- Reports Third-Quarter Diluted EPS of $1.00 on a GAAP Basis, a Decrease of 54.8
Percent; Adjusted Diluted EPS of $2.95, a Decrease of 19.4 Percent; These Results
Include an Unfavorable Impact of $0.04 Per Share Related to Acquired IPR&D and
Milestones Expense
- Delivers Third-Quarter Net Revenues of $13.927 Billion, a Decrease of 6.0 Percent on a
Reported Basis and 5.8 Percent on an Operational Basis
- Third-Quarter Global Net Revenues from the Immunology
Portfolio Were $6.783 Billion, a
Decrease of 11.3 Percent; Global Humira Net Revenues Were
$3.547 Billion; Global Skyrizi Net
Revenues Were $2.126 Billion; Global
Rinvoq Net Revenues Were $1.110
Billion
- Third-Quarter Global Net Revenues from the Oncology
Portfolio Were $1.512 Billion a
Decrease of 8.4 Percent on a Reported Basis, or 8.6 Percent on an
Operational Basis; Global Imbruvica Net Revenues Were $908 Million; Global Venclexta Net Revenues Were
$590 Million
- Third-Quarter Global Net Revenues from the
Neuroscience Portfolio Were $2.043
Billion, an Increase of 22.1 Percent on a Reported Basis, or
22.0 Percent on an Operational Basis; Global Botox Therapeutic Net
Revenues Were $748 Million; Global
Vraylar Net Revenues Were $751
Million; Combined Global Ubrelvy and Qulipta Net Revenues
Were $365 Million
- Third-Quarter Global Net Revenues from the Aesthetics
Portfolio Were $1.239 Billion, a
Decrease of 4.7 Percent on a Reported Basis, or 4.0 Percent on an
Operational Basis; Global Botox Cosmetic Net Revenues Were
$620 Million; Global Juvederm Net
Revenues Were $321 Million
- Raises 2023 Adjusted Diluted EPS Guidance Range from
$10.86 - $11.06 to $11.19 -
$11.23, which Includes an Unfavorable
Impact of $0.27 Per Share Related to
Acquired IPR&D and Milestones Expense Incurred Year-To-Date
Through the Third Quarter 2023
- Raises 2024 Adjusted Diluted EPS Guidance Floor from
$10.70 to $11.00, which Excludes any Impact Related to
Acquired IPR&D and Milestones Expense
- Announces 2024 Dividend Increase of 4.7 Percent, Beginning
with Dividend Payable in February
2024
NORTH CHICAGO, Ill.,
Oct. 27,
2023 /PRNewswire/ -- AbbVie (NYSE:ABBV)
announced financial results for the third quarter ended
September 30, 2023.
"We delivered another quarter of outstanding results driven by
accelerating performance across our non-Humira growth platform,
which is demonstrating double-digit growth," said Richard A. Gonzalez, chairman and chief
executive officer, AbbVie. "Based upon the strength and momentum of
our business, we are once again raising our full-year 2023 guidance
as well as our floor EPS outlook for next year. We are also
increasing our quarterly dividend, underscoring our confidence in
AbbVie's long-term outlook."
Third-Quarter Results
- Worldwide net revenues were $13.927
billion, a decrease of 6.0 percent on a reported basis, or
5.8 percent on an operational basis.
- Global net revenues from the immunology portfolio were
$6.783 billion, a decrease of 11.3
percent.
- Global Humira net revenues of $3.547
billion decreased 36.2 percent. U.S. Humira net revenues
were $3.020 billion, a decrease of
39.1 percent. Internationally, Humira net revenues were
$527 million, a decrease of 12.6
percent on a reported basis, or 12.2 percent on an operational
basis.
- Global Skyrizi net revenues were $2.126
billion, an increase of 52.1 percent on a reported basis, or
51.9 percent on an operational basis.
- Global Rinvoq net revenues were $1.110
billion, an increase of 59.8 percent on a reported basis, or
59.6 percent on an operational basis.
- Global net revenues from the oncology portfolio were
$1.512 billion, a decrease of 8.4
percent on a reported basis, or 8.6 percent on an operational
basis.
- Global Imbruvica net revenues were $908
million, a decrease of 20.0 percent, with U.S. net revenues
of $678 million and international
profit sharing of $230 million.
- Global Venclexta net revenues were $590
million, an increase of 14.6 percent on a reported basis, or
14.0 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$2.043 billion, an increase of 22.1
percent on a reported basis, or 22.0 percent on an operational
basis.
- Global Botox Therapeutic net revenues were $748 million, an increase of 7.1 percent on a
reported basis, or 7.4 percent on an operational basis.
- Global Vraylar net revenues were $751
million, an increase of 35.4 percent.
- Global Ubrelvy net revenues were $233
million, an increase of 45.6 percent.
