- Reports Third-Quarter Diluted EPS of $2.21 on a GAAP Basis, an Increase of 24.2
Percent; Adjusted Diluted EPS of $3.66, an Increase of 29.3 Percent; These Results
Include an Unfavorable Impact of $0.02 Per Share related to Acquired IPR&D and
Milestones Expense 1
- Delivers Third-Quarter Net Revenues of $14.812 Billion, an Increase of 3.3 Percent on a
Reported Basis and 5.4 Percent Operationally
- Third-Quarter Global Net Revenues from the Immunology
Portfolio Were $7.651 Billion, an
Increase of 14.6 Percent on a Reported Basis, or 16.4 Percent on an
Operational Basis; U.S. Humira Net Revenues Were $4.956 Billion, an Increase of 7.4 Percent;
Internationally, Humira Net Revenues Were $603 Million, a Decrease of 25.9 Percent on a
Reported Basis, or 16.8 Percent on an Operational Basis, Due to
Biosimilar Competition; Global Skyrizi Net Revenues Were
$1.397 Billion; Global Rinvoq Net
Revenues Were $695 Million
- Third-Quarter Global Net Revenues from the
Hematologic Oncology Portfolio Were $1.650
Billion, a Decrease of 11.7 Percent on a Reported Basis, or
9.9 Percent on an Operational Basis; Global Imbruvica Net Revenues
Were $1.135 Billion, a Decrease of
17.4 Percent, with U.S. Net Revenues of $849 Million and International Profit Sharing of
$286 Million; Global Venclexta Net
Revenues Were $515 Million
- Third-Quarter Global Net Revenues from the
Neuroscience Portfolio Were $1.672
Billion, an Increase of 6.7 Percent on a Reported Basis, or
8.3 Percent on an Operational Basis; Global Botox Therapeutic Net
Revenues Were $699 Million; Vraylar
Net Revenues Were $554
Million
- Third-Quarter Global Net Revenues from the Aesthetics
Portfolio Were $1.301 Billion, an
Increase of 4.0 Percent on a Reported Basis, or 8.1 Percent on an
Operational Basis; Global Botox Cosmetic Net Revenues Were
$637 Million; Global Juvederm Net
Revenues Were $352 Million
- Confirms Midpoint of 2022 Adjusted Diluted EPS
Guidance Range and Narrows Range from $13.76 - $13.96 to
$13.84 - $13.88, which Includes an Unfavorable Impact of
$0.25 Per Share Related to Acquired
IPR&D and Milestones Expense Incurred Year-To-Date Through the
Third Quarter 2022
- Announces 2023 Dividend Increase of 5.0 Percent, Beginning
with Dividend Payable in February
2023
NORTH
CHICAGO, Ill., Oct. 28,
2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced
financial results for the third quarter ended September 30, 2022.
"We continue to see strong momentum from our key immunology
assets, Skyrizi and Rinvoq, and this performance – combined with
strength from other growth drivers within our diverse portfolio –
has mitigated the impact of temporary economic headwinds on our
aesthetics products to deliver another quarter of strong results,"
said Richard A. Gonzalez, chairman
and chief executive officer, AbbVie. "Based upon our performance
and confidence in AbbVie's long-term outlook, we are once again
meaningfully raising our dividend."
Note: "Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
1 Beginning 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.
|
Third-Quarter Results
- Worldwide net revenues were $14.812
billion, an increase of 3.3 percent on a GAAP basis, or 5.4
percent on an operational basis.
- Global net revenues from the immunology portfolio were
$7.651 billion, an increase of 14.6
percent on a reported basis, or 16.4 percent on an operational
basis.
-
- Global Humira net revenues of $5.559
billion increased 2.5 percent on a reported basis, or 3.9
percent on an operational basis. U.S. Humira net revenues were
$4.956 billion, an increase of 7.4
percent. Internationally, Humira net revenues were $603 million, a decrease of 25.9 percent on a
reported basis, or 16.8 percent on an operational basis, due to
biosimilar competition.
- Global Skyrizi net revenues were $1.397
billion, an increase of 75.4 percent on a reported basis, or
78.3 percent on an operational basis.
