NORTH CHICAGO, Ill., Feb. 3,
2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced
financial results for the fourth quarter and full year ended
December 31, 2020.
"We successfully completed the transformative Allergan
acquisition and delivered another year of strong results in 2020,
despite the challenges presented by the global pandemic," said
Richard A. Gonzalez, chairman and
chief executive officer, AbbVie. "Based on our broad portfolio of
diversified growth assets and the robust momentum of our business,
we expect impressive growth again in 2021."
Fourth-Quarter Results
- Worldwide net revenues were $13.858
billion, an increase of 59.2 percent on a reported basis, or
an increase of 6.8 percent on a comparable operational basis.
- Global net revenues from the immunology portfolio were
$5.958 billion, an increase of 15.3
percent on a reported basis, or 14.8 percent on an operational
basis.
-
- Global Humira net revenues of $5.152
billion increased 4.8 percent on a reported basis, or 4.4
percent on an operational basis. U.S. Humira net revenues were
$4.293 billion, an increase of 8.2
percent. Internationally, Humira net revenues were $859 million, a decrease of 9.4 percent on a
reported basis, or 11.4 percent on an operational basis, due to
biosimilar competition.
- Global Skyrizi net revenues were $525
million.
- Global Rinvoq net revenues were $281
million.
- Global net revenues from the hematologic oncology portfolio
were $1.789 billion, an increase of
15.7 percent on a reported basis, or 15.5 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.424 billion, an increase of 9.8 percent, with
U.S. net revenues of $1.165 billion
and international profit sharing of $259
million.
- Global Venclexta net revenues were $365
million, an increase of 46.2 percent on a reported basis, or
45.0 percent on an operational basis.
- Global net revenues from the aesthetics portfolio were
$1.142 billion, a decrease of 0.7
percent on a comparable operational basis.
-
- Global Botox Cosmetic net revenues were $493 million, an increase of 9.1 percent on a
comparable operational basis.
- Global net revenues from the neuroscience portfolio were
$1.389 billion, an increase of over
100.0 percent on a reported basis, or 14.9 percent on a comparable
operational basis.
-
- Global Botox Therapeutic net revenues were $567 million, a decrease of 1.0 percent on a
comparable operational basis.
- Global Vraylar net revenues were $401
million, an increase of 38.0 percent on a comparable
operational basis.
- Global Ubrelvy net revenues were $65
million.
- On a GAAP basis, the gross margin ratio in the fourth quarter
was 66.2 percent. The adjusted gross margin ratio was 81.8
percent.
- On a GAAP basis, selling, general and administrative expense
was 23.3 percent of net revenues. The adjusted SG&A expense was
22.3 percent of net revenues.
- On a GAAP basis, research and development expense was 13.6
percent of net revenues. The adjusted R&D expense was 12.6
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
27.1 percent. The adjusted operating margin was 46.9 percent.
- On a GAAP basis, net interest expense was $618 million.
- On a GAAP basis, the tax rate in the quarter was 102.5 percent.
The adjusted tax rate was 11.6 percent.
- Diluted EPS in the fourth quarter was $0.01 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.92.
- Recorded a $4.7 billion increase
in the Skyrizi contingent consideration liability due to higher
estimated future sales driven by stronger market share uptake and
favorable clinical trial results as well as lower interest
rates.
Note: "Comparable Operational" comparisons include full-quarter
current year and prior year results for Allergan, which was
acquired on May 8, 2020, as if the
acquisition closed on January 1,
2019, and are presented at constant currency rates and
reflect comparative local currency net revenues at the prior year's
foreign exchange rates. Refer to the Key Product Revenues schedules
for further details. "Operational" comparisons are presented at
constant currency rates and reflect comparative local currency net
revenues at the prior year's foreign exchange rates.
Recent Events
- AbbVie announced that the European Commission (EC) has approved
Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of
adults with active psoriatic arthritis (PsA) and active ankylosing
spondylitis (AS). Rinvoq is the first oral, once-daily, selective
and reversible JAK inhibitor approved for three adult rheumatic
indications in the European Union: rheumatoid arthritis (RA), PsA
and AS. The EC approval is supported by data from three pivotal
clinical studies in PsA and AS where Rinvoq met all primary and key
secondary endpoints with a safety profile consistent with that seen
in RA.
