4:03 pm Eastern Time
SEATTLE--(BW HealthWire)--August 9, 2001-- Corixa Corporation (Nasdaq: CRXA - news), a developer of immunotherapeutics, today announced results for the second quarter ended June 30, 2001.
For the second quarter, Corixa reported total revenue of $15.6 million compared with total revenue of $7.9 million for the prior year period. Net loss applicable to common stockholders for the second quarter was $32.4 million compared with $8.8 million for the second quarter of 2000. Excluding intangible amortization related to the acquisition of Coulter Pharmaceutical, Inc., net loss applicable to common stockholders for the second quarter was $18.8 million, which represents a net loss per share of $0.46. Including intangible amortization, basic and diluted net loss per common share for the second quarter was $0.79 compared with $0.43 in the prior period. As discussed in Corixa's 2000 year-end earnings announcement, the results for the quarter and six months ended June 30, 2000 have been restated to reflect Corixa's adoption of the Securities and Exchange Commission Staff Accounting Bulletin No. 101 as of January 1, 2000.
At the end of the quarter, Corixa had approximately $155 million in cash, cash equivalents and investments. This balance is after year-to-date operating expenses and first quarter payments of $2.7 million to settle the Bitterroot environmental litigation remaining from the Ribi acquisition, and an $8.7 million debt retirement. After the end of the second quarter, Corixa replaced the retired debt with a $7.5 million line of credit.
The increase in revenue for the second quarter was due primarily to collaborative agreements with GlaxoSmithKline, Medicis Pharmaceutical Corporation, Zenyaku Kogyo and Purdue Pharma.
``Results of the second quarter demonstrated our ability to simultaneously meet stated company objectives, advance existing initiatives and generate additional areas of growth,'' said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. ``By continuing to focus on advancing our near-term products, broadening our product pipeline and executing on our partnering strategy, we believe that we minimize the impact of current market conditions on Corixa and position ourselves for long-term success.''
Corixa expects its quarterly revenues to continue to vary as it enters into new agreements, reaches certain research and development milestones and receives committed and future license and research and development payments.
Program Updates and Second Quarter Milestones
Bexxar
In a separate press release issued today, Corixa and GlaxoSmithKline announced the recent submission of documentation, data and analyses to the U.S. Food and Drug Administration (FDA) in support of the response to the FDA's Complete Review Letter received on March 16, 2001 regarding the Biologics License Application (BLA) for Bexxar(TM). The submission contains a complete response to all questions raised regarding the Chemistry, Manufacturing and Controls section of the BLA, and to a majority of the questions regarding the Clinical section of the BLA. The remainder of the response will be submitted following final compilation of an independent review of clinical response data from two recently completed Bexxar trials, as well as technical database information which was discussed by the agency in the last week. Corixa expects to submit the remainder of the response shortly. Additionally, the companies expect the review period will commence upon FDA acceptance of all data submitted in response to the FDA's Complete Review Letter.
On July 12, Corixa and Nycomed Amersham Imaging announced an agreement in which Corixa's U.S. sales force is co-promoting Nycomed Amersham's METASTRON® (strontium-89 chloride injection) for the palliation of metastatic bone pain. Corixa will receive financial incentives based on specified sales levels. This agreement fulfills the Company's previous commitment to contract the services of its sales force while Bexxar continues to undergo regulatory review. In addition to increasing the reach of an important palliative agent for metastatic bone pain, the agreement allows the company to leverage its expertise in oncology and further solidify long-term relationships with key oncologists and physicians as it continues to pursue approval for Bexxar.
Patent Update
Corixa also announced today in a separate press release that the U.S. Patent and Trademark Office (USPTO) has issued the Company three patents, including a method potentially useful in establishing the optimal radiation dose given to a patient based on the patient's specific traits - a method used in administering Bexxar.
The first patent awarded to Corixa -- U.S. Patent 6,251,362 -- relates to the administration of radiopharmaceutical compounds for the therapy of cancer and other diseases and covers the administration and dosing of radiopharmaceuticals to minimize toxicity while keeping the dosage high enough to successfully treat the disease. The patent covers a variety of methods of determining radioisotope levels in patients after therapeutic administration, including but not limited to imaging. Additional patents issued today include U.S. Patents 6,262,245 and 6,261,562 covering DNA sequences and methods of use for multiple prostate antigens potentially useful as vaccine or antibody targets.
In addition to the patent announcements made today, Corixa announced on April 30th that the USPTO issued the Company a patent covering the use of certain gene sequences for the detection of lung cancer and another covering certain of its discoveries potentially useful in the diagnosis and treatment of Babesia microti (B. microti) and Ehrlichia infections.
Kirin Parnership
Corixa and Kirin Brewery Co., Ltd., announced on June 21st an agreement to discover and develop fully human monoclonal antibodies directed against targets from Corixa's extensive library of autoimmune disease, cancer and infectious disease antigens. Kirin will contribute its new TC Mouse® technology, including the KM Mouse(TM), a new crossbred mouse developed by Kirin and Medarex, Inc., to the multi-year agreement that's designed to generate, screen and characterize fully human monoclonal antibodies directed against Corixa's antigens. Corixa has option rights to exclusively develop and commercialize antibodies created using the TC Mouse and KM Mouse. In return, Kirin will receive license fees and payments on achievement of certain milestones and royalties on product sales.
DARPA Contract
On June 11th, Corixa announced it has been awarded a $3.5 million, two-year contract from the Space and Naval Warfare (SPAWAR) Systems Center in San Diego. The contract is for a Defense Advanced Research Projects Agency (DARPA)-sponsored program to develop methods of enhancing immune responses to infectious diseases, including agents of biological warfare.
Melacine
On June 20, Corixa announced the completion of its year 2000 to May 2001 data sweep associated with its completed pivotal trial of Melacine® vaccine for Stage II melanoma in an effort to provide the FDA and its advisory panel reviewers with as up-to-date a data package as possible. Re-analysis of overall disease free survival including these new data, showed that Melacine continued to provide an improvement in overall disease free survival, although the statistical significance of that conclusion was lost with the convergence of the resultant disease free survival curves (p>0.05). However, analysis of clinical benefit following completion of the data sweep in patients who were positive for expression of either Class I MHC HLA A2 or C3 genes continues to show a highly statistically significant clinical benefit of Melacine vs. observation in terms of increased disease free survival (p=0.005). Furthermore, Corixa's analyses demonstrated a statistically significant improvement in overall survival in class I MHC HLA A2 or C3 positive patients that received Melacine vs. observation (p=0.003). As a result, Corixa has begun a discussion with FDA regarding the advisability of filing a BLA for accelerated approval of Melacine in patients that express either Class I MHC HLA A2 or C3 genes.
Conference Call
Corixa's earnings conference call and web cast will take place on Thursday, August 09, 2001 at 5:00 p.m. EDT/2:00 p.m. PDT. Participants can access the call by dialing 800.406.5356. Web cast participants can sign up at the Investors page of Corixa's web site at corixa.com. |
