On July 24, 2024 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2024 (Press release, Alkermes, JUL 24, 2024, View Source [SID1234645034]).
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"Our second quarter results reflect solid execution across our business, delivering double-digit, year-over-year growth for our proprietary commercial product portfolio and robust profitability. We enter the second half of the year in a strong financial position with clear operational priorities to drive the performance of our commercial portfolio and advance our neuroscience development pipeline, including the phase 2 program for ALKS 2680 in narcolepsy type 1 and type 2," said Richard Pops, Chief Executive Officer of Alkermes. "As a profitable, smid-cap biotech growth company with multiple commercial products and a development pipeline with significant value potential, we are executing our plan to become a leader in the field of neuroscience."
Key Financial Highlights
Revenues
(In millions)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Total Revenues
$
399.1
$
617.4*
$
749.5
$
905.0*
Total Proprietary Net Sales
$
269.3
$
231.5
$
502.8
$
446.2
VIVITROL
$
111.9
$
102.1
$
209.5
$
198.7
ARISTADAi
$
86.0
$
82.4
$
164.9
$
162.5
LYBALVI
$
71.4
$
47.0
$
128.4
$
85.0
Profitability
(In millions)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
GAAP Net Income From Continuing Operations
$
94.7
$
279.1
$
133.6
$
267.1
GAAP Net Loss From Discontinued Operations
$
(3.3)
$
(42.0)
$
(5.4)
$
(71.8)
GAAP Net Income
$
91.4
$
237.1*
$
128.2
$
195.2*
Non-GAAP Net Income From Continuing Operations
$
123.4
$
134.3
$
199.6
$
164.4
Non-GAAP Net Loss From Discontinued Operations
$
(3.3)
$
(40.0)
$
(5.4)
$
(67.7)
Non-GAAP Net Income
$
120.1
$
94.3
$
194.2
$
96.7
EBITDA From Continuing Operations
$
118.6
$
299.1
$
170.1
$
306.2
EBITDA From Discontinued Operations
$
(3.9)
$
(41.4)
$
(6.4)
$
(77.4)
EBITDA
$
114.7
$
257.7*
$
163.7
$
228.9*
*As a result of the successful resolution of the arbitration with Janssen Pharmaceutica N.V., the three months ended June 30, 2023 included approximately $245.5 million of back royalties (and related interest) related to U.S. net sales of long-acting INVEGA products (consisting of $195.4 million for 2022 and $50.1 million for the first quarter of 2023) that would ordinarily have been recognized in prior periods.
Revenue Highlights
LYBALVI
Revenues for the quarter were $71.4 million.
Revenues and total prescriptions for the quarter grew 52% and 44%, respectively, compared to the second quarter of 2023.
ARISTADAi
Revenues for the quarter were $86.0 million.
New to brand prescriptions for the quarter grew 6% sequentially compared to the first quarter of 2024.
VIVITROL
Revenues for the quarter were $111.9 million.
Revenues for the quarter grew 10% compared to the second 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 $78.7 million.
VUMERITY manufacturing and royalty revenues for the quarter were $35.2 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued operations.
(In millions)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
R&D Expense – Continuing Operations
$
59.6
$
68.2
$
127.3
$
132.0
R&D Expense – Discontinued Operations
$
3.9
$
32.6
$
6.4
$
62.4
SG&A Expense – Continuing Operations
$
168.1
$
195.8
$
347.9
$
363.6
SG&A Expense – Discontinued Operations
$
–
$
9.5
$
–
$
16.1
Balance Sheet
At June 30, 2024, the company recorded cash, cash equivalents and total investments of $962.5 million, compared to $807.8 million at March 31, 2024. The company’s total debt outstanding as of June 30, 2024 was $289.5 million.
Share Repurchase Program
During the second quarter of 2024, the company repurchased approximately 3.5 million of the company’s ordinary shares under the share repurchase program authorized in February 2024, at a total purchase price of $84.7 million. As of June 30, 2024, the company had $315.3 million (exclusive of any fees, commissions or other expenses related to such repurchases) 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 April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b proof-of-concept study evaluating ALKS 2680, the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy.
In April 2024, the company announced initiation of its Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1.
In May 2024, the company completed the sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. Alkermes received a cash payment for the facility and certain related assets of approximately $91 million.
In May and June 2024, the company presented research related to its psychiatry franchise products—LYBALVI (olanzapine and samidorphan) and ARISTADA (aripiprazole lauroxil)—at several scientific conferences. The conferences included: American Psychiatric Association (APA) Annual Meeting, American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, and Psych Congress Elevate.
In June 2024, the company presented new research related to ALKS 2680 and narcolepsy, including new data from the full narcolepsy type 1 cohort in its phase 1b, proof-of-concept study evaluating ALKS 2680, at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies (APSS).
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 six months ended June 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 Wednesday, July 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.