NORTH CHICAGO, Ill., Feb. 7,
2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial
results for the fourth quarter and full year ended
December 31, 2019.
"Our strong performance this quarter completes another excellent
year for AbbVie," said Richard A.
Gonzalez, chairman and chief executive officer, AbbVie. "The
launches of Skyrizi and Rinvoq are going extremely well, and we are
entering 2020 with substantial momentum. We also look forward to
completing the planned Allergan acquisition in the first
quarter."
Fourth-Quarter Results
- Worldwide net revenues were $8.704
billion, an increase of 4.8 percent on a reported basis, or
5.3 percent operationally. Excluding the unfavorable impact of
international HUMIRA net revenues due to biosimilar competition,
fourth-quarter net revenues grew 11.0 percent operationally.
- U.S. HUMIRA net revenues were $3.969
billion, an increase of 9.8 percent. Internationally, HUMIRA
net revenues were $948 million, a
decrease of 27.3 percent on a reported basis, or 25.4 percent
operationally, due to biosimilar competition. Global HUMIRA net
revenues of $4.917 billion were flat
on a reported basis and increased 0.5 percent operationally.
- Global IMBRUVICA net revenues were $1.296 billion, an increase of 28.9 percent, with
U.S. net revenues of $1.073 billion
and international profit sharing of $223
million. Global VENCLEXTA net revenues were $251 million. Global net revenues from the
hematologic oncology portfolio were $1.547
billion, an increase of 37.0 percent on a reported basis, or
37.2 percent operationally.
- Global SKYRIZI net revenues were $216
million and global RINVOQ net revenues were $33 million.
- On a GAAP basis, the gross margin ratio in the fourth quarter
was 77.0 percent. The adjusted gross margin ratio was 81.6
percent.
- On a GAAP basis, selling, general and administrative expense
was 22.4 percent of net revenues. The adjusted SG&A expense was
21.6 percent of net revenues.
- On a GAAP basis, research and development expense was 17.7
percent of net revenues. The adjusted R&D expense was 15.3
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- On a GAAP basis, the operating margin in the fourth quarter was
45.5 percent. The adjusted operating margin was 44.6 percent.
- On a GAAP basis, net interest expense was $455 million. The adjusted net interest expense
was $282 million.
- On a GAAP basis, the tax rate in the quarter was 8.9 percent.
The adjusted tax rate was 8.8 percent.
- Diluted EPS in the fourth quarter was $1.88 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.21.
Note: "Operational" comparisons are presented at constant
currency rates and reflect comparative local currency net revenues
at the prior year's foreign exchange rates.
Recent Events
- AbbVie and Allergan announced that Allergan has entered into
definitive agreements to divest brazikumab and Zenpep in
conjunction with the ongoing regulatory approval process for
AbbVie's acquisition of Allergan. AstraZeneca will acquire
brazikumab, an investigational IL-23 inhibitor in Phase
2b/3 development for Crohn's Disease
and in Phase 2 development for ulcerative colitis, including global
development and commercial rights. Nestle will acquire and take
full operational ownership of Zenpep, a treatment for exocrine
pancreatic insufficiency, as well as Viokace, another pancreatic
enzyme preparation, as part of the transaction. The closings of the
divestitures of brazikumab and Zenpep are contingent upon receipt
of U.S. Federal Trade Commission and European Commission (EC)
approval, closing of AbbVie's pending acquisition of Allergan and
the satisfaction of other customary closing conditions. AbbVie and
Allergan continue to expect to close the pending transaction in the
first quarter of 2020.
- AbbVie announced regulatory approvals for RINVOQ (upadacitinib)
for the treatment of adult patients with moderate to severe
rheumatoid arthritis (RA). The approvals from the EC and the
Japanese Ministry of Health, Labour and Welfare are based on
results from the SELECT Phase 3 program, one of the largest
registrational Phase 3 programs in RA, with approximately 4,400
patients evaluated across five studies.
- AbbVie announced positive top-line data from the Phase 3
SELECT-PsA 1 study, the second of two registration-enabling trials
evaluating RINVOQ in psoriatic arthritis (PsA). In this study, both
doses of RINVOQ (15 mg and 30 mg, once daily) met the primary
endpoint of ACR20 at week 12 versus placebo in adult patients with
active PsA who have responded inadequately or are intolerant to one
or more non-biologic disease modifying anti-rheumatic drugs
(DMARDs). RINVOQ also demonstrated significant improvements in
signs and symptoms of the disease across a variety of endpoints
compared to placebo. Both doses of RINVOQ also significantly
inhibited radiographic progression at week 24 compared to placebo.
The 30 mg dose of RINVOQ achieved superiority to adalimumab in
terms of ACR20 response at week 12, whereas both doses achieved
non-inferiority vs. adalimumab. The safety profile of RINVOQ was
consistent with previously reported results across indications,
with no new safety risks detected. Detailed data from both pivotal
studies will be presented at an upcoming medical meeting and AbbVie
expects to submit our regulatory applications for RINVOQ in PsA in
the second quarter of this year.
