Corixa Announces Third-Quarter Financial Results.SEATTLE -- Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced financial results for the third quarter ended September 30, 2004. For the third quarter of 2004 Corixa reported total revenue of $8.9 million, compared with total revenue of $7.4 million for the third quarter of 2003. Net loss applicable to common stockholders for the third quarter of 2004 was $20.5 million, compared with net loss of $28.1 million for the third quarter of 2003. The net loss for the third quarter of 2003 included a $5.9 million impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. charge associated with sub-leasing of an additional 17,000 square feet of improved space in 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. . Diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. net loss per common share for the third quarter of 2004 was $0.37, compared with diluted net loss per common share of $0.51 for the third quarter of 2003. Excluding acquisition-related charges, such as intangible and deferred compensation amortization and a lease-related impairment charge, net loss applicable to common stockholders and diluted net loss per common share for the third quarter of 2004 were $20.3 million and $0.36, respectively, compared with net loss applicable to common stockholders and diluted net loss per common share of $21.9 million and $0.40, respectively, for the third quarter of 2003. Corixa co-promotion revenue or expense under its agreement with GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) for the sale of BEXXAR(R) therapeutic regimen regimen /reg·i·men/ (rej´i-men) a strictly regulated scheme of diet, exercise, or other activity designed to achieve certain ends. reg·i·men n. 1. 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. is determined based on the calculation of joint profit or loss, which is included in revenue for the quarter ended September 30, 2004. Until product sales increase, Corixa expects to record losses from the joint business agreement, reflecting increased expenses for the cost of co-promotion revenue, promotion, education and training. BEXXAR sales in the third quarter of 2004 were $2.5 million, compared with second-quarter 2004 sales of $2.2 million. For the first nine months of 2004, Corixa reported total revenue of $22 million, compared with total revenue of $36.5 million for the first nine months of 2003. Net loss applicable to common stockholders for the first nine months of 2004 was $52.2 million, compared with net loss of $68.0 million for the first nine months of 2003. Diluted net loss per common share for the first nine months of 2004 was $0.94, compared with diluted net loss per common share of $1.31 for the first nine months of 2003. Excluding acquisition-related charges, such as intangible and deferred compensation amortization, and a lease-related impairment charge, net loss applicable to common stockholders and diluted net loss per common share for the first nine months of 2004 were $51.7 million and $0.93, respectively, compared with net loss applicable to common stockholders and diluted net loss per common share of $48.2 million and $0.93, respectively, for the first nine months of 2003. 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 with the respective non-GAAP amounts for the three and nine months ended September 30, 2004, and September 30, 2003, is included at the end of this press release. As of September 30, 2004, Corixa had $134.4 million in cash, cash equivalents and investments. "We are pleased with our commercial progress to date within our 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. product franchise and look forward to the role this business will play in the overall success of our company," said Steve Gillis, Ph.D., chairman and chief executive officer of Corixa. "While BEXXAR sales increased in the third quarter, sales growth occurred at a slower rate than expected. As a result, we are focusing our efforts on refining several commercial strategic options to more effectively facilitate product adoption. These include intensified in·ten·si·fy v. in·ten·si·fied, in·ten·si·fy·ing, in·ten·si·fies v.tr. 1. To make intense or more intense: effort toward recruitment of physician advocates and speakers, patient outreach and education as well as continued collaboration with radiopharmacies, publication of clinical trial data and progress on the expanded labeling for BEXXAR." Recent Progress --Entered into a new manufacturing and guaranteed supply agreement with GlaxoSmithKline Biologicals (GSK) covering the production of Corixa's flagship adjuvant, monophosphoryl lipid A Lipid A is a lipid component of an endotoxin held responsible for toxicity of Gram-negative bacteria. It is the innermost of the three regions of the lipopolysaccharide (LPS, also called endotoxin) molecule, and its hydrophobic nature allows it to anchor the LPS to the outer , or 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). The agreement, which runs through 2012, guarantees payments to Corixa for supplying GSK with increasing annual quantities of MPL peaking in 2008 at the current maximum output of Corixa's 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. , MPL manufacturing facility (approximately 2 kilograms/year). --Filed with and received acceptance from 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. ) of a supplemental Biologics License Application for expanded use of the BEXXAR therapeutic regimen. Corixa has requested approval for BEXXAR's expanded use in treatment of patients with relapsed or refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. low grade, 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. , or transformed CD20 positive 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 , whose disease has relapsed following chemotherapy. The BEXXAR therapeutic regimen is currently indicated for the treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to the antibody treatment Rituximab and has relapsed following chemotherapy. An FDA decision is expected in January 2005. --Following the close of the quarter, GSK and Corixa announced the publication of proof of concept data published in the October 16 issue of The Lancet lancet /lan·cet/ (lan´set) a small, pointed, two-edged surgical knife. lan·cet n. in which researchers reported that GSK's malaria vaccine Malaria vaccines are an area of intensive research, however, no effective vaccine has yet been introduced into clinical practice. Justification for malaria vaccine research candidate containing Corixa's MPL