NORTH CHICAGO, Ill., July 26,
2019 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced
financial results for the second quarter ended June 30,
2019.
"We continue to see strong momentum in our business, as we
delivered revenue and adjusted EPS ahead of our expectations for
the quarter and announced plans to acquire Allergan, a
transformative transaction that will provide scale and diversity to
our business and position AbbVie for top-tier performance over
the long term," said Richard A.
Gonzalez, chairman and chief executive officer, AbbVie.
"Based on our strong performance year-to-date and our
confidence in the outlook for the second half, we are raising our
revenue and adjusted EPS guidance for 2019."
Second-Quarter Results
- Worldwide net revenues were $8.255
billion, a decrease of 0.3 percent on a GAAP basis. Adjusted
net revenues were flat on a reported basis and increased 1.5
percent operationally.
- Global HUMIRA net revenues of $4.870
billion decreased 6.1 percent on a reported basis, or 4.8
percent operationally. U.S. HUMIRA net revenues were $3.793 billion, an increase of 7.7 percent.
Internationally, HUMIRA net revenues were $1.077 billion, a decrease of 35.2 percent on a
reported basis, or 31.0 percent operationally, due to biosimilar
competition.
- Global net revenues from the hematologic oncology portfolio
were $1.268 billion, an increase of
38.7 percent on a reported basis, or 39.1 percent operationally.
Global IMBRUVICA net revenues were $1.099
billion, an increase of 29.3 percent, with U.S. net revenues
of $886 million and international
profit sharing of $213 million.
Global VENCLEXTA net revenues were $169
million.
- Global HCV net revenues were $784 million, a decrease of
19.4 percent on a reported basis, or 17.1 percent operationally. In
the U.S., HCV net revenues of $396
million decreased 6.2 percent in the quarter.
Internationally, HCV net revenues of $388
million decreased 29.5 percent on a reported basis, or 25.4
percent operationally.
- On a GAAP basis, the gross margin ratio in the second quarter
was 78.0 percent. The adjusted gross margin ratio was 82.7
percent.
- On a GAAP basis, selling, general and administrative expense
was 20.0 percent of net revenues. The adjusted SG&A expense was
19.6 percent of net revenues.
- On a GAAP basis, research and development expense was 15.6
percent of net revenues. The adjusted R&D expense was 14.9
percent of net revenues, reflecting funding actions supporting all
stages of our pipeline.
- On a GAAP basis, the operating margin in the second quarter was
41.2 percent. The adjusted operating margin was 48.2 percent.
- On a GAAP basis, net interest expense was $309 million. On a GAAP basis, the tax rate in
the quarter was 8.1 percent. The adjusted tax rate was 8.7
percent.
- Diluted EPS in the second quarter was $0.49 on a GAAP basis. Adjusted diluted EPS,
excluding specified items, was $2.26.
- Recorded a $2.3 billion increase
in fair value of contingent consideration related to SKYRIZI future
milestones and royalty payments, which was primarily due to a
higher risk-adjusted cash flow forecast following regulatory
approvals in the second quarter, as well as lower discount
rates.
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 plc announced that the companies have
entered into a definitive transaction agreement under which AbbVie
will acquire Allergan in a cash and stock transaction for a
transaction equity value of approximately $63 billion. The proposed acquisition is
transformational for both companies and provides immediate scale,
diversity and profitability to AbbVie's growth platform; enhances
long-term R&D investment and sustained focus on innovative
science; and increases global commercial scale to further maximize
the value of Allergan's portfolio. The combined company will
produce robust cash flow to support continued dividend growth and
reduction of debt levels. Additional information on the transaction
can be found at www.abbvie.com/abbvie-allergan.html
- AbbVie announced the U.S. Food and Drug Administration (FDA)
and European Commission (EC) approvals of SKYRIZI (risankizumab)
for the treatment of moderate to severe plaque psoriasis in adult
patients who are candidates for systemic therapy. The approvals are
based on results from four pivotal Phase 3 studies, ultIMMa-1,
ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients
with moderate to severe plaque psoriasis. SKYRIZI is part of a
collaboration between Boehringer Ingelheim (BI) and AbbVie, with
AbbVie leading development and commercialization globally.