- AbbVie announced positive data from a head-to-head Phase 3
study evaluating SKYRIZI (risankizumab) compared to Cosentyx in
adult patients with moderate to severe plaque psoriasis. In the
study, SKYRIZI met both primary endpoints and all ranked secondary
endpoints, demonstrating higher rates of skin clearance compared to
Cosentyx. SKYRIZI met the primary endpoint of superiority with at
least a 90 percent improvement from baseline in the Psoriasis Area
and Severity Index (PASI 90) at week 52. Of patients treated with
SKYRIZI, 87 percent achieved PASI 90 compared to 57 percent of
Cosentyx-treated patients at 52 weeks. At week 16, SKYRIZI met the
other primary endpoint of non-inferiority to Cosentyx, with 74
percent of SKYRIZI patients achieving PASI 90 compared to 66
percent of Cosentyx patients. SKYRIZI also showed superiority
compared to Cosentyx for all ranked secondary endpoints, including
PASI 100, and PASI 75, as well as a static Physician Global
Assessment score of clear or almost clear at week 52. The safety
profile of SKYRIZI was consistent with that observed in previously
reported studies, with no new safety signals observed through week
52. SKYRIZI is part of a collaboration between Boehringer Ingelheim
and AbbVie, with AbbVie leading development and commercialization
globally.
- At the American College of Rheumatology (ACR)/Association for
Rheumatology Health Professionals (ARHP) Annual Meeting, AbbVie
presented data for RINVOQ, HUMIRA (adalimumab) and SKYRIZI, with 38
abstracts presented across multiple rheumatic conditions, including
RA, ankylosing spondylitis (AS) and PsA. Included in the
presentations were new data from the Phase 2/3 SELECT-AXIS 1 trial
in which twice as many adult patients with active AS treated with
RINVOQ achieved the primary endpoint of Assessment of
SpondyloArthritis International Society (ASAS) 40 response at week
14 versus placebo. The safety profile of RINVOQ was consistent with
that of previous studies in rheumatoid arthritis, with no new
safety risks detected. AbbVie also presented long-term data from
the SELECT Phase 3 program further evaluating efficacy and safety
across measures with RINVOQ, even without methotrexate, in patients
with moderate to severe RA.
- AbbVie announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has granted
a positive opinion for VENCLYXTO (venetoclax) in combination with
obinutuzumab for the treatment of patients with chronic lymphocytic
leukemia (CLL) who were previously untreated. The CHMP positive
opinion is based on results from the Phase 3 CLL14 clinical trial,
which showed that patients who completed one year of treatment with
VENCLYXTO plus obinutuzumab had prolonged progression-free survival
(PFS) and higher rates of minimal residual disease (MRD) negativity
compared to patients receiving a standard of care
chemoimmunotherapy regimen of obinutuzumab and chlorambucil. This
represents the third positive CHMP opinion for VENCLYXTO and if
approved by the EC, VENCLYXTO plus obinutuzumab would be the first
chemotherapy-free, oral combination regimen given with a fixed
duration for patients with previously-untreated CLL. Venetoclax is
being developed by AbbVie and Roche and is jointly commercialized
by AbbVie and Genentech, a member of the Roche Group, in the U.S.
and by AbbVie outside of the U.S.
- AbbVie announced the submission of a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA)
for IMBRUVICA (ibrutinib) in combination with rituximab for the
first-line treatment of younger patients (70 years old or younger)
with CLL or small lymphocytic lymphoma (SLL). The application is
being reviewed under the FDA's Real-Time Oncology Review pilot
program and is based on results from the Phase 3 E1912 study, which
showed significantly improved PFS and overall survival (OS) in
patients treated with IMBRUVICA plus rituximab compared to those
treated with fludarabine, cyclophosphamide and rituximab (FCR).
Safety data were consistent with the known safety profile of
IMBRUVICA and if approved, the milestone will mark the
11th FDA approval for IMBRUVICA across six distinct
disease areas. IMBRUVICA is jointly developed and commercialized
with Janssen Biotech, Inc.
- At the American Society of Hematology Annual Meeting &
Exposition (ASH), AbbVie presented data from more than 40
abstracts, including 18 oral presentations, featuring the latest
scientific progress from its Hematologic Oncology programs. Key
data presentations included new data from the Phase 2 CAPTIVATE
study evaluating IMBRUVICA plus VENCLEXTA (venetoclax) in
previously untreated patients with CLL; new data from the Phase 3
E1912 study evaluating IMBRUVICA plus rituximab versus FCR in
front-line CLL, results of a 7.5-year pooled analysis for IMBRUVICA
monotherapy showing earlier treatment extended PFS and increased
the likelihood of a complete response in patients with
relapsed/refractory mantle cell lymphoma; updated data from the
Phase 3 MURANO trial four-year analysis demonstrating PFS and OS
benefits with VENCLEXTA plus rituximab in patients with
relapsed/refractory CLL; and results from a Phase 2 study of
navitoclax in combination with ruxolitinib showing clinically
meaningful spleen responses, reductions in allelic burden and
improvements in total symptom score, as well as improvements in
bone marrow fibrosis.
- AbbVie announced that the CHMP of the EMA has recommended a
change to the marketing authorization for MAVIRET
(glecaprevir/pibrentasvir) to shorten once-daily treatment duration
from 12 to 8 weeks in treatment-naïve, compensated cirrhotic,
chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.
If approved by the EC, MAVIRET will be the only pan-genotypic
8-week treatment option for treatment-naïve, chronic HCV patients,
without cirrhosis or with compensated cirrhosis. The positive
recommendation is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8
weeks of MAVIRET, an overall 98 percent patients achieved a
sustained virologic response 12 weeks after treatment
(SVR12), and for patients with GT3, the SVR12
rate was over 95%. A final EC decision is expected in 2020.
