- Reports First-Quarter Diluted EPS of $2.51 on a GAAP Basis, an Increase of 26.1
Percent; Adjusted Diluted EPS of $3.16, an Increase of 9.3 Percent; These Results
Include an Unfavorable Impact of $0.08 Per Share related to Acquired IPR&D and
Milestones Expense 1
- Delivers First-Quarter Net Revenues of $13.538 Billion, an Increase of 4.1 Percent on a
Reported Basis and 5.4 Percent Operationally
- First-Quarter Global Net Revenues from the Immunology
Portfolio Were $6.141 Billion, an
Increase of 6.9 Percent on a Reported Basis, or 8.1 Percent on an
Operational Basis; U.S. Humira Net Revenues Were $3.993 Billion, an Increase of 2.2 Percent;
Internationally, Humira Net Revenues Were $743 Million, a Decrease of 22.6 Percent on a
Reported Basis, or 17.9 Percent on an Operational Basis, Due to
Biosimilar Competition; Global Skyrizi Net Revenues Were
$940 Million; Global Rinvoq Net
Revenues Were $465 Million
- First-Quarter Global Net Revenues from the Hematologic
Oncology Portfolio Were $1.646
Billion, a Decrease of 1.6 Percent on a Reported Basis, or
0.6 Percent on an Operational Basis; Global Imbruvica Net Revenues
Were $1.173 Billion, a Decrease of
7.4 Percent, with U.S. Net Revenues of $874 Million and International Profit Sharing of
$299 Million; Global Venclexta Net
Revenues Were $473 Million
- First-Quarter Global Net Revenues from the Neuroscience
Portfolio Were $1.488 Billion, an
Increase of 19.2 Percent on a Reported Basis, or 20.4 Percent on an
Operational Basis; Global Botox Therapeutic Net Revenues Were
$614 Million; Vraylar Net Revenues
Were $427 Million
- First-Quarter Global Net Revenues from the Aesthetics
Portfolio Were $1.374 Billion, an
Increase of 20.5 Percent on a Reported Basis, or 22.5 Percent on an
Operational Basis; Global Botox Cosmetic Net Revenues Were
$641 Million; Global Juvederm Net
Revenues Were $410 Million
- Updates 2022 Adjusted Diluted EPS Guidance Range from
$14.00 - $14.20 to $13.92 -
$14.12, which Includes an Unfavorable
Impact of $0.08 Per Share Related to
Acquired IPR&D and Milestones Expense Incurred During the First
Quarter 2022
NORTH
CHICAGO, Ill., April 29,
2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced
financial results for the first quarter ended March 31, 2022.
"This year is off to a strong start. Our first quarter results
highlight the diversity of our portfolio and include compelling
performance from key growth drivers Skyrizi, Rinvoq, Aesthetics and
Neuroscience," said Richard A.
Gonzalez, chairman and chief executive officer, AbbVie. "Our
momentum combined with ramping contributions from new products and
new indications will drive accelerating revenue and EPS growth
through the rest of the year."
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.
|
First-Quarter Results
- Worldwide net revenues were $13.538
billion, an increase of 4.1 percent on a GAAP basis, or 5.4
percent on an operational basis.
- Global net revenues from the immunology portfolio were
$6.141 billion, an increase of 6.9
percent on a reported basis, or 8.1 percent on an operational
basis.
-
- Global Humira net revenues of $4.736
billion decreased 2.7 percent on a reported basis, or 1.8
percent on an operational basis. U.S. Humira net revenues were
$3.993 billion, an increase of 2.2
percent. Internationally, Humira net revenues were $743 million, a decrease of 22.6 percent on a
reported basis, or 17.9 percent on an operational basis, due to
biosimilar competition.
- Global Skyrizi net revenues were $940
million, an increase of 63.7 percent on a reported basis, or
65.6 percent on an operational basis.
- Global Rinvoq net revenues were $465
million, an increase of 53.6 percent on a reported basis, or
57.3 percent on an operational basis.
- Global net revenues from the hematologic oncology portfolio
were $1.646 billion, a decrease of
1.6 percent on a reported basis, or 0.6 percent on an operational
basis.
-
- Global Imbruvica net revenues were $1.173 billion, a decrease of 7.4 percent, with
U.S. net revenues of $874 million and
international profit sharing of $299
million.
- Global Venclexta net revenues were $473
million, an increase of 16.9 percent on a reported basis, or
21.1 percent on an operational basis.
