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Collaborative Research, Development and License Agreements
12 Months Ended
Dec. 31, 2017
Research And Development [Abstract]  
Collaborative Research, Development and License Agreements

10.

Collaborative Research, Development and License Agreements

AstraZeneca

Pursuant to a research collaboration and license agreement with AstraZeneca AB (AstraZeneca”), as amended, we discovered and performed initial clinical development of AZD1419, a TLR9 agonist product candidate for the treatment of   asthma. In June 2016, all of our remaining performance obligations under our agreement with AstraZeneca were completed.

In November 2016, AstraZeneca initiated the Phase 2a trial of AZD1419 in asthma patients. Upon AstraZeneca’s initiation of the Phase 2a trial, we earned a milestone payment of $7.2 million, which was offset against $7.4 million in unused development funding previously advanced by AstraZeneca. We recognized the $7.2 million milestone as revenue during the fourth quarter of 2016. The remaining balance of unused development funding, net of the $7.2 million milestone payment, was $0.2 million which was paid during the first quarter of 2017.  No liability related to unused development funding remains on the accompanying consolidated balance sheet as of December 31, 2017.

Under the terms of the agreement, as amended, we are eligible to receive up to approximately $100 million in additional milestone payments, based on the achievement of certain development and regulatory objectives. Additionally, upon commercialization of AZD1419, 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 consolidated statements of operations (in thousands):

 

 

 

 

 

 

 

Year ended December 31,

 

 

 

2017

 

 

2016

 

 

2015

 

Initial and milestone payment

 

$

-

 

 

$

7,722

 

 

$

238

 

Subsequent payment

 

 

-

 

 

 

1,953

 

 

 

892

 

Performance of research activities

 

 

-

 

 

 

103

 

 

 

1,635

 

Total

 

$

-

 

 

$

9,778

 

 

$

2,765

 

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.

Coley Pharmaceutical Group, Inc.

In June 2007, we entered into a license agreement with Coley Pharmaceutical Group, Inc. (“Coley”), under which Coley granted us a non-exclusive, royalty bearing license to patents, with the right to grant sublicenses for HEPLISAV-B.  Under the terms of this agreement, we are responsible for royalties in the low single-digit based on product sales arising from the license.  We met one of the regulatory milestones upon FDA approval of HEPLISAV-B in November 2017 and recorded $2.5 million as an intangible asset on the consolidated balance sheets.  See Note 6. At December 31, 2017, the $2.5 million payment due to Coley was included in accounts payable on the consolidated balance sheet. The agreement continues in effect through February 2018, at which time the license becomes a perpetual, irrevocable, fully paid-up and royalty free license. No further milestone payments are expected prior to termination.