Dendreon Corporation Reports Fourth Quarter and Year End 2003 Financial Results & Corporate Highlights.Business Editors/Health/Medical Writers BIOWIRE2K SEATTLE--(BUSINESS WIRE)--Feb. 26, 2004 Dendreon Corporation (Nasdaq:DNDN) today reported results for the year and quarter ended Dec. 31, 2003. Revenues for the year ended Dec. 31, 2003, were $27.0 million, compared to $15.3 million for the year ended Dec. 31, 2002. Revenues for the fourth quarter of 2003 were $21.7 million, compared to $4.1 million for the same period in 2002. Revenues for the fourth quarter of 2003 were primarily from Dendreon's recent license agreement with Kirin Brewery Co., Ltd. The net loss for the year ended Dec. 31, 2003, was $28.4 million, or $0.82 per share, compared to $24.7 million, or $0.96 per share for the year ended Dec. 31, 2002. Net income for the fourth quarter of 2003 was $1.3 million, or $0.03 per 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. share, compared to a net loss of $5.8 million, or $0.22 per share, for the same period in 2002. Dendreon's 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 year ended Dec. 31, 2003, were $54.3 million compared to $41.2 million in 2002. Net cash used by operations in 2003 was $38.8 million compared to $26.5 million in 2002. As of Dec. 31, 2003, Dendreon had approximately $113.2 million in cash, cash equivalents, short-term and long-term investments compared to $55.0 million as of Dec. 31, 2002. In January 2004, the company conducted a follow-on public offering of common stock resulting in gross proceeds of $150.0 million, or $140.5 million net of offering costs. Dendreon's cash balance following the sale of the common stock was $250.2 million. As Dendreon continues to advance its clinical programs and develop its commercialization infrastructure for Provenge, the Company estimates that cash used in operations in 2004 will be approximately $60 million to $65 million. This may be impacted by our ongoing collaboration discussions for Provenge as well as our investment in commercialization infrastructure for Provenge. "Dendreon has established a strong financial foundation while continuing to advance its clinical programs during 2003," said Martin Simonetti, senior vice president of finance and chief financial officer. "We delivered on this commitment through our business development activities, access to the capital markets and by continuing the progress of our lead product candidate, Provenge(R). Our balance sheet has never been stronger and data from our first Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Provenge, including the recent survival data, support continuing to advance this product candidate toward commercialization." Dendreon's 2003 highlights include: Clinical & Regulatory -- The company's investigational immunotherapy Immunotherapy The treatment of cancer by improving the ability of a tumor-bearing individual (the host) to reject the tumor immunologically. There are molecules on the surface of tumor cells, and perhaps in their interior, that are recognized as different from product, Provenge, received Fast Track designation from the U.S. Food and Drug Administration. -- Receipt of a binding agreement, known as a Special Protocol Assessment, from the U.S. Food and Drug Administration in June 2003 allowing for Dendreon's pivotal Phase 3 clinical trial (D9902B) to serve as basis for a Biologics License Application for Provenge for the treatment of 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 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. , if it is successful in meeting its predetermined pre·de·ter·mine v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines v.tr. 1. To determine, decide, or establish in advance: objectives. -- The presentation of new data from the completed Phase 3 clinical trial (D9901) of Provenge at the American Society of Clinical 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. (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 ) Annual Meeting in June 2003 confirming that the underlying mechanism of action of Provenge, a T-cell 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. , is consistent with the clinical benefit seen in men with advanced, 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. prostate cancer with Gleason scores 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 and less. -- The presentation of long-term results from Dendreon's Phase 1 trial of its cancer immunotherapy Cancer immunotherapy is the use of the immune system to reject cancer. The main premise is stimulating the patient's immune system to attack the malignant tumor cells that are responsible for the disease. APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 8024 in patients with advanced, metastatic, Her-2/neu positive breast cancer at the ASCO annual meeting in June 2003. Data was presented on 16 patients whose disease had progressed after receiving chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. . Fifteen of these patients had progressive disease following Herceptin therapy. Following treatment with APC8024, 25 percent of patients demonstrated clinical benefit defined as a partial response or prolonged pro·long tr.v. pro·longed, pro·long·ing, pro·longs 1. To lengthen in duration; protract. 