- Global Rinvoq net revenues were $695
million, an increase of 53.5 percent on a reported basis, or
59.3 percent on an operational basis.
- Global net revenues from the hematologic oncology portfolio
were $1.650 billion, a decrease of
11.7 percent on a reported basis, or 9.9 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.135 billion, a decrease of 17.4 percent, with
U.S. net revenues of $849 million and
international profit sharing of $286
million.
- Global Venclexta net revenues were $515
million, an increase of 4.5 percent on a reported basis, or
11.3 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.672 billion, an increase of 6.7
percent on a reported basis, or 8.3 percent on an operational
basis.
-
- Global Botox Therapeutic net revenues were $699 million, an increase of 8.2 percent on a
reported basis, or 10.0 percent on an operational basis.
- Vraylar net revenues were $554
million, an increase of 20.2 percent.
- Global Ubrelvy net revenues were $160
million.
- Global net revenues from the aesthetics portfolio were
$1.301 billion, an increase of 4.0
percent on a reported basis, or 8.1 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $637 million, an increase of 16.9 percent on a
reported basis, or 21.6 percent on an operational basis.
- Global Juvederm net revenues were $352
million, a decrease of 0.6 percent on a reported basis, or
an increase of 5.3 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the third quarter
was 66.1 percent. The adjusted gross margin ratio was 85.4
percent.
- On a GAAP basis, selling, general and administrative (SG&A)
expense was 22.3 percent of net revenues. The adjusted SG&A
expense was 20.9 percent of net revenues.
- On a GAAP basis, research and development (R&D) expense was
10.9 percent of net revenues. The adjusted R&D expense was 10.8
percent of net revenues.
- Acquired IPR&D and milestones expense was 0.3 percent of
net revenues.
- On a GAAP basis, the operating margin in the third quarter was
31.1 percent. The adjusted operating margin was 53.4 percent.
- Net interest expense was $497
million.
- On a GAAP basis, the tax rate in the quarter was 10.2 percent.
The adjusted tax rate was 12.9 percent.
- Diluted EPS in the third quarter was $2.21 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $3.66.
These results include an unfavorable impact of $0.02 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 U.S. Food and Drug Administration (FDA)
approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment
of adults with active non-radiographic axial spondyloarthritis
(nr-axSpA) with objective signs of inflammation who have had an
inadequate response or intolerance to tumor necrosis factor (TNF)
blocker therapy. The approval is supported by data from the
SELECT-AXIS 2 clinical trial, in which Rinvoq delivered rapid and
meaningful disease control as well as significant improvement in
signs and symptoms of nr-axSpA. This approval marks the sixth FDA
approved indication for Rinvoq in chronic immune-mediated
diseases.
- AbbVie announced the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) recommended
the approval of Skyrizi (risankizumab) 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 positive opinion is based on
results from three Phase 3 studies in which Skyrizi demonstrated
significant improvements in clinical remission and endoscopic
response, compared to placebo, as both induction and maintenance
therapy. If the CHMP recommendation is accepted by the European
Commission (EC), this would mark the third indication for Skyrizi
in the European Union. Skyrizi is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization globally.
- At the United European Gastroenterology (UEG) Week 2022, AbbVie
shared 17 abstracts, including seven oral presentations, from a
broad range of studies in inflammatory bowel disease (IBD).
Highlights included final analyses from the U-ACHIEVE Phase 3
maintenance study of Rinvoq in moderately to severely active
ulcerative colitis (UC), data from the U-EXCEL Phase 3 study
evaluating the efficacy and safety of Rinvoq as induction therapy
for use in adults with moderately to severely active CD as well as
data evaluating Skyrizi for use in patients with moderate to severe
CD.
- At the American College of Gastroenterology (ACG) Annual
Scientific Meeting, AbbVie presented 26 abstracts that illustrate
AbbVie's commitment to providing research and innovative solutions
that support patients with high disease burden and unmet need. Key
presentations focused on the treatment of moderate to severe CD,
including late-breaking Phase 3 data from the Rinvoq 52 week
maintenance trial, as well as efficacy and safety outcomes from the
Skyrizi pivotal clinical program.
