— First Quarter Revenues of
$350.4 Million —
— GAAP Net Income from
Continuing Operations of $38.9
Million and Diluted GAAP Earnings per Share from Continuing
Operations of $0.23 —
— Company Reiterates 2024
Financial Expectations —
DUBLIN, May 1, 2024 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today reported financial results for the first
quarter of 2024.
"The first quarter of 2024 marks
our first full quarter as a profitable, pure-play neuroscience
company. During the quarter, we continued to advance our strategic
priorities across the business, highlighted by solid underlying
prescription growth for LYBALVI® and advancement of ALKS
2680, our novel, investigational, oral orexin 2 receptor (OX2R)
agonist in development as a once-daily treatment for narcolepsy,"
said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS
2680, we recently initiated our Vibrance-1 phase 2 study in
narcolepsy type 1 and announced positive topline phase 1b results in narcolepsy type 2. With these new
data now in hand, we plan to initiate a phase 2 study in narcolepsy
type 2 in the second half of 2024. In an area where there remains
significant unmet patient need, orexin 2 biology represents an
important new potential approach to treating disorders
characterized by excessive daytime sleepiness. ALKS 2680 is the
first candidate from our orexin portfolio to advance in the clinic
and we plan to share details regarding our other orexin development
programs later this year."
Key Financial Highlights
Revenues
|
(In
millions)
|
Three Months
Ended
March 31,
|
|
2024
|
2023
|
Total
Revenues
|
$
|
350.4
|
$
|
287.6
|
Total Proprietary Net
Sales
|
$
|
233.5
|
$
|
214.7
|
VIVITROL®
|
$
|
97.7
|
$
|
96.7
|
ARISTADA®i
|
$
|
78.9
|
$
|
80.1
|
LYBALVI®
|
$
|
57.0
|
$
|
38.0
|
Profitability
|
(In
millions)
|
Three Months
Ended
March 31,
|
|
2024
|
2023
|
GAAP Net Income (Loss)
From Continuing Operations
|
$
|
38.9
|
$
|
(12.1)
|
GAAP Net Loss From
Discontinued Operations
|
$
|
(2.1)
|
$
|
(29.8)
|
GAAP Net Income
(Loss)
|
$
|
36.8
|
$
|
(41.8)
|
|
|
|
|
|
Non-GAAP Net Income
From Continuing Operations
|
$
|
76.2
|
$
|
30.1
|
Non-GAAP Net Loss
From Discontinued Operations
|
$
|
(2.1)
|
$
|
(27.6)
|
Non-GAAP Net
Income
|
$
|
74.1
|
$
|
2.4
|
|
|
|
|
|
EBITDA From Continuing
Operations
|
$
|
51.5
|
$
|
7.2
|
EBITDA From
Discontinued Operations
|
$
|
(2.5)
|
$
|
(36.0)
|
EBITDA
|
$
|
49.0
|
$
|
(28.8)
|
Revenue Highlights
LYBALVI
- Revenues for the quarter were $57.0
million.
- Revenues and total prescriptions for the quarter grew 50% and
56%, respectively, compared to the first quarter of 2023.
- Inventory in the channel decreased by approximately
$2.3 million during the quarter.
ARISTADAi
- Revenues for the quarter were $78.9
million.
- Inventory in the channel decreased by approximately
$3.6 million during the quarter.
VIVITROL
- Revenues for the quarter were $97.7
million.
- Inventory in the channel decreased by approximately
$4.3 million during the quarter.
Manufacturing & Royalty Revenues
- Royalty revenues from INVEGA
SUSTENNA®/XEPLION®, INVEGA
TRINZA®/TREVICTA® and INVEGA
HAFYERA®/BYANNLI® for the quarter were
$62.7 million.
- VUMERITY® manufacturing and royalty revenues for the
quarter were $31.3 million.
Key Operating Expenses
Please see Note 1 below for details regarding discontinued
operations.
(In
millions)
|
Three Months
Ended
March 31,
|
|
2024
|
2023
|
R&D Expense –
Continuing Operations
|
$
|
67.6
|
$
|
63.8
|
R&D Expense –
Discontinued Operations
|
$
|
2.5
|
$
|
29.9
|
|
|
|
|
|
SG&A Expense –
Continuing Operations
|
$
|
179.7
|
$
|
167.8
|
SG&A Expense –
Discontinued Operations
|
$
|
-
|
$
|
6.6
|
- Year-over-year increase in R&D expense related to
continuing operations was driven primarily by investment in the
ALKS 2680 development program and approximately $3.2 million of non-recurring share-based
compensation expenses.
