Corixa Reports First Quarter Financial Results.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--May 12, 2003 Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced financial results for the first quarter ended March 31, 2003. For the first quarter of 2003, Corixa reported total revenue of $9.1 million compared with total revenue of $15.6 million for the first quarter of 2002. Net loss applicable to common stockholders for the first quarter of 2003 was $19.0 million, compared to $176.9 million for the first quarter of 2002, which included a goodwill impairment charge of $161.1 million. Diluted net loss per common share for the first quarter of 2003 was $0.38 compared with diluted net loss per common share of $4.25 for the first quarter of 2002. Excluding acquisition-related charges, such as intangible and deferred compensation amortization and the goodwill impairment charge, net loss applicable to common stockholders and diluted net loss per common share for the first quarter of 2003 were $18.4 million and $0.37, respectively, compared with net loss applicable to common stockholders and diluted net loss per common share of $14.3 million and $0.34, respectively, for the first quarter of 2002. A reconciliation of the Generally Accepted Accounting Principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting (GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). ) net loss and net loss per share to the respective non-GAAP amounts, for the three months ended March 31, 2003 and 2002 is set forth at the end of this press release. The decrease in revenue for the first quarter of 2003 compared with the prior year period was primarily due to the anticipated expiration of the funded research phases of Corixa's vaccine development collaborative agreement with GlaxoSmithKline, the expiration of certain collaborative agreements with Japan Tobacco, Zambon and The Infectious Disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. Research Institute and a decrease in reimbursement revenue from our collaborative agreement for BEXXAR(R) therapy with GlaxoSmithKline. These decreases were partially offset by an increase in research product revenue. As of March 31, 2003, Corixa had $101.1 million in cash, cash equivalents and investments. Corixa also continues to have access to, subject to certain conditions, 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. . As of March 31, 2003, draws under the credit line totaled $2.6 million. Corixa expects its quarterly revenues to continue to vary as it enters into new agreements, as existing agreements expire or are terminated, as it reaches future research and development milestones, and as it receives license and research development payments under existing and new agreements. "Although we incurred an anticipated decrease in revenue in the first quarter, the period was highlighted by progress in many areas, including closing steps toward product approval of BEXXAR(R) therapy, updated collaborations focused on product commercialization opportunities and further advancement and validation of key preclinical programs," said Steven Gillis, Ph.D., chairman and chief executive officer at Corixa. "We have the necessary financial strength to continue to advance our product pipeline, including the anticipated launch of BEXXAR therapy." First Quarter Developments: -- Appointment of Vaughn B. Himes, Ph.D., as Vice President, Worldwide Manufacturing; -- Reacquisition of the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. rights to certain lung cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine from Japan Tobacco; -- License of an antigen to 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. , L.P. for development of monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). for the treatment of a female reproductive tract cancer; -- Initiation of a Phase I clinical study with the Infectious Disease Research Institute to test the safety and tolerability of an investigational vaccine to treat or protect against various forms of human leishmaniasis leishmaniasis (lēsh'mənī`əsĭs), any of a group of tropical diseases caused by parasitic protozoans of the genus Leishmania. ; and -- Receipt of Orphan Medicinal Product medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. designation for BEXXAR (tositumomab and iodine I 131 tositumomab) therapy in Europe. On Monday, May 5, 2003, Corixa and GlaxoSmithKline announced that many of the steps required for approval of BEXXAR therapy are complete. However, the U.S. Food and Drug Administration has extended its review of the BEXXAR therapy application for up to an additional three months. The three-month extension provides additional time to further refine post marketing commitments and package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific language and to ensure that they are consistent with an updated safety database requested by 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. and submitted by Corixa in early April 2003. And in a separate announcement issued today, Corixa announced that its partner, GlaxoSmithKline Biologicals (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) Bio) has filed for regulatory approval of Fendrix(R) with the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ). Fendrix is a novel vaccine designed to prevent infection from 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 in high-risk groups such as pre-haemodialysis and haemodialysis Noun 1. haemodialysis - dialysis of the blood to remove toxic substances or metabolic wastes from the bloodstream; used in the case of kidney failure hemodialysis patients and it includes the GSK Bio hepatitis B antigen hepatitis B antigen Hepatitis B surface antigen, see there with the addition of Corixa's 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. . The Fendrix filing represents the first regulatory filing for approval of an infectious disease vaccine that contains Corixa's proprietary MPL adjuvant. Conference Call Corixa's earnings conference call and web cast will take place on May 12, 2003 at 5:00 pm ET/2:00 pm PT. Web cast participants can sign up at the Investors page (http://www.shareholder.com/corixa/medialist.cfm) of Corixa's web site. 