Corixa Reports Strong Third Quarter Results; Revenue for the Third Quarter Up 76 Percent.Business Editors & Health/Medical Writers BIOWIRE2K SEATTLE--(BW HealthWire)--Oct. 31, 2001 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced results for the third quarter ended September 30, 2001 and the first nine months of 2001. For the third quarter of 2001, Corixa reported total revenue of $14 million compared with total revenue of $8 million for the third quarter of 2000. Net loss applicable to common stockholders for the third quarter of 2001 was $40.7 million, compared to $6.7 million for the third quarter of 2000. Diluted net loss per common share for the third quarter of 2001 was $0.99 compared with diluted net loss per common share of $0.32 for the third quarter of 2000. Excluding acquisition related charges associated with the Coulter Pharmaceutical, Inc. transaction, net loss applicable to common stockholders for the third quarter was $24.4 million, which represents a net loss per share of $0.59. As discussed in Corixa's 2000 year-end earnings announcement, the results for the quarter and nine months ended September 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. For the first nine months of 2001, Corixa's total revenue was $43.2 million, compared to total revenue of $25.4 million for the first nine months of 2000. For the first nine months of 2001, net loss applicable to common stockholders was $115.7 million compared with $30.3 million for the first nine months of 2000. Diluted net loss per common share for the first nine months of 2001 was $2.83 compared to diluted net loss per common share of $1.50 for the first nine months of 2000. The increase in revenue for the third quarter of 2001 and the first nine months of 2001 was primarily due to collaborative agreements with GlaxoSmithKline, Medicis, Zenyaku Kogyo and Purdue Pharma Purdue Pharma L.P., is privately-held pharmaceutical company founded by physicians. It is located in Stamford, Connecticut. Purdue is best known for painkillers, but they have also branched into other areas such as oncology and nutraceuticals. . At the end of the quarter, Corixa had more than $137.1 million in cash, cash equivalents and investments. "The third quarter marked continued progress for our clinical programs, as well as the successful execution of new and existing collaborations," stated Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "We continue to work with the 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. regarding Bexxar's potential approval, as well as a filing strategy for Melacine, while readying additional developments for advancement into human clinical trials." 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 Third Quarter Milestones Bexxar Corixa has received formal FDA acceptance of its response submitted in full on September 7 to the FDA's questions outlined in its Complete Review Letter of March 16, 2001. The FDA will now have up to six months from September 10, 2001 to provide a regulatory decision on Bexxar(R). The agenda for the December Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) has been set and includes issues that were postponed as a result of the September 11 events. Corixa continues to work with the FDA regarding a Bexxar presentation at ODAC and will provide further updates when one is scheduled. In a separate announcement issued October 29, 2001, Corixa and Amersham Health (formerly Nycomed Amersham Imaging) announced that they have entered into an agreement whereby Amersham Health will market Bexxar in Europe. Bexxar will be registered by Amersham Health under a different trade name in Europe. Under the terms of the agreement, Corixa and Amersham Health will cooperate to register the product in Europe for the treatment of certain types 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 . Corixa will be responsible for generation of clinical trial data to support registration in Europe. Amersham Health will be responsible for manufacture and sale of radiolabeled antibody in the territory. Amersham Health will purchase up to $15 million in Corixa common stock, a portion of which will be purchased at execution of the agreement at an undisclosed premium. Amersham Health will purchase the remaining portion of Corixa common stock at Corixa's election at time points in the future. In addition, Amersham Health will pay Corixa multi-million dollar milestone payments upon regulatory approvals in the territory as well as multi-million dollar milestone payments based on achievement of certain sales volume targets. Finally, Amersham Health will pay Corixa undisclosed royalties on all future product sales in Europe. Corixa has a co-development and co-marketing agreement for Bexxar