Celldex Reports Third Quarter 2012 Financial Results
<0> Celldex Therapeutics, Inc.Sarah Cavanaugh, 781-433-3161Vice President of IR & Corp CommorCelldex Therapeutics, Inc.Avery W. Catlin, 781-433-0771Chief Financial OfficerorBMC CommunicationsBrad Miles </0>
(NASDAQ: CLDX) today reported financial results for the third quarter ended September 30, 2012. Celldex reported a net loss of $15.0 million, or $0.25 per share, for the third quarter of 2012 compared to a net loss of $11.8 million, or $0.27 per share, for the third quarter of 2011. For the nine months ended September 30, 2012, Celldex reported a net loss of $42.3 million, or $0.75 per share, compared to a net loss of $32.1 million, or $0.85 per share, for the nine months ended September 30, 2011.
Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics commented, “In the third quarter, Celldex continued to advance our two lead programs, rapidly opening clinical sites for the Phase 3 ACT IV study and the Phase 2 ReACT study of rindopepimut in glioblastoma and preparing for an end-of-Phase 2 meeting with the Food and Drug Administration to discuss future development of CDX-011 in breast cancer. We look forward to presenting updates from these programs at the Society for Neuro-Oncology Annual Meeting in November and the San Antonio Breast Cancer Symposium in December. Further, by year-end, we anticipate completing accrual in the solid tumor arm of the Phase 1 study of CDX-1127. We will also initiate a Phase 2 pilot study of CDX-1135 in dense deposit disease. These events, coupled with ongoing activity in a number of other programs, will set the stage for a series of future significant milestones in 2013 and beyond.”
At September 30, 2012, Celldex reported cash, cash equivalents and marketable securities of $77.6 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014. The decrease of $1.1 million from June 30, 2012 is due primarily to planned, increased operational expenses during the quarter related to ongoing studies of rindopepimut (CDX-110), including the pivotal ACT IV study in patients with newly diagnosed EGFRvIII-positive glioblastoma and the Phase 2 ReACT study in patients with recurrent EGFRvIII-positive glioblastoma. The cash outflows for these expenses were offset by the issuance of 2.0 million shares during the quarter through our Cantor ATM facility that raised net proceeds to Celldex of $10.9 million.
Celldex expects to:
The net loss of $15.0 million for the third quarter of 2012 represents an increase of $3.2 million when compared to the net loss of $11.8 million for the same period in 2011, primarily due to increases in research and development (R&D) expenses and general and administrative (G&A) expenses, partially offset by decreases in amortization expense.
Revenues for the third quarter of 2012 increased when compared to revenues in 2011, primarily because of Rotarix related product royalty revenues and contracts and grants revenue received related to an APC-based HIV vaccine being funded through an SBIR grant in collaboration with The Rockefeller University.
R&D expenses in the third quarter of 2012 and 2011 were $11.8 million and $8.6 million, respectively, an increase of $3.2 million from 2011 to 2012. The increase in R&D expenses between 2012 and 2011 primarily reflect higher costs related to our rindopepimut program, including the ACT IV and ReACT clinical trials, and related consulting expenses in 2012.
G&A expenses in the third quarters of 2012 and 2011 were $2.8 million and $2.3 million, respectively, an increase of $0.5 million from 2011 to 2012. G&A expense in 2012 included higher personnel-related, consulting, and rindopepimut-related commercialization expenses compared to 2011.
The net loss of $42.3 million for the first nine months of 2012 represents an increased loss of $10.2 million when compared to the net loss of $32.1 million for the same period in 2011. The increased loss resulted from higher R&D expenses primarily for clinical trial costs and higher G&A expenses, partially offset by lower amortization expenses in 2012.
Revenues for the first nine months of 2012 and 2011 were $7.6 million and $6.8 million, respectively, an increase of $0.8 million from 2011 to 2012. Higher product royalty, contracts and grants revenues were experienced in 2012.
R&D expense for the first nine months of 2012 was $33.7 million, an increase of $11.1 million compared to $22.6 million in 2011. Increases in costs were primarily related to our rindopepimut program, including the ACT IV and ReACT clinical trials, and related consulting expenses in 2012.
G&A expense was $7.4 million and $6.8 million in the first nine months of 2012 and 2011, respectively. Higher personnel-related, consulting and rindopepimut-related commercialization expenses as well as investor relations expenses related to our R&D Day held earlier this year were offset in part by lower insurance and professional services costs in 2012 compared to 2011.
As of September 30, 2012, Celldex had approximately 60.8 million shares outstanding.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit .