NORTH CHICAGO, Ill., Feb. 2, 2022 /PRNewswire/ --
AbbVie (NYSE:ABBV) announced financial results for the fourth
quarter and full year ended December 31,
2021.
"We delivered another year of outstanding performance in 2021
with double-digit revenue and EPS growth that were well above our
initial expectations," said Richard A.
Gonzalez, chairman and chief executive officer, AbbVie. "We
are entering 2022 with significant momentum and expect our diverse
set of growth assets, robust pipeline and excellent execution to
deliver continued strong performance this year and over the long
term."
Fourth-Quarter Results
- Worldwide net revenues were $14.886
billion, an increase of 7.4 percent on a reported basis, or
7.5 percent on an operational basis.
- Global net revenues from the immunology portfolio were
$6.746 billion, an increase of 13.2
percent on a reported basis, or 13.3 percent on an operational
basis.
-
- Global Humira net revenues of $5.334
billion increased 3.5 percent on a reported and operational
basis. U.S. Humira net revenues were $4.553
billion, an increase of 6.0 percent. Internationally, Humira
net revenues were $781 million, a
decrease of 9.1 percent on a reported basis, or 8.8 percent on an
operational basis, due to biosimilar competition.
- Global Skyrizi net revenues were $895
million.
- Global Rinvoq net revenues were $517
million.
- Global net revenues from the hematologic oncology portfolio
were $1.873 billion, an increase of
4.6 percent on a reported basis, or 4.7 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.385 billion, a decrease of 2.7 percent, with
U.S. net revenues of $1.114 billion
and international profit sharing of $271
million.
- Global Venclexta net revenues were $488
million, an increase of 33.3 percent on a reported basis, or
34.0 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.654 billion, an increase of 19.0
percent on a reported and operational basis.
-
- Global Botox Therapeutic net revenues were $671 million, an increase of 18.3 percent on a
reported basis, or 18.1 percent on an operational basis.
- Vraylar net revenues were $489
million, an increase of 21.8 percent.
- Global Ubrelvy net revenues were $183
million.
- Global net revenues from the aesthetics portfolio were
$1.407 billion, an increase of 23.3
percent on a reported basis, or 22.8 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $626 million, an increase of 27.0 percent on a
reported basis, or 26.6 percent on an operational basis.
- Global Juvederm net revenues were $432
million, an increase of 30.6 percent on a reported basis, or
29.8 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the fourth quarter
was 71.0 percent. The adjusted gross margin ratio was 83.6
percent.
- On a GAAP basis, selling, general and administrative expense
was 21.9 percent of net revenues. The adjusted SG&A expense was
22.2 percent of net revenues.
- On a GAAP basis, research and development expense was 12.3
percent of net revenues. The adjusted R&D expense was 12.1
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- On a GAAP basis, the operating margin in the fourth quarter was
34.1 percent. The adjusted operating margin was 49.3 percent.
- On a GAAP basis, net interest expense was $571 million.
- On a GAAP basis, the tax rate in the quarter was 5.3 percent.
The adjusted tax rate was 12.5 percent.
- Diluted EPS in the fourth quarter was $2.26 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $3.31.
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 confirmed prior revenue guidance of greater than
$15 billion in combined Skyrizi
(risankizumab) and Rinvoq (upadacitinib) risk-adjusted sales in
2025. AbbVie expects each asset to deliver risk-adjusted sales of
greater than $7.5 billion in 2025.
Skyrizi is part of a collaboration between Boehringer Ingelheim and
AbbVie, with AbbVie leading development and commercialization
globally.
- AbbVie announced that the U.S. Food and Drug Administration
(FDA) approved Rinvoq for the treatment of moderate to severe
atopic dermatitis (AD) in adults and children 12 years of age and
older whose disease did not respond to previous treatment and is
not well controlled with other pills or injections, including
biologic medicines, or when use of other pills or injections is not
recommended. The approval includes two dose strengths (15 mg and 30
mg, once daily) and is supported by efficacy and safety data from
one of the largest registrational Phase 3 programs for AD with more
than 2,500 patients evaluated across three studies. This milestone
marked the third FDA-approved indication for Rinvoq.
- AbbVie announced the FDA approved Rinvoq (15 mg, once daily)
for the treatment of adults with active psoriatic arthritis (PsA)
who have had an inadequate response or intolerance to one or more
tumor necrosis factor (TNF) blockers. The approval is supported by
two Phase 3 clinical studies where Rinvoq showed efficacy across
multiple measures of disease activity in active PsA with a safety
profile consistent with that seen in rheumatoid arthritis (RA).
This milestone marked the second FDA-approved indication for
Rinvoq.
