AbbVie 2014 Annual Report Download - page 44

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• In 2014, AbbVie completed two Phase 2b studies of ABT-126, an Ȋ7-NNR modulator, in both
Alzheimer’s disease and cognitive impairment associated with schizophrenia. Based on the results of
these studies, AbbVie does not plan to advance the molecule in either of these indications.
Women’s Health
AbbVie is developing a novel oral gonadotropin-releasing hormone (GnRH) antagonist, elagolix, under a
collaboration with Neurocrine Biosciences for the treatment of endometriosis-related pain and uterine
fibroids. A Phase 3 study in endometriosis began in mid-2012 and a second Phase 3 trial for endometriosis
was initiated in 2013. Positive top-line efficacy results from the initial Phase 3 study were recently
announced and additional safety and efficacy data is expected in 2015. A Phase 2a study for uterine
fibroids was initiated in November 2011 and transitioned to Phase 2b in 2013.
Other
Given the numerous sources for potential future growth, no individual project is expected to be
material to cash flows or results of operations over the next five years. Factors considered included R&D
expenses projected to be incurred for the project over the next year relative to AbbVie’s total R&D
expenses, as well as qualitative factors such as marketplace perceptions and impact of a new product on
AbbVie’s overall market position. There were no delays in AbbVie’s 2014 R&D activities that are expected to
have a material impact on operations.
While the aggregate cost to complete the numerous pharmaceutical projects currently in development
is expected to be material, the total cost to complete will depend upon AbbVie’s ability to successfully
complete each project, the rate at which each project advances, the nature and extent of cost-sharing
arrangements, and the ultimate timing for completion. Given the potential for significant delays and the
high rate of failure inherent in the research and development of new pharmaceutical products, it is not
possible to accurately estimate the total cost to complete all projects currently in development.
Separation from Abbott Laboratories and Basis of Historical Presentation
AbbVie was incorporated in Delaware on April 10, 2012. On January 1, 2013, AbbVie became an
independent, publicly-traded company as a result of the distribution by Abbott Laboratories (Abbott) of
100 percent of the outstanding common stock of AbbVie to Abbott’s shareholders.
Prior to the separation, the historical financial statements were prepared on a stand-alone basis and
were derived from Abbott’s consolidated financial statements and accounting records as if the former
research-based pharmaceutical business of Abbott had been part of AbbVie for all periods presented.
Accordingly, AbbVie’s financial statements for periods prior to January 1, 2013 are presented on a combined
basis and reflect AbbVie’s financial position, results of operations and cash flows as its business was
operated as part of Abbott prior to the separation, in conformity with generally accepted accounting
principles (GAAP) in the United States. The combined financial statements principally represent the
historical results of operations and assets and liabilities of Abbott’s former research-based pharmaceutical
business.
For periods prior to January 1, 2013, the historical combined financial statements also reflected an
allocation of expenses related to certain Abbott corporate functions, including senior management, legal,
human resources, finance, information technology and quality assurance. These expenses were allocated to
AbbVie based on direct usage or benefit where identifiable, with the remainder allocated on a pro rata
basis of revenues, headcount, square footage, number of transactions or other measures. AbbVie considers
the expense allocation methodology and results to be reasonable. However, the allocations may not be
indicative of the actual expenses that would have been incurred had AbbVie operated as an independent,
stand-alone, publicly-traded company for the periods presented. Accordingly, the historical financial
information presented for periods prior to January 1, 2013 may not be indicative of the results of
operations or financial position that would have been achieved if AbbVie had been an independent, stand-
alone, publicly-traded company during the periods shown or of AbbVie’s performance for periods
subsequent to December 31, 2012.
38 2014 Form 10-K