NEW YORK, March 8, 2012 /PRNewswire/ -- Delcath Systems (NASDAQ: DCTH) today announced highlights of its 2011 fiscal year and recent weeks, and confirmed that on March 6, 2012, the Company filed its Form 10K with the SEC for the fiscal year ended December 31, 2011.
In 2011, Delcath made progress toward our goal of realizing the commercial potential of our chemosaturation system in Europe, said Eamonn P. Hobbs, President and CEO of Delcath. This progress has gathered momentum in recent weeks as we have begun to see the results of our efforts during 2011 including the roll out of our initial training and launch centers and the announcement of the first treatments of patients in Europe. We also made significant progress toward submission of our New Drug Application to the FDA, which we expect to complete by the end of the second quarter of this year. For 2012, our focus is to continue to execute on our EU commercialization plan, enter new markets for our CHEMOSAT system outside the EU, and to begin expanding the clinical application of our chemosaturation system to include other chemotherapeutic agents such as doxorubicin.
Highlights for the 2011 fiscal year and recent developments include:
- Initiation of Patient Treatments in Europe- First procedures with the Hepatic CHEMOSAT® delivery system performed outside of a clinical trial setting at two leading European cancer centers; treatments include patients with liver dominant metastases from gastric and breast cancer as well as cutaneous and ocular melanoma
- European Commercialization - Obtained CE Mark for the Delcath Hepatic CHEMOSAT® delivery system; established European commercial operations headquartered in Galway, Ireland; executed three initial launch and training agreements with leading cancer treatment and research centers in Europe
- U. S. Regulatory Continued progress and on-going preparations for expected submission of its New Drug Application to the FDA by the end of Q2 2012
- International Regulatory - Expanded addressable markets for the CHEMOSAT system with regulatory approval in Australia and certification in New Zealand; submitted CE Mark application for Generation Two of the CHEMOSAT System
- Leadership Team Expansion - Appointment of Graham G. Miao, Executive Vice President and Chief Financial Officer, Harold Mapes, Executive Vice President - Global Operations, and J. Chris Houchins, Senior Vice President - Clinical and Medical Affairs to the executive management team; appointment of Gabriel Leung to the Delcath Board of Directors; appointment of Gregory Gores, M.D. to the Delcath Medical Advisory Board
For the three months ended December 31, 2011, Delcath's operating loss was $16.0 million, which included $1.0 million in non-cash stock-based compensation expense. Operating loss for the three months ended December 31, 2010 was $9.5 million, which included approximately $1.6 million in non-cash stock-based compensation expense. General and administrative (G&A) expenses were $6.1 million for the fourth quarter of 2011, compared to $3.8 million for the same period in 2010. The increase was primarily due to an expansion in staff as the Company continued its progress in transitioning to a commercial enterprise, including initiation of our European commercialization efforts. Research and development (R&D) expenses were $9.8 million for the fourth quarter of 2011, compared to $5.8 million for the same period in 2010. The increase was primarily due to expanded research and development activities and regulatory expenses related to the preparation of our NDA submission for the FDA.
For the year ended December 31, 2011, the Company's operating loss was $46.5 million, which included approximately $4.3 million in non-cash stock-based compensation expense. Operating loss for the year ended December 31, 2010 was $30.7 million, which included approximately $5.5 million in non-cash stock-based compensation expense. G&A expenses were $21.3 million for the year ended December 31, 2011, compared to $13.2 million for the year ended December 31, 2010. R&D expenses were $25.2 million for the year ended December 31, 2011, compared to $17.6 million during the year ended December 31, 2010. Throughout 2010, the Companys R&D expenses primarily related to completing our Phase III clinical trial. The reduction in trial-related expenses during 2011 was more than offset by an increase in expenses related to expanded R&D activities and regulatory expenses related to the Companys NDA submission to the FDA.
At December 31, 2011, cash, cash equivalents and certificates of deposit were $30.8 million, compared to $45.6 million at December 31, 2010. On December 29, 2011, the Company established an At the Market financing program to sell up to $39.75 million in shares of the Companys common stock from time-to-time.
Conference Call and Webcast
The Company will host a conference call on March 9, 2012 at 10:00 a.m. ET. To participate in the live call by telephone, please dial 800-901-5259 for domestic participants and 617-786-4514 for international participants, both using passcode 96181474. To access the live webcast of the meeting, go to Delcath's website at www.delcath.com.
A taped replay of the conference call will also be available beginning approximately two hours after the call's conclusion and will be available for seven days. This replay can be accessed by dialing 888-286-8010 for domestic callers and 617-801-6888 for international callers, both using passcode 90238135. An archived webcast will also be available at www.delcath.com.
About Delcath Systems
Delcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath announced that its randomized Phase III clinical trial for patients with metastatic melanoma in the liver had successfully achieved the studys primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT System in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at www.delcath.com