- Global Qulipta net revenues were $132
million.
- Global net revenues from the aesthetics portfolio were
$1.239 billion, a decrease of 4.7
percent on a reported basis, or 4.0 percent on an operational
basis.
- Global Botox Cosmetic net revenues were $620 million, a decrease of 2.7 percent on a
reported basis, or 1.7 percent on an operational basis.
- Global Juvederm net revenues were $321
million, a decrease of 8.6 percent on a reported basis, or
7.9 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the third quarter
was 53.4 percent. The adjusted gross margin ratio was 83.5
percent.
- On a GAAP basis, selling, general and administrative (SG&A)
expense was 24.2 percent of net revenues. The adjusted SG&A
expense was 23.9 percent of net revenues.
- Research and development (R&D) expense on a GAAP and
adjusted basis was 12.4 percent of net revenues, reflecting funding
actions supporting all stages of our pipeline.
- Acquired IPR&D and milestones expense was 0.5 percent of
net revenues.
- On a GAAP basis, the operating margin in the third quarter was
16.4 percent. The adjusted operating margin was 46.7 percent.
- Net interest expense was $398
million.
- On a GAAP basis, the tax rate in the quarter was 8.8 percent.
The adjusted tax rate was 15.7 percent.
- Diluted EPS in the third quarter was $1.00 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.95.
These results include an unfavorable impact of $0.04 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 it submitted applications for a new
indication to the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) for Skyrizi (risankizumab) for the
treatment of adult patients with moderately to severely active
ulcerative colitis (UC). The submissions are supported by two Phase
3 clinical trials demonstrating Skyrizi achieved the primary
endpoint of clinical remission (per Adapted Mayo Score) and key
secondary endpoints as an induction and maintenance treatment.
Skyrizi is part of a collaboration between Boehringer Ingelheim and
AbbVie, with AbbVie leading development and commercialization
globally.
- AbbVie announced positive topline results from SEQUENCE, a
Phase 3 study evaluating Skyrizi versus Stelara (ustekinumab) in
patients with moderately to severely active Crohn's disease (CD)
who have failed one or more anti-TNF therapies. In the study,
Skyrizi met both primary endpoints (non-inferiority for clinical
remission per CDAI at week 24 and superiority of endoscopic
remission at week 48) versus Stelara. All secondary endpoints in
the trial achieved statistical significance for superiority versus
Stelara. Safety results were consistent with the overall safety
profile of Skyrizi, with no new safety risks identified.
- AbbVie announced that its Phase 2b study evaluating Rinvoq (upadacitinib) in
adults with non-segmental vitiligo (NSV) met the primary endpoint
of percent change from baseline in the Facial Vitiligo Area Scoring
Index (F-VASI) at week 24 with the 11 mg and 22 mg doses versus
placebo. The percent reduction from baseline in F-VASI at week 52
was numerically greater than results at week 24 for all Rinvoq
doses. No new safety signals were identified beyond the known
safety profile for Rinvoq. Based on these data, AbbVie is advancing
its clinical program of Rinvoq in vitiligo to Phase 3.
- At the United European Gastroenterology (UEG) Week 2023, AbbVie
shared 23 abstracts, including 11 oral presentations and 12 poster
presentations, spanning research on Skyrizi and Rinvoq in both CD
and UC. Highlights included late-breaking data from the
head-to-head Phase 3 SEQUENCE study evaluating Skyrizi versus
Stelara in CD, primary efficacy and safety results from the Phase 3
INSPIRE induction study for Skyrizi in UC, as well as analyses on
clinical and endoscopic outcomes from AbbVie's maintenance trials
for Skyrizi and Rinvoq in CD and for Rinvoq in UC.
- At the European Academy of Dermatology and Venereology (EADV)
Congress, AbbVie announced new data analyses from the Measure Up 1,
Measure Up 2 and AD Up Phase 3 studies that further demonstrated
the long-term efficacy and safety profile of Rinvoq among adults
and adolescents 12 years and older with moderate to severe atopic
dermatitis (AD). Across all 3 studies, response rates for EASI 75
and vIGA-AD 0/1 (co-primary endpoints) and for EASI 90 and WP-NRS
0/1 at week 16 were sustained through week 140 among patients
treated with Rinvoq. Safety results were consistent with the known
safety profile of Rinvoq, with no new safety signals observed.
- AbbVie announced that the European Commission (EC) granted
conditional marketing authorization for Tepkinly (epcoritamab) as a
monotherapy for the treatment of adult patients with relapsed or
refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or
more lines of systemic therapy. Tepkinly is the first and only
subcutaneous T-cell engaging bispecific antibody approved for the
treatment of this patient population in the European Union (EU).
