- Reports Full-Year Diluted EPS of $6.63 on a GAAP Basis, an Increase of 2.8
Percent; Adjusted Diluted EPS of $13.77, an Increase of 16.4 Percent; These
Results Include an Unfavorable Impact of $0.39 Per Share related to 2022 Acquired
IPR&D and Milestones Expense1
- Delivers Full-Year Net Revenues of $58.054 Billion, an Increase of 3.3 Percent on a
Reported Basis and 5.1 Percent on an Operational Basis
- Full-Year Global Net Revenues from the Immunology Portfolio
Were $28.924 Billion, an Increase of
14.4 Percent on a Reported Basis, or 16.0 Percent on an Operational
Basis; Global Humira Net Revenues Were $21.237 billion; Global Skyrizi Net Revenues Were
$5.165 Billion; Global Rinvoq Net
Revenues Were $2.522 Billion
- Full-Year Global Net Revenues from the Hematologic Oncology
Portfolio Were $6.577 Billion, a
Decrease of 9.0 Percent on a Reported Basis, or 7.6 Percent on an
Operational Basis; Global Imbruvica Net Revenues Were $4.568 Billion; Global Venclexta Net Revenues
Were $2.009 Billion
- Full-Year Global Net Revenues from the Neuroscience
Portfolio Were $6.528 Billion, an
Increase of 10.1 Percent on a Reported Basis, or 11.6 Percent on an
Operational Basis; Global Botox Therapeutic Net Revenues Were
$2.719 Billion; Global Vraylar Net
Revenues Were $2.038
Billion
- Full-Year Global Net Revenues from the Aesthetics Portfolio
Were $5.333 Billion, an Increase of
1.9 Percent on a Reported Basis, or 5.1 Percent on an Operational
Basis; Global Botox Cosmetic Net Revenues Were $2.615 Billion; Global Juvederm Net Revenues Were
$1.428 Billion
- Reports Fourth-Quarter Diluted EPS of $1.38 on a GAAP Basis, a decrease of 38.9
Percent; Adjusted Diluted EPS of $3.60, an increase of 16.9 Percent; These Results
Include an Unfavorable Impact of $0.13 Per Share Related to Fourth-Quarter 2022
Acquired IPR&D and Milestones Expense
- Delivers Fourth-Quarter Net Revenues of $15.121 Billion, an Increase of 1.6 Percent on a
Reported Basis and 3.8 Percent on an Operational Basis
- Provides 2023 Adjusted Diluted EPS Guidance Range of
$10.70 to $11.10, which Excludes Any Unfavorable Impact
Related to Acquired IPR&D and Milestones Expense
NORTH
CHICAGO, Ill., Feb. 9, 2023
/PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for
the fourth quarter and full year ended December 31, 2022.
"2022 was another highly productive year capping a decade of
outstanding performance. Since our inception, we have built a
diverse portfolio of growth products with significant leadership
positions, developed a robust pipeline of innovative assets and
created a culture of strong execution," said Richard A. Gonzalez, chairman and chief
executive officer, AbbVie. "Looking forward, we have a solid
foundation which will allow us to absorb the U.S. Humira loss of
exclusivity, return to strong top-line growth in 2025 and drive
top-tier financial performance over the long term."
Note: "Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
1Beginning in the first quarter 2022,
AbbVie includes the impact of upfront and milestone payments
related to collaborations, licensing agreements and other asset
acquisitions in its reported non-GAAP financial
measures.
|
Fourth-Quarter Results
- Worldwide net revenues were $15.121
billion, an increase of 1.6 percent on a reported basis, or
3.8 percent on an operational basis.
- Global net revenues from the immunology portfolio were
$7.925 billion, an increase of 17.5
percent on a reported basis, or 19.5 percent on an operational
basis.
-
- Global Humira net revenues of $5.579
billion increased 4.6 percent on a reported, or 6.0 percent
on an operational basis. U.S. Humira net revenues were $5.006 billion, an increase of 9.9 percent.
Internationally, Humira net revenues were $573 million, a decrease of 26.5 percent on a
reported basis, or 16.9 percent on an operational basis.
- Global Skyrizi net revenues were $1.576
billion, an increase of 76.1 percent on a reported basis, or
78.9 percent on an operational basis.
- Global Rinvoq net revenues were $770
million, an increase of 49.0 percent on a reported basis, or
55.4 percent on an operational basis.
- Global net revenues from the hematologic oncology portfolio
were $1.631 billion, a decrease of
12.9 percent on a reported basis, or 11.2 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.115 billion, a decrease of 19.5 percent, with
U.S. net revenues of $841 million and
international profit sharing of $274
million.
