- Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4
Percent; Adjusted Diluted EPS of $3.37, an Increase of 11.2 Percent; These Results
Include an Unfavorable Impact of $0.14 Per Share related to Acquired IPR&D and
Milestones Expense 1
- Delivers Second-Quarter Net Revenues of $14.583 Billion, an Increase of 4.5 Percent on a
Reported Basis and 6.1 Percent Operationally
- Second-Quarter Global Net Revenues from the Immunology
Portfolio Were $7.207 Billion, an
Increase of 17.8 Percent on a Reported Basis, or 19.2 Percent on an
Operational Basis; U.S. Humira Net Revenues Were $4.664 Billion, an Increase of 9.6 Percent;
Internationally, Humira Net Revenues Were $699 Million, a Decrease of 13.8 Percent on a
Reported Basis, or 7.3 Percent on an Operational Basis, Due to
Biosimilar Competition; Global Skyrizi Net Revenues Were
$1.252 Billion; Global Rinvoq Net
Revenues Were $592 Million; Combined
Global Skyrizi and Rinvoq Net Revenues Were $1.844 Billion
- Second-Quarter Global Net Revenues from the Hematologic
Oncology Portfolio Were $1.650
Billion, a Decrease of 9.1 Percent on a Reported Basis, or
7.9 Percent on an Operational Basis; Global Imbruvica Net Revenues
Were $1.145 Billion, a Decrease of
17.1 Percent, with U.S. Net Revenues of $862 Million and International Profit Sharing of
$283 Million; Global Venclexta Net
Revenues Were $505 Million
- Second-Quarter Global Net Revenues from the Neuroscience
Portfolio Were $1.658 Billion, an
Increase of 13.7 Percent on a Reported Basis, or 15.2 Percent on an
Operational Basis; Global Botox Therapeutic Net Revenues Were
$678 Million; Vraylar Net Revenues
Were $492 Million
- Second-Quarter Global Net Revenues from the Aesthetics
Portfolio Were $1.371 Billion, a
Decrease of 4.4 Percent on a Reported Basis, or 2.1 Percent on an
Operational Basis; Global Botox Cosmetic Net Revenues Were
$695 Million; Global Juvederm Net
Revenues Were $344 Million,
Unfavorably Impacted by COVID-19 Restrictions in China and Suspension of Aesthetics Operations
in Russia
- Confirms 2022 Adjusted Diluted EPS Guidance Range of
$13.78 - $13.98, which Includes an Unfavorable Impact of
$0.23 Per Share Related to Acquired
IPR&D and Milestones Expense Incurred Year-To-Date Through the
Second Quarter 2022
NORTH CHICAGO, Ill.,
July 29,
2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced
financial results for the second quarter ended June 30, 2022.
"We delivered another strong quarter with substantial progress
for our new products and indications. Importantly, Skyrizi and
Rinvoq continued their impressive ramps and are on pace to deliver
approximately $7.5 billion in
combined annual sales, underscoring their significant potential,"
said Richard A. Gonzalez, chairman
and chief executive officer, AbbVie. "The momentum of our business,
combined with advances across our pipeline continue to support
AbbVie's promising long-term outlook."
Note: "Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
|
|
1 Beginning
in the first quarter 2022, AbbVie includes the impact of upfront
and milestone payments related to collaborations, licensing
agreements and other asset acquisitions in its reported non-GAAP
financial measures.
|
Second-Quarter Results
- Worldwide net revenues were $14.583
billion, an increase of 4.5 percent on a GAAP basis, or 6.1
percent on an operational basis.
- Global net revenues from the immunology portfolio were
$7.207 billion, an increase of 17.8
percent on a reported basis, or 19.2 percent on an operational
basis.
-
- Global Humira net revenues of $5.363
billion increased 5.8 percent on a reported basis, or 6.8
percent on an operational basis. U.S. Humira net revenues were
$4.664 billion, an increase of 9.6
percent. Internationally, Humira net revenues were $699 million, a decrease of 13.8 percent on a
reported basis, or 7.3 percent on an operational basis, due to
biosimilar competition.
- Global Skyrizi net revenues were $1.252
billion, an increase of 85.9 percent on a reported basis, or
88.3 percent on an operational basis.
- Global Rinvoq net revenues were $592
million, an increase of 56.3 percent on a reported basis, or
60.7 percent on an operational basis.
- Combined global Skyrizi and Rinvoq net revenues were
$1.844 billion.
- Global net revenues from the hematologic oncology portfolio
were $1.650 billion, a decrease of
9.1 percent on a reported basis, or 7.9 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.145 billion, a decrease of 17.1 percent, with
U.S. net revenues of $862 million and
international profit sharing of $283
million.
- Global Venclexta net revenues were $505
million, an increase of 16.2 percent on a reported basis, or
21.2 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.658 billion, an increase of 13.7
percent on a reported basis, or 15.2 percent on an operational
basis.