- 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 approximately
$6.2 million of non-recurring
share-based compensation expenses.
Balance Sheet
At March 31, 2024, the company
recorded cash, cash equivalents and total investments of
$807.8 million, compared to
$813.4 million at Dec. 31, 2023. The company's total debt
outstanding as of March 31, 2024 was
$290.1 million.
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 March 2024, the company
announced the appointment of new independent director Nancy S.
Lurker to the company's board of directors.
- In April 2024, the company
presented data from its long-term safety study of LYBALVI
(olanzapine and samidorphan) at the 2024 Congress of the
Schizophrenia International Research Society (SIRS).
- In April 2024, the company
announced positive topline results from the narcolepsy type 2 and
idiopathic hypersomnia cohorts in its phase 1b study of ALKS 2680, the company's novel,
investigational orexin 2 receptor (OX2R) agonist in development as
a once-daily treatment for narcolepsy.
- In April 2024, the company
announced initiation of the Vibrance-1 phase 2 study of ALKS 2680
in patients with narcolepsy type 1.
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 months ended March 31,
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, May 1,
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.
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; the company's
expectations regarding advancement of its development pipeline,
including plans and expected timelines for the ALKS 2680 clinical
development program; and the therapeutic and commercial potential
of ALKS 2680 and the company's other development programs. 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 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
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)
|
|
March 31,
2024
|
|
March 31,
2023
|
Revenues:
|
|
|
|
|
Product sales,
net
|
|
$
233,536
|
|
$
214,727
|
Manufacturing and
royalty revenues
|
|
116,833
|
|
72,862
|
Research and
development revenue
|
|
3
|
|
6
|
Total
Revenues
|
|
350,372
|
|
287,595
|
Expenses:
|
|
|
|
|
Cost of goods
manufactured and sold
|
|
58,644
|
|
58,164
|
Research and
development
|
|
67,611
|
|
63,770
|
Selling, general and
administrative
|
|
179,749
|
|
167,833
|
Amortization of
acquired intangible assets
|
|
1,059
|
|
8,800
|
Total
Expenses
|
|
307,063
|
|
298,567
|
Operating Income
(Loss)
|
|
43,309
|
|
(10,972)
|
Other Income (Expense),
net:
|
|
|
|
|
Interest
income
|
|
9,399
|
|
4,966
|
Interest
expense
|
|
(5,978)
|
|
(5,288)
|
Other income
(expense), net
|
|
182
|
|
(39)
|
Total Other Income
(Expense), net
|
|
3,603
|
|
(361)
|
Income (Loss) Before
Income Taxes
|
|
46,912
|
|
(11,333)
|
Income Tax
Provision
|
|
7,964
|
|
717
|
Net Income (Loss)
From Continuing Operations
|
|
38,948
|
|
(12,050)
|
Loss from
Discontinued Operations — Net of Tax
|
|
(2,120)
|
|
(29,795)
|
Net Income (Loss) —
GAAP
|
|
$
36,828
|
|
$
(41,845)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Basic:
|
|
|
|
|
From continuing
operations
|
|
$
0.23
|
|
$
(0.07)
|
From discontinued
operations
|
|
(0.01)
|
|
(0.18)
|
Earnings (loss) per
share
|
|
$
0.22
|
|
$
(0.25)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Diluted:
|
|
|
|
|
From continuing
operations
|
|
$
0.23
|
|
$
(0.07)
|
From discontinued
operations
|
|
(0.01)
|
|
(0.18)
|
Earnings (loss) per
share
|
|
$
0.21
|
|
$
(0.25)
|
|
|
|
|
|
Weighted Average
Number of Ordinary Shares Outstanding:
|
|
|
|
|
Basic —
GAAP
|
|
167,984
|
|
165,085
|
Diluted —
GAAP
|
|
172,981
|
|
165,085
|
Diluted —
Non-GAAP
|
|
172,981
|
|
170,270
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations - GAAP
