- Reports Second-Quarter Diluted EPS of $1.14 on a GAAP Basis, an Increase of 123.5
Percent; Adjusted Diluted EPS of $2.91, a Decrease of 13.6 Percent; These Results
Include an Unfavorable Impact of $0.15 Per Share Related to Acquired IPR&D and
Milestones Expense
- Delivers Second-Quarter Net Revenues of $13.865 Billion, a Decrease of 4.9 Percent on a
Reported Basis and 4.2 Percent on an Operational Basis
- Second-Quarter Global Net Revenues from the
Immunology Portfolio Were $6.813
Billion, a Decrease of 5.5 Percent on a Reported Basis, or
5.0 Percent on an Operational Basis; Global Humira Net Revenues
Were $4.012 Billion; Global Skyrizi
Net Revenues Were $1.883 Billion;
Global Rinvoq Net Revenues Were $918
Million
- Second-Quarter Global Net Revenues from the
Hematologic Oncology Portfolio Were $1.478
Billion, a Decrease of 10.4 Percent on a Reported Basis, or
9.8 Percent on an Operational Basis; Global Imbruvica Net Revenues
Were $907 Million; Global Venclexta
Net Revenues Were $571
Million
- Second-Quarter Global Net Revenues from the
Neuroscience Portfolio Were $1.885
Billion, an Increase of 13.6 Percent on a Reported Basis, or
14.2 Percent on an Operational Basis; Global Botox Therapeutic Net
Revenues Were $748 Million; Global
Vraylar Net Revenues Were $658
Million
- Second-Quarter Global Net Revenues from the
Aesthetics Portfolio Were $1.384
Billion, an Increase of 1.0 Percent on a Reported Basis, or
2.9 Percent on an Operational Basis; Global Botox Cosmetic Net
Revenues Were $685 Million; Global
Juvederm Net Revenues Were $368
Million
- Raises 2023 Adjusted Diluted EPS Guidance Range from
$10.57 - $10.97 to $10.90 -
$11.10, 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 2023
NORTH
CHICAGO, Ill., July 27,
2023 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced
financial results for the second quarter ended June 30, 2023.
"AbbVie's second quarter results were well ahead of our
expectations as we continue to demonstrate outstanding operational
execution. The strong performance was driven predominantly by our
non-Humira business, which delivered high single-digit sales
growth, in line with our long-term outlook," said Richard A. Gonzalez, chairman and chief
executive officer, AbbVie. "We continue to make progress across all
stages of our pipeline and based upon the strong momentum of our
diversified portfolio, we are once again raising our full year
guidance."
Second-Quarter Results
- Worldwide net revenues were $13.865
billion, a decrease of 4.9 percent on a reported basis, or
4.2 percent on an operational basis.
- Global net revenues from the immunology portfolio were
$6.813 billion, a decrease of 5.5
percent on a reported basis, or 5.0 percent on an operational
basis.
-
- Global Humira net revenues of $4.012 billion decreased 25.2 percent on a
reported basis, or 24.8 percent on an operational basis. U.S.
Humira net revenues were $3.452
billion, a decrease of 26.0 percent. Internationally, Humira
net revenues were $560 million, a
decrease of 19.8 percent on a reported basis, or 17.0 percent on an
operational basis.
- Global Skyrizi net revenues were $1.883 billion, an increase of 50.4 percent on a
reported basis, or 51.0 percent on an operational basis.
- Global Rinvoq net revenues were $918 million, an increase of 55.1 percent on a
reported basis, or 56.7 percent on an operational basis.
- Global net revenues from the hematologic oncology portfolio
were $1.478 billion, a decrease of
10.4 percent on a reported basis, or 9.8 percent on an operational
basis.
-
- Global Imbruvica net revenues were $907
million, a decrease of 20.8 percent, with U.S. net revenues
of $666 million and international
profit sharing of $241 million.
- Global Venclexta net revenues were $571
million, an increase of 13.1 percent on a reported basis, or
15.0 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.885 billion, an increase of 13.6
percent on a reported basis, or 14.2 percent on an operational
basis.
-
- Global Botox Therapeutic net revenues were $748 million, an increase of 10.2 percent on a
reported basis, or 11.3 percent on an operational basis.