-
- Global Botox Therapeutic net revenues were $678 million, an increase of 12.6 percent on a
reported basis, or 14.5 percent on an operational basis.
- Vraylar net revenues were $492
million, an increase of 13.9 percent.
- Global Ubrelvy net revenues were $185
million.
- Global net revenues from the aesthetics portfolio were
$1.371 billion, a decrease of 4.4
percent on a reported basis, or 2.1 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $695 million, an increase of 18.9 percent on a
reported basis, or 21.2 percent on an operational basis.
- Global Juvederm net revenues were $344
million, a decrease of 19.5 percent on a reported basis, or
15.7 percent on an operational basis, unfavorably impacted by
COVID-19 restrictions in China and
suspension of aesthetics operations in Russia.
- On a GAAP basis, the gross margin ratio in the second quarter
was 71.4 percent. The adjusted gross margin ratio was 84.7
percent.
- On a GAAP basis, selling, general and administrative expense
was 37.1 percent of net revenues. The adjusted SG&A expense was
20.8 percent of net revenues.
- Research and development expense was 11.0 percent of net
revenues on both a GAAP and Non-GAAP adjusted basis.
- Acquired IPR&D and milestones expense was 1.8 percent of
net revenues.
- On a GAAP basis, the operating margin in the second quarter was
22.6 percent. The adjusted operating margin was 51.0 percent, which
includes an unfavorable 180 basis point impact from acquired
IPR&D and milestones expense.
- Net interest expense was $532
million.
- On a GAAP basis, the tax rate in the quarter was 21.6 percent.
The adjusted tax rate was 13.4 percent.
- Diluted EPS in the second quarter was $0.51 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $3.37.
These results include an unfavorable impact of $0.14 per share related to acquired IPR&D and
milestones expense.
Note: "Operational"
comparisons are presented at constant currency rates that reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
|
Recent Events
- AbbVie announced that the U.S. Food and Drug Administration
(FDA) approved Skyrizi (risankizumab) as the first and only
specific interleukin-23 inhibitor for the treatment of adults with
moderately to severely active Crohn's disease (CD). The approval is
supported by three pivotal Phase 3 studies in which Skyrizi
demonstrated significant improvements in clinical remission and
endoscopic response, compared to placebo, as both induction and
maintenance therapy. This marks Skyrizi's third FDA approved
indication. Skyrizi is a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
- AbbVie announced that the FDA approved Rinvoq (upadacitinib, 15
mg, once daily) for the treatment of adults with active ankylosing
spondylitis (AS) who have had an inadequate response or intolerance
to one or more tumor necrosis factor (TNF) blockers. The approval
is supported by data from two pivotal clinical trials in which
Rinvoq delivered rapid and meaningful disease control. This
approval marks the fifth FDA approved indication for Rinvoq in
chronic immune-mediated diseases.
- AbbVie announced the European Commission (EC) approved Rinvoq
(45 mg (induction dose) and 15 mg and 30 mg (maintenance doses))
for the treatment of adult patients with moderately to severely
active ulcerative colitis (UC). The approval is based on results
from two Phase 3 induction studies and one maintenance study in
which significantly more patients treated with Rinvoq achieved the
primary and all secondary endpoints compared to placebo.
- AbbVie announced the EC approved Rinvoq (15 mg, once daily) for
the treatment of adult patients with active non-radiographic axial
spondyloarthritis (nr-Axial SpA). The approval is based on results
from the Phase 3 SELECT-AXIS 2 study in which Rinvoq met the
primary endpoint and 12 of 14 ranked secondary endpoints.
- AbbVie announced that it submitted applications for a new
indication to the FDA and European Medicines Agency (EMA) for
Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance
doses)) for the treatment of adult patients with moderately to
severely active CD. The submissions are supported by three Phase 3
clinical trials demonstrating Rinvoq achieved the co-primary
endpoints of clinical remission and endoscopic response as
induction and maintenance treatment.
- AbbVie announced positive top-line results from the Phase 3
maintenance study, U-ENDURE, evaluating Rinvoq in adult patients
with moderate to severe CD. The results showed Rinvoq (15 mg or 30
mg, once daily) achieved the co-primary endpoints of endoscopic
response and clinical remission, as well as the secondary endpoint
of endoscopic remission, at one year (week 52) compared to placebo.
The safety results in this study were generally consistent with the
known profile of Rinvoq, with no new safety risks observed. Full
results from the study will be presented at upcoming medical
conferences and published in a peer-reviewed journal.
- At the Digestive Disease Week (DDW) Annual Meeting, AbbVie
presented 27 abstracts that reinforced its leadership in advancing
research and the standards of care across multiple
gastroenterological conditions. Presentations included further
analyses of Phase 3 clinical study programs for Rinvoq in
moderately to severely active UC and investigational use of Skyrizi
in moderately to severely active CD.
