AbbVie Reports Third-Quarter 2013 Financial Results

             AbbVie Reports Third-Quarter 2013 Financial Results

  PR Newswire

  NORTH CHICAGO, Illinois, Oct. 25, 2013

NORTH CHICAGO, Illinois, Oct. 25, 2013 /PRNewswire/ --

  *Reports Third-Quarter Adjusted EPS of $0.82, Above Previous Guidance
    Range; GAAP EPS of $0.60
  *Raises 2013 Adjusted EPS Guidance to $3.11-$3.13, GAAP EPS Guidance of
  *Delivers Revenue of $4.658 Billion, an Increase of 3.3 Percent (Up 3.6
    Percent Excluding Foreign Exchange); Revenue Up 10.9 Percent Excluding
    Exchange and TriCor/Trilipix Due to Loss of Exclusivity
  *Revenue Growth Reflects 19.1 Percent Global Sales Growth from HUMIRA and
    Strong Growth from Other Products Including Synthroid, Creon, Zemplar and
  *Strong R&D Investment Supports Pipeline Advancements Including the
    Initiation of a Large Single-Agent Study of ABT-199 in CLL, Start of a
    Second Phase 3 Study of Elagolix in Endometriosis, and Significant
    Progress Toward the Completion of our Comprehensive Global Phase 3 HCV
  *Continues to Enhance Early-Stage Pipeline with Two New Collaborations in
    Inflammatory Diseases and Cystic Fibrosis

AbbVie (NYSE: ABBV) today announced financial results for the third quarter
ended Sept. 30, 2013.

"Our third-quarter performance demonstrates the strength and durability of our
product portfolio and the continued execution of our key strategic priorities
as an independent biopharmaceutical company," said Richard A. Gonzalez,
chairman and chief executive officer, AbbVie. "Our mid- to late-stage
pipeline contains a number of potentially significant opportunities, and we
look forward to a series of milestones across our pipeline in the coming

Third-Quarter Results

  *Worldwide sales were $4.658 billion in the third quarter, up 3.3 percent.
    On an operational basis, sales increased 3.6 percent, excluding a 0.3
    percent unfavorable impact from foreign exchange rate fluctuations. Sales
    increased in the quarter despite the decline in TriCor/Trilipix sales due
    to the loss of exclusivity. Excluding TriCor/Trilipix sales and foreign
    exchange, sales increased 10.9 percent in the quarter. 
  *Sales growth was driven by the continued strength of HUMIRA. Global
    HUMIRA sales increased 19.1 percent on both a reported and operational
    basis. U.S. HUMIRA sales grew 22.3 percent. Total company sales growth
    was also driven by strong growth from other products including Synthroid,
    Creon, Zemplar and Duodopa.
  *Third-quarter adjusted gross margin ratio was 79.7 percent, excluding
    intangible asset amortization and other specified items. Gross margin
    strength in the quarter was driven by operational efficiencies and product
    mix, including strong HUMIRA sales and better-than-expected lipid
    performance despite loss of exclusivity. The gross margin ratio under
    U.S. generally accepted accounting principles (GAAP) was 76.6 percent. 
  *Adjusted selling, general and administrative (SG&A) expense was 26.1
    percent of sales in the third quarter, reflecting continued investment in
    our growth brands. On a GAAP basis, SG&A was 27.1 percent of sales.
  *Adjusted research and development (R&D) was 15.2 percent of sales in the
    quarter, reflecting funding actions in support of our emerging mid- and
    late-stage pipeline assets and the continued pursuit of additional HUMIRA
    indications. On a GAAP basis, R&D was 15.3 percent of sales.
  *Net interest expense was $69 million, and the adjusted tax rate was 22.3
    percent in the quarter. On a GAAP basis, the third-quarter tax rate was
    25.0 percent.
  *Third-quarter diluted earnings per share were $0.60 on a GAAP basis.
    Adjusted diluted earnings per share, excluding intangible asset
    amortization expense and other specified items, were $0.82, above the
    company's previous guidance range. 

