XML 22 R11.htm IDEA: XBRL DOCUMENT v3.4.0.3
Collaborative Research and Development Agreements
3 Months Ended
Mar. 31, 2016
Research And Development [Abstract]  
Collaborative Research and Development Agreements

5. Collaborative Research and Development Agreements

AstraZeneca

In September 2006, we entered into a research collaboration and license agreement with AstraZeneca AB (“AstraZeneca”) for the discovery and development of TLR9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease.

In October 2011, we amended our agreement with AstraZeneca to provide that we would conduct initial clinical development of AZD1419 and AstraZeneca agreed to fund all program expenses to cover the cost of development activities through Phase 2a. Under the terms of the amended agreement, we received an initial payment of $3.0 million in 2011 to begin the clinical development program. We and AstraZeneca agreed to advance AZD1419 towards a Phase 1 clinical trial, which resulted in a development funding payment of $6.0 million received in the fourth quarter of 2012.

In January 2014, we amended our agreement with AstraZeneca for the clinical development of AZD1419 whereby responsibility for conducting clinical trials was transferred from Dynavax to AstraZeneca upon completion of the Phase 1 trial. In the first quarter of 2014, we received a $5.4 million payment that was due upon execution of this amended agreement.

In December 2014, we amended our agreement with AstraZeneca whereby AstraZeneca would fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma. In the fourth quarter of 2014, we received an $8.0 million payment upon execution of this amendment, to be applied towards research and development expenses incurred in conducting the Phase 2a study.

In January 2016, we amended our agreement with AstraZeneca whereby AstraZeneca will conduct the Phase 2a safety and efficacy trial of AZD1419 in patients with asthma that originally was to be conducted by Dynavax. We therefore revised the estimated remaining period of performance of development from June 2018 to September 2016. The remaining balance as of December 31, 2015 related to deferred payments of $5.4 million, received in the first quarter of 2014, and $3.0 million, received in 2011, are nonrefundable and are being recognized starting in January 2016 over the estimated remaining period of performance of development work through September 2016.

Under the terms of the January 2016 amendment, the $8.0 million payment received in December 2014, which was also deferred and is being recognized as research and development expenses are incurred, will be returned to AstraZeneca or applied to future milestone payments that may be earned by us under the agreement, net of amounts we recognize as development work is performed. In December 2015, we reclassified $7.4 million of the $8.0 million payment from deferred revenue to a current liability. As of March 31, 2016, the current liability related to the payment was $7.3 million on the accompanying condensed consolidated balance sheet.

Under the terms of this agreement, as amended, we are eligible to receive up to $100 million in additional milestone payments, based on the achievement of certain development and regulatory objectives. Additionally, upon commercialization, we are eligible to receive tiered royalties ranging from the mid to high single-digits based on product sales of any products originating from the collaboration. We have the option to co-promote in the United States products arising from the collaboration, if any. AstraZeneca has the right to sublicense its rights upon our prior consent.

The following table summarizes the revenues earned under our agreement with AstraZeneca, included as collaboration revenue in our condensed consolidated statements of operations (in thousands):

 

Three Months Ended

 

 

March 31,

 

 

2016

 

 

2015

 

Initial payment

$

174

 

 

$

63

 

Subsequent payment

 

651

 

 

 

237

 

Performance of research activities

 

70

 

 

 

171

 

Total

$

895

 

 

$

471

 

 

As of March 31, 2016 and December 31, 2015, total deferred revenue from the initial payment, subsequent payment and development funding payments was $1.8 million and $2.7 million, respectively.

Absent early termination, the agreement will expire when all of AstraZeneca’s payment obligations expire. AstraZeneca has the right to terminate the agreement at any time upon prior written notice and either party may terminate the agreement early upon written notice if the other party commits an uncured material breach of the agreement.

National Institutes of Health (“NIH”) and Other Funding

We have been awarded various grants from the NIH and the NIH’s National Institute of Allergy and Infectious Disease (“NIAID”) in order to fund research. The awards are related to specific research objectives and we earn revenue as the related research expenses are incurred. We have earned revenue during the three month periods ended March 31, 2016 and 2015 from the following awards:

 

·

August 2014, the NIH awarded us $0.2 million to fund research in developing a transgenic mouse model to study human TLR9 role in disease.

 

·

May 2012, the NIH awarded us $0.4 million to fund development of TLR8 inhibitors for treatment of rheumatoid arthritis. In February 2016, the NIH awarded us an additional $0.5 million to fund this study.

 

·

August 2010, the NIAID awarded us a grant to take a systems biology approach to study the differences between individuals who do or do not respond to vaccination against the hepatitis B virus. This study is one of several projects conducted under a grant to the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program. We have been awarded a total of $1.4 million under this grant.

The following table summarizes the revenues recognized under the various arrangements with the NIH (in thousands):

 

Three Months Ended

 

 

March 31,

 

 

2016

 

 

2015

 

NIH contracts

$

39

 

 

$

148

 

Total grant revenue

$

39

 

 

$

148