— Total Revenues of $1.66 Billion in 2023; Net Sales of Proprietary
Products Increased Approximately 18% Year-Over-Year —
— GAAP Net Income of $356 Million and Diluted GAAP Earnings per Share
of $2.10 for 2023 —
— Company Expects to Generate 30% EBITDA
Margin in 2024 —
DUBLIN, Feb. 15, 2024 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today reported financial results for the quarter and
year ended Dec. 31, 2023 and provided
financial expectations for 2024.
"We entered 2024 as a pure-play neuroscience company and are
well positioned to deliver on our strategic priorities to drive
growth of our proprietary commercial products, advance the clinical
development of ALKS 2680 for the treatment of narcolepsy, and
generate significant cash flow," said Richard Pops, Chief Executive
Officer of Alkermes. "Our financial expectations for 2024 reflect
our sharpened strategic focus and our work to position the business
for sustained profitability and growth. As we look ahead, 2024 will
be an important year as we focus on maintaining strong momentum in
the launch of LYBALVI® and advancing and expanding our
development pipeline. We look forward to sharing our progress."
Key Financial Highlights
Revenues
|
|
(In
millions)
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2023
|
2022
|
|
2023
|
2022
|
Total
Revenues
|
$
|
377.5
|
$
|
304.7
|
|
$
|
1,663.4
|
$
|
1,111.8
|
Total Proprietary Net
Sales
|
$
|
242.0
|
$
|
216.1
|
|
$
|
920.0
|
$
|
777.6
|
VIVITROL®
|
$
|
102.4
|
$
|
102.0
|
|
$
|
400.4
|
$
|
379.5
|
ARISTADA®i
|
$
|
83.4
|
$
|
79.2
|
|
$
|
327.7
|
$
|
302.1
|
LYBALVI®
|
$
|
56.2
|
$
|
34.9
|
|
$
|
191.9
|
$
|
96.0
|
|
|
Profitability
|
|
(In
millions)
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2023
|
2022
|
|
2023
|
2022
|
GAAP Net Income
(Loss)
|
$
|
112.8
|
$
|
(28.3)
|
|
$
|
355.8
|
$
|
(158.3)
|
GAAP Net Income
(Loss)
From Continuing Operations
|
$
|
160.6
|
$
|
17.2
|
|
$
|
519.2
|
$
|
(33.2)
|
Non-GAAP Net
Income
|
$
|
37.4
|
$
|
24.2
|
|
$
|
243.7
|
$
|
57.9
|
Non-GAAP Net Income
From
Continuing Operations
|
$
|
81.8
|
$
|
67.4
|
|
$
|
396.5
|
$
|
174.9
|
EBITDA
|
$
|
32.3
|
$
|
(1.2)
|
|
$
|
323.8
|
$
|
(84.0)
|
EBITDA From
Continuing
Operations
|
$
|
72.8
|
$
|
34.6
|
|
$
|
486.3
|
$
|
50.6
|
Please refer to Note 2 below for details related to certain tax
provisions recorded during the quarter ended Dec. 31, 2023 which impacted GAAP Net Income and
Non-GAAP Net Income during the quarter.
Revenue Highlights
LYBALVI
- Revenues for the fourth quarter and year ended
Dec. 31, 2023 were $56.2 million and $191.9
million, respectively.
- Fourth quarter revenues and total prescriptions grew 61%
and 65%, respectively, compared to the fourth quarter of 2022.
ARISTADAi
- Revenues for the fourth quarter and year ended
Dec. 31, 2023 were $83.4 million and $327.7
million, respectively.
- Fourth quarter revenues and total prescriptions (on a
months of therapy basis) grew 5% and 4%, respectively, compared to
the fourth quarter of 2022.
VIVITROL
- Revenues for the fourth quarter and year ended
Dec. 31, 2023 were $102.4 million and $400.4
million, respectively.
Manufacturing & Royalties
- Royalty revenues from INVEGA
SUSTENNA®/XEPLION®, INVEGA
TRINZA®/TREVICTA® and INVEGA
HAFYERA®/BYANNLI® for the fourth quarter and
year ended Dec. 31, 2023 were $75.2
million and $486.1 million,
respectively. 2023 royalty revenues included $195.4 million of back royalties and associated
interest related to U.S. net sales of these products in 2022,
following favorable resolution of the arbitration proceedings
related to these products in the second quarter of 2023.
