AbbVie 2012 Annual Report Download - page 52

The comparisons presented at constant currency rates reflect comparative local currency sales at the
prior year’s foreign exchange rates. This measure provides information on the change in net sales
assuming that foreign currency exchange rates have not changed between the prior and the current
period. AbbVie believes that the non-GAAP measure of change in net sales at constant currency rates,
when used in conjunction with the GAAP measure of change in net sales at actual currency rates, may
provide a more complete understanding of the company’s operations and can facilitate analysis of the
company’s results of operations, particularly in evaluating performance from one period to another.
The increase in HUMIRA sales reflects market growth and higher market share across various
countries as well as higher pricing in certain geographies. HUMIRA received approval from the
European Commission in April 2012 and from the FDA in October 2012 for the treatment of
moderately to severely active ulcerative colitis in adult patients who have had an inadequate response
to conventional therapy. With its approval from the European Commission, HUMIRA became the first
and only self-injectable biologic therapy for the treatment of moderately to severely active ulcerative
colitis in adults. In July 2012, HUMIRA received approval from the European Commission for the
treatment of severe axial spondyloarthritis in adult patients who have no X-ray evidence of structural
damage. In November 2012, HUMIRA received approval from the European Commission for the
treatment of pediatric patients aged 6 to 17 years with severe active Crohn’s disease who failed, are
intolerant to, or have contraindications to conventional therapy. The approval marked the ninth
indication for HUMIRA in the European Union.
The decline in TriCor, TRILIPIX, and Niaspan sales reflects softness in the overall branded cholesterol
market and the introduction of a generic version of TriCor in the United States market in November
2012. As a result, sales for AbbVie’s combined lipid franchise including TriCor, TRILIPIX and Niaspan
declined 14 percent in 2012 compared to 2011. Under a license agreement for TRILIPIX 45 mg and
135 mg, generic competition may begin in January 2014, except that under certain circumstances the
license may commence as early as July 2013. Under an agreement relating to AbbVie’s niacin products
acquired with the Kos Pharmaceuticals acquisition, Niaspan may become subject to generic competition
in September 2013.
The decline in Kaletra revenues was primarily due to lower market share in various countries due to
the impact of competition.
The increase in AndroGel sales reflected higher prices, market share gains, the launch of AndroGel
1.62% in the second quarter of 2011, and volume growth in the U.S. testosterone replacement market
where AndroGel holds the number one market share position. AndroGel 1% sales are expected to be
impacted by generic competition in 2015.
Sales of Sevoflurane were impacted by generic competition in 2012 and 2011. Sales of Zemplar in 2011
and 2010 were impacted by changes in reimbursement regulations resulting from health care reform
legislation.
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