AbbVie Reports Full-Year and Fourth-Quarter 2017 Financial Results

 

- Reports Full-Year Diluted EPS of $3.30 on a GAAP Basis; Adjusted Diluted EPS of $5.60 Reflects Growth of 16.2 Percent
- Delivers Full-Year Net Revenues of $28.216 Billion; Adjusted Net Revenues Increased 10.1 Percent on an Operational Basis
- Full-Year Global HUMIRA Sales of $18.427 Billion Increased 14.6 Percent on a Reported Basis, or 14.4 Percent on an Operational Basis
- Full-Year Global IMBRUVICA Net Revenues Were $2.573 Billion, an Increase of 40.5 Percent
- Reports Fourth-Quarter Diluted EPS of $0.03 on a GAAP Basis; Adjusted Diluted EPS of $1.48 Reflects Growth of 23.3 Percent Over Fourth-Quarter 2016
- Delivers Fourth-Quarter Net Revenues of $7.739 Billion; Adjusted Net Revenues Grew 12.6 Percent on an Operational Basis
- Provides 2018 Guidance for Revenue of Approaching $32 Billion, Reflecting Industry-Leading Top-Line Growth of Approximately 13 Percent
- Announces 2018 GAAP Diluted EPS Guidance Range of $6.45 to $6.55; Raises 2018 Adjusted Diluted EPS Guidance Range to $7.33 to $7.43, Representing Growth of 32 Percent at the Midpoint and Reflecting Both Stronger Operating Performance and the Impact of U.S. Tax Reform
- AbbVie Plans to Make Investments of Approximately $2.5 Billion Over the Next Five Years in Capital Projects in the U.S., a One-Time Contribution of Approximately $350 Million to Select Charitable Organizations in 2018, and Enhancements to Non-Executive Employee Compensation and Other Benefits

 
[26-January-2018]
 
 

NORTH CHICAGO, Ill., Jan. 26, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the fourth quarter ended December 31, 2017.

"2017 reflects another year of top-tier performance, demonstrating the strong momentum in our business," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our guidance for 2018 underscores our confidence in our ability to continue to deliver industry-leading performance. This is an exciting time for AbbVie -- we are poised to launch a number of differentiated products over the next 12 to 18 months that will fuel significant growth in the coming years. We remain committed to delivering on our long-term strategic vision for AbbVie."

Fourth-Quarter Results

  • Worldwide net revenues were $7.739 billion in the fourth quarter, up 13.9 percent year-over-year on a GAAP basis. On an operational basis, adjusted net revenues increased 12.6 percent, excluding a 1.5 percent favorable impact from foreign exchange.
  • Global HUMIRA sales increased 14.0 percent on a reported basis, or 12.3 percent operationally, excluding a 1.7 percent favorable impact from foreign exchange. In the U.S., HUMIRA sales grew 15.1 percent in the quarter. Internationally, HUMIRA sales grew 6.5 percent, excluding a 5.2 percent favorable impact from foreign exchange.
  • Fourth-quarter global IMBRUVICA net revenues were $708 million, with U.S. sales of $585 million and international profit sharing of $123 million for the quarter, reflecting growth of 38.7 percent.
  • On a GAAP basis, the gross margin ratio in the fourth quarter was 70.5 percent. The adjusted gross margin ratio was 79.0 percent.
  • On a GAAP basis, selling, general and administrative expense was 25.2 percent of net revenues. The adjusted SG&A expense was 21.2 percent of net revenues.
  • On a GAAP basis, research and development expense was 18.1 percent of net revenues. The adjusted R&D expense was 17.1 percent, reflecting funding actions supporting all stages of our pipeline.
  • On a GAAP basis, the operating margin in the fourth quarter was 23.2 percent. The adjusted operating margin was 40.7 percent.
  • On a GAAP basis, net interest expense was $252 million.
  • Financial results for 2017 reflected a net charge of $0.77 per diluted share related to the December 2017 enactment of the Tax Cuts and Jobs Act. The net charge included the one-time impact of approximately $4.5 billion for mandatory taxation on previously unrepatriated earnings, partially offset by the revaluation of tax-related balance sheet items. These amounts have been treated as specified and excluded from adjusted diluted EPS. On a GAAP basis, the tax rate in the quarter was 95.6 percent. The adjusted tax rate was 18.9 percent.
  • Diluted EPS in the fourth quarter was $0.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.48, up 23.3 percent.