- AbbVie announced the FDA approved Skyrizi for the treatment of
adults with active PsA. The approval is supported by two Phase 3
clinical studies where Skyrizi demonstrated significant improvement
in joint symptoms, including swollen, tender and painful joints,
compared to placebo. This milestone marked the second FDA-approved
indication for Skyrizi.
- AbbVie announced the European Commission (EC) approved Skyrizi
alone or in combination with methotrexate (MTX), for the treatment
of active PsA in adults who have had an inadequate response or who
have been intolerant to one or more disease-modifying
anti-rheumatic drugs (DMARDs). The positive opinion is based on
data from two pivotal Phase 3 studies which evaluated the efficacy
and safety of Skyrizi in adults with active PsA and marks Skyrizi's
second indication in the European Union (EU).
- AbbVie announced that it submitted applications to the FDA and
European Medicines Agency (EMA) seeking approval for Rinvoq (15 mg,
once daily) for the treatment of adults with active
non-radiographic axial spondyloarthritis (nr-axSpA). The
submissions are supported by the Phase 3 SELECT-AXIS 2 (study 2)
clinical trial in which Rinvoq demonstrated significant
improvements in signs and symptoms as well as physical function and
disease activity versus placebo. No new safety risks were observed
compared to the known safety profile of Rinvoq. In addition, AbbVie
requested label enhancements for Rinvoq in the EU to include adult
patients with active AS who had an inadequate response to biologic
DMARDs, based on newly generated clinical data. These data were
also provided to the FDA in support of the agency's ongoing review
of the supplemental New Drug Application (sNDA) for Rinvoq in
AS.
- AbbVie announced that it submitted an application to the EMA
seeking approval for Skyrizi (600 mg intravenous induction and 360
mg subcutaneous maintenance therapy) for the treatment of patients
16 years and older with moderate to severe Crohn's disease (CD).
The submission is supported by three pivotal Phase 3 studies in
which Skyrizi demonstrated significant improvements in clinical
remission and endoscopic response as both induction and maintenance
therapy. The overall safety findings in these pivotal studies were
generally consistent with the known safety profile of Skyrizi. If
approved, CD will mark the third indication for Skyrizi in the
EU.
- AbbVie announced positive top-line results from the Phase 3
induction study, U-EXCEED, which showed Rinvoq (45 mg, once daily)
achieved both primary endpoints of clinical remission and
endoscopic response at week 12 as well as key secondary endpoints
in patients with moderate to severe CD. The safety results in this
study were consistent with the known profile of Rinvoq, with no new
safety risks observed. U-EXCEED is the first of two Phase 3
induction studies to evaluate the safety and efficacy of Rinvoq in
adults with moderate to severe CD and full results from the study
will be presented at a future medical meeting and submitted for
publication in a peer-reviewed journal.
- At the American College of Rheumatology's (ACR) annual meeting,
AbbVie shared 38 abstracts from across its rheumatology portfolio
that underscored AbbVie's commitment to advancing its portfolio of
medicines to help more people living with rheumatic diseases.
Highlights included new efficacy data on Rinvoq in people with
active PsA and axial involvement, new long-term analysis evaluating
the sustainability of response to Rinvoq among patients with RA as
well as efficacy and safety data from the KEEPsAKE 1 and KEEPsAKE 2
trials evaluating Skyrizi in adults with PsA treated through 24
weeks.
- AbbVie announced that the FDA granted Breakthrough Therapy
Designation (BTD) to investigational telisotuzumab vedotin
(Teliso-V) for the treatment of patients with advanced/metastatic
epidermal growth factor receptor (EGFR) wild type, nonsquamous
non-small cell lung cancer (NSCLC) with high levels of c-Met
overexpression whose disease has progressed on or after
platinum-based therapy. The BTD is supported by interim data from
the ongoing Phase 2 LUMINOSITY study and a Phase 3 study is planned
to begin in the first half of 2022.
- At the American Society of Hematology Annual Meeting (ASH),
AbbVie presented results from nearly 30 abstracts across 8 types of
cancer. Highlights included data from the Phase 2 CAPTIVATE and
Phase 3 GLOW studies evaluating minimal residual disease (MRD) and
disease-free survival outcomes with fixed duration treatment in
patients with chronic lymphocytic leukemia (CLL)/small lymphocytic
leukemia (SLL) who received the Imbruvica (ibrutinib) + Venclexta
(venetoclax) combination regimen; results from several studies
evaluating Venclexta in approved and investigational indications;
as well as data evaluating ABBV-383, epcoritamab and lemzoparlimab.
