NORTH CHICAGO, Ill., April 30, 2021 /PRNewswire/ --
AbbVie (NYSE:ABBV) announced financial results for the first
quarter ended March 31, 2021.
"We are off to an excellent start to 2021, with strong
performance across our core therapeutic areas and first quarter
revenue and earnings results ahead of our expectations," said
Richard A. Gonzalez, chairman and
chief executive officer, AbbVie. "Our new products are delivering
impressive performance and we are on the cusp of potential
commercial approvals for more than a dozen new products or
indications over the next two years – including five expected
approvals in 2021."
First-Quarter Results
- Worldwide GAAP net revenues were $13.010
billion, an increase of 51.0 percent on a reported basis.
Worldwide adjusted net revenues of $12.935
billion increased 5.2 percent on a comparable operational
basis.
- Global net revenues from the immunology portfolio were
$5.744 billion, an increase of 12.9
percent on a reported basis, or 11.8 percent on an operational
basis.
-
- Global Humira net revenues of $4.867
billion increased 3.5 percent on a reported basis, or 2.6
percent on an operational basis. U.S. Humira net revenues were
$3.907 billion, an increase of 6.9
percent. Internationally, Humira net revenues were $960 million, a decrease of 8.3 percent on a
reported basis, or 12.6 percent on an operational basis, due to
biosimilar competition.
- Global Skyrizi net revenues were $574
million.
- Global Rinvoq net revenues were $303
million.
- Global net revenues from the hematologic oncology portfolio
were $1.673 billion, an increase of
8.0 percent on a reported basis, or 7.3 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.268 billion, an increase of 2.9 percent, with
U.S. net revenues of $999 million and
international profit sharing of $269
million.
- Global Venclexta net revenues were $405
million, an increase of 27.9 percent on a reported basis, or
24.5 percent on an operational basis.
- Global net revenues from the aesthetics portfolio were
$1.141 billion, an increase of 34.9
percent on a comparable operational basis.
-
- Global Botox Cosmetic net revenues were $477 million, an increase of 44.7 percent on a
comparable operational basis.
- Global net revenues from the neuroscience portfolio were
$1.248 billion, an increase of over
100.0 percent on a reported basis, or 10.9 percent on a comparable
operational basis.
-
- Global Botox Therapeutic net revenues were $532 million, an increase of 7.0 percent on a
comparable operational basis.
- Global Vraylar net revenues were $346
million, an increase of 21.2 percent on a comparable
operational basis.
- Global Ubrelvy net revenues were $81
million.
- On a GAAP basis, the gross margin ratio in the first quarter
was 67.6 percent. The adjusted gross margin ratio was 83.9
percent.
- On a GAAP basis, selling, general and administrative expense
was 21.8 percent of net revenues. The adjusted SG&A expense was
21.2 percent of net revenues.
- On a GAAP basis, research and development expense was 13.7
percent of net revenues. The adjusted R&D expense was 11.6
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- On a GAAP basis, the operating margin in the first quarter was
31.5 percent. The adjusted operating margin was 51.0 percent.
- On a GAAP basis, net interest expense was $622 million.
- On a GAAP basis, the tax rate in the quarter was 8.1 percent.
The adjusted tax rate was 12.3 percent.
- Diluted EPS in the first quarter was $1.99 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.95.
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 it submitted applications to the U.S.
Food and Drug Administration (FDA) and European Medicines Agency
(EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the
treatment of adults with active psoriatic arthritis (PsA). The
applications are supported by two Phase 3 studies in which Skyrizi
demonstrated improved skin and joint symptoms and physical
function, with a greater proportion of patients achieving minimal
disease activity versus placebo. The safety profile of Skyrizi in
these studies was generally consistent with the safety profile of
Skyrizi in plaque psoriasis, 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 results from the Phase 3 induction
study, U-ACCOMPLISH, which showed Rinvoq (upadacitinib, 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. U-ACCOMPLISH is the second of two Phase 3 induction
studies to evaluate the safety and efficacy of Rinvoq in adults
with moderate to severe UC and the results were consistent with
findings from the first Phase 3 induction study, U-ACHIEVE. Safety
results were also consistent with the previous Phase 3 induction
study and the known profile of Rinvoq, with no new safety risks
observed. Full results from the study will be presented at a future
medical meeting and submitted for publication in a peer-reviewed
journal. Results from the Phase 3 maintenance study and regulatory
submissions are expected in 2H 2021.
