

$

2.10

 

 

$

(0.97

)

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

Basic — GAAP and Non-GAAP

 

 

166,223

 

 

 

163,742

 

Diluted — GAAP

 

 

169,730

 

 

 

163,742

 

Diluted — Non-GAAP

 

 

169,730

 

 

 

168,362

 

 

 

 

 

 

 

 

An itemized reconciliation between net income (loss) from continuing operations on a GAAP basis and EBITDA is as follows:

 

 

 

 

 

 

Net Income (Loss) from Continuing Operations

 

$

519,157

 

 

$

(33,152

)

Adjustments:

 

 

 

 

 

 

Depreciation expense

 

 

36,921

 

 

 

39,959

 

Amortization expense

 

 

35,689

 

 

 

36,363

 

Interest income

 

 

(30,854

)

 

 

(7,629

)

Interest expense

 

 

23,032

 

 

 

13,040

 

Income tax (benefit) provision

 

 

(97,638

)

 

 

2,024

 

EBITDA from Continuing Operations

 

 

486,307

 

 

 

50,605

 

EBITDA from Discontinued Operations

 

 

(162,484

)

 

 

(134,637

)

EBITDA

 

$

323,823

 

 

$

(84,032

)

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP (Continued)

 

Year Ended

 

 

Year Ended

 

(In thousands, except per share data)

 

December 31, 2023

 

 

December 31, 2022

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

Net Income (Loss) from Continuing Operations

 

$

519,157

 

 

$

(33,152

)

Adjustments:

 

 

 

 

 

 

Share-based compensation expense

 

 

92,719

 

 

 

87,676

 

Depreciation expense

 

 

36,921

 

 

 

39,959

 

Amortization expense

 

 

35,689

 

 

 

36,363

 

Separation expense

 

 

38,364

 

 

 

1,355

 

Income tax effect related to reconciling items

 

 

25,343

 

 

 

2,254

 

Final award in the Janssen arbitration (2022 back royalties and interest)

 

 

(197,092

)

 

 

—

 

Deferred tax valuation release

 

 

(160,953

)

 

 

—

 

Restructuring

 

 

5,938

 

 

 

—

 

Non-cash net interest expense

 

 

461

 

 

 

466

 

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

 

 

—

 

 

 

24,032

 

Legal settlement

 

 

—

 

 

 

15,905

 

Non-GAAP Net Income from Continuing Operations

 

 

396,547

 

 

 

174,858

 

Non-GAAP Net Loss from Discontinued Operations

 

 

(152,894

)

 

 

(116,999

)

Non-GAAP Net Income

 

$

243,653

 

 

$

57,859

 

 

 

 

 

 

 

 

Non-GAAP diluted earnings per share from continuing operations

 

$

2.34

 

 

$

1.04

 

Non-GAAP diluted loss per share from discontinued operations

 

$

(0.90

)

 

$

(0.69

)

Non-GAAP diluted earnings per share

 

$

1.44

 

 

$

0.34

 

 

 

 

 

 

 

 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

December 31,

 

 

December 31,

 

(In thousands)

 

2023

 

 

2022

 

Cash, cash equivalents and total investments

 

$

813,378

 

 

$

740,075

 

Receivables

 

 

332,477

 

 

 

287,967

 

Inventory

 

 

186,406

 

 

 

181,418

 

Contract assets

 

 

706

 

 

 

8,929

 

Prepaid expenses and other current assets

 

 

98,166

 

 

 

41,203

 

Property, plant and equipment, net

 

 

226,943

 

 

 

222,919

 

Intangible assets, net and goodwill

 

 

85,018

 

 

 

120,707

 

Assets held for sale

 

 

94,260

 

 

 

93,871

 

Assets from discontinued operations

 

 

—

 

 

 

40,087

 

Other assets

 

 

298,869

 

 

 

226,802

 

Total Assets

 

$

2,136,223

 

 

$

1,963,978

 

Long-term debt — current portion

 

$

3,000

 

 

$

3,000

 

Other current liabilities

 

 

512,678

 

 

 

488,898

 

Long-term debt

 

 

287,730

 

 

 

290,270

 

Liabilities from discontinued operations

 

 

4,542

 

 

 

19,386

 

Other long-term liabilities

 

 

125,587

 

 

 

118,671

 

Total shareholders' equity

 

 

1,202,686

 

 

 

1,043,753

 

Total Liabilities and Shareholders' Equity

 

$

2,136,223

 

 

$

1,963,978

 

 

 

 

 

 

 

Ordinary shares outstanding (in thousands)

 

 

166,980

 

 

 

164,377

 

 

 

 

 

 

 

 

This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Annual Report on Form 10-K for the year ended December 31, 2023, which the company intends to file in February 2024.