- AbbVie announced top-line results from the Phase 3b Heads Up study showing that Rinvoq (30 mg,
once daily) achieved superiority to Dupixent (dupilumab, 300 mg,
every other week) for the primary endpoint, the proportion of
patients with at least a 75 percent improvement in the Eczema Area
Severity Index (EASI 75) at week 16, in adults with moderate to
severe atopic dermatitis (AD). Rinvoq also showed superiority
versus Dupixent for all ranked secondary endpoints, including early
improvements in itch and skin clearance. The safety profile of
Rinvoq was consistent with previous AD studies, with no new safety
risks observed. Full results from the Heads Up study will be
submitted for publication in a peer-reviewed journal.
- AbbVie announced positive results from the Phase 3 induction
study, U-ACHIEVE, which showed Rinvoq (45 mg, once daily) met the
primary endpoint of clinical remission (per Adapted Mayo Score) at
week 8 in adult patients with moderate to severe ulcerative colitis
(UC). Additionally, all ranked secondary endpoints, including
clinical, endoscopic and histologic outcomes, were met. The safety
results in this study were consistent with the known profile of
Rinvoq, with no new safety risks observed. U-ACHIEVE is the first
of two Phase 3 induction studies to evaluate the safety and
efficacy of Rinvoq in adults with moderate to severe UC and full
results from the study will be presented at a future medical
meeting and submitted for publication in a peer-reviewed
journal.
- AbbVie announced positive top-line results from the Phase 3
ADVANCE and MOTIVATE studies, which evaluated the efficacy and
safety of Skyrizi (risankizumab) for induction therapy in adult
patients with moderate to severe Crohn's disease (CD). In ADVANCE
and MOTIVATE, both doses of Skyrizi (600mg and 1200mg) met the
co-primary endpoints of clinical remission and endoscopic response
at week 12, demonstrating superiority versus placebo. Additionally,
key secondary endpoints showed significant clinical and endoscopic
outcomes, with symptom improvement observed as early as week 4. The
overall safety results in these studies were generally consistent
with the known safety profile of Skyrizi, with no new safety risks
observed. Skyrizi is part of a collaboration between Boehringer
Ingelheim and AbbVie, with AbbVie leading development and
commercialization globally.
- AbbVie announced positive top-line results from the Phase 3
KEEPsAKE-1 and KEEPsAKE-2 studies evaluating Skyrizi (150 mg) in
adults with active PsA, with Skyrizi demonstrating strong levels of
response on both joint and skin endpoints. In both Phase 3 trials,
significantly more patients treated with Skyrizi achieved the
primary endpoint of ACR20 response at week 24 versus placebo.
Results of ranked secondary endpoints showed significant
improvements in skin clearance (as measured by at least a 90
percent improvement in Psoriasis Area Severity Index (PASI 90)),
physical function (as measured by the Health Assessment
Questionnaire Disability Index (HAQ-DI)) and minimal disease
activity (MDA) at week 24. The safety results in these studies
to-date were generally consistent with the known profile of Skyrizi
in psoriasis (PsO) patients. Detailed data from both pivotal
studies will be presented at an upcoming medical meeting and we
expect to submit our regulatory applications for Skyrizi in PsA in
the first half of this year.
- AbbVie hosted an Immunology Strategic Update event on
December 14, 2020 for members of the
investment community. The event highlighted AbbVie's immunology
leadership, market expectations, strong and growing body of
clinical data, innovative pipeline, and strategy to capitalize on a
best-in-class immunology portfolio over the long term. As part of
the event, AbbVie raised its 2025 risk-adjusted combined sales
guidance for Skyrizi and Rinvoq to greater than $15 billion, above previous guidance of greater
than $10 billion. Supporting
materials from the Immunology Strategic Update, including the event
presentation and an archived webcast, can be found on AbbVie's
Investor Relations website at investors.abbvie.com.
- At the virtual American Society of Hematology Annual Meeting
and Exposition (ASH), AbbVie presented data from nearly 40
abstracts on 8 investigational and approved products across 11
cancer types, including 10 oral presentations. Key data
presentations included new disease-free survival data from the
Phase 2 CAPTIVATE study evaluating Imbruvica (ibrutinib) plus
Venclexta (venetoclax) in previously untreated patients with
chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL); new extended follow-up data for fixed duration treatment
Venclexta in CLL from the Phase 3 Murano and Phase 3 CLL14 studies;
results from several long-term follow-up studies evaluating
Imbruvica in multiple types of blood cancers; and data from
collaborations on pipeline candidates in partnership with Genmab
and I-Mab. 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.