Key Events from the Third Quarter

  *In the quarter we made significant progress toward the completion of our
    Phase 3 interferon-free hepatitis C program. AbbVie's Phase 3 program,
    which includes six trials in more than 2,000 patients and trial sites in
    30 countries, represents the largest interferon-free HCV registrational
    program conducted to date. This comprehensive program was designed to
    characterize the performance of AbbVie's 3-DAA regimen across genotype 1
    populations and includes independent studies in difficult to treat
    patients. We expect to begin reporting the initial results from these
    studies in the fourth quarter and into early next year, supporting
    registration submissions in the second quarter of 2014. 
  *New data from AbbVie's Phase 2 hepatitis C clinical development program
    will be presented at the Liver Meeting, the annual meeting of the American
    Association for the Study of Liver Diseases (AASLD) in Washington, D.C.,
    beginning next week. Abstracts presented will include additional analyses
    from the Phase 2b AVIATOR study. The data examine sustained virologic
    response (SVR) concordance, patient adherence to the regimen, patient
    reported outcomes and the impact of ribavirin dose reduction.
  *AbbVie presented Phase 2 data evaluating the efficacy of HUMIRA in
    patients with hidradenitis suppurativa (HS), a chronic inflammatory skin
    disease, at the European Dermatology and Venereology (EADV) meeting in
    Istanbul, Turkey. The post-hoc analysis found that HUMIRA induced a
    significant response rate in adult patients with moderate-to-severe HS at
    week 16 versus placebo. HUMIRA is the first therapy to enter Phase 3
    studies in HS. Two fully-enrolled Phase 3 clinical trials are underway to
    evaluate the safety and efficacy of HUMIRA in approximately 600 adult HS
  *AbbVie recently initiated a large single-agent study of our Bcl-2
    inhibitor, ABT-199, in previously-treated chronic lymphocytic leukemia
    (CLL) patients with the 17p deletion. Data from this study will likely
    read out at the end of 2014. ABT-199 is being developed in collaboration
    with Roche. In addition, we started the second Phase 3 pivotal trial to
    evaluate elagolix for the treatment of endometriosis. The second Phase 3
    trial is similar in design to the initial Phase 3 trial, which is
    scheduled to provide top-line data in the second half of 2014.
  *With partner Biogen Idec, AbbVie presented data from sub-analyses of the
    Phase 2 SELECT and SELECTION studies evaluating daclizumab. Daclizumab
    High-Yield Process (DAC HYP) is being developed as a once-monthly
    subcutaneous injection for patients with relapsing/remitting multiple
    sclerosis (MS). DAC HYP is believed to target the activated immune cells
    that can play a key role in MS without causing general immune cell
    depletion. A second registrational study, the DECIDE trial, is expected
    to complete in mid-2014, supporting a potential regulatory submission by
    year-end 2014.
  *AbbVie and Ablynx announced a global license agreement to develop and
    commercialize ALX-0061 to treat inflammatory diseases including rheumatoid
    arthritis (RA) and systemic lupus erythematosus. ALX-0061 is Ablynx's
    proprietary anti-IL-6R Nanobody that successfully completed a Phase 2a
    study in Feb. 2013 reporting strong efficacy and safety data in patients
    with moderately to severely active RA on a stable background of
    methotrexate. ALX-0061 targets the interleukin 6 pathway via the IL-6
    receptor, which plays a key role in the inflammatory process in RA.
  *AbbVie and Galapagos announced a global alliance to discover, develop and
    commercialize novel potentiator and combination therapies for cystic
    fibrosis (CF) that address the main mutations in CF patients, including
    F508del and G551D, with the aim to initiate Phase 1 studies at the end of
  *On Sept. 19, the board of directors of AbbVie declared a quarterly cash
    dividend of $0.40 per share, payable Nov. 15, 2013 to stockholders of
    record at the close of business on Oct. 15, 2013. AbbVie was named to the
    S&P 500 Dividend Aristocrats Index.