- Global net revenues from the neuroscience portfolio were
$1.488 billion, an increase of 19.2
percent on a reported basis, or 20.4 percent on an operational
basis.
-
- Global Botox Therapeutic net revenues were $614 million, an increase of 15.4 percent on a
reported basis, or 16.6 percent on an operational basis.
- Vraylar net revenues were $427
million, an increase of 23.4 percent.
- Global Ubrelvy net revenues were $138
million.
- Global net revenues from the aesthetics portfolio were
$1.374 billion, an increase of 20.5
percent on a reported basis, or 22.5 percent on an operational
basis.
-
- Global Botox Cosmetic net revenues were $641 million, an increase of 34.4 percent on a
reported basis, or 36.6 percent on an operational basis.
- Global Juvederm net revenues were $410
million, an increase of 27.5 percent on a reported basis, or
30.9 percent on an operational basis.
- On a GAAP basis, the gross margin ratio in the first quarter
was 70.1 percent. The adjusted gross margin ratio was 84.5
percent.
- On a GAAP basis, selling, general and administrative expense
was 23.1 percent of net revenues. The adjusted SG&A expense was
21.1 percent of net revenues.
- On a GAAP basis, research and development expense was 11.1
percent of net revenues. The adjusted R&D expense was 10.9
percent of net revenues.
- Acquired IPR&D and milestones expense was 1.1 percent of
net revenues.
- On a GAAP basis, the operating margin in the first quarter was
34.8 percent. The adjusted operating margin was 51.4 percent, which
includes an unfavorable 110 basis point impact from acquired
IPR&D and milestones expense.
- Net interest expense was $539
million.
- On a GAAP basis, the tax rate in the quarter was 8.8 percent.
The adjusted tax rate was 12.1 percent.
- Diluted EPS in the first quarter was $2.51 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $3.16.
These results include an unfavorable impact of $0.08 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, 45 mg (induction dose) and 15
mg and 30 mg (maintenance dose)) for the treatment of adults with
moderately to severely active ulcerative colitis (UC) 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
Phase 3 induction studies and one maintenance study. In these
studies, significantly more patients treated with Rinvoq achieved
the primary and all secondary endpoints compared to placebo. The
safety of Rinvoq, including the 45 mg dose as induction therapy, in
these studies was generally consistent with the known safety
profile of Rinvoq, with no new important safety risks observed.
This approval marks the first indication for Rinvoq in
gastroenterology and represents Rinvoq's fourth FDA approved
indication.
- AbbVie announced positive top-line results from the Phase 3
induction study U-EXCEL, which showed Rinvoq (45 mg, once daily)
achieved both primary endpoints of clinical remission and
endoscopic response, compared to placebo at week 12, as well as
most key secondary endpoints in patients with moderate to severe
Crohn's disease (CD). The safety results in this study were
consistent with the known profile of Rinvoq, with no new safety
risks observed. U-EXCEL is the second of two Phase 3 induction
studies to evaluate the safety and efficacy of Rinvoq in adults
with moderate to severe CD and full results will be presented at
upcoming medical conferences and published in a peer-reviewed
journal. Positive top-line results from the Phase 3 portion of the
first induction study, U-EXCEED, were announced in December 2021 and the maintenance study for both
clinical trials is ongoing.
- AbbVie announced that the FDA extended the review period for
Skyrizi (risankizumab) for the treatment of moderate to severe CD
by three months to review additional data submitted by AbbVie,
including information about the on-body injector. Currently
approved indications for Skyrizi were not affected by this
extension. Skyrizi is a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
- AbbVie announced that it resolved all U.S. Humira (adalimumab)
litigation with Alvotech. Under the terms of the resolution, AbbVie
will grant Alvotech a non-exclusive license to its Humira-related
patents in the U.S., which will begin on July 1, 2023. AbbVie will make no payments of any
form to Alvotech, and Alvotech will pay royalties to AbbVie for
licensing its Humira patents and acknowledges the validity and
enforceability of the licensed patents. The resolution included
dismissal of the patent and trade secret litigation between AbbVie
and Alvotech.
- At the Congress of European Crohn's and Colitis Organization
(ECCO), AbbVie shared 26 abstracts, including 16 oral and digital
oral presentations, that reinforced AbbVie's commitment to research
that helps advance standards of care for inflammatory bowel disease
(IBD) patients. Highlights included new post-hoc analyses from the
pivotal Phase 3 Skyrizi program in CD as well as results from a
post-hoc analysis of Phase 3 Rinvoq pivotal trials evaluating UC
symptoms.
