Dynavax Technologies Corporation
) reported a loss of 5 cents per share in the first quarter of
2014, in line with the Zacks Consensus Estimate. The loss
reported in the year-ago quarter was 11 cents per share.
Dynavax reported revenues of $3.5 million, up 67.8% from the
year-ago period and was in line with the Zacks Consensus
Quarter In Detail
Collaboration revenues came in at $2.4 million, up 168.7% from
the year-ago quarter. The increase in revenues was primarily due
to the recognition of revenue under Dynavax' collaboration
We note that Dynavax is developing AZD1419 for the treatment
of asthma, in partnership with AstraZeneca.
Grant revenue increased 48.0% to $1.1 million from the
Research and development expenses declined 6.6% to $13.2
million in the first quarter of 2014. General and administrative
expenses declined 52.8% to $8.8 million.
First quarter results came in line with estimates. We remind
investors that Dynavax is developing a hepatitis B vaccine,
Heplisav, for adults. Heplisav is currently under review in the
U.S. and Europe.
However, Heplisav's road to approval has been bumpy. Dynavax
has received setbacks both in the U.S. and Europe in getting
In Apr 2014, Dynavax commenced a new phase III study (HBV-23)
on Heplisav. HBV-23 is a large safety and immunogenicity study,
which is designed to address the complete response letter (CRL)
issued by the U.S. Food and Drug Administration (FDA) in Feb
2013. The phase III study will evaluate the overall safety and
immunogenicity of Heplisav as compared to
) Engerix-B in adults in the age group of 18 to 70 years.
This study will provide safety database that will be adequate
to support licensure. The study is expected to complete enrolment
by the end of 2014 with follow-up expected in the fourth quarter
In Feb 2014, Dynavax withdrew its Marketing Authorization
Application (MAA) for Heplisav as the Day 180 List of Outstanding
issues provided by the European Medicines Agency (EMA) suggested
that the current safety database for Heplisav was too small to
rule out a risk of less common serious adverse events.
Dynavax carries a Zacks Rank #3 (Hold). Right now,
) looks well placed with a Zacks Rank #1 (Strong Buy).
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