- AbbVie announced that the U.S. Food and Drug Administration
(FDA) approved the update of the Imbruvica Prescribing Information
to include efficacy and safety data for the combination of
Imbruvica with rituximab for the treatment of Waldenström's
macroglobulinemia (WM). The update is based on more than 5 years of
Phase 3 iNNOVATE final analysis data, which demonstrated Imbruvica
plus rituximab significantly prolonged progression-free survival
(PFS) versus rituximab alone in adults with WM. Imbruvica was
approved as a monotherapy for WM in 2015 and as a combination
therapy with rituximab in 2018 based on the iNNOVATE primary
analysis.
- Allergan Aesthetics announced the launch of CoolSculpting
Elite, its next generation fat reduction system with new technology
that allows for the treatment of two areas of fat at once and new
elite applicators designed for improved fit and comfort.
CoolSculpting Elite harnesses proven CoolSculpting technology to
target, freeze, and eliminate treated fat cells. CoolSculpting
Elite is FDA cleared to treat visible fat bulges in nine areas of
the body including the thigh, abdomen, and flank, along with bra
fat, back fat, underneath the buttocks (also known as banana roll),
upper arm, and the submental and submandibular areas.
- Allergan Aesthetics entered into a warrant agreement with
Cypris Medical, a privately held medical device company, that
provides Allergan Aesthetics the right to acquire Cypris Medical,
including the company's Xact device, following the completion of a
clinical trial to be initiated in 2021. The Xact device is a
minimally-invasive alternative option for performing face and neck
lifts and the planned clinical trial will evaluate the safety and
effectiveness of Xact in treating midface descent as well as for
neck lifts.
- AbbVie presented results from 16 neurotoxin research abstracts
across multiple therapeutic and cosmetic indications at the TOXINS
2021 Virtual Conference. The presentations included new analyses
from the CD-PROBE study evaluating sustained efficacy and
tolerability of Botox (onabotulinumtoxinA) in patients with
cervical dystonia, new analyses from the ASPIRE study on patient
adherence to Botox for management of spasticity, data on Botox
treatment in adult patients with overactive bladder and in
pediatric patients with neurogenic detrusor overactivity, a
meta-analysis of immunogenicity rates across 10 therapeutic and
aesthetic indications and results from a clinical trial evaluating
the safety and pharmacodynamic response with higher doses of Botox
on clinician and patient reported outcomes in patients with
moderate to severe glabellar lines.
- At the virtual American Academy of Ophthalmology (AAO) 2020,
AbbVie presented new Phase 2 efficacy data for an investigational
treatment of presbyopia, new data evaluating the effectiveness of
Durysta (bimatoprost implant) and additional analysis of data from
Phase 3 ARTEMIS studies that shed light on how glaucoma patients
with different characteristics may respond to Durysta.
- AbbVie recently provided new long-term sales guidance. The
company expects continued strong total company sales growth leading
up to the U.S. Humira (adalimumab) loss of exclusivity (LOE) in
2023. AbbVie expects total company sales to decline in 2023,
following the LOE, with modest top-line growth expected in 2024.
The company expects a rapid return to strong top-line growth in
2025, with a high-single digit compound annual growth rate (CAGR)
through the remainder of the decade. AbbVie also outlined
expectations for high-single digit annual growth for its aesthetics
portfolio over the next decade, peak Vraylar (cariprazine) sales
approaching $4 billion in current
approved indications, peak Ubrelvy (ubrogepant) sales of greater
than $1 billion and peak atogepant
sales of greater than $1 billion. The
company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and
Skyrizi global sales in 2025.
- AbbVie and Frontier Medicines, Corp., a precision medicine
company drugging challenging protein targets to develop
breakthrough medicines that change the course of human diseases,
announced a global strategic collaboration to discover, develop and
commercialize a pipeline of innovative small molecule therapeutics
against high-interest, difficult-to-drug protein targets. Under the
multi-year collaboration, AbbVie and Frontier will utilize
Frontier's proprietary chemoproteomics platform to identify small
molecules for programs directed to novel E3 ligases and certain
oncology and immunology targets.