- Global Vraylar net revenues were $658 million, an increase of 33.9 percent.
- Global Ubrelvy net revenues were $196 million, an increase of 5.9 percent on a
reported basis, or 6.0 percent on an operational basis.
- Global net revenues from the aesthetics portfolio were
$1.384 billion, an increase of 1.0
percent on a reported basis, or 2.9 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $685 million, a decrease of 1.4 percent on a
reported basis, or an increase of 0.7 percent on an operational
basis.
- Global Juvederm net revenues were $368 million, an increase of 6.9 percent on a
reported basis, or 9.7 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the second quarter
was 69.4 percent. The adjusted gross margin ratio was 84.7
percent.
- On a GAAP basis, selling, general and administrative (SG&A)
expense was 23.6 percent of net revenues. The adjusted SG&A
expense was 23.2 percent of net revenues.
- On a GAAP basis, research and development (R&D) expense was
12.5 percent of net revenues. The adjusted R&D expense was 12.5
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- Acquired IPR&D and milestones expense was 2.0 percent
of net revenues.
- On a GAAP basis, the operating margin in the second quarter was
32.5 percent. The adjusted operating margin was 47.0 percent.
- Net interest expense was $454
million.
- On a GAAP basis, the tax rate in the quarter was 22.3 percent.
The adjusted tax rate was 15.8 percent.
- Diluted EPS in the second quarter was $1.14 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.91.
These results include an unfavorable impact of $0.15 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 Rinvoq (upadacitinib) for the treatment of adults
with moderately to severely active Crohn's disease (CD) who have
had an inadequate response or intolerance to one or more TNF
blockers. The approval is based on results from three studies in
which Rinvoq achieved the co-primary endpoints of clinical
remission and endoscopic response, compared to placebo, as both
induction and maintenance therapy. This is the seventh FDA approved
indication for Rinvoq across gastroenterology, rheumatology and
dermatology.
- AbbVie announced Skyrizi (risankizumab) met the primary and key
secondary endpoints in a 52-week Phase 3 maintenance study in
patients with moderately to severely active ulcerative colitis
(UC). In UC patients with a clinical response to Skyrizi induction
treatment, a significantly higher proportion of patients treated
with Skyrizi (180 mg or 360 mg) achieved the primary endpoint of
clinical remission (per Adapted Mayo Score) at week 52 compared to
withdrawal from Skyrizi treatment. Safety results in this study
were 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 the British Journal of Dermatology
published results from the head-to-head Phase 4 IMMpulse study that
evaluated the efficacy and safety of Skyrizi compared to Otezla
among adult patients with moderate plaque psoriasis (PsO) eligible
for systemic therapy. In the study, significantly more patients
achieved co-primary endpoints of psoriasis area and severity index
(PASI) 90 and static physician's global assessment (sPGA) 0/1 at
week 16 with Skyrizi versus Otezla. Skyrizi was well-tolerated with
no new safety signals identified.
- At the 2023 European Congress of Rheumatology
(EULAR), AbbVie presented results from the Phase 2 SLEek study
which demonstrated that Rinvoq, alone or as combination therapy,
met the primary and key secondary endpoints in adults with
moderately to severely active systemic lupus erythematosus (SLE).
AbbVie also presented long-term data further supporting the
efficacy and safety profile of Rinvoq across additional rheumatic
diseases. Presentations included five-year results from the
SELECT-COMPARE clinical trial evaluating Rinvoq and Humira
(adalimumab), both in combination with methotrexate (MTX), in adult
patients with moderate to severely active rheumatoid arthritis (RA)
who had an inadequate response to MTX; three-year results from the
SELECT-PsA 1 clinical trial evaluating Rinvoq in psoriatic
arthritis (PsA) patients with prior inadequate response or
intolerance to one or more non-biologic disease-modifying
antirheumatic drugs (DMARDs); and one-year results from the
SELECT-AXIS 2 clinical trial evaluating Rinvoq in patients with
active ankylosing spondylitis (AS) who had an inadequate response
to biologic DMARD therapy.