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 or by dialing 888/203-1112 (domestic) or 719/457-0820 (international), passcode 424041. The call will be rebroadcast until midnight ET, May 19, 2003. 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 infectious diseases: see communicable 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 standalone basis. Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials. Corixa is currently seeking FDA approval of BEXXAR therapy, an investigational radioimmunotherapy that combines the targeting ability of 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 and the therapeutic potential of radiation, with patient-specific dosing. BEXXAR has been studied in patients with follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. low-grade 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 (NHL NHL Non-Hodgkin's lymphoma, see there ). Corixa was founded in 1994 and is headquartered in Seattle, with additional operations in Hamilton, Mont., and South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. . For more information, please visit Corixa's Web site at www.corixa.com. Corixa Forward Looking Statements Except for the historical information presented, certain matters discussed in this press release, including statements about the anticipated commercial release of BEXXAR, 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 that BEXXAR is not approved for commercial sale when and as expected and the "Important Factors That May Affect Our Business, Our Results of Operations and Our Stock Price," described in Corixa's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2002, copies of which are available from Corixa's investor relations Investor relations The process by which the corporation communicates with its investors. 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)
Three months ended
March 31,
-----------------------
2003 2002
----------- -----------
Revenue:
Collaborative agreements $8,068 $15,005
Government grants and contracts 1,057 561
----------- -----------
Total revenue 9,125 15,566
Operating expenses:
Research and development 25,219 26,814
Sales, general and administrative 3,506 5,239
Intangible asset amortization 110 110
Goodwill impairment - 161,060
----------- -----------
Total operating expenses 28,835 193,223
Loss from operations (19,710) (177,657)
Interest income 825 1,195
Interest expense (258) (550)
Other income 448 322
----------- -----------
Net loss (18,695) (176,690)
Preferred stock dividend (276) (226)
----------- -----------
Net loss applicable to common stockholders $(18,971) $(176,916)
=========== ===========
Basic and diluted net loss per common share $(0.38) $(4.25)
=========== ===========
Shares used in computation of basic net loss
per common share 50,228 41,596
=========== ===========
March 31, December
31,
2003 2002
----------- -----------
Balance Sheet Data:
Cash, cash equivalents and securities
available-for-sale $101,130 $116,757
Working capital 27,511 55,792
Total assets 173,315 196,106
Long-term obligations less current portion 5,723 6,920
Accumulated deficit (1,129,336) (1,110,641)
Total stockholders' equity 109,751 128,392
Three months ended
March 31,
-----------------------
2003 2002
----------- -----------
Non-GAAP Financial Measures:
Reconciliation of net loss to net loss
excluding acquisition related charges:
Net loss applicable to common stockholders $(18,971) $(176,916)
Goodwill impairment - 161,060
Intangible asset and leasehold amortization 495 495
Deferred compensation amortization 59 1,081
----------- -----------
Net loss excluding acquisition related charges $(18,417) $(14,280)
=========== ===========
Basic and diluted net loss per share excluding
acquisition related charges $(0.37) $(0.34)
=========== ===========
To supplement our consolidated financial statements presented on a
GAAP basis, Corixa uses non-GAAP measures of net loss and net loss per
share, which are adjusted to exclude certain expenses we believe
appropriate to enhance an overall understanding of our past financial
performance and also our prospects for the future. These adjustments
to our current period GAAP results are made with the intent of
providing both management and investors a more complete understanding
of Corixa's underlying operational results and trends and our
marketplace performance. For example, the non-GAAP results are an
indication of our baseline performance before other charges that are
considered by management to be outside of our core operating results.
In addition, these adjusted non-GAAP results are among the primary
indicators management uses as a basis for our planning and forecasting
of future periods. The presentation of this additional information is
not meant to be considered in isolation or as a substitute for net
loss or net loss per share prepared in accordance with generally
accepted accounting principles in the United States.
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