-ADCETRIS® Net Product Sales of $33.7
Million in the Third Quarter of 2012 and $102.8 Million Year-to-Date in
2012-
-Multiple ADCETRIS Data Presentations Planned for ASH from Clinical
Trials in Broad Range of CD30-Positive Malignancies-
-Conference call today at 4:30 p.m. ET-
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 7, 2012--
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results
for the third quarter and nine months ended September 30, 2012. The
company also highlighted ADCETRIS (brentuximab vedotin)
commercialization and clinical development activities, antibody-drug
conjugate (ADC) pipeline and collaborator progress and upcoming
milestones.
“Through significant commercial, regulatory and clinical development
efforts we are continuing to bring ADCETRIS to patients, expanding into
other territories under our collaboration with Millennium/Takeda, and
advancing the evaluation of ADCETRIS into earlier lines of therapy and
other CD30-positive malignancies,” said Clay B. Siegall, Ph.D.,
President and Chief Executive Officer at Seattle Genetics. “At the
upcoming American Society of Hematology (ASH) annual meeting in
December, there will be more than a dozen data presentations by Seattle
Genetics and investigators highlighting the evaluation of ADCETRIS in
numerous lymphoma types. In addition, at ASH we will introduce our lead
preclinical program, SGN-CD33A, which employs our next generation ADC
technology, and we expect multiple data presentations by our ADC
collaborators. The substantial progress with ADCETRIS and our other
pipeline programs, as well as by our collaborators reinforces our ADC
leadership position as we strive to change the way cancer is treated.”
Recent ADCETRIS Highlights
-
Announced that Takeda Pharmaceutical Company Limited and Millennium:
The Takeda Oncology Company received European Commission conditional
marketing authorization for ADCETRIS for relapsed or refractory
CD30-positive Hodgkin lymphoma (HL) and relapsed or refractory
systemic anaplastic large cell lymphoma (sALCL). The approvals
triggered milestone payments to Seattle Genetics totaling $25 million.
-
In collaboration with Millennium, initiated a global phase III
clinical trial of ADCETRIS in combination with chemotherapy for
front-line advanced HL. The trial is being conducted under a Special
Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA) and scientific advice from the European Medicines
Agency.
-
Received an SPA agreement from the FDA supporting the design of a
planned phase III clinical trial in front-line mature T-cell lymphomas.
-
Announced the completion of patient enrollment in a phase III clinical
trial for post-transplant HL patients. The phase III trial, also known
as the AETHERA trial, is evaluating ADCETRIS versus placebo for the
treatment of patients at high risk of residual Hodgkin lymphoma
following autologous stem cell transplant (ASCT).
-
Initiated a phase II trial in front-line Hodgkin lymphoma patients age
60 or older. The trial is designed to assess the efficacy and
tolerability of single-agent ADCETRIS for patients who have received
no prior treatment.
-
Supported initiation of an investigator-sponsored trial (IST) designed
to evaluate ADCETRIS in the treatment of diffuse large B-cell
lymphoma. A total of 11 ADCETRIS ISTs are ongoing.
ADC Collaborator Progress
-
Expanded our ADC collaboration with Abbott, generating an upfront
payment to Seattle Genetics of $25 million. In addition, Seattle
Genetics may receive up to $220 million in potential milestone
payments per additional target upon achieving predetermined
development and commercial objectives, as well as mid-to-high
single-digit royalties on worldwide net sales of any resulting
products under the multi-target collaboration.
-
Achieved milestone payments under our ADC collaboration with
Genentech, a member of the Roche Group, triggered by Genentech’s
advancement of two ADCs utilizing Seattle Genetics technology into
phase II clinical development.
-
Achieved a milestone under our ADC collaboration with Abbott triggered
by Abbott’s initiation of a phase I clinical trial of an ADC utilizing
Seattle Genetics technology for patients with squamous cell tumors.
-
Achieved a milestone under our ADC collaboration with Progenics
triggered by Progenics’ initiation of a phase II clinical trial of an
ADC targeted to PSMA for patients with prostate cancer.
Other Recent Highlights
-
Initiated a phase I trial of SGN-75 in combination with everolimus, an
mTOR inhibitor, for advanced metastatic renal cell carcinoma.
-
Submitted to the FDA an investigational new drug application for
SGN-CD19A, a CD19-targeted ADC. Phase I trials are expected to begin
by early 2013.