- Global Venclexta net revenues were $516
million, an increase of 5.7 percent on a reported basis, or
12.2 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.710 billion, an increase of 3.4
percent on a reported basis, or 5.1 percent on an operational
basis.
-
- Global Botox Therapeutic net revenues were $728 million, an increase of 8.5 percent on a
reported basis, or 10.7 percent on an operational basis.
- Global Vraylar net revenues were $565
million, an increase of 15.5 percent.
- Global Ubrelvy net revenues were $197
million, an increase of 7.7 percent.
- Global net revenues from the aesthetics portfolio were
$1.287 billion, a decrease of 8.5
percent on a reported basis, or 4.2 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $642 million, an increase of 2.6 percent on a
reported basis, or 7.1 percent on an operational basis.
- Global Juvederm net revenues were $322
million, a decrease of 25.4 percent on a reported basis, or
19.0 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the fourth quarter
was 72.4 percent. The adjusted gross margin ratio was 86.0
percent.
- On a GAAP basis, selling, general and administrative (SG&A)
expense was 22.6 percent of net revenues. The adjusted SG&A
expense was 20.8 percent of net revenues.
- On a GAAP basis, research and development (R&D) expense was
11.8 percent of net revenues. The adjusted R&D expense was 11.5
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- Acquired IPR&D and milestones expense was 1.6 percent of
net revenues.
- On a GAAP basis, the operating margin in the fourth quarter was
36.4 percent. The adjusted operating margin was 52.1 percent.
- Net interest expense was $476
million.
- On a GAAP basis, the tax rate in the quarter was 16.6 percent.
The adjusted tax rate was 13.4 percent.
- Diluted EPS in the fourth quarter was $1.38 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $3.60.
These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and
milestones expense.
Note: "Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
|
Recent Events
- AbbVie announced the European Commission (EC) approved Skyrizi
(risankizumab, 600 mg intravenous induction and 360 mg subcutaneous
maintenance therapy) as the first specific interleukin-23 (IL-23)
inhibitor for the treatment of adults with moderately to severely
active Crohn's disease (CD) who have had inadequate response, lost
response or were intolerant to conventional or biologic therapy.
The approval is supported by results from three Phase 3 studies in
which Skyrizi demonstrated significant improvement in clinical
remission and endoscopic response, compared to placebo, as both
induction and maintenance therapy. This approval marks the third
indication for Skyrizi in the European Union (EU). Skyrizi is part
of a collaboration between Boehringer Ingelheim and AbbVie, with
AbbVie leading development and commercialization globally.
- At the American College of Rheumatology's (ACR) annual meeting,
AbbVie shared 36 abstracts that underscore AbbVie's commitment to
advancing research to help more people living with rheumatic
diseases. Analyses presented showcased data from the clinical trial
programs evaluating Rinvoq (upadacitinib) for the treatment of
rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial
spondyloarthritis (AS) as well as data evaluating Skyrizi for the
treatment of psoriasis (PsO) and PsA.
- AbbVie announced that the U.S. Food and Drug Administration
(FDA) accepted, for priority review, the Biologics License
Application (BLA) for epcoritamab, an investigational subcutaneous
bispecific antibody for the treatment of adult patients with
relapsed/refractory (r/r) large B-cell lymphoma (LBCL).
Additionally, AbbVie announced the European Medicines Agency (EMA)
validated AbbVie's Marketing Authorization Application (MAA) for
epcoritamab for the treatment of adult patients with r/r diffuse
LBCL. Both applications are supported by data from the EPCORE NHL-1
Phase 2 trial evaluating the safety and preliminary efficacy of
subcutaneous epcoritamab in adult patients with relapsed,
progressive or refractory CD20+ mature B-cell non-Hodgkin's
lymphoma (NHL). Epcoritamab is being co-developed by Genmab and
AbbVie.
- At the American Society of Hematology (ASH) Annual Meeting,
AbbVie presented results from nearly 65 abstracts, including 15
oral presentations, across eight types of cancer. Highlights
included four oral presentations evaluating investigational
epcoritamab for the treatment of r/r follicular lymphoma (FL),
previously untreated FL, r/r diffuse LBCL as well as Richter's
syndrome; data from cohort three of the Phase 2 REFINE study
evaluating navitoclax in combination with ruxolitinib in JAK
inhibitor-naïve patients with myelofibrosis (MF); data from the
Phase 2 CAPTIVATE and Phase 3 GLOW studies evaluating
fixed-duration treatment in patients with chronic lymphocytic
leukemia (CLL)/small lymphocytic leukemia (SLL) who received the
Imbruvica (ibrutinib) + Venclexta (venetoclax) combination regimen.
