Feb 3, 2021 SOURCE: PR NewsWire
AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results
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 Twelve Months
Ended December 31 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
SG&A
R&D Acquired
Other
expense,
products IPR&D net
sold
---
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 Income Tax rate
(loss)
taxes
---
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
SG&A
R&D Acquired
Other Interest Other
operating expense, expense,
products IPR&D income net net
sold
---
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 Tax rate
taxes
---
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 Cost of
SG&A
R&D Acquired Interest Net foreign
Other
revenues expense, exchange expense,
products IPR&D net loss net
sold
---
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 - (5,753)
consideration
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 Tax rate
taxes
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
SG&A
R&D Acquired
Other Interest
Other
operating expense, expense,
products IPR&D income net net
sold
---
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 Tax rate
taxes
---
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
%
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SOURCE AbbVie