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. Imbruvica is
jointly developed and commercialized with Janssen Biotech, Inc.
Epcoritamab is being co-developed by Genmab and AbbVie.
Lemzoparlimab is being developed through a collaboration with
AbbVie and I-Mab.
- Allergan Aesthetics announced the successful completion of its
acquisition of Soliton, Inc. The addition of Soliton and its
technology complements Allergan Aesthetics' portfolio of
non-invasive body contouring treatments to now include a proven
treatment for the appearance of cellulite.
- At the American Society for Dermatologic Surgery meeting,
Allergan Aesthetics presented 6 abstracts from its leading
portfolio of aesthetic treatments and products, which highlighted
its approach to innovative science and commitment to bring new and
impactful treatments to customers and patients globally. Highlights
included two Botox Cosmetic (OnabotulinumtoxinA) abstracts that
were recognized as "Best of Cosmetic Oral Abstracts".
- AbbVie announced the FDA approved Vuity (pilocarpine HCl
ophthalmic solution) 1.25% for the treatment of presbyopia,
commonly known as age-related blurry near vision, in adults. Vuity
is the first and only FDA-approved eye drop to treat this common
and progressive eye condition that affects nearly half of the U.S.
adult population. The approval is supported by two pivotal Phase 3
studies that demonstrated Vuity works in as early as 15 minutes and
lasts for up to 6 hours, as measured on day 30, to improve near and
intermediate vision without impacting distance vision.
- At the American Academy of Ophthalmology Annual Meeting (AAO),
AbbVie presented new data from its leading eye care portfolio.
Highlights included new pooled post-hoc analyses and
patient-reported outcomes of Vuity 1.25%, analyses on Durysta
(bimatoprost intracameral implant) and 3 real-world data studies on
the glaucoma patient journey.
- AbbVie announced that it has extended its preclinical oncology
research collaboration agreement with the University of Chicago through 2025. Under the
agreement, the organizations will continue working together to
advance research in several areas, focusing on oncology, and AbbVie
gains an option for an exclusive license to certain University of Chicago discoveries made as part of
the collaboration.
Full-Year 2022 Outlook
AbbVie is issuing its GAAP diluted EPS guidance for the
full-year 2022 of $9.26 to
$9.46. AbbVie expects to deliver
adjusted diluted EPS for the full-year 2022 of $14.00 to $14.20.
The company's 2022 adjusted diluted EPS guidance excludes
$4.74 per share of intangible asset
amortization expense, non-cash charges for contingent consideration
adjustments and other specified items.
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, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie
on Twitter, Facebook, LinkedIn or Instagram.
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 2021 and 2020 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.
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. The company's 2022 financial guidance is also
being provided on both a reported and a non-GAAP basis.