- VUMERITY® revenues for the fourth quarter and
year ended Dec. 31, 2023 were $33.6
million and $129.3 million,
respectively.
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,
|
|
|
|
|
|
|
|
|
2023
|
2022
|
2023
|
2022
|
R&D Expense –
Continuing Operations
|
$
|
73.9
|
$
|
73.0
|
$
|
270.8
|
$
|
272.7
|
R&D Expense
–
Discontinued Operations
|
$
|
21.5
|
$
|
31.6
|
$
|
116.2
|
$
|
121.1
|
SG&A Expense –
Continuing Operations
|
$
|
169.8
|
$
|
152.9
|
$
|
689.8
|
$
|
590.8
|
SG&A Expense
–
Discontinued Operations
|
$
|
19.4
|
$
|
4.7
|
$
|
48.6
|
$
|
15.0
|
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 certain
one-time expenses related to the successful resolution of legal
proceedings including the Janssen arbitration and VIVITROL patent
litigation.
Balance Sheet
At Dec. 31, 2023, the company
recorded cash, cash equivalents and total investments of
$813.4 million, compared to
$740.1 million at Dec. 31, 2022. The company's total debt
outstanding as of Dec. 31, 2023 was
$290.7 million.
Share Repurchase Program
On Feb. 15, 2024, the company's board of directors
approved a new share repurchase program, authorizing the company to
repurchase up to $400 million of the
company's ordinary shares (exclusive of any fees, commissions or
other expenses related to such repurchases). The program does not
have an expiration date and can be discontinued at any time. Please
refer to Note 3 below for further details.
Financial Expectations for 2024
All line items are
according to GAAP, except as otherwise noted.
In
millions
|
|
2024
Expectations
|
|
|
|
Total
Revenues a
|
|
$1,500 –
$1,600
|
VIVITROL Net
Sales
|
|
$410 – $430
|
ARISTADAi
Net Sales
|
|
$340 – $360
|
LYBALVI Net
Sales
|
|
$275 – $295
|
Cost of Goods
Sold
|
|
$230 – $250
|
R&D
Expenses
|
|
$225 – $255
|
SG&A
Expenses
|
|
$625 – $655
|
GAAP Net Income
b
|
|
$350 – $390
|
Non-GAAP Net Income
b
|
|
$465
– $505
|
EBITDA
|
|
$445 – $485
|
Effective Tax Rate
|
|
~17%
|
|
a Expected Total Revenues reflect
expiration of the U.S. royalty related to INVEGA SUSTENNA in August
2024.
|
b Expected
2024 weighted average basic share count of approximately 169.0
million shares outstanding and a weighted average diluted share
count of approximately 173.0 million shares outstanding.
|
Recent Events
- In November 2023, the
company completed the separation of its oncology business into
Mural Oncology plc, a new, independent, publicly-traded
company.
- In December 2023, the
company announced that it had entered into a definitive agreement
to sell its development and manufacturing facility in Athlone,
Ireland to Novo Nordisk. Under the
terms of the agreement, upon closing of the transaction, Alkermes
will be entitled to a one-time cash payment of $92.5 million for the facility and related
assets, subject to customary adjustments in accordance with the
agreement. The transaction is expected to close in mid-2024,
subject to certain closing conditions.
- In January 2024, the
company announced topline results from a phase 3, open-label
extension study assessing the long-term safety, tolerability and
durability of treatment effect of LYBALVI in patients with
schizophrenia, schizophreniform disorder or bipolar I disorder for
up to four years of treatment, following treatment received in
prior LYBALVI studies.
- In January 2024, the
company announced that it had completed the narcolepsy type 1
cohort in its phase 1b study of ALKS
2680, the company's novel, investigational orexin 2 receptor
agonist in development for the treatment of narcolepsy. The data
supported dose selection of 4 mg, 6 mg, and 8 mg once daily for the
planned phase 2 study in narcolepsy type 1, which the company plans
to initiate in the first half of 2024.
