Earnings Release • Oct 28, 2016
Earnings Release
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NORTH CHICAGO, Illinois, October 28, 2016 /PRNewswire/ --
- Delivers Third-Quarter Net Revenues of $6.43 Billion on a GAAP Basis; Adjusted Net Revenues Grew 8.0 Percent on an Operational Basis
- Revenue Growth Reflects 11.3 Percent HUMIRA Global Reported Sales Growth; 12.1 Percent Growth on an Operational Basis
- Third-Quarter Global IMBRUVICA Net Revenue was $501 Million
- Reports Operating Margin of 36.7 Percent on a GAAP Basis; 42.8 Percent on an Adjusted Basis
- Raises 2016 GAAP Diluted EPS Guidance Range to $3.74 to $3.76 and Adjusted EPS Guidance Range to $4.80 to $4.82, Representing Growth of 12.1 Percent at the Midpoint
- Announces 2017 Dividend Increase of 12 Percent, Beginning with Dividend Payable in February 2017
Oct. 28, 2016 -- AbbVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2016.
"We delivered another strong quarter, with EPS growth ahead of our expectations. Year-to-date, we've driven strong commercial, operational and R&D execution, and we have advanced our pipeline and other strategic priorities," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "AbbVie represents a unique investment opportunity, offering both compelling growth, along with a strong return of capital to investors, including a rapidly growing dividend, which has grown 60 percent since we became an independent company nearly four years ago."
Third-Quarter Results
Key Events from the Third Quarter
AbbVie Raises Full-Year 2016 Outlook
AbbVie is raising GAAP diluted EPS guidance for the full-year 2016 to $3.74 to $3.76. AbbVie is raising its adjusted diluted EPS guidance for the full-year 2016 to $4.80 to $4.82. The company's 2016 adjusted diluted EPS guidance excludes $1.06 per share of intangible asset amortization expense, acquisition related costs and accounting impacts, the impact of the Venezuelan currency devaluation, and other specified items.
Company Declares Dividend Increase of 12 Percent
AbbVie is also announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $0.57 per share to $0.64 per share beginning with the dividend payable on February 15, 2017 to shareholders of record as of January 13, 2017. This reflects an increase of approximately 12 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its dividend by 60 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view our Facebook and LinkedIn pages.
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our third-quarter performance. The call will be webcast through AbbVie's Investor Relations website at www.abbvieinvestor.com. An archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 2015 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 2016 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 2015 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 September 30, 2016
(Unaudited)
% Change vs. 3Q15
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED
NET
REVENUESa $4,047 $2,339 $6,386 9.7% 5.4% 3.8% 8.0% 7.4%
Humira 2,647 1,413 4,060 16.7 4.5 2.4 12.1 11.3
Imbruvicab 437 64 501 63.6 70.6 70.6 64.5 64.5
Viekira 76 302 378 (68.8) 30.9 32.5 (20.4) (19.6)
Lupron 155 38 193 (2.7) (8.7) (9.4) (3.9) (4.1)
Synagis - 96 96 n/a (2.4) 2.5 (2.4) 2.5
Synthroid 188 - 188 (0.3) n/a n/a (0.3) (0.3)
Creon 187 - 187 16.6 n/a n/a 16.6 16.6
AndroGel 174 - 174 (2.1) n/a n/a (2.1) (2.1)
Kaletra 27 110 137 (30.6) (9.0) (14.7) (14.1) (18.4)
Sevoflurane 19 83 102 (9.9) (13.8) (17.4) (13.1) (16.1)
Duodopa 10 64 74 >100.0 12.1 11.7 21.4 21.0
Note: "Operational" growth reflects the percentage change over
the prior year excluding the impact of exchange rate
fluctuations.
n/a = not applicable
a U.S. and total net revenues for the quarter ended September
30, 2016 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
Nine Months Ended September 30, 2016
(Unaudited)
% Change vs. 9M15
Net Revenues (in
millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED
NET
REVENUESa $11,641 $7,135 $18,776 19.9% 9.8% 5.7% 15.7% 14.1%
Humira 7,554 4,232 11,786 24.4 4.4 0.2 16.2 14.5
Imbruvicab 1,146 175 1,321 >100.0 >100.0 >100.0 >100.0 >100.0
Viekira 288 923 1,211 (52.5) 95.0 92.8 12.6 11.6
Lupron 485 117 602 4.3 (2.2) (7.4) 2.9 1.8
Synagis - 460 460 n/a 1.8 (3.0) 1.8 (3.0)
Synthroid 558 - 558 (0.5) n/a n/a (0.5) (0.5)
Creon 517 - 517 15.7 n/a n/a 15.7 15.7
AndroGel 501 - 501 0.2 n/a n/a 0.2 0.2
Kaletra 90 326 416 (26.9) (9.4) (16.7) (13.5) (19.1)
Sevoflurane 58 269 327 (1.8) (7.4) (12.4) (6.5) (10.7)
Duodopa 26 189 215 >100.0 17.8 16.3 28.6 27.1
Note: "Operational" growth reflects the percentage change over
the prior year excluding the impact of exchange rate
fluctuations.