Key Events from the Fourth Quarter

  • AbbVie announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial evaluating upadacitinib (ABT-494) as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity versus continuing prior stable methotrexate therapy. Both doses also achieved all ranked and all key secondary endpoints. The safety profile of upadacitinib was consistent with previously reported Phase 3 SELECT clinical trials and Phase 2 studies, and no new safety signals were detected. AbbVie expects data from two additional registrational studies in the first half of 2018, supporting regulatory submissions in the second half of 2018.
  • AbbVie announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for upadacitinib in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy, supported by positive Phase 2b results. The Phase 3 clinical program for upadacitinib in atopic dermatitis is expected to begin in the first half of 2018.
  • AbbVie announced top-line results from the IMMhance study, the fourth pivotal clinical trial evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. Results showed that risankizumab met all co-primary and ranked secondary endpoints in the study. At week 16, nearly half (47 percent) of patients receiving risankizumab achieved complete skin clearance (PASI 100) versus placebo (1 percent), and static Physician Global Assessment (sPGA) score of clear or almost clear skin was achieved by 84 percent of risankizumab patients compared to 7 percent of placebo patients. Among patients who achieved clear or almost clear skin at week 28, 87 percent of patients maintained this response at one year, compared to 61 percent who were switched to placebo at week 28. Risankizumab's safety profile in IMMhance was consistent with previously reported Phase 3 clinical trials, with no new safety signals detected across the Phase 3 program. The company plans to submit its applications for regulatory approval in the first half of 2018. Risankizumab is being developed in collaboration with Boehringer Ingelheim.
  • AbbVie presented results from the Phase 3 MURANO study of VENCLEXTA/VENCLYXTO (venetoclax) in combination with Rituxan at the American Society of Hematology (ASH) Annual Meeting. Results show that patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) achieved significantly prolonged median progression-free survival (PFS) with VENCLEXTA in combination with Rituxan compared with bendamustine in combination with Rituxan. Investigator-assessed twenty-four month PFS estimates were 84.9 percent and 36.3 percent, respectively, with independent review committee (IRC)-assessed PFS showing similar results. Also in the trial, 83.5 percent of patients achieved peripheral blood minimal residual disease (MRD)-negativity with VENCLEXTA in combination with Rituxan, compared to 23.1 percent with bendamustine in combination with Rituxan. At the time of the analysis, safety data were consistent with the known safety profiles of the medicines. Regulatory applications were recently submitted for VENCLEXTA in combination with Rituxan for treatment of patients with R/R CLL. VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group.
  • AbbVie presented new and updated IMBRUVICA (ibrutinib) data at the ASH meeting, including pooled analysis results of the longest follow-up data to-date in Bruton's tyrosine kinase (BTK) inhibition for R/R mantle cell lymphoma (MCL) patients treated with IMBRUVICA, demonstrating that, at three years, 45 percent of patients were able to achieve overall survival (OS) and 26 percent had PFS. AbbVie also presented new three-year follow-up data from the RESONATE-2 study (PCYC-1115/1116), which found that previously-untreated CLL/SLL patients reported sustained improvements in measures of well-being with IMBRUVICA versus chemotherapy with chlorambucil. At 30 months, IMBRUVICA was also associated with a greater PFS rate of 85 percent versus chlorambucil, which had a PFS rate of 28 percent. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.
  • AbbVie announced the Phase 3 iNNOVATE trial evaluating IMBRUVICA in combination with Rituxan in patients with treatment-naïve and previously-treated Waldenström's macroglobulinemia successfully met its primary endpoint and demonstrated improvement of PFS compared to Rituxan alone. The Independent Data Monitoring Committee recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. The company expects to submit these data for label augmentation in 2018.
  • At the American Society for Reproductive Medicine Scientific Congress & Expo (ASRM), AbbVie, in cooperation with Neurocrine Biosciences, presented detailed results from two replicate Phase 3 extension studies evaluating the long-term efficacy and safety of elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluated for the management of endometriosis with associated pain. In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. The safety and tolerability of elagolix was consistent with the anticipated effects of reduced estradiol levels and no new safety concerns were identified with elagolix use for the 12-month treatment period. Elagolix is currently under priority regulatory review for the management of endometriosis with associated pain.

Full-Year 2018 Outlook, Including Impact of U.S. Tax Reform

GAAP diluted EPS for the full-year 2018 is expected to be between $6.45 and $6.55.

AbbVie is raising its previously announced adjusted EPS guidance range for the full-year 2018 from $6.37 to $6.57 to $7.33 to $7.43 to reflect the impact of U.S. tax reform and stronger operating performance. The midpoint of this guidance reflects year-over-year growth of 32 percent, more than half of which is driven by growth in the underlying business. Relative to the previously issued 2018 guidance provided in October 2017, this guidance includes an increase of $0.08 as a result of stronger operating dynamics.