- At the 2023 Digestive Disease Week (DDW) Annual Meeting, AbbVie
presented 29 abstracts demonstrating the breadth of its
gastroenterology portfolio. Notable presentations highlighted
efficacy and safety outcomes from the Rinvoq and Skyrizi clinical
trial programs in adults with moderately to severely active CD as
well as investigational use of Linzess (linaclotide) in treating
functional constipation in pediatric patients aged 6 to 17
years.
- AbbVie and Genmab announced that the FDA approved Epkinly
(epcoritamab) as the first bispecific antibody for the treatment of
adult patients with relapsed or refractory (r/r) diffuse large
B-cell lymphoma (DLBCL), not otherwise specified (NOS), including
DLBCL arising from indolent lymphoma and high-grade B-cell
lymphoma, after two or more lines of systemic therapies.
Additionally, the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
for Tepkinly (epcoritamab) for the treatment of adults with r/r
DLBCL. Epkinly/Tepkinly is being co-developed by AbbVie and
Genmab.
- AbbVie and Genmab announced positive topline results from the
follicular lymphoma (FL) cohort of the Phase 1/2 EPCORE NHL-1
clinical trial evaluating Epkinly in patients with r/r FL. The
topline results showed an overall response rate (ORR) of 82
percent, which exceeded the protocol prespecified threshold for
efficacy, and the median duration of response (DOR) was not reached
and longer follow-up will be required. No new safety signals were
observed with Epkinly and full study results will be submitted for
presentation at a future medical meeting. Based on the topline
results, AbbVie and Genmab will engage global regulatory
authorities to discuss next steps.
- At the European Hematology Association (EHA) Annual Congress,
AbbVie announced new data from two studies which continued to show
sustained progression free survival (PFS) in chronic lymphocytic
leukemia (CLL) patients after fixed-duration treatment with
Venclexta (venetoclax) combination regimens across different lines
of therapy. The findings were from a six-year median follow-up from
the Phase 3 CLL14 study as well as a final seven-year follow-up
from the Phase 3 MURANO trial. Venclexta is being developed by
AbbVie and Roche. It 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 that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) adopted a
positive opinion recommending the approval of atogepant for the
prophylaxis of migraine in adults who have four or more migraine
days per month. The positive CHMP opinion is based on results from
two pivotal Phase 3 studies evaluating atogepant for the
prophylaxis of migraine in adults with episodic or chronic
migraine. If approved, AbbVie will be the only company to offer a
once daily oral calcitonin gene-related peptide (CGRP) receptor
antagonist treatment spanning both episodic and chronic migraine in
the European Union (EU).
- Allergan Aesthetics announced that the FDA approved
Skinvive by Juvederm for improved skin smoothness of the cheeks.
Skinvive is the first and only hyaluronic acid (HA) intradermal
microdroplet injection for skin smoothness available in the U.S.
with results lasting through six months with optimal
treatment.
- AbbVie and Calibr announced an expanded strategic collaboration
to advance several innovative preclinical and early-stage clinical
assets across AbbVie's core therapeutic areas including immunology,
oncology, neuroscience and other areas of interest. This
partnership is an expansion of the collaboration AbbVie and Scripps
Research formed in 2019 to develop a broad range of potential new
and novel therapeutics.
Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full
year 2023 from $10.57 - $10.97
to $10.90 - $11.10, 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 2023. The company's 2023 adjusted diluted EPS
guidance excludes any impact from acquired IPR&D and milestones
that may be incurred beyond the second quarter of 2023, 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 and eye care - and 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, Instagram, YouTube 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 2023 and 2022 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.