- At the American Academy of Dermatology (AAD) Annual Meeting,
AbbVie and Allergan Aesthetics presented new research that
demonstrated their shared commitment to advancing science across a
spectrum of dermatologic conditions and aesthetic indications. The
research included new data on the efficacy, durability and safety
of Rinvoq and Skyrizi as well as data from across the Allergan
Aesthetics portfolio.
- AbbVie and Genmab announced topline results from the first
cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating
epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory
large B-cell lymphoma (LBCL) who received at least two prior lines
of systemic therapy. Results from this cohort demonstrated a
confirmed overall response rate (ORR) of 63.1 percent with a
12-month median duration of response. Based on the topline results,
the companies will engage global regulatory authorities and data
from the clinical trial will be presented at a future medical
meeting. Epcoritamab is being co-developed by AbbVie and
Genmab.
- At the American Association of Cancer Research (AACR) Annual
Meeting, AbbVie presented positive results from a Phase 2 trial
evaluating navitoclax in combination with ruxolitinib in patients
with myelofibrosis that previously had a suboptimal response or
disease progression with ruxolitinib monotherapy. The study
evaluated 34 patients and median overall survival was not reached
for patients who had a ≥ 1 grade improvement in bone marrow
fibrosis (BMF) or ≥ 20% variant allele frequency (VAF) reduction.
Additionally, at the time of analysis with > 2 year follow up,
the survival estimate was 100% in patients who had improvements in
BMF or VAF.
- AbbVie announced that it submitted a supplemental New Drug
Application (sNDA) to the FDA for Vraylar (cariprazine) for the
adjunctive treatment of major depressive disorder (MDD). The
submission is based on clinical trial results that showed
clinically and statistically significant improvement in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score in
patients with MDD treated with Vraylar and an antidepressant. If
approved, this milestone will be the fourth indication for Vraylar
joining approvals for the treatment of adults with schizophrenia,
the acute treatment of manic or mixed episodes associated with
bipolar I disorder and the treatment of depressive episodes
associated with bipolar I disorder. Vraylar is being co-developed
by AbbVie and Gedeon Richter Plc.
- AbbVie announced that the Phase 3 PROGRESS trial evaluating
Qulipta (atogepant), an oral calcitonin gene-related peptide (CGRP)
receptor antagonist (gepant) for the preventive treatment of
chronic migraine in adults, met its primary endpoint of
statistically significant reduction from baseline in mean monthly
migraine days compared to placebo, for both the 60 mg once daily
(QD) and 30 mg twice daily (BID) doses, across the 12-week
treatment period. The study also demonstrated statistically
significant improvement in all secondary endpoints and the overall
safety profile of Qulipta was consistent with safety findings
observed in previous studies with an episodic migraine population.
Data from this study will support a submission to expand the use of
Qulipta to include preventive treatment of chronic migraine in the
U.S. and additional submissions globally.
- At the American Academy of Neurology (AAN) Annual Meeting,
AbbVie shared 30 abstracts demonstrating the breadth of its
neuroscience portfolio. The abstracts highlighted AbbVie's
continued migraine treatment research across the spectrum of the
disease, AbbVie's commitment to patients with advanced Parkinson's
disease and new studies in spasticity and cervical dystonia.
- AbbVie and Gedeon Richter Plc. (Richter) announced a new
co-development and license agreement to research, develop and
commercialize novel dopamine receptor modulators for the potential
treatment of neuropsychiatric diseases. The collaboration is based
on the results of preclinical research carried out by Richter and
includes several new chemical entities selected for development.
AbbVie and Richter have collaborated for 15 years on Central
Nervous System (CNS) projects, including globally launched products
such as Vraylar.
- AbbVie announced the successful completion of its acquisition
of Syndesi Therapeutics SA. The acquisition gives AbbVie access to
Syndesi's portfolio of novel modulators of the synaptic vesicle
protein 2A (SV2A), including its lead molecule SDI-118, which is
currently being evaluated for the potential treatment of cognitive
impairment and other symptoms associated with a range of
neuropsychiatric and neurodegenerative disorders, such as
Alzheimer's disease and MDD.
- Allergan Aesthetics announced that the FDA approved Juvederm
Volbella XC for improvement of infraorbital (undereye) hollows in
adults over the age of 21. With this approval, Juvederm Volbella XC
became the first and only dermal filler to receive FDA approval for
the improvement of infraorbital hollows.