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 2020 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
December 31, 2021
|
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
4Q20
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$11,677
|
|
$3,209
|
|
$14,886
|
|
9.5%
|
|
0.5%
|
|
7.4%
|
|
0.9%
|
|
7.5%
|
Immunology
|
5,696
|
|
1,050
|
|
6,746
|
|
14.2
|
|
8.3
|
|
13.2
|
|
9.0
|
|
13.3
|
Humira
|
4,553
|
|
781
|
|
5,334
|
|
6.0
|
|
(9.1)
|
|
3.5
|
|
(8.8)
|
|
3.5
|
Skyrizi
|
761
|
|
134
|
|
895
|
|
68.6
|
|
82.1
|
|
70.5
|
|
84.8
|
|
70.9
|
Rinvoq
|
382
|
|
135
|
|
517
|
|
57.1
|
|
>100.0
|
|
84.4
|
|
>100.0
|
|
85.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,363
|
|
510
|
|
1,873
|
|
(0.7)
|
|
22.5
|
|
4.6
|
|
23.1
|
|
4.7
|
Imbruvicab
|
1,114
|
|
271
|
|
1,385
|
|
(4.3)
|
|
4.6
|
|
(2.7)
|
|
4.6
|
|
(2.7)
|
Venclexta
|
249
|
|
239
|
|
488
|
|
19.4
|
|
51.8
|
|
33.3
|
|
53.5
|
|
34.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
877
|
|
530
|
|
1,407
|
|
21.1
|
|
27.1
|
|
23.3
|
|
25.8
|
|
22.8
|
Botox
Cosmetic
|
397
|
|
229
|
|
626
|
|
31.3
|
|
20.3
|
|
27.0
|
|
19.3
|
|
26.6
|
Juvederm
Collection
|
180
|
|
252
|
|
432
|
|
22.8
|
|
36.8
|
|
30.6
|
|
35.3
|
|
29.8
|
Other
Aesthetics
|
300
|
|
49
|
|
349
|
|
9.1
|
|
15.3
|
|
9.9
|
|
13.9
|
|
9.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,440
|
|
214
|
|
1,654
|
|
21.1
|
|
7.1
|
|
19.0
|
|
7.0
|
|
19.0
|
Botox
Therapeutic
|
561
|
|
110
|
|
671
|
|
18.9
|
|
15.4
|
|
18.3
|
|
14.1
|
|
18.1
|
Vraylar
|
489
|
|
—
|
|
489
|
|
21.8
|
|
n/a
|
|
21.8
|
|
n/a
|
|
21.8
|
Duodopa
|
29
|
|
99
|
|
128
|
|
0.1
|
|
(2.0)
|
|
(1.5)
|
|
(0.7)
|
|
(0.5)
|
Ubrelvy
|
183
|
|
—
|
|
183
|
|
>100.0
|
|
n/a
|
|
>100.0
|
|
n/a
|
|
>100.0
|
Other
Neuroscience
|
178
|
|
5
|
|
183
|
|
(19.9)
|
|
42.0
|
|
(18.9)
|
|
34.3
|
|
(19.0)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
672
|
|
288
|
|
960
|
|
7.6
|
|
(4.7)
|
|
3.6
|
|
(3.8)
|
|
3.9
|
Lumigan/Ganfort
|
72
|
|
77
|
|
149
|
|
6.2
|
|
(9.2)
|
|
(2.4)
|
|
(9.0)
|
|
(2.3)
|
Alphagan/Combigan
|
102
|
|
39
|
|
141
|
|
9.0
|
|
(4.3)
|
|
4.9
|
|
(3.6)
|
|
5.1
|
Restasis
|
350
|
|
14
|
|
364
|
|
4.9
|
|
28.1
|
|
5.7
|
|
32.8
|
|
5.9
|
Other Eye
Care
|
148
|
|
158
|
|
306
|
|
14.2
|
|
(4.8)
|
|
3.6
|
|
(3.7)
|
|
4.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Women's
Health
|
216
|
|
7
|
|
223
|
|
(12.5)
|
|
(18.4)
|
|
(12.7)
|
|
(22.1)
|
|
(12.8)
|
Lo Loestrin
|
123
|
|
5
|
|
128
|
|
(10.6)
|
|
16.1
|
|
(10.0)
|
|
9.9
|
|
(10.1)
|
Orilissa/Oriahnn
|
37
|
|
2
|
|
39
|
|
3.6
|
|
44.1
|
|
4.8
|
|
37.2
|
|
4.6
|
Other Women's
Health
|
56
|
|
—
|
|
56
|
|
(24.2)
|
|
(75.9)
|
|
(26.2)
|
|
(75.8)
|
|
(26.2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,146
|
|
283
|
|
1,429
|
|
0.9
|
|
(8.6)
|
|
(1.1)
|
|
(6.8)
|
|
(0.7)
|
Mavyret
|
197
|
|
230
|
|
427
|
|
(10.9)
|
|
(11.6)
|
|
(11.3)
|
|
(9.4)
|
|
(10.1)
|
Creon
|
327
|
|
—
|
|
327
|
|
7.8
|
|
n/a
|
|
7.8
|
|
n/a
|
|
7.8
|
Lupron
|
148
|
|
44
|
|
192
|
|
6.1
|
|
5.4
|
|
6.0
|
|
5.5
|
|
6.0
|
Linzess/Constella
|
278
|
|
9
|
|
287
|
|
0.1
|
|
20.4
|
|
0.6
|
|
17.4
|
|
0.5
|
Synthroid
|
196
|
|
—
|
|
196
|
|
0.9
|
|
n/a
|
|
0.9
|
|
n/a
|
|
0.9
|
|
|
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
|
AbbVie
Inc.