- AbbVie announced that the FDA extended the review period for
the supplemental New Drug Applications (sNDA) for Rinvoq in the
treatment of adult patients with active PsA as well as in the
treatment of adults and adolescents with moderate to severe atopic
dermatitis (AD). AbbVie received information requests from the FDA
for an updated assessment of the benefit-risk profile for Rinvoq in
both indications. AbbVie responded to the requests and the FDA will
require additional time for a full review of the submissions. The
updated Prescription Drug User Fee Act (PDUFA) action dates have
been extended three months to late 2Q 2021 for PsA and early 3Q
2021 for AD.
- AbbVie announced that the Committee for Medicinal Products for
Human Use (CHMP) of the EMA adopted a positive opinion for
Venclyxto (venetoclax) in combination with hypomethylating agents
for the treatment of adult patients with newly-diagnosed acute
myeloid leukemia (AML) who are ineligible for intensive
chemotherapy. The positive CHMP opinion is based on data from the
VIALE-A and M14-358 trials and represents the third positive CHMP
opinion for an extension of indications for Venclyxto. If approved
by the European Commission (EC), Venclyxto in combination with
hypomethylating agents would be a new regimen for patients with
AML. The EC is expected to deliver its final decision on Venclyxto
combination therapy for use in AML in 2Q 2021. Venetoclax is being
developed by AbbVie and Roche and is jointly commercialized by
AbbVie and Genentech, a member of the Roche Group, in the U.S. and
by AbbVie outside of the U.S.
- AbbVie announced the FDA accepted its New Drug Application
(NDA) for atogepant, an investigational orally administered
calcitonin gene-related peptide (CGRP) receptor antagonist
(gepant), for the preventive treatment of migraine in adults who
meet criteria for episodic migraine. The NDA is supported by data
from a clinical program evaluating the efficacy, safety and
tolerability of orally administered atogepant in nearly 2,500
patients who experience 4-14 migraine days per month, including
data from the pivotal Phase 3 ADVANCE study in which all active
treatment arms of atogepant met their primary endpoint and the 30
and 60 mg doses met all six secondary endpoints with statistical
significance. If approved, atogepant will be the first and only
oral CGRP receptor antagonist specifically developed for the
preventive treatment of migraine. AbbVie anticipates a regulatory
decision in late 3Q 2021.
- At the 2021 American Academy of Neurology (AAN) Annual Meeting,
AbbVie presented data across its neuroscience portfolio. A total of
33 abstracts, including 4 oral presentations, were shared from a
broad range of studies across the spectrum of migraine, advanced
Parkinson's disease (PD) and spasticity. Researchers presented
migraine related data from the Phase 3 ADVANCE trial results on the
safety and efficacy of atogepant in the preventive treatment of
migraine, real-world data on the role of Botox (onabotulinumtoxinA)
in combination with CGRP monoclonal antibodies (mAbs) for chronic
migraine prevention, as well as data evaluating the efficacy and
safety of Botox and Ubrelvy (ubrogepant). In addition,
investigators presented the study design of the Phase 3 study
assessing the efficacy and safety of the investigational treatment
ABBV-951 (foslevodopa/foscarbidopa), a levodopa/carbidopa prodrug
administered as a 24-hour continuous subcutaneous infusion, in
people with advanced PD.
- AbbVie announced that it submitted a NDA to the FDA for
investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution
for the treatment of presbyopia. Presbyopia is a common,
progressive condition that reduces the aging eye's ability to focus
on near objects and affects nearly half of the adult U.S.
population. The application is primarily based on data from two
pivotal Phase 3 studies involving 750 patients. In both studies
AGN-190584 met the primary endpoint reaching statistical
significance in improvement in near vision without a loss of
distance vision. If approved, AGN-190584 is expected to be the
first eye drop to treat presbyopia and the FDA is expected to act
on the NDA by the end of 2021.
- AbbVie announced the launch of Refresh Digital lubricant eye
drops, a new lubricant eye drop formulated to specifically relieve
dryness and irritation that may occur from prolonged screen time.
Refresh Digital features proprietary HydroCell technology that
supports all three layers of the tear film to keep eyes
hydrated.
- Allergan Aesthetics announced the launch of SkinMedica Neck
Correct Cream, the first product from the professional-grade
skincare line formulated to address the specific biology of the
skin on the neck and décolleté area. SkinMedica Neck Correct Cream
was designed to prevent the early signs as well as treat the
visible appearance of moderate to severe neck aging. It is
clinically proven to firm and tighten the look of crepey skin,
prevent and reduce the look of sagging, smooth deep lines and
wrinkles and enhance skin tone evenness.
