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Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM) - Seite 2
trial of the H7N9 avian influenza VLP vaccine candidate with Matrix-M in
the second half of 2014;
-- Initiate a Phase 2 clinical trial of our RSV F protein nanoparticle vaccine
in pregnant women in the fourth quarter of 2014; and
-- Initiate a Phase 2 clinical trial of our quadrivalent VLP seasonal
influenza vaccine in the fourth quarter of 2014.
'We made substantial progress in advancing our RSV and influenza vaccine
development programs during 2013 and I believe 2014 holds the potential for
even greater accomplishments across our entire pipeline,' said Stan Erck,
president and CEO of Novavax, Inc. 'Our rapid response to the emergence of an
avian H7N9 influenza strain continues to demonstrate the power and flexibility
of our vaccine and adjuvant technologies. This year we plan to report top-line
results from our ongoing RSV and influenza studies, initiate our first RSV
clinical trial in pregnant women and report top-line results from the first
study of our H7N9 avian influenza vaccine candidate with our Matrix-M adjuvant.
These will be important milestones for these programs for which I anticipate
continued success in 2014.'
Financial Results for the Fourth Quarter and Year Ended December 31, 2013
In connection with its acquisition on July 31, 2013, Novavax AB's operations
have been included in the company's consolidated results of operations and
financial position as of the acquisition date. Novavax reported a net loss of
$14.1 million, or $0.07 per share, for the fourth quarter of 2013, compared to
a net loss of $8.0 million, or $0.06 per share, for the fourth quarter of 2012.
For the full year 2013, the net loss was $52.0 million, or $0.31 per share,
compared to a net loss of $28.5 million, or $0.22 per share, for 2012.
Novavax revenue in the fourth quarter of 2013 increased 92% to $8.7 million as
compared to $4.6 million for the same period in 2012. The increase in revenue
was primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and
other activities and the PATH amendment to support the company's Phase 2
clinical trial in women of childbearing age.
Research and development expenses increased 69% to $16.3 million in the fourth
quarter of 2013, compared to $9.6 million for the same period in 2012,
primarily as a result of increased costs relating to the company's RSV and
pandemic (H7N9) influenza clinical trials and higher employee-related costs.
General and administrative expenses increased 65% to $4.1 million in the fourth
quarter of 2013 as compared to $2.5 million for the same period in 2012,
In connection with its acquisition on July 31, 2013, Novavax AB's operations
have been included in the company's consolidated results of operations and
financial position as of the acquisition date. Novavax reported a net loss of
$14.1 million, or $0.07 per share, for the fourth quarter of 2013, compared to
a net loss of $8.0 million, or $0.06 per share, for the fourth quarter of 2012.
For the full year 2013, the net loss was $52.0 million, or $0.31 per share,
compared to a net loss of $28.5 million, or $0.22 per share, for 2012.
Novavax revenue in the fourth quarter of 2013 increased 92% to $8.7 million as
compared to $4.6 million for the same period in 2012. The increase in revenue
was primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and
other activities and the PATH amendment to support the company's Phase 2
clinical trial in women of childbearing age.
Research and development expenses increased 69% to $16.3 million in the fourth
quarter of 2013, compared to $9.6 million for the same period in 2012,
primarily as a result of increased costs relating to the company's RSV and
pandemic (H7N9) influenza clinical trials and higher employee-related costs.
General and administrative expenses increased 65% to $4.1 million in the fourth
quarter of 2013 as compared to $2.5 million for the same period in 2012,
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