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8-K - FORM 8-K - DENDREON CORP | v58398e8vk.htm |
Exhibit 99.1
Dendreon Reports Fourth Quarter and 2010 Year End Financial Results
Conference Call to be Hosted March 1, 2011 at 4:30 p.m. ET
Conference Call to be Hosted March 1, 2011 at 4:30 p.m. ET
SEATTLE, March 1, 2011 Dendreon Corporation (Nasdaq: DNDN) today reported results for the
year and quarter ended December 31, 2010. Revenue for the year ended December 31, 2010 was $48.1
million compared to $0.1 million for the year ended December 31, 2009. Revenue for the fourth
quarter of 2010 was $25.0 million compared to $21,000 for the quarter ended December 31, 2009.
The net loss for the year ended December 31, 2010 was $439.5 million, or $3.18 per share, compared
to $220.2 million, or $2.04 per share for the year ended December 31, 2009. This loss in 2010
includes a non-cash fair value adjustment of $142.6 million or $1.03 per share associated with a
change in the fair value of our warrants, compared with a non-cash fair value adjustment of $118.8
million, or $1.10 per share for the year ended December 31, 2009. 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 2010 was $91.8 million or $0.64 per share, compared to a net loss of $32.5
million, or $0.28 per share, for the same period in 2009. Dendreons total operating expenses for
the year ended December 31, 2010 were $311.7 million compared to $100.1 million in 2009.
As of December 31, 2010, Dendreon had approximately $277.3 million in cash, cash equivalents, and
short-term and long-term investments compared to $606.4 million as of December 31, 2009 (excluding
the $607.3 million raised in January 2011).
Recent Highlights:
| Raised net proceeds of $607.3 million through an offering of convertible senior notes to support U.S. commercialization and advance European regulatory and manufacturing plans | ||
| Submitted a post-approval supplement for PROVENGE® (sipuleucel-T) requesting licensure of 36 additional work stations to manufacture PROVENGE in the New Jersey facility | ||
| Submitted a post-approval supplement on February 28, 2011 for PROVENGE requesting licensure of 36 work stations in the Los Angeles facility to manufacture PROVENGE | ||
| Announced plans to seek European marketing authorization for PROVENGE with an anticipated filing by end of 2011/early 2012 | ||
| Secured acceptance from the U.S. Food and Drug Administration for the Investigational New Drug application for DN24-02 for the treatment of invasive bladder cancer and expect to begin enrolling patients in the second half of 2011 |
In 2010, we began to establish PROVENGE as the foundation of care, said Mitchell H. Gold, M.D.,
president and chief executive officer. As we look to 2011, it will be a year of both
execution and a year of growth for Dendreon, all of which is designed with a single goal in mind:
to help patients with cancer live longer and live better lives.
Conference Call Information
Dendreon will host a conference call on March 1, 2011 at 4:30 p.m. ET. To access the live call,
dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international); the conference ID number is
42044580. The call will also be audio webcast and will be available from the Companys website at
http://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 1-800-642-1687 or +1-706-645-9291 for international callers; the conference ID
number is 42044580. The replay will be available from 7:30 p.m. ET on Tuesday, March 1, until 11:59
p.m. ET on Saturday, May 7. In addition, the webcast will be archived for on-demand listening for
30 days at http://www.dendreon.com.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform
lives through the discovery, development, commercialization and manufacturing of novel
therapeutics. The Company applies its expertise in antigen identification, engineering and cell
processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate
an immune response in a variety of tumor types. Dendreons first product, PROVENGE® (sipuleucel-T),
was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring
the application of additional ACI product candidates and small molecules for the potential
treatment of a variety of cancers. The Company is headquartered 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 http://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. 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
Katherine Stueland
Vice President, Corporate Communications and Investor Relations
206-829-1522
kstueland@dendreon.com
Susan Specht
Director, Investor Relations
206-455-2220
sspecht@dendreon.com
Director, Investor Relations
206-455-2220
sspecht@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 | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenue |
$ | 25,007 | $ | 21 | $ | 48,057 | $ | 101 | ||||||||
Cost of revenue |
13,395 | | 28,520 | | ||||||||||||
Gross profit |
11,612 | 21 | 19,537 | 101 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
12,243 | 19,974 | 75,941 | 61,586 | ||||||||||||
Selling, general and administrative |
85,710 | 16,430 | 235,760 | 38,556 | ||||||||||||
Total operating expenses |
97,953 | 36,404 | 311,701 | 100,142 | ||||||||||||
Loss from operations |
(86,341 | ) | (36,383 | ) | (292,164 | ) | (100,041 | ) | ||||||||
Interest income |
197 | 239 | 1,144 | 964 | ||||||||||||
Interest expense |
(973 | ) | (390 | ) | (1,588 | ) | (2,321 | ) | ||||||||
Loss on debt conversion |
(4,716 | ) | | (4,716 | ) | | ||||||||||
(Loss) gain from valuation of
warrant liability |
| 4,025 | (142,567 | ) | (118,763 | ) | ||||||||||
Net loss before income tax benefit |
(91,833 | ) | (32,509 | ) | (439,891 | ) | (220,161 | ) | ||||||||
Income tax benefit |
| | 411 | | ||||||||||||
Net loss |
($91,833 | ) | ($32,509 | ) | ($439,480 | ) | ($220,161 | ) | ||||||||
Basic and diluted net loss per share |
($0.64 | ) | ($0.28 | ) | ($3.18 | ) | ($2.04 | ) | ||||||||
Shares used in computation of basic and
diluted net loss per share |
142,571 | 116,814 | 138,206 | 108,050 | ||||||||||||
December 31, | December 31, | |||||||
2010 | 2009 | |||||||
Balance Sheet Data: |
||||||||
Cash and cash equivalents |
$ | 132,995 | $ | 409,829 | ||||
Short-term investments |
121,796 | 167,116 | ||||||
Long-term investments |
22,505 | 29,441 | ||||||
Trade accounts receivable |
12,679 | | ||||||
Prepaid antigen costs |
17,656 | 18,975 | ||||||
Inventory |
30,928 | 1,882 | ||||||
Total assets |
603,953 | 735,415 | ||||||
Warrant liability |
| 132,953 | ||||||
Convertible senior subordinated notes |
27,685 | 52,535 | ||||||
Total stockholders equity |
492,774 | 503,564 |