|
| [February 25, 2013] |
 |
Dendreon Announces Fourth Quarter and 2012 Year End Results
SEATTLE --(Business Wire)--
Dendreon Corporation (Nasdaq: DNDN) today reported results for the
fourth quarter and full year ended December 31, 2012. Net product
revenue for the year ended December 31, 2012 was $325.3 million compared
to $213.5 million for the year ended December 31, 2011. Net product
revenue for the fourth quarter ended December 31, 2012 was $85.5
million, which includes a $3.8 million favorable adjustment to the
Company's chargebacks reserve due to a change in estimate. On a
pro-forma basis, excluding this adjustment, net product revenue for the
quarter and year ended December 31, 2012 was $81.6 million and $321.5
million, respectively, up 5% on a sequential quarter over quarter basis
and 51% year over year.
Net loss for the year ended December 31, 2012 was $393.6 million, or
$2.65 per share, compared to $337.8 million, or $2.31 per share for the
year ended December 31, 2011.
As of December 31, 2012, Dendreon had approximately $429.8 million in
cash, cash equivalents, and short-term and long-term investments,
compared to $617.7 million as of December 31, 2011.
Fourth Quarter Highlights:
-
Continued strong performance in community accounts:
-
Community urology grew 25% overall quarter over quarter
-
Community oncology grew 4% overall quarter over quarter
-
Community accounts represent 71% of total sales, up from 58% in
the fourth quarter of 2011
-
Natural shift away from academic, which declined 9% quarter over
quarter
-
Continued new physician interest in PROVENGE®
(sipuleucel-T):
-
Added 61 net new accounts in the fourth quarter, bringing total
number of infusing accounts to 802
-
Continued improvement in reimbursement landscape for physicians
-
Noridian enhanced its coverage policy for PROVENGE prescribers
-
Reported average time to payment remains less than 30 days for
physicians
-
Announced direct-to-consumer advertising campaign
-
Addresses significant need for patient education and awareness
-
National campaign targeted to key markets with efficient media buy
of approximately $5 million per quarter
-
First commercial to air early in the second quarter of 2013; will
be previewed live on the earnings call
-
Continue making progress with strategic restructuring:
-
Sold interest in Morris Plains, NJ facility to Novartis for $43
million and preserved approximately 100 jobs
-
Expect to reduce cost of goods sold (COGS) to below 50% of net
product revenue in the beginning of the third quarter 2013
-
Expect to begin to see net benefits associated with the
restructuring initiatives to begin to appear in financial results
as early as the first half of 2013, with full benefits realized in
the third quarter of 2013
-
Continued focus on expanding clinical data:
-
Data presented at the American Society of Clinical Oncology
Genitourinary Cancers Symposium (ASCO-GU) continues to provide
important insights into the treatment of advanced prostate cancer
with PROVENGE, particularly as it relates to investigational uses
of PROVENGE in combination or sequenced with other treatments
-
Actively evaluating partnering strategies for European expansion;
continuing to enroll patients in the sipuleucel-T European Union
open-label study; expect a mid-2013 regulatory decision in Europe
-
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
-
Initiating an early detection registry, in which men with castrate
resistant prostate cancer but without known metastases, will be
imaged regularly for evidence of metastatic disease
"We are pleased to have delivered a strong quarter for community sales,"
said John H. Johnson, chairman, president and chief executive officer.
"Given the need for increased patient awareness and education, we will
build on our direct-to-consumer programs with targeted advertising
beginning in the second quarter. As we work to drive the top line, we
continue to reduce our cost of goods sold and streamline our cost
position, and expect to begin to see net benefits of these actions as
early as the first half of 2013."
Conference Call Information
Dendreon will host a conference call on February 25, 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 95297228.
