AbbVie Reports First-Quarter 2017 Financial Results

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

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#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

Key Events from the First Quarter

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 %

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CONTACT: Media: Adelle Infante, (847) 938-8745, Investors: Liz Shea, (847) 935-2211, Sharon Greenlees, (847) 935-0900, Todd Bosse, (847) 936-1182

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