- At the European Alliance of Associations for Rheumatology
(EULAR) 2022 Congress, AbbVie showcased its leadership in
rheumatology research with new data across multiple inflammatory
joint diseases. Key data presented included SELECT-AXIS 2 trial
results evaluating the efficacy and safety of Rinvoq in patients
with nr-Axial SpA, and in patients with AS; two-year data from the
SELECT-PsA 1 and SELECT-PsA 2 studies of Rinvoq in patients with
psoriatic arthritis (PsA); and results of the one-year data
evaluating the efficacy and safety of Skyrizi in patients with
active PsA in the KEEPsAKE 1 and KEEPsAKE 2 clinical trials.
- At the American Society of Clinical Oncology (ASCO) Annual
Meeting and European Hematology Association (EHA) Congress, AbbVie
presented 46 abstracts for six investigational and approved
medicines across eight cancer types. Highlights included new data
that showed Venclexta (venetoclax) plus obinutuzumab demonstrated
sustained progression-free survival (PFS) in chronic lymphocytic
leukemia (CLL) patients after four years off treatment; results
from a Phase 2 trial of epcoritamab which showed clinically
meaningful efficacy in challenging-to-treat, highly refractory,
large B-cell lymphoma (LBCL) patients; and new data from the Phase
2 REFINE study of investigational navitoclax in combination with
ruxolitinib that is supportive of early intervention in
myelofibrosis (MF) to achieve improved clinical outcomes in spleen
volume reduction (SVR), symptom score and bone marrow fibrosis
(BMF). 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.
Epcoritamab is being co-developed by AbbVie and Genmab.
- AbbVie announced that it submitted a New Drug Application (NDA)
to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the
treatment of motor fluctuations in patients with advanced
Parkinson's disease (PD). The submission is based on results from a
Phase 3, head-to-head, randomized and controlled clinical trial
demonstrating statistically significant improvement in "On" time
without troublesome dyskinesia compared to oral immediate-release
carbidopa/levodopa (CD/LD). If approved, ABBV-951 will offer
patients the first continuous subcutaneous delivery of CD/LD
prodrugs.
- AbbVie announced that it submitted a supplemental NDA to the
FDA for Qulipta (atogepant) to support label expansion for the
preventive treatment of migraine in adult patients with chronic
migraine. AbbVie also submitted a marketing authorization
application for Qulipta with the EMA for the preventive treatment
of migraine in adult patients who have at least four migraine days
per month.
- At the American Headache Society (AHS) Annual Scientific
Meeting, AbbVie presented 29 abstracts that covered a wide range of
studies across AbbVie's migraine portfolio. Presentations
highlighted positive results from the Phase 3 PROGRESS trial
investigating Qulipta for the preventive treatment of migraine in
patients with chronic migraine, clinical trial results evaluating
Ubrelvy (ubrogepant) for acute treatment of migraine and data
evaluating Botox (onabotulinumtoxinA) for the preventive treatment
of migraine in patient with chronic migraine.
- At the American Psychiatric Association (APA) Annual Meeting,
AbbVie presented positive data from a Phase 3 trial of Vraylar
(cariprazine, 1.5 mg/day) for the adjunctive treatment of major
depressive disorder (MDD) in patients with an inadequate response
to ongoing antidepressant therapy. The study met its primary
endpoint of statistically significant improvement using the
Montgomery-Åsberg Depression Rating Scale (MADRS) total score in
patients compared with placebo. Vraylar's safety profile was
consistent with that of previous studies across indications in the
treatment of adults with depressive episodes associated with
bipolar I disorder, the acute treatment of manic or mixed episodes
associated with bipolar I disorder and schizophrenia. Vraylar is
being co-developed by AbbVie and Gedeon Richter Plc.
- At the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting, AbbVie presented new data from its leading
portfolio of eye care treatments. Highlights included new data on
Vuity (pilocarpine HCl ophthalmic solution) 1.25%, the first and
only FDA-approved eye drop for the treatment of presbyopia
(age-related blurry near vision) in adults, and Durysta
(bimatoprost intracameral implant), a first-of-its-kind
biodegradable implant to lower eye pressure for glaucoma
patients.
- AbbVie and Cugene Inc., a clinical-stage biotechnology company
focused on developing next-generation precision immunology and
oncology medicines to treat autoimmune disease and cancer,
announced an exclusive worldwide license option agreement for
CUG252, a potential best-in-class Treg-selective IL-2 mutein, as
well as other novel IL-2 muteins, for the potential treatment of
autoimmune and inflammatory diseases.
- AbbVie and iSTAR Medical announced a strategic transaction to
further develop and commercialize iSTAR Medical's MINIject device,
a next-generation minimally invasive glaucoma surgical (MIGS)
device for patients with glaucoma. This alliance accelerates iSTAR
Medical's goal to bring MINIject to more patients globally and
provides an opportunity for AbbVie to further expand its diverse
eye care portfolio.