- AbbVie announced that it will collaborate with 6 nonprofit
partners as part of its $50 million
investment to support health and education opportunity in
underserved Black communities across the U.S. The partners include
Direct Relief, University of Chicago
Medicine's Urban Health Initiative, National Urban League, Year Up,
United Negro College Fund (UNCF) and Providence St. Mel School.
Additionally, as part of the announcement, AbbVie expanded its
employee matching program to 3:1 for donations to civil rights
nonprofits fostering racial equity.
Full-Year 2021 Outlook
AbbVie is issuing its GAAP diluted EPS guidance for the
full-year 2021 of $6.69 to
$6.89. AbbVie expects to deliver
adjusted diluted EPS for the full-year 2021 of $12.32 to $12.52.
The company's 2021 adjusted diluted EPS guidance excludes
$5.63 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 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 2020 and 2019 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 2021 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 2019 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, 2020
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
4Q19
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Comparable
Operational a, b
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$10,665
|
|
$3,193
|
|
$13,858
|
|
65.9%
|
|
40.4%
|
|
59.2%
|
|
9.4%
|
|
(1.2)%
|
|
6.8%
|
Immunology
|
4,988
|
|
970
|
|
5,958
|
|
18.9
|
|
(0.1)
|
|
15.3
|
|
18.9
|
|
(2.5)
|
|
14.8
|
Humira
|
4,293
|
|
859
|
|
5,152
|
|
8.2
|
|
(9.4)
|
|
4.8
|
|
8.2
|
|
(11.4)
|
|
4.4
|
Skyrizi
|
451
|
|
74
|
|
525
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
Rinvoq
|
244
|
|
37
|
|
281
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,373
|
|
416
|
|
1,789
|
|
11.7
|
|
30.9
|
|
15.7
|
|
11.7
|
|
29.9
|
|
15.5
|
Imbruvicac
|
1,165
|
|
259
|
|
1,424
|
|
8.6
|
|
15.7
|
|
9.8
|
|
8.6
|
|
15.7
|
|
9.8
|
Venclexta
|
208
|
|
157
|
|
365
|
|
33.5
|
|
67.3
|
|
46.2
|
|
33.5
|
|
64.1
|
|
45.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
724
|
|
418
|
|
1,142
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(2.5)
|
|
2.5
|
|
(0.7)
|
Botox
Cosmetic*
|
303
|
|
190
|
|
493
|
|
n/m
|
|
n/m
|
|
n/m
|
|
11.1
|
|
6.0
|
|
9.1
|
Juvederm
Collection*
|
147
|
|
184
|
|
331
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(12.1)
|
|
3.4
|
|
(4.0)
|
Other
Aesthetics*
|
274
|
|
44
|
|
318
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(9.3)
|
|
(13.1)
|
|
(9.8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,188
|
|
201
|
|
1,389
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
18.3
|
|
(2.0)
|
|
14.9
|
Botox
Therapeutic*
|
472
|
|
95
|
|
567
|
|
n/m
|
|
n/m
|
|
n/m
|
|
0.3
|
|
(7.1)
|
|
(1.0)
|
Vraylar*
|
401
|
|
—
|
|
401
|
|
n/m
|
|
n/a
|
|
n/m
|
|
38.0
|
|
n/a
|
|
38.0
|
Duodopa
|
28
|
|
101
|
|
129
|
|
8.5
|
|
9.6
|
|
9.3
|
|
8.5
|
|
3.6
|
|
4.6
|
Ubrelvy*
|
65
|
|
—
|
|
65
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience*
|
222
|
|
5
|
|
227
|
|
n/m
|
|
n/m
|
|
n/m
|
|
1.7
|
|
(0.4)
|
|
1.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
