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     1030  0 Kommentare AbbVie Reports Full-Year and Fourth-Quarter 2016 Financial Results

    - 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

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    - 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

    NORTH CHICAGO, Ill., Jan. 27, 2017 /PRNewswire/ -- 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

    • Worldwide GAAP net revenues were $6.796 billion in the fourth quarter, up 6.2 percent. Worldwide adjusted net revenues of $6.784 billion increased 6.9 percent, excluding a 0.2 percent unfavorable impact from foreign exchange rate fluctuations.
    • Global HUMIRA sales increased 15.5 percent on a reported basis, or 16.2 percent operationally, excluding a 0.7 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 23.5 percent in the quarter. Internationally, HUMIRA sales grew 4.1 percent, excluding a 2.0 percent unfavorable impact from foreign exchange. Strong sales growth was driven by continued momentum across all three major market categories – rheumatology, dermatology and gastroenterology.
    • Fourth-quarter global IMBRUVICA net revenue was $511 million, with U.S. sales of $434 million and international profit sharing of $77 million for the quarter.
    • On a GAAP basis, the gross margin ratio in the fourth quarter was 77.1 percent. The adjusted gross margin ratio was 81.0 percent.
    • On a GAAP basis, selling, general and administrative expense was 24.3 percent of net revenues. The adjusted SG&A expense was 23.9 percent of net revenues.
    • On a GAAP basis, research and development expense was 17.5 percent of net revenues. The adjusted R&D expense was 17.3 percent, reflecting funding actions supporting all stages of our pipeline.
    • On a GAAP basis, the operating margin in the fourth quarter was 34.7 percent. The adjusted operating margin was 39.8 percent.
    • On a GAAP basis, net interest expense was $290 million. Adjusted net interest expense was $251 million. On a GAAP basis, the tax rate in the quarter was 30.4 percent. The adjusted tax rate was 20.2 percent.
    • Diluted EPS in the fourth quarter was $0.85 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.20, up 6.2 percent.

    Key Events from the Fourth Quarter

    • AbbVie announced that the U.S. Food and Drug Administration (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 presented long-term follow-up data evaluating up to five years of IMBRUVICA use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) at the American Society of Hematology Annual Meeting and Exposition. In this analysis, 89 percent of treatment-naïve and relapsed/refractory patients with CLL/SLL, including those with high-risk disease, show a complete or partial response. Additionally, at the meeting, AbbVie presented encouraging efficacy and safety findings from a number of ongoing trials in NHL.
    • AbbVie announced positive results from a registration-enabling Phase 2 study evaluating IMBRUVICA in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating complication of stem cell or bone marrow transplant, who failed prior systemic therapy. The study found IMBRUVICA demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate of 67 percent. In 2016, the U.S. FDA granted Breakthrough Therapy Designation and Orphan Drug Designation for IMBRUVICA as a potential treatment for cGVHD after failure of one or more lines of systemic therapy, and the company expects to submit its regulatory application in the first quarter of 2017.
    • AbbVie announced the European Commission has granted conditional marketing authorization for VENCLYXTO™ (venetoclax) monotherapy for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. In 2016, the U.S. FDA granted accelerated approval of Venclexta for the treatment of patients with CLL with 17p deletion who have received at least one prior therapy. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group.
    • AbbVie submitted a New Drug Application to the U.S. FDA 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). In Phase 3 clinical studies, eight weeks of therapy with G/P achieved high sustained virologic response (SVR) rates across all major genotypes (GT 1-6) in patients without cirrhosis, which represents the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease. In historically difficult to treat populations, including those not cured by prior direct-acting antiviral (DAA) treatment regimens, high SVR rates were achieved with durations as short as 12 weeks. AbbVie received U.S. FDA Breakthrough Therapy Designation for its investigational regimen for the treatment of patients who failed previous therapy with DAAs in genotype 1. AbbVie also submitted its regulatory application in the EU and remains on track for submission in Japan in the first quarter of 2017. The company anticipates commercialization of the next-generation combination in 2017.
    • AbbVie announced several new global research collaborations with leading healthcare innovators to advance early-stage research in key therapeutic areas such as oncology and immunology. These included a research and license agreement with Pure MHC, a privately-held target discovery company, to discover and validate peptide targets for use with T-cell receptor therapeutics in several types of cancers; an exclusive license with Dong-A-ST, a leading specialty healthcare company in South Korea, for MerTK inhibitors in pre-clinical development for use in conjunction with immuno-oncology therapies; and a partnership with Zebra Biologics, Inc., a discovery stage biotechnology company, to discover agonist antibody therapeutics for inflammatory diseases.

    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 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 REVENUESa

    $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

    Imbruvicab

    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


    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

    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 REVENUESa

    $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

    Imbruvicab

    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



    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 Twelve Months Ended December 31, 2016 and 2015

    (Unaudited) (In millions, except per share data)



    Fourth Quarter
    Ended December 31


    Twelve Months
    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 sharea

    $

    1.20



    $

    1.13



    $

    4.82



    $

    4.29










    Weighted-average diluted shares outstanding

    1,623



    1,640



    1,631



    1,637


     

    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 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


    Net

    revenues


    Cost of

    products
    sold


    SG&A


    R&D


    Acquired
     IPR&D


    Interest
    expense,
    net


    Other
    expense
    (income),
    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


    Net
    Revenues


    Cost of

    products
    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


    Net
    revenues


    Cost of
    products 
    sold


    SG&A


    R&D


    Acquired
    IPR&D


    Interest
    expense,
    net


    Net
    foreign
    exchange
    loss


    Other
    expense, 
    net

    As reported (GAAP)

    $

    25,638



    $

    5,833



    $

    5,855



    $

    4,366



    $

    200



    $

    965



    $

    303



    $

    232


    Adjusted for specified items:
















    Intangible asset amortization



    (764)














    Milestones and other R&D expenses







    (80)










    Acquired IPR&D









    (200)








    Acquisition related costs



    (197)



    (41)



    (140)









    (14)


    Change in fair value of contingent consideration















    (228)


    Venezuela devaluation loss













    (298)




    Other

    (78)



    (66)



    (38)



    6





    (39)






    As adjusted (non-GAAP)

    $

    25,560



    $

    4,806



    $

    5,776



    $

    4,152



    $



    $

    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


    Net
    Revenues


    Cost of
    products
    sold


    SG&A


    R&D


    Acquired
    IPR&D


    Interest
    expense,
    net


    Net
    foreign
    exchange 
    loss

    As reported (GAAP)

    $

    22,859



    $

    4,500



    $

    6,387



    $

    4,285



    $

    150



    $

    686



    $

    193


    Adjusted for specified items:














    Intangible asset amortization



    (419)












    Separation costs



    (5)



    (265)










    Pharmacyclics acquisition related costs



    (113)



    (294)



    (152)





    (86)




    Milestones and other R&D expenses







    (480)








    Acquired IPR&D









    (150)






    Shire termination













    (170)


    Restructuring



    (42)



    (39)



    (32)








    Legal reserves





    (165)










    Other

    (40)



    (16)



    (3)



    (4)








    As adjusted (non-GAAP)

    $

    22,819



    $

    3,905



    $

    5,621



    $

    3,617



    $



    $

    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

    %

     

    AbbVie

    Logo - http://mma.prnewswire.com/media/386913/abbvielogo_preferred_coatedcmyk_copy_Logo.jpg

     



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    AbbVie Reports Full-Year and Fourth-Quarter 2016 Financial Results - 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 …

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