Full-Year 2022 Outlook
AbbVie is confirming its adjusted diluted EPS guidance range for
the full-year 2022 of $13.78 -
$13.98 which includes an unfavorable
impact of $0.23 per share related to
acquired IPR&D and milestones expense incurred year-to-date
through the second quarter 2022. The company's 2022 adjusted
diluted EPS guidance excludes any impact from acquired IPR&D
and milestones that may be incurred beyond the second quarter of
2022, as both cannot be reliably forecasted.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology and gastroenterology, in
addition to products and services across our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook or
LinkedIn.
Conference Call
AbbVie will host an investor conference call today at
8:00 a.m. Central time to discuss our
second-quarter performance. The call will be webcast through
AbbVie's Investor Relations website at investors.abbvie.com. An
archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 2022 and 2021 are presented on both a
reported and a non-GAAP basis. Reported results were prepared in
accordance with GAAP and include all revenue and expenses
recognized during the period. Non-GAAP results adjust for certain
non-cash items and for factors that are unusual or unpredictable,
and exclude those costs, expenses, and other specified items
presented in the reconciliation tables later in this release.
Beginning in the first quarter of 2022, the company includes the
impact of upfront and milestone payments related to collaborations,
licensing agreements, and other asset acquisitions in its reported
non-GAAP financial measures. Prior periods have been revised to
conform to the current period presentation. AbbVie's management
believes non-GAAP financial measures provide useful information to
investors regarding AbbVie's results of operations and assist
management, analysts, and investors in evaluating the performance
of the business. Non-GAAP financial measures should be considered
in addition to, and not as a substitute for, measures of financial
performance prepared in accordance with GAAP.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, the failure to
realize the expected benefits of AbbVie's acquisition of Allergan
or to promptly and effectively integrate Allergan's business,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. Additional
information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations
is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual
Report on Form 10-K, which has been filed with the Securities and
Exchange Commission, as updated by its Quarterly Reports on Form
10-Q and in other documents that AbbVie subsequently files with the
Securities and Exchange Commission that update, supplement or
supersede such information. AbbVie undertakes no obligation to
release publicly any revisions to forward-looking statements as a
result of subsequent events or developments, except as required by
law.
AbbVie
Inc.
Key Product
Revenues
Quarter Ended June
30, 2022
(Unaudited)
|
|
|
|
|
|
|
|
% Change vs.
2Q21
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$11,410
|
|
$3,173
|
|
$14,583
|
|
5.6 %
|
|
0.6 %
|
|
4.5 %
|
|
7.6 %
|
|
6.1 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
6,155
|
|
1,052
|
|
7,207
|
|
20.3
|
|
4.9
|
|
17.8
|
|
13.4
|
|
19.2
|
Humira
|
4,664
|
|
699
|
|
5,363
|
|
9.6
|
|
(13.8)
|
|
5.8
|
|
(7.3)
|
|
6.8
|
Skyrizi
|
1,079