AbbVie also presented multiple abstracts evaluating Venclexta in
approved CLL and acute myeloid leukemia (AML) indications and the
investigational multiple myeloma (MM) indication. Imbruvica is
jointly developed and commercialized with Janssen Biotech, Inc.
Venetoclax is being developed by AbbVie and Roche and is jointly
commercialized by AbbVie and Genentech, a member of the Roche
Group, in the U.S. and by AbbVie outside of the U.S.
- AbbVie announced that the FDA approved Vraylar (cariprazine) as
an adjunctive therapy to antidepressants for the treatment of major
depressive disorder (MDD) in adults. The approval marks the fourth
indication for Vraylar, which is now the first and only dopamine
and serotonin partial agonist FDA-approved for the most common
forms of depression – as an adjunctive treatment for MDD and the
treatment of depressive episodes associated with bipolar I
disorder. The approval is supported by clinical data demonstrating
the efficacy and well-established tolerability of Vraylar as an
adjunctive treatment for MDD with an antidepressant therapy.
Vraylar is being co-developed by AbbVie and Gedeon Richter
Plc.
- At the European Headache Federation Congress (EHC) 2022, AbbVie
shared 15 abstracts which underscore its commitment to people
living with migraine. Presentations highlighted late-breaking data
from the Chronic Migraine Epidemiology and Outcomes - International
(CaMEO-I) study, evaluating the frequency and burden of neck pain
with headache among people with and without migraine, as well as
results from the Phase 3 PROGRESS trial evaluating Qulipta
(atogepant) for the preventive treatment of chronic migraine (CM)
in patients living in Europe.
- AbbVie announced new results from its exploratory NOVA phase 2
dose-ranging study evaluating the efficacy and safety of
AGN-151607, a novel investigational neurotoxin for the prevention
of postoperative atrial fibrillation (POAF) in cardiac surgery
patients, at the American Heart Association Scientific Sessions
meeting. The study's primary endpoint was not met for the modified
intent-to-treat (mITT) population; however, the data showed
relative risk reduction in specific study populations such as
coronary artery bypass graft (CABG) patients and patients aged 65
years and older, as well as overall lower rates of
rehospitalization within 30 days compared to placebo. Adverse
Events (AEs) were numerically similar across all treatment
groups.
- AbbVie and HotSpot Therapeutics, Inc., a biotechnology company
pioneering the discovery and development of small molecule
allosteric therapies for the treatment of cancer and autoimmune
diseases, announced an exclusive worldwide collaboration and option
to license agreement for HotSpot's discovery-stage interferon
regulatory factor 5 (IRF5) inhibitor program for the potential
treatment of autoimmune diseases.
- AbbVie and Immunome, a clinical-stage biopharmaceutical company
that utilizes its human memory B cell platform to discover and
develop first-in-class antibody therapeutics, announced a worldwide
collaboration and option agreement directed to the discovery of up
to 10 novel antibody-target pairs arising from three specified
tumor types using Immunome's Discovery Engine.
- AbbVie and Anima Biotech, announced a collaboration to discover
and develop mRNA biology modulators for three targets across
Immunology and Oncology. Anima will use its mRNA Lightning platform
to discover novel mRNA biology modulators against the collaboration
targets providing AbbVie exclusive rights to license and further
develop and commercialize the programs.
Full-Year 2023 Outlook
AbbVie is issuing its adjusted diluted EPS guidance for the
full-year 2023 of $10.70 to
$11.10. The company's 2023 adjusted
diluted EPS guidance excludes any impact from acquired IPR&D
and milestones that may be incurred during 2023, as both cannot be
reliably forecasted.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, and gastroenterology,
in addition to products and services across our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook or
LinkedIn.
Conference Call
AbbVie will host an investor conference call today at
8:00 a.m. Central time to discuss our
fourth-quarter performance. The call will be webcast through
AbbVie's Investor Relations website at investors.abbvie.com. An
archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 2022 and 2021 are presented on both a
reported and a non-GAAP basis. Reported results were prepared in
accordance with GAAP and include all revenue and expenses
recognized during the period. Non-GAAP results adjust for certain
non-cash items and for factors that are unusual or unpredictable,
and exclude those costs, expenses, and other specified items
presented in the reconciliation tables later in this release.
Beginning in the first quarter of 2022, the company includes the
impact of upfront and milestone payments related to collaborations,
licensing agreements, and other asset acquisitions in its reported
non-GAAP financial measures. Prior periods have been revised to
conform to the current period presentation. AbbVie's management
believes non-GAAP financial measures provide useful information to
investors regarding AbbVie's results of operations and assist
management, analysts, and investors in evaluating the performance
of the business. Non-GAAP financial measures should be considered
in addition to, and not as a substitute for, measures of financial
performance prepared in accordance with GAAP.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions and uses of future
or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its Quarterly
Reports on Form 10-Q and in other documents that AbbVie
subsequently files with the Securities and Exchange Commission that
update, supplement or supersede such information. AbbVie undertakes
no obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
AbbVie
Inc.