- At the European Academy of Dermatology and Venereology (EADV)
Congress, AbbVie presented 23 abstracts from across its dermatology
portfolio that underscore AbbVie's commitment to advancing research
in dermatology for people living with immune-mediated skin diseases
such as psoriasis (PsO), psoriatic arthritis (PsA), atopic
dermatitis (AD) and vitiligo. Presentations included long-term
efficacy and safety results, including real-world data, from
studies of Skyrizi in moderate to severe PsO and active PsA as well
as data from the largest-of-its-kind study that demonstrate the
real-world burden of AD.
- AbbVie announced that the FDA approved the use of Imbruvica
(ibrutinib) for the treatment of pediatric patients one year and
older with chronic graft versus host disease (cGVHD) after failure
of one or more lines of systemic therapy. The approval marks the
first approved treatment option for children with cGVHD under 12
years of age and the only Bruton's tyrosine kinase inhibitor (BTKi)
treatment for a pediatric patient population. Imbruvica is jointly
developed and commercialized with Janssen Biotech, Inc.
- At the International Parkinson and Movement Disorder Society's
(MDS) International Congress, AbbVie presented 13 abstracts across
multiple disease states that highlighted AbbVie's continued
commitment to advancing the management of movement disorders.
Highlights included results from the Phase 3 M15-736 trial
evaluating the continuous subcutaneous infusion of ABBV-951
(foslevodopa/foscarbidopa) in people with advanced Parkinson's
disease (PD) as well as data on the real-world efficacy of Botox
(onabotulinumtoxinA) for the treatment of spasticity and treatment
of cervical dystonia.
- At the Migraine Trust International Symposium (MTIS), AbbVie
shared 13 abstracts, including 4 oral presentations, from a wide
range of studies across its migraine portfolio that underscore
AbbVie's leadership and commitment to people living with migraine.
Highlights included Phase 3 PROGRESS study results evaluating
Qulipta (atogepant) for the preventive treatment of chronic
migraine as well as data from studies evaluating Botox and Ubrelvy
(ubrogepant) in the treatment of migraine.
- Allergan Aesthetics announced that the FDA approved Juvederm
Volux XC for the improvement of jawline definition in adults over
the age of 21 with moderate to severe loss of jawline definition.
Juvederm Volux XC is the first and only hyaluronic acid (HA) filler
to receive FDA approval for jawline definition.
- At the American Society for Dermatologic Surgery (ASDS),
Allergan Aesthetics shared data from across its facial injectables,
body contouring and skincare portfolio that highlighted Allergan
Aesthetics' continued commitment to advancing aesthetic medicine.
Highlights included analyses of 15 years of post-marketing
surveillance data that demonstrated the global reported rate of
delayed-onset nodules associated with dermal fillers on the Vycross
technology platform is low, as well as results from three clinical
studies showcasing a customizable platform with patent-pending LTN
Complex, to address the appearance of facial
hyperpigmentation.
- AbbVie announced the acquisition of DJS Antibodies (DJS), a
biotechnology company dedicated to discovering and developing
antibody medicines that target difficult-to-drug disease-causing
proteins. The acquisition includes DJS' lead program DJS-002, a
potential first-in-class LPAR1 antagonist antibody in preclinical
studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF)
and other fibrotic diseases as well as the company's proprietary
HEPTAD platform.
Full-Year 2022 Outlook
AbbVie is confirming the midpoint of its full-year 2022 adjusted
diluted EPS guidance range and narrowing the range from $13.76
- $13.96 to $13.84 - $13.88,
which includes an unfavorable impact of $0.25 per share related to acquired IPR&D and
milestones expense incurred year-to-date through the third quarter
2022. The company's 2022 adjusted diluted EPS guidance excludes any
impact from acquired IPR&D and milestones that may be incurred
beyond the third quarter of 2022, as both cannot be reliably
forecasted.
Company Declares Dividend Increase of 5.0 Percent
AbbVie is announcing today that its board of directors declared
an increase in the company's quarterly cash dividend from
$1.41 per share to $1.48 per share beginning with the dividend
payable on February 15, 2023 to
shareholders of record as of January 13,
2023. This reflects an increase of approximately 5.0
percent, continuing AbbVie's strong commitment to returning cash to
shareholders through a growing dividend. Since the company's
inception in 2013, AbbVie has increased its quarterly dividend by
270 percent. AbbVie is a member of the S&P Dividend Aristocrats
Index, which tracks companies that have annually increased their
dividend for at least 25 consecutive years.