|
Key Product
Revenues
|
Twelve Months
Ended December 31, 2021
|
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
12M20
|
|
Net Revenues (in millions)
|
|
Reported
|
Comparable
Operationala, b
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
ADJUSTED NET
REVENUESc
|
$43,435
|
|
$12,687
|
|
$56,122
|
|
24.6%
|
|
16.1%
|
|
22.6%
|
|
12.3%
|
|
4.7%
|
|
10.5%
|
Immunology
|
21,087
|
|
4,197
|
|
25,284
|
|
16.2
|
|
4.8
|
|
14.1
|
|
16.2
|
|
1.2
|
|
13.5
|
Humira
|
17,330
|
|
3,364
|
|
20,694
|
|
7.6
|
|
(9.6)
|
|
4.3
|
|
7.6
|
|
(12.8)
|
|
3.7
|
Skyrizi
|
2,486
|
|
453
|
|
2,939
|
|
79.6
|
|
>100.0
|
|
84.9
|
|
79.6
|
|
>100.0
|
|
84.0
|
Rinvoq
|
1,271
|
|
380
|
|
1,651
|
|
94.8
|
|
>100.0
|
|
>100.0
|
|
94.8
|
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
5,255
|
|
1,973
|
|
7,228
|
|
2.8
|
|
28.0
|
|
8.7
|
|
2.8
|
|
26.2
|
|
8.3
|
Imbruvicad
|
4,321
|
|
1,087
|
|
5,408
|
|
0.4
|
|
7.7
|
|
1.8
|
|
0.4
|
|
7.7
|
|
1.8
|
Venclexta
|
934
|
|
886
|
|
1,820
|
|
16.1
|
|
66.2
|
|
36.1
|
|
16.1
|
|
60.9
|
|
34.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
3,350
|
|
1,883
|
|
5,233
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
44.7
|
|
52.2
|
|
47.3
|
Botox
Cosmetic*
|
1,424
|
|
808
|
|
2,232
|
|
>100.0
|
|
90.0
|
|
>100.0
|
|
57.4
|
|
42.6
|
|
51.8
|
Juvederm
Collection*
|
658
|
|
877
|
|
1,535
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
53.6
|
|
61.3
|
|
57.9
|
Other
Aesthetics*
|
1,268
|
|
198
|
|
1,466
|
|
90.2
|
|
>100.0
|
|
93.0
|
|
29.2
|
|
56.9
|
|
32.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
5,061
|
|
866
|
|
5,927
|
|
76.8
|
|
36.7
|
|
69.5
|
|
23.0
|
|
10.6
|
|
21.1
|
Botox
Therapeutic*
|
2,012
|
|
439
|
|
2,451
|
|
74.3
|
|
89.0
|
|
76.7
|
|
20.5
|
|
22.8
|
|
20.9
|
Vraylar*
|
1,728
|
|
—
|
|
1,728
|
|
81.7
|
|
n/a
|
|
81.7
|
|
24.5
|
|
n/a
|
|
24.5
|
Duodopa
|
102
|
|
409
|
|
511
|
|
(1.0)
|
|
4.6
|
|
3.4
|
|
(1.0)
|
|
(0.1)
|
|
(0.3)
|
Ubrelvy*
|
552
|
|
—
|
|
552
|
|
>100.0
|
|
n/a
|
|
>100.0
|
|
>100.0
|
|
n/a
|
|
>100.0
|
Other
Neuroscience*
|
667
|
|
18
|
|
685
|
|
26.3
|
|
77.4
|
|
27.2
|
|
(17.7)
|
|
14.2
|
|
(17.2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
2,403
|
|
1,164
|
|
3,567
|
|
65.9
|
|
58.2
|
|
63.3
|
|
5.6
|
|
2.2
|
|
4.5
|
Lumigan/Ganfort*
|
273
|
|
306
|
|
579
|
|
64.7
|
|
44.1
|
|
53.1
|
|
(0.1)
|
|
(10.2)
|
|
(5.6)
|
Alphagan/Combigan*
|
373
|
|
156
|
|
529
|
|
66.5
|
|
52.5
|
|
62.1
|
|
5.7
|
|
1.7
|
|
4.5
|
Restasis*
|
1,234
|
|
56
|
|
1,290
|
|
63.3
|
|
75.3
|
|
63.8
|
|
4.1
|
|
24.9
|
|
4.9
|
Other Eye
Care*
|
523
|
|
646
|
|
1,169
|
|
72.7
|
|
66.1
|
|
69.0
|
|
12.9
|
|
7.6
|
|
10.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Women's
Health
|
771
|
|
25
|
|
796
|
|
19.1
|
|
(1.6)
|
|
18.3
|
|
(16.0)
|
|
(33.7)
|
|
(16.6)
|
Lo
Loestrin*
|
423
|
|
14
|
|
437
|
|
21.9
|
|
43.3
|
|
22.5
|
|
(18.5)
|
|
(4.9)
|
|
(18.2)
|
Orilissa/Oriahnn
|
139
|
|
6
|
|
145
|
|
15.4
|
|
57.7
|
|
16.7
|
|
15.4
|
|
47.6
|
|
16.4
|
Other Women's
Health*
|
209
|
|
5
|
|
214
|
|
16.2
|
|
(57.5)
|
|
11.7
|
|
(24.8)
|
|
(73.9)
|
|
(27.7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
4,322
|
|
1,167
|
|
5,489
|
|
10.3
|
|
(3.9)
|
|
6.9
|
|
2.8
|
|
(7.1)
|
|
0.6
|
Mavyret
|
754
|
|
956
|
|
1,710
|
|
(4.0)
|
|
(8.5)
|
|
(6.5)
|
|
(4.0)
|
|
(10.8)
|
|
(7.8)
|
Creon
|
1,191
|
|
—
|
|
1,191
|
|
6.9
|
|
n/a
|
|
6.9
|
|
6.9
|
|
n/a
|
|
6.9
|
Lupron
|
604
|
|
179
|
