Corixa Announces Second-Quarter Financial Results.SEATTLE -- Corixa Corporation (Nasdaq:CRXA), a developer of immunotherapeutics, today announced financial results for the second quarter ended June 30, 2004. For the second quarter of 2004 Corixa reported total revenue of $5.8 million, compared with total revenue of $20.0 million for the second quarter of 2003. The decrease in 2004 second-quarter revenues compared with 2003 is due primarily to one-time milestone and reimbursement revenue received in the second quarter of 2003 from GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) following 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. approval of BEXXAR(R). Net loss applicable to common stockholders for the second quarter of 2004 was $10.6 million, compared with net loss of $20.9 million for the second quarter of 2003. The net loss for the second quarter of 2004 includes other income of $9.9 million which represents the $20 million payment received from Biogen IDEC Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec for the settlement of BEXXAR patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. net of the portion paid to other parties. The net loss for the second quarter of 2003 included a $12.6 million impairment charge associated with lease-related assets. Diluted net loss per common share for the second quarter of 2004 was $0.19, compared with diluted net loss per common share of $0.41 for the second 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 second quarter of 2004 were $10.4 million and $0.19, respectively, compared with net loss applicable to common stockholders and diluted net loss per common share of $7.9 million and $0.15, respectively, for the second quarter of 2003. Corixa co-promotion revenue or expense under its agreement with GSK for the sale of BEXXAR therapeutic regimen 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 sales, general and administrative expense for the quarter ended June 30, 2004. During the initial period of product availability, 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 second quarter of 2004 were $2.2 million, compared with first-quarter 2004 sales of $1.3 million - a 69 percent increase from the previous quarter. For the first six months of 2004, Corixa reported total revenue of $13.1 million, compared with total revenue of $29.1 million for the first six months of 2003. Net loss applicable to common stockholders for the first six months of 2004 was $31.7 million, compared with net loss of $39.9 million for the first six months of 2003. Diluted net loss per common share for the first six months of 2004 was $0.57, compared with diluted net loss per common share of $0.79 for the first six 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 six months of 2004 were $31.4 million and $0.56, respectively, compared with net loss applicable to common stockholders and diluted net loss per common share of $26.3 million and $0.52, respectively, for the first six 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 months ended June 30, 2004, and June 30, 2003, is included at the end of this press release. As of June 30, 2004, Corixa had $168.5 million in cash, cash equivalents and investments. "We continue to make progress toward achieving our long-term objectives for the Company," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "During the first six months of 2004, we moved two new potential products into human clinical trials, we secured additional funding from the National Institutes of Health for our innate immunity innate immunity n. Immunity that occurs naturally as a result of a person's genetic constitution or physiology and does not arise from a previous infection or vaccination. program, and completed a long-term, guaranteed supply agreement with GlaxoSmithKline for our 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. 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. . All of these accomplishments will contribute to the long-term success of Corixa." Second-Quarter Accomplishments --Initiated a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to test the safety and immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. activity of CRX-675 for seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. . CRX-675 is one of Corixa's proprietary compounds that interact with and trigger toll-like receptor Toll-like receptors (TLRs) are a class of single membrane-spanning non-catalytic receptors that recognize structurally conserved molecules derived from microbes once they have breached physical barriers such as the skin or intestinal tract mucosa, and activate immune cell 4 (TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) 4). --Signed a 12-year agreement with the Australian Nuclear Science and Technology Organization (ANSTO ANSTO Australian Nuclear Science and Technology Organisation ) to develop, market and sell BEXXAR in certain countries within Australasia, including Australia, China, India, Indonesia, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. and Singapore. Corixa also granted ANSTO co-exclusive rights to supply BEXXAR to Japan, South Korea and Taiwan. --Presented research at the 40th annual meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) showing that therapy with two standard chemotherapeutic regimens, each followed by a single treatment with the BEXXAR therapeutic regimen, produced complete responses in 80 percent to 83 percent of patients when used as front-line, initial treatment for 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. B-cell 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 . --Appointed Christof Marre as vice president of marketing. In this position, Marre will lead Corixa's domestic and international marketing and strategic planning Strategic planning is an organization's process of defining its strategy, or direction, and making decisions on allocating its resources to pursue this strategy, including its capital and people. efforts for the company's commercial programs, including BEXXAR. Recent Accomplishments --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(R). The agreement, which runs through 2012, guarantees payment 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). Conference Call Corixa will hold a conference call and webcast to discuss the second-quarter financial results on August 3, 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) 314-7867 or (719) 867-0640. 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 177386. The call will be rebroadcast until 12 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT August 12th. About Corixa Corixa is a biopharmaceutical company developing oncology and immunology products that manage human diseases. On June 30, 2003, Corixa announced that the FDA approved BEXXAR 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 refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. to Rituximab and has relapsed following chemotherapy. 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. 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 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 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 March 31, 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 Six months ended
June 30, June 30,
------------------- -----------------------
2004 2003 2004 2003
--------- --------- ----------- -----------
Revenue:
Collaborative agreements $5,120 $19,537 $11,613 $27,605
Government grants and
contracts 712 472 1,503 1,529
--------- --------- ----------- -----------
Total revenue 5,832 20,009 13,116 29,134
Operating expenses:
Research and development 17,363 23,322 37,586 48,267
Sales, general and
administrative 7,859 4,992 15,004 8,434
Impairment of lease-
related assets - 12,564 - 12,564
--------- --------- ----------- -----------
Total operating
expenses 25,222 40,878 52,590 69,265
--------- --------- ----------- -----------
Loss from operations (19,390) (20,869) (39,474) (40,131)
Interest income 870 707 1,825 1,532
Interest expense (1,813) (479) (3,594) (737)
Other income, net 9,891 18 9,891 18
--------- --------- ----------- -----------
Net loss (10,442) (20,623) (31,352) (39,318)
Preferred stock dividend (125) (326) (380) (602)
--------- --------- ----------- -----------
Net loss applicable to
common stockholders $(10,567) $(20,949) $(31,732) $(39,920)
========= ========= =========== ===========
Basic and diluted net loss
per common share $(0.19) $(0.41) $(0.57) $(0.79)
========= ========= =========== ===========
Shares used in computation of basic
and diluted net loss
per common share 55,979 51,481 55,739 50,535
========= ========= =========== ===========
June 30, Dec. 31,
2004 2003
----------- ----------
Balance Sheet Data:
Cash, cash equivalents and securities
available-for-sale $168,464 $191,985
Working capital 78,356 107,519
Total assets 242,180 250,566
Long-term obligations less current portion 120,635 108,138
Accumulated deficit (1,225,912) (1,194,560)
Total stockholders' equity 49,696 80,956
Three months ended Six months ended
June 30, June 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 $(10,567) $(20,949) $(31,732) $(39,920)
Impairment of lease-
related assets - 12,564 - 12,564
Intangible asset and
leasehold amortization 182 449 364 944
Deferred compensation
amortization 4 80 14 139
--------- --------- ----------- -----------
Net loss excluding
acquisition related
charges $(10,381) $(7,856) $(31,354) $(26,273)
========= ========= =========== ===========
Basic and diluted net loss per share
excluding acquisition
related charges $(0.19) $(0.15) $(0.56) $(0.52)
========= ========= =========== ===========
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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