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 and uses of future
or conditional verbs, 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 expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to 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 2022 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, and specifically declines, 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, 2023
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
2Q22
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$10,720
|
|
$3,145
|
|
$13,865
|
|
(6.0) %
|
|
(0.9) %
|
|
(4.9) %
|
|
2.6 %
|
|
(4.2) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
5,731
|
|
1,082
|
|
6,813
|
|
(6.9)
|
|
3.0
|
|
(5.5)
|
|
6.5
|
|
(5.0)
|
Humira
|
3,452
|
|
560
|
|
4,012
|
|
(26.0)
|
|
(19.8)
|
|
(25.2)
|
|
(17.0)
|
|
(24.8)
|
Skyrizi
|
1,634
|
|
249
|
|
1,883
|
|
51.4
|
|
44.2
|
|
50.4
|
|
48.6
|
|
51.0
|
Rinvoq
|
645
|
|
273
|
|
918
|
|
56.4
|
|
52.2
|
|
55.1
|
|
57.5
|
|
56.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
931
|
|
547
|
|
1,478
|
|
(16.4)
|
|
2.1
|
|
(10.4)
|
|
3.9
|
|
(9.8)
|
Imbruvicab
|
666
|
|
241
|
|
907
|
|
(22.8)
|
|
(14.7)
|
|
(20.8)
|
|
(14.7)
|
|
(20.8)
|
Venclexta
|
265
|
|
306
|
|
571
|
|
5.2
|
|
21.0
|
|
13.1
|
|
24.9
|
|
15.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
829
|
|
555
|
|
1,384
|
|
(6.2)
|
|
13.9
|
|
1.0
|
|
19.3
|
|
2.9
|
Botox
Cosmetic
|
420
|
|
265
|
|
685
|
|
(6.5)
|
|
7.9
|
|
(1.4)
|
|
13.8
|
|
0.7
|
Juvederm
Collection
|
125
|
|
243
|
|
368
|
|
(14.5)
|
|
22.8
|
|
6.9
|
|
27.6
|
|
9.7
|
Other
Aesthetics
|
284
|
|
47
|
|
331
|
|
(1.3)
|
|
6.8
|
|
(0.2)
|
|
12.0
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,649
|
|
236
|
|
1,885
|
|
14.6
|
|
7.3
|
|
13.6
|
|
11.5
|
|
14.2
|
Botox
Therapeutic
|
614
|
|
134
|
|
748
|
|
10.1
|
|
10.7
|
|
10.2
|
|
17.0
|
|
11.3
|
Vraylar
|
657
|
|
1
|
|
658
|
|
33.7
|
|
>100.0
|
|
33.9
|
|
>100.0
|
|
33.9
|
Duodopa
|
24
|
|
93
|
|
117
|
|
(7.6)
|
|
(1.6)
|
|
(2.9)
|
|
(0.5)
|
|
(2.0)
|
Ubrelvy
|
194
|
|
2
|
|
196
|
|
4.5
|
|
n/m
|
|
5.9
|
|
n/m
|
|
6.0
|
Qulipta
|
95
|
|
1
|
|
96
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
65
|
|
5
|
|
70
|
|
(55.9)
|
|
4.7
|
|
(53.8)
|
|
11.4
|
|
(53.6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
309
|
|
308
|
|
617
|
|
(24.1)
|
|
(0.6)
|
|
(13.9)
|
|
3.0
|
|
(12.3)
|
Ozurdex
|
34
|
|
85
|
|
119
|
|
(3.3)
|
|
14.2
|
|
8.6
|
|
16.6
|
|
10.2
|
Lumigan/Ganfort
|
51
|
|
68
|
|
119
|
|
(13.1)
|
|
(3.9)
|
|
(8.1)
|
|
(1.1)
|
|
(6.6)
|
Alphagan/Combigan
|
32
|
|
33
|
|
65
|
|
(41.7)
|
|
(13.3)
|
|
(29.7)
|
|
(8.6)
|
|
(27.7)
|
Restasis
|
82
|
|
17
|
|
99
|
|
(45.8)
|
|
(0.7)
|
|
(41.1)
|
|
5.2
|
|
(40.5)
|
Other Eye
Care
|
110
|
|
105
|
|
215
|
|
1.9
|
|
(4.1)
|
|
(1.1)
|
|
—
|
|
1.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
744
|
|