625
|
|
302
|
|
927
|
|
n/m
|
|
n/m
|
|
n/m
|
|
2.5
|
|
(4.5)
|
|
0.1
|
Lumigan/Ganfort*
|
68
|
|
85
|
|
153
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(14.1)
|
|
(13.1)
|
|
(13.5)
|
Alphagan/Combigan*
|
92
|
|
42
|
|
134
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(1.5)
|
|
—
|
|
(1.1)
|
Restasis*
|
333
|
|
11
|
|
344
|
|
n/m
|
|
n/m
|
|
n/m
|
|
0.7
|
|
(30.4)
|
|
(1.0)
|
Other Eye
Care*
|
132
|
|
164
|
|
296
|
|
n/m
|
|
n/m
|
|
n/m
|
|
24.4
|
|
2.4
|
|
11.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Women's
Health
|
249
|
|
7
|
|
256
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
(12.5)
|
|
(48.1)
|
|
(14.1)
|
Lo
Loestrin*
|
139
|
|
3
|
|
142
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(13.6)
|
|
(31.7)
|
|
(14.1)
|
Orilissa/Oriahnn
|
37
|
|
1
|
|
38
|
|
10.0
|
|
41.0
|
|
10.7
|
|
10.0
|
|
41.5
|
|
10.7
|
Other Women's
Health*
|
73
|
|
3
|
|
76
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(18.7)
|
|
(65.0)
|
|
(22.6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,136
|
|
310
|
|
1,446
|
|
16.4
|
|
(15.7)
|
|
7.7
|
|
(6.5)
|
|
(19.5)
|
|
(9.6)
|
Mavyret
|
220
|
|
261
|
|
481
|
|
(27.8)
|
|
(19.0)
|
|
(23.3)
|
|
(27.8)
|
|
(22.1)
|
|
(24.9)
|
Creon
|
304
|
|
—
|
|
304
|
|
4.0
|
|
n/a
|
|
4.0
|
|
4.0
|
|
n/a
|
|
4.0
|
Lupron
|
139
|
|
42
|
|
181
|
|
(19.7)
|
|
(8.4)
|
|
(17.4)
|
|
(19.7)
|
|
(5.8)
|
|
(16.9)
|
Linzess/Constella*
|
279
|
|
7
|
|
286
|
|
n/m
|
|
n/m
|
|
n/m
|
|
16.1
|
|
6.3
|
|
15.9
|
Synthroid
|
194
|
|
—
|
|
194
|
|
(5.1)
|
|
n/a
|
|
(5.1)
|
|
(5.1)
|
|
n/a
|
|
(5.1)
|
|
|
a
|
"Comparable
Operational" comparisons include full-quarter 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
|
Reflects profit
sharing for Imbruvica international revenues.
|
*
|
Represents product(s)
acquired as part of the Allergan acquisition.
|
n/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Twelve Months
Ended December 31, 2020
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
12M19
|
|
Net Revenues (in millions)
a
|
|
Reported
|
|
Comparable
Operational b, c
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
ADJUSTED NET
REVENUES d
|
$34,859
|
|
$10,925
|
|
$45,784
|
|
45.8%
|
|
16.7%
|
|
37.6%
|
|
6.7%
|
|
(6.8)%
|
|
3.3%
|
Immunology
|
18,150
|
|
4,003
|
|
22,153
|
|
19.2
|
|
(7.9)
|
|
13.2
|
|
19.2
|
|
(6.9)
|
|
13.4
|
Humira
|
16,112
|
|
3,720
|
|
19,832
|
|
8.4
|
|
(13.6)
|
|
3.5
|
|
8.4
|
|
(12.5)
|
|
3.7
|
Skyrizi
|
1,385
|
|
205
|
|
1,590
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
Rinvoq
|
653
|
|
78
|
|
731
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
5,109
|
|
1,542
|
|
6,651
|
|
17.4
|
|
38.3
|
|
21.7
|
|
17.4
|
|
38.5
|
|
21.7
|
Imbruvicae
|
4,305
|
|
1,009
|
|
5,314
|
|
12.4
|
|
19.5
|
|
13.7
|
|
12.4
|
|
19.5
|
|
13.7
|
Venclexta
|
804
|
|
533
|
|
1,337
|
|
54.4
|
|
97.0
|
|
69.0
|
|
54.4
|
|
97.8
|
|
69.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
1,671
|
|
919
|
|
2,590
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(16.5)
|
|
(17.6)
|
|
(16.9)
|
Botox
Cosmetic*
|
687
|
|
425
|
|
1,112