- AbbVie and Harpoon Therapeutics, Inc., a clinical-stage
immunotherapy company developing a novel class of T cell engagers
targeting both solid tumors and hematologic malignancies, announced
an exclusive worldwide option and license transaction for HPN217,
Harpoon's B cell maturation antigen (BCMA)-targeting Tri-specific T
cell Activating Construct (TriTAC), and an expansion of their
existing discovery collaboration for up to six additional targets.
These agreements build upon the discovery collaboration established
by the two companies in October 2017
and are expected to advance and broaden the use of Harpoon's
proprietary TriTAC platform. The collaboration broadens AbbVie's
oncology research platform to expand the development of potentially
life-changing treatments for patients.
- AbbVie announced a collaboration with Scripps Research to
develop new therapies for a range of diseases, including in the
therapeutic areas of oncology, immunology, neurology and fibrosis.
Under the terms of the license agreement, Scripps Research will
continue to conduct pre-clinical research and development
activities and, in some cases, Phase 1 clinical trials with AbbVie
having an exclusive option to further develop and commercialize.
The collaboration broadens AbbVie's research platform to expand the
development of potentially life-changing treatments for
patients.
- The Chinese health authorities have requested supply of Aluvia
(lopinavir/ritonavir) as part of the government's broader efforts
to address the coronavirus crisis in China. In response to this request, AbbVie has
confirmed a donation of Aluvia as an experimental option to support
this growing public health crisis.
Full-Year 2020 Outlook
AbbVie is issuing its standalone GAAP diluted EPS guidance for
the full-year 2020 of $7.66 to
$7.76, representing growth of 46.0
percent at the midpoint. AbbVie expects to deliver standalone
adjusted diluted EPS for the full-year 2020 of $9.61 to $9.71,
representing growth of 8.1 percent at the midpoint. The company's
standalone 2020 adjusted diluted EPS guidance excludes $1.95 per share of intangible asset amortization
expense, non-cash charges for contingent consideration adjustments
and other specified items.
AbbVie expects standalone revenue growth approaching 8.0 percent
on an operational basis.
Statements Required by the Irish Takeover Rules
The directors of AbbVie accept responsibility for the
information contained in this announcement. To the best of the
knowledge and belief of the directors of AbbVie (who have taken all
reasonable care to ensure that such is the case), the information
contained in this announcement is in accordance with the facts and
does not omit anything likely to affect the import of such
information.
Any holder of 1% or more of any class of relevant securities of
AbbVie Inc. may have disclosure obligations under Rule 8.3 of the
Irish Takeover Panel Act, 1997, Takeover Rules 2013.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company
committed to developing innovative advanced therapies for some of
the world's most complex and critical conditions. The company's
mission is to use its expertise, dedicated people and unique
approach to innovation to markedly improve treatments across four
primary therapeutic areas: immunology, oncology, virology and
neuroscience. In more than 75 countries, AbbVie employees are
working every day to advance health solutions for people around the
world. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on Twitter, Facebook or
LinkedIn.
Conference Call
AbbVie will host an investor conference call today at
8:00 a.m. Central time to discuss our
fourth-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 2019 and 2018 are presented on both a
reported and a non-GAAP basis. Reported results were prepared in
accordance with GAAP and include all revenue and expenses
recognized during the period. Non-GAAP results adjust for certain
non-cash items and for factors that are unusual or unpredictable,
and exclude those costs, expenses, and other specified items
presented in the reconciliation tables later in this release.
AbbVie's management believes non-GAAP financial measures provide
useful information to investors regarding AbbVie's results of
operations and assist management, analysts, and investors in
evaluating the performance of the business. Non-GAAP financial
measures should be considered in addition to, and not as a
substitute for, measures of financial performance prepared in
accordance with GAAP. The company's 2020 financial guidance is also
being provided on both a reported and a non-GAAP basis.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, the possibility
that the proposed acquisition of Allergan will not be pursued,
failure to obtain necessary regulatory approvals or required
financing or to satisfy any of the other conditions to the proposed
acquisition, failure to realize the expected benefits of the
proposed acquisition, failure to promptly and effectively integrate
Allergan's businesses, significant transaction costs and/or unknown
or inestimable liabilities, potential litigation associated with
the proposed acquisition, 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 2018 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission (SEC). 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.
Profit Forecasts
AbbVie is issuing its GAAP diluted EPS guidance for the
full-year 2020 of $7.66 to
$7.76, representing growth of 46.0
percent at the midpoint.
AbbVie is issuing its adjusted diluted EPS guidance for the
full-year 2020 of $9.61 to
$9.71, representing growth of 8.1
percent at the midpoint.
AbbVie expects adjusted diluted EPS guidance for the first
quarter of 2020 of between $2.28 and
$2.30, excluding approximately
53 cents of non-cash amortization and
other specified items.
The guidance statements above regarding GAAP EPS and adjusted
EPS for the full-year 2020 and adjusted EPS for the first quarter
of 2020 each constitute a profit forecast for the purposes of the
Rule 28 of the Irish Takeover Rules.
The company will issue 2020 proforma guidance following the
close of the planned Allergan acquisition.
* Adjusted Earnings Per Share ("EPS") is a non-GAAP diluted
earnings per share, typically reported in AbbVie's quarterly and
annual financial results for the full year guidance and in the
earnings calls for the next quarter guidance updates. This is not
prepared in accordance with U.S. GAAP. This non-GAAP financial
measure should not be considered in isolation from, as a substitute
for, or superior to financial measures prepared in accordance with
U.S. GAAP.
Adjusted EPS is calculated as net income excluding certain
non-cash items and factors which are unusual or unpredictable,
which include: amortization and impairment of intangible assets;
change in fair value of contingent consideration; major
restructuring costs, integration and other related transaction
costs relating to acquisitions; litigation reserves; R&D
milestones and acquired IPR&D, together with the tax effects of
all these items.
Basis of Preparation
The AbbVie profit forecasts (the "Profit Forecasts") are
based on the forecast of the results for the twelve months ending
December 31, 2020.
In accordance with Rule 28 of the Irish Takeover Rules, the
directors of AbbVie confirm that the Profit Forecasts have been
properly compiled on the basis of the assumptions stated below on a
basis consistent with the accounting policies of AbbVie, which are
in accordance with U.S. GAAP and those which AbbVie anticipates
will be applicable for the full year ending December 31, 2020 (as adjusted for AbbVie
non-GAAP policy to disclose adjusted earnings excluding specified
items).
The AbbVie non-GAAP profit forecast does not include the
proposed acquisition of Allergan. However, the AbbVie GAAP profit
forecast includes estimated one-time expenses relating to the
transaction such as financing costs, legal, consultants,
accountants, regulatory and other fees, which are expected to be
incurred in the first quarter of 2020.
Principal Assumptions
The Profit Forecasts have been compiled on the basis of the
following assumptions:
Assumptions which are within AbbVie's influence or
control:
- Executed licensing and partnership collaboration transaction
impacts and transactions expected to be executed in the next
quarter are included. In line with AbbVie's historical practices,
management continues to evaluate and pursue opportunities for
further partnership collaborations and in-licensing transactions.
No material acquisitions or disposals are anticipated in 2020;
- There will be no material change in the operational strategy or
current management of AbbVie during the year ending December 31, 2020 other than those already
announced;
- There will be no major site closures or rationalization during
the twelve-month forecast period to December
31, 2020 other than those already commenced; and
- Share repurchases and issuances are expected to be relatively
flat during the twelve-month forecast period to December 31, 2020.
Assumptions which are outside of AbbVie's influence or
control:
- There will be no material supply chain, manufacturing and
distribution disruptions and other business interruptions,
including natural disasters or industrial disputes;
- There will be no material adverse events that affect AbbVie's
key products, including adverse regulatory and clinical findings or
publications, product recalls, liability claims, or loss of patent
protection;
- There will be no material changes to current litigation
provisions due to a new or ongoing litigation claim;
- There will be no material change in general market, economic,
competitive environments or levels of demand in countries in which
AbbVie operates that would materially affect AbbVie's
business;
- There will be no material change to AbbVie customers'
agreements, rebates, or discount programs from those currently
prevailing;
- There will be no changes in exchange rates, interest rates,
bases of taxes, tax laws or interpretations, or legislative or
regulatory requirements from those currently prevailing that would
have a material impact on AbbVie's operations or its accounting
policies;
- There will be no material change to discount rate assumptions
for calculating the fair value of contingent consideration from
those currently prevailing; and
- There will be no intangible asset impairments due to
unfavorable clinical study results or safety signals.
AbbVie
Inc.
Key Product
Revenues
Quarter Ended
December 31, 2019
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
4Q18
|
|
Net Revenues (in
millions)
|
|
|
|
International
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Operational
|
|
Reported
|
Operational
|
|
Reported
|
ADJUSTED NET
REVENUESa
|
$6,429
|
|
$2,275
|
|
$8,704
|
|
13.0%
|
|
(11.5)%
|
|
(13.1)%
|
5.3%
|
|
4.8%
|
Immunology
|
4,195
|
|
971
|
|
5,166
|
|
16.0
|
|
(23.6)
|
|
(25.5)
|
5.5
|
|
5.0
|
Humira
|
3,969
|
|
948
|
|
4,917
|
|
9.8
|
|
(25.4)
|
|
(27.3)
|
0.5
|
|
—
|
Skyrizi
|
193
|
|
23
|
|
216
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
Rinvoq
|
33
|
|
—
|
|
33
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,230
|
|
317
|
|
1,547
|
|
32.6
|
|
58.6
|
|
57.4
|
37.2
|
|
37.0
|
Imbruvicab
|
1,073
|
|
223
|
|
1,296
|
|
28.0
|
|
33.8
|
|
33.8
|
28.9
|
|
28.9
|
Venclexta
|
157
|
|
94
|
|
251
|
|
75.8
|
|
>100.0
|
|
>100.0
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HCV
|
306
|
|
326
|
|
632
|
|
(25.1)
|
|
(27.6)
|
|
(28.1)
|
(26.4)
|
|
(26.7)
|
Mavyret
|
306
|
|
322
|
|
628
|
|
(25.4)
|
|
(20.8)
|
|
(21.4)
|
(23.1)
|
|
(23.4)
|
Viekira
|
—
|
|
4
|
|
4
|
|
n/m
|
|
(91.1)
|
|
(90.5)
|
(89.7)
|
|
(89.1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
780
|
|
506
|
|
1,286
|
|
(3.0)
|
|
(3.7)
|
|
(5.1)
|
(3.2)
|
|
(3.8)
|
Creon
|
292
|
|
—
|
|
292
|
|
11.5
|
|
n/a
|
|
n/a
|
11.5
|
|
11.5
|
Lupron
|
174
|
|
45
|
|
219
|
|
(11.3)
|
|
16.5
|
|
13.7
|
(6.6)
|
|
(7.1)
|
Synthroid
|
204
|
|
—
|
|
204
|
|
(2.2)
|
|
n/a
|
|
n/a
|
(2.2)
|
|
(2.2)
|
Synagis
|
—
|
|
261
|
|
261
|
|
n/a
|
|
(1.2)
|
|
(1.4)
|
(1.2)
|
|
(1.4)
|
Duodopa
|
25
|
|
93
|
|
118
|
|
8.3
|
|
6.9
|
|
3.1
|
7.1
|
|
4.1
|
Sevoflurane
|
21
|
|
60
|
|
81
|
|
13.9
|
|
(8.6)
|
|
(10.4)
|
(3.6)
|
|
(5.0)
|
Kaletra
|
8
|
|
46
|
|
54
|
|
(41.8)
|
|
(34.0)
|
|
(35.6)
|
(35.3)
|
|
(36.6)
|
AndroGel
|
23
|
|
—
|
|
23
|
|
(69.1)
|
|
n/a
|
|
n/a
|
(69.1)
|
|
(69.1)
|
Orilissa
|
33
|
|
1
|
|
34
|
|
>100.0
|
|
n/m
|
|
n/m
|
>100.0
|
|
>100.0
|
|
Note: "Operational"
comparisons are presented at constant currency rates and reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
|
|
n/a = not
applicable
|
n/m = not
meaningful
|
|
a
Adjusted net revenues exclude specified items. Refer to the
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
for further details. Percentage change is calculated using adjusted
net revenues.
