Dynavax Technologies Corporation
) posted a loss of 11 cents per share, wider than the Zacks
Consensus Estimate of a loss of 8 cents per share and the
year-ago loss of 3 cents per share.
Dynavax reported revenues of $1.8 million, down 84.2% from a
year ago and much lower than the Zacks Consensus Estimate of $6
million. The huge decline was attributable to a 90% reduction in
collaboration revenues to $1 million.
Collaboration revenues in the year-ago quarter were higher due
to the recognition of certain milestones achieved as per
Dynavax's partnership with
) to develop and commercialize toll-like receptor (TLR)
Research and development expenses increased 7.7% year over
year to $12.5 million.
General and administrative expenses jumped 104.4% year over
year to $9.3 million due to higher stock-based compensation
expenses, an increase in administrative headcount and market
research costs related to hepatitis B vaccine, Heplisav.
Dynavax is developing Heplisav, in collaboration with
We note that Heplisav is under review in Europe. In Feb 2013,
the company received a setback in its efforts to get the
candidate approved in the US.
The US Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) to the company refusing to approve Heplisav
in adults in age bracket 18-70 without further evaluation of
safety. The company intends to meet the FDA shortly to discuss
the steps necessary to get the candidate approved.
Apart from lead candidate Heplisav, Dynavax is also developing
another candidate. We remind investors that Dynavax is developing
AZD1419, a proprietary second generation TLR-9 for the treatment
of asthma, in partnership with
Total revenues in 2012 were $9.7 million, down 55.0% year over
year and significantly below the Zacks Consensus Estimate of $14
million. Loss per share of 41 cents was wider than the loss of 39
cents posted in 2011 and the Zacks Consensus Estimate of 37
Dynavax carries a Zacks Rank #3 (Hold). Right now,
) looks well placed in the pharma sector with a Zacks Rank #2
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