8-K
0001520262FalseAlkermes plc.00015202622024-10-242024-10-24

 

 

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): October 24, 2024

ALKERMES PUBLIC LIMITED COMPANY

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-35299

 

98-1007018

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

 

Connaught House, 1 Burlington Road

Dublin 4, Ireland D04 C5Y6

(Address of principal executive offices)

 

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

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

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

 

 

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

 

 

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

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Ordinary shares, $0.01 par value

 

ALKS

 

Nasdaq Global Select Market

 

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

 

 

 

Emerging growth company

 

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

 

 

 


 

Item 2.02 Results of Operations and Financial Condition.

 

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

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press release issued by Alkermes plc on October 24, 2024 announcing financial results for the three and nine months ended September 30, 2024.

99.2

 

Investor presentation to be displayed by Alkermes plc on October 24, 2024.

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: October 24, 2024

By:

 

/s/ Blair C. Jackson

 

 

 

Blair C. Jackson

 

 

 

Executive Vice President, Chief Operating Officer (Interim Principal Financial Officer)

 

3


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 Third Quarter 2024 Financial Results

— Third Quarter Revenues of $378.1 Million —

— Net Sales of Proprietary Products Increased Approximately 18% Year-Over-Year —

— GAAP Net Income from Continuing Operations of $92.8 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.56 —

— Company Reiterates 2024 Financial Expectations —

 

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

 

“Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value. We plan to manage the business to deliver significant profitability and cash flow while investing in these strategic initiatives,” said Richard Pops, Chief Executive Officer of Alkermes. “2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2, and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development and we believe a significant opportunity for Alkermes and our shareholders.”

 

Key Financial Highlights

Revenues

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

(In millions)

2024

2023

 

2024

2023

Total Revenues

$

378.1

$

380.9

 

$

1,127.6

$

1,285.9*

Total Proprietary Net Sales

$

273.0

$

231.8

 

$

775.8

$

678.0

     VIVITROL®

$

113.7

$

99.3

 

$

323.2

$

298.0

     ARISTADA®i

$

84.7

$

81.8

 

$

249.6

$

244.3

     LYBALVI®

$

74.7

$

50.7

 

$

203.1

$

135.7

Profitability

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

(In millions)

2024

2023

 

2024

2023*

GAAP Net Income From Continuing Operations

$

92.8

$

91.6

 

$

226.4

$

358.6

GAAP Net Loss From Discontinued Operations

$

(0.4)

$

(43.8)

 

$

(5.8)

$

(115.6)

GAAP Net Income

$

92.4

$

47.8

 

$

220.6

$

243.0

 

 

 

 

 

 

 

 

 

 

Non-GAAP Net Income From Continuing Operations

$

121.4

$

150.4

 

$

321.0

$

314.7

Non-GAAP Net Loss From Discontinued Operations

$

(0.4)

$

(40.8)

 

$

(5.8)

$

(108.5)

Non-GAAP Net Income

$

121.0

$

109.5

 

$

315.2

$

206.2

 

 

 

 

 

 

 

 

 

 

EBITDA From Continuing Operations

$

112.3

$

107.2

 

$

282.4

$

413.5

EBITDA From Discontinued Operations

$

(0.5)

$

(44.6)

 

$

(6.9)

$

(121.9)

EBITDA

$

111.8

$

62.7

 

$

275.5

$

291.5

 

1


 

*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the nine months ended September 30, 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 quarter were $74.7 million.
Revenues and total prescriptions for the quarter grew 47% and 37%, respectively, compared to the third quarter of 2023.

ARISTADAi

Revenues for the quarter were $84.7 million.

VIVITROL

Revenues for the quarter were $113.7 million.
Revenues for the quarter grew 14% compared to the third quarter of 2023, driven by the alcohol dependence indication.

Manufacturing & Royalty Revenues

Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $58.4 million.
VUMERITY® manufacturing and royalty revenues for the quarter were $32.6 million.

 

Key Operating Expenses

Please see Note 1 below for details regarding discontinued operations.