Key Product
Revenues
Quarter Ended
December 31, 2022
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
4Q21
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$
12,192
|
|
$
2,929
|
|
$
15,121
|
|
4.4 %
|
|
(8.7) %
|
|
1.6 %
|
|
1.8 %
|
|
3.8 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
6,975
|
|
950
|
|
7,925
|
|
22.5
|
|
(9.5)
|
|
17.5
|
|
3.2
|
|
19.5
|
Humira
|
5,006
|
|
573
|
|
5,579
|
|
9.9
|
|
(26.5)
|
|
4.6
|
|
(16.9)
|
|
6.0
|
Skyrizi
|
1,403
|
|
173
|
|
1,576
|
|
84.3
|
|
29.1
|
|
76.1
|
|
47.9
|
|
78.9
|
Rinvoq
|
566
|
|
204
|
|
770
|
|
48.6
|
|
50.1
|
|
49.0
|
|
74.5
|
|
55.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,110
|
|
521
|
|
1,631
|
|
(18.7)
|
|
2.6
|
|
(12.9)
|
|
8.8
|
|
(11.2)
|
Imbruvicab
|
841
|
|
274
|
|
1,115
|
|
(24.6)
|
|
1.6
|
|
(19.5)
|
|
1.6
|
|
(19.5)
|
Venclexta
|
269
|
|
247
|
|
516
|
|
7.7
|
|
3.7
|
|
5.7
|
|
17.0
|
|
12.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
835
|
|
452
|
|
1,287
|
|
(4.7)
|
|
(14.8)
|
|
(8.5)
|
|
(3.4)
|
|
(4.2)
|
Botox
Cosmetic
|
422
|
|
220
|
|
642
|
|
6.4
|
|
(4.0)
|
|
2.6
|
|
8.3
|
|
7.1
|
Juvederm
Collection
|
128
|
|
194
|
|
322
|
|
(28.3)
|
|
(23.3)
|
|
(25.4)
|
|
(12.4)
|
|
(19.0)
|
Other
Aesthetics
|
285
|
|
38
|
|
323
|
|
(5.3)
|
|
(21.4)
|
|
(7.6)
|
|
(11.7)
|
|
(6.2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,506
|
|
204
|
|
1,710
|
|
4.7
|
|
(5.7)
|
|
3.4
|
|
7.2
|
|
5.1
|
Botox
Therapeutic
|
614
|
|
114
|
|
728
|
|
9.6
|
|
2.8
|
|
8.5
|
|
16.2
|
|
10.7
|
Vraylar
|
564
|
|
1
|
|
565
|
|
15.4
|
|
n/m
|
|
15.5
|
|
n/m
|
|
15.5
|
Duodopa
|
23
|
|
84
|
|
107
|
|
(18.3)
|
|
(15.8)
|
|
(16.3)
|
|
(3.2)
|
|
(6.5)
|
Ubrelvy
|
197
|
|
—
|
|
197
|
|
7.5
|
|
n/m
|
|
7.7
|
|
n/m
|
|
7.7
|
Qulipta
|
52
|
|
—
|
|
52
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
56
|
|
5
|
|
61
|
|
(66.2)
|
|
(8.8)
|
|
(64.5)
|
|
(1.1)
|
|
(64.3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
338
|
|
252
|
|
590
|
|
(49.7)
|
|
(12.4)
|
|
(38.5)
|
|
(1.3)
|
|
(35.2)
|
Lumigan/Ganfort
|
56
|
|
67
|
|
123
|
|
(22.1)
|
|
(13.0)
|
|
(17.4)
|
|
(3.3)
|
|
(12.4)
|
Alphagan/Combigan
|
41
|
|
33
|
|
74
|
|
(59.4)
|
|
(16.2)
|
|
(47.4)
|
|
(4.5)
|
|
(44.1)
|
Restasis
|
103
|
|
7
|
|
110
|
|
(70.5)
|
|
(49.0)
|
|
(69.6)
|
|
(45.0)
|
|
(69.4)
|
Other Eye
Care
|
138
|
|
145
|
|
283
|
|
(7.7)
|
|
(7.8)
|
|
(7.7)
|
|
4.5
|
|
(1.4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
791
|
|
195
|
|
986
|
|
(1.5)
|
|
(18.4)
|
|
(5.4)
|
|
(6.2)
|
|
(2.6)
|
Mavyret
|
193
|
|
187
|
|
380
|
|
(1.8)
|
|
(18.8)
|
|
(11.0)
|
|
(6.5)
|
|
(4.4)
|
Creon
|
337
|
|
—
|
|
337
|
|
3.0
|
|
n/m
|
|
3.0
|
|
n/m
|
|
3.0
|
Linzess/Constella
|
261
|
|
8
|
|
269
|
|
(6.5)
|
|
(7.5)
|
|
(6.6)
|
|
2.2
|
|
(6.3)
|
|
|
a
|
"Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues
at the prior year's foreign exchange rates.