This conditional marketing authorization approval represents
AbbVie's second approved hematological cancer treatment in the EU
and is supported by data from the pivotal Phase 1/2 EPCORE NHL-1
clinical trial. Tepkinly is being co-developed by AbbVie and
Genmab.
- In August 2023, as part of
Inflation Reduction Act (IRA) of 2022, the company's oncology
product Imbruvica, sold in the U.S., was included on the list of
products selected for price negotiation by the Centers for Medicare
& Medicaid Services (CMS). The selection contributed to a
significant decrease in the estimated future cash flows for the
product and represented a triggering event which required the
company to evaluate the underlying definite lived-intangible asset
for impairment. The company utilized a discounted cash flow
analysis to estimate the fair value of the intangible asset
resulting in a partial impairment of both the gross and net
carrying amount. Based on the revised cash flows, the company
recorded a pre-tax impairment charge of $2.1
billion to cost of products sold in the condensed
consolidated statement of earnings for the third quarter of 2023.
The remaining intangible asset carrying value related to Imbruvica
in the U.S. totaled $1.8 billion as
of September 30, 2023.
- AbbVie announced results from CANOVA, a Phase 3 study
evaluating Venclexta (venetoclax) plus dexamethasone (VenDex) for
patients with t(11;14)-positive r/r multiple myeloma (MM) who
received two or more prior treatments. Data did not demonstrate
that the treatment combination significantly improved
progression-free survival (PFS), the primary endpoint of the trial.
Patients receiving VenDex showed improvement in median PFS of 9.9
months compared to 5.8 months with the combination of study
comparator pomalidomide and dexamethasone (PomDex); however, the
results did not reach statistical significance. Results were
presented at the International Myeloma Society (IMS) Annual Meeting
and AbbVie will discuss the data with health authorities to further
understand the potential of venetoclax as a biomarker-driven
therapy in MM. 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 (EC) approved Aquipta (atogepant) for
the prophylaxis of migraine in adults who have four or more
migraine days per month. The approval makes Aquipta the only
once-daily oral calcitonin gene-related peptide (CGRP) receptor
antagonist (gepant) treatment in the EU for the preventive
treatment of both chronic and episodic migraine. The approval is
based on two pivotal Phase 3 studies that demonstrated
statistically significant reduction in mean monthly migraine days
with Aquipta compared to placebo in adult patients with both
chronic and episodic migraine.
- Allergan Aesthetics announced positive topline results from the
second of three Phase 3 clinical studies evaluating Botox Cosmetic
(onabotulinumtoxinA) for the treatment of moderate to severe
platysma prominence associated with platysma muscle activity. All
primary and secondary endpoints were met for this study and results
were consistent with findings from the first Phase 3 study. Results
support Botox Cosmetic as a potential treatment option for moderate
to severe platysma prominence and data will be included as part of
an upcoming FDA regulatory submission expected near the end of the
year. If approved, Botox Cosmetic will be the first and only
neurotoxin for this indication.
- Allergan Aesthetics announced positive topline results from two
pivotal Phase 3 clinical studies evaluating trenibotulinumtoxinE
(BoNT/E) for the treatment of moderate to severe glabellar lines.
All primary and secondary endpoints were met for both studies and
results support trenibotulinumtoxinE as a novel botulinum
neurotoxin serotype E characterized by a rapid onset of action as
early as 8 hours after administration and short duration of effect
within 2-3 weeks.
- AbbVie announced that it exercised its exclusive right to
acquire of Mitokinin, a discovery-stage biotechnology company
developing a potentially first-in-class disease-modifying treatment
for Parkinson's Disease (PD). Mitokinin's lead compound, a
selective PINK1 activator, is designed to address mitochondrial
dysfunction that is believed to be a major contributing factor to
PD pathogenesis and progression.
Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full
year 2023 from $10.86 - $11.06
to $11.19 - $11.23, which includes an unfavorable impact of
$0.27 per share related to acquired
IPR&D and milestones expense incurred year-to-date through the
third 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 third quarter of 2023, as both
cannot be reliably forecasted.
AbbVie Raises 2024 EPS Guidance Floor
AbbVie is raising its adjusted diluted EPS guidance floor for
the full year 2024 from $10.70 to
$11.00, which excludes any impact
from acquired IPR&D and milestones, as both cannot be reliably
forecasted. This is an update to guidance that was initially issued
in February 2023 as part of AbbVie's
fourth quarter 2022 earnings call. As a result of this update,
AbbVie does not expect adjusted diluted EPS for full year 2024 to
be below $11.00 per share. The
company will issue its formal 2024 adjusted diluted EPS guidance
range in conjunction with fourth quarter 2023 results.