|
783
|
|
0.5
|
|
18.0
|
|
4.0
|
|
0.5
|
|
15.0
|
|
3.4
|
Linzess/Constella*
|
1,006
|
|
32
|
|
1,038
|
|
55.1
|
|
77.3
|
|
55.7
|
|
8.0
|
|
9.9
|
|
8.1
|
Synthroid
|
767
|
|
—
|
|
767
|
|
(0.6)
|
|
n/a
|
|
(0.6)
|
|
(0.6)
|
|
n/a
|
|
(0.6)
|
|
|
a
|
"Comparable
Operational" comparisons include full-period current year and prior
year results for Allergan products, as if the acquisition closed on
January 1, 2019, and are presented at constant currency rates that
reflect comparative local currency net revenues at the prior year's
foreign exchange rates.
|
b
|
All historically
reported Allergan revenues have been recast to conform to AbbVie's
revenue recognition accounting policies and reporting conventions
for certain rebates and discounts. Historically reported Allergan
revenues also exclude Zenpep and Viokace product revenues, which
were both divested as part of the acquisition, as well as specified
items.
|
c
|
Adjusted net revenues
exclude specified items. Refer to the Reconciliation of GAAP
Reported to Non-GAAP Adjusted Information for further details.
Percentage change is calculated using adjusted net
revenues.
|
d
|
Reflects profit
sharing for Imbruvica international revenues.
|
* Represents
product(s) acquired as part of the Allergan acquisition.
|
n/a = not
applicable
|
AbbVie
Inc.
|
Consolidated
Statements of Earnings
|
Quarter and Twelve
Months Ended December 31, 2021 and 2020
|
(Unaudited) (In
millions, except per share data)
|
|
|
Fourth
Quarter
Ended December
31
|
|
Twelve
Months
Ended December
31
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Net
revenues
|
$
14,886
|
|
$
13,858
|
|
$
56,197
|
|
$
45,804
|
Cost of products
sold
|
4,320
|
|
4,684
|
|
17,446
|
|
15,387
|
Selling, general and
administrative
|
3,260
|
|
3,231
|
|
12,349
|
|
11,299
|
Research and
development
|
1,827
|
|
1,890
|
|
7,084
|
|
6,557
|
Acquired in-process
research and development
|
405
|
|
300
|
|
962
|
|
1,198
|
Other operating
expense, net
|
—
|
|
—
|
|
432
|
|
—
|
Total operating costs
and expenses
|
9,812
|
|
10,105
|
|
38,273
|
|
34,441
|
|
|
|
|
|
|
|
|
Operating
earnings
|
5,074
|
|
3,753
|
|
17,924
|
|
11,363
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
571
|
|
618
|
|
2,384
|
|
2,280
|
Net foreign exchange
loss
|
16
|
|
17
|
|
51
|
|
71
|
Other expense,
net
|
216
|
|
4,625
|
|
2,500
|
|
5,614
|
Earnings (loss)
before income tax expense
|
4,271
|
|
(1,507)
|
|
12,989
|
|
3,398
|
Income tax expense
(benefit)
|
226
|
|
(1,545)
|
|
1,440
|
|
(1,224)
|
Net
earnings
|
4,045
|
|
38
|
|
11,549
|
|
4,622
|
Net earnings
attributable to noncontrolling interest
|
1
|
|
2
|
|
7
|
|
6
|
Net earnings
attributable to AbbVie Inc.
|
$
4,044
|
|
$
36
|
|
$
11,542
|
|
$
4,616
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
2.26
|
|
$
0.01
|
|
$
6.45
|
|
$
2.72
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
3.31
|
|
$
2.92
|
|
$
12.70
|
|
$
10.56
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,778
|
|
1,776
|
|
1,777
|
|
1,673
|
|
|
a
|
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
|
Quarter Ended
December 31, 2021
|
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
4Q21
|
|
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)
|
Acquired
IPR&D
|
405
|
|
405
|
|
0.23
|
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)
|
$
6,764
|
|
$
5,919
|
|
$
3.31
|
|
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.