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

(In millions)

2024

2023

 

2024

2023

R&D Expense – Continuing Operations

$

59.9

$

64.9

 

$

187.2

$

196.9

R&D Expense – Discontinued Operations

$

0.5

$

32.3

 

$

6.9

$

94.7

 

 

 

 

 

 

 

 

 

 

SG&A Expense – Continuing Operations

$

150.4

$

156.4

 

$

498.2

$

520.0

SG&A Expense – Discontinued Operations

$

$

13.1

 

$

$

29.2

 

Balance Sheet

At Sept. 30, 2024, the company recorded cash, cash equivalents and total investments of $927.8 million, compared to $962.5 million at June 30, 2024. The company’s total debt outstanding as of Sept. 30, 2024 was $288.8 million.

Share Repurchase Program

During the third quarter of 2024, the company repurchased approximately 4.4 million of the company’s ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $115.6 million. As of Sept. 30, 2024, the company had $200 million (exclusive of any fees, commissions or other related expenses) remaining under the program.

2


 

Financial Expectations for 2024

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

Recent Events

In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), and discussed the study design for its ongoing phase 2 studies in NT1 and NT2. The company also announced its plans to initiate a phase 2 study in patients with IH in 2025.
In September 2024, the company presented positive clinical data from its phase 1b study of ALKS 2680 in patients with NT2 and IH at the European Sleep Research Society’s 27th Congress, Sleep Europe 2024.
In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with NT2.
In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes’ website.

 

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 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 nine months ended Sept. 30, 2023.

 

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Thursday, Oct. 24, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

 

About Alkermes plc

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical 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.

 

3


 

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 drivers of shareholder value 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 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; the unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company’s products or products using the company’s proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company’s development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to government payers; the company’s products may prove difficult to manufacture, be

4


 

precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

 

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

 

(tables follow)

i

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

 

 

5


 

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)

 

September 30, 2024

 

 

September 30, 2023

 

Revenues:

 

 

 

 

Product sales, net

 

$

272,999

 

 

$

231,822

 

Manufacturing and royalty revenues

 

 

105,144

 

 

 

149,113

 

Research and development revenue

 

 

 

 

 

3

 

Total Revenues

 

 

378,143

 

 

 

380,938

 

Expenses:

 

 

 

 

Cost of goods manufactured and sold

 

 

63,099

 

 

 

61,498

 

Research and development

 

 

59,892

 

 

 

64,878

 

Selling, general and administrative

 

 

150,382

 

 

 

156,373

 

Amortization of acquired intangible assets

 

 

14

 

 

 

8,995

 

Total Expenses

 

 

273,387

 

 

 

291,744

 

Operating Income

 

 

104,756

 

 

 

89,194

 

Other Income, net:

 

 

 

 

 

 

Interest income

 

 

10,916

 

 

 

9,370

 

Interest expense

 

 

(6,000

)

 

 

(6,006

)

Other income, net

 

 

558

 

 

 

149

 

Total Other Income, net

 

 

5,474

 

 

 

3,513

 

Income Before Income Taxes

 

 

110,230

 

 

 

92,707

 

Income Tax Provision

 

 

17,435

 

 

 

1,153

 

Net Income From Continuing Operations

 

 

92,795

 

 

 

91,554

 

Loss From Discontinued Operations — Net of Tax

 

 

(414

)

 

 

(43,796

)

Net Income — GAAP

 

$

92,381

 

 

$

47,758

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Ordinary Share - Basic:

 

 

 

 

 

 

From continuing operations

 

$

0.57

 

 

$

0.55

 

From discontinued operations

 

$

(0.00

)

 

$

(0.26

)

From net income

 

$

0.57

 

 

$

0.29

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Ordinary Share - Diluted:

 

 

 

 

 

 

From continuing operations

 

$

0.56

 

 

$

0.53

 

From discontinued operations

 

$

(0.00

)

 

$

(0.25

)

From net income

 

$

0.55

 

 

$

0.28

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

Basic — GAAP and Non-GAAP

 

 

163,368

 

 

 

166,607

 

Diluted — GAAP and Non-GAAP

 

 

167,025

 

 

 

171,903

 

 

 

 

 


 

Condensed Consolidated Statements of Operations - GAAP (Continued)

 

Three Months Ended

 

 

Three Months Ended

 

(In thousands, except per share data)

 

September 30, 2024

 

 

September 30, 2023

 

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

 

 

 

 

 

 

Net Income from Continuing Operations

 

$

92,795

 

 

$

91,554

 