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
third-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, among others,
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 indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, the failure to
realize the expected benefits of AbbVie's acquisition of Allergan
or to promptly and effectively integrate Allergan's business,
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 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 September 30, 2022
(Unaudited)
|
|
|
|
|
|
|
|
% Change vs.
3Q21
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$11,763
|
|
$3,049
|
|
$14,812
|
|
4.3 %
|
|
(0.4) %
|
|
3.3 %
|
|
9.6 %
|
|
5.4 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
6,682
|
|
969
|
|
7,651
|
|
18.5
|
|
(6.3)
|
|
14.6
|
|
5.6
|
|
16.4
|
Humira
|
4,956
|
|
603
|
|
5,559
|
|
7.4
|
|
(25.9)
|
|
2.5
|
|
(16.8)
|
|
3.9
|
Skyrizi
|
1,221
|
|
176
|
|
1,397
|
|
79.8
|
|
50.1
|
|
75.4
|
|
70.0
|
|
78.3
|
Rinvoq
|
505
|
|
190
|
|
695
|
|
44.7
|
|
82.9
|
|
53.5
|
|
>100.0
|
|
59.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,108
|
|
542
|
|
1,650
|
|
(17.7)
|
|
3.9
|
|
(11.7)
|
|
10.3
|
|
(9.9)
|
Imbruvicab
|
849
|
|
286
|
|
1,135
|
|
(23.5)
|
|
7.6
|
|
(17.4)
|
|
7.6
|
|
(17.4)
|
Venclexta
|
259
|
|
256
|
|
515
|
|
9.2
|
|
0.1
|
|
4.5
|
|
13.2
|
|
11.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
760
|
|
541
|
|
1,301
|
|
(7.4)
|
|
25.6
|
|
4.0
|
|
37.4
|
|
8.1
|
Botox
Cosmetic
|
370
|
|
267
|
|
637
|
|
4.1
|
|
41.0
|
|
16.9
|
|
54.5
|
|
21.6
|
Juvederm
Collection
|
125
|
|
227
|
|
352
|
|
(21.9)
|
|
16.9
|
|
(0.6)
|
|
27.7
|
|
5.3
|
Other
Aesthetics
|
265
|
|
47
|
|
312
|
|
(13.1)
|
|
(0.8)
|
|
(11.4)
|
|
8.3
|
|
(10.2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,464
|
|
208
|
|
1,672
|
|
8.6
|
|
(5.0)
|
|
6.7
|
|
6.3
|
|
8.3
|
Botox
Therapeutic
|
584
|
|
115
|
|
699
|
|
9.2
|
|
3.6
|
|
8.2
|
|
14.2
|
|
10.0
|
Vraylar
|
554
|
|
—
|
|
554
|
|
20.1
|
|
n/a
|
|
20.2
|
|
n/a
|
|
20.2
|
Duodopa
|
22
|
|
88
|
|
110
|
|
(4.9)
|
|
(15.0)
|
|
(13.1)
|
|
(2.6)
|
|
(3.0)
|
Ubrelvy
|
160
|
|
—
|
|
160
|
|
(1.4)
|
|
n/a
|
|
(1.4)
|
|
n/a
|
|
(1.4)
|
Qulipta
|
62
|
|
—
|
|
62
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience
|
82
|
|
5
|
|
87
|
|
(50.5)
|
|
10.2
|
|
(49.0)
|
|
14.1
|
|
(48.9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
362
|
|
261
|
|
623
|
|
(38.1)
|
|
(9.1)
|
|
(28.6)
|
|
1.3
|
|
(25.2)
|
Lumigan/Ganfort
|
59
|
|
62
|
|
121
|
|
(4.4)
|
|
(18.7)
|
|
(12.2)
|
|
(8.7)
|
|
(6.7)
|
Alphagan/Combigan
|
37
|
|
36
|
|
73
|
|
(58.2)
|
|
(8.9)
|
|
(43.0)
|
|
2.9
|
|
(39.4)
|