Acquired IPR&D represents initial costs to acquire rights to
in-process R&D projects through R&D collaborations,
licensing arrangements or other asset acquisitions. Other primarily
includes COVID-19 related expenses and tax related
items.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
4Q21
|
|
Cost of products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired IPR&D
|
|
Other expense,
net
|
As reported
(GAAP)
|
$
4,320
|
|
$
3,260
|
|
$
1,827
|
|
$
405
|
|
$
216
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,806)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(43)
|
|
250
|
|
(16)
|
|
—
|
|
—
|
Acquired
IPR&D
|
—
|
|
—
|
|
—
|
|
(405)
|
|
—
|
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 12.5 percent, as detailed
below:
|
|
|
4Q21
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
4,271
|
|
$
226
|
|
5.3
%
|
Specified
items
|
2,493
|
|
618
|
|
24.8 %
|
As adjusted
(non-GAAP)
|
$
6,764
|
|
$
844
|
|
12.5
%
|
AbbVie
Inc.
|
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
|
Quarter Ended
December 31, 2020
|
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
4Q20
|
|
Earnings
(Loss)
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
(1,507)
|
|
$
36
|
|
$
0.01
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,838
|
|
1,444
|
|
0.81
|
Acquisition and
integration costs
|
467
|
|
399
|
|
0.22
|
Milestones and other
R&D expenses
|
48
|
|
39
|
|
0.02
|
Acquired
IPR&D
|
300
|
|
296
|
|
0.16
|
Change in fair value
of contingent consideration
|
4,675
|
|
4,671
|
|
2.63
|
Tax audit
settlements
|
—
|
|
(140)
|
|
(0.08)
|
Impacts related to tax
law changes
|
—
|
|
(1,492)
|
|
(0.84)
|
Other
|
92
|
|
(28)
|
|
(0.01)
|
As adjusted
(non-GAAP)
|
$
5,913
|
|
$
5,225
|
|
$
2.92
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs and amortization of the
acquisition date fair value step-up for inventory related to the
Allergan acquisition. Milestones and other R&D expenses include
milestone payments for previously announced collaborations.
Acquired IPR&D represents initial costs to acquire rights to
in-process R&D projects through R&D collaborations,
licensing arrangements or other asset acquisitions. Other primarily
includes tax related items and COVID-19 related
expenses.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
4Q20
|
|
Cost of products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other expense,
net
|
As reported
(GAAP)
|
$
4,684
|
|
$
3,231
|
|
$
1,890
|
|
$
300
|
|
$
4,625
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,838)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(272)
|
|
(126)
|
|
(69)
|
|
—
|
|
—
|
Milestones and other
R&D expenses
|
—
|
|
—
|
|
(48)
|
|
—
|
|
—
|
Acquired
IPR&D
|
—
|
|
—
|
|
—
|
|
(300)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(4,675)
|
Other
|
(51)
|
|
(16)
|
|
(22)
|
|
—
|
|
(3)
|
As
adjusted (non-GAAP)
|
$
2,523
|
|
$
3,089
|
|
$
1,751
|
|
$
—
|
|
$
(53)
|
|
3. The adjusted tax rate for
the fourth quarter of 2020 was 11.6 percent, as detailed
below:
|
|
|
4Q20
|
|
Pre-tax earnings
(loss)
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
(1,507)
|
|
$
(1,545)
|
|
102.5
%
|
Specified
items
|
7,420
|
|
2,231
|
|
30.1 %
|
As
adjusted (non-GAAP)
|
$
5,913
|
|
$
686
|
|
11.6
%
|
AbbVie
Inc.
|
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
|
Twelve Months
Ended December 31, 2021
|
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
12M21
|
|
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
|
Milestones and other
R&D expenses
|
359
|
|
307
|
|
0.17
|
Acquired
IPR&D
|
962
|
|
948
|
|
0.53
|
Calico
collaboration
|
500
|
|
500
|
|
0.28
|
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
|
88
|
|
100
|
|
0.06
|
As adjusted
(non-GAAP)
|
$
25,946
|
|
$
22,696
|
|
$
12.70
|
|
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. Milestones and other R&D
expenses include milestone payments for previously announced
collaborations and the purchase of FDA priority review vouchers
from third parties. Acquired IPR&D represents initial costs to
acquire rights to in-process R&D projects through R&D
collaborations, licensing arrangements or other asset acquisitions.