Company Declares Dividend Increase of 4.7 Percent
AbbVie is announcing today that its board of directors declared
an increase in the company's quarterly cash dividend from
$1.48 per share to $1.55 per share beginning with the dividend
payable on February 15, 2024
to shareholders of record as of January
16, 2024. This reflects an increase of approximately 4.7
percent, continuing AbbVie's strong commitment to returning
cash to shareholders through a growing dividend. Since the
company's inception in 2013, AbbVie has increased its
quarterly dividend by more than 285 percent. AbbVie is a
member of the S&P Dividend Aristocrats Index, which tracks
companies that have annually increased their dividend for at least
25 consecutive years.
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 X (formerly
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
third-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
September 30, 2023
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
3Q22
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$10,852
|
|
$3,075
|
|
$13,927
|
|
(7.7) %
|
|
0.8 %
|
|
(6.0) %
|
|
1.4 %
|
|
(5.8) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
5,696
|
|
1,087
|
|
6,783
|
|
(14.7)
|
|
12.1
|
|
(11.3)
|
|
11.9
|
|
(11.3)
|
Humira
|
3,020
|
|
527
|
|
3,547
|
|
(39.1)
|
|
(12.6)
|
|
(36.2)
|
|
(12.2)
|
|
(36.2)
|
Skyrizi
|
1,875
|
|
251
|
|
2,126
|
|
53.5
|
|
42.5
|
|
52.1
|
|
40.7
|
|
51.9
|
Rinvoq
|
801
|
|
309
|
|
1,110
|
|
59.0
|
|
61.8
|
|
59.8
|
|
61.2
|
|
59.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
973
|
|
539
|
|
1,512
|
|
(12.3)
|
|
(0.4)
|
|
(8.4)
|
|
(1.0)
|
|
(8.6)
|
Imbruvicab
|
678
|
|
230
|
|
908
|
|
(20.2)
|
|
(19.6)
|
|
(20.0)
|
|
(19.6)
|
|
(20.0)
|
Venclexta
|
281
|
|
309
|
|
590
|
|
8.1
|
|
21.1
|
|
14.6
|
|
19.9
|
|
14.0
|
Epkinlyc
|
14
|
|
—
|
|
14
|
|
n/m
|
|
n/m
|
|
n/m
|
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
759
|
|
480
|
|
1,239
|
|
—
|
|
(11.4)
|
|
(4.7)
|
|
(9.7)
|
|
(4.0)
|
Botox
Cosmetic
|
388
|
|
232
|
|
620
|
|
5.0
|
|
(13.3)
|
|
(2.7)
|
|
(10.9)
|
|
(1.7)
|
Juvederm
Collection
|
116
|
|
205
|
|
321
|
|
(6.4)
|
|
(9.8)
|
|
(8.6)
|
|
(8.7)
|
|
(7.9)
|
Other
Aesthetics
|
255
|
|
43
|
|
298
|
|
(4.0)
|
|
(8.1)
|
|
(4.6)
|
|
(7.0)
|
|
(4.4)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,817
|
|
226
|
|
2,043
|
|
24.0
|
|
8.9
|
|
22.1
|
|
8.4
|
|
22.0
|
Botox
Therapeutic
|
626
|
|
122
|
|
748
|
|
7.2
|
|
6.5
|
|
7.1
|
|
8.6
|
|
7.4
|
Vraylar
|
750
|
|
1
|
|
751
|
|
35.2
|
|
>100.0
|
|
35.4
|
|
>100.0
|
|
35.4
|
Duodopa
|
25
|
|
93
|
|
118
|
|
10.6
|
|
6.6
|
|
7.4
|
|
2.3
|
|
4.0
|
Ubrelvy
|
230
|
|
3
|
|
233
|
|
43.7
|
|
>100.0
|
|
45.6
|
|
>100.0
|
|
45.6
|
Qulipta
|
131
|
|
1
|
|
132
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
55
|
|
6
|
|
61
|
|
(31.9)
|
|
6.2
|
|
(29.9)
|
|
9.6
|
|
(29.7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
310
|
|
295
|
|
605
|
|
(14.0)
|
|
13.1
|
|
(2.7)
|
|
13.9
|
|
(2.4)
|
Ozurdex
|
34
|
|
86
|
|
120
|
|
(4.5)
|
|
22.3
|
|
13.2
|
|
21.7
|
|
12.8
|
Lumigan/Ganfort
|
28
|
|
63
|
|
91
|
|
(53.0)
|
|
2.7
|
|
(24.8)
|
|
1.4
|
|
(25.5)
|
Alphagan/Combigan
|
30
|
|
40
|
|
70
|
|
(16.0)
|
|
10.1
|
|
(3.1)
|
|
17.3
|
|
0.4
|
Restasis
|
104
|
|
13
|
|
117
|
|
(20.7)
|
|
35.0
|
|
(17.0)
|
|
42.1
|
|
(16.5)
|
Other Eye
Care
|
114
|
|
93
|
|
207
|
|
16.3
|
|
11.9
|
|
14.2
|
|
12.0
|
|
14.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
751
|
|
212
|
|
963
|
|
(4.6)
|
|
4.4
|
|
(2.8)
|
|
4.9
|
|
(2.7)
|
Mavyret
|
167
|
|
203
|
|
370
|
|
(12.3)
|
|
5.2
|
|
(3.5)
|
|
5.8
|
|
(3.2)
|
Creon
|
305
|
|
—
|
|
305
|
|
(9.1)
|
|
n/m
|
|
(9.1)
|
|
n/m
|
|
(9.1)
|
Linzess/Constella
|
279
|
|
9
|
|
288
|
|
6.8
|
|
(11.1)
|
|
6.2
|
|
(13.0)
|
|
6.1
|
|
|
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.