|
b
|
Reflects profit sharing
for Imbruvica international revenues.
|
n/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Twelve Months Ended
December 31, 2022
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
12M21
|
|
Net Revenues (in millions)
|
|
Reported
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$
45,713
|
|
$
12,341
|
|
$
58,054
|
|
5.1 %
|
|
(2.7) %
|
|
3.3 %
|
|
5.5 %
|
|
5.1 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
24,897
|
|
4,027
|
|
28,924
|
|
18.1
|
|
(4.0)
|
|
14.4
|
|
5.7
|
|
16.0
|
Humira
|
18,619
|
|
2,618
|
|
21,237
|
|
7.4
|
|
(22.2)
|
|
2.6
|
|
(14.9)
|
|
3.8
|
Skyrizi
|
4,484
|
|
681
|
|
5,165
|
|
80.4
|
|
50.4
|
|
75.7
|
|
67.1
|
|
78.3
|
Rinvoq
|
1,794
|
|
728
|
|
2,522
|
|
41.2
|
|
91.4
|
|
52.8
|
|
>100.0
|
|
58.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
4,435
|
|
2,142
|
|
6,577
|
|
(15.6)
|
|
8.6
|
|
(9.0)
|
|
13.9
|
|
(7.6)
|
Imbruvicab
|
3,426
|
|
1,142
|
|
4,568
|
|
(20.7)
|
|
5.1
|
|
(15.5)
|
|
5.1
|
|
(15.5)
|
Venclexta
|
1,009
|
|
1,000
|
|
2,009
|
|
8.0
|
|
12.9
|
|
10.4
|
|
24.6
|
|
16.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
3,324
|
|
2,009
|
|
5,333
|
|
(0.8)
|
|
6.7
|
|
1.9
|
|
15.6
|
|
5.1
|
Botox
Cosmetic
|
1,654
|
|
961
|
|
2,615
|
|
16.2
|
|
18.9
|
|
17.2
|
|
28.8
|
|
20.8
|
Juvederm
Collection
|
548
|
|
880
|
|
1,428
|
|
(16.7)
|
|
0.3
|
|
(7.0)
|
|
8.9
|
|
(2.1)
|
Other
Aesthetics
|
1,122
|
|
168
|
|
1,290
|
|
(11.5)
|
|
(14.9)
|
|
(12.0)
|
|
(8.3)
|
|
(11.1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
5,681
|
|
847
|
|
6,528
|
|
12.3
|
|
(2.3)
|
|
10.1
|
|
7.7
|
|
11.6
|
Botox
Therapeutic
|
2,255
|
|
464
|
|
2,719
|
|
12.1
|
|
5.6
|
|
10.9
|
|
15.3
|
|
12.6
|
Vraylar
|
2,037
|
|
1
|
|
2,038
|
|
17.9
|
|
n/m
|
|
17.9
|
|
n/m
|
|
17.9
|
Duodopa
|
95
|
|
363
|
|
458
|
|
(6.7)
|
|
(11.3)
|
|
(10.4)
|
|
(0.8)
|
|
(2.0)
|
Ubrelvy
|
680
|
|
—
|
|
680
|
|
23.2
|
|
n/m
|
|
23.3
|
|
n/m
|
|
23.3
|
Qulipta
|
158
|
|
—
|
|
158
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
456
|
|
19
|
|
475
|
|
(30.5)
|
|
4.8
|
|
(29.6)
|
|
9.0
|
|
(29.5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
1,603
|
|
1,098
|
|
2,701
|
|
(33.3)
|
|
(5.7)
|
|
(24.3)
|
|
3.7
|
|
(21.2)
|
Lumigan/Ganfort
|
242
|
|
272
|
|
514
|
|
(11.0)
|
|
(11.3)
|
|
(11.2)
|
|
(3.0)
|
|
(6.8)
|
Alphagan/Combigan
|
202
|
|
144
|
|
346
|
|
(45.8)
|
|
(7.9)
|
|
(34.6)
|
|
2.5
|
|
(31.5)
|
Restasis
|
621
|
|
45
|
|
666
|
|
(49.6)
|
|
(20.2)
|
|
(48.3)
|
|
(13.8)
|
|
(48.0)
|
Other Eye
Care
|
538
|
|
637
|
|
1,175
|
|
2.3
|
|
(1.2)
|
|
0.4
|
|
8.7
|
|
5.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
3,036
|
|
818
|
|
3,854
|
|
2.9
|
|
(17.2)
|
|
(2.2)
|
|
(7.9)
|
|
0.1
|
Mavyret
|
755
|
|
786
|
|
1,541
|
|
0.2
|
|
(17.8)
|
|
(9.9)
|
|
(8.5)
|
|
(4.7)
|
Creon
|
1,278
|
|
—
|
|
1,278
|
|
7.3
|
|
n/m
|
|
7.3
|
|
n/m
|
|
7.3
|
Linzess/Constella
|
1,003
|
|
32
|
|
1,035
|
|
(0.4)
|
|
0.3
|
|
(0.3)
|
|
7.6
|
|
(0.1)
|
|
|
a
|
"Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues
at the prior year's foreign exchange rates.
