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License and Collaboration Agreements
9 Months Ended
Sep. 30, 2013
License and Collaboration Agreements  
License and Collaboration Agreements

4. License and Collaboration Agreements

 

Sanofi

 

On September 30, 2009, the Company entered into a license and collaboration agreement with Sanofi for the development and commercialization of a drug candidate being developed by the Company under the name MM-121. The agreement became effective on November 10, 2009 and Sanofi paid the Company a nonrefundable, noncreditable upfront license fee of $60.0 million. During the years ended 2010 and 2011, the Company received a total of $20.0 million in milestone payments associated with dosing the first patients in Phase 2 clinical trials in breast cancer and non-small cell lung cancer. During the first quarter of 2012, the Company received an additional milestone payment of $5.0 million associated with dosing the first patient in a Phase 2 clinical trial in ovarian cancer. The Company is eligible to receive additional future development, regulatory and sales milestone payments as well as future royalty payments depending on the success of MM-121.

 

Under the agreement, Sanofi is responsible for all MM-121 development and manufacturing costs. The Company has the right, but not the obligation, to co-promote MM-121 in the United States and to participate in the development of MM-121 through Phase 2 proof of concept trials. Sanofi reimburses the Company for direct costs incurred in development and compensates the Company for its internal development efforts based on a full time equivalent (“FTE”) rate. Also as part of the agreement, the Company was required to manufacture certain quantities of MM-121 and, at Sanofi’s and the Company’s option, may continue to manufacture additional quantities of MM-121 in the future. Sanofi reimburses the Company for direct costs incurred in manufacturing and compensates the Company for its internal manufacturing efforts based on an FTE rate. The Company has satisfied its manufacturing obligations under the agreement as of September 30, 2013.

 

The Company applied revenue recognition guidance to determine whether the performance obligations under this collaboration, including the license, the right to future technology, back-up compounds, participation on steering committees, development services and manufacturing services, could be accounted for separately or as a single unit of accounting. The Company determined that its development services performance obligation is considered a separate unit of accounting, as it is set at the Company’s option, has stand-alone value and the FTE rate is considered fair value. Therefore, the Company recognizes cost reimbursements for MM-121 development services within the period they are incurred and billable. Billable expenses are defined during each annual budget period. In the event that total development services expense incurred, during any particular budget period, plus estimated development services expense to be incurred during the same period exceed the total contractually allowed billable amount for development services during the same period, the Company recognizes only a percentage of the development services incurred as revenue during that period. This percentage is calculated as total development services expense incurred during the annual budget period divided by the sum of total development services expense incurred plus estimated development services expense to be incurred during the annual period, multiplied by the total contractually allowed billable amount for development services during the annual period, less development services revenue previously recognized within the annual period. The Company determined that the license, the right to future technology, back-up compounds, participation on steering committees and manufacturing services performance obligations represented a single unit of accounting. As the Company cannot reasonably estimate its level of effort over the collaboration, the Company recognizes revenue from the upfront payment, milestone payment and manufacturing services payments using the contingency-adjusted performance model over the expected development period, which is currently estimated to be 12 years from the effective date of the agreement. Under this model, when a milestone is earned or manufacturing services are rendered and product is delivered, revenue is immediately recognized on a pro-rata basis in the period the milestone was achieved or product was delivered based on the time elapsed from the effective date of the agreement. Thereafter, the remaining portion is recognized on a straight-line basis over the remaining development period.

 

During the three and nine months ended September 30, 2012 and 2013, the Company recognized revenue based on the following components of the Sanofi agreement:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

(in thousands)

 

2012

 

2013

 

2012

 

2013

 

Upfront payment

 

$

1,250

 

$

1,250

 

$

3,750

 

$

3,750

 

Milestone payments

 

521

 

521

 

2,454

 

1,562

 

Development services

 

8,598

 

4,521

 

25,900

 

30,794

 

Manufacturing services and other

 

935

 

564

 

2,562

 

3,304

 

Total

 

$

11,304

 

$

6,856

 

$

34,666

 

$

39,410

 

 

For the three months ended September 30, 2013, the Company performed development services under the Sanofi agreement of $11.3 million and recognized development services revenue of $4.5 million. During the nine months ended September 30, 2013, the Company performed development services under the Sanofi agreement of $37.6 million and recognized development services revenue of $30.8 million. For the three and nine months ended September 30, 2012, the Company performed development services and recognized revenue under the Sanofi agreement of $8.6 million and $25.9 million, respectively.

 

As of December 31, 2012 and September 30, 2013, the Company maintained the following assets and liabilities related to the Sanofi agreement:

 

(in thousands)

 

December 31, 2012

 

September 30, 2013

 

 

 

 

 

 

 

Accounts receivable, billed

 

$

1,577

 

$7,212

 

Accounts receivable, unbilled

 

7,690

 

1,623

 

Deferred revenue

 

79,913

 

75,726

 

 

GTC Biotherapeutics, Inc.

 

In July 2009, the Company entered into a license agreement with GTC Biotherapeutics, Inc. (“GTC”) for the development of MM-093 by GTC. On March 19, 2013, GTC terminated the license agreement. As a result, the Company recognized the remaining $0.6 million of deferred revenue related to this license agreement during the first quarter of 2013.

 

PharmaEngine, Inc.

 

On May 5, 2011, the Company entered into an assignment, sublicense and collaboration agreement with PharmaEngine, Inc. (“PharmaEngine”) under which the Company reacquired rights in Europe and certain countries in Asia to a drug being developed under the name MM-398. In exchange, the Company agreed to pay PharmaEngine a nonrefundable, noncreditable upfront payment of $10.0 million and will be required to make up to an aggregate of $80.0 million in development and regulatory milestone payments and $130.0 million in sales milestone payments upon the achievement of specified development, regulatory and annual net sales milestones. During the first quarter of 2012, the Company paid a milestone of $5.0 million under the collaboration agreement with PharmaEngine in connection with dosing the first patient in a Phase 3 clinical trial of MM-398 in pancreatic cancer. PharmaEngine is also entitled to tiered royalties on net sales of MM-398 in Europe and certain countries in Asia. The Company is responsible for all future development costs of MM-398 except those required specifically for regulatory approval in Taiwan.

 

During the three months ended September 30, 2012 and 2013, the Company recognized research and development expenses of $0.3 million and $0.5 million, respectively, and during the nine months ended September 30, 2012 and 2013, the Company recognized research and development expenses of $5.8 million and $1.0 million, respectively, related to the agreement with PharmaEngine. These amounts included a $5.0 million milestone payment expensed in the first quarter of 2012.