Raising Full-Year 2013 Outlook

AbbVie is raising its diluted earnings-per-share guidance for the full-year
2013 to $3.11 to $3.13 (from $3.07 to $3.13) on an adjusted basis, or $2.54 to
$2.56 on a GAAP basis. The company's 2013 adjusted diluted earnings-per-share
guidance excludes $0.57 per share of intangible asset amortization expense,
acquired in-process research and development, and other specified items
primarily associated with certain separation-related costs and ongoing
restructuring activities.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013
following separation from Abbott. 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. In 2013, AbbVie employs approximately 21,000 people
worldwide and markets medicines in more than 170 countries. For further
information on the company and its people, portfolio and commitments, please
visit . Follow @abbvie on Twitter or view careers on our
Facebook or LinkedIn page.

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time
to discuss our third-quarter performance. Participating on the call will be
Rick Gonzalez, chairman and chief executive officer; Bill Chase, executive
vice president and chief financial officer; Laura Schumacher, executive vice
president of business development, external affairs and general counsel;
Scott Brun, vice president of clinical development; and Larry Peepo, vice
president of investor relations. The call will be webcast through AbbVie's
Investor Relations Web site at . An archived edition
of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results

Financial results for 2013 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 2013
financial guidance is also being provided on both a reported and a non-GAAP

Forward-Looking Statements

Some statements in this news release may be 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," in AbbVie's 2012
Annual Report on Form 10-K/A, 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 Sales Quarter Ended September 30, 2013 (Unaudited)
                                                    % Change vs. 3Q12
                Sales (in millions)            International            Total
                 U.S.  Int'l. Total   U.S.  Operational Reported Operational Reported
TOTAL SALES     $2,616 $2,042 $4,658 (1.8%)       11.6%    10.8%        3.6%     3.3%
Humira           1,389  1,381  2,770   22.3        16.0     16.1        19.1     19.1
AndroGel           248     --    248 (11.1)     n/a       n/a         (11.1)   (11.1)
Kaletra             63    174    237 (11.3)      (11.2)   (11.2)      (11.2)   (11.2)
Niaspan            201     --    201 (13.4)     n/a       n/a         (13.4)   (13.4)
Lupron             141     55    196    6.8       (1.7)    (3.5)         4.2      3.7
Synthroid          161     --    161   22.9     n/a       n/a           22.9     22.9
Sevoflurane         19    119    138  (5.0)         6.1      3.5         4.4      2.2
Creon              101     --    101    9.8     n/a       n/a            9.8      9.8
Zemplar             57     43    100    9.6         7.7     10.3         8.8      9.9
Synagis             --     98     98  n/a          15.6      2.1        15.6      2.1
Duodopa             --     46     46  n/a          18.9     24.3        18.9     24.3
TriCor/Trilipix     39     --     39 (88.3)     n/a       n/a         (88.3)   (88.3)
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.n/a = not applicable

    AbbVie Inc. Key Product Sales Nine Months Ended September 30, 2013 (Unaudited)
                                                     % Change vs. 9M12
                 Sales (in millions)            International            Total
                 U.S.  Int'l.  Total   U.S.  Operational Reported Operational Reported
TOTAL SALES     $7,363 $6,316 $13,679     --       10.4%     8.7%        4.6%     3.8%
Humira           3,569  4,051   7,620   20.4        13.0     11.9        16.3     15.7
AndroGel           746     --     746  (5.2)     n/a       n/a          (5.2)    (5.2)
Kaletra            181    553     734  (7.7)       (1.4)    (2.5)       (3.0)    (3.8)
Niaspan            619     --     619  (2.4)     n/a       n/a          (2.4)    (2.4)
Lupron             410    166     576  (1.0)       (4.0)    (5.1)       (1.9)    (2.2)
Synagis             --    513     513  n/a           9.9      1.4         9.9      1.4
Synthroid          433     --     433   13.1     n/a       n/a           13.1     13.1
Sevoflurane         54    358     412    1.9       (6.4)    (8.4)       (5.4)    (7.2)
Creon              297     --     297   19.8     n/a       n/a           19.8     19.8
Zemplar            161    127     288     --         9.5     10.4         3.9      4.3
TriCor/Trilipix    274     --     274 (69.5)     n/a       n/a         (69.5)   (69.5)
Duodopa             --    129     129  n/a          16.6     19.4        16.6     19.4
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.n/a = not applicable