AbbVie's adjusted EPS guidance range reflects an effective tax rate of approximately 9 percent in 2018. In 2018, AbbVie will experience a one-time net tax benefit related to the timing of the phase in of provisions of the new legislation on certain subsidiaries. This benefit has been excluded from the adjusted EPS guidance, and included in the GAAP guidance range.

AbbVie anticipates the company's adjusted effective tax rate to increase to 13 percent over the next five years as a result of increased domestic income and investment.

Increased U.S. Investments

Over the next five years, AbbVie plans to invest approximately $2.5 billion in capital projects in the U.S. and the company is currently evaluating additional expansion of its U.S. facilities. Also, in 2018, the company plans to make a one-time charitable contribution of approximately $350 million to select not-for-profit organizations based in the United States. The company also plans to accelerate pension funding by $750 million, as well as enhance non-executive employee compensation.

Provisional Estimates of the Impact of U.S. Tax Reform

Financial results for 2017 reflect provisional amounts related to the December 2017 enactment of the Tax Cuts and Jobs Act. These provisional estimates are based on AbbVie's initial analysis and current interpretation of the legislation. Given the complexity of the legislation, anticipated guidance from the U.S. Treasury, and the potential for additional guidance from the Securities and Exchange Commission (SEC) or the Financial Accounting Standards Board, these estimates may be adjusted during 2018.

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 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 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 2018 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 SEC. 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, 2017

                                                                                       (Unaudited)


                                                                                                               % Change vs. 4Q16

                 Net Revenues (in millions)                          International           Total

                       U.S.                 Int'l.        Total                                U.S.                              Operational         Reported          Operational            Reported
                       ----                 ------        -----                                ----                              -----------         --------          -----------            --------

    ADJUSTED NET
     REVENUESa                $4,967               $2,772       $7,739                                   15.9%                                 7.0%            11.0%                 12.6%               14.1%

    Humira                     3,313                1,579        4,892                                    15.1                                   6.5              11.7                   12.3                 14.0

    Imbruvicab                   585                  123          708                                    35.3                                  57.8              57.8                   38.7                 38.7

    HCV                          214                  296          510                           >100.0                                        14.5              15.4                   62.7                 63.4

    Lupron                       181                   43          224                                     1.5                                   3.3               5.6                    1.8                  2.2

    Creon                        235                    -         235                                    10.6                           n/a                n/a                        10.6                 10.6

    Synagis                        -                 282          282                             n/a                                          4.3               4.4                    4.3                  4.4

    Synthroid                    205                    -         205                                       -                          n/a                n/a                           -                   -

    AndroGel                     140                    -         140                                  (19.6)                          n/a                n/a                      (19.6)              (19.6)

    Kaletra                       17                   96          113                                  (33.7)                               (11.3)            (9.7)                (15.6)              (14.3)

    Sevoflurane                   22                   77           99                                   (1.3)                                (3.4)            (1.6)                 (2.9)               (1.5)

    Duodopa                       17                   83          100                                    55.2                                  15.7              23.0                   21.3                 27.6

    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, 2017

                                                                                      (Unaudited)


                                                                                                                % Change vs. 12M16

                 Net Revenues (in millions)                           International           Total

                       U.S.                 Int'l.        Total                                 U.S.                               Operational         Reported           Operational            Reported
                       ----                 ------        -----                                 ----                               -----------         --------           -----------            --------

    ADJUSTED NET
     REVENUESa                 $18,251             $9,965       $28,216                                   14.6%                                  2.7%              3.4%                 10.1%               10.4%

    Humira                      12,361              6,066        18,427                                    18.5                                    6.7                7.4                   14.4                 14.6

    Imbruvicab                   2,144                429         2,573                                    35.8                                   70.0               70.0                   40.5                 40.5

    HCV                            338                936         1,274                                   (1.4)                                (20.5)            (20.6)                (16.2)              (16.3)

    Lupron                         669                160           829                                     0.8                                    0.5                1.4                    0.7                  0.9

    Creon                          831                  -          831                                    13.9                            n/a                n/a                         13.9                 13.9

    Synagis                          -               738           738                             n/a                                           0.6                1.2                    0.6                  1.2

    Synthroid                      781                  -          781                                     2.3                            n/a                n/a                          2.3                  2.3

    AndroGel                       577                  -          577                                  (14.5)                           n/a                n/a                       (14.5)              (14.5)

    Kaletra                         71                352           423                                  (38.6)                                (21.1)            (18.8)                (24.7)              (22.9)

    Sevoflurane                     78                332           410                                   (2.1)                                 (3.7)             (4.6)                 (3.4)               (4.1)