Restasis
|
132
|
|
10
|
|
142
|
|
(56.7)
|
|
(30.7)
|
|
(55.6)
|
|
(37.7)
|
|
(55.9)
|
Other Eye
Care
|
134
|
|
153
|
|
287
|
|
3.7
|
|
(2.7)
|
|
0.1
|
|
9.1
|
|
6.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
788
|
|
202
|
|
990
|
|
5.5
|
|
(19.4)
|
|
(0.7)
|
|
(9.1)
|
|
1.9
|
Mavyret
|
190
|
|
193
|
|
383
|
|
3.5
|
|
(20.6)
|
|
(10.2)
|
|
(10.3)
|
|
(4.4)
|
Creon
|
336
|
|
—
|
|
336
|
|
8.5
|
|
n/a
|
|
8.5
|
|
n/a
|
|
8.5
|
Linzess/Constella
|
262
|
|
9
|
|
271
|
|
3.4
|
|
16.0
|
|
3.8
|
|
25.8
|
|
4.1
|
|
|
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/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Nine Months Ended
September 30, 2022
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
9M21
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$33,521
|
|
$9,412
|
|
$42,933
|
|
5.3 %
|
|
(0.7) %
|
|
3.9 %
|
|
6.7 %
|
|
5.6 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
17,922
|
|
3,077
|
|
20,999
|
|
16.4
|
|
(2.2)
|
|
13.3
|
|
6.6
|
|
14.8
|
Humira
|
13,613
|
|
2,045
|
|
15,658
|
|
6.5
|
|
(20.9)
|
|
1.9
|
|
(14.3)
|
|
3.0
|
Skyrizi
|
3,081
|
|
508
|
|
3,589
|
|
78.6
|
|
59.3
|
|
75.6
|
|
75.1
|
|
78.1
|
Rinvoq
|
1,228
|
|
524
|
|
1,752
|
|
38.0
|
|
>100.0
|
|
54.5
|
|
>100.0
|
|
59.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
3,325
|
|
1,621
|
|
4,946
|
|
(14.5)
|
|
10.7
|
|
(7.6)
|
|
15.6
|
|
(6.3)
|
Imbruvicab
|
2,585
|
|
868
|
|
3,453
|
|
(19.4)
|
|
6.3
|
|
(14.2)
|
|
6.3
|
|
(14.2)
|
Venclexta
|
740
|
|
753
|
|
1,493
|
|
8.1
|
|
16.2
|
|
12.1
|
|
27.3
|
|
17.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
2,489
|
|
1,557
|
|
4,046
|
|
0.6
|
|
15.1
|
|
5.8
|
|
23.1
|
|
8.6
|
Botox
Cosmetic
|
1,232
|
|
741
|
|
1,973
|
|
20.0
|
|
27.9
|
|
22.8
|
|
36.8
|
|
26.0
|
Juvederm
Collection
|
420
|
|
686
|
|
1,106
|
|
(12.3)
|
|
9.9
|
|
0.3
|
|
17.6
|
|
4.6
|
Other
Aesthetics
|
837
|
|
130
|
|
967
|
|
(13.4)
|
|
(12.8)
|
|
(13.4)
|
|
(7.2)
|
|
(12.7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
4,175
|
|
643
|
|
4,818
|
|
15.2
|
|
(1.1)
|
|
12.8
|
|
7.9
|
|
14.2
|
Botox
Therapeutic
|
1,641
|
|
350
|
|
1,991
|
|
13.1
|
|
6.5
|
|
11.9
|
|
15.0
|
|
13.5
|
Vraylar
|
1,473
|
|
—
|
|
1,473
|
|
18.9
|
|
n/a
|
|
18.9
|
|
n/a
|
|
18.9
|
Duodopa
|
72
|
|
279
|
|
351
|
|
(2.4)
|
|
(9.8)
|
|
(8.4)
|
|
—
|
|
(0.5)
|
Ubrelvy
|
483
|
|
—
|
|
483
|
|
31.0
|
|
n/a
|
|
31.0
|
|
n/a
|
|
31.0
|
Qulipta
|
106
|
|
—
|
|
106
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience
|
400
|
|
14
|
|
414
|
|
(18.3)
|
|
10.3
|
|
(17.6)
|
|
13.1
|
|
(17.5)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
1,265
|
|
846
|
|
2,111
|
|
(26.9)
|
|
(3.5)
