AbbVie Reports Fourth-Quarter and Full-Year 2013 Financial Results

      AbbVie Reports Fourth-Quarter and Full-Year 2013 Financial Results

  PR Newswire

  NORTH CHICAGO, Illinois, Jan. 31, 2014

- Reports Fourth-Quarter Adjusted EPS of $0.82 (GAAP EPS of $0.70); Reports
Full-Year Adjusted EPS of $3.14 (GAAP EPS of $2.56)

- Delivers Fourth-Quarter Revenue of $5.1 Billion; Global HUMIRA Sales Growth
of 13.4 Percent

- Completes Successful First Year as an Independent Company, with Strong
Execution Across Commercial, Regulatory, Clinical, Operational and Financial
Objectives

- Announces Completion of Phase 3 HCV Program, Including Compelling Results
From Remaining Four Phase 3 Studies (See Separate News Release Issued Today)

- Now Expects U.S. HCV Therapy Approval in 2014

-With Record Number of Programs Currently in Late-Stage Development, Pipeline
Continues to Advance in 2014 With Numerous Data Milestones, Phase Transitions,
and Regulatory Submissions for Two Major Pipeline Assets in HCV and
Neuroscience

-Issues 2014 Adjusted EPS Guidance of $3.00 to $3.10, or $2.63 to $2.73 on a
GAAP Basis

NORTH CHICAGO, Illinois, Jan. 31, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV)
today announced financial results for the fourth quarter and full year ended
Dec. 31, 2013.

"We are pleased with AbbVie's performance in our first full year as an
independent biopharmaceutical company," said Richard A. Gonzalez, chairman and
chief executive officer, AbbVie. "We achieved all of the objectives we set
forth for 2013, exceeded our original earnings guidance, and established a
solid foundation for the future. We intend to build on this momentum in 2014
as we invest in our key products, advance our pipeline, and prepare for
significant product launches that will drive growth in 2015 and beyond."

Fourth-Quarter Results

  *Worldwide sales were $5.111 billion in the fourth quarter, down 1.8
    percent. On an operational basis, sales decreased 1.1 percent, excluding a
    0.7 percent unfavorable impact from foreign exchange rate fluctuations.
    Excluding sales from our lipid franchise due to the loss of exclusivity,
    sales increased 7.9 percent on an operational basis in the quarter.
  *Fourth-quarter sales were led by the continued strength of HUMIRA. Global
    HUMIRA sales increased 13.4 percent. U.S. HUMIRA sales grew 18.1 percent.
  *Fourth-quarter adjusted gross margin ratio was 77.1 percent, excluding
    intangible asset amortization and other specified items. The gross margin
    ratio under U.S. generally accepted accounting principles (GAAP) was 74.9
    percent.
  *Adjusted selling, general and administrative (SG&A) expense was 26.5
    percent of sales in the fourth quarter, reflecting continued investment in
    our growth brands. On a GAAP basis, SG&A was 28.3 percent of sales.
  *Research and development (R&D) was 15.6 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.
  *Net interest expense was $68 million, and the adjusted tax rate was 22.2
    percent in the quarter. On a GAAP basis, the fourth-quarter tax rate was
    21.6 percent.
  *Fourth-quarter diluted earnings per share were $0.70 on a GAAP basis.
    Adjusted diluted earnings per share, excluding intangible asset
    amortization expense and other specified items, were $0.82.

Key Events from the Fourth Quarter

  *This morning, AbbVie announced completion of its Phase 3 hepatitis C virus
    (HCV) studies; including top-line results from four remaining
    registrational HCV trials: TURQUOISE-II, PEARL-II, PEARL-III, and PEARL-IV
    trials.

Results from the TURQUOISE-II study, which examined treatment of HCV in 380
patients with cirrhosis, a difficult-to-treat population, showed that patients
treated for 12 weeks with the AbbVie combination achieved 92 percent sustained
virologic response at 12 weeks post treatment (SVR [12] ). 96 percent of
patients treated with the AbbVie regimen for 24 weeks achieved SVR [12] .