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 (FASB) Accounting Standards Codification (ASC) 205,
Discontinued Operations. Accordingly, the accompanying consolidated
financial statements for all periods presented have been updated to
present the assets and liabilities associated with the oncology
business as discontinued operations on the consolidated balance
sheets, and the results of all discontinued operations reported as
a separate component of loss in the consolidated statements of
operations and comprehensive income (loss).
2. During the quarter ended Dec. 31,
2023, the company recorded a $102.2
million net tax benefit from continuing operations and an
income tax provision of $6.9 million
from discontinued operations driven by a $161.0 million tax benefit related to the partial
release of a valuation allowance against certain Irish deferred tax
assets, partially offset by
(i) an income tax expense related to a
reduced foreign derived intangible income deduction following the
publication of new guidance on the application of Section 174 of
the U.S. Internal Revenue Code of 1986, as amended, and
(ii) a one-time charge related to the
transfer of certain intellectual property in connection with the
separation of the company's oncology business.
The tax benefit related to the release of the valuation
allowance was excluded from non-GAAP net income due to the one-time
nature of the benefit.
3. Under the share repurchase program, the company may
repurchase ordinary shares of the company from time to time in an
aggregate amount of up to $400
million (exclusive of any fees, commissions or other
expenses related to such repurchases), subject to general business
and market conditions and other investment opportunities, through
open market purchases, conducted through Rule 10b5-1 plans or
10b-18 plans pursuant to the
Securities Exchange Act of 1934, as amended, or through other
mechanisms permitted by the company's constitution.
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 Thursday, Feb. 15,
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. Headquartered in
Dublin, Ireland, Alkermes has a
research and development center in Waltham, Massachusetts; a research and
manufacturing facility in Athlone, Ireland; and a manufacturing facility in
Wilmington, 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 its
ability to grow its proprietary commercial products, generate cash
and sustain profitability; the company's expectations regarding
advancement of its development pipeline, including plans and
expected timelines for the ALKS 2680 clinical development
program, including initiation of the phase 2 study; the company's
expectations regarding its share repurchase program; and the
company's expectations regarding the sale of its development and
manufacturing facility in Athlone, Ireland. 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 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.
|
(tables follow)
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)
|
|
December 31,
2023
|
|
December 31,
2022
|
Revenues:
|
|
|
|
|
Product sales,
net
|
|
$
241,972
|
|
$
216,117
|
Manufacturing and
royalty revenues
|
|
135,500
|
|
88,546
|
Research and
development revenue
|
|
3
|
|
11
|
Total
Revenues
|
|
377,475
|
|
304,674
|
Expenses:
|
|
|
|
|
Cost of goods
manufactured and sold
|
|
70,126
|
|
53,954
|
Research and
development
|
|
73,933
|
|
73,011
|
Selling, general and
administrative
|
|
169,789
|
|
152,852
|
Amortization of
acquired intangible assets
|
|
8,996
|
|
9,165
|
Total
Expenses
|
|
322,844
|
|
288,982
|
Operating
Income
|
|
54,631
|
|
15,692
|
Other Income (Expense),
net:
|
|
|
|
|
Interest
income
|
|
9,749
|
|
3,921
|
Interest
expense
|
|
(6,054)
|
|
(4,769)
|
Other expense,
net
|
|
(10)
|
|
(258)
|
Total Other Income
(Expense), net
|
|
3,685
|
|
(1,106)
|
Income Before Income
Taxes
|
|
58,316
|
|
14,586
|
Income Tax
Benefit
|
|
(102,236)
|
|
(2,589)
|
Net Income From
Continuing Operations
|
|
160,552
|
|
17,175
|
Loss from
Discontinued Operations — Net of Tax
|
|
$
(47,773)
|
|
$
(45,429)
|
Net Income (Loss) —
GAAP
|
|
$
112,779
|
|
$
(28,254)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Basic:
|
|
|
|
|
From continuing
operations
|
|
$
0.96
|
|
$
0.10
|
From discontinued
operations
|
|
$
(0.29)
|
|
$
(0.28)
|
Earnings (loss) per
share
|
|
$
0.68
|
|
$
(0.17)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Diluted:
|
|
|
|
|
From continuing
operations
|
|
$
0.94
|
|
$
0.10
|
From discontinued
operations
|
|
$
(0.28)
|
|
$
(0.27)
|
Earnings (loss) per
share
|
|
$
0.66
|
|
$
(0.17)
|
|
|
|
|
|
Weighted Average
Number of Ordinary Shares Outstanding:
|
|
|
|
|
Basic — GAAP and
Non-GAAP
|
|
166,898
|
|
164,336
|
Diluted — GAAP and
Non-GAAP
|
|
170,138
|
|
169,304
|
|
|
|
|
|
An itemized
reconciliation between net income from continuing operations on a
GAAP basis and EBITDA is as follows:
|
Net Income from
Continuing Operations
|
|
$
160,552
|
|
$
17,175
|
Adjustments:
|
|
|
|
|
Depreciation
expense
|
|
9,225
|
|
10,013
|
Amortization
expense
|
|
8,996
|
|
9,165
|
Interest
income
|
|
(9,749)
|
|
(3,921)
|
Interest
expense
|
|
6,054
|
|
4,769
|
Income tax (benefit)
provision
|
|
(102,236)
|
|
(2,589)
|
EBITDA from
Continuing Operations
|
|
72,842
|
|
34,612
|
EBITDA from
Discontinued Operations
|
|
(40,537)
|
|
(35,777)
|
EBITDA
|
|
$
32,305
|
|
$
(1,165)
|
|
|
|
|
|
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
|
|
$
160,552
|
|
$
17,175
|
Adjustments:
|
|
|
|
|
Share-based
compensation expense
|
|
22,776
|
|
24,692
|
Depreciation
expense
|
|
9,225
|
|
10,013
|
Amortization
expense
|
|
8,996
|
|
9,165
|
Separation
expense
|
|
19,084
|
|
1,355
|
Income tax effect
related to reconciling items
|
|
22,011
|
|
4,847
|
Deferred tax valuation
release
|
|
(160,953)
|
|
—
|
Non-cash net interest
expense
|
|
115
|
|
116
|
Non-GAAP Net Income
from Continuing Operations
|
|
81,806
|
|
67,363
|
Non-GAAP Net Loss
from Discontinued Operations
|
|
(44,383)
|
|
(43,142)
|
Non-GAAP Net
Income
|
|
$
37,423
|
|
$
24,221
|
|
|
|
|
|
Non-GAAP diluted
earnings per share from continuing operations
|
|
$
0.48
|
|
$
0.40
|
Non-GAAP diluted loss
per share from discontinued operations
|
|
$
(0.26)
|
|
$
(0.25)
|
Non-GAAP diluted
earnings per share
|
|
$
0.22
|
|
$
0.14
|
|
|
|
|
|
Alkermes plc and
Subsidiaries
|
Selected Financial
Information (Unaudited)
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations - GAAP
|
|
Year
Ended
|
|
Year
Ended
|
(In thousands,
except per share data)
|
|
December 31,
2023
|
|
December 31,
2022
|
Revenues:
|
|
|
|
|
Product sales,
net
|
|
$
919,998
|
|
$
777,552
|
Manufacturing and
royalty revenues
|
|
743,388
|
|
331,983
|
License
revenue
|
|
—
|
|
2,000
|
Research and
development revenue
|
|
19
|
|
260
|
Total
Revenues
|
|
1,663,405
|
|
1,111,795
|
Expenses:
|
|
|
|
|
Cost of goods
manufactured and sold
|
|
253,037
|
|
218,068
|
Research and
development
|
|
270,806
|
|
272,702
|
Selling, general and
administrative
|
|
689,751
|
|
590,751
|
Amortization of
acquired intangible assets
|
|
35,689
|
|
36,363
|
Total
Expenses
|
|
1,249,283
|
|
1,117,884
|
Operating Income
(Loss)
|
|
414,122
|
|
(6,089)
|
Other Income (Expense),
net:
|
|
|
|
|
Interest
income
|
|
30,854
|
|
7,629
|
Interest
expense
|
|
(23,032)
|
|
(13,040)
|
Change in the
fair value of contingent consideration
|
|
—
|
|
(21,750)
|
Other (expense)
income, net
|
|
(425)
|
|
2,122
|
Total Other Income
(Expense), net
|
|
7,397
|
|
(25,039)
|
Income (Loss) Before
Income Taxes
|
|
421,519
|
|
(31,128)
|
Income Tax (Benefit)
Provision
|
|
(97,638)
|
|
2,024
|
Net Income (Loss)
From Continuing Operations
|
|
519,157
|
|
(33,152)
|
Discontinued
Operations — Net of Tax
|
|
(163,400)
|
|
(125,115)
|
Net Income (Loss) —
GAAP
|
|
$
355,757
|
|
$
(158,267)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Basic:
|
|
|
|
|
From continuing
operations
|
|
$
3.12
|
|
$
(0.20)
|
From discontinued
operations
|
|
$
(0.98)
|
|
$
(0.76)
|
Earnings (loss) per
share
|
|
$
2.14
|
|
$
(0.97)
|
|
|
|
|
|
GAAP Earnings (Loss)
Per Share - Diluted:
|
|
|
|
|
From continuing
operations
|
|
$
3.06
|
|
$
(0.20)
|
From discontinued
operations
|
|
$
(0.96)
|
|
$
(0.76)
|
Earnings (loss) per
share
|
|
$
2.10
|
|
$
(0.97)
|
|
|
|
|
|
Weighted Average
Number of Ordinary Shares Outstanding:
|
|
|
|
|
Basic — GAAP and
Non-GAAP
|
|
166,223
|
|
163,742
|
Diluted —
GAAP
|
|
169,730
|
|
163,742
|
Diluted —
Non-GAAP
|
|
169,730
|
|
168,362
|
|
|
|
|
|
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
|
|
$
519,157
|
|
$
(33,152)
|
Adjustments:
|
|
|
|
|
Depreciation
expense
|
|
36,921
|
|
39,959
|
Amortization
expense
|
|
35,689
|
|
36,363
|
Interest
income
|
|
(30,854)
|
|
(7,629)
|
Interest
expense
|
|
23,032
|
|
13,040
|
Income tax (benefit)
provision
|
|
(97,638)
|
|
2,024
|
EBITDA from
Continuing Operations
|
|
486,307
|
|
50,605
|
EBITDA from
Discontinued Operations
|
|
(162,484)
|
|
(134,637)
|
EBITDA
|
|
$
323,823
|
|
$
(84,032)
|
|
|
|
|
|
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
|
|
$
519,157
|
|
$
(33,152)
|
Adjustments:
|
|
|
|
|
Share-based
compensation expense
|
|
92,719
|
|
87,676
|
Depreciation
expense
|
|
36,921
|
|
39,959
|
Amortization
expense
|
|
35,689
|
|
36,363
|
Separation
expense
|
|
38,364
|
|
1,355
|
Income tax effect
related to reconciling items
|
|
25,343
|
|
2,254
|
Final award in the
Janssen arbitration (2022 back royalties and interest)
|
|
(197,092)
|
|
—
|
Deferred tax valuation
release
|
|
(160,953)
|
|
—
|
Restructuring
|
|
5,938
|
|
—
|
Non-cash net interest
expense
|
|
461
|
|
466
|
Reduction in the fair
value of contingent consideration and other related
assets
|
|
—
|
|
24,032
|
Legal
settlement
|
|
—
|
|
15,905
|
Non-GAAP Net Income
from Continuing Operations
|
|
396,547
|
|
174,858
|
Non-GAAP Net Loss
from Discontinued Operations
|
|
(152,894)
|
|
(116,999)
|
Non-GAAP Net
Income
|
|
$
243,653
|
|
$
57,859
|
|
|
|
|
|
Non-GAAP diluted
earnings per share from continuing operations
|
|
$
2.34
|
|
$
1.04
|
Non-GAAP diluted loss
per share from discontinued operations
|
|
$
(0.90)
|
|
$
(0.69)
|
Non-GAAP diluted
earnings per share
|
|
$
1.44
|
|
$
0.34
|
Alkermes plc and
Subsidiaries
|
Selected Financial
Information (Unaudited)
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
December
31,
|
|
December
31,
|
(In
thousands)
|
|
2023
|
|
2022
|
Cash, cash equivalents
and total investments
|
|
$
813,378
|
|
$
740,075
|
Receivables
|
|
332,477
|
|
287,967
|
Inventory
|
|
186,406
|
|
181,418
|
Contract
assets
|
|
706
|
|
8,929
|
Prepaid expenses and
other current assets
|
|
98,166
|
|
41,203
|
Property, plant and
equipment, net
|
|
226,943
|
|
222,919
|
Intangible assets, net
and goodwill
|
|
85,018
|
|
120,707
|
Assets held for
sale
|
|
94,260
|
|
93,871
|
Assets from
discontinued operations
|
|
—
|
|
40,087
|
Other assets
|
|
298,869
|
|
226,802
|
Total
Assets
|
|
$
2,136,223
|
|
$
1,963,978
|
Long-term debt —
current portion
|
|
$
3,000
|
|
$
3,000
|
Other current
liabilities
|
|
512,678
|
|
488,898
|
Long-term
debt
|
|
287,730
|
|
290,270
|
Liabilities from
discontinued operations
|
|
4,542
|
|
19,386
|
Other long-term
liabilities
|
|
125,587
|
|
118,671
|
Total shareholders'
equity
|
|
1,202,686
|
|
1,043,753
|
Total Liabilities
and Shareholders' Equity
|
|
$
2,136,223
|
|
$
1,959,436
|
|
|
|
|
|
Ordinary shares
outstanding (in thousands)
|
|
166,980
|
|
164,377
|
|
|
|
|
|
This selected financial
information should be read in conjunction with the consolidated
financial statements and notes thereto included in
Alkermes plc's Annual Report on Form 10-K for the year ended
December 31, 2023, which the company intends to file in February
2024.
|
Alkermes plc and
Subsidiaries
|
Amounts included in
Discontinued Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Year
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
|
December 31,
|
(In
thousands)
|
|
2023
|
|
2023
|
|
2023
|
|
2023
|
|
2023
|
Cost of goods
manufactured and sold
|
|
$
11
|
|
$
11
|
|
$
11
|
|
$
6
|
|
$
39
|
Research and
development
|
|
29,867
|
|
32,563
|
|
32,262
|
|
21,485
|
|
116,177
|
Selling, general and
administrative
|
|
6,644
|
|
9,502
|
|
13,073
|
|
19,368
|
|
48,587
|
Income tax (benefit)
provision
|
|
(6,727)
|
|
(40)
|
|
(1,550)
|
|
6,914
|
|
(1,403)
|
Loss from
discontinued operations, net of tax
|
|
$
29,795
|
|
$
42,036
|
|
$
43,796
|
|
$
47,773
|
|
$
163,400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Year
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
|
December 31,
|
(In
thousands)
|
|
2022
|
|
2022
|
|
2022
|
|
2022
|
|
2022
|
Cost of goods
manufactured and sold
|
|
$
10
|
|
$
10
|
|
$
10
|
|
$
10
|
|
$
40
|
Research and
development
|
|
29,161
|
|
27,475
|
|
32,929
|
|
31,575
|
|
121,140
|
Selling, general and
administrative
|
|
3,201
|
|
3,488
|
|
3,618
|
|
4,689
|
|
14,996
|
Income tax (benefit)
provision
|
|
(22,883)
|
|
1,374
|
|
1,293
|
|
9,155
|
|
(11,061)
|
Loss from
discontinued operations, net of tax
|
|
$
9,489
|
|
$
32,347
|
|
$
37,850
|
|
$
45,429
|
|
$
125,115
|
Alkermes plc and
Subsidiaries
|
Revenues for
Calendar Year 2023 and 2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Year
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
|
December 31,
|
(In
thousands)
|
|
2023
|
|
2023
|
|
2023
|
|
2023
|
|
2023
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
VIVITROL
|
|
$
96,659
|
|
$
102,070
|
|
$
99,305
|
|
$
102,385
|
|
$
400,419
|
ARISTADA
|
|
80,077
|
|
82,410
|
|
81,834
|
|
83,369
|
|
327,690
|
LYBALVI
|
|
37,991
|
|
46,997
|
|
50,683
|
|
56,218
|
|
191,889
|
Total Proprietary
Sales
|
|
214,727
|
|
231,477
|
|
231,822
|
|
241,972
|
|
919,998
|
|
|
|
|
|
|
|
|
|
|
|
PARTNERED LONG-ACTING
ANTIPSYCHOTICS (1)
|
|
24,543
|
|
326,380
|
|
90,993
|
|
81,461
|
|
523,377
|
VUMERITY
|
|
28,874
|
|
32,295
|
|
34,561
|
|
33,596
|
|
129,326
|
Key Commercial
Product Revenues
|
|
268,144
|
|
590,152
|
|
357,376
|
|
357,029
|
|
1,572,701
|
|
|
|
|
|
|
|
|
|
|
|
Legacy Product
Revenues
|
|
19,445
|
|
27,238
|
|
23,559
|
|
20,443
|
|
90,685
|
Research and
Development Revenues
|
|
6
|
|
7
|
|
3
|
|
3
|
|
19
|
Total
Revenues
|
|
$
287,595
|
|
$
617,397
|
|
$
380,938
|
|
$
377,475
|
|
$ 1,663,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Three Months
|
|
Year
|
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
Ended
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
|
December 31,
|
(In
thousands)
|
|
2022
|
|
2022
|
|
2022
|
|
2022
|
|
2022
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
VIVITROL
|
|
$
84,854
|
|
$
96,105
|
|
$
96,534
|
|
$
101,985
|
|
$
379,478
|
ARISTADA
|
|
72,485
|
|
74,622
|
|
75,719
|
|
79,226
|
|
302,052
|
LYBALVI
|
|
13,929
|
|
20,060
|
|
27,127
|
|
34,906
|
|
96,022
|
Total Proprietary
Sales
|
|
171,268
|
|
190,787
|
|
199,380
|
|
216,117
|
|
777,552
|
|
|
|
|
|
|
|
|
|
|
|
PARTNERED LONG-ACTING
ANTIPSYCHOTICS (1)
|
|
54,480
|
|
37,039
|
|
36,965
|
|
37,085
|
|
165,569
|
VUMERITY
|
|
30,595
|
|
26,170
|
|
26,250
|
|
32,481
|
|
115,496
|
Key Commercial
Product Revenues
|
|
256,343
|
|
253,996
|
|
262,595
|
|
285,683
|
|
1,058,617
|
|
|
|
|
|
|
|
|
|
|
|
Legacy Product
Revenues
|
|
20,095
|
|
22,117
|
|
(10,274)
|
|
18,980
|
|
50,918
|
License
Revenue
|
|
2,000
|
`
|
—
|
|
—
|
|
—
|
|
2,000
|
Research and
Development Revenues
|
|
107
|
|
106
|
|
36
|
|
11
|
|
260
|
Total
Revenues
|
|
$
278,545
|
|
$
276,219
|
|
$
252,357
|
|
$
304,674
|
|
$ 1,111,795
|
|
(1) - Includes
RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA
and INVEGA HAFYERA/BYANNLI.
|
Alkermes plc and
Subsidiaries
|
2024 Guidance — GAAP
to EBITDA
|
|
|
|
An itemized
reconciliation between projected net income on a GAAP basis and
EBITDA is as
follows:
|
|
|
|
(In millions, except
per share data)
|
|
Amount
|
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 Net Income on
a GAAP basis and Projected EBITDA reflect mid-points within
ranges
of estimated guidance.
|
Alkermes plc and
Subsidiaries
|
2024 Guidance — GAAP
to Non-GAAP Adjustments
|
|
|
|
|
|
|
|
An itemized
reconciliation between projected earnings per share on a GAAP basis
and projected earnings per share on a non-
GAAP basis is as follows:
|
|
|
|
|
|
|
|
(In millions, except
per share data)
|
|
Amount
|
|
Shares
|
|
Earnings Per
Share
|
Projected Net Income —
GAAP
|
|
$
370.0
|
|
173.0
|
|
$
2.14
|
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
|
|
173.0
|
|
$
2.80
|
|
|
|
|
|
|
|
Projected GAAP and
non-GAAP measures reflect mid-points within ranges of estimated
guidance.
|
Alkermes Contacts:
For Investors: Sandy Coombs
+1 781 609 6377
For Media: Katie
Joyce +1 781 249 8927
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