NORTH CHICAGO, Illinois, January 27, 2017 /PRNewswire/ --
- Reports Full-Year Diluted EPS of $3.63 on a GAAP Basis; Adjusted Diluted EPS of $4.82, Reflecting Growth of 12.4 Percent
- Delivers Full-Year Net Revenues of $25.638 Billion on a GAAP Basis; Adjusted Net Revenues of $25.560 Billion Grew 13.3 Percent on an Operational Basis
- Full-Year Global Humira Sales of $16.078 Billion Increased 16.1 Percent on an Operational Basis
- Full-Year Global IMBRUVICA Net Revenues Exceeded $1.8 Billion
- Reports Fourth-Quarter Diluted EPS of $0.85 on a GAAP Basis; Adjusted Diluted EPS of $1.20 Reflects Growth of 6.2 Percent Over Fourth-Quarter 2015
- Delivers Fourth-Quarter Net Revenues of $6.796 Billion on a GAAP Basis; Adjusted Net Revenues of $6.784 Billion Grew 6.9 Percent on an Operational Basis
- Revenue Growth in the Quarter Reflects 15.5 Percent HUMIRA Global Reported Sales Growth; 16.2 Percent Growth on an Operational Basis
- Provides 2017 GAAP Diluted EPS Guidance Range of $4.55 to $4.65; Provides 2017 Adjusted Diluted EPS Guidance Range of $5.44 to $5.54, Representing Growth of 13.9 Percent at the Midpoint
AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2016.
"The fourth quarter was a continuation of the strong performance and business momentum AbbVie has delivered since we became an independent company in 2013. Our 2016 revenue and EPS growth rank us among the leaders in our industry," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We continue to make significant progress on our objectives across each aspect of our company strategy, with strong commercial execution, financial discipline and a focus on our advancing pipeline to drive long-term sustainable growth. Our guidance for 2017 reflects continued strong performance and confidence in our business fundamentals."
Fourth-Quarter Results
Key Events from the Fourth Quarter
Full-Year 2017 Outlook
AbbVie is issuing GAAP diluted EPS guidance for the full-year 2017 of $4.55 to $4.65. AbbVie expects to deliver adjusted diluted EPS guidance 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-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 approximately 30,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit http://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 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 2016 and 2015 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 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 December 31, 2016
(Unaudited)
% Change vs. 4Q15
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED
NET
REVENUES[a] $4,286 $2,498 $6,784 12.5% (1.3)% (2.0)% 6.9% 6.7%
Humira 2,878 1,414 4,292 23.5 4.1 2.1 16.2 15.5
Imbruvica[b] 434 77 511 46.9 61.3 61.3 48.9 48.9
Viekira 54 257 311 (72.3) (27.5) (27.9) (43.5) (43.7)
Lupron 178 41 219 (5.4) (13.2) (11.5) (6.9) (6.6)
Synagis - 270 270 n/a (4.3) 1.3 (4.3) 1.3
Synthroid 205 - 205 5.9 n/a n/a 5.9 5.9
Creon 213 - 213 14.9 n/a n/a 14.9 14.9
AndroGel 174 - 174 (10.4) n/a n/a (10.4) (10.4)
Kaletra 26 107 133 (34.8) (24.3) (26.6) (26.5) (28.3)
Sevoflurane 22 79 101 0.9 (5.7) (8.2) (4.3) (6.3)
Duodopa 11 67 78 >100.0 19.3 18.9 26.7 26.4
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.
n/a = not applicable
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
[a] adjusted net revenues.
[b] Reflects profit sharing for Imbruvica international revenues.
AbbVie Inc.
Key Product Revenues
Twelve Months Ended December 31, 2016
(Unaudited)
% Change vs. 12M15
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED
NET
REVENUES[a] $15,927 $9,633 $25,560 17.8% 6.7% 3.6% 13.3% 12.0%
Humira 10,432 5,646 16,078 24.1 4.3 0.7 16.1 14.7
Imbruvica[b] 1,580 252 1,832 >100.0 >100.0 >100.0 >100.0 >100.0
Viekira 342 1,180 1,522 (57.4) 42.7 41.3 (6.4) (7.1)
Lupron 663 158 821 1.5 (5.2) (8.5) 0.1 (0.6)
Synagis - 730 730 n/a (0.4) (1.5) (0.4) (1.5)
Synthroid 763 - 763 1.1 n/a n/a 1.1 1.1
Creon 730 - 730 15.5 n/a n/a 15.5 15.5
AndroGel 675 - 675 (2.8) n/a n/a (2.8) (2.8)
Kaletra 116 433 549 (28.8) (13.3) (19.3) (16.9) (21.5)
Sevoflurane 80 348 428 (1.0) (6.9) (11.4) (6.0) (9.7)
Duodopa 37 256 293 >100.0 18.1 16.9 28.1 26.9
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.
n/a = not applicable
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
[a] adjusted net revenues.
[b] Reflects profit sharing for Imbruvica international revenues.
AbbVie Inc.