|
|
(19.0)
|
|
5.4
|
|
(16.0)
|
Lumigan/Ganfort
|
186
|
|
205
|
|
391
|
|
(7.1)
|
|
(10.8)
|
|
(9.0)
|
|
(2.9)
|
|
(4.8)
|
Alphagan/Combigan
|
161
|
|
111
|
|
272
|
|
(40.8)
|
|
(5.1)
|
|
(30.0)
|
|
4.9
|
|
(27.0)
|
Restasis
|
518
|
|
38
|
|
556
|
|
(41.3)
|
|
(10.1)
|
|
(39.9)
|
|
(2.8)
|
|
(39.6)
|
Other Eye
Care
|
400
|
|
492
|
|
892
|
|
6.3
|
|
0.9
|
|
3.3
|
|
10.1
|
|
8.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
2,245
|
|
623
|
|
2,868
|
|
4.5
|
|
(16.9)
|
|
(1.0)
|
|
(8.6)
|
|
1.2
|
Mavyret
|
562
|
|
599
|
|
1,161
|
|
0.9
|
|
(17.5)
|
|
(9.5)
|
|
(9.1)
|
|
(4.7)
|
Creon
|
941
|
|
—
|
|
941
|
|
9.0
|
|
n/a
|
|
9.0
|
|
n/a
|
|
9.0
|
Linzess/Constella
|
742
|
|
24
|
|
766
|
|
2.0
|
|
3.2
|
|
2.0
|
|
9.6
|
|
2.2
|
|
|
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/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
(Unaudited)
|
|
(in millions, except
per share data)
|
Third
Quarter
Ended September
30
|
|
Nine
Months
Ended September
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net revenues
|
$
14,812
|
|
$
14,342
|
|
$
42,933
|
|
$
41,311
|
Cost of products
sold
|
5,022
|
|
4,390
|
|
13,244
|
|
13,126
|
Selling, general and
administrative
|
3,304
|
|
3,083
|
|
11,843
|
|
9,089
|
Research and
developmenta
|
1,614
|
|
1,661
|
|
4,720
|
|
5,095
|
Acquired IPR&D and
milestonesa
|
40
|
|
402
|
|
454
|
|
719
|
Other operating
expense, net
|
229
|
|
500
|
|
57
|
|
432
|
Total operating costs
and expenses
|
10,209
|
|
10,036
|
|
30,318
|
|
28,461
|
|
|
|
|
|
|
|
|
Operating
earnings
|
4,603
|
|
4,306
|
|
12,615
|
|
12,850
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
497
|
|
585
|
|
1,568
|
|
1,813
|
Net foreign exchange
loss
|
36
|
|
12
|
|
108
|
|
35
|
Other expense (income),
net
|
(330)
|
|
21
|
|
427
|
|
2,284
|
Earnings before income
tax expense
|
4,400
|
|
3,688
|
|
10,512
|
|
8,718
|
Income tax
expense
|
448
|
|
508
|
|
1,139
|
|
1,214
|
Net earnings
|
3,952
|
|
3,180
|
|
9,373
|
|
7,504
|
Net earnings
attributable to noncontrolling interest
|
3
|
|
1
|
|
10
|
|
6
|
Net earnings
attributable to AbbVie Inc.
|
$
3,949
|
|
$
3,179
|
|
$
9,363
|
|
$
7,498
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
2.21
|
|
$
1.78
|
|
$
5.24
|
|
$
4.19
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per shareb
|
$
3.66
|
|
$
2.83
|
|
$
10.18
|
|
$
8.75
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,776
|
|
1,777
|
|
1,777
|
|
1,776
|
|
|
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 $12 million
for the three months and $162 million for the nine months ended
September 30, 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.
