On February 12, 2025 Alkermes plc (Nasdaq: ALKS) reported financial results for the quarter and year ended Dec. 31, 2024 and provided financial expectations for 2025 (Press release, Alkermes, FEB 12, 2025, View Source [SID1234650203]).
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"2024 marked the completion of a multi-year effort to transition the business into a highly profitable, pure-play neuroscience company. We enter 2025 with a diversified portfolio of proprietary commercial products generating substantial profitability and an advancing development pipeline that represents a significant value creation opportunity in one of the most exciting potential new therapeutic categories in neuroscience," said Richard Pops, Chief Executive Officer of Alkermes. "Looking ahead, we are well positioned to deliver on our financial goals and advance the development programs for our portfolio of orexin 2 receptor agonists. This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia and advance ALKS 4510 and ALKS 7290 into planned phase 1 studies in disease areas beyond central disorders of hypersomnolence. Each of these initiatives is an important element of our strategy to unlock what we believe is a multi-billion-dollar market opportunity for this category."
"2024 was Alkermes’ strongest year of financial and operational performance to date. Financially, we generated more than $1 billion in revenue from our proprietary commercial product portfolio, delivered EBITDA from continuing operations of approximately $452 million, repurchased $200 million of the company’s ordinary shares, retired approximately $290 million of debt and ended the year debt-free with approximately $825 million of cash and investments on the balance sheet. Operationally, we completed the sale of our manufacturing business in Ireland and made significant progress advancing our neuroscience development pipeline," said Blair Jackson, Chief Operating Officer of Alkermes. "We will continue to manage the business with a sharp focus on efficiency and profitability as we invest in the programs that we believe will drive the company’s next phase of growth."
Key Financial Highlights
Revenues
(In millions)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2024
2023
2024
2023
Total Revenues
$
430.0
$
377.5
$
1,557.6
$
1,663.4*
Total Proprietary Net Sales
$
307.7
$
242.0
$
1,083.5
$
920.0
VIVITROL
$
134.1
$
102.4
$
457.3
$
400.4
ARISTADAi
$
96.6
$
83.4
$
346.2
$
327.7
LYBALVI
$
77.0
$
56.2
$
280.0
$
191.9
Profitability
(In millions)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2024
2023
2024
2023*
GAAP Net Income From Continuing Operations
$
145.7
$
160.6
$
372.1
$
519.2
GAAP Net Income (Loss) From Discontinued Operations
$
0.8
$
(47.8)
$
(5.1)
$
(163.4)
GAAP Net Income
$
146.5
$
112.8
$
367.1
$
355.8
Non-GAAP Net Income From Continuing Operations
$
173.4
$
81.8
$
494.4
$
396.5
Non-GAAP Net Income (Loss) From Discontinued Operations
$
0.8
$
(44.4)
$
(5.1)
$
(152.9)
Non-GAAP Net Income
$
174.2
$
37.4
$
489.3
$
243.7
EBITDA From Continuing Operations
$
170.0
$
72.8
$
452.4
$
486.3
EBITDA From Discontinued Operations
$
1.1
$
(40.5)
$
(5.8)
$
(162.5)
EBITDA
$
171.1
$
32.3
$
446.6
$
323.8
*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the twelve months ended December 31, 2023 included approximately $195.4 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products that would ordinarily have been recognized in prior periods.
Revenue Highlights
LYBALVI
Revenues for the fourth quarter were $77.0 million.
Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023.
During the quarter, the company recorded LYBALVI revenue of approximately $4 million related to year-end inventory fluctuations.
ARISTADAi
Revenues for the fourth quarter were $96.6 million.
Fourth quarter revenues grew 16% compared to the fourth quarter of 2023.
During the quarter, the company recorded ARISTADA revenue of approximately $9 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
VIVITROL
Revenues for the fourth quarter were $134.1 million.
Fourth quarter revenues grew 31% compared to the fourth quarter of 2023.
During the quarter, the company recorded VIVITROL revenue of approximately $23 million related to year-end inventory fluctuations and gross-to-net favorability, primarily driven by Medicaid utilization adjustments.
Manufacturing & Royalty Revenues
Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million.
VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million.
FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward.
RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
(In millions)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2024
2023
2024
2023
R&D Expense – Continuing Operations
$
58.2
$
73.9
$
245.3
$
270.8
R&D Expense – Discontinued Operations
$
(1.1)
$
21.5
$
5.8
$
116.2
SG&A Expense – Continuing Operations
$
147.0
$
169.8
$
645.2
$
689.8
SG&A Expense – Discontinued Operations
$
–
$
19.4
$
–
$
48.6
Balance Sheet
At Dec. 31, 2024, the company recorded cash, cash equivalents and total investments of $824.8 million, compared to $813.4 million at Dec. 31, 2023.
In December 2024, the company prepaid and retired in full all of its outstanding long-term debt in the amount of approximately $290 million.
Financial Expectations for 2025
All line items are according to GAAP, except as otherwise noted.
In millions
2025 Expectations
Total Revenues
$1,340 – $1,430
VIVITROL Net Sales
$440 – $460
ARISTADAi Net Sales
$335 – $355
LYBALVI Net Sales
$320 – $340
Cost of Goods Sold
$185 – $205
R&D Expenses
$305 – $335
SG&A Expenses
$655 – $685
GAAP Net Income a
$175 – $205
EBITDA
$215 – $245
Adjusted EBITDA
$310 – $340
Effective Tax Rate
~17%
a Expected 2025 weighted average basic share count of approximately 165.5 million shares outstanding and a weighted average diluted share count of approximately 169.5 million shares outstanding.
Notes and Explanations
1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and twelve months ended Dec. 31, 2023.
Conference Call
Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. EST (1:00 p.m. GMT) on Wednesday, Feb. 12, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +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.