Dendreon Announces Preliminary Fourth Quarter 2012 Revenues

Mon Jan 7, 2013 9:00am EST

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SEATTLE--(Business Wire)--
Dendreon Corporation (NASDAQ: DNDN) today announced preliminary revenues for the
fourth quarter ended December 31, 2012. Net product revenue for the quarter is
expected to be approximately $85.5 million, which includes an approximate $3.8
million favorable adjustment to the Company`s chargebacks reserve due to a
change in estimate. On a pro-forma basis, excluding this adjustment, revenue for
the quarter is expected to be approximately $81.6 million, up 5% on a sequential
basis. 

Recent Highlights:

* Continued strong performance in community accounts:

* Community urology grew 25% overall quarter over quarter 
* Community oncology grew 4% overall quarter over quarter 
* Community accounts represent 71% of total sales, up from 58% in Q4 2011 
* Natural shift away from academic, which declined 9% quarter over quarter

* Continued new physician interest in PROVENGE® (sipuleucel-T):

* Added 61 net new accounts in the fourth quarter, bringing total number of
infusing accounts to 802

"We have focused our commercial efforts on growing our community accounts, where
we see the greatest long-term revenue opportunity. Having achieved our highest
quarter ever for community sales, we believe that our community strategy is
working," said John H. Johnson, president, chairman and chief executive officer.
"Our key account management teams, combined with improved sales execution and
direct-to-patient initiatives, are contributing to the increased use of PROVENGE
in community oncology and urology settings, a trend we saw beginning in the
third quarter. We are pleased that physicians continue to recognize the
importance of sequencing therapy options in advanced prostate cancer treatment
and the key role PROVENGE can play as front-line therapy in mCRPC." 

Dendreon will present at the 31st Annual J.P. Morgan Healthcare Conference in
San Francisco, CA, today at 3:30 p.m. PT. The presentation will be webcast live
and available for replay from Dendreon's website, www.dendreon.com. If you are
unable to listen to the live webcast, it will be archived on the site following
the presentation. To access the replay, go to the Investor Relations section of
the website. 

About PROVENGE

PROVENGE Indication and Important Safety Information

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for
the treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. 

PROVENGE is intended solely for autologous use and is not routinely tested for
transmissible infectious diseases. 

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in
four randomized clinical trials who underwent at least one leukapheresis. The
most common adverse events (incidence greater-than or equal to 15%) are chills,
fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse
events reported in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In controlled
clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5%
of patients in the PROVENGE group. Reactions included chills, fever, fatigue,
asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension,
muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were
reported in patients in the PROVENGE group. 

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, expectations and
beliefs regarding Dendreon`s profitability and Dendreon`s ability to achieve
improved performance as a result of the restructuring, expectations regarding
regulatory approval of PROVENGE® in Europe, expectations regarding the
presentation of clinical data, developments affecting Dendreon's U.S. and global
business and prospects and potential revenue and earnings from product sales,
expectations regarding market size and market opportunity, 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 Quarterly Report on Form 10-Q for the quarter ended September 30,
2012. All forward-looking statements are qualified in their entirety by this
cautionary statement. Dendreon is providing this information as of the date of
this press 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
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com
or
Joele Frank, Wilkinson Brimmer Katcher
Investor Relations
Andrea Rose, 212-355-4449
InvestorRelations@dendreon.com

Copyright Business Wire 2013

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