n/a = not applicable
a U.S. and total net revenues for the nine months ended
September 30, 2016 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 Nine Months Ended September 30, 2016 and 2015
(Unaudited) (In millions, except per share data)
Third Quarter Nine Months
Ended September 30 Ended September 30
2016 2015 2016 2015
Net revenues $ 6,432 $ 5,944 $ 18,842 $ 16,459
Cost of products
sold 1,504 1,167 4,278 3,025
Selling, general
and
administrative 1,381 1,474 4,202 4,650
Research and
development 1,106 1,418 3,176 3,210
Acquired
in-process
research and
development 80 - 160 150
Total operating
cost and
expenses 4,071 4,059 11,816 11,035
Operating
earnings 2,361 1,885 7,026 5,424
Interest
expense, net 250 197 675 487
Net foreign
exchange loss (4) 13 313 191
Other expense
(income), net 101 28 152 25
Earnings before
income tax
expense 2,014 1,647 5,886 4,721
Income tax
expense 416 408 1,324 1,094
Net earnings $ 1,598 $ 1,239 $ 4,562 $ 3,627
Diluted earnings
per share $ 0.97 $ 0.74 $ 2.78 $ 2.21
Diluted earnings
per share,
excluding
specified itemsa $ 1.21 $ 1.13 $ 3.62 $ 3.16
Weighted-average
diluted shares
outstanding 1,640 1,664 1,633 1,635
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 September 30, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
3Q16
Earnings Diluted
Pre-tax After-tax EPS
As reported
(GAAP) $ 2,014 $ 1,598 $ 0.97
Adjusted for
specified items:
Intangible
asset
amortization 208 168 0.11
Acquired
IPR&D 80 80 0.05
Acquisition
related
costs 123 70 0.04
Change in
fair value
of contingent
consideration 104 104 0.06
Other (40) (26) (0.02)
As adjusted
(non-GAAP) $ 2,489 $ 1,994 $ 1.21
Acquired IPR&D primarily reflects an R&D collaboration. Acquisition related costs
primarily include compensation expense and other costs associated with the
acquisition of Stemcentrx, as well as the amortization of the acquisition date
fair value step-up for inventory related to the acquisition of Pharmacyclics.
Other includes milestone revenue under a previously announced collaboration,
prior period royalty revenue related to a patent lawsuit settlement and
restructuring charges associated with streamlining global operations.
2. The impact of the specified items by line item was as follows:
3Q16
Net Cost of Acquired Other
revenues products sold SG&A R&D IPR&D expense, net
As reported
(GAAP) $ 6,432 $ 1,504 $ 1,381 $ 1,106 $ 80 $ 101
Adjusted
for
specified
items:
Intangible
asset
amortization - (208) - - - -
Milestones
and other
R&D expenses - - - - - -
Acquired
IPR&D - - - - (80) -
Acquisition
related
costs - (53) (16) (54) - -
Change in
fair value
of contingent
consideration - - - - - (104)
Other (46) (8) 3 (1) - -
As adjusted
(non-GAAP) $ 6,386 $ 1,235 $ 1,368 $ 1,051 $ - $ (3)
3. The adjusted tax rate for the third quarter of 2016 was 19.9 percent, as
detailed below:
3Q16
Pre-tax Income
income taxes Tax rate
As
reported
(GAAP) $ 2,014 $ 416 20.7 %
Specified
items 475 79 16.6 %
As
adjusted
(non-GAAP) $ 2,489 $ 495 19.9 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended September 30, 2015
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
3Q15
Earnings Diluted
Pre-tax After-tax EPS
As reported
(GAAP) $ 1,647 $ 1,239 $ 0.74
Adjusted for
specified items:
Intangible
asset
amortization 125 94 0.05
Separation
costs 45 39 0.02
Pharmacyclics
transaction
and other
costs 120 85 0.05
Milestones
and other R&D
expenses 480 433 0.27
Other 12 9 -
As adjusted
(non-GAAP) $ 2,429 $ 1,899 $ 1.13
Separation costs are expenses related to the separation of AbbVie from Abbott.
Pharmacyclics transaction and other costs reflect transaction, financing,
integration and other costs related to the acquisition of Pharmacyclics.
Milestones and other R&D expenses consist of a milestone payment for a
previously announced collaboration and the purchase of an FDA priority review
voucher from a third-party. Other is primarily associated with restructuring
activities.