Adjustments:

 

 

 

 

 

 

Depreciation expense

 

 

6,958

 

 

 

8,886

 

Amortization expense

 

 

14

 

 

 

8,995

 

Interest income

 

 

(10,916

)

 

 

(9,370

)

Interest expense

 

 

6,000

 

 

 

6,006

 

Income tax provision

 

 

17,435

 

 

 

1,153

 

EBITDA from Continuing Operations

 

 

112,286

 

 

 

107,224

 

EBITDA from Discontinued Operations

 

 

(481

)

 

 

(44,567

)

EBITDA

 

$

111,805

 

 

$

62,657

 

 

 

 

 

 

 

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

 

$

92,795

 

 

$

91,554

 

Adjustments:

 

 

 

 

 

 

Share-based compensation expense

 

 

22,533

 

 

 

21,733

 

Depreciation expense

 

 

6,958

 

 

 

8,886

 

Amortization expense

 

 

14

 

 

 

8,995

 

Non-cash net interest expense

 

 

114

 

 

 

115

 

Separation expense

 

 

206

 

 

 

9,640

 

Income tax effect related to reconciling items

 

 

(1,255

)

 

 

3,511

 

Restructuring expense

 

 

 

 

 

5,938

 

Non-GAAP Net Income from Continuing Operations

 

 

121,365

 

 

 

150,372

 

Non-GAAP Net Loss from Discontinued Operations

 

 

(414

)

 

 

(40,835

)

Non-GAAP Net Income

 

$

120,951

 

 

$

109,537

 

 

 

 

 

 

 

Non-GAAP diluted earnings per ordinary share from continuing operations

 

$

0.73

 

 

$

0.87

 

Non-GAAP diluted loss per ordinary share from discontinued operations

 

$

(0.00

)

 

$

(0.24

)

Non-GAAP diluted earnings per ordinary share from net income

 

$

0.72

 

 

$

0.64

 

 

 

 


 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations - GAAP

 

Nine Months Ended

 

 

Nine Months Ended

 

(In thousands, except per share data)

 

September 30, 2024

 

 

September 30, 2023

 

Revenues:

 

 

 

 

Product sales, net

 

$

775,808

 

 

$

678,026

 

Manufacturing and royalty revenues

 

 

351,835

 

 

 

607,888

 

Research and development revenue

 

 

3

 

 

 

16

 

Total Revenues

 

 

1,127,646

 

 

 

1,285,930

 

Expenses:

 

 

 

 

Cost of goods manufactured and sold

 

 

183,215

 

 

 

182,911

 

Research and development

 

 

187,152

 

 

 

196,873

 

Selling, general and administrative

 

 

498,244

 

 

 

519,962

 

Amortization of acquired intangible assets

 

 

1,087

 

 

 

26,693

 

Total Expenses

 

 

869,698

 

 

 

926,439

 

Operating Income

 

 

257,948

 

 

 

359,491

 

Other Income, net:

 

 

 

 

 

 

  Interest income

 

 

31,050

 

 

 

21,105

 

  Interest expense

 

 

(17,930

)

 

 

(16,978

)

  Other income (expense), net

 

 

2,793

 

 

 

(415

)

Total Other Income, net

 

 

15,913

 

 

 

3,712

 

Income Before Income Taxes

 

 

273,861

 

 

 

363,203

 

Income Tax Provision

 

 

47,460

 

 

 

4,598

 

Net Income From Continuing Operations

 

 

226,401

 

 

 

358,605

 

Loss From Discontinued Operations — Net of Tax

 

 

(5,834

)

 

 

(115,627

)

Net Income — GAAP

 

$

220,567

 

 

$

242,978

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Ordinary Share - Basic:

 

 

 

 

 

 

From continuing operations

 

$

1.36

 

 

$

2.16

 

From discontinued operations

 

$

(0.04

)

 

$

(0.70

)

From net income

 

$

1.32

 

 

$

1.47

 

 

 

 

 

 

 

GAAP Earnings (Loss) Per Ordinary Share - Diluted:

 

 

 

 

 

 

From continuing operations

 

$

1.33

 

 

$

2.10

 

From discontinued operations

 

$

(0.03

)

 

$

(0.68

)

From net income

 

$

1.30

 

 

$

1.42

 

 

 

 