|
|
173
|
|
1,252
|
|
91.1
|
|
59.1
|
|
85.9
|
|
73.9
|
|
88.3
|
Rinvoq
|
412
|
|
180
|
|
592
|
|
39.4
|
|
>100.0
|
|
56.3
|
|
>100.0
|
|
60.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,115
|
|
535
|
|
1,650
|
|
(15.7)
|
|
8.5
|
|
(9.1)
|
|
12.9
|
|
(7.9)
|
Imbruvicab
|
862
|
|
283
|
|
1,145
|
|
(21.6)
|
|
0.5
|
|
(17.1)
|
|
0.5
|
|
(17.1)
|
Venclexta
|
253
|
|
252
|
|
505
|
|
13.4
|
|
19.1
|
|
16.2
|
|
29.3
|
|
21.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
883
|
|
488
|
|
1,371
|
|
(4.5)
|
|
(4.2)
|
|
(4.4)
|
|
2.1
|
|
(2.1)
|
Botox
Cosmetic
|
449
|
|
246
|
|
695
|
|
22.4
|
|
12.9
|
|
18.9
|
|
19.2
|
|
21.2
|
Juvederm
Collection
|
147
|
|
197
|
|
344
|
|
(24.9)
|
|
(15.0)
|
|
(19.5)
|
|
(8.1)
|
|
(15.7)
|
Other
Aesthetics
|
287
|
|
45
|
|
332
|
|
(20.9)
|
|
(24.4)
|
|
(21.4)
|
|
(20.2)
|
|
(20.8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,438
|
|
220
|
|
1,658
|
|
16.2
|
|
(0.3)
|
|
13.7
|
|
9.4
|
|
15.2
|
Botox
Therapeutic
|
557
|
|
121
|
|
678
|
|
14.2
|
|
5.6
|
|
12.6
|
|
15.6
|
|
14.5
|
Vraylar
|
492
|
|
—
|
|
492
|
|
13.9
|
|
n/a
|
|
13.9
|
|
n/a
|
|
13.9
|
Duodopa
|
26
|
|
94
|
|
120
|
|
3.2
|
|
(7.4)
|
|
(5.4)
|
|
2.2
|
|
2.3
|
Ubrelvy
|
185
|
|
—
|
|
185
|
|
47.6
|
|
n/a
|
|
47.6
|
|
n/a
|
|
47.6
|
Qulipta
|
33
|
|
—
|
|
33
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience
|
145
|
|
5
|
|
150
|
|
(13.6)
|
|
9.6
|
|
(12.9)
|
|
12.9
|
|
(12.8)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
407
|
|
310
|
|
717
|
|
(34.1)
|
|
2.5
|
|
(22.0)
|
|
10.8
|
|
(19.3)
|
Lumigan/Ganfort
|
60
|
|
70
|
|
130
|
|
(17.4)
|
|
(8.1)
|
|
(12.5)
|
|
(0.9)
|
|
(8.7)
|
Alphagan/Combigan
|
54
|
|
38
|
|
92
|
|
(48.5)
|
|
(2.3)
|
|
(35.6)
|
|
6.6
|
|
(33.1)
|
Restasis
|
151
|
|
17
|
|
168
|
|
(51.5)
|
|
14.9
|
|
(48.4)
|
|
24.2
|
|
(48.0)
|
Other Eye
Care
|
142
|
|
185
|
|
327
|
|
9.7
|
|
7.4
|
|
8.4
|
|
16.0
|
|
13.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
768
|
|
203
|
|
971
|
|
3.7
|
|
(17.8)
|
|
(1.6)
|
|
(9.7)
|
|
0.4
|
Mavyret
|
203
|
|
195
|
|
398
|
|
0.2
|
|
(18.0)
|
|
(9.7)
|
|
(9.8)
|
|
(5.3)
|
Creon
|
318
|
|
—
|
|
318
|
|
13.6
|
|
n/a
|
|
13.6
|
|
n/a
|
|
13.6
|
Linzess/Constella
|
247
|
|
8
|
|
255
|
|
(4.2)
|
|
(12.5)
|
|
(4.5)
|
|
(7.8)
|
|
(4.4)
|
a
"Operational" comparisons are
presented at constant currency rates that reflect comparative local
currency net revenues at the prior year's foreign exchange
rates.
|
b
Reflects profit
sharing for Imbruvica international revenues.
|
n/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Six Months Ended
June 30, 2022
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
6M21
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$21,758
|
|
$6,363
|
|
$28,121
|
|
5.9 %
|
|
(0.8) %
|
|
4.3 %
|
|
5.3 %
|
|
5.7 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
11,240
|
|
2,108
|
|
13,348
|
|
15.3
|
|
(0.2)
|
|
12.5
|
|
7.0
|
|
13.8
|
Humira
|
8,657
|
|
1,442
|
|
10,099
|
|
6.0
|
|
(18.6)
|
|
1.7
|
|
(13.1)
|
|
2.7
|
Skyrizi
|
1,860
|
|
332
|
|
2,192
|
|
77.8
|
|
64.7
|
|
75.7
|
|
78.1
|
|
77.9
|
Rinvoq
|
723
|
|
334
|
|
1,057
|
|
33.7
|
|
>100.0
|
|
55.1
|
|
>100.0
|
|
59.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
2,217
|
|
1,079
|
|
3,296
|
|
(12.9)
|
|
14.4
|
|
(5.5)
|
|
18.5
|
|
(4.4)
|
Imbruvicab
|
1,736
|
|
582
|
|
2,318
|
|
(17.2)
|
|
5.6
|
|
(12.5)
|
|
5.6
|
|
(12.5)
|
Venclexta
|
481
|
|
497
|
|
978
|
|
7.5
|
|
26.8
|
|
16.5
|
|