|
c
|
Reflects profit sharing
for Epkinly U.S. revenues.
|
n/m = not
meaningful
|
AbbVie
Inc.
Key Product
Revenues
Nine Months Ended
September 30, 2023
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
9M22
|
|
Net Revenues (in
millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET
REVENUES
|
$30,773
|
|
$9,244
|
|
$40,017
|
|
(8.2) %
|
|
(1.8) %
|
|
(6.8) %
|
|
1.6 %
|
|
(6.0) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
15,963
|
|
3,220
|
|
19,183
|
|
(10.9)
|
|
4.6
|
|
(8.6)
|
|
8.1
|
|
(8.1)
|
Humira
|
9,420
|
|
1,680
|
|
11,100
|
|
(30.8)
|
|
(17.9)
|
|
(29.1)
|
|
(14.8)
|
|
(28.7)
|
Skyrizi
|
4,648
|
|
721
|
|
5,369
|
|
50.9
|
|
41.8
|
|
49.6
|
|
45.5
|
|
50.1
|
Rinvoq
|
1,895
|
|
819
|
|
2,714
|
|
54.4
|
|
56.1
|
|
54.9
|
|
61.0
|
|
56.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
2,807
|
|
1,599
|
|
4,406
|
|
(15.6)
|
|
(1.3)
|
|
(10.9)
|
|
0.2
|
|
(10.4)
|
Imbruvicab
|
1,982
|
|
711
|
|
2,693
|
|
(23.4)
|
|
(18.0)
|
|
(22.0)
|
|
(18.0)
|
|
(22.0)
|
Venclexta
|
811
|
|
888
|
|
1,699
|
|
9.4
|
|
18.1
|
|
13.8
|
|
21.4
|
|
15.5
|
Epkinlyc
|
14
|
|
—
|
|
14
|
|
n/m
|
|
n/m
|
|
n/m
|
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
2,365
|
|
1,558
|
|
3,923
|
|
(4.9)
|
|
—
|
|
(3.0)
|
|
5.3
|
|
(1.0)
|
Botox
Cosmetic
|
1,217
|
|
747
|
|
1,964
|
|
(1.1)
|
|
0.7
|
|
(0.4)
|
|
6.0
|
|
1.6
|
Juvederm
Collection
|
363
|
|
681
|
|
1,044
|
|
(13.3)
|
|
(0.8)
|
|
(5.6)
|
|
4.5
|
|
(2.3)
|
Other
Aesthetics
|
785
|
|
130
|
|
915
|
|
(6.3)
|
|
0.5
|
|
(5.4)
|
|
5.4
|
|
(4.7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
4,929
|
|
694
|
|
5,623
|
|
18.0
|
|
7.9
|
|
16.7
|
|
11.7
|
|
17.2
|
Botox
Therapeutic
|
1,827
|
|
388
|
|
2,215
|
|
11.3
|
|
10.9
|
|
11.3
|
|
16.6
|
|
12.3
|
Vraylar
|
1,967
|
|
3
|
|
1,970
|
|
33.6
|
|
>100.0
|
|
33.7
|
|
>100.0
|
|
33.7
|
Duodopa
|
74
|
|
279
|
|
353
|
|
2.8
|
|
—
|
|
0.6
|
|
1.1
|
|
1.5
|
Ubrelvy
|
574
|
|
7
|
|
581
|
|
18.8
|
|
>100.0
|
|
20.3
|
|
>100.0
|
|
20.3
|
Qulipta
|
292
|
|
2
|
|
294
|
|
>100.0
|
|
n/m
|
|
>100.0
|
|
n/m
|
|
>100.0
|
Other
Neuroscience
|
195
|
|
15
|
|
210
|
|
(51.3)
|
|
6.4
|
|
(49.3)
|
|
11.8
|
|
(49.1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye
Care
|
938
|
|
892
|
|
1,830
|
|
(25.8)
|
|
5.5
|
|
(13.3)
|
|
9.0
|
|
(11.9)
|
Ozurdex
|
107
|
|
247
|
|
354
|
|
2.6
|
|
13.1
|
|
9.7
|
|
16.1
|
|
11.7
|
Lumigan/Ganfort
|
142
|
|
198
|
|
340
|
|
(23.6)
|
|
(3.1)
|
|
(12.9)
|
|
(0.9)
|
|
(11.8)
|
Alphagan/Combigan
|
90
|
|
116
|
|
206
|
|
(43.5)
|
|
4.2
|
|
(24.0)
|
|
10.6
|
|
(21.4)
|
Restasis
|
265
|
|
43
|
|
308
|
|
(48.8)
|
|
14.2
|
|
(44.5)
|
|
20.1
|
|
(44.1)
|
Other Eye
Care
|
334
|
|
288
|
|
622
|
|
13.0
|
|
5.1
|
|
9.2
|
|
8.6
|
|
10.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