 

 

 

Weighted Average Number of Ordinary Shares Outstanding:

 

 

 

 

 

 

Basic — GAAP and Non-GAAP

 

 

166,546

 

 

 

165,686

 

Diluted — GAAP and Non-GAAP

 

 

170,196

 

 

 

170,747

 

 

 


 

Condensed Consolidated Statements of Operations - GAAP (Continued)

 

Nine Months Ended

 

 

Nine Months Ended

 

(In thousands, except per share data)

 

September 30, 2024

 

 

September 30, 2023

 

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

 

 

 

 

 

 

Net Income from Continuing Operations

 

$

226,401

 

 

$

358,605

 

Adjustments:

 

 

 

 

 

 

Depreciation expense

 

 

20,599

 

 

 

27,696

 

Amortization expense

 

 

1,087

 

 

 

26,693

 

Interest income

 

 

(31,050

)

 

 

(21,105

)

Interest expense

 

 

17,930

 

 

 

16,978

 

Income tax provision

 

 

47,460

 

 

 

4,598

 

EBITDA from Continuing Operations

 

 

282,427

 

 

 

413,465

 

EBITDA from Discontinued Operations

 

 

(6,910

)

 

 

(121,947

)

EBITDA

 

$

275,517

 

 

$

291,518

 

 

 

 

 

 

 

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

 

$

226,401

 

 

$

358,605

 

Adjustments:

 

 

 

 

 

 

Share-based compensation expense

 

 

75,889

 

 

 

69,943

 

Depreciation expense

 

 

20,599

 

 

 

27,696

 

Amortization expense

 

 

1,087

 

 

 

26,693

 

Separation expense

 

 

1,446

 

 

 

19,280

 

Income tax effect related to reconciling items

 

 

(3,316

)

 

 

3,332

 

Gain on sale of Athlone manufacturing facility

 

 

(1,462

)

 

 

 

Restructuring expense

 

 

 

 

 

5,938

 

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

 

 

 

 

 

(197,092

)

Non-cash net interest expense

 

 

342

 

 

 

346

 

Non-GAAP Net Income from Continuing Operations

 

 

320,986

 

 

 

314,741

 

Non-GAAP Net Loss from Discontinued Operations

 

 

(5,834

)

 

 

(108,511

)

Non-GAAP Net Income

 

$

315,152

 

 

$

206,230

 

 

 

 

 

 

 

Non-GAAP diluted earnings per ordinary share from continuing operations

 

$

1.89

 

 

$

1.84

 

Non-GAAP diluted loss per ordinary share from discontinued operations

 

$

(0.03

)

 

$

(0.64

)

Non-GAAP diluted earnings per ordinary share from net income

 

$

1.85

 

 

$

1.21

 

 

 


 

Alkermes plc and Subsidiaries

 

Selected Financial Information (Unaudited)

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

September 30,

 

 

December 31,

 

(In thousands)

 

2024

 

 

2023

 

Cash, cash equivalents and total investments

 

$

927,784

 

 

$

813,378

 

Receivables

 

 

367,211

 

 

 

332,477

 

Inventory

 

 

191,087

 

 

 

186,406

 

Contract assets

 

 

2,969

 

 

 

706

 

Prepaid expenses and other current assets

 

 

94,047

 

 

 

98,166

 

Property, plant and equipment, net

 

 

225,422

 

 

 

226,943

 

Intangible assets, net and goodwill

 

 

83,931

 

 

 

85,018

 

Assets held for sale

 

 

 

 

 

94,260

 

Deferred tax assets

 

 

159,960

 

 

 

195,888

 

Other assets

 

 

102,880

 

 

 

102,981

 

Total Assets

 

$

2,155,291

 

 

$

2,136,223

 

Long-term debt — current portion

 

$

3,000

 

 

$

3,000

 

Other current liabilities

 

 

450,705

 

 

 

512,678

 

Long-term debt

 

 

285,823

 

 

 

287,730

 

Liabilities from discontinued operations

 

 

 

 

 

4,542

 

Other long-term liabilities

 

 

123,658

 

 

 

125,587

 

Total shareholders' equity

 

 

1,292,105

 

 

 

1,202,686

 

Total Liabilities and Shareholders' Equity

 

$

2,155,291

 

 

$

2,136,223

 

 

 

 

 

 

 

Ordinary shares outstanding (in thousands)

 

 

161,776

 

 

 

166,980

 

 

 

 

 

 

 

 

This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which the company intends to file in October 2024.

