[January 13, 2014] |
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Dendreon Announces Preliminary Fourth Quarter 2013 Revenues
SEATTLE --(Business Wire)--
Dendreon Corporation (NASDAQ: DNDN) today announced preliminary revenues
for the fourth quarter ended December 31, 2013. Net product revenue for
the quarter is expected to be approximately $74.8 million, up 10.1% on a
sequential basis.
Recent Highlights:
-
Business has continued to strengthen
-
Community oncology grew 19% overall quarter over quarter
-
Community urology grew 2% overall quarter over quarter
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Community accounts represent 72% of total sales
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Academic grew 5% quarter over quarter
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Continued large account growth
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100 large accounts in Q4, up from 94 in Q3, 85 in Q2 and 54 in Q1
-
Continued to generate new physician interest in PROVENGE®
(sipuleucel-T)
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Added 31 net new accounts in Q4
-
Continued progress on restructuring and cost reduction plan to
accelerate the path to profitability; continue to expect net benefits
to begin to be realized as early as Q1 2014
-
Advancing automation efforts
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Recently conducted a constructive meeting with the FDA regarding
automation of the PROVENGE manufacturing process; Agency expressed
its support for this effort
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Cash on hand of approximately $199 million as of December 31, 2013
-
Continue to develop clinical data in the active cellular immunotherapy
space
-
Plans to present data from ongoing immuno-oncology trials, which
further elucidate the product potency and mechanism of PROVENGE, and
surrounding investigational compound DN24-02, at ASCO-GU later this
month
"Our preliminary fourth quarter results were driven by strong growth in
our oncology accounts as well as improvements in urology and academic
accounts," said John H. Johnson, chairman, president and chief executive
officer of Dendreon. "The DTC campaign is achieving expectations and we
continue to experience growth in large accounts, where we see the
greatest opportunity. With the increasing amount of data surrounding
PROVENGE coming to the marketplace along with a broader understanding of
immunotherapy in cancer, we continue to see our KOL support
strengthening."
Mr. Johnson concluded, "As we work to accelerate our financial progress,
we are pleased to report that our automation efforts are moving forward.
Once implemented, we expect automation to significantly lower our cost
of goods sold, enabling us to accelerate our path to profitability,
which remains a key goal."
Dendreon will present at the 32nd Annual J.P. Morgan Healthcare
Conference in San Francisco, CA (News - Alert), on January 15, 2014 at 2:30 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.
PROVENGE Indication and Important Safety Infrmation
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 1,500 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 recent and prior restructurings, the timing and elements of the
restructurings, the timing and form of related charges, the expected
annual operating expense reductions, expectations and beliefs regarding
Dendreon's financial position, profitability and Dendreon's ability to
break even and achieve improved performance as a result of the
restructurings, statements regarding sequencing studies, statements
regarding studies to advance understanding of immunotherapy and the
treatment of advanced prostate cancer, statements regarding biomarkers,
expectations about automation or the early detection study, expectations
about advancing our pipeline, expectations regarding reductions of cost
of goods sold, expectations regarding reimbursement approvals of
PROVENGE® in Europe or Dendreon's ability to launch and commercialize
PROVENGE in Europe, expectations regarding the presentation of clinical
data, developments affecting Dendreon's U.S. and global business and
prospects, beliefs and expectations regarding potential revenue and
earnings from product sales, including beliefs regarding Dendreon's
ability to grow sales, expectations regarding market size, target
market, and market opportunity, beliefs regarding the impact of our
direct to consumer advertising, expectations with respect to our sales
force execution and effectiveness, progress generally on
commercialization efforts for PROVENGE, and expectations about clinical
trial enrollments. 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 for a variety of
reasons, including competing therapies, instability in our sales
force, the risk that we cannot replace vacant sales positions on a
prompt basis, perceived difficulties in the treatment process, delays in
obtaining reimbursement or for other reasons; any promotional
limitations imposed by the FDA or the EU on our ability to commercialize
and market PROVENGE; unexpected difficulties and costs associated with
the rapid expansion of our commercial operations to support the
commercial launch of PROVENGE; the impact of competing therapies on
sales of PROVENGE, the failure to achieve reimbursement approvals in
Europe, manufacturing or quality difficulties, disruptions or delays and
other factors discussed in the "Risk Factors" section of Dendreon's
Annual Report on Form 10-Q for the quarter ended September 30, 2013. 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.

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