Dendreon Corporation Reports Third Quarter 2002 Financial Results.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Oct. 28, 2002 Dendreon Corporation (Nasdaq:DNDN) today reported results for the third quarter ended Sept. 30, 2002. Revenues for the third quarter of 2002 were $5.0 million, compared to $3.8 million for the same period in 2001. The increase in revenues was due, in part, to a milestone payment received from Kirin Brewery A brewery can be a building or place that produces beer, or a business (brewing company) whose trade is the production and sale of beer. Breweries can take up multiple city blocks, or be a collection of equipment in a homebrewer's kitchen. Co., Ltd. for the start of a clinical trial of Mylovenge in Japan. Revenues also included recognition of a portion of up-front and milestone payments and research support from collaborations with Genentech, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Kirin. The net loss for the quarter ended Sept. 30, 2002 was $5.2 million, or $(0.20) per share, compared to a net loss of $5.8 million, or $(0.23) per share, for the quarter ended Sept. 30, 2001. Research and development expenses were $7.6 million for the third quarter of 2002 compared to $8.1 million for the same period in 2001. Interest income was $361,000 for the quarter ended Sept. 30, 2002 compared to $1.2 million for the same period in 2001. Cash, cash equivalents, short-term and long-term investments as of Sept. 30, 2002 totaled $60.8 million. "The third quarter was significant for Dendreon, as positive data from our first placebo placebo (pləsē`bō), inert substance given instead of a potent drug. Placebo medications are sometimes prescribed when a drug is not really needed or when one would not be appropriate because they make patients feel well taken care of. controlled Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial of Provenge(TM), study D9901, provided support for our vaccine vaccine Preparation containing either killed or weakened live microorganisms or their toxins, introduced by mouth, by injection, or by nasal spray to stimulate production of antibodies against an infectious agent. platform, and we entered into a major collaboration with Genentech to develop targeted 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. derived from our Trp-p8 gene platform," said Christopher S. Henney, Ph.D., D.Sc., chairman and chief executive officer. "Our momentum is continuing, with our announcement today that we have received clearance from 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. to resume enrollment in our second Phase III trial of Provenge, study D9902, in men with hormone hormone, secretory substance carried from one gland or organ of the body via the bloodstream to more or less specific tissues, where it exerts some influence upon the metabolism of the target tissue. resistant 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. . We will continue to work diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d to advance Provenge toward registration as rapidly as possible." Results from study D9901, the first double blind, placebo-controlled Phase III trial of Provenge in men with 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. hormone resistant prostate cancer demonstrated that patients with a Gleason score Gleason score Oncology A value derived from the Gleason grading system which is the sum of the 2 most predominant histologic patterns seen in prostate CA of 7 or less significantly benefited from treatment, with a median time to disease progression of 16.0 weeks compared to 9.0 weeks for the placebo group (p-value=.002). The trial involved 127 men with metastatic, hormone resistant prostate cancer, 82 of whom received Provenge. All patients enrolled in the trial had advanced prostate cancer and most had failed all conventional medical and surgical therapy options at the time they were enrolled. In addition, those patients receiving Provenge whose disease had not progressed six months after randomization randomization (ranˈ·d  ·m had a greater than eight-fold advantage in
progression-free survival compared to those patients who received
placebo (34.7 percent versus 4 percent).The collaboration with Genentech provides for an equity purchase and additional upfront and milestone payments for the resulting development of Trp-p8 products. The companies will be jointly responsible for conducting pre-clinical and clinical work, with Genentech ultimately funding the majority of these activities. Genentech will also be responsible for all manufacturing of resulting products. The Trp-p8 gene, discovered and patented by Dendreon, is over-expressed in a number of cancers including prostate prostate /pros·tate/ (pros´tat) a gland surrounding the bladder neck and urethra in the male; it contributes a secretion to the semen.prostat´ic pros·tate n. The prostate gland. adj. , breast, lung and colon colon, in anatomy colon, in anatomy: see intestine. colon, in punctuation colon, in writing: see punctuation. colon Segment that makes up most of the large intestine. . Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. Dendreon currently has three therapeutic vaccines therapeutic vaccine Immunology A vaccine–eg, Salk's Remune™ intended to treat a viral infection by stimulating the immune system. See Vaccine therapy. in clinical trials. Dendreon's product pipeline also includes 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"). and a pathway pathway /path·way/ (path´wa) 1. a course usually followed. 2. the nerve structures through which an impulse passes between groups of nerve cells or between the central nervous system and an organ or muscle. to small molecules. Dendreon has established important alliances with industry leaders Genentech, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Kirin Brewery Co., Ltd. For more information, 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 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the efficacy of Provenge, risks that the FDA may impose additional or different requirements for D9902 or additional Phase III trials of Provenge, the risk that the data in clinical trial D9901 may not be duplicated in clinical trial D9902, risks associated with clinical trials generally, risks that the safety and/or efficacy results of clinical trials of Provenge or another of our potential products will not support an application for a biologics license, risks that the FDA may not approve an application for a biologics license, risks that the company will be unable to successfully develop therapeutic products in collaboration with Genentech, Inc., Kirin Brewing brewing: see beer. Company, Ltd. or other collaborators, failure by Dendreon to maintain relationships with Genentech and other collaborators or perform obligations owed to them, and risks related to Dendreon's limited operating history, the uncertainty of Dendreon's future access to capital, 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 is providing this information as of September 30, 2002, and does not plan to update this financial information until its next financial results press release.
DENDREON CORPORATION
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
------------------------------------------
2002 2001 2002 2001
-------- ----------- --------- ---------
Total revenue $4,992 $3,789 $11,134 $9,977
Operating expenses:
Research and development 7,636 8,081 23,436 20,502
General and
administrative 2,475 2,236 6,916 5,766
Marketing 146 285 625 1,249
-------- ----------- --------- ---------
Total operating expenses 10,257 10,602 30,977 27,517
-------- ----------- --------- ---------
Loss from operations (5,265) (6,813) (19,843) (17,540)
Interest income 361 1,151 1,476 3,895
Interest expense (92) (132) (262) (412)
-------- ----------- --------- ---------
Interest income, net 269 1,019 1,214 3,483
-------- ----------- --------- ---------
Loss before income taxes (4,996) (5,794) (18,629) (14,057)
Foreign income tax 200 - 200 -
-------- ----------- --------- ---------
Net loss $(5,196) $(5,794) $(18,829) $(14,057)
======== =========== ========= =========
Basic and diluted net loss
per share $(0.20) $(0.23) $(0.74) $(0.57)
======== =========== ========= =========
Shares used in computation
of basic and diluted
net loss per share 25,786 24,818 25,309 24,710
======== =========== ========= =========
DENDREON CORPORATION
BALANCE SHEET DATA
September 30, December 31,
2002 2001
(Unaudited)
----------- ---------
Cash and cash equivalents $20,144 $13,912
Short-term investments 34,452 56,969
Long-term investments 6,209 10,361
Total assets 71,132 91,082
Total stockholders' equity 49,320 65,211
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