- AbbVie and Caribou Biosciences, Inc., a leading clinical-stage
CRISPR genome editing biotechnology company, announced that they
have entered into a collaboration and license agreement for the
research and development of chimeric antigen receptor (CAR)-T cell
therapeutics. Under the multi-year agreement, AbbVie will utilize
Caribou's next-generation Cas12a CRISPR hybrid RNA-DNA genome
editing and cell therapy technologies to research and develop two
new CAR-T cell therapies directed to targets specified by
AbbVie.
Full-Year 2021 Outlook
AbbVie is raising its GAAP diluted EPS guidance for the
full-year 2021 from $6.69 to
$6.89 to $7.27 to $7.47.
AbbVie is raising its adjusted diluted EPS for the full-year 2021
from $12.32 to $12.52 to $12.37 to
$12.57. The company's 2021 adjusted
diluted EPS guidance excludes $5.10
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
first-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 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 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
March 31, 2021
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
1Q20
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Comparable
Operational a, b
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l
|
|
Total
|
ADJUSTED NET
REVENUESc
|
$9,675
|
|
$3,260
|
|
$12,935
|
|
57.1%
|
|
32.5%
|
|
50.1%
|
|
7.3%
|
|
(0.7)%
|
|
5.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
4,633
|
|
1,111
|
|
5,744
|
|
15.7
|
|
2.3
|
|
12.9
|
|
15.7
|
|
(2.8)
|
|
11.8
|
Humira
|
3,907
|
|
960
|
|
4,867
|
|
6.9
|
|
(8.3)
|
|
3.5
|
|
6.9
|
|
(12.6)
|
|
2.6
|
Skyrizi
|
481
|
|
93
|
|
574
|
|
80.6
|
|
>100.0
|
|
91.1
|
|
80.6
|
|
>100.0
|
|
88.9
|
Rinvoq
|
245
|
|
58
|
|
303
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,224
|
|
449
|
|
1,673
|
|
4.8
|
|
17.7
|
|
8.0
|
|
4.8
|
|
14.9
|
|
7.3
|
Imbruvicad
|
999
|
|
269
|
|
1,268
|
|
3.3
|
|
1.4
|
|
2.9
|
|
3.3
|
|
1.4
|
|
2.9
|
Venclexta
|
225
|
|
180
|
|
405
|
|
12.2
|
|
54.9
|
|
27.9
|
|
12.2
|
|
45.6
|
|
24.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
728
|
|
413
|
|
1,141
|
|
n/m
|
|
n/m
|
|
n/m
|
|
23.8
|
|
61.2
|
|
34.9
|
Botox
Cosmetic*
|
305
|
|
172
|
|
477
|
|
n/m
|
|
n/m
|
|
n/m
|
|
43.1
|
|
47.7
|
|
44.7
|
Juvederm
Collection*
|
123
|
|
198
|
|
321
|
|
n/m
|
|
n/m
|
|
n/m
|
|
14.9
|
|
69.6
|
|
43.0
|
Other
Aesthetics*
|
300
|
|
43
|
|
343
|
|
n/m
|
|
n/m
|
|
n/m
|
|
12.1
|
|
87.4
|
|
17.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,037
|
|
211
|
|
1,248
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
12.9
|
|
1.5
|
|
10.9
|
Botox
Therapeutic*
|
429
|
|
103
|
|
532
|
|
n/m
|
|
n/m
|
|
n/m
|
|
6.7
|
|
8.0
|
|
7.0
|
Vraylar*
|
346
|
|
—
|
|
346
|
|
n/m
|
|
n/a
|
|
n/m
|
|
21.2
|
|
n/a
|
|
21.2
|
Duodopa
|
25
|
|
104
|
|
129
|
|
0.8
|
|
4.7
|
|
3.9
|
|
0.8
|
|
(4.5)
|
|
(3.4)
|
Ubrelvy*
|
81
|
|
—
|
|
81
|
|
n/m
|
|
n/a
|
|
n/m
|
|
>100.0
|
|
n/a
|
|
>100.0
|
Other
Neuroscience*
|
156
|
|
4
|
|
160
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(19.5)
|
|
2.0
|
|
(19.1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
530
|
|
287
