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Collaborative Arrangements
9 Months Ended
Sep. 30, 2016
Collaborative Arrangements  
Collaborative Arrangements

 

3. Collaborative Arrangements

 

Revenue from Collaborative Arrangements

 

We recognized the following revenues from our collaborative arrangements:

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

(In thousands)

 

2016

 

2015

 

2016

 

2015

 

Mylan

 

$

25 

 

$

25 

 

$

15,076 

 

$

19,149 

 

Takeda Pharmaceuticals

 

15,075 

 

 

15,075 

 

 

SciClone Pharmaceuticals

 

 

 

 

2,952 

 

R-Pharm

 

 

 

35 

 

2,040 

 

Trek Therapeutics

 

 

8,000 

 

 

8,000 

 

Other

 

63 

 

350 

 

193 

 

376 

 

 

 

 

 

 

 

 

 

 

 

Total revenue from collaborative arrangements

 

$

15,174 

 

$

8,386 

 

$

30,385 

 

$

32,517 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Mylan

 

Development and Commercialization Agreement

 

In January 2015, we established a strategic collaboration with Mylan Ireland Limited (“Mylan”) for the development and, subject to regulatory approval, commercialization of revefenacin (TD-4208), our investigational LAMA in development for the treatment of COPD. We entered into this collaboration to expand the breadth of our revefenacin development program and extend our commercial reach beyond the acute care setting where we currently market VIBATIV.

 

In the first quarter of 2015, upfront payments totaling $19.2 million from Mylan were allocated to the license and committee participation deliverables based on the relative selling price method. The $19.2 million consisted of the initial payment of $15.0 million in cash and the $4.2 million premium related to the equity investment, which represents the difference between the closing price on January 30, 2015 and the issued price of $18.918 per share. For the nine months ended September 30, 2015, we recognized $19.1 million in revenue from the Mylan collaborative arrangement related primarily to the license and technological know-how delivered in the first quarter of 2015.

 

For the three months ended September 30, 2016, we recognized $25,000 for the amortization of previously deferred revenue.  For the nine months ended September 30, 2016, we recognized $15.1 million in revenue, primarily related to the $15.0 million milestone payment received from Mylan for the achievement of 50% enrollment in the Phase 3 twelve-month safety study.

 

Takeda Collaborative Arrangement

 

In June 2016, we entered into a License and Collaboration Agreement (the “Takeda Agreement”) with Millennium Pharmaceuticals, Inc. (“Millennium”), in order to establish a collaboration for the development and commercialization of TD-8954, a selective 5-HT4 receptor agonist.  Prior to the Takeda Agreement, the Company has developed TD-8954 for potential use in the treatment of gastrointestinal motility disorders, including short-term intravenous use for enteral feeding intolerance (“EFI”) to achieve early nutritional adequacy in critically ill patients at high nutritional risk, an indication for which the compound received U.S. Food and Drug Administration (“FDA”) Fast Track Designation.  Millennium is an indirect wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE: 4502) (collectively with Millennium, “Takeda”). Under the terms of the Takeda Agreement, Takeda will be responsible for worldwide development and commercialization of TD-8954.  We received an upfront cash payment of $15 million and will be eligible to receive success based development, regulatory and sales milestone payments by Takeda. The first $110 million of potential milestones are associated with the development, regulatory and commercial launch milestones for EFI or other intravenously dosed indications.  We will also be eligible to receive a tiered royalty on worldwide net sales by Takeda at percentage royalty rates ranging from low double-digits to mid-teens.

 

The transactions contemplated by the Takeda Agreement closed in the third quarter, following the expiration of the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act (“HSR Act”).  Upon closing and the subsequent transfer of the license, technical know-how and related pharmaceutical materials, we recognized $15.1 million in revenue for the three months ended September 30, 2016.

 

Reimbursement of R&D Costs

 

Under certain collaborative arrangements, we are entitled to reimbursement of certain R&D costs. Our policy is to account for the reimbursement payments by our collaboration partners as reductions to R&D expense.

 

The following table summarizes the reductions to R&D expenses related to the reimbursement payments:

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

(In thousands)

 

2016

 

2015

 

2016

 

2015

 

Mylan

 

$

18,638 

 

$

10,128 

 

$

75,782 

 

$

25,869 

 

Alfa Wassermann

 

2,607 

 

704 

 

6,393 

 

1,493 

 

SciClone

 

 

 

98 

 

 

R-Pharm

 

17 

 

130 

 

42 

 

407 

 

 

 

 

 

 

 

 

 

 

 

Total reduction to R&D expense

 

$

21,262 

 

$

10,962 

 

$

82,315 

 

$

27,769