in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. with GlaxoSmithKline. On September 12, Corixa and GlaxoSmithKline announced that they have filed a lawsuit against IDEC IDEC Instituto Brasileiro de Defesa do Consumidor (Portugese: Brazilian Consumer Protection Agency) IDEC Information Design & End-User Computing IDEC Interior Design Educators Council, Inc. Pharmaceuticals Corporation for patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. in connection with IDEC's Zevalin(TM) product for the treatment of non-Hodgkin's lymphoma. Through the lawsuit, Corixa and GlaxoSmithKline are asking the court to declare that IDEC is willfully willfully adv. referring to doing something intentionally, purposefully and stubbornly. Examples: "He drove the car willfully into the crowd on the sidewalk." "She willfully left the dangerous substances on the property." (See: willful) infringing Corixa's patents. The companies are seeking available remedies under the patent laws, including monetary damages Monetary damages, in civil law, refers to compensation given to an injured party by a liable party. Monetary damages may be restitution, a penalty, or both. and permanent injunctive relief injunctive relief n. a court-ordered act or prohibition against an act or condition which has been requested, and sometimes granted, in a petition to the court for an injunction. . Melacine In June, Corixa announced the completion of a 17 month data sweep associated with the completed pivotal trial of Melacine(R) vaccine for Stage II melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. . In an effort to provide the FDA and its advisory panel reviewers with as up-to-date a data package as possible, Corixa committed to obtain additional mortality and disease recurrence data on as many patients as possible in the database, prior to proceeding with completion of a BLA BLA abbr. Bachelor of Liberal Arts filing. Re-analysis of overall disease free survival including these new data, showed that Melacine continues to provide an improvement in overall disease free survival, although the statistical significance of that conclusion was lost (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 MHC major histocompatibility complex. MHC abbr. major histocompatibility complex MHC major histocompatibility complex. HLA HLA human leukocyte antigens. HLA abbr. human leukocyte antigen HLA (human leuckocyte antigen) A2 or C3 genes continued 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). Recent discussions between Corixa and the FDA regarding the outcome of this study indicate that approval of Melacine in the United States will require a confirmatory clinical trial in class I MHC HLA A2 and C3 positive patients. Multiple, national cooperative clinical trial groups have already pledged their support for such a study. Corixa will seek additional input from its worldwide development partner, Schering-Plough, and will continue discussions with the agency regarding the potential for cost recovery associated with such a study before reaching a final decision regarding the regulatory path for Melacine registration in the United States, as well as Corixa's continued support of the program. Corixa will continue to provide public updates when these discussions are completed and a final course of action is agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy with Schering-Plough and with the FDA. Patent Update On August 9, Corixa announced that the U.S. Patent and Trademark Office had 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. Agreements In a separate announcement issued October 29, 2001, Corixa and Wyeth Lederle Vaccines, a business unit of American Home For the American mortgage lender, see . The American Home is a center of intercultural exchange located in Vladimir, Russia. The home is designed to model a typical American suburban home and its main focus is the ESL school that provides lessons for Russian students. Products Corporation, announced the companies have amended their existing MPL 1. (language) MPL - An early possible name for PL/I. [Sammet 1969, p.542]. 2. MPL - MasPar data-parallel version of C. See also ampl. Compiler version 3.1. 3. MPL - Motorola Programming Language. (R) 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 to include Corixa's Ribi-529(TM) adjuvant, as well as newly added disease fields. The agreement grants Wyeth Lederle Vaccines the right to include Corixa's Ribi-529 adjuvant in vaccines to prevent or treat a variety of diseases, including certain infectious diseases infectious diseases: see communicable diseases. and one 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 . Under the restated agreement, Corixa also continues to grant Wyeth Lederle the right to include Corixa's MPL adjuvant in vaccines in several of these disease areas. On July 31, Corixa announced it had received a $1 million milestone payment as a result of its research collaboration and license agreement with the pharmaceutical division of Japan Tobacco Inc. to support Corixa's development of therapeutic lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. vaccines. Under the agreement, Corixa may receive a total of over $40 million in license fees, research funding Research funding is a term generally covering any funding for scientific research, in the areas of both "hard" science and technology and social science. The term often connotes funding obtained through a competitive process, in which potential research projects are evaluated and and milestone payments based upon successful clinical and commercial progress. On July 12, Corixa and Nycomed Amersham Imaging announced an agreement in which Corixa's U.S. sales force will co-promote Nycomed Amersham's METASTRON(R) for the palliation pal·li·ate tr.v. pal·li·at·ed, pal·li·at·ing, pal·li·ates 1. To make (an offense or crime) seem less serious; extenuate. 2. of metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. bone pain. Corixa will receive financial incentives based on specified sales levels. This agreement allows Corixa to contract out its U.S. sales force while Bexxar continues to undergo regulatory review. Conference Call Corixa's earnings conference call and web cast will take place on October 31, 2001 at 5 p.m. ET/2 p.m. PT. Participants can access the call by dialing 800/289-0496 (domestic) and 913/981-5519 (international), passcode 410270. 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 410270. The call will be rebroadcast until 1 a.m. ET, November 3, 2001. 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 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, including its most advanced product candidate, Bexxar, a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing conjugated conjugated adj. Conjugate. estrogens, conjugated Warning - Hazardous drug! C.E.S. to a radioisotope radioisotope: see radioactive isotope. Radioisotope (biology) A radioactive isotope used in studying living systems, such as in the investigation of metabolic processes. . 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 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 "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 June 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 Nine months ended
September 30, September 30,
--------------------- ---------------------
2001 2000 2001 2000
--------- --------- --------- ---------
(Restated) (Restated)
Revenue:
Collaborative
agreements $ 13,330 $ 7,460 $ 40,978 $ 23,724
Government grants 718 537 2,196 1,675
--------- --------- --------- ---------
Total revenue 14,048 7,997 43,174 25,399
Operating expenses:
Research and
development 37,248 14,038 108,467 45,206
Sales, general and
administrative 3,706 1,140 14,387 4,499
Unconsolidated joint
business 701 -- 1,918 --
Intangible
amortization 14,402 777 43,227 2,332
--------- --------- --------- ---------
Total operating
expenses 56,057 15,955 167,999 52,037
--------- --------- --------- ---------
Loss from operations (42,009) (7,958) (124,825) (26,638)
Interest income 2,347 1,522 7,916 3,500
Interest expense (593) (175) (1,848) (516)
Other income 228 57 4,965 145
--------- --------- --------- ---------
Loss before cumulative
effect of change in
accounting principle (40,027) (6,554) (113,792) (23,509)
Cumulative effect of
change in accounting
principle -- -- -- (6,338)
--------- --------- --------- ---------
Net loss (40,027) (6,554) (113,792) (29,847)
Preferred stock
dividend (625) (156) (1,875) (468)
--------- --------- --------- ---------
Net loss applicable to
common stockholders $ (40,652) $ (6,710) $(115,667) $ (30,315)
========= ========= ========= =========
Basic and diluted loss
per share before
cumulative effect of
change in accounting
principle $ (0.99) $ (0.32) $ (2.83) $ (1.19)
Cumulative effect of
change in accounting
principle per share -- -- -- (0.31)
Basic and diluted net
loss per common
share $ (0.99) $ (0.32) $ (2.83) $ (1.50)
========= ========= ========= =========
Shares used in
computation of basic
and diluted net loss
per common share 41,043 21,026 40,844 20,159
========= ========= ========= =========
September 30, December 31,
2001 2000
--------- ---------
Balance Sheet Data:
Cash, cash equivalents and securities
available-for-sale $ 137,193 $ 197,078
Working capital 80,966 146,844
Total assets 396,720 504,880
Long-term obligations less current portion 30,282 33,422
Accumulated deficit (868,997) (755,205)
Total stockholders' equity 308,628 404,575
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