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Collaborative Research and Development Agreements | 6 Months Ended
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Jun. 30, 2015
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 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 will 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 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 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 amendment. The agreement with AstraZeneca has been amended several times including, most recently, in December 2014. Under the terms of this amendment, AstraZeneca will 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 due upon execution of this amendment, to be applied towards research and development expenses incurred in conducting the Phase 2a study. 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. Revenue from the $8.0 million payment received in the fourth quarter of 2014 was deferred and is being recognized as development work is performed, through December 2017. The $5.4 million payment received in the first quarter of 2014 and the $3.0 million initial payment received in 2011 were also deferred and are being recognized over the estimated remaining period of performance of development work, which is approximately 30 months. The following table summarizes the revenues earned under our agreement with AstraZeneca, included as collaboration revenue in our consolidated statements of operations (in thousands):
| Three Months Ended |  |  | Six Months Ended |
| June 30, |  |  | June 30, |
| 2015 |  |  | 2014 |  |  | 2015 |  |  | 2014 |
Initial payment | $ | 63 |  |  | $ | 180 |  |  | $ | 126 |  |  | $ | 360 |
Subsequent payment |  | 237 |  |  |  | 675 |  |  |  | 474 |  |  |  | 1,350 |
Performance of research activities |  | 630 |  |  |  | 545 |  |  |  | 801 |  |  |  | 1,432 |
Total | $ | 930 |  |  | $ | 1,400 |  |  | $ | 1,401 |  |  | $ | 3,142 |
As of June 30, 2015 and December 31, 2014, total deferred revenue from the initial payment, subsequent payment and development funding payments was $11.4 million and $12.8 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 periods ended June 30, 2015 and 2014 from the following awards:
· | August 2014, NIH awarded us $0.2 million to fund research in developing a transgenic mouse model to study human TLR9 role in disease.
· | September 2013, NIH awarded us $0.2 million to fund research in developing TLR antagonists for therapy of hepatic fibrosis and cirrhosis.
· | June 2012, NIH awarded us $0.6 million to fund research in screening for inhibitors of TLR8 for treatment of autoimmune diseases.
· | May 2012, NIH awarded us $0.4 million to fund development of TLR8 inhibitors for treatment of rheumatoid arthritis.
· | August 2010, 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.
· | September 2008, NIAID awarded us a five-year $17 million contract to develop our ISS technology using TLR9 agonists as vaccine adjuvants. The contract supports adjuvant development for anthrax as well as other disease models.
The following table summarizes the revenues recognized under the various arrangements with the NIH and NIAID (in thousands):
| Three Months Ended |  |  | Six Months Ended |
| June 30, |  |  | June 30, |
| 2015 |  |  | 2014 |  |  | 2015 |  |  | 2014 |
NIAID contracts | $ | - |  |  | $ | 965 |  |  | $ | - |  |  | $ | 1,839 |
All other NIH contracts |  | 101 |  |  |  | 42 |  |  |  | 249 |  |  |  | 293 |
Total grant revenue | $ | 101 |  |  | $ | 1,007 |  |  | $ | 249 |  |  | $ | 2,132 |

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 + Details
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