|
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted
Information
(Unaudited)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
|
|
|
Quarter Ended
September 30, 2022
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
4,400
|
|
$
3,949
|
|
$
2.21
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
2,024
|
|
1,673
|
|
0.94
|
Intangible asset
impairment
|
|
|
|
|
770
|
|
604
|
|
0.34
|
Acquisition and
integration costs
|
|
|
|
|
348
|
|
348
|
|
0.20
|
Change in fair value
of contingent consideration
|
|
|
|
|
(214)
|
|
(218)
|
|
(0.12)
|
Litigation
matters
|
|
|
|
|
110
|
|
94
|
|
0.05
|
Other
|
|
|
|
|
58
|
|
78
|
|
0.04
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
7,496
|
|
$
6,528
|
|
$
3.66
|
|
a
Represents net earnings attributable to AbbVie
Inc.
|
|
Acquisition and
integration costs include costs related to the Allergan
acquisition. 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 September 30, 2022 included acquired IPR&D and
milestones expense of $40 million on a pre-tax and after-tax basis,
representing an unfavorable impact of $0.02 to both diluted EPS and
adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
Quarter Ended
September 30, 2022
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense,
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
5,022
|
|
$
3,304
|
|
$
1,614
|
|
$
229
|
|
$
(330)
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(2,024)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(770)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(22)
|
|
(91)
|
|
(6)
|
|
(229)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
214
|
Litigation
matters
|
—
|
|
(110)
|
|
—
|
|
—
|
|
—
|
Other
|
(39)
|
|
(14)
|
|
(1)
|
|
—
|
|
(4)
|
As adjusted
(non-GAAP)
|
$
2,167
|
|
$
3,089
|
|
$
1,607
|
|
$
—
|
|
$
(120)
|
|
|
|
|
|
|
|
|
|
|
3. The adjusted tax rate for
the third quarter of 2022 was 12.9 percent, as detailed
below:
|
|
|
|
|
|
|
|
|
|
|
Quarter Ended
September 30, 2022
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
4,400
|
|
$
448
|
|
10.2 %
|
Specified
items
|
|
|
|
|
3,096
|
|
517
|
|
16.7 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
7,496
|
|
$
965
|
|
12.9 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
|
Quarter Ended
September 30, 2021
|
(in millions, except
per share data)
|
|
|
Earnings
|
|
Diluted
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
$
3,688
|
|
$
3,179
|
|
$
1.78
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
1,904
|
|
1,585
|
|
0.88
|
Acquisition and
integration costs
|
|
|
176
|
|
166
|
|
0.09
|
Change in fair value
of contingent consideration
|
|
|
98
|
|
98
|
|
0.06
|
Other
|
|
|
48
|
|
29
|
|
0.02
|
As adjusted
(non-GAAP)
|
|
|
$
5,914
|
|
$
5,057
|
|
$
2.83
|
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs reflect Allergan-related integration costs. Other
primarily includes restructuring charges associated with
streamlining global operations and COVID-19 related
expenses.
|
|
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 September 30, 2021 included acquired IPR&D
and milestones expense of $402 million on a pre-tax and $396
million on an 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 $0.50 to
both diluted EPS and adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
Quarter Ended
September 30, 2021
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
4,390
|
|
$
3,083
|
|
$
1,661
|
|
$
21
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,904)
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(49)
|
|
(105)
|
|
(22)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
(98)
|
Other
|
(24)
|
|
(17)
|
|
(7)
|
|
—
|
As adjusted
(non-GAAP)
|
$
2,413
|
|
$
2,961
|
|
$
1,632
|
|
$
(77)
|
|
3. The adjusted tax
rate for the third quarter of 2021 was 14.5 percent, as detailed
below:
|
|
|
|
|
Quarter Ended
September 30, 2021
|
(dollars in
millions)
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
$
3,688
|
|
$
508
|
|
13.8 %
|
Specified
items
|
|
|
2,226
|
|
348
|
|
15.6 %
|
As adjusted
(non-GAAP)
|
|
|
$
5,914
|
|
$
856
|
|
14.5 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Nine Months Ended
September 30, 2022
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
10,512
|
|
$
9,363
|
|
$
5.24
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
5,728
|
|
4,794
|
|
2.69
|
Intangible asset
impairment
|