 

 

 

 

 

 

 

 

Alkermes plc and Subsidiaries

 

Amounts included in Discontinued Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Three Months
Ended
March 31,
2023

 

 

Three Months
Ended
June 30,
2023

 

 

Three Months
Ended
September 30,
2023

 

 

Three Months
Ended
December 31,
2023

 

 

Year
Ended
December 31,
2023

 

Cost of goods manufactured and sold

 

$

11

 

 

$

11

 

 

$

11

 

 

$

6

 

 

$

39

 

Research and development

 

 

29,867

 

 

 

32,563

 

 

 

32,262

 

 

 

21,485

 

 

 

116,177

 

Selling, general and administrative

 

 

6,644

 

 

 

9,502

 

 

 

13,073

 

 

 

19,368

 

 

 

48,587

 

Income tax (benefit) provision

 

 

(6,727

)

 

 

(40

)

 

 

(1,550

)

 

 

6,914

 

 

 

(1,403

)

Loss from discontinued operations, net of tax

 

$

29,795

 

 

$

42,036

 

 

$

43,796

 

 

$

47,773

 

 

$

163,400

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Three Months
Ended
March 31,
2022

 

 

Three Months
Ended
June 30,
2022

 

 

Three Months
Ended
September 30,
2022

 

 

Three Months
Ended
December 31,
2022

 

 

Year
Ended
December 31,
2022

 

Cost of goods manufactured and sold

 

$

10

 

 

$

10

 

 

$

10

 

 

$

10

 

 

$

40

 

Research and development

 

 

29,161

 

 

 

27,475

 

 

 

32,929

 

 

 

31,575

 

 

 

121,140

 

Selling, general and administrative

 

 

3,201

 

 

 

3,488

 

 

 

3,618

 

 

 

4,689

 

 

 

14,996

 

Income tax (benefit) provision

 

 

(22,883

)

 

 

1,374

 

 

 

1,293

 

 

 

9,155

 

 

 

(11,061

)

Loss from discontinued operations, net of tax

 

$

9,489

 

 

$

32,347

 

 

$

37,850

 

 

$

45,429

 

 

$

125,115

 

 

 

 

 

 

 

 

Alkermes plc and Subsidiaries

 

Revenues for Calendar Year 2023 and 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Three Months
Ended
March 31,
2023

 

 

Three Months
Ended
June 30,
2023

 

 

Three Months
Ended
September 30,
2023

 

 

Three Months
Ended
December 31,
2023

 

 

Year
Ended
December 31,
2023

 

Revenues:

 

 

 

 

 

 

 

 

 

 

VIVITROL

 

$

96,659

 

 

$

102,070

 

 

$

99,305

 

 

$

102,385

 

 

$

400,419

 

ARISTADA

 

 

80,077

 

 

 

82,410

 

 

 

81,834

 

 

 

83,369

 

 

 

327,690

 

LYBALVI

 

 

37,991

 

 

 

46,997

 

 

 

50,683

 

 

 

56,218

 

 

 

191,889

 

Total Proprietary Sales

 

 

214,727

 

 

 

231,477

 

 

 

231,822

 

 

 

241,972

 

 

 

919,998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

 

24,543

 

 

 

326,380

 

 

 

90,993

 

 

 

81,461

 

 

 

523,377

 

VUMERITY

 

 

28,874

 

 

 

32,295

 

 

 

34,561

 

 

 

33,596

 

 

 

129,326

 

Key Commercial Product Revenues

 

 

268,144

 

 

 

590,152

 

 

