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Dendreon (DNDNQ) Exceeded Revenue Guidance for First Time Ever in Q4

January 14, 2015 8:32 AM EST
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Dendreon (OTCBB: DNDNQ) 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.



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