adjuvant protected a significant percentage of children against uncomplicated malaria malaria, infectious parasitic disease that can be either acute or chronic and is frequently recurrent. Malaria is common in Africa, Central and South America, the Mediterranean countries, Asia, and many of the Pacific islands. , infection, and even severe forms of the disease for at least six months. This was the largest malaria vaccine efficacy trial ever conducted in Africa and re-confirmed the vaccine's safety in one-to-four year old children. --The Company also recently announced that the Committee For Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use the scientific body of the European Medicines Evaluation Agency, issued a positive opinion for Fendrix(R), GSK's vaccine for the prevention of 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 . Fendrix is a novel vaccine, containing Corixa's MPL(R) adjuvant, that is designed to prevent infection from hepatitis B in high-risk groups high-risk group Epidemiology A group of people in the community with a higher-than-expected risk for developing a particular disease, which may be defined on a measurable parameter–eg, an inherited genetic defect, physical attribute, lifestyle, habit, 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. This positive opinion represents an important step in the continuing commercial development of Corixa's MPL adjuvant, which is included in several late stage vaccine product candidates. Conference Call Corixa will hold a conference call and webcast to discuss its third-quarter financial results on November 4, 2004 at 5 p.m. EDT/2 p.m. PDT PDT abbr. Pacific Daylight Time PDT Pacific Daylight Time PDT n abbr (US) (= Pacific Daylight Time) → hora de verano del Pacífico PDT . The live conference call can be accessed by calling (800) 289-0493 or (913) 981-5510. Webcast participants can sign up at the Investors page of Corixa's Web site (http://www.corixa.com/default.asp?pid=invest). A recorded replay of the conference call can be accessed through the Web site, or by dialing (888) 203-1112 or (719) 457-0820 and entering confirmation code 898211. The call will be rebroadcast through November 12, 2004. About Corixa Corixa is a biopharmaceutical company developing oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. and immunology immunology, branch of medicine that studies the response of organisms to foreign substances, e.g., viruses, bacteria, and bacterial toxins (see immunity). Immunologists study the tissues and organs of the immune system (bone marrow, spleen, tonsils, thymus, lymphatic products that manage human diseases. Corixa currently markets BEXXAR therapeutic regimen for the treatment of patients with CD20 positive, follicular, NHL NHL Non-Hodgkin's lymphoma, see there , with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy. 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 standalone stand·a·lone adj. Self-contained and usually independently operating: a standalone computer terminal. basis. In addition to BEXXAR, Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials. 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, with additional operations in Hamilton, Mont., and South San Francisco. For more information, please visit Corixa's Web site at www.corixa.com. Corixa 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. This press release contains forward-looking statements, including statements regarding the commercial potential for BEXXAR, the contribution of recent accomplishments to our long term success, and our plans, objectives, intentions and expectations. 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 our Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended June 30, 2004, copies of which are available from our 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 Nine months ended
September 30, September 30,
------------------- -----------------------
2004 2003 2004 2003
--------- --------- ----------- -----------
Revenue:
Collaborative agreements $8,130 $6,996 $19,743 $34,600
Government grants and
contracts 739 395 2,242 1,924
--------- --------- ----------- -----------
Total revenue 8,869 7,391 21,985 36,524
Operating expenses:
Research and development 18,040 21,037 55,626 69,932
Sales, general and
administrative 9,913 6,558 24,919 15,242
Impairment of lease-
related assets - 5,927 - 18,491
--------- --------- ----------- -----------
Total operating
expenses 27,953 33,522 80,545 103,665
--------- --------- ----------- -----------
Loss from operations (19,084) (26,131) (58,560) (67,141)
Interest income 559 954 2,384 2,486
Interest expense (1,824) (1,716) (5,417) (2,453)
Other income, net (31) (866) 9,860 31
--------- --------- ----------- -----------
Net loss (20,380) (27,759) (51,733) (67,077)
Preferred stock dividend (124) (316) (504) (918)
--------- --------- ----------- -----------
Net loss applicable to
common stockholders $(20,504) $(28,075) $(52,237) $(67,995)
========= ========= =========== ===========
Basic and diluted net loss
per common share $(0.37) $(0.51) $(0.94) $(1.31)
========= ========= =========== ===========
Shares used in computation of basic
and diluted net loss
per common share 55,777 54,875 55,811 51,709
========= ========= =========== ===========
September December
30, 31,
2004 2003
----------- -----------
Balance Sheet Data:
Cash, cash equivalents and securities
available-for-sale $134,436 $191,985
Working capital 76,035 107,519
Total assets 209,159 250,566
Long-term obligations less current portion 119,639 108,138
Accumulated deficit (1,246,293) (1,194,560)
Total stockholders' equity 29,974 80,956
Three months ended Nine months ended
September 30, September 30,
------------------- -----------------------
2004 2003 2004 2003
--------- --------- ----------- -----------
Non-GAAP Financial Measures:
Reconciliation of net loss
to net loss excluding acquisition
related charges:
Net loss applicable to
common stockholders $(20,504) $(28,075) $(52,237) $(67,995)
Impairment of lease-
related assets - 5,927 - 18,491
Intangible asset and
leasehold amortization 182 218 545 1,162
Deferred compensation
amortization 1 31 15 170
--------- --------- ----------- -----------
Net loss excluding
acquisition related
charges $(20,321) $(21,899) $(51,677) $(48,172)
========= ========= =========== ===========
Basic and diluted net loss per share
excluding acquisition
related charges $(0.36) $(0.40) $(0.93) $(0.93)
========= ========= =========== ===========
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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