203
|
|
947
|
|
(3.3)
|
|
0.1
|
|
(2.6)
|
|
2.9
|
|
(2.0)
|
Mavyret
|
193
|
|
194
|
|
387
|
|
(5.0)
|
|
(0.9)
|
|
(3.0)
|
|
1.9
|
|
(1.6)
|
Creon
|
282
|
|
—
|
|
282
|
|
(11.4)
|
|
n/m
|
|
(11.4)
|
|
n/m
|
|
(11.4)
|
Linzess/Constella
|
269
|
|
9
|
|
278
|
|
8.6
|
|
26.7
|
|
9.1
|
|
31.1
|
|
9.2
|
|
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/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Six Months Ended
June 30, 2023
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
6M22
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$19,921
|
|
$6,169
|
|
$26,090
|
|
(8.4) %
|
|
(3.0) %
|
|
(7.2) %
|
|
1.8 %
|
|
(6.1) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
10,267
|
|
2,133
|
|
12,400
|
|
(8.7)
|
|
1.2
|
|
(7.1)
|
|
6.4
|
|
(6.3)
|
Humira
|
6,400
|
|
1,153
|
|
7,553
|
|
(26.1)
|
|
(20.1)
|
|
(25.2)
|
|
(15.9)
|
|
(24.6)
|
Skyrizi
|
2,773
|
|
470
|
|
3,243
|
|
49.1
|
|
41.5
|
|
48.0
|
|
48.2
|
|
49.0
|
Rinvoq
|
1,094
|
|
510
|
|
1,604
|
|
51.2
|
|
52.9
|
|
51.7
|
|
61.0
|
|
54.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,834
|
|
1,060
|
|
2,894
|
|
(17.3)
|
|
(1.7)
|
|
(12.2)
|
|
0.9
|
|
(11.4)
|
Imbruvicab
|
1,304
|
|
481
|
|
1,785
|
|
(24.9)
|
|
(17.3)
|
|
(23.0)
|
|
(17.3)
|
|
(23.0)
|
Venclexta
|
530
|
|
579
|
|
1,109
|
|
10.2
|
|
16.5
|
|
13.4
|
|
22.1
|
|
16.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
1,606
|
|
1,078
|
|
2,684
|
|
(7.1)
|
|
6.1
|
|
(2.2)
|
|
13.3
|
|
0.5
|
Botox
Cosmetic
|
829
|
|
515
|
|
1,344
|
|
(3.8)
|
|
8.7
|
|
0.6
|
|
15.7
|
|
3.1
|
Juvederm
Collection
|
247
|
|
476
|
|
723
|
|
(16.2)
|
|
3.6
|
|
(4.1)
|
|
11.1
|
|
0.4
|
Other
Aesthetics
|
530
|
|
87
|
|
617
|
|
(7.4)
|
|
5.3
|
|
(5.8)
|
|
12.3
|
|
(4.9)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
3,112
|
|
468
|
|
3,580
|
|
14.8
|
|
7.4
|
|
13.8
|
|
13.2
|
|
14.6
|
Botox
Therapeutic
|
1,201
|
|
266
|
|
1,467
|
|
13.6
|
|
13.0
|
|
13.5
|
|
20.4
|
|
14.9
|
Vraylar
|
1,217
|
|
2
|
|
1,219
|
|
32.5
|
|
>100.0
|
|
32.7
|
|
>100.0
|
|
32.7
|
Duodopa
|
49
|
|
186
|
|
235
|
|
(0.8)
|
|
(3.0)
|
|
(2.5)
|
|
0.6
|
|
0.3
|
Ubrelvy
|
344
|
|
4
|
|
348
|
|
6.4
|
|
n/m
|
|
7.7
|
|
n/m
|
|
7.7
|
Qulipta
|
161
|
|
1
|
|
162
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
140
|
|
9
|
|
149
|
|
(56.3)
|
|
5.7
|
|
(54.6)
|
|
12.0
|
|
(54.4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
628
|
|
597
|
|
1,225
|
|
(30.5)
|
|
2.0
|
|
(17.7)
|
|
6.7
|
|
(15.8)
|
Ozurdex
|
73
|
|
161
|
|
234
|
|
6.3
|
|
8.7
|
|
8.0
|
|
13.4
|
|
11.2
|
Lumigan/Ganfort
|
114
|
|
135
|
|
249
|
|
(9.7)
|
|
(5.6)
|
|
(7.5)
|
|
(1.9)
|
|
(5.5)
|
Alphagan/Combigan
|
60
|
|
76
|
|
136
|
|
(51.8)
|
|
1.4
|
|
(31.7)
|
|
7.4
|
|
(29.4)
|
Restasis
|
161
|
|
30
|
|
191
|
|
(58.4)
|
|
7.3
|
|
(54.0)
|
|
12.8
|
|
(53.6)
|
Other Eye
Care
|
220
|
|
195
|
|
415
|
|
11.3
|
|
2.1
|
|
6.8
|
|
7.0