|
|
b
Reflects profit sharing for Imbruvica international
revenues.
|
AbbVie
Inc.
Key Product
Revenues
Twelve Months
Ended December 31, 2019
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
12M18
|
|
Net Revenues (in millions)
|
|
|
|
International
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Operational
|
|
Reported
|
Operational
|
|
Reported
|
ADJUSTED NET
REVENUESa
|
$23,907
|
|
$9,359
|
|
$33,266
|
|
11.1%
|
|
(13.4)%
|
|
(16.5)%
|
2.7%
|
|
1.6%
|
Immunology
|
15,222
|
|
4,349
|
|
19,571
|
|
11.2
|
|
(27.1)
|
|
(30.4)
|
(0.8)
|
|
(1.8)
|
Humira
|
14,864
|
|
4,305
|
|
19,169
|
|
8.6
|
|
(27.8)
|
|
(31.1)
|
(2.9)
|
|
(3.9)
|
Skyrizi
|
311
|
|
44
|
|
355
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
Rinvoq
|
47
|
|
—
|
|
47
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
4,351
|
|
1,115
|
|
5,466
|
|
35.4
|
|
56.7
|
|
55.1
|
39.3
|
|
39.0
|
Imbruvicab
|
3,830
|
|
844
|
|
4,674
|
|
29.1
|
|
35.8
|
|
35.8
|
30.2
|
|
30.2
|
Venclexta
|
521
|
|
271
|
|
792
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HCV
|
1,473
|
|
1,456
|
|
2,929
|
|
(9.0)
|
|
(24.7)
|
|
(27.1)
|
(17.7)
|
|
(19.0)
|
Mavyret
|
1,473
|
|
1,420
|
|
2,893
|
|
(8.8)
|
|
(19.6)
|
|
(22.1)
|
(14.6)
|
|
(15.9)
|
Viekira
|
—
|
|
36
|
|
36
|
|
(100.0)
|
|
(77.2)
|
|
(79.2)
|
(77.6)
|
|
(79.6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
3,019
|
|
1,770
|
|
4,789
|
|
(3.2)
|
|
(0.3)
|
|
(3.9)
|
(2.1)
|
|
(3.4)
|
Creon
|
1,041
|
|
—
|
|
1,041
|
|
12.2
|
|
n/a
|
|
n/a
|
12.2
|
|
12.2
|
Lupron
|
720
|
|
167
|
|
887
|
|
(0.8)
|
|
6.0
|
|
0.8
|
0.5
|
|
(0.5)
|
Synthroid
|
786
|
|
—
|
|
786
|
|
1.3
|
|
n/a
|
|
n/a
|
1.3
|
|
1.3
|
Synagis
|
—
|
|
718
|
|
718
|
|
n/a
|
|
0.9
|
|
(1.2)
|
0.9
|
|
(1.2)
|
Duodopa
|
97
|
|
364
|
|
461
|
|
20.4
|
|
9.8
|
|
4.2
|
11.7
|
|
7.2
|
Sevoflurane
|
74
|
|
274
|
|
348
|
|
2.0
|
|
(9.5)
|
|
(13.8)
|
(7.4)
|
|
(10.9)
|
Kaletra
|
38
|
|
245
|
|
283
|
|
(31.0)
|
|
(9.5)
|
|
(12.9)
|
(12.9)
|
|
(15.8)
|
AndroGel
|
172
|
|
—
|
|
172
|
|
(63.3)
|
|
n/a
|
|
n/a
|
(63.3)
|
|
(63.3)
|
Orilissa
|
91
|
|
2
|
|
93
|
|
>100.0
|
|
n/m
|
|
n/m
|
>100.0
|
|
>100.0
|
|
Note: "Operational"
comparisons are presented at constant currency rates and reflect
comparative local currency net revenues at the prior year's foreign
exchange rates.
|
|
n/a = not
applicable
|
n/m = not
meaningful
|
|
a
Adjusted net revenues exclude specified items. Refer to the
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
for further details. Percentage change is calculated using adjusted
net revenues.
|
|
b
Reflects profit sharing for Imbruvica international
revenues.
|
AbbVie
Inc.
Consolidated
Statements of Earnings
Quarter and Twelve
Months Ended December 31, 2019 and 2018
(Unaudited) (In
millions, except per share data)
|
|
|
Fourth
Quarter
Ended December
31
|
|
Twelve
Months
Ended December
31
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Net
revenues
|
$
|
8,704
|
|
|
$
|
8,305
|
|
|
$
|
33,266
|
|
|
$
|
32,753
|
|
Cost of products
sold
|
2,006
|
|
|
2,022
|
|
|
7,439
|
|
|
7,718
|
|
Selling, general and
administrative
|
1,951
|
|
|
1,929
|
|
|
6,942
|
|
|
7,399
|
|
Research and
development
|
1,542
|
|
|
6,495
|
|
|
6,407
|
|
|
10,329
|
|
Acquired in-process
research and development
|
139
|
|
|
300
|
|
|
385
|
|
|
424
|
|
Other operating
expense (income)
|
(890)
|
|
|
—
|
|
|
(890)
|
|
|
500
|
|
Total operating costs
and expenses
|
4,748
|
|
|
10,746
|
|
|
20,283
|
|
|
26,370
|
|
|
|
|
|
|
|
|
|
Operating earnings
(loss)
|
3,956
|
|
|
(2,441)
|
|
|
12,983
|
|
|
6,383
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
455
|
|
|
319
|
|
|
1,509
|
|
|
1,144
|
|
Net foreign exchange
loss
|
11
|
|
|
6
|
|
|
42
|
|
|
24
|
|
Other expense
(income), net
|
416
|
|
|
(393)
|
|
|
3,006
|
|
|
18
|
|
Earnings (loss)
before income taxes
|
3,074
|
|
|
(2,373)
|
|
|
8,426
|
|
|
5,197
|
|
Income tax expense
(benefit)
|
273
|
|
|
(547)
|
|
|
544
|
|
|
(490)
|
|
Net earnings
(loss)
|
$
|
2,801
|
|
|
$
|
(1,826)
|
|
|
$
|
7,882
|
|
|
$
|
5,687
|
|
|
|
|
|
|
|
|
|
Diluted earnings
(loss) per share
|
$
|
1.88
|
|
|
$
|
(1.23)
|
|
|
$
|
5.28
|
|
|
$
|
3.66
|
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,485
|
|
|
1,496
|
|
|
1,484
|
|
|
1,546
|
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
|
2.21
|
|
|
$
|
1.90
|
|
|
$
|
8.94
|
|
|
$
|
7.91
|
|
|
|
|
|
|
|
|
|
Adjusted
weighted-average diluted shares outstandinga
|
1,485
|
|
|
1,501
|
|
|
1,484
|
|
|
1,546
|
|
|
|
a
|
Refer to the
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
for further details. Weighted-average diluted shares outstanding
includes the effect of dilutive securities. Due to the GAAP net
loss in the fourth quarter ended December 31, 2018, certain shares
issuable under stock-based compensation plans that were dilutive on
a non-GAAP basis were excluded from the computation of GAAP diluted
EPS because the effect would have been antidilutive.
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended
December 31, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
4Q19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
3,074
|
|
|
$
|
2,801
|
|
|
$
|
1.88
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
391
|
|
|
324
|
|
|
0.22
|
|
Acquisition related
costs
|
226
|
|
|
183
|
|
|
0.12
|
|
Milestones and other
R&D expenses
|
217
|
|
|
193
|
|
|
0.13
|
|
Acquired
IPR&D
|
139
|
|
|
123
|
|
|
0.08
|
|
Reata
divestiture
|
(330)
|
|
|
(297)
|
|
|
(0.20)
|
|
Litigation
matters
|
(550)
|
|
|
(435)
|
|
|
(0.29)
|
|
Change in fair value
of contingent consideration
|
438
|
|
|
438
|
|
|
0.29
|
|
Restructuring
|
19
|
|
|
15
|
|
|
0.01
|
|
Tax audit
settlement
|
—
|
|
|
(133)
|
|
|
(0.09)
|
|
Other
|
(10)
|
|
|
82
|
|
|
0.06
|
|
As adjusted
(non-GAAP)
|
$
|
3,614
|
|
|
$
|
3,294
|
|
|
$
|
2.21
|
|
|
Acquisition related
costs reflect transaction and financing costs related to the
proposed Allergan acquisition. Milestones and other R&D
expenses include milestone payments for previously announced
collaborations and the purchase of an FDA priority review voucher
from a third party. Acquired IPR&D primarily reflects upfront
payments related to R&D collaborations and licensing
arrangements with third parties. Litigation matters includes the
settlement of an intellectual property dispute with a third party.
Restructuring is primarily associated with streamlining global
operations. Other primarily includes the impacts of tax law changes
and U.S. tax reform.