 

 

 

 

 


 

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

 

 

Nine Months
Ended
September 30,
2024

 

Cost of goods manufactured and sold

 

$

 

 

$

 

 

$

 

 

$

 

Research and development

 

 

2,516

 

 

 

3,913

 

 

 

481

 

 

 

6,910

 

Selling, general and administrative

 

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

 

(396

)

 

 

(613

)

 

 

(67

)

 

 

(1,076

)

Loss from discontinued operations, net of tax

 

$

2,120

 

 

$

3,300

 

 

$

414

 

 

$

5,834

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(In thousands)

 

Three Months
Ended
March 31,
2023

 

 

Three Months
Ended
June 30,
2023

 

 

Three Months
Ended
September 30,
2023

 

 

Nine Months
Ended
September 30,
2023

 

Cost of goods manufactured and sold

 

$

11

 

 

$

11

 

 

$

11

 

 

$

33

 

Research and development

 

 

29,867

 

 

 

32,563

 

 

 

32,262

 

 

 

94,692

 

Selling, general and administrative

 

 

6,644

 

 

 

9,502

 

 

 

13,073

 

 

 

29,219

 

Income tax benefit

 

 

(6,727

)

 

 

(40

)

 

 

(1,550

)

 

 

(8,317

)

Loss from discontinued operations, net of tax

 

$

29,795

 

 

$

42,036

 

 

$

43,796

 

 

$

115,627

 

 

 


Slide 1

Third Quarter 2024 Financial Results & Business Update October 24, 2024 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 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 unfavorable outcome of arbitration or litigation, including so-called “Paragraph IV” litigation or other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the Company’s products or products using the Company’s proprietary technologies; the Company’s commercial activities may not result in the benefits that the Company anticipates; clinical development activities may not be completed on time or at all and the results of such activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; potential changes in the cost, scope, design or duration of the Company’s development activities; the U.S. Food and Drug Administration or other regulatory authorities may make adverse decisions regarding the Company’s products; the Company and its licensees may not be able to continue to successfully commercialize their products or support growth of such products; there may be a reduction in payment rate or reimbursement for the Company’s products or an increase in the Company’s financial obligations to government payers; the Company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks, assumptions and uncertainties described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the Company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov, and on the Company’s website at www.alkermes.com in the ‘Investors – SEC Filings’ section. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation. Non-GAAP Financial Measures: This presentation includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”), including non-GAAP net income and EBITDA (earnings before interest, taxes, depreciation and amortization). 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. 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

Q3 2024 Financial and Operational Performance


Slide 4

In millions Q3 2024 Financial Results Summary Total Revenue In millions GAAP Net Income GAAP Earnings Per Share Diluted *Q3 2024 results reflect expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024


Slide 5

In millions Q3 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 (earnings before interest, taxes, depreciation and amortization). Reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure can be found in the Appendix of this presentation **Q3 2024 results reflect expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024.


Slide 6

Q3 2024 Revenue Summary Amounts in the table above may not sum due to rounding. In millions Q3’24 Q3’23 Total Proprietary Net Sales $273.0 $231.8 VIVITROL® $113.7 $99.3 ARISTADA®* $84.7 $81.8 LYBALVI® $74.7 $50.7 Manufacturing & Royalty Revenue $105.1 $149.1 Total Revenue $378.1 $380.9 *Inclusive of ARISTADA INITIO® **Reflects expiration of royalty on U.S. net sales of INVEGA SUSTENNA® in August 2024. ** **


Slide 7

Alkermes: 2024 Financial Expectations* *These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on Oct. 24, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. ‡Reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the Appendix of this presentation. (in millions) Financial Expectations for Year Ending Dec. 31, 2024 Total Revenues $1,500 – $1,600 COGS $230 – $250 R&D Expense $225 – $255 SG&A Expense $625 – $655 GAAP Net Income $350 – $390 EBITDA‡ $445 – $485 Non-GAAP Net Income‡ $465 – $505 Effective Tax Rate ~17% Expected net sales of proprietary products: VIVITROL® net sales of $410M – $430M ARISTADA® net sales of $340M – $360M LYBALVI® net sales of $275M – $295M