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(8.8)
|
|
(16.7)
|
|
(12.0)
|
Juvederm
Collection*
|
318
|
|
400
|
|
718
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(27.1)
|
|
(18.2)
|
|
(22.4)
|
Other
Aesthetics*
|
666
|
|
94
|
|
760
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(17.7)
|
|
(19.4)
|
|
(17.9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
2,862
|
|
634
|
|
3,496
|
|
>100.0
|
|
74.0
|
|
>100.0
|
|
14.0
|
|
(2.7)
|
|
11.1
|
Botox
Therapeutic*
|
1,155
|
|
232
|
|
1,387
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(5.4)
|
|
(11.9)
|
|
(6.6)
|
Vraylar*
|
951
|
|
—
|
|
951
|
|
n/m
|
|
n/a
|
|
n/m
|
|
57.5
|
|
n/a
|
|
57.5
|
Duodopa
|
103
|
|
391
|
|
494
|
|
5.9
|
|
7.4
|
|
7.1
|
|
5.9
|
|
6.3
|
|
6.2
|
Ubrelvy*
|
125
|
|
—
|
|
125
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience*
|
528
|
|
11
|
|
539
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(6.4)
|
|
28.1
|
|
(6.0)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
1,448
|
|
736
|
|
2,184
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(0.5)
|
|
(8.8)
|
|
(3.4)
|
Lumigan/Ganfort*
|
165
|
|
213
|
|
378
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(5.0)
|
|
(8.1)
|
|
(6.8)
|
Alphagan/Combigan*
|
223
|
|
103
|
|
326
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(6.8)
|
|
(1.1)
|
|
(5.2)
|
Restasis*
|
755
|
|
32
|
|
787
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(0.8)
|
|
—
|
|
(0.7)
|
Other Eye
Care*
|
305
|
|
388
|
|
693
|
|
n/m
|
|
n/m
|
|
n/m
|
|
9.0
|
|
(11.6)
|
|
(3.6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Women's
Health
|
648
|
|
25
|
|
673
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
(13.1)
|
|
(17.9)
|
|
(13.3)
|
Lo
Loestrin*
|
346
|
|
10
|
|
356
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(14.5)
|
|
0.1
|
|
(14.3)
|
Orilissa/Oriahnn
|
121
|
|
4
|
|
125
|
|
33.3
|
|
96.1
|
|
34.6
|
|
33.3
|
|
97.7
|
|
34.6
|
Other Women's
Health*
|
181
|
|
11
|
|
192
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(22.4)
|
|
(35.2)
|
|
(23.3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
3,919
|
|
1,215
|
|
5,134
|
|
(2.5)
|
|
(23.4)
|
|
(8.4)
|
|
(13.6)
|
|
(24.0)
|
|
(16.2)
|
Mavyret
|
785
|
|
1,045
|
|
1,830
|
|
(46.7)
|
|
(26.4)
|
|
(36.7)
|
|
(46.7)
|
|
(26.8)
|
|
(36.9)
|
Creon
|
1,114
|
|
—
|
|
1,114
|
|
6.9
|
|
n/a
|
|
6.9
|
|
6.9
|
|
n/a
|
|
6.9
|
Lupron
|
600
|
|
152
|
|
752
|
|
(16.6)
|
|
(9.1)
|
|
(15.2)
|
|
(16.6)
|
|
(5.4)
|
|
(14.5)
|
Linzess/Constella*
|
649
|
|
18
|
|
667
|
|
n/m
|
|
n/m
|
|
n/m
|
|
10.2
|
|
16.7
|
|
10.4
|
Synthroid
|
771
|
|
—
|
|
771
|
|
(1.9)
|
|
n/a
|
|
(1.9)
|
|
(1.9)
|
|
n/a
|
|
(1.9)
|
|
|
a
|
Net revenues include
Allergan product revenues from the date of the acquisition, May 8,
2020, through December 31, 2020.
|
b
|
"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.
|
c
|
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.
|
d
|
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.
|
e
|
Reflects profit
sharing for Imbruvica international revenues.
|
*
|
Represents product(s)
acquired as part of the Allergan acquisition.