Other primarily includes COVID-19 related expenses, restructuring
charges associated with streamlining global operations and tax
related items, offset by milestone revenue under an existing
collaboration agreement.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
12M21
|
|
Net
revenues
|
|
Cost of products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other operating
expense, net
|
|
Other expense,
net
|
As reported
(GAAP)
|
$
56,197
|
|
$
17,446
|
|
$
12,349
|
|
$
7,084
|
|
$
962
|
|
$
432
|
|
$
2,500
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
(7,718)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
—
|
|
(215)
|
|
(25)
|
|
(104)
|
|
—
|
|
—
|
|
—
|
Milestones and other
R&D expenses
|
—
|
|
—
|
|
—
|
|
(359)
|
|
—
|
|
—
|
|
—
|
Acquired
IPR&D
|
—
|
|
—
|
|
—
|
|
—
|
|
(962)
|
|
—
|
|
—
|
Calico
collaboration
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(500)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,679)
|
Litigation
matters
|
—
|
|
—
|
|
(307)
|
|
—
|
|
—
|
|
—
|
|
—
|
Other
|
(75)
|
|
(88)
|
|
(53)
|
|
(103)
|
|
—
|
|
68
|
|
13
|
As adjusted
(non-GAAP)
|
$
56,122
|
|
$
9,425
|
|
$
11,964
|
|
$
6,518
|
|
$
—
|
|
$
—
|
|
$
(166)
|
|
3. The adjusted tax rate for
the full-year 2021 was 12.5 percent, as detailed below:
|
|
|
12M21
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
12,989
|
|
$
1,440
|
|
11.1
%
|
Specified
items
|
12,957
|
|
1,803
|
|
13.9 %
|
As adjusted
(non-GAAP)
|
$
25,946
|
|
$
3,243
|
|
12.5
%
|
AbbVie
Inc.
|
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
|
Twelve Months
Ended December 31, 2020
|
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
12M20
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
3,398
|
|
$
4,616
|
|
$
2.72
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
5,805
|
|
4,805
|
|
2.87
|
Acquisition and
integration costs
|
3,366
|
|
3,023
|
|
1.81
|
Milestones and other
R&D expenses
|
273
|
|
241
|
|
0.14
|
Acquired
IPR&D
|
1,198
|
|
1,194
|
|
0.71
|
Change in fair value
of contingent consideration
|
5,753
|
|
5,749
|
|
3.43
|
Tax audit
settlements
|
—
|
|
(200)
|
|
(0.12)
|
Impacts related to tax
law changes
|
—
|
|
(1,689)
|
|
(1.02)
|
Other
|
239
|
|
42
|
|
0.02
|
As adjusted
(non-GAAP)
|
$
20,032
|
|
$
17,781
|
|
$
10.56
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition and
integration costs reflect transaction and financing costs,
compensation expense and other integration costs as well as
amortization of the acquisition date fair value step-up for
inventory related to the Allergan acquisition. Milestones and other
R&D expenses include milestone payments for previously
announced collaborations and the purchase of an FDA priority review
voucher from a third party. Acquired IPR&D represents initial
costs to acquire rights to in-process R&D projects through
R&D collaborations, licensing arrangements or other asset
acquisitions. Other primarily includes tax related items and
COVID-19 related charitable contributions and expenses.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
12M20
|
|
Net
revenues
|
|
Cost of products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Interest expense,
net
|
|
Net foreign exchange
loss
|
|
Other expense,
net
|
As reported
(GAAP)
|
$
45,804
|
|
$
15,387
|
|
$
11,299
|
|
$
6,557
|
|
$
1,198
|
|
$
2,280
|
|
$
71
|
|
$
5,614
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
(5,805)
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
—
|
|
(1,292)
|
|
(1,416)
|
|
(384)
|
|
—
|
|
(274)
|
|
—
|
|
—
|
Milestones and other
R&D expenses
|
—
|
|
—
|
|
—
|
|
(273)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquired
IPR&D
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,198)
|
|
—
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(5,753)
|
Other
|
(20)
|
|
(115)
|
|
(80)
|
|
(70)
|
|
—
|
|
—
|
|
9
|
|
(3)
|
As adjusted
(non-GAAP)
|
$
45,784
|
|
$
8,175
|
|
$
9,803
|
|
$
5,830
|
|
$
—
|
|
$
2,006
|
|
$
80
|
|
$
(142)
|
|
3. The adjusted tax rate for
the full-year 2020 was 11.2 percent, as detailed below:
|
|
12M20
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
3,398
|
|
$
(1,224)
|
|
(36.0)
%
|
Specified
items
|
16,634
|
|
3,469
|
|
20.9 %
|
As adjusted
(non-GAAP)
|
$
20,032
|
|
$
2,245
|
|
11.2
%
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2021-financial-results-301473737.html
SOURCE AbbVie