|
b
|
Reflects profit
sharing for Imbruvica international revenues.
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
(Unaudited)
|
|
(in millions, except
per share data)
|
Fourth
Quarter
Ended December
31
|
|
Twelve
Months
Ended December
31
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net revenues
|
$
15,121
|
|
$
14,886
|
|
$
58,054
|
|
$
56,197
|
Cost of products
sold
|
4,170
|
|
4,320
|
|
17,414
|
|
17,446
|
Selling, general and
administrative
|
3,417
|
|
3,260
|
|
15,260
|
|
12,349
|
Research and
developmenta
|
1,790
|
|
1,827
|
|
6,510
|
|
6,922
|
Acquired IPR&D and
milestonesa
|
243
|
|
405
|
|
697
|
|
1,124
|
Other operating
(income) expense, net
|
(1)
|
|
—
|
|
56
|
|
432
|
Total operating costs
and expenses
|
9,619
|
|
9,812
|
|
39,937
|
|
38,273
|
|
|
|
|
|
|
|
|
Operating
earnings
|
5,502
|
|
5,074
|
|
18,117
|
|
17,924
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
476
|
|
571
|
|
2,044
|
|
2,384
|
Net foreign exchange
loss
|
40
|
|
16
|
|
148
|
|
51
|
Other expense,
net
|
2,021
|
|
216
|
|
2,448
|
|
2,500
|
Earnings before income
tax expense
|
2,965
|
|
4,271
|
|
13,477
|
|
12,989
|
Income tax
expense
|
493
|
|
226
|
|
1,632
|
|
1,440
|
Net earnings
|
2,472
|
|
4,045
|
|
11,845
|
|
11,549
|
Net earnings (loss)
attributable to noncontrolling interest
|
(1)
|
|
1
|
|
9
|
|
7
|
Net earnings
attributable to AbbVie Inc.
|
$
2,473
|
|
$
4,044
|
|
$
11,836
|
|
$
11,542
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
1.38
|
|
$
2.26
|
|
$
6.63
|
|
$
6.45
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per shareb
|
$
3.60
|
|
$
3.08
|
|
$
13.77
|
|
$
11.83
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,778
|
|
1,778
|
|
1,778
|
|
1,777
|
|
|
a
|
During the three months
ended March 31, 2022, AbbVie changed its classification of
development milestone expense
associated with licensing and collaboration arrangements in the
consolidated statement of earnings. Milestone payments
incurred prior to regulatory approval, which were previously
included in research and development expense, are now
presented as acquired IPR&D and milestones expense. The
reclassification decreased research and development
expense and increased acquired IPR&D and milestones expense
by $162 million for the twelve months ended
December 31, 2021 and had no impact on the three months ended
December 31, 2021. The company believes this
presentation assists users of the financial statements to better
understand the total upfront and subsequent development
milestone payments incurred to acquire in-process research and
development projects. Prior periods have been revised
to conform to the current period presentation. The reclassification
had no impact on total operating costs and expenses,
operating earnings, net earnings, net earnings attributable to
AbbVie, Inc., earnings per share, or total equity.
|
|
|
b
|
Refer to the
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
for further details. Weighted-average
diluted shares outstanding includes the effect of dilutive
securities.