|
n/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
Quarter and Twelve
Months Ended December 31, 2020 and 2019
(Unaudited) (In
millions, except per share data)
|
|
|
Fourth
Quarter
Ended December
31
|
|
Twelve
Months
Ended December
31
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Net
revenues
|
$
|
13,858
|
|
|
$
|
8,704
|
|
|
$
|
45,804
|
|
|
$
|
33,266
|
|
Cost of products
sold
|
4,684
|
|
|
2,006
|
|
|
15,387
|
|
|
7,439
|
|
Selling, general and
administrative
|
3,231
|
|
|
1,951
|
|
|
11,299
|
|
|
6,942
|
|
Research and
development
|
1,890
|
|
|
1,542
|
|
|
6,557
|
|
|
6,407
|
|
Acquired in-process
research and development
|
300
|
|
|
139
|
|
|
1,198
|
|
|
385
|
|
Other operating
income
|
—
|
|
|
(890)
|
|
|
—
|
|
|
(890)
|
|
Total operating costs
and expenses
|
10,105
|
|
|
4,748
|
|
|
34,441
|
|
|
20,283
|
|
|
|
|
|
|
|
|
|
Operating
earnings
|
3,753
|
|
|
3,956
|
|
|
11,363
|
|
|
12,983
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
618
|
|
|
455
|
|
|
2,280
|
|
|
1,509
|
|
Net foreign exchange
loss
|
17
|
|
|
11
|
|
|
71
|
|
|
42
|
|
Other expense,
net
|
4,625
|
|
|
416
|
|
|
5,614
|
|
|
3,006
|
|
Earnings (loss)
before income tax expense
|
(1,507)
|
|
|
3,074
|
|
|
3,398
|
|
|
8,426
|
|
Income tax expense
(benefit)
|
(1,545)
|
|
|
273
|
|
|
(1,224)
|
|
|
544
|
|
Net
earnings
|
38
|
|
|
2,801
|
|
|
4,622
|
|
|
7,882
|
|
Net earnings
attributable to noncontrolling interest
|
2
|
|
|
—
|
|
|
6
|
|
|
—
|
|
Net earnings
attributable to AbbVie Inc.
|
$
|
36
|
|
|
$
|
2,801
|
|
|
$
|
4,616
|
|
|
$
|
7,882
|
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
|
0.01
|
|
|
$
|
1.88
|
|
|
$
|
2.72
|
|
|
$
|
5.28
|
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
|
2.92
|
|
|
$
|
2.21
|
|
|
$
|
10.56
|
|
|
$
|
8.94
|
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,776
|
|
|
1,485
|
|
|
1,673
|
|
|
1,484
|
|
|
|
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, 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 primarily reflects upfront payments related to
R&D collaborations and licensing arrangements with third
parties. 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
Quarter Ended
December 31, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
4Q19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
|
3,074
|
|
|
$
|
2,801
|
|
|
$
|
1.88
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
391
|
|
|
324
|
|
|
0.22
|
|
Acquisition related
costs
|
226
|
|
|
183
|
|
|
0.12
|
|
Milestones and other
R&D expenses
|
217
|
|
|
193
|
|
|
0.13
|
|
Acquired
IPR&D
|
139
|
|
|
123
|
|
|
0.08
|
|
Reata
divestiture
|
(330)
|
|
|
(297)
|
|
|
(0.20)
|
|
Litigation
matters
|
(550)
|
|
|
(435)
|
|
|
(0.29)
|
|
Change in fair value
of contingent consideration
|
438
|
|
|
438
|
|
|
0.29
|
|
Restructuring
|
19
|
|
|
15
|
|
|
0.01
|
|
Tax audit
settlement
|
—
|
|
|
(133)
|
|
|
(0.09)
|
|
Other
|
(10)
|
|
|
82
|
|
|
0.06
|
|
As adjusted
(non-GAAP)
|
$
|
3,614
|
|
|
$
|
3,294
|
|
|
$
|
2.21
|
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition related
costs reflect transaction and financing costs 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 primarily reflects upfront payments related to
R&D collaborations and licensing arrangements with third
parties. Litigation matters includes the settlement of an
intellectual property dispute with a third party. Restructuring is
primarily associated with streamlining global operations. Other
primarily includes the impacts of tax law changes and U.S. tax
reform.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
4Q19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
income
|
|
Interest
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
2,006
|
|
|
$
|
1,951
|
|
|
$
|
1,542
|
|
|
$
|
139
|
|
|
$
|
(890)
|
|
|
$
|
455
|
|
|
$
|
416
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(391)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(53)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(173)
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(217)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(139)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Reata
divestiture
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
330
|
|
|
—
|
|