    Duodopa                         61                294           355                                    66.1                                   13.1               14.6                   19.8                 21.1

    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, 2017 and 2016

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


                            Fourth Quarter                               Twelve Months
                         Ended December 31                       Ended December 31

                          2017                 2016                    2017                   2016
                          ----                 ----                    ----                   ----

    Net revenues                  $7,739                                      $6,796                  $28,216  $25,638

    Cost of products
     sold                2,280                          1,555                               7,040        5,833

    Selling, general and
     administrative      1,951                          1,653                               6,275        5,855

    Research and
     development         1,402                          1,190                               4,982        4,366

    Acquired in-process
     research and
     development           312                             40                                 327          200
                           ---

    Total operating cost
     and expenses        5,945                          4,438                              18,624       16,254
                         -----                          -----                              ------       ------


    Operating earnings   1,794                          2,358                               9,592        9,384


    Interest expense,
     net                   252                            290                               1,004          965

    Net foreign exchange
     loss (gain)           320                           (10)                                348          303

    Other expense, net      29                             80                                 513          232
                           ---                            ---                                 ---          ---

    Earnings before
     income tax expense  1,193                          1,998                               7,727        7,884

    Income tax expense   1,141                            607                               2,418        1,931
                         -----                            ---                               -----        -----

    Net earnings                     $52                                      $1,391                   $5,309   $5,953
                                     ===                                      ======                   ======   ======


    Diluted earnings per
     share                         $0.03                                       $0.85                    $3.30    $3.63
                                   =====                                       =====                    =====    =====


    Adjusted diluted
     earnings per sharea           $1.48                                       $1.20                    $5.60    $4.82
                                   =====                                       =====                    =====    =====


    Weighted-average
     diluted shares
     outstanding         1,602                          1,623                               1,603        1,631

    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, 2017

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


    1.     Specified items impacted results as follows:


                                                                                              4Q17

                                                                                  Earnings                         Diluted

                                                                          Pre-tax              After-tax                 EPS
                                                                          -------              ---------                 ---

    As reported (GAAP)                                                                $1,193                                    $52          $0.03

    Adjusted for specified items:

    Intangible asset amortization                                              268                              203                     0.13

    Milestones and other R&D expenses                                           75                               75                     0.05

    Acquired IPR&D                                                             312                              312                     0.19

    Change in fair value of contingent consideration                            79                               79                     0.05

    Litigation reserves                                                        273                              221                     0.14

    Intangible asset impairment                                                354                              244                     0.15

    U.S. tax reform repatriation tax                                             -                           4,509                     2.81

    Other impacts related to tax law change                                    316                          (3,267)                   (2.04)

    Tax audit settlement                                                         -                            (91)                  (0.06)

    Other                                                                       75                               52                     0.03
                                                                               ---                              ---                     ----

    As adjusted (non-GAAP)                                                            $2,945                                 $2,389          $1.48
                                                                                      ======                                 ======          =====

    Milestones and other R&D expenses
     are associated with milestone
     payments for previously announced
     collaborations. Acquired IPR&D
     primarily reflects upfront payments
     related to R&D collaborations and
     licensing arrangements with third
     parties. Other primarily includes
     restructuring charges associated
     with streamlining global
     operations.


    2.     The impact of the specified
     items by line item was as follows:

                                                                                      4Q17

                                                      Cost of         SG&A        R&D             Acquired       Net             Other
                                                     products                                       IPR&D      foreign         expense,
                                                       sold                                                   exchange            net
                                                                                                                loss
                                                                                                                ----

    As reported (GAAP)                                         $2,280                      $1,951                       $1,402                   $312         $320    $29

    Adjusted for specified items:

    Intangible asset amortization                        (268)                 -                          -                -                -            -

    Milestones and other R&D expenses                        -                 -                       (75)                -                -            -

    Acquired IPR&D                                           -                 -                          -            (312)                -            -

    Change in fair value of contingent consideration         -                 -                          -                -                -         (79)

    Litigation reserves                                      -             (273)                          -                -                -            -

    Intangible asset impairment                          (354)                 -                          -                -                -            -

    Other impacts related to tax law change                  -                 -                          -                -            (316)            -

    Other                                                 (33)              (37)                        (5)                -                -            -
                                                           ---                ---                         ---               ---              ---          ---

    As adjusted (non-GAAP)                                     $1,625                      $1,641                       $1,322                 $    -          $4  $(50)
                                                               ======                      ======                       ======               ===  ===         ===   ====