(Continued)
|
|
Three Months
Ended
|
|
Three Months
Ended
|
(In thousands,
except per share data)
|
|
March 31,
2024
|
|
March 31,
2023
|
|
|
|
|
|
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
|
|
$
38,948
|
|
$
(12,050)
|
Adjustments:
|
|
|
|
|
Depreciation
expense
|
|
6,997
|
|
9,384
|
Amortization
expense
|
|
1,059
|
|
8,800
|
Interest
income
|
|
(9,399)
|
|
(4,966)
|
Interest
expense
|
|
5,978
|
|
5,288
|
Income tax
provision
|
|
7,964
|
|
717
|
EBITDA from
Continuing Operations
|
|
51,547
|
|
7,173
|
EBITDA from
Discontinued Operations
|
|
(2,516)
|
|
(35,992)
|
EBITDA
|
|
$
49,031
|
|
$
(28,819)
|
|
|
|
|
|
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
|
|
$
38,948
|
|
$
(12,050)
|
Adjustments:
|
|
|
|
|
Share-based
compensation expense
|
|
32,755
|
|
21,023
|
Depreciation
expense
|
|
6,997
|
|
9,384
|
Amortization
expense
|
|
1,059
|
|
8,800
|
Non-cash net interest
expense
|
|
114
|
|
116
|
Separation
expense
|
|
427
|
|
3,783
|
Income tax effect
related to reconciling items
|
|
(4,121)
|
|
(995)
|
Non-GAAP Net Income
from Continuing Operations
|
|
76,179
|
|
30,061
|
Non-GAAP Net Loss
from Discontinued Operations
|
|
(2,120)
|
|
(27,645)
|
Non-GAAP Net
Income
|
|
$
74,059
|
|
$
2,416
|
|
|
|
|
|
Non-GAAP diluted
earnings per share from continuing operations
|
|
$
0.44
|
|
$
0.18
|
Non-GAAP diluted loss
per share from discontinued operations
|
|
(0.01)
|
|
(0.16)
|
Non-GAAP diluted
earnings per share
|
|
$
0.43
|
|
$
0.01
|
|
|
|
|
|
Alkermes plc and
Subsidiaries
|
Selected Financial
Information (Unaudited)
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
March
31,
|
|
December
31,
|
(In
thousands)
|
|
2024
|
|
2023
|
Cash, cash equivalents
and total investments
|
|
$
807,830
|
|
$
813,378
|
Receivables
|
|
315,848
|
|
332,477
|
Inventory
|
|
198,369
|
|
186,406
|
Contract
assets
|
|
1,229
|
|
706
|
Prepaid expenses and
other current assets
|
|
111,539
|
|
98,166
|
Property, plant and
equipment, net
|
|
224,590
|
|
226,943
|
Intangible assets, net
and goodwill
|
|
83,959
|
|
85,018
|
Assets held for
sale
|
|
96,792
|
|
94,260
|
Deferred tax
assets
|
|
182,536
|
|
195,888
|
Other assets
|
|
101,204
|
|
102,981
|
Total
Assets
|
|
$
2,123,896
|
|
$
2,136,223
|
Long-term debt —
current portion
|
|
$
3,000
|
|
$
3,000
|
Other current
liabilities
|
|
455,977
|
|
512,678
|
Long-term
debt
|
|
287,095
|
|
287,730
|
Liabilities from
discontinued operations
|
|
—
|
|
4,542
|
Other long-term
liabilities
|
|
123,061
|
|
125,587
|
Total shareholders'
equity
|
|
1,254,763
|
|
1,202,686
|
Total Liabilities
and Shareholders' Equity
|
|
$
2,123,896
|
|
$
2,136,223
|
|
|
|
|
|
Ordinary shares
outstanding (in thousands)
|
|
169,185
|
|
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 March 31, 2024,
which the company intends to file in May 2024.
|
Alkermes plc and
Subsidiaries
|
Amounts included
in Discontinued Operations
|
|
|
|
|
|
|
|
|
(In
thousands)
|
|
Three Months
Ended
March 31,
2024
|
|
Cost of goods
manufactured and sold
|
|
$
-
|
|
Research and
development
|
|
2,516
|
|
Selling, general and
administrative
|
|
|
|
Income tax
benefit
|
|
(396)
|
|
Loss from
discontinued operations, net of tax
|
|
$
2,120
|
|
|
|
|
|
|
|
|
|
(In
thousands)
|
|
Three Months
Ended
March 31,
2023
|
|
Cost of goods
manufactured and sold
|
|
$
11
|
|
Research and
development
|
|
29,867
|
|
Selling, general and
administrative
|
|
6,644
|
|
Income tax
benefit
|
|
(6,727)
|
|
Loss from
discontinued operations, net of tax
|
|
$
29,795
|
|
|
|
|
|
Alkermes Contacts:
For Investors: Sandy Coombs
+1 781 609 6377
For Media: Katie
Joyce +1 781 249 8927
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