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8-K - FORM 8-K - DENDREON CORP | v59035e8vk.htm |
Exhibit 99.1
Dendreon Reports First Quarter 2011 Financial Results
Conference Call to be Hosted May 2, 2011 at 4:30 p.m. ET
Conference Call to be Hosted May 2, 2011 at 4:30 p.m. ET
SEATTLE, May 2, 2011 Dendreon Corporation (Nasdaq: DNDN) today reported results for the
first quarter ended March 31, 2011. Revenue for the quarter ended March 31, 2011 was $28.1 million
compared to $21,000 for the quarter ended March 31, 2010.
The GAAP net loss for the quarter ended March 31, 2011 was $111.8 million, or $0.77 per share, compared
to $125.7 million, or $0.96 per share for the quarter ended March 31, 2010.
On a pro-forma basis, excluding non-cash expenses associated with
depreciation and amortization, non-cash imputed interest expense, and
non-cash deferred stock compensation, Dendreons net loss was
approximately $85 million or $0.59 per share.
Dendreons total
operating expenses for the quarter ended March 31, 2011 were $112.9 million compared to $57.6
million for the three months ended March 31, 2010.
As of March 31, 2011, Dendreon had approximately $779.0 million in cash, cash equivalents, and
short-term and long-term investments compared to $277.3 million as of December 31, 2010.
Recent Highlights:
| In addition to the $28.1 million in revenue in the first quarter, sales of PROVENGE® (sipuleucel-T) in April 2011 were approximately $15 million, reflecting increasing demand and increasing utilization of its newly approved capacity. Dendreon continues to expect revenue this year of between $350-400 million with approximately half of that in the fourth quarter. | ||
| The number of accounts infusing PROVENGE as of March 31, 2011 increased from approximately 50 to approximately 135 and is on track to meet its goal of 225 sites by the end of Q2. | ||
| The U.S. Food and Drug Administration (FDA) approved 36 additional workstations in the New Jersey manufacturing facility, which will come online in a staged approach. | ||
| As previously announced, Dendreon filed for FDA approval of the Los Angeles area manufacturing facility and has an action date of June 30, 2011. | ||
| Dendreon filed for FDA approval of the Atlanta facility on April 28 and expects a decision in late August or early September. | ||
| The Centers for Medicare and Medicaid Services (CMS) issued a proposed decision memo supporting the on-label coverage of PROVENGE. | ||
| Dendreon selected a contract manufacturing organization in Europe and a location for a manufacturing facility outside Frankfurt, Germany. |
We are proud of our accomplishments as we continue to expand the launch of PROVENGE. Our recent
increased sales and marketing efforts have had an impact, and we will continue to build on this
momentum as we bring additional capacity online throughout this year to make PROVENGE more broadly
available, said Mitchell H. Gold, M.D., president and chief executive officer.
Conference Call Information
Dendreon will host a conference call on May 2, 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 57436485.
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 57436485. The replay will be available from 7:30 p.m. ET on May 2 until 11:59 p.m. ET on
May 9. 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 | ||||||||
March 31, | ||||||||
2011 | 2010 | |||||||
(unaudited) | ||||||||
Revenue |
$ | 28,061 | $ | 21 | ||||
Cost of revenue |
18,338 | | ||||||
Gross profit |
9,723 | 21 | ||||||
Operating expenses: |
||||||||
Research and development |
17,609 | 29,414 | ||||||
Selling, general and administrative |
95,289 | 28,218 | ||||||
Total operating expenses |
112,898 | 57,632 | ||||||
Loss from operations |
(103,175 | ) | (57,611 | ) | ||||
Interest income |
400 | 278 | ||||||
Interest expense |
(8,993 | ) | (314 | ) | ||||
(Loss) gain from valuation of
warrant liability |
| (68,083 | ) | |||||
Net loss |
($111,768 | ) | ($125,730 | ) | ||||
Basic and diluted net loss per share |
($0.77 | ) | ($0.96 | ) | ||||
Shares used in computation of basic and
diluted net loss per share |
145,494 | 131,456 | ||||||
March 31, | December 31, | |||||||
2011 | 2010 | |||||||
Balance Sheet Data: |
||||||||
Cash and cash equivalents |
$ | 555,297 | $ | 132,995 | ||||
Short-term investments |
157,094 | 121,796 | ||||||
Long-term investments |
66,630 | 22,505 | ||||||
Trade accounts receivable |
16,864 | 12,679 | ||||||
Prepaid antigen costs |
24,325 | 17,656 | ||||||
Inventory |
38,872 | 30,928 | ||||||
Total assets |
1,130,688 | 603,953 | ||||||
Convertible senior notes due 2016 |
491,424 | | ||||||
Convertible senior subordinated notes due 2014 |
27,685 | 27,685 | ||||||
Total stockholders equity |
526,451 | 492,774 |
DENDREON CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
Three Months Ended | ||||||||
March 31, | ||||||||
2011 | 2010 | |||||||
(unaudited) | ||||||||
GAAP net loss |
($111,768 | ) | ($125,730 | ) | ||||
Non-GAAP adjustments: |
||||||||
Depreciation and amortization expense |
7,409 | 2,465 | ||||||
Stock-based compensation expense |
14,676 | 7,070 | ||||||
Imputed interest related to the convertible
senior notes due 2016 |
4,300 | | ||||||
Non-GAAP net loss |
($85,383 | ) | ($116,195 | ) | ||||
Non-GAAP net loss per share- basic and diluted |
($0.59 | ) | ($0.88 | ) | ||||
Shares used in computation of basic and
diluted net loss per share |
145,494 | 131,456 | ||||||
The above table provides certain non-GAAP financial measures that include adjustments to GAAP figures.
Dendreon believes that these non-GAAP financial measures, when considered together with the GAAP figures,
can enhance an overall understanding of Dendreons financial performance and its prospects for the future.
The non-GAAP financial measures are included with the intent of providing investors with a
more complete understanding of operational results and trends.
We believe excluding these non-cash items provides important insight
into our operational results, important for a
company at our stage in development.
In addition, these non-GAAP financial
measures are among the indicators Dendreon management uses for planning and forecasting purposes and
measuring the Companys performance. These non-GAAP financial measures are not intended to be considered in
isolation or as a substitute for GAAP figures.