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Biotech / Medical : Corixa [CRXA] - cancer vaccines

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To: SemiBull who wrote (128)1/31/2002 7:19:52 PM
From: SemiBull   of 222
 
Corixa Reports Strong Fourth Quarter and Year-End Results

Revenue in 2001 Increased 57 Percent

Results Within Provided Earnings Estimates

SEATTLE--(BW HealthWire)--Jan. 31, 2002--Corixa Corporation (Nasdaq:CRXA - news), 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, 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 Capital Markets, a subsidiary of the Bank of New York, 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 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®, an investigational radioimmunotherapy for the treatment of 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). For example, Bexxar demonstrated improved clinical responses in chemotherapy refractory non-Hodgkin's lymphoma patients in a study conducted at the University of Michigan Cancer Center and published in the Journal of Clinical Oncology. 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 trial data and a proposed second Phase III clinical trial design for Melacine®, Corixa's therapeutic melanoma 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 with the progress of additional clinical studies for psoriasis and hepatitis B. 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 results for PVAC(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, 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 polypeptide for vaccination therapy of certain autoimmune disease, a chlamydia 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 corixa.com. 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, cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic 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 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, with additional operations in Hamilton, Montana and South San Francisco, California. For more information, please visit Corixa's Website at www.corixa.com or call the company's investor relations 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 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 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)
-------- ---------


--------------------------------------------------------------------------------
Contact:
Corixa Corporation
Jim DeNike, 206/754-5716
denike@corixa.com
or
FitzGerald Communications Inc.
A.J. Desjardins, 415/845-4416
ajdesjardins@fitzgerald.com
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