XML 31 R25.htm IDEA: XBRL DOCUMENT v2.4.1.9
Segment Information and Concentration of Customers and Suppliers
12 Months Ended
Dec. 31, 2014
Segment Information and Concentration of Customers and Suppliers  
Segment Information and Concentration of Customers and Suppliers

Note 18. 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.

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.

        Product revenue by geographic region is as follows for the years ended December 31 (in thousands):

                                                                                                                                                                                    

 

 

2014

 

2013

 

 

 

U.S.

 

ROW

 

Total

 

U.S.

 

ROW

 

Total

 

Qsymia—Net product revenue

 

$

45,277 

 

$

 

$

45,277 

 

$

23,718 

 

$

 

$

23,718 

 

STENDRA/SPEDRA—License and milestone revenue

 

 

15,406 

 

 

23,208 

 

 

38,614 

 

 

30,393 

 

 

25,445 

 

 

55,838 

 

STENDRA/SPEDRA—Supply revenue

 

 

9,059 

 

 

17,460 

 

 

26,519 

 

 

1,080 

 

 

446 

 

 

1,526 

 

STENDRA/SPEDRA—Royalty revenue

 

 

2,176 

 

 

1,595 

 

 

3,771 

 

 

 

 

 

 

—  

 

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

Total revenue

 

$

71,918 

 

$

42,263 

(1)

$

114,181 

 

$

55,191 

 

$

25,891 

(2)

$

81,082 

 

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

 

                                                                                                                                                                                    

 

 

2012

 

 

 

 

 

 

 

 

 

U.S.

 

ROW

 

Total

 

 

 

 

 

 

 

Qsymia—Net product revenue

 

$

2,012 

 

$

 

$

2,012 

 

 

 

 

 

 

 

 

 

 

STENDRA/SPEDRA—License and milestone revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STENDRA/SPEDRA—Supply revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STENDRA/SPEDRA—Royalty revenue

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

​  

​  

​  

​  

​  

​  

Total revenue

 

$

2,012 

 

$

 

$

2,012 

 

 

 

 

 

 

 

 

 

 

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  

​  


(1)

$37.2 million of which is attributable to Germany.

(2)

$21.0 million of which is attributable to Germany.

Major customers

        Revenues from significant customers as a percentage of total revenues for the years ended December 31, 2014, 2013 and 2012, is as follows:

                                                                                                                                                                                    

 

 

2014

 

2013

 

2012

 

Auxilium

 

 

23 

%

 

39 

%

 

%

Menarini

 

 

32 

%

 

26 

%

 

%

Amerisource Bergen

 

 

14 

%

 

%

 

%

McKesson

 

 

13 

%

 

%

 

%

Cardinal Health, Inc. 

 

 

11 

%

 

%

 

%

Express Scripts, Inc. 

 

 

%

 

%

 

10 

%

CVS

 

 

%

 

%

 

50 

%

Walgreens

 

 

%

 

%

 

39 

%

        Accounts receivable at December 31, 2014 and 2013 by significant customer as a percentage of the total gross accounts receivable balance are as follows:

                                                                                                                                                                                    

 

 

2014

 

2013

 

Menarini

 

 

25 

%

 

41 

%

Cardinal Health, Inc. 

 

 

20 

%

 

12 

%

Amerisource Bergen

 

 

19 

%

 

26 

%

McKesson

 

 

18 

%

 

13 

%

Auxilium

 

 

16 

%

 

%

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. In July 2013, the Company entered into a Commercial Supply Agreement with Sanofi Chimie to manufacture and supply the API for our drug avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU, Latin America and other territories. In November 2013, the Company entered into a Manufacturing and Supply Agreement with Sanofi Winthrop Industrie to manufacture and supply the avanafil tablets on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU, Latin America and other territories.

        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, 2014, 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 27%, 29% and 13%, respectively, of total research and development expenses.