2,222
|
|
616
|
|
2,838
|
|
(1.0)
|
|
(1.2)
|
|
(1.1)
|
|
2.1
|
|
(0.4)
|
Mavyret
|
531
|
|
590
|
|
1,121
|
|
(5.6)
|
|
(1.5)
|
|
(3.5)
|
|
1.8
|
|
(1.8)
|
Creon
|
892
|
|
—
|
|
892
|
|
(5.2)
|
|
n/m
|
|
(5.2)
|
|
n/m
|
|
(5.2)
|
Linzess/Constella
|
799
|
|
26
|
|
825
|
|
7.7
|
|
7.0
|
|
7.7
|
|
9.3
|
|
7.8
|
|
|
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.
|
c
|
Reflects profit sharing
for Epkinly U.S. revenues.
|
n/m = not
meaningful
|
AbbVie
Inc.
Consolidated
Statements of Earnings
(Unaudited)
|
|
(in millions, except
per share data)
|
Third
Quarter
Ended September
30
|
|
Nine
Months
Ended September
30
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Net revenues
|
$
13,927
|
|
$
14,812
|
|
$
40,017
|
|
$
42,933
|
Cost of products
sold
|
6,485
|
|
5,022
|
|
14,711
|
|
13,244
|
Selling, general and
administrative
|
3,372
|
|
3,304
|
|
9,679
|
|
11,843
|
Research and
development
|
1,723
|
|
1,614
|
|
5,748
|
|
4,720
|
Acquired IPR&D and
milestones
|
66
|
|
40
|
|
496
|
|
454
|
Other operating expense
(income), net
|
—
|
|
229
|
|
(179)
|
|
57
|
Total operating costs
and expenses
|
11,646
|
|
10,209
|
|
30,455
|
|
30,318
|
|
|
|
|
|
|
|
|
Operating
earnings
|
2,281
|
|
4,603
|
|
9,562
|
|
12,615
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
398
|
|
497
|
|
1,306
|
|
1,568
|
Net foreign exchange
loss
|
25
|
|
36
|
|
97
|
|
108
|
Other expense (income),
net
|
(95)
|
|
(330)
|
|
3,121
|
|
427
|
Earnings before income
tax expense
|
1,953
|
|
4,400
|
|
5,038
|
|
10,512
|
Income tax
expense
|
172
|
|
448
|
|
989
|
|
1,139
|
Net earnings
|
1,781
|
|
3,952
|
|
4,049
|
|
9,373
|
Net earnings
attributable to noncontrolling interest
|
3
|
|
3
|
|
8
|
|
10
|
Net earnings
attributable to AbbVie Inc.
|
$
1,778
|
|
$
3,949
|
|
$
4,041
|
|
$
9,363
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
$
1.00
|
|
$
2.21
|
|
$
2.26
|
|
$
5.24
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
2.95
|
|
$
3.66
|
|
$
8.32
|
|
$
10.18
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,771
|
|
1,776
|
|
1,772
|
|
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
September 30, 2023
|
(in millions, except
per share data)
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
1,953
|
|
$
1,778
|
|
$
1.00
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
2,039
|
|
1,728
|
|
0.98
|
Intangible asset
impairment
|
2,114
|
|
1,660
|
|
0.93
|
Acquisition and
integration costs
|
60
|
|
54
|
|
0.03
|
Change in fair value
of contingent consideration
|
8
|
|
8
|
|
—
|
Other
|
59
|
|
22
|
|
0.01
|
As adjusted
(non-GAAP)
|
$
6,233
|
|
$
5,250
|
|
$
2.95
|
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Intangible asset
impairment reflects a partial impairment charge related to the U.S.