2. The impact of the specified items by line item was as follows:
3Q15
Cost of
products sold SG&A R&D
As reported
(GAAP) $ 1,167 $ 1,474 $ 1,418
Adjusted for
specified items:
Intangible
asset
amortization (125) - -
Separation
costs - (45) -
Pharmacyclics
transaction
and other
costs (45) (57) (18)
Milestones
and other R&D
expenses - - (480)
Other (6) (2) (4)
As adjusted
(non-GAAP) $ 991 $ 1,370 $ 916
3. The adjusted tax rate for the third quarter of 2015 was 21.9 percent, as
detailed below:
3Q15
Pre-tax Income
income taxes Tax rate
As
reported
(GAAP) $ 1,647 $ 408 24.8 %
Specified
items 782 122 15.6 %
As
adjusted
(non-GAAP) $ 2,429 $ 530 21.9 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Nine Months Ended September 30, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
9M16
Earnings Diluted
Pre-tax After-tax EPS
As reported
(GAAP) $ 5,886 $ 4,562 $ 2.78
Adjusted
for
specified
items:
Intangible
asset
amortization 554 445 0.27
Milestones
and other
R&D expenses 70 70 0.04
Acquired
IPR&D 160 160 0.10
Acquisition
related
costs 327 229 0.15
Change in
fair value
of contingent
consideration 145 145 0.09
Foreign
exchange
loss 298 298 0.18
Other 4 31 0.01
As adjusted
(non-GAAP) $ 7,444 $ 5,940 $ 3.62
Milestones and other R&D expenses consist of milestone payments for
previously announced collaborations. Acquired IPR&D primarily reflects an R&D
collaboration, as well as upfront payments related to licensing
arrangements with third parties. Acquisition related costs primarily
include compensation expense, financing and other costs associated with the
acquisition of Stemcentrx and Boehringer Ingelheim, as well as the amortization
of the acquisition date fair value step-up for inventory related to the
acquisition of Pharmacyclics. The foreign exchange loss relates to a
devaluation of AbbVie's net monetary assets denominated in the Venezuelan
bolivar. Other includes a charge for the impairment of an intangible asset,
restructuring charges associated with streamlining global operations, a charge
to increase tax reserves, milestone revenue under a previously announced
collaboration, and prior period royalty revenue related to a patent lawsuit
settlement.
2. The impact of the specified items by line item was as follows:
9M16
Net Cost of Acquired Net foreign Other
revenues products sold SG&A R&D IPR&D exchange expense, net
loss
As reported
(GAAP) $ 18,842 $ 4,278 $ 4,202 $ 3,176 $ 160 $ 313 $ 152
Adjusted for
specified items:
Intangible
asset
amortization - (554) - - - - -
Milestones
and other
R&D
expenses - - - (70) - - -
Acquired
IPR&D - - - - (160) - -
Acquisition
related
costs - (144) (36) (135) - - (12)
Change in
fair value
of contingent
consideration - - - - - - (145)
Venezuela
devaluation
loss - - - - - (298) -
Other (66) (61) (15) 6 - - -
As adjusted
(non-GAAP) $ 18,776 $ 3,519 $ 4,151 $ 2,977 $ - $ 15 $(5)
3. The adjusted tax rate for the first nine months of 2016 was 20.2
percent, as detailed below:
9M16
Pre-tax Income
income taxes Tax rate
As
reported
(GAAP) $ 5,886 $ 1,324 22.5 %
Specified
items 1,558 180 11.6 %
As
adjusted
(non-GAAP
) $ 7,444 $ 1,504 20.2 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Nine Months Ended September 30, 2015
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
9M15
Earnings Diluted
Pre-tax After-tax EPS
As reported
(GAAP) $ 4,721 $ 3,627 $ 2.21
Adjusted for
specified
items:
Intangible
asset
amortization 279 212 0.13
Separation
costs 244 208 0.12
Pharmacyclics
transaction
and other
costs 540 342 0.20
Milestones
and other R&D
expenses 480 433 0.27
Acquired
IPR&D 150 150 0.10
Shire
termination 170 170 0.10
Other 80 57 0.03
As adjusted
(non-GAAP) $ 6,664 $ 5,199 $ 3.16
Separation costs are expenses related to the separation of AbbVie from Abbott.
Pharmacyclics transaction and other costs reflect transaction, financing,
integration and other costs related to the acquisition of Pharmacyclics.
Milestones and other R&D expenses consist of a milestone payment for a
previously announced collaboration and the purchase of an FDA priority review
voucher from a third-party. Acquired IPR&D primarily reflects the C2N
collaboration. Shire termination reflects the completed liquidation of
remaining foreign currency positions related to the terminated Shire
transaction, as communicated in the fourth quarter of 2014. Other is
primarily associated with restructuring activities.
2. The impact of the specified items by line item was as follows:
9M15
Cost of Interest
products Acquired expense, Net foreign
sold SG&A R&D IPR&D net exchange loss
As reported
(GAAP) $ 3,025 $ 4,650 $ 3,210 $ 150 $ 487 $ 191
Adjusted for
specified
items:
Intangible
asset
amortization (279) - - - - -
Separation
costs (5) (239) - - - -
Pharmacyclics
transaction
and other
costs (64) (279) (111) - (86) -
Milestones
and other R&D
expenses - - (480) - - -
Acquired
IPR&D - - - (150) - -
Shire
termination - - - - - (170)
Other (18) (42) (20) - - -
As adjusted
(non-GAAP) $ 2,659 $ 4,090 $ 2,599 $ - $ 401 $ 21
3. The adjusted tax rate for the first nine months of 2015 was 22.0
percent, as detailed below:
9M15
Pre-tax Income
income taxes Tax rate
As
reported
(GAAP) $ 4,721 $ 1,094 23.2 %
Specified
items 1,943 371 19.1 %
As
adjusted
(non-GAAP) $ 6,664 $ 1,465 22.0 %
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