SEATTLE--(BUSINESS WIRE)-- August 8, 2013--Dendreon Corporation (NAS: DNDN) today reported results for the second quarter ended June 30, 2013. Net product revenue for the quarter was $73.3 million compared to $80.0 million for the quarter ended June 30, 2012, down 8.4% year over year and up 8.4% on a sequential basis.
Net loss in the second quarter of 2013 was $68.8 million, or $0.45 per share, compared to a net loss of $96.1 million, or $0.65 per share for the same period in 2012.
As of June 30, 2013, Dendreon had $280.6 million in cash, cash equivalents, and short-term and long-term investments, compared to $429.8 million as of December 31, 2012.
"During the second quarter, we made progress turning around what was a challenging first quarter, with solid growth in large accounts where we are focused," said John H. Johnson, chairman, president and chief executive officer of Dendreon. "Urology led the way, with 37% quarter-over-quarter growth, and our highest-ever sales in this segment. We have received supportive feedback from physicians, patients and key opinion leaders about PROVENGE, and remain focused on improving utilization through our direct-to-consumer advertising campaign, which is generating positive early indicators."
Second Quarter Highlights:
Received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE® (sipuleucel-T) be granted marketing authorization in the European Union (EU)
Continued new physician interest in PROVENGE:
Added 42 net new accounts in the second quarter
Continued to make traction with direct-to-consumer (DTC) advertising campaign:
Addresses significant need for patient education and awareness
First national television commercial aired on March 7
Patients contacting Dendreon directly for more information, resulting in a significant increase in call center and relationship marketing activity
Seeing registrations to relationship marketing program increase significantly when ad is on the air and registrations are converting to enrollments faster than expected
Continued focus on expanding clinical data
Completed enrollment of PROVENGE and ADT (androgen deprivation therapy) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Completed enrollment of PROVENGE and Zytiga® (abiraterone acetate) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Finalized trial design and named steering committee for Phase II trial for sequencing PROVENGE with Xtandi® (enzalutamide) and expect to begin enrolling patients in the fourth quarter of 2013
Supporting 19 novel investigator initiated trials (IITs) to advance understanding of immunotherapy and the treatment of advanced prostate cancer
Intensifying efforts in the biomarker discovery program and identified some potential pre-treatment biomarkers in a preliminary data set
Initiated an early detection study named PREDICT that will image castrate-resistant patients without known metastatic disease. Data from this study may help physicians better identify mCRPC patients early in the disease state.
Continuing to advance pipeline including DN24-02, Dendreon's investigational autologous cell immunotherapy based on the same platform as PROVENGE but targeting the tumor antigen HER2/neu
The Company noted that urology sales have grown to its highest level since launch and sales trends in large accounts have rebounded since Q1 of 2013. The number of large accounts, defined as having an annual run rate of more than $1 million in sales, has grown to its highest level post competitive entries. However, based upon current enrollment trends in July and August, Dendreon does not expect to see enough of a sales increase in the second half of the year to meet its goal of growing PROVENGE year over year. The Company noted that the competitive environment remains largely unchanged from the first quarter.
Net loss in the second quarter of 2013 was $68.8 million, or $0.45 per share, compared to a net loss of $96.1 million, or $0.65 per share for the same period in 2012.
As of June 30, 2013, Dendreon had $280.6 million in cash, cash equivalents, and short-term and long-term investments, compared to $429.8 million as of December 31, 2012.
"During the second quarter, we made progress turning around what was a challenging first quarter, with solid growth in large accounts where we are focused," said John H. Johnson, chairman, president and chief executive officer of Dendreon. "Urology led the way, with 37% quarter-over-quarter growth, and our highest-ever sales in this segment. We have received supportive feedback from physicians, patients and key opinion leaders about PROVENGE, and remain focused on improving utilization through our direct-to-consumer advertising campaign, which is generating positive early indicators."
Second Quarter Highlights:
Received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE® (sipuleucel-T) be granted marketing authorization in the European Union (EU)
Continued new physician interest in PROVENGE:
Added 42 net new accounts in the second quarter
Continued to make traction with direct-to-consumer (DTC) advertising campaign:
Addresses significant need for patient education and awareness
First national television commercial aired on March 7
Patients contacting Dendreon directly for more information, resulting in a significant increase in call center and relationship marketing activity
Seeing registrations to relationship marketing program increase significantly when ad is on the air and registrations are converting to enrollments faster than expected
Continued focus on expanding clinical data
Completed enrollment of PROVENGE and ADT (androgen deprivation therapy) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Completed enrollment of PROVENGE and Zytiga® (abiraterone acetate) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Finalized trial design and named steering committee for Phase II trial for sequencing PROVENGE with Xtandi® (enzalutamide) and expect to begin enrolling patients in the fourth quarter of 2013
Supporting 19 novel investigator initiated trials (IITs) to advance understanding of immunotherapy and the treatment of advanced prostate cancer
Intensifying efforts in the biomarker discovery program and identified some potential pre-treatment biomarkers in a preliminary data set
Initiated an early detection study named PREDICT that will image castrate-resistant patients without known metastatic disease. Data from this study may help physicians better identify mCRPC patients early in the disease state.
Continuing to advance pipeline including DN24-02, Dendreon's investigational autologous cell immunotherapy based on the same platform as PROVENGE but targeting the tumor antigen HER2/neu
The Company noted that urology sales have grown to its highest level since launch and sales trends in large accounts have rebounded since Q1 of 2013. The number of large accounts, defined as having an annual run rate of more than $1 million in sales, has grown to its highest level post competitive entries. However, based upon current enrollment trends in July and August, Dendreon does not expect to see enough of a sales increase in the second half of the year to meet its goal of growing PROVENGE year over year. The Company noted that the competitive environment remains largely unchanged from the first quarter.