- At the Aesthetic and Anti-aging Medicine World Congress (AMWC),
Allergan Aesthetics presented research that demonstrated its
commitment to the future of aesthetics with a forward-facing trends
report. The meeting also marked Allergan Aesthetics' entry into the
emerging category of Hybrid Injectables with the launch of
HArmonyCa with lidocaine across Europe. The dual-effect Hybrid Injectable
contains two active ingredients, hyaluronic acid, a well-known
ingredient found in facial fillers, and calcium hydroxyapatite
(CaHA), which is known to help stimulate collagen production.
- AbbVie announced positive results from the Phase 3 VIRGO trial
evaluating the safety and efficacy of investigational twice-daily
administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25%
in adults with age-related blurry near vision (presbyopia).
Additional details of this trial will be presented at future
medical congresses and will serve as the basis for a sNDA
submission for an optional twice-daily administration to the FDA in
the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, Vuity is the
first and only eye drop to treat age-related blurry near vision in
adults.
- At the American Glaucoma Society (AGS) Annual Meeting and the
American Society of Cataract and Refractive Surgery (ASCRS) Annual
Meeting, AbbVie presented data from its leading portfolio of eye
care treatments. Highlights included updated analyses that help
further scientific understanding of Durysta (bimatoprost
intracameral implant), a first-of-its-kind biodegradable implant to
lower eye pressure for glaucoma patients; new data on the Xen Gel
Stent, a surgical implant designed to lower high eye pressure
approved for refractory glaucoma patients; and new data on Vuity
1.25%.
- AbbVie and Scripps Research, an independent, non-profit
biomedical research and drug discovery institute, announced a
global collaboration to develop potential novel, direct-acting
antiviral treatments for COVID-19.
Full-Year 2022 Outlook
AbbVie is updating its adjusted diluted EPS guidance range for
the full-year 2022 from $14.00 -
$14.20 to $13.92 - $14.12
which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and
milestones expense incurred during the first 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 first 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, LinkedIn or Instagram.
Conference Call
AbbVie will host an investor conference call today at
8:00 a.m. Central time to discuss our
first-quarter performance. The call will be webcast through
AbbVie's Investor Relations website at investors.abbvie.com. An
archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 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 March
31, 2022
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs. 1Q21
|
|
Net Revenues (in millions)
|
|
Reported
|
|
Operationala
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
Int'l.
|
|
Total
|
NET REVENUES
|
$10,348
|
|
$3,190
|
|
$13,538
|
|
6.1%
|
|
(2.1)%
|
|
4.1%
|
|
3.2%
|
|
5.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunology
|
5,085
|
|
1,056
|
|
6,141
|
|
9.7
|
|
(4.9)
|
|
6.9
|
|
1.1
|
|
8.1
|
Humira
|
3,993
|
|
743
|
|
4,736
|
|
2.2
|
|
(22.6)
|
|
(2.7)
|
|
(17.9)
|
|
(1.8)
|
Skyrizi
|
781
|
|
159
|
|
940
|
|
62.3
|
|
71.2
|
|
63.7
|
|
82.9
|
|
65.6
|
Rinvoq
|
311
|
|
154
|
|
465
|
|
26.8
|
|
>100.0
|
|
53.6
|
|
>100.0
|
|
57.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic Oncology
|
1,102
|
|
544
|
|
1,646
|
|
(9.8)
|
|
20.9
|
|
(1.6)
|
|
24.7
|
|
(0.6)
|
Imbruvicab
|
874
|
|
299
|
|
1,173
|
|
(12.4)
|
|
11.0
|
|
(7.4)
|
|
11.0
|
|
(7.4)
|
Venclexta
|
228
|
|
245
|
|
473
|
|
1.7
|
|
35.8
|
|
16.9
|
|
45.2
|
|
21.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aesthetics
|
846
|
|
528
|
|
1,374
|
|
16.3
|
|
27.9
|
|
20.5
|
|
33.5
|
|
22.5
|
Botox Cosmetic
|
413
|
|
228
|
|
641
|
|
35.5
|
|
32.5
|
|
34.4
|
|
38.6
|
|
36.6
|
Juvederm Collection
|
148
|
|
262
|
|
410
|
|
20.1
|
|
32.2
|
|
27.5
|
|
37.7
|
|
30.9
|
Other Aesthetics
|
285
|
|
38
|
|
323
|
|
(4.9)
|
|
(9.9)
|
|
(5.5)
|
|
(6.2)
|
|
(5.0)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroscience
|
1,273
|
|
215
|
|
1,488
|
|
22.7
|
|
2.0
|
|
19.2
|
|
8.8
|
|
20.4
|
Botox Therapeutic
|
500
|
|
114
|
|
614
|
|
16.5
|
|
10.7
|
|
15.4
|
|
17.1
|
|
16.6
|
Vraylar
|
427
|
|
—
|
|
427
|
|
23.4
|
|
n/a
|
|
23.4
|
|
n/a
|
|
23.4
|
Duodopa
|
24
|
|
97
|
|
121
|
|
(5.6)
|
|
(6.9)
|
|
(6.7)
|
|
0.5
|
|
(0.8)
|
Ubrelvy
|
138
|
|
—
|
|
138
|
|
70.0
|
|
n/a
|
|
70.0
|
|
n/a
|
|
70.0
|
Qulipta
|
11
|
|
—
|
|
11
|
|
n/m
|
|
n/a
|
|
n/m
|
|
n/a
|
|
n/m
|
Other Neuroscience
|
173
|
|
4
|
|
177
|
|
11.0
|
|
11.4
|
|
11.0
|
|
12.2
|
|
11.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye Care
|
496
|
|
275
|
|
771
|
|
(6.3)
|
|
(4.2)
|
|
(5.6)
|
|
3.7
|
|
(2.8)
|
Lumigan/Ganfort
|
67
|
|
73
|
|
140
|
|
1.5
|
|
(5.7)
|
|
(2.4)
|
|
0.7
|
|
1.0
|
Alphagan/Combigan
|
70
|
|
37
|
|
107
|
|
(11.5)
|
|
(3.9)
|
|
(9.0)
|
|
5.5
|
|
(6.0)
|
Restasis
|
235
|
|
11
|
|
246
|
|
(11.9)
|
|
(18.1)
|
|
(12.2)
|
|
1.9
|
|
(11.3)
|
Other Eye Care
|
124
|
|
154
|
|
278
|
|
5.5
|
|
(2.4)
|
|
0.9
|
|
4.8
|
|
5.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key Products
|
689
|
|
218
|
|
907
|
|
4.3
|
|
(13.4)
|
|
(0.6)
|
|
(6.7)
|
|
1.2
|
Mavyret
|
169
|
|
211
|
|
380
|
|
(1.0)
|
|
(13.9)
|
|
(8.6)
|
|
(7.2)
|
|
(4.6)
|
Creon
|
287
|
|
—
|
|
287
|
|
4.7
|
|
n/a
|
|
4.7
|
|
n/a
|
|
4.7
|
Linzess/Constella
|
233
|
|
7
|
|
240
|
|
7.9
|
|
6.0
|
|
7.8
|
|
10.2
|
|
7.9
|
|
|
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 Ended March
31, 2022 and 2021
(Unaudited) (In
millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter
Ended March 31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2022
|
|
2021
|
Net revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
13,538
|
|
$
13,010
|
Cost of products
sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,052
|
|
4,213
|
Selling, general and
administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,127
|
|
2,842
|
Research and
developmenta
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,497
|
|
1,667
|
Acquired IPR&D and
milestonesa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
145
|
|
185
|
Total operating costs
and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,821
|
|
8,907
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
earnings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,717
|
|
4,103
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
539
|
|
622
|
Net foreign exchange
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25
|
|
9
|
Other income,
net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(776)
|
|
(395)
|
Earnings before income
tax expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,929
|
|
3,867
|
Income tax
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
436
|
|
312
|
Net earnings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,493
|
|
3,555
|
Net earnings
attributable to noncontrolling interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
2
|
Net earnings
attributable to AbbVie Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
4,490
|
|
$
3,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per
share attributable to AbbVie Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
2.51
|
|
$
1.99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per shareb
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
3.16
|
|
$
2.89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,778
|
|
1,775
|
|
|
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 $115 million
for the three months ended March 31, 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 March
31, 2022
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
1Q22
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported (GAAP)
|
$
4,929
|
|
$
4,490
|
|
$
2.51
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset amortization
|
1,855
|
|
1,565
|
|
0.88
|
Acquisition and integration costs
|
138
|
|
121
|
|
0.07
|
Change in fair value of contingent consideration
|
(748)
|
|
(746)
|
|
(0.42)
|
Litigation matters
|
184
|
|
148
|
|
0.08
|
Other
|
64
|
|
63
|
|
0.04
|
As adjusted (non-GAAP)
|
$
6,422
|
|
$
5,641
|
|
$
3.16
|
|
a
Represents net earnings attributable
to AbbVie Inc.
|
|
Acquisition and
integration costs reflect integration costs related to
the Allergan acquisition. Other primarily includes
restructuring charges associated with streamlining global
operations.
|
|
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. Reported
GAAP earnings and adjusted non-GAAP earnings for the
first quarter of 2022 included acquired IPR&D and
milestones expense
of $145 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:
|
|
1Q22
|
|
Cost of
products sold
|
|
SG&A
|
|
R&D
|
|
Other
income, net
|
As reported (GAAP)
|
$
4,052
|
|
$
3,127
|
|
$
1,497
|
|
$
(776)
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
Intangible asset amortization
|
(1,855)
|
|
—
|
|
—
|
|
—
|
Acquisition and integration costs
|
(34)
|
|
(93)
|
|
(11)
|
|
—
|
Change in fair value of contingent consideration
|
—
|
|
—
|
|
—
|
|
748
|
Litigation matters
|
—
|
|
(184)
|
|
—
|
|
—
|
Other
|
(60)
|
|
2
|
|
(6)
|
|
—
|
As adjusted (non-GAAP)
|
$
2,103
|
|
$
2,852
|
|
$
1,480
|
|
$
(28)
|
|
3. The adjusted tax rate for
the first quarter of 2022 was 12.1 percent, as detailed
below:
|
|
|
1Q22
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported (GAAP)
|
$
4,929
|
|
$
436
|
|
8.8%
|
Specified
items
|
1,493
|
|
342
|
|
22.9%
|
As adjusted (non-GAAP)
|
$
6,422
|
|
$
778
|
|
12.1%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended March
31, 2021
(Unaudited) (In
millions, except per share data)
|
|
1.
Specified items impacted results as follows:
|
|
1Q21
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-taxa
|
|
EPS
|
As reported (GAAP)
|
$
3,867
|
|
$
3,553
|
|
$
1.99
|
Adjusted for specified
items:
|
|
|
|
|
|
Intangible asset amortization
|
2,009
|
|
1,682
|
|
0.94
|
Acquisition and integration costs
|
224
|
|
155
|
|
0.09
|
Change in fair value of contingent consideration
|
(343)
|
|
(343)
|
|
(0.19)
|
Other
|
141
|
|
112
|
|
0.06
|
As adjusted (non-GAAP)
|
$
5,898
|
|
$
5,159
|
|
$
2.89
|
|
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 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 upfront and milestone
payments related to collaborations,
licensing agreements, and other asset acquisitions in its
reported non-GAAP financial measures. Reported GAAP
earnings and
adjusted non-GAAP earnings for the first quarter of 2021
included acquired IPR&D and milestones expense of $185
million on
a pre-tax and $168 million on an after-tax basis, representing an
unfavorable impact of $0.09 to both diluted EPS and
adjusted
diluted EPS.
|
|
2. The impact of the
specified items by line item was as follows:
|
|
|
1Q21
|
|
Cost of
products sold
|
|
SG&A
|
|
R&D
|
|
Other
income, net
|
As reported (GAAP)
|
$
4,213
|
|
$
2,842
|
|
$
1,667
|
|
$
(395)
|
Adjusted for specified
items:
|
|
|
|
|
|
|
|
Intangible asset amortization
|
(2,009)
|
|
—
|
|
—
|
|
—
|
Acquisition and integration costs
|
(99)
|
|
(76)
|
|
(49)
|
|
—
|
Change in fair value of contingent consideration
|
—
|
|
—
|
|
—
|
|
343
|
Other
|
(20)
|
|
(23)
|
|
(113)
|
|
15
|
As adjusted (non-GAAP)
|
$
2,085
|
|
$
2,743
|
|
$
1,505
|
|
$
(37)
|
|
3. The adjusted tax rate for
the first quarter of 2021 was 12.5 percent, as detailed
below:
|
|
|
1Q21
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported (GAAP)
|
$
3,867
|
|
$
312
|
|
8.1%
|
Specified
items
|
2,031
|
|
425
|
|
20.9%
|
As adjusted (non-GAAP)
|
$
5,898
|
|
$
737
|
|
12.5%
|
View original
content:https://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2022-financial-results-301536204.html
SOURCE AbbVie