The PEARL-II and PEARL-III studies evaluated the potential for ribavirin-free
therapy in genotype 1b (GT1b) experienced and naive patients, respectively.
PEARL-IV evaluated the potential for ribavirin-free therapy in genotype 1a
(GT1a) naive patients. Results from the PEARL-II study (n=179) showed that 100
percent of the GT1b experienced patients treated with the AbbVie combination
without ribavirin achieved SVR [12] . Patients treated with the
ribavirin-containing regimen, achieved 97 percent SVR [12] . Results from the
PEARL-III study (n=419) showed that GT1b naive patients treated with our
combination, with and without ribavirin, achieved 99 percent SVR [12] . The
PEARL-IV study (n=305) showed that even in the more difficult to treat GT1a
patients, our regimen with ribavirin achieved an SVR [12] rate of 97 percent
and the ribavirin-free regimen produced an SVR [12] rate of 90 percent.

  *During the quarter, AbbVie announced top-line Phase 3 HCV results from the
    SAPPHIRE-I and SAPPHIRE-II studies, which examined AbbVie's HCV regimen in
    naive and treatment-experienced patients. Results from the SAPPHIRE trials
    showed that in both naive and treatment-experienced patients, treatment
    with AbbVie's 3-DAA therapy plus ribavirin produced high SVR rates of 96
    percent. Additionally, the regimen was well-tolerated, with
    discontinuations due to adverse events reported in only one percent of
    patients receiving the combination.
  *AbbVie recently announced the initiation of a Phase 3 clinical trial
    evaluating the safety and efficacy of its investigational compound,
    veliparib (ABT-888), when added to carboplatin, a chemotherapy, in women
    with early-stage, triple-negative breast cancer. The three-arm trial will
    compare the addition of veliparib plus carboplatin or placebo plus
    carboplatin to standard neoadjuvant chemotherapy. We expect Phase 3 starts
    for veliparib in additional cancer types in 2014.
  *AbbVie and its partner recently initiated a Phase 3 comparative clinical
    trial designed to evaluate the efficacy and safety of ABT-199/GDC-0199, an
    investigational BCL-2 (B-cell lymphoma 2) selective inhibitor, in patients
    with relapsed refractory chronic lymphocytic leukemia (CLL). The study
    will compare the combination of ABT-199/GDC-0199 and rituximab to the
    combination of bendamustine and rituximab. Rituximab and bendamustine are
    commonly used to treat patients with CLL.

Issuing Full-Year 2014 Outlook

AbbVie expects 2014 revenue of approximately $19 billion, excluding any
potential revenue from the expected 2014 U.S. launch of our HCV therapy.
AbbVie is issuing diluted earnings-per-share guidance for the full-year 2014
of $3.00 to $3.10 on an adjusted basis, or $2.63 to $2.73 on a GAAP basis. The
company's 2014 adjusted diluted earnings-per-share guidance excludes $0.37 per
share of intangible asset amortization expense 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 Laboratories. The company's mission is to use
its expertise, dedicated people and unique approach to innovation to develop
and market advanced therapies that address some of the world's most complex
and serious diseases. AbbVie employs approximately 25,000 people worldwide and
markets medicines in more than 170 countries. For further information on the
company and its people, portfolio and commitments, please visit www.abbvie.com
. Follow @abbvie on Twitter or view 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 fourth-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, 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 www.abbvieinvestor.com . An archived edition of the call
will be available after 10:00 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 2014
financial guidance is also being provided on both a reported and a non-GAAP
basis.