Slide 8

Q3 2024 Commercial Review


Slide 9

LYBALVI® Performance and Expectations *These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on Oct. 24, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. LYBALVI Quarterly Net Sales ($M) Q3’24 LYBALVI® net sales of $74.7M reflects 47% growth compared to Q3’23 Q3’24 gross-to-net deductions: ~30% Outlook: FY’24 net sales expected to range from $275M – $295M*


Slide 10

LYBALVI® Prescription Growth Trends Q3’24 total TRx: ~57,500 reflecting 5% sequential growth compared to Q2’24 *Source: IQVIA NPA Weekly Post-Launch TRx* (Through 10/11/24) TRx Week


Slide 11

ARISTADA® Performance and Expectations ARISTADA Quarterly Net Sales* ($M) Q3’24 ARISTADA® net sales were $84.7M Outlook: FY’24 net sales expected to range from $340M – $360M†* *Inclusive of ARISTADA INITIO® † These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on Oct. 24, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations.


Slide 12

VIVITROL® Performance and Expectations VIVITROL Quarterly Net Sales ($M) * These expectations were initially provided by the Company on Feb. 15, 2024, are reiterated by the Company on Oct. 24, 2024 and are effective only as of such date. The Company expressly disclaims any obligation to update or reaffirm these expectations. Q3’24 VIVITROL® net sales were $113.7M Outlook: FY’24 net sales expected to range from $410M – $430M*


Slide 13

Appendix


Slide 14

Appendix: Amounts Included in Discontinued Operations (In millions) Year Ended December 31, 2023 Three Months Ended September 30, 2024 Cost of goods manufactured and sold $ --- Research and development 0.5 Selling, general and administrative --- Income tax benefit $ (0.1) Loss from discontinued operations, net of tax $ 0.4 (In millions) Year Ended December 31, 2023 Three Months Ended September 30, 2023 Cost of goods manufactured and sold $ 0.0 Research and development 32.3 Selling, general and administrative 13.1 Income tax benefit $ (1.6) Loss from discontinued operations, net of tax $ 43.8


Slide 15

Appendix: Financial Results GAAP to EBITDA Adjustments (In millions) Three Months Ended September 30, 2024 Three Months Ended September 30, 2023 Net Income from Continuing Operations — GAAP $ 92.8 $ 91.6 Adjustments: Depreciation expense 7.0 8.9 Amortization expense 0.0 9.0 Interest income (10.9) (9.4) Interest expense 6.0 6.0 Income tax provision 17.4 1.2 EBITDA from Continuing Operations $ 112.3 $ 107.2 EBITDA from Discontinued Operations $ (0.5) $ (44.6) EBITDA $ 111.8 $ 62.7


Slide 16

Appendix: Financial Results GAAP to Non-GAAP Adjustments (In millions) Three Months Ended September 30, 2024 Three Months Ended September 30, 2023 Net Income from Continuing Operations — GAAP $ 92.8 $ 91.6 Adjustments: Share-based compensation expense 22.5 21.7 Depreciation expense 7.0 8.9 Amortization expense 0.0 9.0 Non-cash net interest expense 0.1 0.1 Separation expense 0.2 9.6 Income tax effect related to reconciling items (1.3) 3.5 Restructuring expense --- 5.9 Non-GAAP Net Income from Continuing Operations $ 121.4 $ 150.4 Non-GAAP Net Loss from Discontinued Operations $ (0.4) $ (40.8) Non-GAAP Net Income $ 121.0 $ 109.5 Amounts in the table above may not sum due to rounding.


Slide 17

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


Slide 18

Appendix: 2024 Guidance GAAP to Non-GAAP Adjustments (In millions) Year Ended December 31, 2023 Year Ending December 31, 2024 Projected Net Income — GAAP $ 370.0 Adjustments: Share-based compensation expense 86.0 Depreciation expense 35.0 Amortization expense 1.0 Non-cash net interest expense 0.5 Income tax effect related to reconciling items (7.5) Projected Net Income — Non-GAAP $ 485.0 Projected GAAP and non-GAAP measures reflect the mid-points within the Company’s financial expectations ranges.


Slide 19

www.alkermes.com