Corixa Reports Strong Fourth Quarter and Year-End Results; Revenue in 2001 Increased 57 Percent; Results Within Provided Earnings Estimates.Business/High-Tech Editors, Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Jan. 31, 2002 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced results for the fourth quarter and year ended December 31, 2001. For the fourth quarter of 2001, Corixa reported total revenue of $14.9 million compared with total revenue of $11.6 million for the fourth quarter of 2000. Net loss applicable to common stockholders for the fourth quarter of 2001 was $34.1 million, compared to $646.7 million for the fourth quarter of 2000. The change in the fourth quarter net loss compared with a year ago was due primarily to a one-time charge of $629.7 million for in-process research and development related to Corixa's December 22, 2000 acquisition of Coulter Pharmaceutical, Inc. Diluted net loss per common share for the fourth quarter of 2001 was $0.83 compared with diluted net loss per common share of $27.81 for the fourth quarter of 2000. Excluding acquisition related charges such as intangible and deferred compensation amortization, net loss applicable to common stockholders for the fourth quarter of 2001 was $18.8 million, which represents a net loss per share of $0.46. For fiscal year 2001, Corixa's total revenue was $58.1 million, compared to total revenue of $37 million for fiscal year 2000. Net loss applicable to common stockholders was $149.8 million compared with $677.1 million for fiscal year 2000. The change in the net loss compared with a year ago was primarily due to a one-time charge of $629.7 million for in-process research and development related to Corixa's December 22, 2000 acquisition of Coulter Pharmaceutical Inc. Diluted net loss per common share for 2001 was $3.66 compared to diluted net loss per common share of $32.30 for 2000. Excluding acquisition related charges such as intangible and deferred compensation amortization, net loss applicable to common stockholders for fiscal year 2001 was $80.4 million, which represents a net loss per share of $1.96. The increase in revenue for the fourth quarter of 2001 and fiscal year 2001 was primarily due to revenue recognized from collaborative agreements with GlaxoSmithKline, Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. , Wyeth Lederle Vaccines and Zenyaku Kogyo. At December 31, 2001, Corixa had $121 million in cash, cash equivalents and investments. In addition to the $121 million, Corixa secured a $75 million equity line of credit from BNY BNY Bank of New York Capital Markets, a subsidiary of the Bank of New York The Bank of New York, abbrieviated to BNY, was a global financial services company that existed until its merger with the Mellon Financial Corporation on July 2, 2007.[1] The bank now continues under the new name of The Bank of New York Mellon Corporation. , that has not yet been accessed. "We are pleased with our progress in 2001 -- progress marked by advancement in the clinic, continued innovation in the lab and expanded development and marketing collaborations," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We continued to make progress in moving multiple programs through various stages of clinical study and benefited by expanding our discovery efforts in new disease fields. In addition, we continued to strive to diminish the impact of adverse market and industry trends with the addition of new collaborations and opportunities as demonstrated through our Bexxar and Metastron agreements with Amersham Health, our enhanced adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. license agreement with Wyeth Lederle Vaccines and our recently announced license and collaboration agreement with Beaufour Ipsen. Our cash position remains strong, affording us an opportunity to further expand our product development in the coming year and deliver on our goal of bringing leading immunotherapies to patients worldwide." 2001 in Review Products and Programs in Development Bexxar(R), an investigational radioimmunotherapy for the treatment of non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma , continued to demonstrate improved clinical responses in a variety of study settings while it remains under review for approval by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). For example, Bexxar demonstrated improved clinical responses in chemotherapy refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. non-Hodgkin's lymphoma patients in a study conducted at the University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. Cancer Center and published in the Journal of Clinical Oncology The Journal of Clinical Oncology is a medical journal published by the American Society of Clinical Oncology. The Journal was founded in 1983 and publishes original research and review articles on topics relating to cancer. It is published 3 times a month. . Research presented at the American Society of Hematology 43rd annual meeting also showed durable responses with Bexxar alone or when used following various chemotherapies for treatment of low-grade non-Hodgkin's lymphoma. Corixa also recently announced that the Oncologic Drugs Advisory Committee will review in February 2002, completed Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial data and a proposed second Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the design for Melacine(R), Corixa's therapeutic melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. vaccine. Corixa announced in February 2001, Melacine's commercial availability in Canada. In addition to its near-term oncology programs, Corixa continued to demonstrate its commitment to product developments for autoimmune and infectious diseases infectious diseases: see communicable diseases. with the progress of additional clinical studies for psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the and hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic . Moreover, Corixa reported positive preliminary Phase III results for its RC-529 synthetic adjuvant in vaccination to prevent hepatitis B infection. Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II results for PVAC PVAC Polyvinyl Acetate PVAC Petaluma Valley Athletic Club PVAC Professional Video Analyzing Computer PVAC Pajaro Valley Arts Council (Watsonville, CA) PVAC Peninsula Volunteer Ambulance Corps (Rockaway, NY) (TM) treatment suggested that the therapy was well tolerated and suggested clinical benefit at certain doses in patients suffering from psoriasis. Partnerships Corixa also entered into several new relationships in 2001 and reported progress and expansion of existing collaborations, including agreements with Kirin Brewery Co., Ltd., SPAWAR SPAWAR Space & Naval Warfare Systems Command (US Navy) SPAWAR Space Warfare , Organon, Amersham Health, Wyeth Lederle Vaccines, and the pharmaceutical division of Japan Tobacco Inc, as well as Beaufour Ipsen in January 2002. Technology Corixa continued to strengthen its patent estate by receiving multiple patents from the U.S. Patent and Trademark Office. Some of the 32 U.S. patents Corixa received in 2001 included claims covering a chemokine receptor Chemokine receptor A receptor on the surface of some types of immune cells that helps to mediate entry of HIV into the cell. Mentioned in: AIDS polypeptide polypeptide: see peptide. for vaccination therapy of certain autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma , a chlamydia chlamydia (kləmĭd`ēə), genus of microorganisms that cause a variety of diseases in humans and other animals. Psittacosis, or parrot fever, caused by the species Chlamydia psittaci, vaccine, and 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. Conference Call Corixa's earnings conference call and web cast will take place on January 31, 2002 at 8 a.m. ET/5 a.m. PT. Participants can access the call by dialing 888/202-2422 (domestic) and 913/981-5592 (international), passcode 595669. Web cast participants can sign up at the Investors page of Corixa's web site at http://www.corixa.com/default.asp?pid=investor. Individuals who are unable to participate in the conference call can access a recorded rebroadcast by going to the Investors page of Corixa's web site (www.corixa.com) or by dialing 888/203-1112 (domestic) and 719/457-0820 (international), passcode 595669. The call will be rebroadcast until 12 a.m. ET, February 5, 2002. About Corixa Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause , cancer and infectious diseases by understanding and directing the immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . Corixa is focused on immunotherapeutic im·mu·no·ther·a·py n. pl. im·mu·no·ther·a·pies Treatment of disease by inducing, enhancing, or suppressing an immune response. im products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a stand-alone basis. Corixa currently has 16 programs in clinical development and 22 programs in preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington  This page is protected from moves until disputes have been resolved on the .The reason for its protection is listed on the protection policy page. , with additional operations in Hamilton, Montana Hamilton is a city in Ravalli County, Montana, United States. The population was 3,705 at the 2000 census. It is the county seat of Ravalli CountyGR6. History Hamilton was founded by copper king Marcus Daly in the late 19th century. and South San Francisco, California South San Francisco is a city in San Mateo County, California, United States, located on the San Francisco Peninsula in the San Francisco Bay Area. The population was 60,552 at the 2000 census. . For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations Investor relations The process by which the corporation communicates with its investors. information line at 1.877.4CORIXA or 877/426-7492. Forward Looking Statements Except for the historical information presented, certain matters discussed in this press release, including statements about our future product development, statements about expected regulatory approval timelines, statements about the potential efficacy and safety of our product candidates and statements about our future operating results are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa's actual results include, but are not limited to, the risk we are unable to commercialize our product candidates, the risk of delay or rejection of our product candidates in the regulatory approval process, the risk that clinical trials of our product candidates do not successfully demonstrate the safety or efficacy of those product candidates, the risk that our future operating results will vary from quarter to quarter and the other "Factors Affecting Our Operating Results, Our Business and Our Stock Price," described in Corixa's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended September 30, 2001, copies of which are available from Corixa's investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.
Corixa Corporation
Consolidated Statement of Operations
(In thousands except per share data)
(Unaudited)
Three months ended Twelve months ended
December 31, December 31,
2001 2000 2001 2000
-------------------------------------------
Revenue:
Collaborative
agreements $14,150 $10,919 $55,128 $34,643
Government grants 741 656 2,937 2,331
------- ------- ------- -------
Total revenue 14,891 11,575 58,065 36,974
Operating expenses:
Research and
development 30,154 16,705 138,621 61,911
Sales, general and
administrative 4,479 2,195 18,866 6,694
Unconsolidated
joint business 1,577 -- 3,495 --
Intangible
amortization 14,398 2,167 57,625 4,499
Acquired in-process
research and
development -- 629,700 -- 629,700
------- ------- ------- -------
Total operating
expenses 50,608 650,767 218,607 702,804
------- ------- ------- -------
Loss from operations (35,717) (639,192) (160,542) (665,830)
Interest income 1,433 1,878 9,349 5,378
Interest expense (447) (294) (2,295) (810)
Other income 486 286 5,451 431
------- ------- ------- -------
Loss before cumulative
effect of change in
accounting principle (34,245) (637,322) (148,037) (660,831)
Cumulative effect of
change in accounting
principle -- -- -- (6,338)
------- ------- ------- -------
Net loss (34,245) (637,322) (148,037) (667,169)
Preferred stock
dividend 145 (9,419) (1,730) (9,887)
------- ------- ------- -------
Net loss applicable
to common
stockholders $(34,100) $(646,741) $(149,767) $(677,056)
======== ========= ========= =========
Basic and diluted loss
per share before
cumulative effect of
change in accounting
principle $(0.83) $(27.81) $(3.66) $(32.00)
Cumulative effect of
change in accounting
principle per share -- -- -- (0.30)
Basic and diluted net
loss per common share $(0.83) $(27.81) $(3.66) $(32.30)
======== ========= ========= =========
Shares used in
computation of basic
and diluted net loss
per common share 41,311 23,254 40,961 20,961
======== ========= ========= =========
December 31, December 31,
2001 2000
--------------------------------
Balance Sheet Data:
Cash, cash equivalents and
securities available-for-sale $121,064 $197,078
Working capital 53,946 146,844
Total assets 367,382 504,334
Long-term obligations less
current portion 27,657 33,422
Accumulated deficit (903,242) (755,205)
Total stockholders' equity 281,765 404,575
Three months ended Twelve months ended
December 31, 2001 December 31, 2001
---------------------------------------
Reconciliation of net loss
to net loss excluding Coulter
acquisition related charges:
Net loss applicable to
common stockholders $(34,100) $(149,767)
Intangible amortization 13,660 54,675
Deferred compensation
amortization 1,612 14,648
-------- ---------
Net loss excluding
acquisition related charges $(18,828) $(80,444)
======== =========
Basic and diluted net loss
per share excluding acquisition
related charges $(0.46) $(1.96)
-------- ---------
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