|
|
|
|
770
|
|
604
|
|
0.34
|
Acquisition and
integration costs
|
|
|
|
|
595
|
|
567
|
|
0.32
|
Change in fair value
of contingent consideration
|
|
|
|
|
647
|
|
657
|
|
0.37
|
Pylera
divestiture
|
|
|
|
|
(172)
|
|
(126)
|
|
(0.07)
|
Litigation
matters
|
|
|
|
|
2,497
|
|
2,021
|
|
1.13
|
Other
|
|
|
|
|
281
|
|
295
|
|
0.16
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
20,858
|
|
$
18,175
|
|
$
10.18
|
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs 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. 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 nine
months ended September 30, 2022 included acquired IPR&D and
milestones expense of $454 million on a pre-tax and $439 million on
an after-tax basis, representing an unfavorable impact of $0.25 to
both diluted EPS and adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Nine Months Ended
September 30, 2022
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense,
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
13,244
|
|
$
11,843
|
|
$
4,720
|
|
$
57
|
|
$
427
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(5,728)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(770)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(84)
|
|
(263)
|
|
(19)
|
|
(229)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(647)
|
Pylera
divestiture
|
—
|
|
—
|
|
—
|
|
172
|
|
—
|
Litigation
matters
|
—
|
|
(2,497)
|
|
—
|
|
—
|
|
—
|
Other
|
(160)
|
|
(107)
|
|
(7)
|
|
—
|
|
(7)
|
As adjusted
(non-GAAP)
|
$
6,502
|
|
$
8,976
|
|
$
4,694
|
|
$
—
|
|
$
(227)
|
|
3. The adjusted tax rate for
the first nine months of 2022 was 12.8 percent, as detailed
below:
|
|
|
|
|
|
|
Nine Months Ended
September 30, 2022
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
10,512
|
|
$
1,139
|
|
10.8 %
|
Specified
items
|
|
|
|
|
10,346
|
|
1,534
|
|
14.8 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
20,858
|
|
$
2,673
|
|
12.8 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Nine Months Ended
September 30, 2021
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
8,718
|
|
$
7,498
|
|
$
4.19
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
5,912
|
|
4,929
|
|
2.77
|
Acquisition and
integration costs
|
|
|
|
|
535
|
|
427
|
|
0.23
|
Change in fair value
of contingent consideration
|
|
|
|
|
2,447
|
|
2,445
|
|
1.38
|
Litigation
matters
|
|
|
|
|
107
|
|
86
|
|
0.05
|
Other
|
|
|
|
|
319
|
|
255
|
|
0.13
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
18,038
|
|
$
15,640
|
|
$
8.75
|
|
a
Represents net earnings attributable to AbbVie
Inc.
|
|
Acquisition and
integration costs reflect integration costs as well as amortization
of the acquisition date fair value step-up for inventory related to
the Allergan acquisition. Other primarily includes the purchase of
FDA priority review vouchers from third parties, restructuring
charges associated with streamlining global operations and COVID-19
related expenses.
|
|
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 nine
months ended September 30, 2021 included acquired IPR&D
and milestones expense of $719 million on a pre-tax and $696
million on an 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 $0.67 to
both diluted EPS and adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Nine Months Ended
September 30, 2021
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense,
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
13,126
|
|
$
9,089
|
|
$
5,095
|
|
$
432
|
|
$
2,284
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(5,912)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(172)
|
|
(275)
|
|
(88)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,447)
|
Litigation
matters
|
—
|
|
(107)
|
|
—
|
|
—
|
|
—
|
Other
|
(65)
|
|
(50)
|
|
(287)
|
|
68
|
|
15
|
As adjusted
(non-GAAP)
|
$
6,977
|
|
$
8,657
|
|
$
4,720
|
|
$
500
|
|
$
(148)
|
|
3. The adjusted tax rate for
the first nine months of 2021 was 13.3 percent, as detailed
below:
|
|
|
|
|
|
|
Nine Months Ended
September 30, 2021
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
8,718
|
|
$
1,214
|
|
13.9 %
|
Specified
items
|
|
|
|
|
9,320
|
|
1,178
|
|
12.6 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
18,038
|
|
$
2,392
|
|
13.3 %
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-third-quarter-2022-financial-results-301661927.html
SOURCE AbbVie