36.7
|
|
21.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
1,729
|
|
1,016
|
|
2,745
|
|
4.6
|
|
10.2
|
|
6.6
|
|
16.2
|
|
8.7
|
Botox
Cosmetic
|
862
|
|
474
|
|
1,336
|
|
28.3
|
|
21.5
|
|
25.8
|
|
27.7
|
|
28.1
|
Juvederm
Collection
|
295
|
|
459
|
|
754
|
|
(7.5)
|
|
6.7
|
|
0.7
|
|
13.0
|
|
4.3
|
Other
Aesthetics
|
572
|
|
83
|
|
655
|
|
(13.6)
|
|
(18.3)
|
|
(14.2)
|
|
(14.3)
|
|
(13.7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
2,711
|
|
435
|
|
3,146
|
|
19.2
|
|
0.8
|
|
16.2
|
|
9.1
|
|
17.5
|
Botox
Therapeutic
|
1,057
|
|
235
|
|
1,292
|
|
15.3
|
|
8.0
|
|
13.9
|
|
16.3
|
|
15.5
|
Vraylar
|
919
|
|
—
|
|
919
|
|
18.1
|
|
n/a
|
|
18.1
|
|
n/a
|
|
18.1
|
Duodopa
|
50
|
|
191
|
|
241
|
|
(1.2)
|
|
(7.2)
|
|
(6.0)
|
|
1.3
|
|
0.8
|
Ubrelvy
|
323
|
|
—
|
|
323
|
|
56.4
|
|
n/a
|
|
56.4
|
|
n/a
|
|
56.4
|
Qulipta
|
44
|
|
—
|
|
44
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/a
|
|
n/m
|
Other
Neuroscience
|
318
|
|
9
|
|
327
|
|
(1.7)
|
|
10.4
|
|
(1.4)
|
|
12.6
|
|
(1.3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
903
|
|
585
|
|
1,488
|
|
(21.2)
|
|
(0.7)
|
|
(14.3)
|
|
7.4
|
|
(11.6)
|
Lumigan/Ganfort
|
127
|
|
143
|
|
270
|
|
(8.3)
|
|
(6.9)
|
|
(7.5)
|
|
(0.1)
|
|
(3.9)
|
Alphagan/Combigan
|
124
|
|
75
|
|
199
|
|
(32.3)
|
|
(3.1)
|
|
(23.6)
|
|
6.0
|
|
(20.9)
|
Restasis
|
386
|
|
28
|
|
414
|
|
(33.2)
|
|
(0.2)
|
|
(31.7)
|
|
14.0
|
|
(31.0)
|
Other Eye
Care
|
266
|
|
339
|
|
605
|
|
7.7
|
|
2.6
|
|
4.8
|
|
10.5
|
|
9.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,457
|
|
421
|
|
1,878
|
|
4.0
|
|
(15.6)
|
|
(1.1)
|
|
(8.2)
|
|
0.8
|
Mavyret
|
372
|
|
406
|
|
778
|
|
(0.4)
|
|
(15.9)
|
|
(9.1)
|
|
(8.4)
|
|
(4.9)
|
Creon
|
605
|
|
—
|
|
605
|
|
9.2
|
|
n/a
|
|
9.2
|
|
n/a
|
|
9.2
|
Linzess/Constella
|
480
|
|
15
|
|
495
|
|
1.3
|
|
(3.8)
|
|
1.1
|
|
0.7
|
|
1.2
|
a "Operational" comparisons
are presented at constant currency rates that reflect comparative
local currency net revenues at the prior year's foreign exchange
rates.
|
b Reflects profit sharing for
Imbruvica international revenues.
|
n/a = not
applicable
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
Quarter and Six
Months Ended June 30, 2022 and 2021
(Unaudited) (In
millions, except per share data)
|
|
|
Second
Quarter
Ended June
30
|
|
Six
Months
Ended June
30
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Net revenues
|
$
14,583
|
|
$
13,959
|
|
$
28,121
|
|
$
26,969
|
Cost of products
sold
|
4,170
|
|
4,523
|
|
8,222
|
|
8,736
|
Selling, general and
administrative
|
5,412
|
|
3,164
|
|
8,539
|
|
6,006
|
Research and
developmenta
|
1,609
|
|
1,767
|
|
3,106
|
|
3,434
|
Acquired IPR&D and
milestonesa
|
269
|
|
132
|
|
414
|
|
317
|
Other operating
income
|
(172)
|
|
(68)
|
|
(172)
|
|
(68)
|
Total operating costs
and expenses
|
11,288
|
|
9,518
|
|
20,109
|
|
18,425
|
|
|
|
|
|
|
|
|
Operating
earnings
|
3,295
|
|
4,441
|
|
8,012
|
|
8,544
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
532
|
|
606
|
|
1,071
|
|
1,228
|
Net foreign exchange
loss
|
47
|
|
14
|
|
72
|
|
23
|
Other expense,
net
|
1,533
|
|
2,658
|
|
757
|
|
2,263
|
Earnings before income
tax expense
|
1,183
|
|
1,163
|
|
6,112
|
|
5,030
|
Income tax
expense
|
255
|
|
394
|
|
691
|
|
706
|
Net earnings
|
928
|
|
769
|
|
5,421
|
|
4,324
|
Net earnings
attributable to noncontrolling interest
|
4
|
|
3
|
|
7
|
|
5
|
Net earnings
attributable to AbbVie Inc.