|
2. The impact of the
specified items by line item was as follows:
|
|
|
4Q19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
expense
(income)
|
|
Interest
expense,
net
|
|
Other
(income)
expense,
net
|
As reported
(GAAP)
|
$
|
2,006
|
|
|
$
|
1,951
|
|
|
$
|
1,542
|
|
|
$
|
139
|
|
|
$
|
(890)
|
|
|
$
|
455
|
|
|
$
|
416
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(391)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(53)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(173)
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(217)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(139)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Reata
divestiture
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
330
|
|
|
—
|
|
|
—
|
|
Litigation
matters
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
550
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(438)
|
|
Restructuring
|
(10)
|
|
|
(15)
|
|
|
6
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Other
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
As adjusted
(non-GAAP)
|
$
|
1,605
|
|
|
$
|
1,883
|
|
|
$
|
1,331
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
282
|
|
|
$
|
(22)
|
|
3. The adjusted tax rate for
the fourth quarter of 2019 was 8.8 percent, as detailed
below:
|
|
|
4Q19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
3,074
|
|
|
$
|
273
|
|
|
8.9
|
%
|
Specified
items
|
540
|
|
|
47
|
|
|
8.6
|
%
|
As adjusted
(non-GAAP)
|
$
|
3,614
|
|
|
$
|
320
|
|
|
8.8
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended
December 31, 2018
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
4Q18
|
|
Earnings
(Loss)
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
(2,373)
|
|
|
$
|
(1,826)
|
|
|
$
|
(1.23)
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
320
|
|
|
262
|
|
|
0.18
|
|
Milestones and other
R&D expenses
|
50
|
|
|
50
|
|
|
0.03
|
|
Acquired
IPR&D
|
300
|
|
|
300
|
|
|
0.20
|
|
Stemcentrx-related
impairment
|
4,642
|
|
|
4,117
|
|
|
2.75
|
|
Charitable
contributions
|
115
|
|
|
89
|
|
|
0.06
|
|
Change in fair value
of contingent consideration
|
46
|
|
|
46
|
|
|
0.03
|
|
Litigation
reserves
|
7
|
|
|
6
|
|
|
—
|
|
Impacts of U.S. tax
reform
|
—
|
|
|
(86)
|
|
|
(0.05)
|
|
Tax audit
settlement
|
—
|
|
|
(131)
|
|
|
(0.09)
|
|
Other
|
44
|
|
|
35
|
|
|
0.02
|
|
As adjusted
(non-GAAP)
|
$
|
3,151
|
|
|
$
|
2,862
|
|
|
$
|
1.90
|
|
|
Milestones and other
R&D expenses are associated with milestone payments for
previously announced collaborations. Acquired IPR&D primarily
reflects upfront payments related to R&D collaborations and
licensing arrangements with third parties. Stemcentrx-related
impairment refers to the net impact of the intangible asset
impairment and the related fair value adjustment to contingent
consideration liabilities. Impacts of U.S. tax reform primarily
reflects a net tax benefit related to the timing of the new
legislation's phase in on certain subsidiaries. Other primarily
includes restructuring charges associated with streamlining global
operations.
|
2. The impact of the
specified items by line item was as follows:
|
|
|
4Q18
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
(income)
expense, net
|
As reported
(GAAP)
|
$
|
2,022
|
|
|
$
|
1,929
|
|
|
$
|
6,495
|
|
|
$
|
300
|
|
|
$
|
(393)
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(320)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(50)
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(300)
|
|
|
—
|
|
Stemcentrx-related
impairment
|
—
|
|
|
—
|
|
|
(5,070)
|
|
|
—
|
|
|
428
|
|
Charitable
contributions
|
—
|
|
|
(115)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(46)
|
|
Litigation
reserves
|
—
|
|
|
(7)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Other
|
(28)
|
|
|
(10)
|
|
|
(6)
|
|
|
—
|
|
|
—
|
|
As adjusted
(non-GAAP)
|
$
|
1,674
|
|
|
$
|
1,797
|
|
|
$
|
1,369
|
|
|
$
|
—
|
|
|
$
|
(11)
|
|
3. The adjusted tax rate for
the fourth quarter of 2018 was 9.1 percent, as detailed
below:
|
|
|
4Q18
|
|
Pre-tax
earnings
(loss)
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
(2,373)
|
|
|
$
|
(547)
|
|
|
23.1
|
%
|
Specified
items
|
5,524
|
|
|
836
|
|
|
15.1
|
%
|
As adjusted
(non-GAAP)
|
$
|
3,151
|
|
|
$
|
289
|
|
|
9.1
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Twelve Months
Ended December 31, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
12M19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
8,426
|
|
|
$
|
7,882
|
|
|
$
|
5.28
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,553
|
|
|
1,286
|
|
|
0.86
|
|
Acquisition related
costs
|
415
|
|
|
338
|
|
|
0.23
|
|
Milestones and other
R&D expenses
|
312
|
|
|
288
|
|
|
0.20
|
|
Acquired
IPR&D
|
385
|
|
|
364
|
|
|
0.25
|
|
Reata
divestiture
|
(330)
|
|
|
(297)
|
|
|
(0.20)
|
|
Litigation
matters
|
(523)
|
|
|
(414)
|
|
|
(0.28)
|
|
Change in fair value
of contingent consideration
|
3,182
|
|
|
3,184
|
|
|
2.14
|
|
Restructuring
|
207
|
|
|
168
|
|
|
0.10
|
|
Stemcentrx-related
impairment
|
939
|
|
|
823
|
|
|
0.56
|
|
Tax audit
settlement
|
—
|
|
|
(400)
|
|
|
(0.27)
|
|
Other
|
10
|
|
|
102
|
|
|
0.07
|
|
As adjusted
(non-GAAP)
|
$
|
14,576
|
|
|
$
|
13,324
|
|
|
$
|
8.94
|
|
|
Acquisition related
costs reflect transaction and financing costs related to the
proposed Allergan acquisition. Milestones and other R&D
expenses include milestone payments for previously announced
collaborations and the purchase of an FDA priority review voucher
from a third party. Acquired IPR&D primarily reflects upfront
payments related to R&D collaborations and licensing
arrangements with third parties. Litigation matters includes the
settlement of an intellectual property dispute with a third party.
