Dendreon Corporation Reports Third Quarter 2003 Financial Results & Highlights Recent Company Milestones.Business Editors BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Nov. 6, 2003 Dendreon Corporation (Nasdaq:DNDN) today reported results for the quarter ended Sept. 30, 2003, and provided an overview of recent company achievements. Revenues for the third quarter of 2003 were $1.8 million compared to $5.0 million for the quarter ended Sept. 30, 2002. Revenues for the third quarter of 2003 were from Dendreon's research collaboration with Kirin Brewery Co., Ltd. The net loss for the quarter ended Sept. 30, 2003, was $13.9 million, or $0.35 per share, compared to a net loss of $5.2 million, or $0.20 per share, for the quarter ended Sept. 30, 2002. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the third quarter of 2003 were $15.9 million compared to $10.3 million for the same period in 2002. The difference of $5.6 million included $1.8 million of in-process research and development expenses associated with the July 30, 2003, acquisition of Corvas International, Inc. Research and development expenses were $9.3 million for the third quarter of 2003 compared to $7.6 million for the same period in 2002. General and administrative expenses were $4.7 million for the third quarter of 2003 compared to $2.5 million for the same period in 2002. Total non-cash expenses Noun 1. non-cash expense - an expense (such as depreciation) that is not paid for in cash disbursal, disbursement, expense - amounts paid for goods and services that may be currently tax deductible (as opposed to capital expenditures) for the third quarter of 2003 were $3.1 million. Cash, cash equivalents and short-term and long-term investments as of Sept. 30, 2003, totaled $123.1 million compared to $60.8 million as of Sept. 30, 2002. "Our acquisition of Corvas International has strengthened our balance sheet in addition to broadening our therapeutic platforms," said Martin Simonetti, senior vice president of finance and chief financial officer of Dendreon. "We continued to make significant strides in the third quarter of 2003, most notably with the acquisition of Corvas and the advancement of our lead development program, Provenge(R)," said Mitchell H. Gold, M.D., chief executive officer of Dendreon. Recent company highlights include: -- Fast Track designation 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. ) for Provenge, the company's investigational immunotherapyfor the treatment of asymptomatic a·symp·to·mat·ic adj. Exhibiting or producing no symptoms. Asymptomatic Persons who carry a disease and are usually capable of transmitting the disease but, who do not exhibit symptoms of the disease are said to be , 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. , androgen androgen (ăn`drəjən): see testosterone. androgen Any of a group of hormones that mainly influence the development of the male reproductive system. independent prostate cancer. Fast Track designation allows for a rolling submission of a potential Biologics License Application with the FDA for Provenge and ordinarily provides for a six-month priority review cycle. Provenge is currently in a pivotal double-blind, placebo-controlled Phase 3 trial seeking to confirm previous results that indicate the product candidate may delay progression of disease and the development of disease-related pain. Dendreon previously received a positive assessment from the FDA under the Special Protocol Assessment (SPA) provision indicating the trial, D9902B, may serve as the basis for a Biologics License Application for Provenge. -- Announcement on Sept. 18, 2003, of preliminary survival data from D9901, the completed randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo controlled Phase 3 trial of Provenge. The preliminary analysis on 60 men who contributed a death event showed a median survival of 26.3 months in patients randomized to the Provenge-treated group compared to 19.3 months in patients randomized to the placebo group who never received active therapy; a survival difference of 7 months. Of the 127 men enrolled in the trial between January 2000 and October 2001, over half (67 men) are still alive, with more than 90 percent having received active treatment either with Provenge as initial treatment or as part of a salvage protocol. -- The presentation of preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. data on a lead compound, CVS (1) (Concurrent Versions System) A version control system for Unix that was initially developed as a series of shell scripts in the mid-1980s. CVS maintains the changes between one source code version and another and stores all the changes in one file. 10290, from Dendreon's Protease protease /pro·te·ase/ (pro´te-as) endopeptidase. pro·te·ase n. Any of various enzymes, including the proteinases and peptidases, that catalyze the hydrolytic breakdown of proteins. Activated Therapy (PACT) therapeutic platform. In preclinical testing Noun 1. preclinical test - a laboratory test of a new drug or a new invasive medical device on animal subjects; conducted to gather evidence justifying a clinical trial preclinical phase, preclinical trial to date, the compound has demonstrated a significant reduction in tumor tumor: see neoplasm. volume compared to conventional chemotherapy. Data presented demonstrate in preclinical in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. models of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. that CVS 10290 produced an approximately 85 