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

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

- 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

PR Newswire

NORTH CHICAGO, Ill., Jan. 31, 2014

NORTH CHICAGO, Ill., 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

  oWorldwide 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.
  oFourth-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.
  oFourth-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.
  oAdjusted 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.
  oResearch 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.
  oNet 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.
  oFourth-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

  oThis 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.

  oDuring 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.
  oAbbVie 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.
  oAbbVie 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
Facebookor 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    48          28        338         288
development
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              1,608       1,577     1,604       1,577
outstanding

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
                           Cost of                   Acquired     Other
                           products sold SG&A   R&D  IPR&D        (income)
                                                                  expense
As reported (GAAP)        $1,282        $1,448 $798 $48          $13
Adjusted for specified
items:
Intangible asset          (101)         --     --   --           --
amortization
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                Acquired Net foreign      Other
                     products SG&A   R&D    IPR&D    exchange (gain)  (income)
                     sold                            loss             expense
As reported (GAAP)  $4,581   $5,352 $2,855 $338     $55              ($1)
Adjusted for
specified items:
Intangible asset    (509)    --     --     --       --               --
amortization
Separation costs    (16)     (230)  (9)    --       --               --
Acquired IPR&D      --       --     --     (338)    --               --
Restructuring/Other (5)      (38)   (15)   --       (11)             (12)
As adjusted         $4,051   $5,084 $2,831 --       44               ($13)
(non-GAAP)



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%

SOURCE AbbVie

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.