Restructuring is primarily associated with streamlining global
operations. Stemcentrx-related impairment refers to the net impact
of the intangible asset impairment and the related fair value
adjustment to contingent consideration liabilities. Other primarily
includes the impacts of tax law changes and U.S. tax
reform.
|
2. The impact of the
specified items by line item was as follows:
|
|
|
12M19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
expense
(income)
|
|
Interest
expense,
net
|
|
Other
(income)
expense,
net
|
As reported
(GAAP)
|
$
|
7,439
|
|
|
$
|
6,942
|
|
|
$
|
6,407
|
|
|
$
|
385
|
|
|
$
|
(890)
|
|
|
$
|
1,509
|
|
|
$
|
3,006
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(1,553)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(103)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(312)
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(312)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(385)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Reata
divestiture
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
330
|
|
|
—
|
|
|
—
|
|
Litigation
matters
|
—
|
|
|
(27)
|
|
|
—
|
|
|
—
|
|
|
550
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,182)
|
|
Restructuring
|
(25)
|
|
|
(125)
|
|
|
(57)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Stemcentrx-related
impairment
|
—
|
|
|
—
|
|
|
(1,030)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
91
|
|
Other
|
(1)
|
|
|
—
|
|
|
(19)
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
As adjusted
(non-GAAP)
|
$
|
5,860
|
|
|
$
|
6,687
|
|
|
$
|
4,989
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,197
|
|
|
$
|
(85)
|
|
3. The adjusted tax rate for
the full-year 2019 was 8.6 percent, as detailed below:
|
|
|
12M19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
8,426
|
|
|
$
|
544
|
|
|
6.5
|
%
|
Specified
items
|
6,150
|
|
|
708
|
|
|
11.5
|
%
|
As adjusted
(non-GAAP)
|
$
|
14,576
|
|
|
$
|
1,252
|
|
|
8.6
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Twelve Months
Ended December 31, 2018
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items impacted
results as follows:
|
|
|
12M18
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
5,197
|
|
|
$
|
5,687
|
|
|
$
|
3.66
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
1,294
|
|
|
1,063
|
|
|
0.69
|
|
Milestones and other
R&D expenses
|
137
|
|
|
137
|
|
|
0.09
|
|
Acquired
IPR&D
|
424
|
|
|
424
|
|
|
0.27
|
|
Calico
collaboration
|
500
|
|
|
500
|
|
|
0.32
|
|
Stemcentrx-related
impairment
|
4,642
|
|
|
4,117
|
|
|
2.66
|
|
Charitable
contributions
|
350
|
|
|
271
|
|
|
0.18
|
|
Change in fair value
of contingent consideration
|
478
|
|
|
478
|
|
|
0.31
|
|
Litigation
reserves
|
353
|
|
|
282
|
|
|
0.18
|
|
Impacts of U.S. tax
reform
|
—
|
|
|
(620)
|
|
|
(0.40)
|
|
Tax audit
settlement
|
—
|
|
|
(131)
|
|
|
(0.09)
|
|
Other
|
82
|
|
|
74
|
|
|
0.04
|
|
As adjusted
(non-GAAP)
|
$
|
13,457
|
|
|
$
|
12,282
|
|
|
$
|
7.91
|
|
|
Milestones and other
R&D expenses are associated with milestone payments for
previously announced collaborations. Acquired IPR&D primarily
reflects upfront payments related to R&D collaborations and
licensing arrangements with third parties. Stemcentrx-related
impairment refers to the net impact of the intangible asset
impairment and the related fair value adjustment to contingent
consideration liabilities. Impacts of U.S. tax reform primarily
reflects a net tax benefit related to the timing of the new
legislation's phase in on certain subsidiaries. Other primarily
includes restructuring charges associated with streamlining global
operations and milestone revenue under a previously announced
collaboration.
|
2. The impact of the
specified items by line item was as follows:
|
|
|
12M18
|
|
Net
revenues
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
expense
(income)
|
|
Other
(income)
expense,
net
|
As reported
(GAAP)
|
$
|
32,753
|
|
|
$
|
7,718
|
|
|
$
|
7,399
|
|
|
$
|
10,329
|
|
|
$
|
424
|
|
|
$
|
500
|
|
|
$
|
18
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
|
(1,294)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
—
|
|
|
(137)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(424)
|
|
|
—
|
|
|
—
|
|
Calico
collaboration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(500)
|
|
|
—
|
|
Stemcentrx-related
impairment
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,070)
|
|
|
—
|
|
|
—
|
|
|
428
|
|
Charitable
contributions
|
—
|
|
|
—
|
|
|
(350)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(478)
|
|
Litigation
reserves
|
—
|
|
|
—
|
|
|
(353)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Other
|
(20)
|
|
|
(62)
|
|
|
(11)
|
|
|
(29)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
As adjusted
(non-GAAP)
|
$
|
32,733
|
|
|
$
|
6,362
|
|
|
$
|
6,685
|
|
|
$
|
5,093
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(32)
|
|
3. The adjusted tax rate for
the full-year 2018 was 8.7 percent, as detailed below:
|
|
|
12M18
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
5,197
|
|
|
$
|
(490)
|
|
|
(9.4)
|
%
|
Specified
items
|
8,260
|
|
|
1,665
|
|
|
20.2
|
%
|
As adjusted
(non-GAAP)
|
$
|
13,457
|
|
|
$
|
1,175
|
|
|
8.7
|
%
|
View original
content:http://www.prnewswire.com/news-releases/abbvie-reports-full-year-and-fourth-quarter-2019-financial-results-301000918.html
SOURCE AbbVie