    3.     The adjusted tax
     rate for the fourth
     quarter of 2017 was
     18.9 percent, as
     detailed below:

                                            4Q17

                           Pre-tax         Income       Tax rate
                           income           taxes
                           ------           -----

    As reported (GAAP)              $1,193                       $1,141          95.6%

    Specified items           1,752               (585)                 (33.4)%
                              -----                ----                   ------

    As adjusted (non-GAAP)          $2,945                         $556          18.9%
                                    ======                         ====           ====

 

                                                                             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            Cost of        SG&A            R&D      Acquired        Interest   Other
                                                     revenues         products                                   IPR&D         expense, expense,
                                                                         sold                                                     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       Tax rate
                income           taxes
                ------           -----

    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

                                                                      Twelve Months Ended December 31, 2017

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


    1.     Specified items impacted results as follows:


                                                                                                                   12M17

                                                                                                        Earnings                      Diluted

                                                                                               Pre-tax               After-tax              EPS
                                                                                               -------               ---------              ---

    As reported (GAAP)                                                                                      $7,727                              $5,309          $3.30

    Adjusted for specified items:

    Intangible asset amortization                                                                 1,076                            809                     0.51

    Milestones and other R&D expenses                                                               143                            143                     0.09

    Acquired IPR&D                                                                                  327                            327                     0.20

    Acquisition related costs                                                                        73                             49                     0.03

    Change in fair value of contingent consideration                                                626                            625                     0.39

    Litigation reserves                                                                             370                            286                     0.18

    Intangible asset impairment                                                                     354                            244                     0.15

    U.S. tax reform repatriation tax                                                                  -                         4,509                     2.81

    Other impacts related to tax law change                                                         316                        (3,267)                   (2.04)

    Tax audit settlement                                                                              -                          (91)                  (0.06)

    Other                                                                                            94                             68                     0.04

    As adjusted (non-GAAP)                                                                                 $11,106                              $9,011          $5.60
                                                                                                           =======                              ======          =====

    Milestones and other R&D expenses are
     associated with milestone payments
     for previously announced
     collaborations. Acquired IPR&D
     primarily reflects upfront payments
     related to R&D collaborations and
     licensing arrangements with third
     parties. Acquisition related costs
     primarily includes 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:

                                                                                     12M17

                                                      Cost of         SG&A       R&D             Acquired      Net             Other
                                                     products                                      IPR&D     foreign         expense,
                                                       sold                                                 exchange            net
                                                                                                              loss
                                                                                                              ----

    As reported (GAAP)                                         $7,040                     $6,275                      $4,982                   $327       $348    $513

    Adjusted for specified items:

    Intangible asset amortization                      (1,076)                 -                         -               -                -             -

    Milestones and other R&D expenses                        -                 -                     (143)               -                -             -

    Acquired IPR&D                                           -                 -                         -           (327)                -             -

    Acquisition related costs                             (52)              (14)                       (5)               -                -           (2)

    Change in fair value of contingent consideration         -                 -                         -               -                -         (626)

    Litigation reserves                                      -             (370)                         -               -                -             -

    Intangible asset impairment                          (354)                 -                         -               -                -             -

    Other impacts related to tax law change                  -                 -                         -               -            (316)             -

    Other                                                 (47)              (42)                       (5)               -                -             -
                                                                             ---                        ---

    As adjusted (non-GAAP)                                     $5,511                     $5,849                      $4,829                 $    -       $32  $(115)
                                                               ======                     ======                      ======               ===  ===       ===   =====

    3.     The adjusted tax
     rate for the full-year
     2017 was 18.9 percent,
     as detailed below:

                                            12M17

                           Pre-tax          Income       Tax rate
                           income            taxes
                           ------            -----

    As reported (GAAP)               $7,727                       $2,418        31.3%

    Specified items           3,379                (323)                 (9.6)%
                                                                         -----

    As adjusted (non-GAAP)          $11,106                       $2,095        18.9%
                                    =======                       ======         ====

 

                                                                                   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
     includes compensation expense,
     financing and other costs associated
     with the acquisitions of Stemcentrx
     and Boehringer Ingelheim compounds,
     as well as the amortization of the
     acquisition date fair value step-up
     for inventory related to the
     acquisition of Pharmacyclics. 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             Cost of       SG&A            R&D    Acquired         Interest    Net             Other
                                                     revenues          products                                IPR&D          expense,  foreign         expense,
                                                                          sold                                                   net   exchange            net
                                                                                                                                         loss
                                                                                                                                         ----

    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     Tax rate
                            income                taxes
                            ------                -----

    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%
                                    ======                    ======       ====

 

 

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SOURCE AbbVie

 
 
Company Codes: NYSE:ABBV
 

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