Consolidated Statements of Earnings
Quarter and Twelve Months Ended December 31, 2016 and 2015
(Unaudited) (In millions, except per share data)
Fourth Quarter Twelve Months
Ended December 31 Ended December 31
2016 2015 2016 2015
Net revenues $ 6,796 $ 6,400 $ 25,638 $ 22,859
Cost of products
sold 1,555 1,475 5,833 4,500
Selling, general
and
administrative 1,653 1,737 5,855 6,387
Research and
development 1,190 1,075 4,366 4,285
Acquired
in-process
research and
development 40 - 200 150
Total operating
cost and
expenses 4,438 4,287 16,254 15,322
Operating
earnings 2,358 2,113 9,384 7,537
Interest
expense, net 290 199 965 686
Net foreign
exchange loss
(gain) (10) 2 303 193
Other expense
(income), net 80 (12) 232 13
Earnings before
income tax
expense 1,998 1,924 7,884 6,645
Income tax
expense 607 407 1,931 1,501
Net earnings $ 1,391 $ 1,517 $ 5,953 $ 5,144
Diluted earnings
per share $ 0.85 $ 0.92 $ 3.63 $ 3.13
Adjusted diluted
earnings per
share[a] $ 1.20 $ 1.13 $ 4.82 $ 4.29
Weighted-average
diluted shares
outstanding 1,623 1,640 1,631 1,637
Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for
[a] further details.
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended December 31, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
4Q16
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 1,998 $ 1,391 $ 0.85
Adjusted for
specified items:
Intangible asset
amortization 210 170 0.10
Milestones and
other R&D expenses 10 10 0.01
Acquired IPR&D 40 40 0.02
Acquisition
related costs 63 42 0.02
Change in fair
value of contingent
consideration 85 85 0.05
Revaluation
due to Section 987
tax law change - 187 0.12
Other 55 39 0.03
As adjusted (non-GAAP) $ 2,461 $ 1,964 $ 1.20
Milestones and other R&D expenses are associated with milestone payments for
previously announced collaborations. Acquired IPR&D primarily reflects an R&D
collaboration. 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 a debt extinguishment charge as a result of
the redemption of the company's 1.75% senior notes, 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:
4Q16
Other
Cost of Interest expense
Net products Acquired expense, (income),
revenues sold SG&A R&D IPR&D net net
As reported (GAAP) $ 6,796 $ 1,555 $ 1,653 $ 1,190 $ 40 $ 290 $ 80
Adjusted for
specified items:
Intangible
asset
amortization - (210) - - - - -
Milestones and
other R&D expenses - - - (10) - - -
Acquired IPR&D - - - - (40) - -
Acquisition
related costs - (53) (5) (5) - - -
Change in fair
value of contingent
consideration - - - - - - (85)
Other (12) (5) (23) - - (39) -
As adjusted
(non-GAAP) $ 6,784 $ 1,287 $ 1,625 $ 1,175 $ - $ 251 $ (5)
3. The adjusted tax rate for the fourth quarter of 2016 was 20.2 percent, as detailed
below:
4Q16
Pre-tax Income
income taxes Tax rate
As reported(GAAP) $ 1,998 $ 607 30.4 %
Specified items 463 (110) (24.0) %
As adjusted (non-GAAP) $ 2,461 $ 497 20.2 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended December 31, 2015
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
4Q15
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 1,924 $ 1,517 $ 0.92
Adjusted for
specified items:
Intangible asset
amortization 140 116 0.07
Pharmacyclics
acquisition
related costs 105 68 0.04
Restructuring 79 58 0.04
Legal reserves 125 101 0.06
Separation costs
and other 3 1 -
As adjusted (non-GAAP) $ 2,376 $ 1,861 $ 1.13
Pharmacyclics acquisition related costs reflect compensation expense, integration and
other costs related to the acquisition of Pharmacyclics. Restructuring is primarily
associated with streamlining our global operations. Separation costs and other is
primarily related to the separation of AbbVie from Abbott and milestone revenue under
a previously announced collaboration.
2. The impact of the specified items by line item was as follows:
4Q15
Cost of
Net products
Revenues sold SG&A R&D
As reported (GAAP) $ 6,400 $ 1,475 $ 1,737 $ 1,075
Adjusted for specified items:
Intangible asset amortization - (140) - -
Pharmacyclics acquisition
related costs - (49) (15) (41)
Restructuring - (24) (39) (16)
Legal reserves - - (125) -
Separation costs and other (40) (16) (27) -
As adjusted (non-GAAP) $ 6,360 $ 1,246 $ 1,531 $ 1,018
3. The adjusted tax rate for the fourth quarter of 2015 was 21.6 percent, as detailed
below:
4Q15
Pre-tax Income
income taxes Tax rate
As reported (GAAP) $ 1,924 $ 407 21.1 %
Specified items 452 108 23.9 %
As adjusted (non-GAAP) $ 2,376 $ 515 21.6 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
12M16
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 7,884 $ 5,953 $ 3.63
Adjusted for specified items:
Intangible asset amortization 764 615 0.38
Milestones and other R&D expenses 80 80 0.05
Acquired IPR&D 200 200 0.12
Acquisition related costs 392 273 0.16
Change in fair value
of contingent consideration 228 228 0.14
Venezuela devaluation loss 298 298 0.18
Revaluation due to Section 987
tax law change - 187 0.12
Other 59 70 0.04
As adjusted (non-GAAP) $ 9,905 $ 7,904 $ 4.82
Milestones and other R&D expenses are associated with milestone payments for
previously announced collaborations. Acquired IPR&D primarily reflects R&D
collaborations as well as upfront payments related to licensing arrangements with
third parties. Acquisition related costs primarily include the amortization of the
acquisition date fair value step-up for inventory related to the acquisition of
Pharmacyclics and compensation expense, financing and other costs associated with the
acquisitions of Stemcentrx and Boehringer Ingelheim. Other includes a debt
extinguishment charge as a result of the redemption of the company's 1.75% senior
notes, 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 previously announced collaborations and prior period royalty
revenue related to a patent lawsuit settlement.
