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8-K - FORM 8-K - DENDREON CORP | v55039e8vk.htm |
Exhibit 99.1
Dendreon Reports Fourth Quarter and 2009 Year End Financial Results
Conference Call to be Hosted Today at 4:30 p.m. ET
Conference Call to be Hosted Today at 4:30 p.m. ET
SEATTLE, February 22, 2010 Dendreon Corporation (Nasdaq: DNDN) today reported results for the
year and quarter ended December 31, 2009. Revenue for the year ended December 31, 2009 was $101,000
compared to $111,000 for year ended December 31, 2008. Revenue for the fourth quarter of 2009 was
$21,000 compared to $28,000 for the quarter ended December 31, 2008.
The net loss for the year ended December 31, 2009 was $220.2 million, or $2.04 per share, compared
to $71.6 million, or $0.79 per share for the year ended December 31, 2008. This loss
includes a non-cash fair value adjustment of $118.8 million or $1.10 per share associated with a
change in the fair value of our warrants The size of this re-measurement is directly related to the
price increase our common stock experienced this year. Net loss in the fourth quarter of 2009 was
$32.5 million or $0.28 per share, compared to a net loss of $8.8 million, or $0.09 per share, for
the same period in 2008. Dendreons total operating expenses for the year ended December 31, 2009
were $100.1 million compared to $70.6 million in 2008.
As of December 31, 2009, Dendreon had approximately $606 million in cash, cash equivalents, and
short-term and long-term investments compared to $111 million as of December 31, 2008.
Recent Highlights:
| Submitted an amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) for which the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010. | |
| Raised $409.5 million in net proceeds through a common stock offering in the fourth quarter 2009, bringing the total net funds raised for the year to approximately $630 million, allowing the Company to accelerate the build out of the Atlanta, Georgia and Orange County, California commercial manufacturing facilities, which we expect will become operational in mid-2011. | |
| Hired Hans Bishop as chief operating officer. Hans was most recently president of the specialty medicine business at Bayer and executive vice president of Bayer Healthcare LLC. | |
| Elected Ian Clark, chief executive officer and head of North American commercial operations at Genentech, and Pedro Granadillo, former senior vice president of global manufacturing and human resources at Eli Lilly & Company, to Board of Directors. |
The positive results from our IMPACT study of PROVENGE made 2009 a momentous year for Dendreon and
its stockholders as we initiated the transition to a commercial enterprise to serve patients with
late-stage prostate cancer, said Mitchell H. Gold, M.D., president and chief executive officer.
To continue this transformation in 2010, we are investing in our commercial and manufacturing
infrastructure to support the launch of PROVENGE pending FDA approval.
Conference Call Information
Dendreon will host a conference call today at 1:30 p.m. PT, 4:30 p.m. ET. To access the live call,
dial 1-800-260-8140 (domestic) or +1-617-614-3672 (international); the conference ID number is
15732512. The call will also be audio webcast and will be available from the Companys website at
www.dendreon.com under the Investor/Webcasts and Presentations section. A recorded rebroadcast
will be available for interested parties unable to participate in the live conference call by
dialing 1-888-286-8010 or +1-617-801-6888 for international callers; the conference ID number is
13123096. The replay will be available from 7:30 pm ET on Monday, February 22nd, until
11:59
pm ET on Monday, March 1st. In addition, the webcast will be archived for on-demand
listening for 30 days at www.dendreon.com.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform
lives through the discovery, development and commercialization of novel therapeutics. The Company
applies its expertise in antigen identification, engineering and cell processing to produce ACI
product candidates designed to stimulate an immune response. Dendreon is also developing an
orally-available small molecule that targets TRPM8 that could be applicable to multiple types of
cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle,
Washington, and is traded on the Nasdaq Global Market under the symbol DNDN. For more information
about the Company and its programs, visit www.dendreon.com.
This news release contains forward-looking statements that are subject to risks and uncertainties.
Factors that could affect these forward-looking statements include, but are not limited to,
developments affecting Dendreons business and prospects, including progress on the
commercialization efforts for PROVENGE and requisite receipt of FDA licensure for marketing.
Information on the factors and risks that could affect Dendreons business, financial condition and
results of operations are contained in Dendreons public disclosure filings with the U.S.
Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors
not to place undue reliance on the forward-looking statements contained in this press release. All
forward-looking statements are based on information currently available to Dendreon on the date
hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements
to reflect events or circumstances after the date of this press release, except as required by law.
Contact Information:
Katherine Stueland
Vice President, Corporate Communications and Investor Relations
206-829-1522
kstueland@dendreon.com
Vice President, Corporate Communications and Investor Relations
206-829-1522
kstueland@dendreon.com
DENDREON CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
(unaudited) | ||||||||||||||||
Revenue |
$ | 21 | $ | 28 | $ | 101 | $ | 111 | ||||||||
Operating expenses: |
||||||||||||||||
Research and development |
19,974 | 10,755 | 61,586 | 50,086 | ||||||||||||
General and administrative |
16,430 | 4,783 | 38,556 | 20,503 | ||||||||||||
Total operating expenses |
36,404 | 15,538 | 100,142 | 70,589 | ||||||||||||
Loss from operations |
(36,383 | ) | (15,510 | ) | (100,041 | ) | (70,478 | ) | ||||||||
Interest income |
239 | 712 | 964 | 3,619 | ||||||||||||
Interest expense |
(390 | ) | (1,161 | ) | (2,321 | ) | (5,156 | ) | ||||||||
Gain (Loss) from valuation of warrant
liability |
4,025 | 7,122 | (118,763 | ) | 371 | |||||||||||
Net loss |
$ | (32,509 | ) | $ | (8,837 | ) | $ | (220,161 | ) | $ | (71,644 | ) | ||||
Basic and diluted net loss per share |
$ | (0.28 | ) | $ | (0.09 | ) | $ | (2.04 | ) | $ | (0.79 | ) | ||||
Shares used in computation of basic and
diluted net loss per share |
116,814 | 95,109 | 108,050 | 90,357 | ||||||||||||
December 31, | December 31, | |||||||
2009 | 2008 | |||||||
Balance Sheet Data: |
||||||||
Cash and cash equivalents |
$ | 409,829 | $ | 59,523 | ||||
Short-term investments |
167,116 | 45,638 | ||||||
Long-term investments |
29,441 | 5,416 | ||||||
Prepaid antigen costs |
18,975 | | ||||||
Total assets |
735,415 | 147,204 | ||||||
Warrant liability |
132,953 | 14,190 | ||||||
Convertible senior subordinated notes |
52,535 | 85,250 | ||||||
Total stockholders equity |
503,564 | 27,006 |