 

357,376

 

 

 

357,029

 

 

 

1,572,701

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Legacy Product Revenues

 

 

19,445

 

 

 

27,238

 

 

 

23,559

 

 

 

20,443

 

 

 

90,685

 

Research and Development Revenues

 

 

6

 

 

 

7

 

 

 

3

 

 

 

3

 

 

 

19

 

Total Revenues

 

$

287,595

 

 

$

617,397

 

 

$

380,938

 

 

$

377,475

 

 

$

1,663,405

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Three Months
Ended
March 31,
2022

 

 

Three Months
Ended
June 30,
2022

 

 

Three Months
Ended
September 30,
2022

 

 

Three Months
Ended
December 31,
2022

 

 

Year
Ended
December 31,
2022

 

Revenues:

 

 

 

 

 

 

 

 

 

 

VIVITROL

 

$

84,854

 

 

$

96,105

 

 

$

96,534

 

 

$

101,985

 

 

$

379,478

 

ARISTADA

 

 

72,485

 

 

 

74,622

 

 

 

75,719

 

 

 

79,226

 

 

 

302,052

 

LYBALVI

 

 

13,929

 

 

 

20,060

 

 

 

27,127

 

 

 

34,906

 

 

 

96,022

 

Total Proprietary Sales

 

 

171,268

 

 

 

190,787

 

 

 

199,380

 

 

 

216,117

 

 

 

777,552

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PARTNERED LONG-ACTING ANTIPSYCHOTICS (1)

 

 

54,480

 

 

 

37,039

 

 

 

36,965

 

 

 

37,085

 

 

 

165,569

 

VUMERITY

 

 

30,595

 

 

 

26,170

 

 

 

26,250

 

 

 

32,481

 

 

 

115,496

 

Key Commercial Product Revenues

 

 

256,343

 

 

 

253,996

 

 

 

262,595

 

 

 

285,683

 

 

 

1,058,617

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Legacy Product Revenues

 

 

20,095

 

 

 

22,117

 

 

 

(10,274

)

 

 

18,980

 

 

 

50,918

 

License Revenue

 

 

2,000

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

2,000

 

Research and Development Revenues

 

 

107

 

 

 

106

 

 

 

36

 

 

 

11

 

 

 

260

 

Total Revenues

 

$

278,545

 

 

$

276,219

 

 

$

252,357

 

 

$

304,674

 

 

$

1,111,795

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

Alkermes plc and Subsidiaries

 

2024 Guidance — GAAP to EBITDA

 

 

 

 

 

An itemized reconciliation between projected net income on a GAAP basis and EBITDA is as follows:

 

 

 

 

 

(In millions, except per share data)

 

Amount

 

Projected Net Income — GAAP

 

$

370.0

 

   Adjustments:

 

 

 

Net interest income

 

 

(16.0

)

Depreciation expense

 

 

35.0

 

Amortization expense

 

 

1.0

 

Provision for income taxes

 

 

75.0

 

Projected EBITDA

 

$

465.0

 

 

 

 

Projected Net Income on a GAAP basis and Projected EBITDA reflect mid-points within ranges of estimated guidance.

 

 

 

 

 

 

 

 

 

 

Alkermes plc and Subsidiaries

 

2024 Guidance — GAAP to Non-GAAP Adjustments

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

(In millions, except per share data)

 

Amount

 

Shares

 

 

Earnings Per Share

 

Projected Net Income — GAAP

 

$

370.0

 

 

 

173.0

 

 

$

2.14

 

   Adjustments:

 

 

 

 

 

 

 

 

 

Share-based compensation expense

 

 

86.0

 

 

 

 

 

 

 

Depreciation expense

 

 

35.0

 

 

 

 

 

 

 

Amortization expense

 

 

1.0

 

 

 

 

 

 

 

Non-cash net interest expense

 

 

0.5

 

 

 

 

 

 

 

Income tax effect related to reconciling items

 

 

(7.5

)

 

 

 

 

 

 

Projected Net Income — Non-GAAP

 

$

485.0

 

 

 

173.0

 

 

$

2.80

 

 

 

 

 

 

 

 

 

 

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