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License and collaboration agreements
3 Months Ended
Jun. 30, 2013
License and collaboration agreements [Abstract]  
License and collaboration agreements

6.  License and collaboration agreements:

 

Trevena license

 

On May 9, 2013, the Company entered into a collaborative licensing option agreement with Trevena for the development of TRV027, a novel beta-arrestin biased ligand of the angiotensin II type 1 receptor for the treatment of acute decompensated heart failure.  Pursuant to the agreement, the Company purchased $30.0 million of Trevena preferred stock in a round of private placement financing which is recorded in the non-current 'Marketable securities and investments'caption in the condensed consolidated Balance Sheet.  This investment is accounted for using the cost method and will be reviewed for impairment annually or more frequently if a triggering event is deemed to have occurred.    

 

Ironwood collaboration

 

In September 2007, the Company entered into a collaboration agreement with Ironwood to jointly develop and commercialize Linzess® (linaclotide) for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).  Under the terms of the agreement, the Company shares equally with Ironwood all profits and losses from the development and sale of linaclotide in the U.S. In addition, Forest obtained exclusive rights to the linaclotide license in Canada and Mexico, for which the Company will pay royalties to Ironwood based on net sales in those territories; subject to receiving regulatory approval. 

 

The agreement included contingent milestone payments as well as a contingent equity investment based on the achievement of specific clinical and commercial milestones.  As of June 30, 2013, payments totaling $230 million, relating to development and approval milestones, have been made.  The Company may be obligated to pay up to an additional $100 million if certain sales milestones are achieved.  The contingent equity investment required the Company to purchase $25 million of Ironwood's convertible preferred stock when a specific clinical milestone was met. This investment is accounted for using the fair value method and is recorded in the non-current 'Marketable securities and investments' caption in the condensed consolidated Balance Sheet. 

 

Linzess received FDA approval as a once-daily treatment for adult men and women suffering from IBS-C and CIC in August 2012 and for the three-month period ended June 30, 2013, Linzess sales in the U.S. totaled $28.8 million.

 

Based on the nature of the arrangement (including its contractual terms), the nature of the payments and applicable guidance, the Company records receipts from and payments to Ironwood in two pools; the Development pool, which consists of research and development (R&D) expenses, and the Commercialization pool, which consists of revenue, cost of sales and selling, general and administrative (SG&A) expense.  The net payment to or receipt from Ironwood for the Development pool is recorded in R&D expense and the net payment to or receipt from Ironwood for the Commercialization pool is recorded in SG&A expense.

 

The following illustrates activity related to the Ironwood collaboration agreement for the periods presented:

 

 
 
 
Three Months Ended
 
June 30,
 
2013
 
2012
(In thousands)
 
 
 
Revenue
 
 
 
 
 
Net Sales attributed to the Ironwood
 
 
 
 
 
collaboration agreement
$
28,763
 
$
-
Cost of sales
 
 
 
 
 
Cost of sales attributed to the Ironwood
 
 
 
 
 
collaboration agreement
 
2,912
 
 
-
Selling, general and administrative
 
 
 
 
 
Payment to/ (receipt from) Ironwood for the
 
 
 
 
 
Commercialization pool
 
(12,355)
 
 
(3,101)
Research and development
 
 
 
 
 
Payment to/ (receipt from) Ironwood for the.
 
 
 
 
 
Development pool
 
24
 
 
(868)
 
 
 
 
 
 

 

 

 

 

moksha8

 

On October 22, 2012, the Company announced an agreement with moksha8, a privately-held pharmaceutical company which markets products in Latin America.  The agreement includes an exclusive license from Forest to moksha8 to commercialize Viibryd, and potentially other Forest products, in Latin America.  In addition, the Company agreed to provide up to $125 million in debt financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals.  As of June 30, 2013, a total of $95.0 million has been funded of which $12.3 million was funded during the three months ended June 30, 2013.  The loan is collateralized by the assets of moksha8.  At the conclusion of the two-year period, the Company will have the option to acquire moksha8 in a merger transaction at a fixed price of $157 million.  At such time, moksha8 shareholders will have the ability to put to Forest all interests of moksha8 at a fixed price of $144 million, provided moksha8 achieves certain business objectives.


The balances recorded in the Company's condensed consolidated Balance Sheet in connection with the agreements with moksha8 are included in the 'Other assets' caption and are as follows:

 

(In thousands)

 

June 30, 2013

 

March 31, 2013

Value of call/put option

$

10,700

 

$

10,700

Loan receivable

 

84,300

 

 

72,000