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
95297228. The replay will be available from 12:00 p.m. ET on Monday,
February 25, 2013 until 11:59 p.m. ET on Sunday, March 3, 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 and potential revenue
and earnings from product sales, expectations regarding market size and
market opportunity, beliefs regarding the impact of our direct to
consumer advertising, expectations with respect to our sales force
execution, and progress generally on commercialization efforts for
PROVENGE. 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 due to competing therapies, instability in our
sales force, including 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 operations to support the
commercial launch of PROVENGE; the impact of competing therapies on
sales of PROVENGE, and other factors discussed in the "Risk Factors"
section of Dendreon's Annual Report on Form 10-K for the year ended
December 31, 2012. 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
|
|
|
|
Year Ended
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
2012
|
|
|
|
|
|
2011
|
|
|
|
|
|
2012
|
|
|
|
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net
|
|
|
|
$
|
85,455
|
|
|
|
|
$
|
76,962
|
|
|
|
|
$
|
325,333
|
|
|
|
|
$
|
213,511
|
|
|
Royalty and other revenue
|
|
|
|
|
38
|
|
|
|
|
|
125,183
|
|
|
|
|
|
197
|
|
|
|
|
|
128,102
|
|
|
Total revenue
|
|
|
|
|
85,493
|
|
|
|
|
|
202,145
|
|
|
|
|
|
325,530
|
|
|
|
|
|
341,613
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
|
|
54,371
|
|
|
|
|
|
57,020
|
|
|
|
|
|
227,892
|
|
|
|
|
|
159,090
|
|
|
Research and development
|
|
|
|
|
18,960
|
|
|
|
|
|
17,699
|
|
|
|
|
|
74,643
|
|
|
|
|
|
74,290
|
|
|
Selling, general and administrative
|
|
|
|
|
73,488
|
|
|
|
|
|
76,062
|
|
|
|
|
|
317,131
|
|
|
|
|
|
361,342
|
|
|
Restructuring, contract termination and asset impairment
|
|
|
|
|
(36,302
|
)
|
|
|
|
|
105
|
|
|
|
|
|
45,667
|
|
|
|
|
|
38,587
|
|
|
Total operating expenses
|
|
|
|
|
110,517
|
|
|
|
|
|
150,886
|
|
|
|
|
|
665,333
|
|
|
|
|
|
633,309
|
|
|
Income (loss) from operations
|
|
|
|
|
(25,024
|
)
|
|
|
|
|
51,259
|
|
|
|
|
|
(339,803
|
)
|
|
|
|
|
(291,696
|
)
|
|
Interest income
|
|
|
|
|
273
|
|
|
|
|
|
337
|
|
|
|
|
|
1,344
|
|
|
|
|
|
1,415
|
|
|
Interest expense
|
|
|
|
|
(13,940
|
)
|
|
|
|
|
(13,681
|
)
|
|
|
|
|
(55,252
|
)
|
|
|
|
|
(47,705
|
)
|
|
Other income (expense)
|
|
|
|
|
(4
|
)
|
|
|
|
|
182
|
|
|
|
|
|
101
|
|
|
|
|
|
180
|
|
|
Net income (loss)
|
|
|
|
$
|
(38,695
|
)
|
|
|
|
$
|
38,097
|
|
|
|
|
$
|
(393,610
|
)
|
|
|
|
$
|
(337,806
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net income (loss) per share
|
|
|
|
$
|
(0.26
|
)
|
|
|
|
$
|
0.26
|
|
|
|
|
$
|
(2.65
|
)
|
|
|
|
$
|
(2.31
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computation of basic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
net income (loss) per share
|
|
|
|
|
149,737
|
|
|
|
|
|
146,789
|
|
|
|
|
|
148,777
|
|
|
|
|
|
146,163
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computation of diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
net income (loss) per share
|
|
|
|
|
149,737
|
|
|
|
|
|
150,163
|
|
|
|
|
|
148,777
|
|
|
|
|
|
146,163
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
2011
|
|
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
|
$
|
188,408
|
|
|
|
$
|
427,100
|
|
|
|
|
Short-term investments
|
|
|
|
|
165,396
|
|
|
|
|
111,525
|
|
|
|
|
Long-term investments
|
|
|
|
|
76,045
|
|
|
|
|
79,071
|
|
|
|
|
Total cash and cash equivalents, short-term investments and
long-term investments
|
|
|
|
$
|
429,849
|
|
|