|
$
924
|
|
$
766
|
|
$
5,414
|
|
$
4,319
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
0.51
|
|
$
0.42
|
|
$
3.03
|
|
$
2.41
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per shareb
|
$
3.37
|
|
$
3.03
|
|
$
6.52
|
|
$
5.92
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,776
|
|
1,776
|
|
1,777
|
|
1,776
|
a
|
During the three months
ended March 31, 2022, AbbVie changed its classification of
development milestone expense associated with licensing and
collaboration arrangements in the consolidated statement of
earnings. Milestone payments incurred prior to regulatory approval,
which were previously included in research and development expense,
are now presented as acquired IPR&D and milestones expense. The
reclassification decreased research and development expense and
increased acquired IPR&D and milestones expense by
$35 million for the three months and $150 million for the
six months ended June 30, 2021. The company believes this
presentation assists users of the financial statements to better
understand the total upfront and subsequent development milestone
payments incurred to acquire in-process research and development
projects. Prior periods have been revised to conform to the current
period presentation. The reclassification had no impact on total
operating costs and expenses, operating earnings, net earnings, net
earnings attributable to AbbVie, Inc., earnings per share, or total
equity.
|
|
|
b
|
Refer to the
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
for further details.
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June
30, 2022
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
|
2Q22
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
1,183
|
|
$
924
|
|
$
0.51
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,849
|
|
1,556
|
|
0.88
|
Acquisition and
integration costs
|
109
|
|
98
|
|
0.05
|
Change in fair value
of contingent consideration
|
1,609
|
|
1,621
|
|
0.91
|
Pylera
divestiture
|
(172)
|
|
(126)
|
|
(0.07)
|
Litigation
matters
|
2,203
|
|
1,779
|
|
1.00
|
Other
|
159
|
|
154
|
|
0.09
|
As adjusted
(non-GAAP)
|
$
6,940
|
|
$
6,006
|
|
$
3.37
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs related to the Allergan
acquisition. Litigation matters primarily includes a charge related
to a potential settlement of litigation involving Allergan's past
sales of opioid products. Other primarily includes restructuring
charges associated with streamlining global operations and COVID-19
related expenses.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the three
months ended June 30, 2022 included acquired IPR&D and
milestones expense of $269 million on a pre-tax and
$254 million on an after-tax basis, representing an
unfavorable impact of $0.14 to both diluted EPS and adjusted
diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
2Q22
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
4,170
|
|
$
5,412
|
|
$
1,609
|
|
$
(172)
|
|
$
1,533
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,849)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(28)
|
|
(79)
|
|
(2)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,609)
|
Pylera
divestiture
|
—
|
|
—
|
|
—
|
|
172
|
|
—
|
Litigation
matters
|
—
|
|
(2,203)
|
|
—
|
|
—
|
|
—
|
Other
|
(61)
|
|
(95)
|
|
—
|
|
—
|
|
(3)
|
As adjusted
(non-GAAP)
|
$
2,232
|
|
$
3,035
|
|
$
1,607
|
|
$
—
|
|
$
(79)
|
|
3. The adjusted tax rate for
the second quarter of 2022 was 13.4 percent, as detailed
below:
|
|
|
2Q22
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
1,183
|
|
$
255
|
|
21.6 %
|
Specified
items
|
5,757
|
|
675
|
|
11.7 %
|
As adjusted
(non-GAAP)
|
$
6,940
|
|
$
930
|
|
13.4 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June
30, 2021
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
2Q21
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
1,163
|
|
$
766
|
|
$
0.42
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,999
|
|
1,662
|
|
0.95
|
Acquisition and
integration costs
|
135
|
|
106
|
|
0.05
|
Change in fair value
of contingent consideration
|
2,692
|
|
2,690
|
|
1.51
|
Litigation
matters
|
107
|
|
93
|
|
0.05
|
Other
|
130
|
|
107
|
|
0.05
|
As adjusted
(non-GAAP)
|
$
6,226
|
|
$
5,424
|
|
$
3.03
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs related to the Allergan
acquisition. Other primarily includes the purchase of an FDA
priority review voucher from a third party, restructuring charges
associated with streamlining global operations and COVID-19 related
expenses.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the three
months ended June 30, 2021 included acquired IPR&D and
milestones expense of $132 million on a pre-tax and after-tax
basis, representing an unfavorable impact of $0.08 to both diluted
EPS and adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
2Q21
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$ 4,523
|
|
$ 3,164
|
|
$ 1,767
|
|
$
(68)
|
|
$ 2,658
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,999)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(24)
|
|
(94)
|
|
(17)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,692)
|
Litigation
