Dendreon Corp. (USOTC:DNDNQ)
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5 Years : From Nov 2014 to Nov 2019
Company begins new year exceeding 2014 revenue target and announces
first commercial PROVENGE® (sipuleucel-T)
patient outside U.S. starts treatment
January 14, 2015 – Dendreon Corporation today announced that the
company grew sales in four quarters successively, exceeded its revenue
target for the first time ever, and achieved cash-flow break even in the
fourth quarter (adjusted for non-recurring items), starting 2015 on a
strong footing. In addition, the first commercial European patient
initiated treatment with PROVENGE® (sipuleucel-T) in Germany
– the first country outside of the U.S. to offer the novel immunotherapy
for advanced prostate cancer since receiving marketing authorization in
the European Union (EU) in 2013.
Dendreon finished 2014 strong with a net product revenue for the year
ended December 31, 2014 of $303.8 million compared to $283.7 million for
the year ended December 31, 2013. Net product revenue for the fourth
quarter ended December 31, 2014 was $79.8 million compared to $74.8
million for the fourth quarter ended December 31, 2013. As of December
31, 2014, Dendreon had approximately $122 million in cash, cash
equivalents, and short-term and long-term investments.
“Achieving these three major milestones – delivering four consecutive
quarters of year over year growth, exceeding our target revenue and
commercializing PROVENGE in Europe – starts 2015 on a positive note,”
said W. Thomas Amick, president and chief executive officer of Dendreon.
“Dendreon is moving in the right direction, and we are delivering on our
commitment to expand access to PROVENGE for advanced prostate cancer
In early January, the first commercial patient in Germany began
treatment with PROVENGE for advanced prostate cancer, demonstrating
Dendreon’s continued commitment to bring the first personalized
immunotherapy to patients in new markets. To help meet the need for
innovative therapies for advanced prostate cancer in the EU, PROVENGE,
which stimulates a patient’s own immune system to fight cancer, is being
made available through a growing network of regional cancer treatment
centers where select physicians are being trained in the treatment
process. Initially, PROVENGE is available at four centers in Germany.
Adding to the product’s broadening access, Dendreon has also registered
PROVENGE in Puerto Rico, making it available for distribution.
“It is a privilege to be the first institution in the EU using a
pioneering therapy like PROVENGE to treat advanced prostate cancer,”
said Axel Heidenreich, MD, Uniklinik RWTH Aachen, Klinik for Urologie,
Aachen, Germany. “The availability of PROVENGE in Europe gives
physicians a brand-new way to fight this difficult-to-treat disease and
may extend the lives of patients, who currently have limited effective
In 2012, approximately 417,000 men were diagnosed with prostate cancer
in Europe, and more than 92,000 men died from the disease.1
PROVENGE is approved in the EU for the treatment of asymptomatic or
minimally symptomatic metastatic (non-visceral) castrate-resistant
prostate cancer in male adults in whom chemotherapy is not yet
clinically indicated. Dendreon received marketing authorization for
PROVENGE from the European Commission in September 2013, which provides
approval for the commercialization of PROVENGE in all 28 countries of
the EU as well as Norway, Iceland and Liechtenstein. The product is also
approved by the Food and Drug Administration in the United States.
On November 10, 2014, Dendreon announced that it reached agreements on
the terms of a financial restructuring with the Senior Noteholders of
the Company's 2.875% Convertible Senior Notes due 2016, representing
approximately 84% of the $620 million aggregate principal amount of the
2016 Notes. Under the terms of the agreements, the financial
restructuring may take the form of a stand-alone recapitalization or a
sale of the Company or its assets. To implement the financial
restructuring contemplated under the agreements with the relevant Senior
Noteholders, Dendreon and its U.S. subsidiaries filed voluntary
petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy
Court for the District of Delaware. The transactions under the
agreements will enable continued delivery of PROVENGE without disruption
or impact to access for providers and appropriate patients in need of
this revolutionary personalized immunotherapy treatment.
Important Safety Information for PROVENGE
PROVENGE® (sipuleucel-T) is an autologous cellular
immunotherapy indicated for the treatment of asymptomatic or minimally
symptomatic metastatic castrate-resistant (hormone-refractory) prostate
Before getting PROVENGE, tell your doctor if you:
Have heart problems
Have lung problems
Have a history of stroke
Take any other medicines, including prescription and nonprescription
drugs, vitamins, and dietary supplements.
What are the possible side effects of PROVENGE?
PROVENGE infusion can cause serious reactions.
Tell your doctor right away if you:
Have breathing problems, chest pains, racing heart or irregular
heartbeats, high or low blood pressure, dizziness, fainting, nausea,
or vomiting after getting PROVENGE. Any of these may be signs of heart
or lung problems.
Develop numbness or weakness on one side of the body, decreased vision
in one eye or difficulty speaking. Any of these may be signs of a
Develop symptoms of thrombosis which may include pain and/or swelling
of an arm or leg with warmth over the affected area, discoloration of
an arm or leg, unexplained shortness of breath or chest pain that
worsens on deep breathing.
Get a fever over 100°F, or redness or pain at the infusion or
collection sites. Any of these may be signs of infection.
The most common side effects of PROVENGE include chills, fatigue, fever,
back pain, nausea, joint ache, and headache.
These are not all the possible side effects of PROVENGE treatment. For
more information, talk with your doctor.
Call your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information on PROVENGE, please see the Full Prescribing
Information or call 1-877-336-3736.
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. For
more information about the Company and its programs, visit http://www.dendreon.com/.
Certain information in this press release may constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements contained in this press
release that are not statements of historical fact, and other estimates,
projections, future trends and the outcome of events that have not yet
occurred referenced in this press release should be considered
forward-looking statements. Words such as "anticipate," "estimate,"
"expect," "project," "intend," "plan," "believe," "may," "predict,"
"will," "would," "could," "should," "target" and similar expressions are
often used to identify forward-looking statements. Actual results or
events could differ materially from those indicated in forward-looking
statements as a result of risks and uncertainties, including, among
others, the potential adverse impact of the Chapter 11 filings on
Dendreon’s liquidity or results of operations, changes in Dendreon’s
ability to meet financial obligations during the Chapter 11 process or
to maintain contracts that are critical to Dendreon’s operations, the
outcome or timing of the Chapter 11 process and the proposed stand-alone
restructuring, asset sale or plan sale (including the occurrence or
likelihood of qualified bids or an auction), the effect of the Chapter
11 filings or proposed stand-alone restructuring, asset sale or plan
sale on Dendreon’s relationships with third parties, regulatory
authorities and employees, proceedings that may be brought by third
parties in connection with the Chapter 11 process or the proposed
stand-alone restructuring, asset sale or plan sale, Bankruptcy Court
approval or other conditions or termination events in connection with
the proposed stand-alone restructuring, asset sale or plan sale, and the
timing or amount of any distributions to Dendreon’s stakeholders. For a
discussion of some of the additional risks and important factors that
Dendreon believes could cause actual results or events to differ from
the forward-looking statements that it makes, see the sections entitled
"Risk Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Dendreon’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2014. In addition, new
risks and uncertainties emerge from time to time, and it is not possible
for Dendreon to predict or assess the impact of every factor that may
cause its actual results or events to differ from those contained in any
forward-looking statements. Accordingly, you should not place undue
reliance on any forward-looking statements contained in this press
release. Any forward-looking statements speak only as of the date of
this press release. Dendreon undertakes no obligation to publicly update
forward-looking statements, whether as a result of new information,
future events or otherwise.
1. Ferlay, EJC 49 (2013). 1374-1403
Dendreon CorporationCorporate CommunicationsApril Falcone,