ABBVIE INC. NORTH CHICAGO, Ill., April 27, 2017 /PRNewswire/ -- 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)
% Change vs. 1Q16
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
---- ------ ----- ---- ----------- -------- ----------- --------
NET REVENUES $4,052 $2,486 $6,538 15.9% 1.8% 0.9% 10.1% 9.7%
Humira 2,696 1,422 4,118 22.8 4.6 2.9 15.8 15.1
Imbruvicaa 457 94 551 40.7 68.0 68.0 44.7 44.7
Viekira 38 225 263 (69.6) (20.8) (21.9) (35.5) (36.3)
Lupron 155 39 194 1.9 (0.2) 1.2 1.4 1.7
Creon 185 - 185 22.8 n/a n/a 22.8 22.8
Synagis - 300 300 n/a (8.2) (5.9) (8.2) (5.9)
Synthroid 192 - 192 5.7 n/a n/a 5.7 5.7
AndroGel 136 - 136 (12.8) n/a n/a (12.8) (12.8)
Kaletra 19 96 115 (41.8) (6.4) (4.4) (15.1) (13.6)
Sevoflurane 18 89 107 0.7 (3.0) (4.9) (2.4) (4.0)
Duodopa 14 66 80 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
sharea $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
Cost of SG&A R&D Other
products sold expense
(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 Tax rate
income taxes
------ -----
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
Cost of SG&A R&D Acquired Net foreign
products IPR&D exchange
sold 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 Tax rate
income taxes
------ -----
As reported (GAAP) $1,776 $422 23.7%
Specified items 587 67 11.4%
As adjusted (non-GAAP) $2,363 $489 20.7%
====== ==== ====
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SOURCE AbbVie
