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Published on 31 January 2013

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AbbVie issues inaugural full-year outlook for 2013

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AbbVie has confirmed it delivered strong sales growth with its marketed pharmaceutical products in 2012.  The proprietary pharmaceutical segment of Abbott, representing the majority of AbbVie’s revenue, grew more than 8% globally on an operational basis, excluding a nearly 3% negative impact from foreign exchange.  
Performance was driven by solid double-digit growth from both HUMIRA and AndroGel and continued growth from the company’s portfolio of market-leading therapies, including Creon and Synthroid.
Additionally, AbbVie is issuing adjusted earnings-per-share guidance for the full-year 2013 of $3.03 to $3.13, or $2.66 to $2.76 on a Generally Accepted Accounting Principles (GAAP) basis.  The company’s 2013 adjusted earnings-per-share guidance excludes $0.37 per share of non-cash intangible amortisation expense and specified items, primarily associated with certain separation-related costs and previously announced ongoing restructuring activities.
“AbbVie’s portfolio of marketed products delivered solid growth in 2012, positioning us well for healthy performance in our first year as an independent company,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie.  “In 2013, we expect to deliver on AbbVie’s key priorities of driving continued strong growth of HUMIRA, maximising our specialty product portfolio, advancing our promising pipeline including our late-stage HCV program, and delivering returns to shareholders through our strong dividend.”
 
Pipeline and regulatory milestones
In addition to strong sales growth, in 2012 AbbVie continued to execute on its regulatory and clinical objectives.  This includes securing approvals for four new HUMIRA indications; the addition of two promising mid-stage compounds, including a next-generation JAK1 inhibitor and a novel therapy for acute kidney injury; and the advancement of key development programs, including the start of Phase III studies for our interferon-free Hepatitis C (HCV) combination and elagolix.
AbbVie expects long-term growth will be fuelled by a compelling pipeline of therapies in development to address medical conditions with high unmet need.  The company is focused on advancing a number of Phase III programs, including: an interferon-free oral combination for HCV; daclizumab for relapsing remitting multiple sclerosis (in partnership with Biogen); elagolix for endometriosis; elotuzumab for multiple myeloma (in partnership with Bristol Myers Squibb); and several new indications for HUMIRA.
In 2013, the company expects to initiate several Phase III programs including atrasentan for diabetic kidney disease and ABT-199 in chronic lymphocytic leukaemia (CLL).  Additionally, AbbVie is planning Phase IIB starts for: elagolix in uterine fibroids; our partnered JAK1 inhibitor (GLPG0634) for rheumatoid arthritis (RA); BT-061 for RA; and ABT-719 for acute kidney injury associated with major cardiac and other surgeries.  Finally, in 2013, the company intends to present data from a number of key development programs, including our rapidly advancing HCV program, oncology, renal disease, immunology and Alzheimer’s disease.


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