AbbVie Reports Third-Quarter 2013 Financial Results

PR Newswire/Les Echos/ 
AbbVie Reports Third-Quarter 2013 Financial Results 
NORTH CHICAGO, III., Oct. 25, 2013 -- 
* 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
$2.54-$2.56
* 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 Duodopa
* 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 Program
* 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 months." 
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 patients.
* 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 2014.
* 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 
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 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 www.abbvieinvestor.com. 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 
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 September 30, 2013
(Unaudited) 


         
                        Sales (in millions)


                 U.S.      Int'l.    Total 
TOTAL SALES         $2,616    $2,042    $4,658 
Humira               1,389     1,381     2,770 
AndroGel               248        --       248 
Kaletra                 63       174       237 
Niaspan                201        --       201 
Lupron                 141        55       196 
Synthroid              161        --       161 
Sevoflurane             19       119       138 
Creon                  101        --       101 
Zemplar                 57        43       100 
Synagis                 --        98        98 
Duodopa                 --        46        46 
TriCor/Trilipix         39        --        39 
                      % Change vs. 3Q12 
       International                               Total
U.S.        Operational       Reported         Operational   Reported
(1.8%)         11.6%            10.8%              3.6%         3.3%
 22.3          16.0             16.1              19.1         19.1
(11.1)          n/a             n/a              (11.1)       (11.1)
(11.3)        (11.2)           (11.2)            (11.2)       (11.2)
(13.4)          n/a              n/a             (13.4)       (13.4)
  6.8          (1.7)            (3.5)              4.2          3.7
 22.9           n/a              n/a              22.9         22.9
 (5.0)          6.1              3.5               4.4          2.2
  9.8           n/a              n/a               9.8          9.8
  9.6           7.7             10.3               8.8          9.9
  n/a          15.6              2.1              15.6          2.1
  n/a          18.9             24.3              18.9         24.3
(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) 
                    Sales (in millions) 


                    U.S.      Int'l.     Total

TOTAL SALES        $7,363    $6,316   $13,679 
Humira              3,569     4,051     7,620 
AndroGel              746        --       746 
Kaletra               181       553       734 
Niaspan               619        --       619 
Lupron                410       166       576 
Synagis               --        513       513 
Synthroid             433        --       433 
Sevoflurane            54       358       412 
Creon                 297        --       297 
Zemplar               161       127       288
TriCor/Trilipix       274        --       274 
Duodopa                --       129       129
                         % Change vs. 9M12


       International                               Total
  U.S.      Operational       Reported        Operational    Reported 
--          10.4%             8.7%            4.6%          3.8%
 20.4          13.0             11.9            16.3          15.7
 (5.2)          n/a              n/a            (5.2)         (5.2)
 (7.7)         (1.4)            (2.5)           (3.0)         (3.8)
 (2.4)          n/a              n/a            (2.4)         (2.4)
 (1.0)         (4.0)            (5.1)           (1.9)         (2.2)
  n/a           9.9              1.4             9.9           1.4
 13.1           n/a              n/a            13.1          13.1
  1.9          (6.4)            (8.4)           (5.4)         (7.2)
 19.8           n/a              n/a            19.8          19.8
  --            9.5             10.4             3.9           4.3
(69.5)          n/a              n/a           (69.5)        (69.5)
 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 data)

1. Specified items impacted results as follows:
                                                     3Q13 
                                       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: 


                                                          3Q13 
                         Cost of                     Acquired Other  (income)


                  products sold     SG&A    R&D      IPR&D        expense 
As reported 
(GAAP)                   $1,092       $1,261   $714       $220          $5
Adjusted for 
specified items:
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
below: 


                                          3Q13
                                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%
 

SOURCE AbbVie 
CONTACT: Media: Jennifer Smoter, (847) 935-8865, or Greg Miley, (847) 938-4898,
or Adelle Infante, (847) 938-8745, or Investors: Larry Peepo, (847) 935-6722, 
or Liz Shea, (847) 935-2211 
                  
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-0- Oct/25/2013 15:27 GMT
 
 
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