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 December 31, 2013
                                     (Unaudited)
                                                    % Change vs. 4Q12
                Sales (in millions)            International            Total
                 U.S.  Int'l. Total   U.S.  Operational Reported Operational Reported
TOTAL SALES     $2,818 $2,293 $5,111 (8.2%)        9.2%     7.5%      (1.1%)   (1.8%)
Humira           1,667  1,372  3,039   18.1         8.0      8.2        13.3     13.4
Synagis             --    314    314  n/m           8.4    (1.4)         2.9    (6.4)
                                                 
AndroGel           289     --    289 (20.9)    n/a       n/a        (20.9)   (20.9)
Kaletra             63    165    228 (24.0)         0.2    (0.9)       (7.8)    (8.6)
Lupron             156     53    209    0.5       (1.7)    (5.0)       (0.1)    (1.0)
                                                 
Synthroid          189     --    189   12.8    n/a       n/a          12.8     12.8
Sevoflurane         23    133    156 (20.9)         6.3      3.6         1.3    (0.9)
                                                 
Creon              115     --    115    9.3    n/a       n/a           9.3      9.3
Zemplar             57     44    101 (16.8)        14.9     16.2       (5.4)    (4.9)
Duodopa             --     49     49  n/a          15.7     20.1        15.7     20.1
                                                 
Niaspan             31     --     31 (88.9)     n/a       n/a        (88.9)   (88.9)
                                                 
TriCor/Trilipix     29     --     29 (85.4)    n/a       n/a        (85.4)   (85.4)
Note: "Operational" growth reflects the percentage change over the prior year
excluding the impact of exchange rate fluctuations.
n/a = not applicable
n/m = not meaningful

                                      AbbVie Inc.
                                   Key Product Sales
                         Twelve Months Ended December 31, 2013
                                      (Unaudited)
                                                      % Change vs. 12M12
                 Sales (in millions)             International            Total
                 U.S.   Int'l.  Total   U.S.  Operational Reported Operational Reported
TOTAL SALES     $10,181 $8,609 $18,790 (2.4%)       10.1%     8.4%        2.9%     2.2%
Humira            5,236  5,423  10,659   19.6        11.7     10.9        15.4     15.0
                                                   
AndroGel          1,035     --   1,035 (10.1)    n/a       n/a      (10.1)   (10.1)
Kaletra             244    718     962 (12.8)       (1.0)    (2.1)       (4.2)    (5.0)
Synagis              --    827     827  n/m           9.2      0.2         7.0    (1.8)
Lupron              566    219     785  (0.6)       (3.2)    (5.0)       (1.4)    (1.9)
                                                   
Niaspan             650     --     650 (28.7)    n/a       n/a      (28.7)   (28.7)
                                                   
Synthroid           622     --     622   12.9    n/a       n/a        12.9     12.9
Sevoflurane          77    491     568  (5.4)       (3.6)    (5.7)       (3.8)    (5.6)
                                                   
Creon               412     --     412   16.5    n/a       n/a        16.5     16.5
Zemplar             218    171     389  (5.1)        10.7     11.7         1.2      1.6
                                                   
TriCor/Trilipix     303     --     303 (72.4)    n/a       n/a      (72.4)   (72.4)
Duodopa              --    178     178  n/a          16.4     19.5        16.4     19.5
Note: "Operational" growth reflects the percentage change over the prior year excluding
the impact of exchange rate fluctuations.
n/a = not applicable
n/m = not meaningful

                                 AbbVie Inc.
                     Consolidated Statements of Earnings
         Quarter and Twelve Months Ended December 31, 2013 and 2012
              (Unaudited) (In millions, except per share data)
                           Fourth Quarter Ended        Twelve Months Ended
                               December 31                  December 31
                           2013            2012          2013         2012
Net sales                   $5,111          $5,206       $18,790      $18,380
Cost of products sold        1,282           1,265         4,581        4,508
Selling, general and
administrative               1,448           1,411         5,352        4,989
Research and
development                    798             681         2,855        2,778
Acquired in-process
research and
development                     48              28           338          288
Total operating cost
and expenses                 3,576           3,385        13,126       12,563
Operating earnings           1,535           1,821         5,664        5,817
Interest (income)
expense, net                    68              88           278           84
Net foreign exchange
(gain) loss                     15            (10)            55           17
Other (income) expense,
net                             13              30           (1)          (9)
Earnings before income
tax                          1,439           1,713         5,332        5,725
Income tax expense             311             173         1,204          450
Net earnings                $1,128          $1,540        $4,128       $5,275
Diluted earnings per
share                        $0.70           $0.98         $2.56        $3.35
Average diluted shares
outstanding             1,608           1,577         1,604        1,577
Note: The computation of diluted earnings per share for the quarter and
twelve months ended Dec. 31, 2013 was calculated pursuant to the two-class
method which requires the allocation of net earnings between common
stockholders and participating security holders. 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
twelve months ended Dec. 31, 2012 was calculated using the shares distributed
on Jan. 1, 2013.