- At the World Congress of Dermatology, AbbVie presented new
two-year data showing SKYRIZI patients with moderate to severe
psoriasis maintained complete skin clearance. Longer-term results
from the Phase 3 IMMhance study showed 73 percent and 72 percent of
patients treated with continuous SKYRIZI experienced complete skin
clearance (defined as static Physician Global Assessment (sPGA) 0
and Psoriasis Area and Severity Index 100, respectively) at week
94, among patients who achieved a sPGA 0/1 at week 28. No new
safety findings were observed at two years.
- At the European Congress of Rheumatology, AbbVie presented new
long-term data from upadacitinib Phase 3 studies SELECT-EARLY and
SELECT-COMPARE showing a significantly higher proportion of
patients with rheumatoid arthritis treated with upadacitinib
monotherapy or in combination with methotrexate (MTX) maintained
clinical remission compared with MTX or adalimumab plus MTX,
respectively, at 48 weeks. Additionally, findings from an
integrated safety analysis across five studies in the SELECT Phase
3 clinical program support the well-characterized safety profile of
upadacitinib in patients with moderately to severely active
rheumatoid arthritis.
- AbbVie announced FDA approval for VENCLEXTA (venetoclax) in
combination with obinutuzumab as a chemotherapy-free combination
regimen for previously untreated chronic lymphocytic leukemia (CLL)
or small lymphocytic lymphoma (SLL) patients. The FDA reviewed the
submission under the Real-Time Oncology Review pilot program and
approval was based on data from the Phase 3 CLL14 trial evaluating
VENCLEXTA in combination with obinutuzumab compared to patients who
received chlorambucil plus obinutuzumab. This is the fourth
approval and the fifth Breakthrough Therapy designation for
VENCLEXTA. 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.
- At the American Society of Clinical Oncology (ASCO) Annual
Meeting and European Hematology Association (EHA) Annual Congress,
AbbVie presented over forty abstracts including results from the
Phase 3 CLL14 trial of VENCLEXTA plus obinutuzumab in previously
untreated CLL patients, results from the Phase 3 BELLINI trial of
VENCLEXTA plus bortezomib and dexamethasone in patients with
relapsed/refractory (r/r) multiple myeloma (MM) and results from
the Phase 3 CLL12 trial of IMBRUVICA (ibrutinib) in the
asymptomatic watch and wait population of CLL. AbbVie also
presented new IMBRUVICA six-year and five-year data from the Phase
3 RESONATE and RESONATE-2 trials, respectively, evaluating its
long-term safety and efficacy benefit in CLL/SLL patients.
IMBRUVICA is jointly developed and commercialized with Janssen
Biotech, Inc.
- AbbVie announced the FDA lifted the partial clinical hold
placed on CANOVA, a Phase 3 trial evaluating VENCLEXTA for the
investigational treatment of r/r MM. The CANOVA trial evaluates
VENCLEXTA in combination with dexamethasone versus
pomalidomide in combination with dexamethasone in patients
with r/r MM positive for the translocation (11;14) abnormality. The
partial clinical hold removal is based upon agreement on revisions
to the CANOVA study protocol, including new risk mitigation
measures, protocol-specified guidelines and updated futility
criteria. The t(11;14) genetic biomarker is among the most common
and routinely tested genetic abnormalities in patients with
MM.
- AbbVie provided an update on the depatuxizumab mafodotin
(Depatux-M) glioblastoma program, announcing that the Phase 3
INTELLANCE-1 study did not meet its primary endpoint of overall
survival at the interim analysis and demonstrated no survival
benefit for newly diagnosed patients receiving Depatux-M. The
Independent Data Monitoring Committee responsible for interim
analysis data review recommended stopping the study due to lack of
survival benefit for patients receiving Depatux-M and enrollment in
all ongoing Depatux-M studies has been halted. Results will be
submitted for presentation at a medical conference and for
publication in a peer-reviewed journal.
- At the American Academy of Neurology Annual Meeting, AbbVie
presented six abstracts, including two oral presentations showing
AbbVie's research progress in difficult to treat neurological
conditions. Investigators presented pharmacokinetics and
safety/tolerability data on ABBV-951, a levodopa/carbidopa prodrug,
delivering a 24-hour continuous, subcutaneous infusion under
investigation for the treatment for advanced Parkinson's disease.
Investigators also presented data from a Phase 1, multiple-dose
study of elezanumab in patients with relapsing forms of multiple
sclerosis.
- AbbVie announced that it has resolved U.S. HUMIRA (adalimumab)
litigation with BI. Under the terms of the resolution, AbbVie will
grant BI a non-exclusive license to its HUMIRA-related intellectual
property in the United States. The
U.S. license for BI will begin on July 1,
2023. BI will pay royalties to AbbVie for licensing its
HUMIRA patents and acknowledges the validity and enforceability of
the licensed patents. AbbVie will make no payments of any form to
BI.
- AbbVie announced the acquisition of Mavupharma, a privately
held biopharmaceutical company focused on novel approaches to
target the STING (STimulator of INterferon Genes) pathway for the
treatment of cancer. STING pathway signaling plays an important
role in the generation of an immune response directed at tumors,
and enhancing STING signaling has shown promise in a variety of
tumor models. STING pathway stimulation has the potential to
increase the susceptibility of tumors and broaden treatment options
for patients. The collaboration broadens AbbVie's oncology research
platform to expand the development of potentially life-changing
treatments for patients.
Full-Year 2019 Outlook
AbbVie is updating its GAAP diluted EPS guidance for the
full-year 2019 from $7.26 to
$7.36 to $5.69 to $5.79,
representing growth of 56.8 percent at the midpoint, inclusive of a
non-cash charge for SKYRIZI contingent consideration following
regulatory approvals in the second quarter. AbbVie is raising its
previously announced adjusted EPS guidance range for the full-year
2019 from $8.73 to $8.83 to $8.82 to
$8.92, representing growth of 12.1
percent at the midpoint. The company's 2019 adjusted diluted EPS
guidance excludes $3.13 per share of
intangible asset amortization expense, non-cash charges for
contingent consideration adjustments and other specified items.
Statements Required by the Irish Takeover Rules
The earnings guidance contained in this press release
constitutes a profit forecast for the purposes of the Irish
Takeover Rules. In accordance with Rule 28.4 of the Irish Takeover
Rules, this profit forecast shall be repeated in the proxy
statement, including the scheme document and the reports required
by Rule 28.3 of the Irish Takeover Rules shall be mailed to
Allergan shareholders with the proxy statement, including the
scheme document.
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
second-quarter performance. The call will be webcast through
AbbVie's Investor Relations website at investors.abbvie.com. An
archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 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 2019 financial guidance is also
being provided on both a reported and a non-GAAP basis.
No Offer or Solicitation
This release is not intended to and does not constitute an offer
to sell or the solicitation of an offer to subscribe for or buy or
an invitation to purchase or subscribe for any securities or the
solicitation of any vote or approval in any jurisdiction pursuant
to the proposed acquisition of Allergan or otherwise, nor shall
there be any sale, issuance or transfer of securities in any
jurisdiction in contravention of applicable law. In particular,
this release is not an offer of securities for sale into the United
States. No offer of securities shall be made in the United States absent registration under
the U.S. Securities Act of 1933, as amended, or pursuant to an
exemption from, or in a transaction not subject to, such
registration requirements. Any securities issued in the proposed
acquisition are anticipated to be issued in reliance upon available
exemptions from such registration requirements pursuant to
Section 3(a)(10) of the U.S. Securities Act of 1933, as
amended. The proposed acquisition will be made solely by means of
the scheme document (or, if applicable, the takeover offer
document), which will contain the full terms and conditions of the
proposed acquisition, including details with respect to the
Allergan shareholder vote in respect of the proposed
acquisition. Any decision in respect of, or other response
to, the proposed acquisition, should be made only on the basis of
the information contained in the scheme document.
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.
