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Dendreon Announces First Quarter 2013 Results



  Dendreon Announces First Quarter 2013 Results

           Conference Call to be Hosted May 9, 2013 at 9:00 a.m. ET

Business Wire

SEATTLE -- May 09, 2013

May 9, 2013--Dendreon Corporation (Nasdaq:DNDN) today reported results for the
first quarter ended March 31, 2013. Net product revenue for the quarter was
$67.6 million compared to $82.0 million for the quarter ended March 31, 2012,
down 17.6% year over year.

Net loss in the first quarter of 2013 was $72.0 million, or $0.48 per share,
compared to a net loss of $103.9 million, or $0.70 per share for the same
period in 2012.

As of March 31, 2013, Dendreon had $337.3 million in cash, cash equivalents,
and short-term and long-term investments, compared to $429.8 million as of
December 31, 2012.

“We remain focused on improving PROVENGE utilization by executing our
direct-to-consumer campaign which began in March, educating potential patients
in the mCRPC market and employing our enhanced sales messaging with our
customers,” said John H. Johnson, chairman, president and chief executive
officer. “Currently, we are seeing an improvement in enrollments, a trend
which began mid-way through the first quarter. As we leverage the power of our
DTC campaign, we are confident in our ability to grow PROVENGE year over
year.”

First Quarter Highlights:

  * Continued new physician interest in PROVENGE^® (sipuleucel-T):

       * Added 33 net new accounts in the first quarter, bringing total number
         of accounts that have infused to 835

  * Demonstrated positive early indicators in effectiveness of
    direct-to-consumer advertising:

       * Addresses significant need for patient education and awareness
       * First national TV commercial aired March 7
       * Patients contacting Dendreon directly for more information, resulting
         in a significant increase in call center and relationship marketing
         activity

  * Continued improvement in reimbursement landscape for physicians:

       * Reported average time to payment remains less than 30 days for
         physicians

  * Continued progress with strategic restructuring:

       * The Company believes it can reduce cost of goods sold (COGS) to below
         50% of net product revenue in the third quarter 2013 at its current
         forecast levels
       * Already seeing net benefits in financial results associated with the
         restructuring initiatives and expect full benefits realized in the
         third quarter of 2013

  * Continued focus on expanding clinical data:

       * Presented data at AUA that further analyzed Phase III IMPACT data to
         identify prognostic variables that may support early administration
         of PROVENGE after diagnosis of metastatic castrate resistant prostate
         cancer
       * Actively evaluating partnering strategies for European expansion;
         continuing to enroll patients in the sipuleucel-T European Union
         open-label study; expect a regulatory decision in Europe in the
         second half of 2013
       * Completed enrollment of PROVENGE and ADT sequencing study; presented
         initial data at ASCO-GU and expect to present additional data in 2013
       * Completed enrollment of PROVENGE and Zytiga^® (abiraterone)
         sequencing study; presented initial data at ASCO-GU and expect to
         present additional data in 2013
       * Supporting 19 novel investigator initiated trials (IITs) to advance
         understanding of immunotherapy and the treatment of advanced prostate
         cancer
       * 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

Conference Call Information

Dendreon will host a conference call on May 9, 2013 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 53497612. The call will also be
audio webcast with supplemental information slides available 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 1-800-585-8367 or +1-404-537-3406 for international callers; the
conference ID number is 53497612. The replay will be available from 12:00 p.m.
ET on Thursday, May 9, 2013 until 11:59 p.m. ET on Wednesday, May 15, 2013. In
addition, the webcast will be archived for on-demand listening for 90 days at
www.dendreon.com and the supplemental information slides will be posted to the
Company’s website.

PROVENGE Indication and Important Safety Information

PROVENGE^® (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 1500
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, 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, 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/.

Statements in this press release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but are not
limited to, statements regarding the expected benefits of the restructuring,
the timing and elements of the restructuring, the timing and form of related
charges, the expected annual operating expense reduction, expectations and
beliefs regarding Dendreon's financial position, profitability and Dendreon's
ability to break even and achieve improved performance as a result of the
restructuring, expectations regarding reductions of cost of goods sold,
expectations regarding regulatory approval of PROVENGE® in Europe,
expectations regarding the presentation of clinical data, developments
affecting Dendreon's U.S. and global business and prospects, beliefs and
expectations regarding potential revenue and earnings from product sales,
including beliefs regarding Dendreon's ability to grow sales, expectations
regarding market size, target market, and market opportunity, beliefs
regarding the impact of our direct to consumer advertising, expectations with
respect to our sales force execution and effectiveness, progress generally on
commercialization efforts for PROVENGE, and expectations about clinical trial
enrollments. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause Dendreon's actual results to
be materially different from historical results or from any results expressed
or implied by such forward-looking statements. These factors include, but are
not limited to, our inability to achieve and sustain commercial success for
PROVENGE; the identification of efficacy, safety or other issues with
PROVENGE; a slower than anticipated adoption by treating physicians of
PROVENGE for the treatment of patients with advanced prostate cancer for a
variety of reasons, including competing therapies, instability in our sales
force, the risk that we cannot replace vacant sales positions on a prompt
basis, perceived difficulties in the treatment process, delays in obtaining
reimbursement or for other reasons; any promotional limitations imposed by the
FDA on our ability to commercialize and market PROVENGE; unexpected
difficulties and costs associated with the rapid expansion of our commercial
operations to support the commercial launch of PROVENGE; the impact of
competing therapies on sales of PROVENGE, the failure to achieve approval in
Europe, manufacturing difficulties, disruptions or delays and other factors
discussed in the "Risk Factors" section of Dendreon's Annual Report on Form
10-Q for the quarter ended March 31, 2013. All forward-looking statements are
qualified in their entirety by this cautionary statement. Dendreon is
providing this information as of the date of this press release and does not
undertake any obligation to update any forward-looking statements contained in
this release as a result of new information, future events or otherwise.

 
DENDREON CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
                                                                 
                                                     Three Months Ended
                                                     March 31,
                                                     2013         2012
                                                     (unaudited)
                                                                   
Product revenue, net                                 $ 67,580     $  81,972
Royalty and other revenue                              14            102
Total revenue                                          67,594        82,074
                                                                   
Operating expenses:
Cost of product revenue                                43,375        60,041
Research and development                               18,448        17,343
Selling, general and administrative                    62,446        95,315
Restructuring and contract termination                 1,960         (124)
Total operating expenses                               126,229       172,575
Loss from operations                                   (58,635)      (90,501)
Interest income                                        218           383
Interest expense                                       (13,629)      (13,812)
Other income                                           41            16
Net loss                                             $ (72,005)   $  (103,914)
                                                                   
Basic and diluted net loss per share                 $ (0.48)     $  (0.70)
                                                                   
Shares used in computation of basic and                151,481       147,599
diluted net loss per share
                                                                   
                                                                   
                                                     March 31,    December 31,
                                                     2013         2012
Balance Sheet Data:
Cash and cash equivalents                            $ 130,577    $  188,408
Short-term investments                                 144,634       165,396
Long-term investments                                  62,059        76,045
Total cash and cash equivalents, short-term            337,270       429,849
investments and long-term investments
Trade accounts receivable                              39,109        38,884
Inventory                                              89,542        76,300
Total assets                                           638,950       721,119
Convertible senior notes due 2016                      539,140       532,744
Convertible senior subordinated notes due              27,685        27,685
2014
Total stockholders' equity (deficit)                   (35,907)      34,613
                                                                   

 
DENDREON CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP NET LOSS
(in thousands, except per share amounts)
                                               
                                                Three Months Ended
                                                March 31,
                                                2013              2012        
                                                (unaudited)
                                                                   
GAAP net loss                                   $ (72,005 )       $ (103,914 )
Non-GAAP adjustments:
Depreciation and amortization expense             7,762             10,864
Imputed interest related to the                   6,396             5,898
convertible senior notes due 2016
Restructuring and contract termination,
including stock-based compensation                1,960             (124     )
expense
Management severance and other
termination benefits:
Severance expense                                 —                 5,173
Non-cash stock-based compensation                 —                 11,678
expense
Other stock-based compensation expense            2,082             19,475    
Non-GAAP net loss                               $ (53,805 )       $ (50,950  )
                                                                   
Non-GAAP net loss per share- basic and          $ (0.36   )       $ (0.35    )
diluted
                                                                   
Shares used in computation of basic and           151,481           147,599   
diluted net loss per share
                                                                              

The above table provides certain non-GAAP financial measures that include
adjustments to GAAP figures. Dendreon believes that these non-GAAP financial
measures, when considered together with the GAAP figures, can enhance an
overall understanding of Dendreon's financial performance and its prospects
for the future. The non-GAAP financial measures are included with the intent
of providing investors with a more complete understanding of operational
results and trends. We believe excluding these items provides important
insight into our operational results, important for a company at our stage in
development. In addition, these non-GAAP financial measures are among the
indicators Dendreon management uses for planning and forecasting purposes and
measuring the Company's performance. These non-GAAP financial measures are not
intended to be considered in isolation or as a substitute for GAAP figures.

Contact:

Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com
or
Investor Relations
Nicole Soley, 206-455-2220
InvestorRelations@dendreon.com
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