percent reduction in tumor growth compared to conventional chemotherapy (p=0.0008). In addition, CVS 10290 was shown to have a considerably better safety profile than conventional chemotherapy. Additional studies with CVS 10290 demonstrated similar results in breast cancer models. -- The appointment of Robert M. Hershberg, M.D., Ph.D., as vice president of strategic product development. Hershberg joins Dendreon from Corixa Corporation, (Nasdaq:CRXA), where he most recently served as vice president of medical genetics medical genetics n. The study of the etiology, pathogenesis, and natural history of diseases and disorders that are at least partially genetic in origin. . Hershberg's range of industry experience in clinical research and development includes work at Corixa on discovery, late-stage pre-clinical, and clinical efforts related to a series of novel compounds to be used as therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. in the treatment of immune-mediated diseases Immune-mediated diseases are conditions which result from abnormal activity of the body's immune system. The immune system may over-react (for example, immune-mediated contact dermatitis) or start attacking the body (for example, autoimmune hemolytic anemia). and clinical activities including strategic development in the areas of oncology and 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. , and immunological immunologic, immunological emanating from or pertaining to immunology. immunologic competence see immunocompetence. immunologic domains monitoring of patient samples in cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. trials. Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes 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 , small molecule and prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. product candidates. Dendreon has research and development alliances with Genentech, Inc., Kirin Brewery Co., Ltd., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com. Except for historical information contained herein, this news release contains 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. that are subject to risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements, particularly those risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such a difference include risks and uncertainties, inherent in an acquisition transaction, including those relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the inability to achieve planned synergies or execute integration plans and establish management and organizational structure  This article has no lead section.To comply with Wikipedia's lead section guidelines, one should be written. . Other risk factors include the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license; the risk that the FDA will not be satisfied with the data we provide for Provenge or approve a product for which a biologics license has been applied; the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial; risks that we may lack the financial resources and access to capital to fund required clinical trials for Provenge; the risks that the safety or efficacy results of preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. will not support further development; risks associated with the development of early stage product candidates through preclinical and clinical research and development, the failure by Dendreon to secure and maintain relationships with collaborators, including a collaborator for the development and commercialization of Provenge; risks associated with completing Dendreon's clinical trials; reliance on key employees, especially senior management; risks related to Dendreon's limited operating history; dependence on the efforts of third parties; and dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations, are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.
DENDREON CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
---------------------------------------
2003 2002 2003 2002
--------- --------- --------- ---------
Total revenue $1,777 $4,992 $5,376 $11,134
Operating expenses:
Research and development 9,315 7,636 23,802 23,436
Write off of acquired in-
process research and
development 1,780 - 1,780 -
General and administrative 4,685 2,475 9,718 6,916
Marketing 106 146 346 625
--------- --------- --------- ---------
Total operating expenses 15,886 10,257 35,646 30,977
--------- --------- --------- ---------
Loss from operations (14,109) (5,265) (30,270) (19,843)
Interest income 400 361 779 1,476
Interest expense (168) (92) (353) (262)
--------- --------- --------- ---------
Interest income, net 232 269 426 1,214
--------- --------- --------- ---------
Loss before income taxes (13,877) (4,996) (29,844) (18,629)
Foreign income tax - 200 - 200
--------- --------- --------- ---------
Net loss $(13,877) $(5,196) $(29,844) $(18,829)
========= ========= ========= =========
Basic and diluted net loss per
share $(0.35) $(0.20) $(0.95) $(0.74)
========= ========= ========= =========
Shares used in computation of
basic and diluted net loss
per share 39,764 25,786 31,420 25,309
========= ========= ========= =========
DENDREON CORPORATION
CONSOLIDATED BALANCE SHEET DATA
September 30, December 31,
2003 2002
(Unaudited)
------------------ -----------------
Cash and cash equivalents $16,130 $11,263
Short-term investments 97,135 35,614
Long-term investments 9,873 8,102
Total assets 135,034 63,724
Total stockholders' equity 113,748 44,743
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