NORTH CHICAGO, Illinois,
April 27, 2017 /PRNewswire/ --
- Reports First-Quarter Diluted EPS of $1.06 on a GAAP Basis; Adjusted Diluted EPS of
$1.28, Reflecting Growth of 11.3
Percent
- Delivers First-Quarter Net Revenues of $6.538 Billion on a GAAP Basis, Reflecting Growth
of 10.1 Percent on an Operational Basis
- First-Quarter Global Humira Sales of $4.118 Billion Increased 15.1 Percent on a
Reported Basis, or 15.8 Percent on an Operational Basis;
First-Quarter U.S. Humira Sales of $2.696
Billion Increased 22.8 Percent
- First-Quarter Global IMBRUVICA Net Revenues Were
$551 Million, an Increase of 44.7
Percent
- Confirms 2017 GAAP Diluted EPS Guidance Range of
$4.55 to $4.65; 2017 Adjusted Diluted
EPS Guidance Range of $5.44 to $5.54,
Representing Growth of 13.9 Percent at the Midpoint
#End headline
#Begin release #Begin Wide Release
AbbVie (NYSE:ABBV) announced financial results for the first
quarter ended March 31, 2017.
"AbbVie delivered strong first quarter results, with
double-digit EPS and operational revenue growth, exceeding our
guidance for the quarter," said Richard A.
Gonzalez, chairman and chief executive officer, AbbVie. "As
we look ahead to the remainder of the year we expect continued
strong commercial execution and significant pipeline progress. This
includes a dozen pivotal trial read-outs and several regulatory
submissions and approvals, further supporting our ability to drive
top-tier performance over the long term. 2017 is an important year
for AbbVie and we are off to an excellent start."
First-Quarter Results
- Worldwide GAAP net revenues were $6.538
billion in the first quarter, increasing 10.1 percent,
excluding a 0.4 percent unfavorable impact from foreign
exchange.
- Global HUMIRA sales increased 15.1 percent on a reported basis,
or 15.8 percent operationally, excluding a 0.7 percent unfavorable
impact from foreign exchange. In the U.S., HUMIRA sales grew 22.8
percent in the quarter. Internationally, HUMIRA sales grew 4.6
percent, excluding a 1.7 percent unfavorable impact from foreign
exchange.
- First-quarter global IMBRUVICA net revenues were $551 million, with U.S. sales of $457 million and international profit sharing of
$94 million for the quarter,
reflecting growth of 44.7 percent.
- On a GAAP basis, the gross margin ratio in the first quarter
was 75.3 percent. The adjusted gross margin ratio was 79.9
percent.
- On a GAAP basis, selling, general and administrative expense
was 20.9 percent of net revenues. The adjusted SG&A expense was
20.7 percent of net revenues.
- On a GAAP basis, research and development expense was 17.4
percent of net revenues. The adjusted R&D expense was 16.9
percent, reflecting funding actions supporting all stages of our
pipeline.
- On a GAAP basis, the operating margin in the first quarter was
37.0 percent. The adjusted operating margin was 42.3 percent.
- On a GAAP basis, net interest expense was $247 million. On a GAAP basis, the tax rate in
the quarter was 18.0 percent. The adjusted tax rate was 18.2
percent.
- Diluted EPS in the first quarter was $1.06 on a GAAP basis. Adjusted diluted EPS,
excluding intangible asset amortization expense and other specified
items, was $1.28, up 11.3
percent.
Key Events from the First Quarter
- AbbVie announced that the U.S. Food and Drug Administration
(FDA) accepted for review a supplemental New Drug Application for
IMBRUVICA in chronic graft-versus-host-disease (cGVHD), after
failure of one or more lines of systemic therapy. cGVHD is a
serious and debilitating complication of stem cell or bone marrow
transplant. If approved, IMBRUVICA will be the first therapy
specifically approved to treat this condition. IMBRUVICA is jointly
developed and commercialized with Janssen Biotech, Inc.
- AbbVie announced that the U.S. FDA approved IMBRUVICA
to treat patients with marginal zone lymphoma (MZL), an indolent
form of non-Hodgkin's lymphoma (NHL). There are currently no other
approved treatments specifically indicated for patients with MZL.
This approval marks the fifth unique type of blood cancer
indication for IMBRUVICA.
- AbbVie announced that its Phase 3 studies of veliparib, an
investigational, oral poly (adenosine diphosphate [ADP]-ribose)
polymerase (PARP) inhibitor, in patients with squamous non-small
cell lung cancer (NSCLC) and triple-negative breast cancer did not
meet their primary endpoints. The studies evaluated veliparib in
combination with the chemotherapy regimen carboplatin and
paclitaxel. Based on these Phase 3 data, AbbVie will not continue
development in these indications. Studies of veliparib in
non-squamous NSCLC, BRCA1/2 breast cancer and ovarian cancer are
ongoing.
- AbbVie, in cooperation with Neurocrine Biosciences, Inc.,
announced detailed results from a Phase 2b clinical trial
evaluating the efficacy and safety of elagolix alone or in
combination with add-back therapy (estradiol/norethindrone acetate)
compared to placebo in women with uterine fibroids. The data
demonstrated that elagolix, with and without add-back therapy, met
the primary efficacy endpoint of reduced heavy menstrual bleeding
as compared to placebo. Uninterrupted treatment with elagolix was
associated with decreased symptom severity and improved quality of
life. Phase 3 trials evaluating elagolix as a potential treatment
for uterine fibroids are ongoing. Additionally, the Phase 3 program
in endometreosis is nearing completion, with regulatory submission
planned for later this year.
- AbbVie announced that the U.S. FDA accepted its New Drug
Application and granted priority review for its investigational,
pan-genotypic, once-daily, ribavirin-free regimen of glecaprevir
(ABT-493)/pibrentasvir (ABT-530) (G/P), being evaluated for the
treatment of chronic hepatitis C virus (HCV). Additionally, AbbVie
announced that its marketing authorization application was
validated and is under accelerated assessment by the European
Medicines Agency (EMA), and that priority review was granted by the
Japanese Ministry of Health, Labour and Welfare. The company
anticipates commercialization of the next-generation combination in
2017.
- AbbVie recently presented data on G/P from the Phase 3
EXPEDITION-1 study and the Phase 3 ENDURANCE-3 study at the
International Liver Conference for the European Association for the
Study of the Liver. The EXPEDITION-1 study results demonstrated
that 99 percent of chronic HCV infected patients with genotype 1,
2, 4, 5 or 6 and compensated cirrhosis achieved sustained virologic
response at 12 weeks post-treatment (SVR12). The ENDURANCE-3 study
results demonstrated that 95 percent of patients infected with
genotype 3 chronic HCV, without cirrhosis and who are new to
treatment, achieved SVR12 following 8 weeks of treatment. Together
with previously reported data, these new study results reinforce
G/P's potential to provide a faster path to cure for the majority
of patients living with HCV across all genotypes, as well as offer
a potential cure to patients with specific treatment
challenges.
- AbbVie announced that the European Committee for Medicinal
Products for Human Use (CHMP) of the EMA granted a positive opinion
for a shorter, eight-week treatment of VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) as an option for previously untreated adult patients with
genotype 1b (GT1b) chronic HCV and minimal to moderate fibrosis.
VIEKIRAX + EXVIERA is currently approved in the European Union for
use as a 12-week treatment for GT1b chronic HCV-infected patients
without cirrhosis or with compensated cirrhosis.
- AbbVie announced the start of two Phase 2 clinical trial
programs to evaluate ABBV-8E12, an investigational anti-tau
antibody, in patients with early Alzheimer's disease and
progressive supranuclear palsy (PSP). In recognition of the lack of
treatment options available to patients with PSP, the U.S. FDA
granted Fast Track Designation to ABBV-8E12. The FDA and EMA also
granted Orphan Drug Designations to ABBV-8E12 for PSP.
Full-Year 2017 Outlook
AbbVie is confirming its GAAP diluted EPS guidance for the
full-year 2017 of $4.55 to $4.65.
AbbVie expects to deliver adjusted diluted EPS for the full-year
2017 of $5.44 to $5.54, representing
growth of 13.9 percent at the mid-point. The company's 2017
adjusted diluted EPS guidance excludes $0.89 per share of intangible asset amortization
expense and other specified items.
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
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 2017 and 2016 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 2017 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, 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 2016 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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, 2017
(Unaudited)
Net Revenues (in millions)
U.S. Int'l. Total
NET
REVENUES $4,052 $2,486 $6,538
Humira 2,696 1,422 4,118
Imbruvica[a] 457 94 551
Viekira 38 225 263
Lupron 155 39 194
Creon 185 - 185
Synagis - 300 300
Synthroid 192 - 192
AndroGel 136 - 136
Kaletra 19 96 115
Sevoflurane 18 89 107
Duodopa 14 66 80
Table continues below
% Change vs. 1Q16
International Total
U.S. Operational Reported Operational Reported
NET
REVENUES 15.9% 1.8% 0.9% 10.1% 9.7%
Humira 22.8 4.6 2.9 15.8 15.1
Imbruvica[a] 40.7 68.0 68.0 44.7 44.7
Viekira (69.6) (20.8) (21.9) (35.5) (36.3)
Lupron 1.9 (0.2) 1.2 1.4 1.7
Creon 22.8 n/a n/a 22.8 22.8
Synagis n/a (8.2) (5.9) (8.2) (5.9)
Synthroid 5.7 n/a n/a 5.7 5.7
AndroGel (12.8) n/a n/a (12.8) (12.8)
Kaletra (41.8) (6.4) (4.4) (15.1) (13.6)
Sevoflurane 0.7 (3.0) (4.9) (2.4) (4.0)
Duodopa 84.6 12.0 8.9 19.8 17.0
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.
n/a = not applicable
[a] Reflects profit sharing for Imbruvica international revenues.
AbbVie Inc.
Consolidated Statements of Earnings
Quarter Ended March 31, 2017 and 2016
(Unaudited) (In millions, except per share data)
First Quarter
Ended March 31
2017 2016
Net revenues $ 6,538 $ 5,958
Cost of products sold 1,616 1,369
Selling, general and administrative 1,368 1,355
Research and development 1,135 946
Acquired in-process research and development - 10
Total operating cost and expenses 4,119 3,680
Operating earnings 2,419 2,278
Interest expense, net 247 200
Net foreign exchange loss 13 302
Other expense, net 73 -
Earnings before income tax expense 2,086 1,776
Income tax expense 375 422
Net earnings $ 1,711 $ 1,354
Diluted earnings per share $ 1.06 $ 0.83
Adjusted diluted earnings per share[a] $ 1.28 $ 1.15
Weighted-average diluted shares outstanding 1,603 1,625
[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 March 31, 2017
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
1Q17
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 2,086 $ 1,711 $ 1.06
Adjusted for specified items:
Intangible asset amortization 271 203 0.13
Milestones and other R&D expenses 28 28 0.02
Acquisition related costs 38 25 0.01
Change in fair value of
contingent consideration 85 84 0.06
Other 10 9 -
As adjusted (non-GAAP) $ 2,518 $ 2,060 $ 1.28
Milestones and other R&D expenses are associated with milestone
payments for previously announced collaborations. Acquisition
related costs primarily include the amortization of the
acquisition date fair value step-up for inventory related to the
acquisition of Pharmacyclics. Other primarily includes
restructuring charges associated with streamlining global
operations.
2. The impact of the specified items by line item was as follows:
1Q17
Other
Cost of expense
products sold SG&A R&D (income), net
As reported (GAAP) $ 1,616 $ 1,368 $ 1,135 $ 73
Adjusted for specified items:
Intangible asset amortization (271) - - -
Milestones and other R&D
expenses - - (28) -
Acquisition related costs (26) (9) (2) (1)
Change in fair value of
contingent consideration - - - (85)
Other (6) (4) - -
As adjusted (non-GAAP) $ 1,313 $ 1,355 $ 1,105 $ (13)
3. The adjusted tax rate for the first quarter of 2017 was 18.2 percent, as
detailed below:
1Q17
Pre-tax Income
income taxes Tax rate
As reported (GAAP) $ 2,086 $ 375 18.0 %
Specified items 432 83 19.2 %
As adjusted (non-GAAP) $ 2,518 $ 458 18.2 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended March 31, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
1Q16
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 1,776 $ 1,354 $ 0.83
Adjusted for specified items:
Intangible asset amortization 165 133 0.08
Acquisition related costs 57 35 0.02
Venezuela devaluation loss 298 298 0.18
Other 67 54 0.04
As adjusted (non-GAAP) $ 2,363 $ 1,874 $ 1.15
Acquisition related costs reflect the amortization of the
acquisition date fair value step-up for inventory as well as
integration and other costs related to the acquisition of
Pharmacyclics. Other is primarily associated with the impairment
of an intangible asset and a milestone payment for a previously
announced collaboration.
2. The impact of the specified items by line item was as follows:
1Q16
Net
Cost of foreign
products Acquired exchange
sold SG&A R&D IPR&D loss
As reported (GAAP) $ 1,369 $ 1,355 $ 946 $ 10 $ 302
Adjusted for specified items:
Intangible asset amortization (165) - - - -
Acquisition related costs (45) (4) (8) - -
Venezuela devaluation loss - - - - (298)
Other (44) (4) (9) (10) -
As adjusted (non-GAAP) $ 1,115 $ 1,347 $ 929 $ - $ 4
3. The adjusted tax rate for the first quarter of 2016 was 20.7 percent, as
detailed below:
1Q16
Pre-tax Income
income taxes Tax rate
As reported (GAAP) $ 1,776 $ 422 23.7 %
Specified items 587 67 11.4 %
As adjusted (non-GAAP) $ 2,363 $ 489 20.7 %
#End Wide Release
CONTACT: Media: Adelle Infante,
(847) 938-8745, Investors: Liz Shea,
(847) 935-2211, Sharon Greenlees,
(847) 935-0900, Todd Bosse, (847)
936-1182
#End release
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