matters
|
—
|
|
(107)
|
|
—
|
|
—
|
|
—
|
Other
|
(21)
|
|
(10)
|
|
(167)
|
|
68
|
|
—
|
As adjusted
(non-GAAP)
|
$ 2,479
|
|
$ 2,953
|
|
$ 1,583
|
|
$
—
|
|
$
(34)
|
|
3. The adjusted tax
rate for the second quarter of 2021 was 12.8 percent, as detailed
below:
|
|
|
2Q21
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
1,163
|
|
$
394
|
|
33.8 %
|
Specified
items
|
5,063
|
|
405
|
|
8.0 %
|
As adjusted
(non-GAAP)
|
$
6,226
|
|
$
799
|
|
12.8 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended
June 30, 2022
(Unaudited) (In
millions, except per share data)
|
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
6M22
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
6,112
|
|
$
5,414
|
|
$
3.03
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
3,704
|
|
3,121
|
|
1.75
|
Acquisition and
integration costs
|
247
|
|
219
|
|
0.12
|
Change in fair value
of contingent consideration
|
861
|
|
875
|
|
0.49
|
Pylera
divestiture
|
(172)
|
|
(126)
|
|
(0.07)
|
Litigation
matters
|
2,387
|
|
1,927
|
|
1.08
|
Other
|
223
|
|
217
|
|
0.12
|
As adjusted
(non-GAAP)
|
$
13,362
|
|
$
11,647
|
|
$
6.52
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs related to the Allergan
acquisition. Litigation matters primarily includes a charge related
to a potential settlement of litigation involving Allergan's past
sales of opioid products. Other primarily includes restructuring
charges associated with streamlining global operations.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the six
months ended June 30, 2022 included acquired IPR&D and
milestones expense of $414 million on a pre-tax and
$399 million on an after-tax basis, representing an
unfavorable impact of $0.23 to both diluted EPS and adjusted
diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
6M22
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$ 8,222
|
|
$ 8,539
|
|
$ 3,106
|
|
$
(172)
|
|
$
757
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(3,704)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(62)
|
|
(172)
|
|
(13)
|
|
—
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(861)
|
Pylera
divestiture
|
—
|
|
—
|
|
—
|
|
172
|
|
—
|
Litigation
matters
|
—
|
|
(2,387)
|
|
—
|
|
—
|
|
—
|
Other
|
(121)
|
|
(93)
|
|
(6)
|
|
—
|
|
(3)
|
As adjusted
(non-GAAP)
|
$ 4,335
|
|
$ 5,887
|
|
$ 3,087
|
|
$
—
|
|
$
(107)
|
|
3. The adjusted tax rate for
the first six months of 2022 was 12.8 percent, as detailed
below:
|
|
|
6M22
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
6,112
|
|
$
691
|
|
11.3 %
|
Specified
items
|
7,250
|
|
1,017
|
|
14.0 %
|
As adjusted
(non-GAAP)
|
$
13,362
|
|
$
1,708
|
|
12.8 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended
June 30, 2021
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
6M21
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
5,030
|
|
$
4,319
|
|
$
2.41
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
4,008
|
|
3,344
|
|
1.88
|
Acquisition and
integration costs
|
359
|
|
261
|
|
0.15
|
Change in fair value
of contingent consideration
|
2,349
|
|
2,347
|
|
1.32
|
Litigation
matters
|
107
|
|
93
|
|
0.05
|
Other
|
271
|
|
219
|
|
0.11
|
As adjusted
(non-GAAP)
|
$
12,124
|
|
$
10,583
|
|
$
5.92
|
a
Represents net earnings attributable to AbbVie
Inc.
|
|
Acquisition and
integration costs reflect integration costs as well as amortization
of the acquisition date fair value step-up for inventory related to
the Allergan acquisition. Other primarily includes the purchase of
FDA priority review vouchers from third parties, restructuring
charges associated with streamlining global operations and COVID-19
related expenses.
|
|
Beginning in the first
quarter of 2022, the company includes acquired IPR&D and
milestones expense in its reported non-GAAP financial measures.
Reported GAAP earnings and adjusted non-GAAP earnings for the six
months ended June 30, 2021 included acquired IPR&D and
milestones expense of $317 million on a pre-tax and $300 million on
an after-tax basis, representing an unfavorable impact of $0.17 to
both diluted EPS and adjusted diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
6M21
|
|
Cost of
products sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense, net
|
As reported
(GAAP)
|
$
8,736
|
|
$
6,006
|
|
$
3,434
|
|
$
(68)
|
|
$
2,263
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(4,008)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(123)
|
|
(170)
|
|
(66)
|
|
—
|
|
—
|
Change in fair value
of contingent
consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,349)
|
Litigation
matters
|
—
|
|
(107)
|
|
—
|
|
—
|
|
—
|
Other
|
(41)
|
|
(33)
|
|
(280)
|
|
68
|
|
15
|
As adjusted
(non-GAAP)
|
$
4,564
|
|
$
5,696
|
|
$
3,088
|
|
$
—
|
|
$
(71)
|
|
3. The adjusted tax rate for
the first six months of 2021 was 12.7 percent, as detailed
below:
|
|
|
6M21
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
5,030
|
|
$
706
|
|
14.0 %
|
Specified
items
|
7,094
|
|
830
|
|
11.7 %
|
As adjusted
(non-GAAP)
|
$
12,124
|
|
$
1,536
|
|
12.7 %
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-second-quarter-2022-financial-results-301596053.html
SOURCE AbbVie