|
|
817
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(12.7)
|
|
(1.8)
|
|
(9.2)
|
Lumigan/Ganfort*
|
66
|
|
77
|
|
143
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(18.4)
|
|
(9.7)
|
|
(14.1)
|
Alphagan/Combigan*
|
80
|
|
38
|
|
118
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(13.5)
|
|
4.1
|
|
(8.5)
|
Restasis*
|
267
|
|
13
|
|
280
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(14.9)
|
|
19.3
|
|
(13.8)
|
Other Eye
Care*
|
117
|
|
159
|
|
276
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(2.4)
|
|
(0.4)
|
|
(1.3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Women's
Health
|
177
|
|
3
|
|
180
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
|
(19.6)
|
|
(61.0)
|
|
(21.2)
|
Lo
Loestrin*
|
102
|
|
2
|
|
104
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(11.2)
|
|
(8.1)
|
|
(11.1)
|
Orilissa/Oriahnn
|
29
|
|
1
|
|
30
|
|
(5.0)
|
|
58.8
|
|
(3.3)
|
|
(5.0)
|
|
52.8
|
|
(3.5)
|
Other Women's
Health*
|
46
|
|
—
|
|
46
|
|
n/m
|
|
n/m
|
|
n/m
|
|
(38.1)
|
|
(100.0)
|
|
(42.8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,021
|
|
294
|
|
1,315
|
|
12.4
|
|
(19.1)
|
|
3.4
|
|
(7.3)
|
|
(25.1)
|
|
(11.7)
|
Mavyret
|
170
|
|
245
|
|
415
|
|
(26.9)
|
|
(24.8)
|
|
(25.7)
|
|
(26.9)
|
|
(29.5)
|
|
(28.4)
|
Creon
|
274
|
|
—
|
|
274
|
|
(0.9)
|
|
n/a
|
|
(0.9)
|
|
(0.9)
|
|
n/a
|
|
(0.9)
|
Lupron
|
171
|
|
42
|
|
213
|
|
(12.1)
|
|
10.8
|
|
(8.3)
|
|
(12.1)
|
|
9.0
|
|
(8.6)
|
Linzess/Constella*
|
215
|
|
7
|
|
222
|
|
n/m
|
|
n/m
|
|
n/m
|
|
11.7
|
|
(6.6)
|
|
11.1
|
Synthroid
|
191
|
|
—
|
|
191
|
|
(6.8)
|
|
n/a
|
|
(6.8)
|
|
(6.8)
|
|
n/a
|
|
(6.8)
|
|
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 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
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
Quarter Ended
March 31, 2021 and 2020
(Unaudited) (In
millions, except per share data)
|
|
|
|
First
Quarter Ended March
31
|
|
|
2021
|
|
2020
|
Net
revenues
|
|
$
|
13,010
|
|
|
$
|
8,619
|
|
Cost of products
sold
|
|
4,213
|
|
|
1,942
|
|
Selling, general and
administrative
|
|
2,842
|
|
|
1,695
|
|
Research and
development
|
|
1,782
|
|
|
1,379
|
|
Acquired in-process
research and development
|
|
70
|
|
|
—
|
|
Total operating costs
and expenses
|
|
8,907
|
|
|
5,016
|
|
|
|
|
|
|
Operating
earnings
|
|
4,103
|
|
|
3,603
|
|
|
|
|
|
|
Interest expense,
net
|
|
622
|
|
|
428
|
|
Net foreign exchange
loss
|
|
9
|
|
|
5
|
|
Other expense
(income), net
|
|
(395)
|
|
|
72
|
|
Earnings before
income tax expense
|
|
3,867
|
|
|
3,098
|
|
Income tax
expense
|
|
312
|
|
|
88
|
|
Net
earnings
|
|
3,555
|
|
|
3,010
|
|
Net earnings
attributable to noncontrolling interest
|
|
2
|
|
|
—
|
|
Net earnings
attributable to AbbVie Inc.
|
|
$
|
3,553
|
|
|
$
|
3,010
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
|
$
|
1.99
|
|
|
$
|
2.02
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
|
$
|
2.95
|
|
|
$
|
2.42
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
|
1,775
|
|
|
1,484
|
|
|
a Refer to the Reconciliation
of GAAP Reported to Non-GAAP Adjusted Information for further
details.