AbbVie Inc. Consolidated Statements of Earnings Quarter and Nine Months Ended
September 30, 2013 and 2012 (Unaudited) (In millions, except per share data)
                            Third Quarter Ended          Nine Months Ended
                               September 30               September 30
                            2013           2012          2013         2012
Net sales                    $4,658         $4,508       $13,679      $13,174
Cost of products sold         1,092          1,014         3,299        3,243
Selling, general and
administrative                1,261          1,085         3,904        3,578
Research and development        714            813         2,057        2,097
Acquired in-process
research and development        220             --           290          260
Total operating cost and
expenses                      3,287          2,912         9,550        9,178
Operating earnings            1,371          1,596         4,129        3,996
Interest (income)
expense, net                     69            (1)           210          (4)
Net foreign exchange
(gain) loss                      11              6            40           27
Other (income) expense,
net                               5           (13)          (14)         (39)
Earnings before income
tax                           1,286          1,604         3,893        4,012
Income tax expense              322             19           893          277
Net earnings                   $964         $1,585        $3,000       $3,735
Diluted earnings per
share                         $0.60          $1.01         $1.86        $2.37
Average diluted shares
outstanding              1,605          1,577         1,602        1,577
Note: On Jan. 1, 2013, Abbott Laboratories distributed 1,577 million shares
of AbbVie common stock to Abbott's shareholders in connection with the
separation of AbbVie from Abbott. The computation of diluted earnings per
share for the quarter and nine months ended Sept. 30, 2012 was calculated
using the shares distributed on Jan. 1, 2013.

AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
 Quarter Ended September 30, 2013 (Unaudited) (In millions, except per share
1. Specified items impacted results
as follows:
                                              Earnings             Diluted
                                       Pre-tax      After-tax        EPS
As reported (GAAP)                         $1,286           $964        $0.60
Adjusted for specified items:
Intangible asset amortization                 137             98         0.06
Separation costs                               51             33         0.02
Acquired IPR&D                                220            220         0.13
Restructuring/Other                      14             12         0.01
As adjusted (non-GAAP)                     $1,708         $1,327        $0.82
Intangible asset amortization reflects costs recognized as a result of
licensing and acquisition activities. Separation costs are expenses related
to the separation of AbbVie from Abbott. Acquired IPR&D reflects the upfront
payment related to the previously announced collaborations with Ablynx and
Galapagos. Restructuring/Other is primarily associated with previously
announced restructuring activities.

2. The impact of the specified items by line item was as follows:
                              Cost of                 Acquired     (income)
                           products sold  SG&A  R&D     IPR&D      expense
As reported (GAAP)               $1,092 $1,261 $714        $220           $5
Adjusted for specified
Intangible asset
amortization                       (137)     --   --          --           --
Separation costs                    (4)   (46)  (1)          --           --
Acquired IPR&D                       --     --   --       (220)           --
Restructuring/Other                 (7)     --  (4)          --          (3)
As adjusted (non-GAAP)             $944 $1,215 $709          --           $2

3. The adjusted tax rate for the third quarter was 22.3 percent, as detailed
                                    Pre-tax        Income
                                    income          taxes        Tax rate
As reported (GAAP)                  $1,286          $322           25.0%
Specified items                       422            59            14.0%
As adjusted (non-GAAP)              $1,708          $381           22.3%

Contact: Media: Jennifer Smoter, +1-847-935-8865, or Greg Miley,
+1-847-938-4898, or Adelle Infante, +1-847-938-8745, or Investors: Larry
Peepo, +1-847-935-6722, or Liz Shea, +1-847-935-2211