2. The impact of the specified items by line item was as follows:
12M16
Cost of
Net products
revenues sold SG&A R&D
As reported (GAAP) $ 25,638 $ 5,833 $ 5,855 $ 4,366
Adjusted for specified items:
Intangible asset
amortization - (764) - -
Milestones and other R&D
expenses - - - (80)
Acquired IPR&D - - - -
Acquisition related costs - (197) (41) (140)
Change in fair value of
contingent consideration - - - -
Venezuela devaluation loss - - - -
Other (78) (66) (38) 6
As adjusted (non-GAAP) $ 25,560 $ 4,806 $ 5,776 $ 4,152
Table continues...
12M16
Net
Interest foreign Other
Acquired expense, exchange expense,
IPR&D net loss net
As reported (GAAP) $ 200 $ 965 $ 303 $ 232
Adjusted for specified items:
Intangible asset amortization - - - -
Milestones and other R&D
expenses - - - -
Acquired IPR&D (200) - - -
Acquisition related costs - - - (14)
Change in fair value of
contingent consideration - - - (228)
Venezuela devaluation loss - - (298) -
Other - (39) - -
As adjusted (non-GAAP) $ - $ 926 $ 5 $ (10)
3. The adjusted tax rate for the full-year 2016 was 20.2 percent, as detailed below:
12M16
Pre-tax Income
income taxes Tax rate
As reported(GAAP) $ 7,884 $ 1,931 24.5 %
Specified items 2,021 70 3.4 %
As adjusted (non-GAAP) $ 9,905 $ 2,001 20.2 %
AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2015
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
12M15
Earnings Diluted
Pre-tax After-tax EPS
As reported (GAAP) $ 6,645 $ 5,144 $ 3.13
Adjusted for specified items:
Intangible asset amortization 419 328 0.20
Separation costs 270 223 0.13
Pharmacyclics acquisition
related costs 645 410 0.25
Milestones and other R&D
expenses 480 433 0.26
Acquired IPR&D 150 150 0.09
Shire termination 170 170 0.10
Restructuring 113 82 0.06
Legal reserves 165 129 0.08
Other (17) (9) (0.01)
As adjusted (non-GAAP) $ 9,040 $ 7,060 $ 4.29
Separation costs are expenses related to the separation of AbbVie from Abbott.
Pharmacyclics acquisition related costs reflect compensation expense, transaction,
financing, integration and other costs related to the acquisition of Pharmacyclics.
Milestones and other R&D expenses are associated with 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. Restructuring is primarily associated
with streamlining our global operations. Other primarily includes a milestone payment
received under a previously announced collaboration.
2. The impact of the specified items by line item was as follows:
12M15
Cost of
Net products
Revenues sold SG&A R&D
As reported (GAAP) $ 22,859 $ 4,500 $ 6,387 $ 4,285
Adjusted for specified items:
Intangible asset amortization - (419) - -
Separation costs - (5) (265) -
Pharmacyclics acquisition
related costs - (113) (294) (152)
Milestones and other R&D
expenses - - - (480)
Acquired IPR&D - - - -
Shire termination - - - -
Restructuring - (42) (39) (32)
Legal reserves - - (165) -
Other (40) (16) (3) (4)
As adjusted (non-GAAP) $ 22,819 $ 3,905 $ 5,621 $ 3,617
Table continues...
12M15
Net
Interest foreign
Acquired expense, exchange
IPR&D net loss
As reported (GAAP) $ 150 $ 686 $ 193
Adjusted for specified items:
Intangible asset amortization - - -
Separation costs - - -
Pharmacyclics acquisition
related costs - (86) -
Milestones and other R&D
expenses - - -
Acquired IPR&D (150) - -
Shire termination - - (170)
Restructuring - - -
Legal reserves - - -
Other - - -
As adjusted (non-GAAP) $ - $ 600 $ 23
3. The adjusted tax rate for the full-year 2015 was 21.9 percent, as detailed below:
12M15
Pre-tax Income
income taxes Tax rate
As reported (GAAP) $ 6,645 $ 1,501 22.6 %
Specified items 2,395 479 20.0 %
As adjusted (non-GAAP) $ 9,040 $ 1,980 21.9 %
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