|
|
9.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,471
|
|
404
|
|
1,875
|
|
0.9
|
|
(3.8)
|
|
(0.2)
|
|
0.8
|
|
0.8
|
Mavyret
|
364
|
|
387
|
|
751
|
|
(2.2)
|
|
(4.7)
|
|
(3.5)
|
|
(0.1)
|
|
(1.1)
|
Creon
|
587
|
|
—
|
|
587
|
|
(3.0)
|
|
n/m
|
|
(3.0)
|
|
n/m
|
|
(3.0)
|
Linzess/Constella
|
520
|
|
17
|
|
537
|
|
8.1
|
|
19.1
|
|
8.5
|
|
24.3
|
|
8.7
|
|
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/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
(Unaudited)
|
|
(in millions, except
per share data)
|
Second
Quarter
Ended June
30
|
|
Six
Months
Ended June
30
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net
revenues
|
$
13,865
|
|
$
14,583
|
|
$
26,090
|
|
$
28,121
|
Cost of products
sold
|
4,240
|
|
4,170
|
|
8,226
|
|
8,222
|
Selling, general and
administrative
|
3,268
|
|
5,412
|
|
6,307
|
|
8,539
|
Research and
development
|
1,733
|
|
1,609
|
|
4,025
|
|
3,106
|
Acquired IPR&D and
milestones
|
280
|
|
269
|
|
430
|
|
414
|
Other operating
income
|
(169)
|
|
(172)
|
|
(179)
|
|
(172)
|
Total operating costs
and expenses
|
9,352
|
|
11,288
|
|
18,809
|
|
20,109
|
|
|
|
|
|
|
|
|
Operating
earnings
|
4,513
|
|
3,295
|
|
7,281
|
|
8,012
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
454
|
|
532
|
|
908
|
|
1,071
|
Net foreign exchange
loss
|
37
|
|
47
|
|
72
|
|
72
|
Other expense,
net
|
1,412
|
|
1,533
|
|
3,216
|
|
757
|
Earnings before income
tax expense
|
2,610
|
|
1,183
|
|
3,085
|
|
6,112
|
Income tax
expense
|
583
|
|
255
|
|
817
|
|
691
|
Net earnings
|
2,027
|
|
928
|
|
2,268
|
|
5,421
|
Net earnings
attributable to noncontrolling interest
|
3
|
|
4
|
|
5
|
|
7
|
Net earnings
attributable to AbbVie Inc.
|
$
2,024
|
|
$
924
|
|
$
2,263
|
|
$
5,414
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
1.14
|
|
$
0.51
|
|
$
1.26
|
|
$
3.03
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
2.91
|
|
$
3.37
|
|
$
5.37
|
|
$
6.52
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,771
|
|
1,776
|
|
1,773
|
|
1,777
|
|
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
(Unaudited)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
|
|
|
Quarter Ended June
30, 2023
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
2,610
|
|
$
2,024
|
|
$
1.14
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
2,070
|
|
1,727
|
|
0.97
|
Acquisition and
integration costs
|
|
|
|
|
(83)
|
|
(94)
|
|
(0.05)
|
Change in fair value
of contingent consideration
|
|
|
|
|
1,552
|
|
1,518
|
|
0.85
|
Other
|
|
|
|
|
(1)
|
|
—
|
|
—
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
6,148
|
|
$
5,175
|
|
$
2.91
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs related to the Allergan
acquisition, including a one-time gain of $169 million related to
the termination
of a development liability associated with a previously divested
product.