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended
March 31, 2021
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
1Q21
|
|
|
Earnings
|
|
Diluted
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
|
3,867
|
|
|
$
|
3,553
|
|
|
$
|
1.99
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
2,009
|
|
|
1,682
|
|
|
0.94
|
|
Milestones and other
R&D expenses
|
210
|
|
|
180
|
|
|
0.10
|
|
Acquisition and
integration costs
|
224
|
|
|
155
|
|
|
0.09
|
|
Acquired
IPR&D
|
70
|
|
|
62
|
|
|
0.03
|
|
Change in fair value
of contingent consideration
|
(343)
|
|
|
(343)
|
|
|
(0.19)
|
|
Other
|
(29)
|
|
|
(21)
|
|
|
(0.01)
|
|
As adjusted
(non-GAAP)
|
$
|
6,008
|
|
|
$
|
5,268
|
|
|
$
|
2.95
|
|
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
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. Acquisition and integration costs
reflect integration costs as well as amortization of the
acquisition date fair value step-up for inventory related to the
Allergan acquisition. Acquired IPR&D primarily reflects upfront
payments related to R&D collaborations and licensing
arrangements with third parties. Other primarily includes milestone
revenue under an existing collaboration agreement, restructuring
charges associated with streamlining global operations and COVID-19
related expenses.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
|
1Q21
|
|
Net
revenues
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
|
13,010
|
|
|
$
|
4,213
|
|
|
$
|
2,842
|
|
|
$
|
1,782
|
|
|
$
|
70
|
|
|
$
|
(395)
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
|
(2,009)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
—
|
|
|
(210)
|
|
|
—
|
|
|
—
|
|
Acquisition and
integration costs
|
—
|
|
|
(99)
|
|
|
(76)
|
|
|
(49)
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(70)
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
343
|
|
Other
|
(75)
|
|
|
(20)
|
|
|
(23)
|
|
|
(18)
|
|
|
—
|
|
|
15
|
|
As
adjusted (non-GAAP)
|
$
|
12,935
|
|
|
$
|
2,085
|
|
|
$
|
2,743
|
|
|
$
|
1,505
|
|
|
$
|
—
|
|
|
$
|
(37)
|
|
|
3. The adjusted tax rate for
the first quarter of 2021 was 12.3 percent, as detailed
below:
|
|
|
|
1Q21
|
|
|
Pre-tax earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
$
|
3,867
|
|
|
$
|
312
|
|
|
|
8.1
|
%
|
Specified
items
|
|
2,141
|
|
|
426
|
|
|
|
19.9
|
%
|
As
adjusted (non-GAAP)
|
|
$
|
6,008
|
|
|
$
|
738
|
|
|
|
12.3
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended
March 31, 2020
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
1Q20
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
|
3,098
|
|
|
$
|
3,010
|
|
|
$
|
2.02
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
444
|
|
|
371
|
|
|
0.24
|
|
Acquisition related
costs
|
188
|
|
|
158
|
|
|
0.11
|
|
Milestones and other
R&D expenses
|
135
|
|
|
115
|
|
|
0.08
|
|
Change in fair value
of contingent consideration
|
72
|
|
|
72
|
|
|
0.05
|
|
Other
|
66
|
|
|
(113)
|
|
|
(0.08)
|
|
As adjusted
(non-GAAP)
|
$
|
4,003
|
|
|
$
|
3,613
|
|
|
$
|
2.42
|
|
|
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.
Other primarily includes the impacts of tax law changes, charitable
contributions to support COVID-19 relief efforts and restructuring
charges associated with streamlining global operations.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
1Q20
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Interest
expense,
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
|
1,942
|
|
|
$
|
1,695
|
|
|
$
|
1,379
|
|
|
$
|
428
|
|
|
$
|
72
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(444)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(44)
|
|
|
—
|
|
|
(144)
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(135)
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(72)
|
|
Other
|
(4)
|
|
|
(52)
|
|
|
(10)
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
1,494
|
|
|
$
|
1,599
|
|
|
$
|
1,234
|
|
|
$
|
284
|
|
|
$
|
—
|
|
|
3. The adjusted tax rate for
the first quarter of 2020 was 9.7 percent, as detailed
below:
|
|
|
|
1Q20
|
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
$
|
3,098
|
|
|
$
|
88
|
|
|
|
2.8
|
%
|
Specified
items
|
|
905
|
|
|
302
|
|
|
|
33.4
|
%
|
As
adjusted (non-GAAP)
|
|
$
|
4,003
|
|
|
$
|
390
|
|
|
|
9.7
|
%
|
View original
content:http://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2021-financial-results-301281124.html
SOURCE AbbVie