                                 AbbVie Inc.
      Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
                       Quarter Ended December 31, 2013
              (Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
                                                       4Q13
                                              Earnings             Diluted
                                       Pre-tax      After-tax        EPS
As reported (GAAP)                         $1,439         $1,128        $0.70
Adjusted for specified items:
Intangible asset amortization                 101             76         0.05
Separation costs                              103             66         0.04
Acquired IPR&D                                 48             48         0.03
Restructuring/Other                      11              7         0.00
As adjusted (non-GAAP)                     $1,702         $1,325        $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 upfront
payments related to previously announced collaborations. Restructuring/Other
is primarily associated with previously announced restructuring activities.

2. The impact of the specified items by line item was as follows:
                                                  4Q13
                                                                    Other
                              Cost of                 Acquired     (income)
                           products sold  SG&A  R&D     IPR&D      expense
As reported (GAAP)               $1,282 $1,448 $798         $48          $13
Adjusted for specified
items:
Intangible asset
amortization                       (101)     --   --          --           --
Separation costs                    (5)   (95)  (3)          --           --
Acquired IPR&D                       --     --   --        (48)           --
Restructuring/Other                 (8)     --   --          --          (3)
As adjusted (non-GAAP)           $1,168 $1,353 $795          --          $10

3. The adjusted tax rate for the fourth quarter was 22.2 percent, as detailed
below:
                                                    4Q13
                                   Pre-tax         Income
                                   income          taxes         Tax rate
As reported (GAAP)                      $1,439           $311           21.6%
Specified items                            263             66           25.1%
As adjusted (non-GAAP)                  $1,702           $377           22.2%

                                 AbbVie Inc.
      Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
                    Twelve Months Ended December 31, 2013
              (Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
                                                      12M13
                                              Earnings             Diluted
                                       Pre-tax      After-tax        EPS
As reported (GAAP)                         $5,332         $4,128        $2.56
Adjusted for specified items:
Intangible asset amortization                 509            370         0.23
Separation costs                              255            163         0.10
Acquired IPR&D                                338            338         0.21
Restructuring/Other                      81             67         0.04
As adjusted (non-GAAP)                     $6,515         $5,066        $3.14
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 upfront
payments related to previously announced collaborations. Restructuring/Other
is primarily associated with previously announced restructuring activities.

2. The impact of the specified items by line item was as follows:
                                              12M13
                     Cost of                           Net foreign    Other
                     products               Acquired exchange (gain) (income)
                       sold    SG&A   R&D    IPR&D        loss       expense
As reported (GAAP)    $4,581 $5,352 $2,855     $338             $55     ($1)
Adjusted for
specified items:
Intangible asset
amortization            (509)     --     --       --              --       --
Separation costs        (16)  (230)    (9)       --              --       --
Acquired IPR&D            --     --     --    (338)              --       --
Restructuring/Other      (5)   (38)   (15)       --            (11)     (12)
As adjusted
(non-GAAP)             $4,051 $5,084 $2,831       --              44    ($13)

3. The adjusted tax rate for the fourth quarter was 22.2 percent, as detailed
below:
                                                   12M13
                                   Pre-tax         Income
                                   income          taxes         Tax rate
As reported (GAAP)                      $5,332         $1,204           22.6%
Specified items                          1,183            245           20.7%
As adjusted (non-GAAP)                  $6,515         $1,449           22.2%

Website: http://www.abbvie.com
Contact: Media: Jennifer Smoter, (847) 935-8865, or Adelle Infante, (847)
938-8745; Investors: Larry Peepo, (847) 935-6722, or Liz Shea, (847) 935-2211
 
Press spacebar to pause and continue. Press esc to stop.