-
Named Samuel Yonren, M.D., as Vice President, Drug Safety.
Upcoming Milestones
-
Multiple clinical data presentations on ADCETRIS and ADC collaborator
programs, as well as preclinical data on SGN-CD33A using the company’s
next generation ADC technology will be presented at the ASH annual
meeting being held December 8-11, 2012 in Atlanta, GA.
-
Initiating a phase III clinical trial of ADCETRIS in front-line mature
T-cell lymphomas, including sALCL, by late 2012 or early 2013.
-
Anticipating a review decision from Health Canada in early 2013 for
ADCETRIS in relapsed HL and sALCL.
-
Initiating a phase I/II clinical trial of ADCETRIS in combination with
bendamustine for second-line HL patients by late 2012.
-
Initiating phase I trials of SGN-CD19A, a CD19-targeted ADC, by early
2013. One trial is planned in acute lymphocytic leukemia and one in
B-cell non-Hodgkin lymphomas.
Third Quarter and First Nine Months 2012 Financial Results
Total revenues in the third quarter of 2012 were $49.8 million, compared
to $20.7 million in the third quarter of 2011. Total revenues for the
nine month period ended September 30, 2012 were $146.9 million, compared
to $45.9 million in 2011. Revenues in 2012 include ADCETRIS net product
sales of $33.7 million in the third quarter and $102.8 million for the
year to date. In addition, revenues include ADCETRIS royalty revenues of
$1.7 million in the third quarter and $2.9 million for the year to date
related to sales of ADCETRIS by Millennium under its international named
patient program. Revenues also reflect amounts earned under the
company’s ADCETRIS and ADC collaborations totaling $14.5 million in the
third quarter of 2012 and $41.1 million for the year to date.
Total costs and expenses for the third quarter of 2012 were $63.6
million, compared to $61.6 million for the third quarter of 2011. For
the first nine months of 2012, total costs and expenses were $193.4
million, compared to $171.6 million in the first nine months of 2011.
The planned increases in 2012 costs and expenses were primarily driven
by ADCETRIS commercialization activities, cost of sales and research and
development of the company’s other ADC pipeline programs.
Under the ADCETRIS collaboration with Millennium, development costs
incurred by Seattle Genetics are included in research and development
expense. Joint development costs are co-funded by Millennium on a 50:50
basis. Reimbursement payments received from Millennium are recognized as
revenue over the development period of the collaboration along with
other development payments received, including the upfront payment and
milestone payments. Seattle Genetics co-funds development activities
performed by Millennium under the collaboration, which reduces the
amount of reimbursement payments received from Millennium.
Non-cash, share-based compensation expense for the first nine months of
2012 was $17.9 million, compared to $14.0 million in the first nine
months of 2011.
Net loss for the third quarter of 2012 was $13.7 million, or $0.12 per
share, compared to a net loss of $40.7 million, or $0.35 per share, for
the third quarter of 2011. For the nine months ended September 30, 2012,
net loss was $43.2 million, or $0.37 per share, compared to a net loss
of $124.9 million, or $1.11 per share, for the same period in 2011.
As of September 30, 2012, Seattle Genetics had $313.9 million in cash,
cash equivalents and investments, compared to $330.7 million as of
December 31, 2011.
2012 Revenue Outlook
Seattle Genetics now anticipates that revenues from ADCETRIS net product
sales will be in the range of $132 million to $137 million in 2012.
Conference Call Details
Seattle Genetics’ management will host a conference call and webcast to
discuss the financial results and provide an update on business
activities. The event will be held today at 1:30 p.m. Pacific Time (PT);
4:30 p.m. Eastern Time (ET). The live event will be available from
Seattle Genetics’ website at www.seattlegenetics.com,
under the Investors and News section, or by calling (866) 225-8754
(domestic) or (480) 629-9866 (international). The access code is
4570300. A replay of the discussion will be available beginning at
approximately 3:30 p.m. PT today from Seattle Genetics’ website or by
calling (800) 406-7325 (domestic) or (303) 590-3030 (international),
using access code 4570300. The telephone replay will be available until
4:00 p.m. PT on Friday, November 9, 2012.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development
and commercialization of monoclonal antibody-based therapies for the
treatment of cancer. The FDA granted accelerated approval of ADCETRIS in
August 2011 for two indications. ADCETRIS is being developed in
collaboration with Millennium: The Takeda Oncology Company. In addition,
Seattle Genetics has three other clinical-stage ADC programs: SGN-75,
ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC
technology with a number of leading biotechnology and pharmaceutical
companies, including Abbott, Agensys (an affiliate of Astellas), Bayer,
Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline,
Millennium, Pfizer and Progenics, as well as ADC co-development
agreements with Agensys and Genmab. More information can be found at www.seattlegenetics.com.