Imbruvica intangible asset acquired as part
of the 2015 acquisition of Pharmacyclics, Inc. The intangible asset
impairment was triggered by selection of Imbruvica for price
negotiation as part of the IRA of 2022, which contributed to a
significant decrease in the estimated future cash flows for the
product.
|
|
Reported GAAP earnings
and adjusted non-GAAP earnings for the three months ended September
30, 2023 included acquired
IPR&D and milestones expense of $66 million on a pre-tax
and after-tax basis, representing an unfavorable impact of $0.04
to
both diluted EPS and adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
Quarter Ended
September 30, 2023
|
(in
millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
6,485
|
|
$
3,372
|
|
$
1,723
|
|
$
(95)
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(2,039)
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(2,114)
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(18)
|
|
(40)
|
|
(2)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
(8)
|
Other
|
(13)
|
|
(2)
|
|
(1)
|
|
(43)
|
As adjusted
(non-GAAP)
|
$
2,301
|
|
$
3,330
|
|
$
1,720
|
|
$
(146)
|
|
3. The adjusted tax rate for
the third quarter of 2023 was 15.7 percent, as detailed
below:
|
|
|
Quarter Ended
September 30, 2023
|
(dollars in
millions)
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
1,953
|
|
$
172
|
|
8.8 %
|
Specified
items
|
4,280
|
|
808
|
|
18.9 %
|
As adjusted
(non-GAAP)
|
$
6,233
|
|
$
980
|
|
15.7 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items
impacted results as follows:
|
|
Quarter Ended
September 30, 2022
|
(in millions, except
per share data)
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
4,400
|
|
$
3,949
|
|
$
2.21
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
2,024
|
|
1,673
|
|
0.94
|
Intangible asset
impairment
|
770
|
|
604
|
|
0.34
|
Acquisition and
integration costs
|
348
|
|
348
|
|
0.20
|
Change in fair value
of contingent consideration
|
(214)
|
|
(218)
|
|
(0.12)
|
Litigation
matters
|
110
|
|
94
|
|
0.05
|
Other
|
58
|
|
78
|
|
0.04
|
As adjusted
(non-GAAP)
|
$
7,496
|
|
$
6,528
|
|
$
3.66
|
|
a
Represents net earnings attributable to
AbbVie Inc.
|
|
Acquisition and
integration costs primarily reflect integration costs related to
the Allergan acquisition. Other primarily
includes restructuring charges associated with streamlining global
operations.
|
|
Reported GAAP earnings
and adjusted non-GAAP earnings for the three months ended September
30, 2022 included acquired
IPR&D and milestones expense of $40 million on a
pre-tax and after-tax basis, representing an unfavorable impact of
$0.02 to
both diluted EPS and adjusted diluted EPS.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
Quarter Ended
September 30, 2022
|
(in
millions)
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense
(income),
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
|
$ 5,022
|
|
$ 3,304
|
|
$ 1,614
|
|
$
229
|
|
$
(330)
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
|
(2,024)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
|
(770)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
|
(22)
|
|
(91)
|
|
(6)
|
|
(229)
|
|
—
|
Change in fair value
of contingent consideration
|
|
—
|
|
—
|
|
—
|
|
—
|
|
214
|
Litigation
matters
|
|
—
|
|
(110)
|
|
—
|
|
—
|
|
—
|
Other
|
|
(39)
|
|
(14)
|
|
(1)
|
|
—
|
|
(4)
|
As adjusted
(non-GAAP)
|
|
$ 2,167
|
|
$ 3,089
|
|
$ 1,607
|
|
$
—
|
|
$
(120)
|
|
3. The adjusted tax
rate for the third quarter of 2022 was 12.9 percent, as detailed
below:
|
|
|
Quarter Ended
September 30, 2022
|
(dollars in
millions)
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
4,400
|
|
$
448
|
|
10.2 %
|
Specified
items
|
3,096
|
|
517
|
|
16.7 %
|
As adjusted
(non-GAAP)
|
$
7,496
|
|
$
965
|
|
12.9 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
Nine Months Ended
September 30, 2023
|
(in millions, except
per share data)
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
5,038
|
|
$
4,041
|
|
$
2.26
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
6,057
|
|
5,101
|
|
2.87
|
Intangible asset
impairment
|
2,824
|
|
2,289
|
|
1.29
|
Acquisition and
integration costs
|
38
|
|
15
|
|
0.01
|
Change in fair value
of contingent consideration
|
3,432
|
|
3,348
|
|
1.88
|
Other
|
75
|
|
16
|
|
0.01
|
As adjusted
(non-GAAP)
|
$
17,464
|
|
$
14,810
|
|
$
8.32
|
|
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.
