Company Announcements

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 /PRNewswire/ -- 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








(In millions)

Three Months Ended
September 30,


Nine Months Ended
September 30,


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








(In millions)

Three Months Ended
September 30,


Nine Months Ended
September 30,


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

*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.

(In millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,


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.

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.

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 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.

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

 

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

 

Alkermes Contacts:

For Investors: 

Sandy Coombs 

+1 781 609 6377

For Media:   

Katie Joyce     

+1 781 249 8927

 

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