Full Press Release Details
Reports Fourth Quarter and Fiscal 2010 Financial Results
Management to Host Conference Call to Discuss Results and Provide 2011
Outlook Today, Thursday, March 3, at 8:30 a.m. Eastern Time -
NEEDHAM, Mass.--(BUSINESS WIRE)--March 3, 2011--Celldex Therapeutics,
Inc. (NASDAQ: CLDX) today reported financial results for the fourth
quarter and the year ended December 31, 2010. Celldex reported net
income of $22.7 million, or $0.71 basic earnings per share, and $0.70
fully diluted earnings per share for the fourth quarter of 2010 compared
to a net loss of $12.9 million, or ($0.41) per basic and diluted share,
for the fourth quarter of 2009. Net income for the fourth quarter of
2010 includes one-time items totaling $30.5 million for rindopepimut
(CDX-110) related revenue recorded as a result of the termination of the
Pfizer license agreement and a charge to royalty expense related to
costs originally capitalized in connection with the Pfizer license
agreement. Celldex regained rights to rindopepimut during the fourth
Excluding these one-time items, on a non-GAAP basis, Celldex would have
reported a net loss of $7.8 million, or ($0.24) per basic share, for the
fourth quarter of 2010. A reconciliation of GAAP to non-GAAP earnings
(loss) per share is attached.
For the twelve months ended December 31, 2010, Celldex reported a net
loss of $2.5 million, or ($0.08) per share, compared to a net loss of
$36.5 million, or ($1.84) per share, for the twelve months ended
December 31, 2009. Net loss for 2010 included the one-time items
described above. Excluding these items, the non-GAAP net loss per share
for 2010 was $33.0 million, or ($1.04) per share.
"Celldex enters 2011 well positioned with several product candidates in
later stage clinical development and two additional programs poised to
enter clinical studies later this year," said Anthony S. Marucci,
President and Chief Executive Officer. "We are excited to regain rights
to develop and commercialize rindopepimut. We are in a strong financial
position, with projected cash flow and financial resources expected to
sufficiently fund planned program development into 2012, including
initiation of a Phase 3 pivotal study for rindopepimut. Our therapeutic
vaccine, antibody drug-conjugate and therapeutic antibody programs will
drive a number of potential value enhancing key events over the course
of this year and next and we look forward to updating shareholders on
our continued progress and overall strategic initiatives."
Fourth Quarter and Recent Highlights
Effective November 1, 2010, Celldex regained rights to develop and
commercialize rindopepimut. Rindopepimut (CDX 110) is widely perceived
by clinicians as one of the most promising drug candidates for
patients with glioblastoma multiforme (GBM)-a population with very
limited treatment options-and we are well positioned to advance
rindopepimut into a pivotal study in the second half of 2011.
At the Society for Neuro-Oncology (SNO) Annual Meeting in November,
Celldex presented complete data for the primary endpoint of ACT III, a
multi-center, single arm, Phase 2 clinical trial of rindopepimut in
patients with newly diagnosed GBM. The data showed 66% of patients
were progression-free at 8.5 months from diagnosis, a statistically
significant increase over a predetermined progression-free rate (PFR)
estimate. These encouraging data are consistent with previous studies
(ACTIVATE and ACT II) with rindopepimut in GBM and provided additional
information to design the future clinical development of rindopepimut.
During the fourth quarter 2010, Celldex received Qualifying
Therapeutic Discovery Project (QTDP) grants totaling approximately
$1.7 million from the U.S. government related to seven of the
Celldex and its collaborators presented positive, preliminary data
from the CDX-1401 Phase 1/2 study at the iSBTc Annual Meeting in
October. Robust anti-NY-ESO-1 immunity was induced with the majority
of the patients developing anti-NY-ESO-1 antibody responses and 39% of
the patients experiencing increases in NY-ESO-1 specific T cell
responses including both CD4 and CD8 responses. CDX-1401 was well
tolerated and there were no dose-limiting toxicities.
To help meet Celldex's anticipated liquidity needs to support the
ongoing clinical development of its later-stage programs, to payoff
certain debt obligations and to provide funding for future working
capital and general corporate purposes, Celldex recently entered into
two financing transactions that the Company believes will extend its
liquidity and cash resources-(i) a debt facility with MidCap
Financial, LLC pursuant to which the Company borrowed an aggregate of
$10 million to retire the approximately $12.8 million of outstanding
principal and accrued interest owed to holders of the Company's 4%
convertible subordinated debt which was paid off on February 14, 2011
and (ii) a controlled equity offering facility with Cantor
Fitzgerald & Co. ("Cantor") pursuant to which the Company may issue
and sell up to 5,000,000 shares of its common stock from time to time
through Cantor, acting as agent. Sales of our common stock through
Cantor, if any, will be made on the NASDAQ Global Market by means of
ordinary brokers' transactions at market prices, in block transactions
or as otherwise agreed by Cantor and Celldex. To date, no sales have
been made under the controlled equity offering facility.
Based on ongoing discussions with the FDA, initiate an international,
double-blinded, placebo-controlled, randomized Phase 3 pivotal study
of rindopepimut in approximately 300 patients with GBM that express
EGFRvIII during the second half of 2011.
Complete enrollment of the 120-patient randomized Phase 2b controlled
study of CDX-011, the Company's antibody drug conjugate for the
treatment of patients with glycoprotein NMB (GPNMB)-expressing
advanced, refractory breast cancer including triple negative disease.
Initiate Phase 1 clinical studies of CDX-301, or MobistaTM,
Further Financial Highlights
The increase in income of $35.6 million between the fourth quarters of
2010 and 2009 is primarily due to one-time items of $35.6 million in
product development and licensing revenues recorded as a result of the
termination of the Pfizer license agreement and a $5.1 million charge to
royalty expense related to costs originally capitalized in connection
with the Pfizer license agreement. The increase was also due to lower
research and development (R&D) and general and administrative (G&A)
expenses in 2010 versus 2009. R&D expense in the fourth quarter of 2010
decreased by $1.4 million compared to R&D expense in 2009 due primarily