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
|
Quarter Ended
December 31, 2022
|
(in millions, except
per share data)
|
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
|
$
2,965
|
|
$
2,473
|
|
$
1.38
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
|
1,961
|
|
1,636
|
|
0.92
|
Acquisition and
integration costs
|
|
|
|
|
|
215
|
|
199
|
|
0.11
|
Change in fair value
of contingent consideration
|
|
|
|
|
|
2,114
|
|
2,113
|
|
1.19
|
Income tax
items
|
|
|
|
|
|
—
|
|
(143)
|
|
(0.08)
|
Other
|
|
|
|
|
|
157
|
|
144
|
|
0.08
|
As adjusted
(non-GAAP)
|
|
|
|
|
|
$
7,412
|
|
$
6,422
|
|
$
3.60
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs primarily include costs related to the Allergan
acquisition. Income tax items include a benefit of $323 million
related to
tax law changes partially offset by certain other tax related
items. Other primarily includes restructuring charges associated
with streamlining global
operations.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the three
months ended December 31, 2022 included acquired IPR&D and
milestones
expense of $243 million on a pre-tax and after-tax basis,
representing an unfavorable impact of $0.13 to both diluted EPS and
adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
|
Quarter Ended
December 31, 2022
|
(in
millions)
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
|
$
4,170
|
|
$
3,417
|
|
$
1,790
|
|
$
(1)
|
|
$
2,021
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
(1,961)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
|
1
|
|
(205)
|
|
(11)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,114)
|
Other
|
|
(99)
|
|
(62)
|
|
(38)
|
|
1
|
|
41
|
As adjusted
(non-GAAP)
|
|
$
2,111
|
|
$
3,150
|
|
$
1,741
|
|
$
—
|
|
$
(52)
|
|
|
3. The adjusted tax rate for
the fourth quarter of 2022 was 13.4 percent, as detailed
below:
|
|
|
|
|
|
|
|
Quarter Ended
December 31, 2022
|
(dollars in
millions)
|
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
|
$
2,965
|
|
$
493
|
|
16.6 %
|
Specified
items
|
|
|
|
|
|
4,447
|
|
498
|
|
11.2 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
|
$
7,412
|
|
$
991
|
|
13.4 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
|
Quarter Ended
December 31, 2021
|
(in millions, except
per share data)
|
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
|
$
4,271
|
|
$
4,044
|
|
$
2.26
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
|
1,806
|
|
1,490
|
|
0.84
|
Acquisition and
integration costs
|
|
|
|
|
|
(191)
|
|
(212)
|
|
(0.12)
|
Change in fair value
of contingent consideration
|
|
|
|
|
|
232
|
|
232
|
|
0.13
|
Litigation
matters
|
|
|
|
|
|
200
|
|
167
|
|
0.09
|
Impacts related to tax
law changes
|
|
|
|
|
|
—
|
|
(265)
|
|
(0.15)
|
Other
|
|
|
|
|
|
41
|
|
58
|
|
0.03
|
As adjusted
(non-GAAP)
|
|
|
|
|
|
$
6,359
|
|
$
5,514
|
|
$
3.08
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs reflect a recovery of certain Allergan
acquisition-related regulatory fees partially offset by
Allergan-related integration
costs and Soliton acquisition costs. Other primarily includes
COVID-19 related expenses and certain tax related items.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reportednon-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the three
months ended December 31, 2021 included acquired IPR&D and
milestones
expense of $405 million on a pre-tax and after-tax basis,
representing an unfavorable impact of $0.23 to both diluted EPS and
adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
|
|
|
Quarter Ended
December 31, 2021
|
(in
millions)
|
|
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
expense,
net
|
As reported
(GAAP)
|
|
|
|
$
4,320
|
|
$
3,260
|
|
$
1,827
|
|
$
216
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
(1,806)
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
|
|
|
(43)
|
|
250
|
|
(16)
|
|
—
|
Change in fair value
of contingent consideration
|
|
|
|
—
|
|
—
|
|
—
|
|
(232)
|
Litigation
matters
|
|
|
|
—
|
|
(200)
|
|
—
|
|
—
|
Other
|
|
|
|
(23)
|
|
(3)
|
|
(13)
|
|
(2)
|
As adjusted
(non-GAAP)
|
|
|
|
$
2,448
|
|
$
3,307
|
|
$
1,798
|
|
$
(18)
|
|
|
3. The adjusted tax rate for
the fourth quarter of 2021 was 13.3 percent, as detailed
below:
|
|
|
|
|
|
|
|
Quarter Ended
December 31, 2021
|
(dollars in
millions)
|
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
|
$
4,271
|
|
$
226
|
|
5.3 %
|
Specified
items
|
|
|
|
|
|
2,088
|
|
618
|
|
29.6 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
|
$
6,359
|
|
$
844
|
|
13.3 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Twelve Months Ended
December 31, 2022
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
13,477
|
|
$
11,836
|
|
$
6.63
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
7,689
|
|
6,430
|
|
3.61
|
Intangible asset
impairment
|
|
|
|
|
770
|
|
604
|
|
0.34
|
Acquisition and
integration costs
|
|
|
|
|
