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Segment Information and Concentration of Customers and Suppliers
12 Months Ended
Dec. 31, 2013
Segment Information and Concentration of Customers and Suppliers  
Segment Information and Concentration of Customers and Suppliers

Note 17. Segment Information and Concentration of Customers and Suppliers

        The Company operates in one business segment—the development and commercialization of novel therapeutic products. Therefore, results of operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Disclosures about product revenues by geographic area; revenues and accounts receivable from major customers, and major suppliers are presented below.

Revenue

        Revenue was as follows for the years ended December 31, 2013, 2012 and 2011 (in thousands):

 
  2013   2012  

Net product revenue:

             

Qsymia

  $ 23,718   $ 2,012  

STENDRA or SPEDRA

    1,526      
           

Total net product revenue

    25,244     2,012  

License revenue

    55,838      
           

Total revenue

  $ 81,082   $ 2,012  
           
           

Geographic Information

        Outside the United States, the Company sells products principally in the EU. The geographic classification of product sales was based on the location of the customer. The geographic classification of all other revenues was based on the domicile of the entity from which the revenues were earned.

        Certain geographic information with respect to revenues was as follows (in thousands):

        Total revenue by geographic region for the years ended December 31, 2013 and 2012, was as follows (in thousands):

 
  Years Ended December 31,  
 
  2013   2012  
 
  U.S   ROW   U.S   ROW  

Qsymia—Net product revenue

  $ 23,718   $   $ 2,012   $  

STENDRA/SPEDRA—Net product revenue

    1,080     446          
                   

Total net product revenue

    24,798     446     2,012      

STENDRA/SPEDRA—License revenue

    30,393     25,445 (1)        
                   

Total revenue

  $ 55,191   $ 25,891   $ 2,012   $  
                   
                   

(1)
$21.0 million of which is attributable to Germany.

Major customers

        Revenues from significant customers as a percentage of total revenues for the year ended December 31, 2013 and 2012, is as follows:

 
  2013   2012  

Auxilium

    39 %   %

Menarini

    26 %   %

CVS

    9 %   50 %

Walgreens

    6 %   39 %

Express Scripts, Inc. 

    3 %   10 %

        Accounts receivable at December 31, 2013 and 2012 by significant customer as a percentage of the total gross accounts receivable balance are as follows:

 
  2013   2012  

Menarini

    41 %   %

Amerisource Bergen

    26 %   %

McKesson

    13 %   %

Cardinal Health, Inc. 

    12 %   %

CVS

    1 %   51 %

Walgreens

    1 %   44 %

Express Scripts, Inc. 

    1 %   1 %

Major suppliers

        The Company relies on third-party sole-source manufacturers to produce its clinical trial materials, raw materials and finished goods. Catalent Pharma Solutions, LLC, or Catalent, which supplied the product for the Phase 3b/4 program for Qsymia, is the Company's sole source of clinical and commercial supplies for Qsymia. MTPC is currently the Company's sole-source supplier for the API and the tablets for STENDRA (avanafil). In August 2012, the Company entered into an amendment to its agreement with MTPC that permits the Company to manufacture the API and STENDRA tablets for avanafil itself or through third-party suppliers at any time. The transition away from MTPC supply will need to occur on or before June 2015. The Company does not have any manufacturing facilities and intends to continue to rely on third parties for the supply of the starting materials, API and tablets. Third-party manufacturers may not be able to meet the Company's needs with respect to timing, quantity or quality.

        The Company has entered into an agreement with PDI, Inc., or PDI, a third-party contract sales organization, to assist with the hiring of sales representatives and the promotion of Qsymia to physicians. Although alternative third-party contract sales organizations exist, the Company would be adversely affected if PDI does not perform its obligations under the agreement.

        During the years ended December 31, 2013 and 2012, the Company incurred expenses for work performed by a third-party clinical research organization, or CRO, for Qsymia and STENDRA post-approval studies that accounted for 29% and 13%, respectively, of total research and development expenses. During the year ended December 31, 2011, the Company did not have any third-party CROs that accounted for 10% or more of total research and development expenses.