- 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 patients worldwide.”
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 therapies available.”
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 cancer.
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 stroke.
- 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.
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. 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.
References
1. Ferlay, EJC 49 (2013). 1374-1403
Dendreon CorporationCorporate CommunicationsApril Falcone,
206-829-1622media@dendreon.com