|
|
Reported GAAP earnings
and adjusted non-GAAP earnings for the three months ended June 30,
2023 included acquired IPR&D and milestones expense of
$280 million on a pre-tax and $261 million on an after-tax basis,
representing an unfavorable impact of $0.15 to both diluted EPS
and adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
Quarter Ended June
30, 2023
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
4,240
|
|
$
3,268
|
|
$
1,733
|
|
$
(169)
|
|
$
1,412
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(2,070)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(33)
|
|
(50)
|
|
(3)
|
|
169
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,552)
|
Other
|
(20)
|
|
—
|
|
—
|
|
—
|
|
21
|
As adjusted
(non-GAAP)
|
$
2,117
|
|
$
3,218
|
|
$
1,730
|
|
$
—
|
|
$
(119)
|
|
3. The adjusted tax rate for
the second quarter of 2023 was 15.8 percent, as detailed
below:
|
|
|
|
|
|
Quarter Ended June
30, 2023
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
2,610
|
|
$
583
|
|
22.3 %
|
Specified
items
|
|
|
|
|
3,538
|
|
387
|
|
10.9 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
6,148
|
|
$
970
|
|
15.8 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items
impacted results as follows:
|
|
|
|
|
|
|
Quarter Ended June
30, 2022
|
(in millions, except
per share data)
|
|
|
|
|
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 primarily 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 sale of opioid products. Other primarily includes
restructuring charges associated
with streamlining global operations and COVID-19 related
expenses.
|
|
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:
|
|
|
Quarter Ended June
30, 2022
|
(in
millions)
|
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:
|
|
|
|
|
|
Quarter Ended June
30, 2022
|
(dollars in
millions)
|
|
|
|
|
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
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Six Months Ended
June 30, 2023
|
(in millions, except
per share data)
|
|
|
|
|
Earnings
|
|
Diluted
|
|
|
|
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
|
|
|
|
$
3,085
|
|
$
2,263
|
|
$
1.26
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
|
|
|
4,018
|
|
3,373
|
|
1.90
|
Intangible asset
impairment
|
|
|
|
|
710
|
|
629
|
|
0.35
|
Acquisition and
integration costs
|
|
|
|
|
(22)
|
|
(39)
|
|
(0.02)
|
Change in fair value
of contingent consideration
|
|
|
|
|
3,424
|
|
3,340
|
|
1.88
|
Other
|
|
|
|
|
16
|
|
(6)
|
|
—
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
11,231
|
|
$
9,560
|
|
$
5.37
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs primarily reflect integration costs related to
the Allergan acquisition, including a one-time gain of $169 million
related to the
termination of a development liability associated with a previously
divested product.
|
|
Reported GAAP earnings
and adjusted non-GAAP earnings for the six months ended June 30,
2023 included acquired IPR&D and milestones expense
of $430
million on a pre-tax and $411 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:
|
|
|
Six Months Ended
June 30, 2023
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
income
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
8,226
|
|
$
6,307
|
|
$
4,025
|
|
$
(179)
|
|
$
3,216
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(4,018)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(80)
|
|
—
|
|
(630)
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(48)
|
|
(94)
|
|
(5)
|
|
169
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(3,424)
|
Other
|
(32)
|
|
(11)
|
|
(3)
|
|
10
|
|
20
|
As adjusted
(non-GAAP)
|
$
4,048
|
|
$
6,202
|
|
$
3,387
|
|
$
—
|
|
$
(188)
|
|
3. The adjusted tax rate for
the first six months of 2023 was 14.8 percent, as detailed
below:
|
|
|
|
|
|
Six Months Ended
June 30, 2023
|
(dollars in
millions)
|
|
|
|
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
|
|
|
|
$
3,085
|
|
$
817
|
|
26.5 %
|
Specified
items
|
|
|
|
|
8,146
|
|
849
|
|
10.4 %
|
As adjusted
(non-GAAP)
|
|
|
|
|
$
11,231
|
|
$
1,666
|
|
14.8 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
|
|
|
|
Six Months Ended
June 30, 2022
|
(in millions, except
per share data)
|
|
|
|
|
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 primarily 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.
|
|
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:
|
|
|
Six Months Ended
June 30, 2022
|
(in
millions)
|
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:
|
|
|
|
|
|
Six Months Ended
June 30, 2022
|
(dollars in
millions)
|
|
|
|
|
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 %
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-second-quarter-2023-financial-results-301887276.html
SOURCE AbbVie