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company’s
expectations for initiation of future clinical trials, data availability
from ongoing clinical trials, expectations for additional regulatory
approvals and expectations for revenue and expenses for the year 2012.
Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include sales of ADCETRIS may not be as
expected or expenses may exceed current projections. We may also be
delayed in our planned trial initiations and regulatory submissions and
approvals for reasons outside of our control. We may also fail to
receive milestone payments under our collaborations. In addition, if we
do not meet our financial guidance or the expectations of analysts or
investors, our stock price may be adversely impacted. More information
about the risks and uncertainties faced by Seattle Genetics is contained
in the company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2012 filed with the Securities and Exchange Commission.
Seattle Genetics disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
|
|
|
Seattle Genetics, Inc.
Condensed Consolidated
Balance Sheets
(Unaudited)
(In thousands)
|
|
|
|
|
|
September 30,
2012
|
|
December 31,
2011
|
|
Assets
|
|
|
|
|
|
Cash, cash equivalents, and investments
|
|
$
|
313,934
|
|
$
|
330,696
|
|
Other assets
|
|
|
101,396
|
|
|
94,520
|
|
Total assets
|
|
$
|
415,330
|
|
$
|
425,216
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
42,525
|
|
$
|
53,048
|
|
Deferred revenue and long-term liabilities
|
|
|
150,229
|
|
|
153,319
|
|
Stockholders' equity
|
|
|
222,576
|
|
|
218,849
|
|
Total liabilities and stockholders' equity
|
|
$
|
415,330
|
|
$
|
425,216
|
|
|
|
|
Seattle Genetics, Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
(In
thousands, except per share amounts)
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
33,658
|
|
|
$
|
10,047
|
|
|
$
|
102,845
|
|
|
$
|
10,047
|
|
|
Collaboration and license agreement revenues
|
|
|
14,476
|
|
|
|
10,619
|
|
|
|
41,119
|
|
|
|
35,844
|
|
|
Royalty revenues
|
|
|
1,698
|
|
|
|
-
|
|
|
|
2,936
|
|
|
|
-
|
|
|
Total revenues
|
|
|
49,832
|
|
|
|
20,666
|
|
|
|
146,900
|
|
|
|
45,891
|
|
|
Costs and expenses
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
2,742
|
|
|
|
724
|
|
|
|
8,808
|
|
|
|
724
|
|
|
Cost of royalty revenues
|
|
|
613
|
|
|
|
-
|
|
|
|
1,115
|
|
|
|
-
|
|
|
Research and development
|
|
|
41,392
|
|
|
|
41,080
|
|
|
|
122,634
|
|
|
|
123,157
|
|
|
Selling, general and administrative
|
|
|
18,842
|
|
|
|
19,795
|
|
|
|
60,889
|
|
|
|
47,705
|
|
|
Total costs and expenses
|
|
|
63,589
|
|
|
|
61,599
|
|
|
|
193,446
|
|
|
|
171,586
|
|
|
Loss from operations
|
|
|
(13,757
|
)
|
|
|
(40,933
|
)
|
|
|
(46,546
|
)
|
|
|
(125,695
|
)
|
|
Investment and other income, net
|
|
|
105
|
|
|
|
248
|
|
|
|
3,360
|
|
|
|
830
|
|
|
Net loss
|
|
$
|
(13,652
|
)
|
|
$
|
(40,685
|
)
|
|
$
|
(43,186
|
)
|
|
$
|
(124,865
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.12
|
)
|
|
$
|
(0.35
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(1.11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing basic and diluted net
loss per share
|
|
|
118,471
|
|
|
|
114,727
|
|
|
|
117,361
|
|
|
|
112,435
|
|
|
|
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Investors:
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
or
Media:
Tricia
Larson, 425-527-4180
tlarson@seagen.com
|