AbbVie
Inc.
|
Key Product
Revenues
|
Quarter Ended June
30, 2019
|
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
2Q18
|
|
Net Revenues (in
millions)
|
|
|
|
International
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Operational
|
|
Reported
|
Operational
|
|
Reported
|
ADJUSTED NET
REVENUESa
|
$5,964
|
|
$2,291
|
|
$8,255
|
|
9.5%
|
|
(13.8)%
|
|
(18.4)%
|
1.5%
|
|
—%
|
Immunology
|
3,835
|
|
1,083
|
|
4,918
|
|
8.9
|
|
(30.7)
|
|
(34.9)
|
(3.9)
|
|
(5.2)
|
Humira
|
3,793
|
|
1,077
|
|
4,870
|
|
7.7
|
|
(31.0)
|
|
(35.2)
|
(4.8)
|
|
(6.1)
|
Skyrizi
|
42
|
|
6
|
|
48
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,003
|
|
265
|
|
1,268
|
|
35.5
|
|
54.1
|
|
52.1
|
39.1
|
|
38.7
|
Imbruvicab
|
886
|
|
213
|
|
1,099
|
|
27.9
|
|
35.9
|
|
35.9
|
29.3
|
|
29.3
|
Venclexta
|
117
|
|
52
|
|
169
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HCV
|
396
|
|
388
|
|
784
|
|
(6.2)
|
|
(25.4)
|
|
(29.5)
|
(17.1)
|
|
(19.4)
|
Mavyret
|
396
|
|
384
|
|
780
|
|
(6.0)
|
|
(20.4)
|
|
(24.7)
|
(14.0)
|
|
(16.3)
|
Viekira
|
—
|
|
4
|
|
4
|
|
n/m
|
|
(86.4)
|
|
(88.8)
|
(87.9)
|
|
(90.3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
720
|
|
311
|
|
1,031
|
|
(6.9)
|
|
(3.2)
|
|
(9.9)
|
(5.7)
|
|
(7.8)
|
Creon
|
257
|
|
—
|
|
257
|
|
17.5
|
|
n/a
|
|
n/a
|
17.5
|
|
17.5
|
Lupron
|
168
|
|
41
|
|
209
|
|
(6.4)
|
|
3.2
|
|
(4.5)
|
(4.5)
|
|
(6.0)
|
Synthroid
|
203
|
|
—
|
|
203
|
|
4.9
|
|
n/a
|
|
n/a
|
4.9
|
|
4.9
|
Synagis
|
—
|
|
38
|
|
38
|
|
n/a
|
|
(3.9)
|
|
(11.9)
|
(3.9)
|
|
(11.9)
|
Duodopa
|
24
|
|
91
|
|
115
|
|
12.8
|
|
11.0
|
|
3.6
|
11.3
|
|
5.3
|
Sevoflurane
|
18
|
|
73
|
|
91
|
|
(3.3)
|
|
(16.3)
|
|
(21.9)
|
(14.1)
|
|
(18.8)
|
Kaletra
|
10
|
|
67
|
|
77
|
|
(33.9)
|
|
(6.8)
|
|
(12.9)
|
(10.8)
|
|
(16.0)
|
AndroGel
|
22
|
|
—
|
|
22
|
|
(83.0)
|
|
n/a
|
|
n/a
|
(83.0)
|
|
(83.0)
|
Orilissa
|
18
|
|
1
|
|
19
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
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
Six Months Ended
June 30, 2019
(Unaudited)
|
|
|
|
|
|
|
|
|
% Change vs.
6M18
|
|
Net Revenues (in
millions)
|
|
|
|
International
|
Total
|
|
U.S.
|
|
Int'l.
|
|
Total
|
|
U.S.
|
|
Operational
|
|
Reported
|
Operational
|
|
Reported
|
ADJUSTED NET
REVENUESa
|
$11,234
|
|
$4,849
|
|
$16,083
|
|
9.7%
|
|
(14.1)%
|
|
(18.6)%
|
1.0%
|
|
(0.7)%
|
Immunology
|
7,050
|
|
2,314
|
|
9,364
|
|
8.1
|
|
(26.8)
|
|
(31.3)
|
(3.9)
|
|
(5.4)
|
Humira
|
7,008
|
|
2,308
|
|
9,316
|
|
7.4
|
|
(27.0)
|
|
(31.5)
|
(4.3)
|
|
(5.8)
|
Skyrizi
|
42
|
|
6
|
|
48
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hematologic
Oncology
|
1,937
|
|
504
|
|
2,441
|
|
37.8
|
|
54.5
|
|
52.5
|
41.0
|
|
40.6
|
Imbruvicab
|
1,715
|
|
406
|
|
2,121
|
|
30.2
|
|
37.6
|
|
37.6
|
31.6
|
|
31.6
|
Venclexta
|
222
|
|
98
|
|
320
|
|
>100.0
|
|
>100.0
|
|
>100.0
|
>100.0
|
|
>100.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HCV
|
799
|
|
800
|
|
1,599
|
|
4.4
|
|
(25.2)
|
|
(29.0)
|
(13.2)
|
|
(15.5)
|
Mavyret
|
799
|
|
771
|
|
1,570
|
|
4.8
|
|
(20.5)
|
|
(24.3)
|
(9.6)
|
|
(11.8)
|
Viekira
|
—
|
|
29
|
|
29
|
|
(100.0)
|
|
(69.1)
|
|
(72.7)
|
(70.6)
|
|
(74.2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Key
Products
|
1,459
|
|
865
|
|
2,324
|
|
(3.9)
|
|
(2.7)
|
|
(8.3)
|
(3.4)
|
|
(5.6)
|
Creon
|
484
|
|
—
|
|
484
|
|
13.1
|
|
n/a
|
|
n/a
|
13.1
|
|
13.1
|
Lupron
|
359
|
|
79
|
|
438
|
|
0.5
|
|
1.0
|
|
(6.7)
|
0.6
|
|
(0.9)
|
Synthroid
|
385
|
|
—
|
|
385
|
|
2.7
|
|
n/a
|
|
n/a
|
2.7
|
|
2.7
|
Synagis
|
—
|
|
325
|
|
325
|
|
n/a
|
|
(6.6)
|
|
(10.9)
|
(6.6)
|
|
(10.9)
|
Duodopa
|
46
|
|
180
|
|
226
|
|
20.1
|
|
11.3
|
|
3.9
|
12.8
|
|
6.8
|
Sevoflurane
|
35
|
|
148
|
|
183
|
|
(2.0)
|
|
(13.2)
|
|
(19.1)
|
(11.4)
|
|
(16.3)
|
Kaletra
|
23
|
|
132
|
|
155
|
|
(15.0)
|
|
1.7
|
|
(3.9)
|
(1.0)
|
|
(5.7)
|
AndroGel
|
96
|
|
—
|
|
96
|
|
(62.8)
|
|
n/a
|
|
n/a
|
(62.8)
|
|
(62.8)
|
Orilissa
|
31
|
|
1
|
|
32
|
|
n/m
|
|
n/m
|
|
n/m
|
n/m
|
|
n/m
|
|
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 Six
Months Ended June 30, 2019 and 2018
(Unaudited) (In
millions, except per share data)
|
|
|
Second Quarter
Ended June 30
|
|
Six Months
Ended June 30
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Net
revenues
|
$
|
8,255
|
|
|
$
|
8,278
|
|
|
$
|
16,083
|
|
|
$
|
16,212
|
|
Cost of products
sold
|
1,819
|
|
|
1,934
|
|
|
3,513
|
|
|
3,861
|
|
Selling, general and
administrative
|
1,654
|
|
|
1,760
|
|
|
3,334
|
|
|
3,551
|
|
Research and
development
|
1,291
|
|
|
1,322
|
|
|
2,580
|
|
|
2,566
|
|
Acquired in-process
research and development
|
91
|
|
|
—
|
|
|
246
|
|
|
69
|
|
Other
expense
|
—
|
|
|
500
|
|
|
—
|
|
|
500
|
|
Total operating costs
and expenses
|
4,855
|
|
|
5,516
|
|
|
9,673
|
|
|
10,547
|
|
|
|
|
|
|
|
|
|
Operating
earnings
|
3,400
|
|
|
2,762
|
|
|
6,410
|
|
|
5,665
|
|
|
|
|
|
|
|
|
|
Interest expense,
net
|
309
|
|
|
272
|
|
|
634
|
|
|
523
|
|
Net foreign exchange
loss
|
6
|
|
|
8
|
|
|
12
|
|
|
16
|
|
Other expense,
net
|
2,278
|
|
|
470
|
|
|
2,413
|
|
|
317
|
|
Earnings before
income tax expense
|
807
|
|
|
2,012
|
|
|
3,351
|
|
|
4,809
|
|
Income tax
expense
|
66
|
|
|
29
|
|
|
154
|
|
|
43
|
|
Net
earnings
|
$
|
741
|
|
|
$
|
1,983
|
|
|
$
|
3,197
|
|
|
$
|
4,766
|
|
|
|
|
|
|
|
|
|
Diluted earnings per
share
|
$
|
0.49
|
|
|
$
|
1.26
|
|
|
$
|
2.14
|
|
|
$
|
2.99
|
|
|
|
|
|
|
|
|
|
Adjusted diluted
earnings per sharea
|
$
|
2.26
|
|
|
$
|
2.00
|
|
|
$
|
4.40
|
|
|
$
|
3.87
|
|
|
|
|
|
|
|
|
|
Weighted-average
diluted shares outstanding
|
1,484
|
|
|
1,572
|