|
—
|
|
Litigation
matters
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
550
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(438)
|
|
Restructuring
|
(10)
|
|
|
(15)
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Other
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
1,605
|
|
|
$
|
1,883
|
|
|
$
|
1,331
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
282
|
|
|
$
|
(22)
|
|
|
3. The adjusted tax rate for
the fourth quarter of 2019 was 8.8 percent, as detailed
below:
|
|
4Q19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
3,074
|
|
|
$
|
273
|
|
|
8.9
|
%
|
Specified
items
|
540
|
|
|
47
|
|
|
8.6
|
%
|
As
adjusted (non-GAAP)
|
$
|
3,614
|
|
|
$
|
320
|
|
|
8.8
|
%
|
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. 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
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Twelve Months
Ended December 31, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
12M19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
|
8,426
|
|
|
$
|
7,882
|
|
|
$
|
5.28
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,553
|
|
|
1,286
|
|
|
0.86
|
|
Acquisition related
costs
|
415
|
|
|
338
|
|
|
0.23
|
|
Milestones and other
R&D expenses
|
312
|
|
|
288
|
|
|
0.20
|
|
Acquired
IPR&D
|
385
|
|
|
364
|
|
|
0.25
|
|
Reata
divestiture
|
(330)
|
|
|
(297)
|
|
|
(0.20)
|
|
Litigation
matters
|
(523)
|
|
|
(414)
|
|
|
(0.28)
|
|
Change in fair value
of contingent consideration
|
3,182
|
|
|
3,184
|
|
|
2.14
|
|
Restructuring
|
207
|
|
|
168
|
|
|
0.10
|
|
Stemcentrx-related
impairment
|
939
|
|
|
823
|
|
|
0.56
|
|
Tax audit
settlement
|
—
|
|
|
(400)
|
|
|
(0.27)
|
|
Other
|
10
|
|
|
102
|
|
|
0.07
|
|
As adjusted
(non-GAAP)
|
$
|
14,576
|
|
|
$
|
13,324
|
|
|
$
|
8.94
|
|
|
a
Represents net earnings attributable to AbbVie Inc.
|
|
Acquisition related
costs reflect transaction and financing costs 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 primarily reflects upfront payments related to
R&D collaborations and licensing arrangements with third
parties. Litigation matters includes the settlement of an
intellectual property dispute with a third party. Restructuring is
primarily associated with streamlining global operations.
Stemcentrx-related impairment refers to the net impact of the
intangible asset impairment and the related fair value adjustment
to contingent consideration liabilities. Other primarily includes
the impacts of tax law changes and U.S. tax reform.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
12M19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
income
|
|
Interest
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
7,439
|
|
|
$
|
6,942
|
|
|
$
|
6,407
|
|
|
$
|
385
|
|
|
$
|
(890)
|
|
|
$
|
1,509
|
|
|
$
|
3,006
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,553)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(103)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(312)
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(312)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(385)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Reata
divestiture
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
330
|
|
|
—
|
|
|
—
|
|
Litigation
matters
|
—
|
|
|
(27)
|
|
|
—
|
|
|
—
|
|
|
550
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,182)
|
|
Restructuring
|
(25)
|
|
|
(125)
|
|
|
(57)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Stemcentrx-related
impairment
|
—
|
|
|
—
|
|
|
(1,030)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
91
|
|
Other
|
(1)
|
|
|
—
|
|
|
(19)
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
As adjusted
(non-GAAP)
|
$
|
5,860
|
|
|
$
|
6,687
|
|
|
$
|
4,989
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,197
|
|
|
$
|
(85)
|
|
|
3. The adjusted tax rate for
the full-year 2019 was 8.6 percent, as detailed below:
|
|
12M19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
8,426
|
|
|
$
|
544
|
|
|
6.5
|
%
|
Specified
items
|
6,150
|
|
|
708
|
|
|
11.5
|
%
|
As adjusted
(non-GAAP)
|
$
|
14,576
|
|
|
$
|
1,252
|
|
|
8.6
|
%
|
View original
content:http://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2020-financial-results-301221231.html
SOURCE AbbVie