810
|
|
766
|
|
0.43
|
Change in fair value
of contingent consideration
|
|
|
|
|
2,761
|
|
2,770
|
|
1.55
|
Pylera
divestiture
|
|
|
|
|
(172)
|
|
(126)
|
|
(0.07)
|
Litigation
matters
|
|
|
|
|
2,506
|
|
2,028
|
|
1.13
|
Income tax
items
|
|
|
|
|
—
|
|
(26)
|
|
(0.02)
|
Other
|
|
|
|
|
429
|
|
315
|
|
0.17
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
28,270
|
|
$
24,597
|
|
$
13.77
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs primarily include costs related to the Allergan
acquisition. Litigation matters primarily include a charge related
to
a potential settlement of litigation involving Allergan's past
sales of opioid products. Income tax items include a benefit of
$323 million related to
tax law changes partially offset by certain other tax related
items. Other primarily includes restructuring charges associated
with streamlining
global operations.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the
twelve months ended December 31, 2022 included acquired IPR&D
and
milestones expense of $697 million on a pre-tax and $682 million on
an after-tax basis, representing an unfavorable impact of $0.39 to
both
diluted EPS and adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Twelve Months Ended
December 31, 2022
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
17,414
|
|
$
15,260
|
|
$
6,510
|
|
$
56
|
|
$
2,448
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(7,689)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(770)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(83)
|
|
(468)
|
|
(30)
|
|
(229)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,761)
|
Pylera
divestiture
|
—
|
|
—
|
|
—
|
|
172
|
|
—
|
Litigation
matters
|
—
|
|
(2,506)
|
|
—
|
|
—
|
|
—
|
Other
|
(259)
|
|
(160)
|
|
(45)
|
|
1
|
|
34
|
As adjusted
(non-GAAP)
|
$
8,613
|
|
$
12,126
|
|
$
6,435
|
|
$
—
|
|
$
(279)
|
|
|
3. The adjusted tax rate for
the full-year 2022 was 13.0 percent, as detailed below:
|
|
|
|
|
|
|
Twelve Months Ended
December 31, 2022
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
13,477
|
|
$
1,632
|
|
12.1 %
|
Specified
items
|
|
|
|
|
14,793
|
|
2,032
|
|
13.7 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
28,270
|
|
$
3,664
|
|
13.0 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Twelve Months Ended
December 31, 2021
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
12,989
|
|
$
11,542
|
|
$
6.45
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
7,718
|
|
6,419
|
|
3.60
|
Acquisition and
integration costs
|
|
|
|
|
344
|
|
215
|
|
0.12
|
Change in fair value
of contingent consideration
|
|
|
|
|
2,679
|
|
2,677
|
|
1.50
|
Litigation
matters
|
|
|
|
|
307
|
|
253
|
|
0.14
|
Impacts related to tax
law changes
|
|
|
|
|
—
|
|
(265)
|
|
(0.15)
|
Other
|
|
|
|
|
360
|
|
313
|
|
0.17
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
24,397
|
|
$
21,154
|
|
$
11.83
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs reflect Allergan integration costs, Soliton
acquisition costs as well as amortization of the acquisition
date
fair value step-up for inventory related to the Allergan
acquisition partially offset by a recovery of certain Allergan
acquisition-related
regulatory fees. Other primarily includes the purchase of FDA
priority review vouchers from third parties, COVID-19 related
expenses,
restructuring charges associated with streamlining global
operations and certain tax related items.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the
twelve months ended December 31, 2021 included acquired IPR&D
and
milestones expense of $1.1 billion on a pre-tax and after-tax
basis, as well as other operating expense related to the Calico
collaboration of $500
million on a pre-tax and after-tax basis, representing an
unfavorable impact of $0.90 to both diluted EPS and adjusted
diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Twelve Months Ended
December 31, 2021
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
17,446
|
|
$
12,349
|
|
$
6,922
|
|
$
432
|
|
$
2,500
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(7,718)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(215)
|
|
(25)
|
|
(104)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,679)
|
Litigation
matters
|
—
|
|
(307)
|
|
—
|
|
—
|
|
—
|
Other
|
(88)
|
|
(53)
|
|
(300)
|
|
68
|
|
13
|
As adjusted
(non-GAAP)
|
$
9,425
|
|
$
11,964
|
|
$
6,518
|
|
$
500
|
|
$
(166)
|
|
|
3. The adjusted tax rate for
the full-year 2021 was 13.3 percent, as detailed below:
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended
December 31, 2021
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
12,989
|
|
$
1,440
|
|
11.1 %
|
Specified
items
|
|
|
|
|
11,408
|
|
1,796
|
|
15.8 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
24,397
|
|
$
3,236
|
|
13.3 %
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2022-financial-results-301742639.html
SOURCE AbbVie