Dendreon Announces Second Quarter 2012 Results
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.
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. Dendreon’s 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/.
Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, statements regarding the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, and Dendreon’s ability to achieve improved performance as a result of the restructuring, developments affecting Dendreon's business and prospects and potential revenue and earnings from product sales, and progress generally on commercialization efforts for PROVENGE. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer due to competing therapies, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; and other factors discussed in the “Risk Factors” section of Dendreon’s Annual Report on Form 10-K for the year ended December 31, 2011. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.| DENDREON CORPORATION | |||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||
| Three Months EndedJune 30, | Six Months EndedJune 30, | ||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Product revenue, net | $ | 79,964 | $ | 48,139 | $ | 161,936 | $ | 75,140 | |||||||
| Royalty and other revenue | 28 | 20 | 130 | 41 | |||||||||||
| Total revenue | 79,992 | 48,159 | 162,066 | 75,181 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of product revenue | 61,731 | 28,754 | 121,772 | 47,092 | |||||||||||
| Research and development | 19,697 | 18,565 | 37,040 | 36,174 | |||||||||||
| Selling, general and administrative | 80,219 | 105,071 | 175,534 | 200,360 | |||||||||||
| Restructuring | 1,099 | — | 975 | — | |||||||||||
| Total operating expenses | 162,746 | 152,390 | 335,321 | 283,626 | |||||||||||
| Loss from operations | (82,754 | ) | (104,231 | ) | (173,255 | ) | (208,445 | ) | |||||||
| Interest income | 375 | 393 | 758 | 793 | |||||||||||
| Interest expense | (13,768 | ) | (12,121 | ) | (27,580 | ) | (21,114 | ) | |||||||
| Other income (expense) | 10 | (26 | ) | 26 | (26 | ) | |||||||||
| Net loss | $ | (96,137 | ) | $ | (115,985 | ) | $ | (200,051 | ) | $ | (228,792 | ) | |||
| Basic and diluted net loss per share | $ | (0.65 | ) | $ | (0.79 | ) | $ | (1.35 | ) | $ | (1.57 | ) | |||
| Shares used in computation of basic and diluted net loss per share | 148,161 | 145,928 | 147,880 | 145,712 | |||||||||||
| June 30, | December 31, | ||||||||||||||
| 2012 | 2011 | ||||||||||||||
| Balance Sheet Data: | |||||||||||||||
| Cash and cash equivalents | $ | 247,493 | $ | 427,100 | |||||||||||
| Short-term investments | 184,743 | 111,525 | |||||||||||||
| Long-term investments | 77,479 | 79,071 | |||||||||||||
| Trade accounts receivable | 35,343 | 35,541 | |||||||||||||
| Prepaid antigen costs | 1,534 | 7,490 | |||||||||||||
| Inventory | 71,558 | 69,502 | |||||||||||||
| Total assets | 875,747 | 1,001,491 | |||||||||||||
| Convertible senior notes due 2016 | 520,335 | 508,418 | |||||||||||||
| Convertible senior subordinated notes due 2014 | 27,685 | 27,685 | |||||||||||||
| Total stockholders' equity | 202,409 | 352,637 | |||||||||||||
| DENDREON CORPORATION | |||||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP NET LOSS | |||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||
| Three Months EndedJune 30, | Six Months EndedJune 30, | ||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| GAAP net loss | $ | (96,137 | ) | $ | (115,985 | ) | $ | (200,051 | ) | $ | (228,792 | ) | |||
| Non-GAAP adjustments: | |||||||||||||||
| Depreciation and amortization expense | 10,790 | 8,644 | 21,654 | 15,955 | |||||||||||
| Imputed interest related to the convertiblesenior notes due 2016 | 6,019 | 5,551 | 11,917 | 9,851 | |||||||||||
| Restructuring | 1,099 | — | 975 | — | |||||||||||
| Management severance and othertermination benefits: | |||||||||||||||
| Severance expense | 1,792 | — | 6,965 | — | |||||||||||
| Non-cash stock-based compensation expense | 3,434 | — | 15,112 | — | |||||||||||
| Other stock-based compensation expense | 12,793 | 16,754 | 32,268 | 31,430 | |||||||||||
| Non-GAAP net loss | $ | (60,210 | ) | $ | (85,036 | ) | $ | (111,160 | ) | $ | (171,556 | ) | |||
| Non-GAAP net loss per share- basic and diluted | $ | (0.41 | ) | $ | (0.58 | ) | $ | (0.75 | ) | $ | (1.18 | ) | |||
| Shares used in computation of basic and diluted net loss per share | 148,161 | 145,928 | 147,880 | 145,712 | |||||||||||
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