Full Press Release Details
Reports First Quarter 2010 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--May 4, 2010--Celldex Therapeutics, Inc.
(NASDAQ: CLDX) today reported financial results for the first quarter
ended March 31, 2010. Celldex reported a net loss of $6.6 million, or
$0.21 per share, for the first quarter of 2010 compared to a net loss of
$7.7 million, or $0.49 per share, for the first quarter of 2009. At
March 31, 2010, Celldex reported cash, cash equivalents and marketable
securities of $75.4 million, which the Company believes will be
sufficient to meet estimated working capital requirements and fund
operations into 2012.
"We entered 2010 with several programs poised to move into randomized
late-stage studies," said Anthony S. Marucci, Celldex's President and
Chief Executive Officer. "Beginning at ASCO next month, these programs
will result in a number of value-driving events over the course of the
year. Celldex has made consistent progress through the first quarter of
2010 and we are in a strong position to continue taking significant
strides through the rest of the year. We look forward to updating
shareholders on our progress as clinical results from these programs
become ready to announce."
First quarter and recent highlights:
Presented important preclinical data for CDX-1127, a
therapeutic antibody candidate for oncology indications, at the 2010
American Association for Cancer Research (AACR) 101st Annual Meeting
in April. Studies demonstrated that targeting CD27 receptors with
Celldex's human anti-CD27 antibodies can increase the numbers of
responding T cells and directly impact tumor cells expressing CD27.
These results support the ongoing development of CDX-1127, which is a
candidate from Celldex's Precision Targeted Immunotherapy Platform.
Received a $3 million sublicense payment from TopoTarget A/S as a
result of its co-development and commercialization agreement with
Spectrum Pharmaceuticals, Inc. for Belinostat, a novel histone
deacetylase (HDAC) inhibitor for the treatment of cancer.
The Company and its collaborators will be making four (4)
presentations at the annual meeting of the American Society of
Clinical Oncology (ASCO) to be held June 4-8th in Chicago,
Illinois. Anticipated presentations include:
Interim data from the ACT III study, a trial testing CDX-110
(PF-04948568) in newly diagnosed Glioblastoma Multiforme (GBM).
CDX-110 is partnered with Pfizer.
Final safety and immune activity data for CDX-011, an
antibody-drug conjugate product, in patients with advanced
Data on the correlation of GPNMB expression with outcomes in
breast cancer patients treated with CDX-011.
The clinical design for a randomized Phase 2b study in
muscle-invasive bladder cancer for CDX-1307, the Company's first
antibody-based dendritic cell targeted vaccine, in combination
with multiple immune modulators.
Further Financial Highlights
The net loss of $6.6 million for the first quarter of 2010 represents an
improvement of $1.1 million when compared to the net loss for the same
period in 2009, primarily due to the receipt of a sublicense income
payment of $3 million from TopoTarget A/S, partially offset by higher
operating expenses in the first quarter of 2010.
Revenues for the first quarters of 2010 and 2009 were approximately the
same at $3.7 million. Product development and licensing revenues in both
2010 and 2009 primarily reflect recognition of $1.3 million in Pfizer
deferred revenue related to CDX-110 in the three-month periods. The
increase in contracts and grants revenue in 2010 compared to 2009
primarily reflects revenues for work performed for Rockefeller
University. In 2010, Celldex also recognized $2.1 million in product
royalty revenue related to offsetting royalty expense payable to
Cincinnati Children's Hospital (CCH) compared to product royalty revenue
of $2.0 million payable to CCH in 2009.
In late March 2010, the FDA decided to temporarily suspend the use of
Rotarix in the United States as a precautionary measure
following the discovery of PCV-1 DNA material in the vaccine. Because of
our agreement with Paul Royalty Fund (PRF), we will not be negatively
impacted by the FDA's decision to suspend use of Rotarix
in future quarters. If our royalty revenue from Rotarix
is negatively impacted by the FDA's decision, our royalty expense for
Rotarix would be similarly impacted and therefore our
net loss or cash position will not be impacted as a result of the FDA's
Research and development (R&D) expense in the first quarter of 2010 and
2009 were approximately $6.4 million and $6.5 million, respectively.
Changes in R&D expenses between 2010 and 2009 primarily reflect lower
clinical trial costs in 2010 as management of the CDX-110 program was
transitioned to Pfizer in mid-2009 and lower contracted research
expenses and license fees in 2010, offset by higher facility-related
expenses and higher personnel-related expenses in 2010.
Royalty expense includes product royalty and sublicense royalty fees on
our out-licensed programs. The $0.1 million increase in royalty expenses
in 2010 was due to an increase in Rotarix related
royalty fees. Our retained interests in Rotarix net
royalties which were not sold to PRF are recorded as product royalty
revenue and a corresponding amount that is payable to CCH is recorded as
General and administrative (G&A) expense decreased by $0.5 million to
$2.8 million in 2010 as compared to G&A expense of $3.3 million in the
first quarter of 2009 was primarily due to $0.7 million in severance
expense, including related non-cash stock-based compensation expense,
incurred during the three months ended March 31, 2009 related to the
departure of our former SVP, Business Development. The effect of these
decreases was partially offset by $0.2 million in higher personnel
expense during the three months ended March 31, 2010, primarily related
to higher headcount.
The $1.4 million increase in amortization expenses for the quarter ended
March 31, 2010 was primarily due to the amortization of intangible
assets acquired in connection with the CuraGen Acquisition.
The $3.0 million increase in investment and other income, net in 2010 is
primarily due to other income of $3.0 million recorded for the
TopoTarget sublicense income payment. The $0.3 million increase in