Intangible asset impairment primarily reflects a partial impairment
charge of $2.1 billion related to the U.S. Imbruvica
intangible asset acquired as part of the 2015 acquisition of
Pharmacyclics, Inc. The intangible asset impairment was
triggered
by selection of Imbruvica for price negotiation as part of the IRA
of 2022, which contributed to a significant decrease in the
estimated future cash flows for the product.
|
|
Reported GAAP earnings
and adjusted non-GAAP earnings for the nine months ended September
30, 2023 included acquired
IPR&D and milestones expense of $496 million on a pre-tax
and $477 million on an after-tax basis, representing an
unfavorable impact of $0.27 to both diluted EPS and adjusted
diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Nine Months Ended
September 30, 2023
|
(in millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense
(income),
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
14,711
|
|
$
9,679
|
|
$
5,748
|
|
$
(179)
|
|
$
3,121
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(6,057)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(2,194)
|
|
—
|
|
(630)
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(66)
|
|
(134)
|
|
(7)
|
|
169
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(3,432)
|
Other
|
(45)
|
|
(13)
|
|
(4)
|
|
10
|
|
(23)
|
As adjusted
(non-GAAP)
|
$
6,349
|
|
$
9,532
|
|
$
5,107
|
|
$
—
|
|
$
(334)
|
|
3. The adjusted tax rate for
the first nine months of 2023 was 15.2 percent, as detailed
below:
|
|
|
Nine Months Ended
September 30, 2023
|
(dollars in
millions)
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
5,038
|
|
$
989
|
|
19.6 %
|
Specified
items
|
12,426
|
|
1,657
|
|
13.3 %
|
As adjusted
(non-GAAP)
|
$
17,464
|
|
$
2,646
|
|
15.2 %
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
(Unaudited)
|
|
1. Specified items impacted
results as follows:
|
|
|
Nine Months Ended
September 30, 2022
|
(in millions, except
per share data)
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported
(GAAP)
|
$
10,512
|
|
$
9,363
|
|
$
5.24
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset
amortization
|
5,728
|
|
4,794
|
|
2.69
|
Intangible asset
impairment
|
770
|
|
604
|
|
0.34
|
Acquisition and
integration costs
|
595
|
|
567
|
|
0.32
|
Change in fair value
of contingent consideration
|
647
|
|
657
|
|
0.37
|
Pylera
divestiture
|
(172)
|
|
(126)
|
|
(0.07)
|
Litigation
matters
|
2,497
|
|
2,021
|
|
1.13
|
Other
|
281
|
|
295
|
|
0.16
|
As adjusted
(non-GAAP)
|
$
20,858
|
|
$
18,175
|
|
$
10.18
|
|
a
Represents net earnings attributable to AbbVie
Inc.
|
|
Acquisition and
integration costs primarily reflect integration costs related to
the Allergan acquisition. Litigation matters
primarily include 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 nine months ended September
30, 2022 included acquired
IPR&D and milestones expense of $454 million on a pre-tax
and $439 million on an after-tax basis, representing an
unfavorable impact of $0.25 to both diluted EPS and adjusted
diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
Nine Months Ended
September 30, 2022
|
(in millions)
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense
(income),
net
|
|
Other
expense
(income),
net
|
As reported
(GAAP)
|
$
13,244
|
|
$
11,843
|
|
$ 4,720
|
|
$
57
|
|
$
427
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(5,728)
|
|
—
|
|
—
|
|
—
|
|
—
|
Intangible asset
impairment
|
(770)
|
|
—
|
|
—
|
|
—
|
|
—
|
Acquisition and
integration costs
|
(84)
|
|
(263)
|
|
(19)
|
|
(229)
|
|
—
|
Change in fair value
of contingent consideration
|
—
|
|
—
|
|
—
|
|
—
|
|
(647)
|
Pylera
divestiture
|
—
|
|
—
|
|
—
|
|
172
|
|
—
|
Litigation
matters
|
—
|
|
(2,497)
|
|
—
|
|
—
|
|
—
|
Other
|
(160)
|
|
(107)
|
|
(7)
|
|
—
|
|
(7)
|
As adjusted
(non-GAAP)
|
$ 6,502
|
|
$ 8,976
|
|
$ 4,694
|
|
$
—
|
|
$
(227)
|
|
3. The adjusted tax rate for
the first nine months of 2022 was 12.8 percent, as detailed
below:
|
|
|
Nine Months Ended
September 30, 2022
|
(dollars in
millions)
|
Pre-tax
earnings
|
|
Income taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
10,512
|
|
$
1,139
|
|
10.8 %
|
Specified
items
|
10,346
|
|
1,534
|
|
14.8 %
|
As adjusted
(non-GAAP)
|
$
20,858
|
|
$
2,673
|
|
12.8 %
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-third-quarter-2023-financial-results-301969530.html
SOURCE AbbVie