|
|
1,483
|
|
|
1,584
|
|
|
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
Quarter Ended June
30, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
2Q19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
807
|
|
|
$
|
741
|
|
|
$
|
0.49
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
388
|
|
|
321
|
|
|
0.22
|
|
Milestones and other
R&D expenses
|
35
|
|
|
35
|
|
|
0.02
|
|
Acquired
IPR&D
|
91
|
|
|
86
|
|
|
0.06
|
|
Change in fair value
of contingent consideration
|
2,304
|
|
|
2,304
|
|
|
1.55
|
|
Restructuring
|
8
|
|
|
6
|
|
|
—
|
|
Litigation
reserves
|
10
|
|
|
8
|
|
|
—
|
|
Acquisition related
costs
|
31
|
|
|
27
|
|
|
0.02
|
|
Tax audit
settlement
|
—
|
|
|
(178)
|
|
|
(0.12)
|
|
Other
|
20
|
|
|
20
|
|
|
0.02
|
|
As adjusted
(non-GAAP)
|
$
|
3,694
|
|
|
$
|
3,370
|
|
|
$
|
2.26
|
|
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. Restructuring is
primarily associated with streamlining global operations.
Acquisition related costs reflect transaction and financing costs
related to the proposed Allergan acquisition.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
2Q19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Interest
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
1,819
|
|
|
$
|
1,654
|
|
|
$
|
1,291
|
|
|
$
|
91
|
|
|
$
|
309
|
|
|
$
|
2,278
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(388)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(35)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(91)
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,304)
|
|
Restructuring
|
(3)
|
|
|
—
|
|
|
(5)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Litigation
reserves
|
—
|
|
|
(10)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(24)
|
|
|
—
|
|
|
—
|
|
|
(7)
|
|
|
—
|
|
Other
|
(1)
|
|
|
—
|
|
|
(19)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
1,427
|
|
|
$
|
1,620
|
|
|
$
|
1,232
|
|
|
$
|
—
|
|
|
$
|
302
|
|
|
$
|
(26)
|
|
|
3. The adjusted tax rate for
the second quarter of 2019 was 8.7 percent, as detailed
below:
|
|
|
|
2Q19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
807
|
|
|
$
|
66
|
|
|
8.1
|
%
|
Specified
items
|
2,887
|
|
|
258
|
|
|
8.9
|
%
|
As
adjusted (non-GAAP)
|
$
|
3,694
|
|
|
$
|
324
|
|
|
8.7
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June
30, 2018
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
2Q18
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
2,012
|
|
|
$
|
1,983
|
|
|
$
|
1.26
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
324
|
|
|
266
|
|
|
0.17
|
|
Milestones and other
R&D expenses
|
55
|
|
|
55
|
|
|
0.03
|
|
Calico
collaboration
|
500
|
|
|
500
|
|
|
0.32
|
|
Charitable
contributions
|
120
|
|
|
93
|
|
|
0.06
|
|
Change in fair value
of contingent consideration
|
485
|
|
|
485
|
|
|
0.30
|
|
Impacts of U.S. tax
reform
|
—
|
|
|
(202)
|
|
|
(0.13)
|
|
Other
|
(20)
|
|
|
(15)
|
|
|
(0.01)
|
|
As adjusted
(non-GAAP)
|
$
|
3,476
|
|
|
$
|
3,165
|
|
|
$
|
2.00
|
|
|
Milestones and other
R&D expenses are associated with milestone payments for
previously announced collaborations. Impacts of U.S. tax reform
reflects a net tax benefit related to the timing of the
legislation's phase in on certain subsidiaries. Other primarily
includes milestone revenue under a previously announced
collaboration.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
2Q18
|
|
Net
revenues
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Other
operating
expense
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
8,278
|
|
|
$
|
1,934
|
|
|
$
|
1,760
|
|
|
$
|
1,322
|
|
|
$
|
500
|
|
|
$
|
470
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
|
(324)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
—
|
|
|
(55)
|
|
|
—
|
|
|
—
|
|
Calico
collaboration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(500)
|
|
|
—
|
|
Charitable
contributions
|
—
|
|
|
—
|
|
|
(120)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(485)
|
|
Other
|
(20)
|
|
|
(3)
|
|
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
8,258
|
|
|
$
|
1,607
|
|
|
$
|
1,643
|
|
|
$
|
1,267
|
|
|
$
|
—
|
|
|
$
|
(15)
|
|
|
3. The adjusted tax rate for
the second quarter of 2018 was 9.0 percent, as detailed
below:
|
|
|
2Q18
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
2,012
|
|
|
$
|
29
|
|
|
1.5
|
%
|
Specified
items
|
1,464
|
|
|
282
|
|
|
19.3
|
%
|
As
adjusted (non-GAAP)
|
$
|
3,476
|
|
|
$
|
311
|
|
|
9.0
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended
June 30, 2019
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
6M19
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
3,351
|
|
|
$
|
3,197
|
|
|
$
|
2.14
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
773
|
|
|
639
|
|
|
0.43
|
|
Milestones and other
R&D expenses
|
75
|
|
|
75
|
|
|
0.05
|
|
Acquired
IPR&D
|
246
|
|
|
241
|
|
|
0.16
|
|
Change in fair value
of contingent consideration
|
2,473
|
|
|
2,475
|
|
|
1.67
|
|
Restructuring
|
171
|
|
|
139
|
|
|
0.09
|
|
Litigation
reserves
|
20
|
|
|
16
|
|
|
0.01
|
|
Acquisition related
costs
|
31
|
|
|
27
|
|
|
0.02
|
|
Tax audit
settlement
|
—
|
|
|
(267)
|
|
|
(0.18)
|
|
Other
|
20
|
|
|
20
|
|
|
0.01
|
|
As adjusted
(non-GAAP)
|
$
|
7,160
|
|
|
$
|
6,562
|
|
|
$
|
4.40
|
|
|
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. Restructuring is
primarily associated with streamlining global operations.
Acquisition related costs reflect transaction and financing costs
related to the proposed Allergan acquisition.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
6M19
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Interest
expense,
net
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
3,513
|
|
|
$
|
3,334
|
|
|
$
|
2,580
|
|
|
$
|
246
|
|
|
$
|
634
|
|
|
$
|
2,413
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
(773)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
(75)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
(246)
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,473)
|
|
Restructuring
|
(9)
|
|
|
(107)
|
|
|
(55)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Litigation
reserves
|
—
|
|
|
(20)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquisition related
costs
|
—
|
|
|
(24)
|
|
|
—
|
|
|
—
|
|
|
(7)
|
|
|
—
|
|
Other
|
(1)
|
|
|
—
|
|
|
(19)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
2,730
|
|
|
$
|
3,183
|
|
|
$
|
2,431
|
|
|
$
|
—
|
|
|
$
|
627
|
|
|
$
|
(60)
|
|
|
3. The adjusted tax rate for
the first six months of 2019 was 8.3 percent, as detailed
below:
|
|
|
6M19
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
3,351
|
|
|
$
|
154
|
|
|
4.6
|
%
|
Specified
items
|
3,809
|
|
|
444
|
|
|
11.6
|
%
|
As
adjusted (non-GAAP)
|
$
|
7,160
|
|
|
$
|
598
|
|
|
8.3
|
%
|
AbbVie
Inc.
Reconciliation of
GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended
June 30, 2018
(Unaudited) (In
millions, except per share data)
|
|
1. Specified items
impacted results as follows:
|
|
|
6M18
|
|
Earnings
|
|
Diluted
|
|
Pre-tax
|
|
After-tax
|
|
EPS
|
As reported
(GAAP)
|
$
|
4,809
|
|
|
$
|
4,766
|
|
|
$
|
2.99
|
|
Adjusted for
specified items:
|
|
|
|
|
|
Intangible asset
amortization
|
654
|
|
|
538
|
|
|
0.34
|
|
Milestones and other
R&D expenses
|
87
|
|
|
87
|
|
|
0.05
|
|
Acquired
IPR&D
|
69
|
|
|
69
|
|
|
0.04
|
|
Calico
collaboration
|
500
|
|
|
500
|
|
|
0.32
|
|
Charitable
contributions
|
120
|
|
|
93
|
|
|
0.06
|
|
Change in fair value
of contingent consideration
|
337
|
|
|
337
|
|
|
0.21
|
|
Litigation
reserves
|
118
|
|
|
100
|
|
|
0.06
|
|
Impacts of U.S. tax
reform
|
—
|
|
|
(357)
|
|
|
(0.22)
|
|
Other
|
31
|
|
|
32
|
|
|
0.02
|
|
As adjusted
(non-GAAP)
|
$
|
6,725
|
|
|
$
|
6,165
|
|
|
$
|
3.87
|
|
|
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. Impacts of U.S. tax
reform reflects a net tax benefit related to the timing of the
legislation's phase in on certain subsidiaries. Other primarily
includes milestone revenue under a previously announced
collaboration and restructuring charges associated with
streamlining global operations.
|
|
2.
The impact of the specified items by line item
was as follows:
|
|
|
6M18
|
|
Net
revenues
|
|
Cost of
products
sold
|
|
SG&A
|
|
R&D
|
|
Acquired
IPR&D
|
|
Other
operating
expense
|
|
Other
expense,
net
|
As reported
(GAAP)
|
$
|
16,212
|
|
|
$
|
3,861
|
|
|
$
|
3,551
|
|
|
$
|
2,566
|
|
|
$
|
69
|
|
|
$
|
500
|
|
|
$
|
317
|
|
Adjusted for
specified items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset
amortization
|
—
|
|
|
(654)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Milestones and other
R&D expenses
|
—
|
|
|
—
|
|
|
—
|
|
|
(87)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Acquired
IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(69)
|
|
|
—
|
|
|
—
|
|
Calico
collaboration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(500)
|
|
|
—
|
|
Charitable
contributions
|
—
|
|
|
—
|
|
|
(120)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Change in fair value
of contingent consideration
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(337)
|
|
Litigation
reserves
|
—
|
|
|
—
|
|
|
(118)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Other
|
(20)
|
|
|
(28)
|
|
|
—
|
|
|
(23)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
As
adjusted (non-GAAP)
|
$
|
16,192
|
|
|
$
|
3,179
|
|
|
$
|
3,313
|
|
|
$
|
2,456
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(20)
|
|
|
3. The adjusted tax rate for
the first six months of 2018 was 8.3 percent, as detailed
below:
|
|
|
6M18
|
|
Pre-tax
earnings
|
|
Income
taxes
|
|
Tax rate
|
As reported
(GAAP)
|
$
|
4,809
|
|
|
$
|
43
|
|
|
0.9
|
%
|
Specified
items
|
1,916
|
|
|
517
|
|
|
27.0
|
%
|
As
adjusted (non-GAAP)
|
$
|
6,725
|
|
|
$
|
560
|
|
|
8.3
|
%
|
View original
content:http://www.prnewswire.com/news-releases/abbvie-reports-second-quarter-2019-financial-results-300891626.html
SOURCE AbbVie