- Management to Host Conference Call Today at 8:30 AM Eastern Time -
Celldex Reports Second Quarter 2012 Financial Results
Celldex Therapeutics, Inc.Sarah Cavanaugh, 781-433-3161Vice President of IR & Corp CommorAvery W. Catlin, 781-433-0771Chief Financial OfficerorFor Media:BMC CommunicationsBrad Miles, 646-513-3125
(NASDAQ: CLDX) today reported financial results for the second quarter ended June 30, 2012. Celldex reported a net loss of $13.8 million, or $0.23 per share, for the second quarter of 2012 compared to a net loss of $10.2 million, or $0.27 per share, for the second quarter of 2011. For the six months ended June 30, 2012, Celldex reported a net loss of $27.3 million, or $0.50 per share, compared to a net loss of $20.3 million, or $0.58 per share, for the six months ended June 30, 2011.
Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics commented, “In the second quarter, Celldex has rapidly opened clinical sites for the Phase 3 ACT IV study and the Phase 2 ReACT study of rindopepimut in glioblastoma (GB). Celldex also reported positive topline data from our Phase 2b EMERGE study of CDX-011 in patients with metastatic breast cancer. The results were consistent with previous studies and suggest that CDX-011 has considerable potential, particularly in key patient populations with more difficult to treat disease, including patients with high GPNMB expression levels and patients with triple negative breast cancer. Together these patients account for more than 35% of the total breast cancer population. We believe CDX-011 could play a vital role as a much needed treatment option for these patients and look forward to updating results from the EMERGE study in the fourth quarter.”
At June 30, 2012, Celldex reported cash, cash equivalents and marketable securities of $78.7 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014. The decrease of $13.5 million from March 31, 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 GB and the Phase 2 ReACT study in patients with recurrent EGFRvIII-positive GB.
Celldex expects to:
The net loss of $13.8 million for the second quarter of 2012 represents an increase of $3.5 million when compared to the net loss for the same period in 2011, primarily due to increases in research and development (R&D) expenses, partially offset by decreases in amortization expense.
Revenues for the second quarter of 2012 increased when compared to revenues in 2011, primarily because of contracts and grants revenue received related to an APC-based HIV vaccine being funded through a Small Business Innovation Research (SBIR) grant in collaboration with The Rockefeller University.
R&D expenses in the second quarter of 2012 and 2011 were $11.1 million and $7.2 million, respectively, an increase of $3.9 million between years. The increase in R&D expenses between 2012 and 2011 primarily reflect higher costs related to the ACT IV and ReACT rindopepimut clinical trials in 2012, offset by lower contracted research and contract manufacturing expenses.
General and administrative (G&A) expense in the second quarters of 2012 and 2011 was approximately $2.2 million. G&A expense in 2012 included higher consulting expense, offset by lower insurance costs compared to 2011.
The net loss of $27.3 million for the first six months of 2012 represents an increased loss of $7.0 million when compared to the net loss of $20.3 million for the same period in 2011. The increased loss resulted from higher R&D expenses primarily for clinical trial costs, partially offset by lower amortization expenses in 2012.
Revenues for the first six months of 2012 and 2011 were relatively consistent during both periods. Lower product royalty revenue was offset by contracts and grants revenue in 2012.
R&D expense for the first six months of 2012 was $21.9 million, an increase of $7.9 million compared to $14.0 million in 2011. Increases in costs were primarily related to the ACT IV and ReACT rindopepimut clinical trials in 2012, offset in part by decreases in laboratory supplies and services and contracted research.
G&A expense was $4.5 million and $4.6 million in the first six months of 2012 and 2011, respectively. Lower insurance and professional services costs were offset in part by higher consulting and investor relations expenses in 2012 compared to 2011.
The $0.4 million decrease in amortization expense for the six months ended June 30, 2012 was primarily due to certain intangible assets becoming fully amortized during 2011.
As of June 30, 2012, Celldex had approximately 58.8 million shares outstanding.
Celldex will host a conference call and live webcast at 8:30 a.m. ET on Friday, August 10, 2012, to provide an update on anticipated research and development and business objectives for the remainder of 2012. The conference call will be webcast live over the Internet and can be accessed by logging on to the Events Calendar under the "News & Events" section of the Celldex Therapeutics website at . The call can also be accessed by dialing 800-510-0178 (within the United States) or 617-614-3450 (outside the United States). The passcode for participants is 67901994. A replay of the call will be available approximately two hours after the live call concludes through August 24, 2012. To access the replay, dial 888-286-8010 (within the United States) or 617-801-6888 (outside the United States). The passcode is 83435012. The webcast will also be archived on the Company’s website.
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 .