|
$
|
617,696
|
|
|
|
|
Trade accounts receivable
|
|
|
|
|
38,884
|
|
|
|
|
35,541
|
|
|
|
|
Prepaid antigen costs
|
|
|
|
|
643
|
|
|
|
|
7,490
|
|
|
|
|
Inventory
|
|
|
|
|
76,300
|
|
|
|
|
69,502
|
|
|
|
|
Total assets
|
|
|
|
|
721,119
|
|
|
|
|
1,001,491
|
|
|
|
|
Convertible senior notes due 2016
|
|
|
|
|
532,744
|
|
|
|
|
508,418
|
|
|
|
|
Convertible senior subordinated notes due 2014
|
|
|
|
|
27,685
|
|
|
|
|
27,685
|
|
|
|
|
Total stockholders' equity
|
|
|
|
|
34,613
|
|
|
|
|
352,637
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DENDREON CORPORATION
RECONCILIATION OF GAAP TO NON-GAAP NET (News - Alert) LOSS
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
Year Ended
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
2012
|
|
|
|
|
|
2011
|
|
|
|
|
|
2012
|
|
|
|
|
|
2011
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss)
|
|
|
|
$
|
(38,695
|
)
|
|
|
|
$
|
38,097
|
|
|
|
|
$
|
(393,610
|
)
|
|
|
|
$
|
(337,806
|
)
|
|
Non-GAAP adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
|
|
|
8,505
|
|
|
|
|
|
10,877
|
|
|
|
|
|
39,657
|
|
|
|
|
|
36,674
|
|
|
Imputed interest related to the convertible senior notes due 2016
|
|
|
|
|
6,267
|
|
|
|
|
|
5,779
|
|
|
|
|
|
24,326
|
|
|
|
|
|
21,294
|
|
|
Restructuring, contract termination and asset impairment, including
stock-based compensation expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance, contract termination and other expense
|
|
|
|
|
10,815
|
|
|
|
|
|
105
|
|
|
|
|
|
25,819
|
|
|
|
|
|
18,735
|
|
|
Non-cash stock-based compensation expense
|
|
|
|
|
325
|
|
|
|
|
|
-
|
|
|
|
|
|
2,015
|
|
|
|
|
|
5,022
|
|
|
Non-cash asset impairment
|
|
|
|
|
(47,442
|
)
|
|
|
|
|
-
|
|
|
|
|
|
17,833
|
|
|
|
|
|
14,830
|
|
|
Management severance and other termination benefits:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance expense
|
|
|
|
|
801
|
|
|
|
|
|
-
|
|
|
|
|
|
7,766
|
|
|
|
|
|
-
|
|
|
Non-cash stock-based compensation expense
|
|
|
|
|
1,179
|
|
|
|
|
|
-
|
|
|
|
|
|
16,291
|
|
|
|
|
|
-
|
|
|
Other stock-based compensation expense
|
|
|
|
|
12,905
|
|
|
|
|
|
12,125
|
|
|
|
|
|
53,367
|
|
|
|
|
|
55,239
|
|
|
Royalty payment related to sale of VICTRELISTM
|
|
|
|
|
-
|
|
|
|
|
|
(125,000
|
)
|
|
|
|
|
-
|
|
|
|
|
|
(125,000
|
)
|
|
Non-GAAP net income (loss)
|
|
|
|
$
|
(45,340
|
)
|
|
|
|
$
|
(58,017
|
)
|
|
|
|
$
|
(206,536
|
)
|
|
|
|
$
|
(311,012
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income (loss) per share- basic
|
|
|
|
$
|
(0.30
|
)
|
|
|
|
$
|
(0.40
|
)
|
|
|
|
$
|
(1.39
|
)
|
|
|
|
$
|
(2.13
|
)
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Shares used in computation of basic
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|
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|
|
|
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net income (loss) per share
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|
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|
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149,737
|
|
|
|
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146,789
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|
|
|
|
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148,777
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|
|
|
|
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146,163
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|
|
|
|
|
|
|
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|
|
|
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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.

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