News Column

Dendreon Announces First Quarter 2014 Results

May 24, 2014



By a News Reporter-Staff News Editor at Marketing Weekly News -- Dendreon Corporation (Nasdaq: DNDN) reported results for the first quarter ended March 31, 2014. Net product revenue for the quarter was $68.8 million compared to $67.6 million in the first quarter of 2013. Net loss in the first quarter of 2014 was $36.4 million, or $0.24 per share, compared to a net loss of $72.0 million, or $0.48 per share for the same period in 2013. As of March 31, 2014, Dendreon had approximately $170 million in cash, cash equivalents, and short-term and long-term investments.

John H. Johnson, chairman, president and chief executive officer of Dendreon, said, "This was the first quarter since the introduction of competition where we saw revenues grow as compared to the prior year, which confirms the progress we are making on a year-over-year basis. Achieving our first quarter results with fewer headcount, reduced expenses and streamlined marketing spend compared to the first quarter of last year speaks to our more efficient use of resources. We continue to work to accelerate our path to profitability, and remain focused on becoming cash flow breakeven as soon as possible."

"During the first quarter, we saw our enrollments increase on a sequential basis. After stabilizing PROVENGE sales in the face of competition, we expect the second quarter to improve from the first quarter, as it did last year," Mr. Johnson continued. "With the increasing amount of data surrounding PROVENGE along with a broader understanding of immunotherapy in cancer, we continue to see KOL support strengthening for PROVENGE, particularly in Europe following a successful European Association of Urology (EAU) meeting and the inclusion of PROVENGE in the new EAU prostate cancer guidelines." Recent Highlights: PROVENGEŽ (sipuleucel-T) sales have continued to stabilize

Community urology, a key focus area, grew 28% overall year over year

Cost of goods sold was approximately $37 million, or 53% of revenue, down from approximately $43 million or 64% of revenue in the first quarter of 2013

Sales, general, and administrative expenses were approximately $39 million, down from approximately $62 million in the first quarter of 2013

Cash burn was $30 million, down significantly from the first quarter of 2013 and down slightly from the fourth quarter of 2013

Continued focus on targeted accounts

93 large accounts, up significantly from 54 in the first quarter of 2013

Competitive environment continued to evolve

Zytiga and Xtandi increasing competitive share in post-chemo setting

Increased competition in pre-chemo in oncology from Xtandi

Continue to see greatest impact of competition in small and low volume accounts across our market segments

Continued progress to make PROVENGE commercially available in Europe

Making PROVENGE available through Centers of Excellence, beginning with fewer than 10 centers

Goal is to have the first commercial patient treated in the fourth quarter of 2014

Preparing for discussions with European regulatory authorities regarding automation

Plan to expand further beyond Centers of Excellence once automation is approved

Inclusion of PROVENGE in the new EAU prostate cancer treatment guidelines, which recommend PROVENGE as a therapeutic option for patients with asymptomatic, minimally symptomatic mCRPC and support the fact that there was a significant overall survival benefit in the PROVENGE arm in the pivotal study, with an overall safety profile that was acceptable

Continued momentum with successful EAU meeting and strong KOL support; in addition, 70% of a panel of physicians in the European Journal of Cancer agreed that PROVENGE should be used prior to Xtandi and Zytiga

Addressing the Company's convertible debt remains a top priority and the Company is exploring its options with advisors

Presented data from ongoing immuno-oncology trials at ASCO-GU, which further elucidate the product potency and mechanism of PROVENGE, in addition to investigational compound DN24-02 for the treatment of urothelial carcinoma

Completed enrollment in randomized Phase II study in high-risk urothelial carcinoma

Presented preliminary data from Phase II STAND study at the 29th Annual EAU Congress Conference Call Information Dendreon will host a conference call on May 8, 2014 at 9:00 a.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international); the conference ID number is 35049713. The call will also be audio webcast from the Company's website at http://www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-855-859-2056 or +1-404-537-3406 for international callers; the conference ID number is 35049713. The replay will be available from 12:00 p.m. EST on Thursday, May 8, 2014, until 11:59 p.m. EST on Thursday, May 15, 2014. In addition, the webcast will be archived for on-demand listening for 90 days at www.dendreon.com. PROVENGE Indication and Important Safety Information PROVENGEŽ (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, PROVENGEŽ (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/.

Keywords for this news article include: Therapy, Oncology, Marketing, Advertising, Drug Resistance, Prostate Cancer, Prostatic Neoplasms, Dendreon Corporation, Adverse Drug Reaction, Clinical Trials and Studies.

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Source: Marketing Weekly News