2. To lengthen in extent. stable disease. -- The presentation of interim results at the ASCO meeting in June 2003 from a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. sponsored by the National Cancer Institute, P-16, indicating that a combination therapy of Provenge and Genentech's Bevacizumab (Avastin(TM)) may provide a significant improvement in the median PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. doubling time doubling time Oncology A parameter used to determine tumor aggressiveness, which serves to prognosticate, measure therapeutic success, and quantify tumor kinetics and growth rate. Cf Gompertzian growth curve. in men with androgen dependent prostate cancer. Corporate -- The acquisition of Corvas International, Inc. on July 30, 2003, through the issuance of Dendreon common stock. -- The raising of $30.7 million through the sale of Dendreon common stock completed on June 17, 2003. -- A licensing agreement with Kirin Brewery Co., Ltd. in November 2003 by which Dendreon licensed patent rights relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the use of certain HLA-DR antibodies for which Kirin agreed to pay $20 million and returned the rights to Dendreon's lead product candidate, Provenge, for countries in Asia that were previously licensed to Kirin. -- The appointment of key management positions including Israel Rios, M.D., vice president of clinical affairs; and Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer. Conference Call Dendreon will host a conference call at 1:30 p.m. Pacific, 4:30 p.m. Eastern, today, Thursday, Feb. 26. To access the live call, dial 888-790-1712 (domestic) or 210-234-8001 (international), the passcode for the call is Dendreon. The call will also be webcast and will be available from the company's website at www.dendreon.com under the "News & Events" section. A replay of the call will be available from the company's website and by calling 800-871-1325 (domestic) or 402-280-9908 (international). Dendreon Corporation is a biotechnology company developing targeted therapies for cancer. In addition to its immunotherapies in clinical and preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. 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., 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 therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. . Factors that may cause such a difference 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 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. 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 risk that we may not realize all of the anticipated benefits of the Corvas acquisition; 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 risks associated with a 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)
Three months ended Twelve months ended
December 31, December 31,
------------------- -------------------
2003 2002 2003 2002
------- ------- -------- --------
Revenue $21,665 $ 4,135 $ 27,041 $ 15,269
Operating expenses:
Research and development 13,636 7,491 37,438 30,927
Acquired in-process
research and development 982 - 2,762 -
General and administrative 3,970 2,627 13,539 9,542
Marketing 252 94 598 719
------- ------- -------- --------
Total operating expenses 18,840 10,212 54,337 41,188
------- ------- -------- --------
Income (loss) from operations 2,825 (6,077) (27,296) (25,919)
Interest income 544 328 1,323 1,803
Interest expense (85) (91) (438) (353)
Other expense (269) - (269) -
------- ------- -------- --------
Interest and other expense,
net 190 237 616 1,450
------- ------- -------- --------
Income (loss) before income
taxes 3,015 (5,840) (26,680) (24,469)
Foreign income tax expense 1,761 - 1,761 200
------- ------- -------- --------
Net income (loss) $ 1,254 $(5,840) $(28,441) $(24,669)
======= ======= ======== ========
Basic net income (loss) per
share $ 0.03 $ (0.22) $ (0.82) $ (0.96)
======= ======= ======== ========
Shares used in computation of
basic net income (loss)
per share 44,621 26,406 34,664 25,576
======= ======= ======== ========
Diluted net income (loss) per
share $ 0.03 $ (0.22) $ (0.82) $ (0.96)
======= ======= ======== ========
Shares used in computation of
diluted net income (loss)
per share 46,258 26,406 34,664 25,576
======= ======= ======== ========
December 31, December 31,
2003 2002
------------ ------------
Balance Sheet Data:
Cash and cash equivalents $ 44,349 $ 11,263
Short-term investments 55,672 35,614
Long-term investments 13,170 8,102
Total assets 137,845 63,724
Total stockholders' equity 118,987 44,743
|
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion