[July 26, 2016] |
|
Seattle Genetics Reports Second Quarter 2016 Financial Results
Seattle
Genetics, Inc. (NASDAQ: SGEN) today reported financial results for
the second quarter ended June 30, 2016. The company also highlighted
ADCETRIS (brentuximab vedotin) commercialization and clinical
development accomplishments, vadastuximab talirine (SGN (News - Alert)-CD33A; 33A)
activities and progress with its pipeline of antibody-drug conjugates
(ADCs) and other proprietary programs.
"We reported record ADCETRIS net sales in the second quarter, which were
up 20 percent for the quarter and year-to-date compared to the same
periods in 2015. To expand on the ADCETRIS opportunity, we are executing
on three ongoing phase 3 clinical trials that are approaching data,
starting with ALCANZA top-line results this quarter," said Clay
Siegall, Ph.D., President and Chief Executive Officer of Seattle
Genetics. "We also demonstrated progress in the second quarter with our
clinical-stage pipeline towards our goal of becoming a multi-product
oncology company. We advanced 33A into a phase 3 trial for acute myeloid
leukemia (AML) and reported encouraging phase 1 data from two ADCs for
urothelial cancer, ASG-15ME and enfortumab vedotin (ASG-22ME). We
anticipate advancing several new programs and generating additional data
from our pipeline over the remainder of 2016."
Recent ADCETRIS Highlights
-
The European Commission approved ADCETRIS for the treatment of adult
patients with CD30+ Hodgkin lymphoma at increased risk of relapse or
progression following autologous stem cell transplant based on data
from the phase 3 AETHERA clinical trial. This is the third approved
indication for ADCETRIS in the European Union.
-
Announced that final data from the ADCETRIS monotherapy pivotal phase
2 clinical trial in relapsed or refractory classical Hodgkin lymphoma
were published in the journal Blood. The manuscript, which
summarizes the five-year, end-of-study results, highlights that many
patients who achieved a complete remission remained in remission at
the time of this final analysis.
-
Takeda continues to receive additional marketing approvals for
ADCETRIS, which is now commercially available in 65 countries
worldwide.
Recent Vadastuximab Talirine (SGN-CD33A) Highlights
-
Initiated the pivotal phase 3 CASCADE (News - Alert) clinical trial evaluating 33A in
combination with the hypomethylating agents (HMAs) azacitidine or
decitabine in approximately 500 older patients with newly diagnosed
AML. The trial is designed to determine if the 33A-containing regimen
improves overall survival compared to patients receiving HMAs alone.
-
Reported data from a phase 1 trial of 33A plus HMAs in older, newly
diagnosed patients with AML in an oral presentation at the 21st
Congress of the European Hematology Association (EHA). The data showed
a 76 percent objective response rate, including a 41 percent complete
remission rate with manageable tolerability profile. The median
overall survival for all patients in the phase 1 trial is interim and
expected to evolve. The estimated median overall survival for the
first 25 patients enrolled in the study was 12.75 months.
Recent Pipeline and Other Highlights
-
Reported data at the American Society of Clinical Oncology (ASCO)
annual meeting from phase 1 trials of ASG-15ME and enfortumab vedotin
in metastatic urothelial cancer, primarily bladder carcinoma. The data
showed that both ADCs had manageable safety profiles and objective
response rates of 40 to 50 percent at the likely recommended doses for
future development. ASG-15ME and enfortumab vedotin are being
co-developed with Astellas.
-
Triggered milestones under ongoing ADC (News - Alert) collaborations based on
progress with programs utilizing Seattle Genetics technology,
including from:
-
Astellas, upon its initiation of a phase 2 clinical trial in
metastatic renal cell carcinoma; and,
-
AbbVie, based on progress with a preclinical program.
-
Added to and promoted several members of the senior management team,
including:
-
Promoting Naomi Hunder, M.D., to Vice President, Clinical
Development. Dr. Hunder joined Seattle Genetics in 2010. She has
most recently served as the clinical lead for the ADCETRIS
program, notably for the company's successful FDA approval in
post-autologous transplant high-risk Hodgkin lymphoma based on
data from the phase 3 AETHERA trial.
-
Promoting Dana Kennedy, Pharm.D., to Vice President, Clinical
Development. Dr. Kennedy joined Seattle Genetics in 2007. Her
contributions have included the clinical development work that led
to the approval of ADCETRIS in systemic anaplastic large cell
lymphoma and serving as clinical and program leader for SGN-CD33A.
-
Hiring Ian Pyrah, Ph.D., as Vice President, Non-Clinical Sciences.
Prior to joining Seattle Genetics, Dr. Pyrah spent 10 years at
Amgen in several leadership roles, including responsibility for
the non-clinical component of a number of successful regulatory
submissions.
-
Hiring Venkat Ramanan, Ph.D., as Vice President, Finance. Dr.
Ramanan previously spent nine years at Gilead Sciences and prior
to that he was at Amgen and ZS Associates. He has served in a
range of roles in finance, business planning and operations
supporting U.S. and international markets.
Anticipated ADCETRIS Upcoming Activities
-
Report top-line data in the third quarter of 2016 from the phase 3
ALCANZA trial in patients with CD30-expressing cutaneous T-cell
lymphoma (CTCL).
-
Report data in the 2017 through mid-2018 timeframe from the phase 3
ECHELON-1 trial in frontline classical Hodgkin lymphoma.
-
Complete enrollment in the phase 3 ECHELON-2 trial in frontline mature
T-cell lymphoma (MTCL) during 2016 and report data in the 2017 to 2018
timeframe.
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin
lymphoma or frontline MTCL.
Anticipated Vadastuximab Talirine (SGN-CD33A) Upcoming Activities
-
Continue clinical site initiations and enrollment of 500 patients to
the pivotal phase 3 CASCADE clinical trial evaluating 33A in
combination with HMAs in older patients with newly diagnosed AML.
-
Report data from ongoing phase 1 trials, including a phase 1b trial of
33A in combination with cytarabine and daunorubicin (7+3) for
frontline, younger AML patients.
More information about 33A and ongoing clinical trials can be found at www.ADC-CD33.com.
Anticipated Pipeline Programs Upcoming Activities
-
Initiate a randomized phase 2 trial of denintuzumab mafodotin
(SGN-CD19A; 19A) in frontline diffuse large B-cell lymphoma (DLBCL)
during 2016.
-
Report additional data from phase 1 trials of ASG-15ME and enfortumab
vedotin at the European Society for Medical Oncology (ESMO) annual
congress being held October 7 to 11, 2016 in Copenhagen, Denmark.
-
Report clinical data during 2016 from other pipeline programs,
including SGN-LIV1A.
-
Initiate a phase 1 trial of SGN-CD123A in relapsed or refractory AML.
SGN-CD123A is an ADC targeted to CD123 utilizing Seattle Genetics'
newest technology, comprising an engineered cysteine antibody (EC-mAb)
stably linked to a highly potent DNA binding agent called a
pyrrolobenzodiazepine (PBD) dimer. CD123 is expressed across AML
subtypes, and is particularly prominent on leukemic stem cells.
-
Advance SGN-CD352A, a novel ADC for multiple myeloma, into a phase 1
clinical trial. SGN-CD352A targets CD352, and utilizes the company's
PBD and EC-mAb technology. CD352 is highly expressed on multiple
myeloma as well as B-cell malignancies, including chronic lymphocytic
leukemia and non-Hodgkin lymphoma.
Second Quarter and Six Months 2016 Financial Results
Total revenues in the quarter and six month periods ended June 30, 2016
increased to $95.4 million and $206.6 million, respectively, compared to
$77.1 million and $159.3 million from the same periods in 2015. Revenues
included:
-
ADCETRIS net sales in the second quarter were $66.2 million, a 20
percent increase from net sales of $55.1 million in the second quarter
of 2015. For the year-to-date, ADCETRIS sales were $124.9 million,
compared to $104.0 million for the year-to-date period in 2015, a 20
percent increase.
-
Royalty revenues in the second quarter of 2016 were $9.2 million,
compared to $7.6 million in the second quarter of 2015. For the
year-to-date in 2016, royalty revenues were $41.5 million, compared to
$18.7 million for the first six months of 2015. Royalty revenues are
primarily driven by international sales of ADCETRIS by Takeda. Royalty
revenues for the year-to-date in 2016 also included a $20.0 million
sales milestone payment from Takeda earned in the first quarter of
2016.
-
Amounts earned under the company's ADCETRIS and ADC collaborations
totaled $20.0 million in the second quarter and $40.2 million for the
first six months of 2016, compared to $14.4 million and $36.6 million
for the same periods in 2015.
Total costs and expenses for the second quarter of 2016 were $128.8
million, compared to $124.7 million for the second quarter of 2015. For
the first six months of 2016, total costs and expenses were $261.0
million, compared to $228.6 million in the first six months of 2015. The
increase in 2016 costs and expenses was primarily driven by progress
with ADCETRIS, 33A clinical development and manufacturing activities and
investment in the company's pipeline programs.
Non-cash, share-based compensation cost for the first six months of 2016
was $24.3 million, compared to $17.6 million for the same period in 2015.
Net loss for the second quarter of 2016 was $32.7 million, or $0.23 per
share, compared to a net loss of $47.5 million, or $0.38 per share, for
the second quarter of 2015. For the six months ended June 30, 2016, net
loss was $53.2 million, or $0.38 per share, compared to a net loss of
$69.2 million, or $0.55 per share, for the same period in 2015.
As of June 30, 2016, Seattle Genetics had $659.5 million in cash, cash
equivalents and investments, compared to $712.7 million as of December
31, 2015.
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 888-576-4398
(domestic) or 719-325-2329 (international). The conference ID is
2574870. A replay of the discussion will be available beginning at
approximately 4:30 p.m. PT today from Seattle Genetics' website or by
calling 888-203-1112 (domestic) or 719-457-0820 (international), using
conference ID 2574870. The telephone replay will be available until 5:00
p.m. PT on Thursday, July 28, 2016.
About Seattle Genetics
Seattle Genetics is an innovative biotechnology company that develops
and commercializes novel antibody-based therapies for the treatment of
cancer. The company's industry-leading antibody-drug conjugate (ADC)
technology harnesses the targeting ability of antibodies to deliver
cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab
vedotin), the company's lead product, in collaboration with Takeda
Pharmaceutical Company Limited, is the first in a new class of ADCs
commercially available globally in 65 countries for relapsed classical
Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell
lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab
talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid
leukemia. Headquartered in Bothell, Washington, Seattle Genetics is also
advancing a robust pipeline of innovative therapies for blood-related
cancers and solid tumors designed to address significant unmet medical
needs and improve treatment outcomes for patients. The company has
collaborations for its proprietary ADC technology with a number of
companies including AbbVie, Astellas, Bayer, Genentech, GlaxoSmithKline
and Pfizer. More information can be found at www.seattlegenetics.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company's
expectations for 2016 ADCETRIS net sales, anticipated financial outlook
including revenues, costs and expenses, upcoming presentations and
publications, anticipated regulatory events and clinical activities,
including enrollment completion and data availability from ALCANZA,
ECHELON-1 and ECHELON-2 and other ongoing clinical trials and the timing
thereof, and the initiation of future clinical trials, the opportunities
for, and the therapeutic and commercial potential of, ADCETRIS, 33A and
the company's other product candidates, as well as other statements that
are not historical facts. 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 the risk
that sales of ADCETRIS may not meet or exceed our guidance or otherwise
be as we expect, including, with respect to the company's 2016 ADCETRIS
net sales and financial guidance as well as other risks related to
future opportunities and plans, including the uncertainty of expected
future financial performance and results. We may also be delayed in our
planned clinical trial initiations, the enrollment in and conduct of our
clinical trials, and obtaining data from clinical trials, in each case
for a variety of reasons, including the difficulty and uncertainty of
pharmaceutical product development and unexpected adverse events or
regulatory action. We may also be unable to expand ADCETRIS' labeled
indications due to unexpected data from our ongoing phase 3 trials or
regulatory action or complete the development of, and obtain regulatory
approval for, our product candidates, each of which are in relatively
early stages of development. More information about the risks and
uncertainties faced by Seattle Genetics is contained under the caption
"Risk Factors" included in the company's Quarterly Report on Form 10-Q
for the quarter ended March 31, 2016 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
|
2015
|
Assets
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments
|
|
$
|
|
659,486
|
|
$
|
712,711
|
|
Other assets
|
|
|
|
|
203,800
|
|
|
182,384
|
|
|
Total assets
|
|
$
|
|
863,286
|
|
$
|
895,095
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Accounts payable and accrued liabilities
|
|
$
|
|
93,574
|
|
$
|
88,031
|
|
Deferred revenue and long-term liabilities
|
|
|
|
101,188
|
|
|
121,153
|
|
Stockholders' equity
|
|
|
|
668,524
|
|
|
685,911
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
|
863,286
|
|
$
|
895,095
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Seattle Genetics, Inc.
|
Condensed Consolidated Statements of Operations
|
(Unaudited)
|
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Six months ended
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
|
|
2015
|
|
|
|
|
2016
|
|
|
|
2015
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
$
|
66,216
|
|
|
$
|
55,095
|
|
|
|
$
|
124,864
|
|
|
$
|
103,981
|
|
|
Collaboration and license agreement revenues
|
|
|
|
19,998
|
|
|
|
14,386
|
|
|
|
|
40,174
|
|
|
|
36,607
|
|
|
Royalty Revenues
|
|
|
|
9,188
|
|
|
|
7,615
|
|
|
|
|
41,519
|
|
|
|
18,665
|
|
|
Total revenues
|
|
|
|
95,402
|
|
|
|
77,096
|
|
|
|
|
206,557
|
|
|
|
159,253
|
|
Costs and expenses
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
6,901
|
|
|
|
5,940
|
|
|
|
|
12,845
|
|
|
|
11,150
|
|
|
Cost of royalty revenues
|
|
|
|
3,107
|
|
|
|
2,639
|
|
|
|
|
6,722
|
|
|
|
5,813
|
|
|
Research and development
|
|
|
|
85,554
|
|
|
|
85,737
|
|
|
|
|
178,425
|
|
|
|
149,132
|
|
|
Selling, general and administrative
|
|
|
|
33,282
|
|
|
|
30,343
|
|
|
|
|
63,029
|
|
|
|
62,464
|
|
|
Total costs and expenses
|
|
|
|
128,844
|
|
|
|
124,659
|
|
|
|
|
261,021
|
|
|
|
228,559
|
|
Loss from operations
|
|
|
|
(33,442
|
)
|
|
|
(47,563
|
)
|
|
|
|
(54,464
|
)
|
|
|
(69,306
|
)
|
Investment income
|
|
|
|
699
|
|
|
|
61
|
|
|
|
|
1,243
|
|
|
|
114
|
|
Net loss
|
|
|
|
|
|
$
|
(32,743
|
)
|
|
$
|
(47,502
|
)
|
|
|
$
|
(53,221
|
)
|
|
$
|
(69,192
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
|
$
|
(0.23
|
)
|
|
$
|
(0.38
|
)
|
|
|
$
|
(0.38
|
)
|
|
$
|
(0.55
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted net loss per share
|
|
|
|
140,283
|
|
|
|
125,064
|
|
|
|
|
140,086
|
|
|
|
124,690
|
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160726006375/en/
[ Back To TMCnet.com's Homepage ]
|