-Record ADCETRIS® (Brentuximab Vedotin) Net
Sales in U.S. and Canada of $159.0 Million in the Second Quarter,
an Increase of 30 Percent Over the Second Quarter of 2018-
-Biologics License Application Submitted to FDA
for Enfortumab Vedotin to Treat Advanced or Metastatic Urothelial
Cancer Based on Results from the EV-201 Pivotal Trial-
-Topline Results from Tucatinib HER2CLIMB
Pivotal Trial Expected in 2019-
-Conference Call Today at 4:30 p.m. ET-
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial
results for the second quarter and six months ended June 30, 2019.
The company also highlighted ADCETRIS (brentuximab vedotin)
commercialization and clinical development accomplishments and
progress with its late-stage clinical programs for cancer.
“In the second quarter, we achieved record ADCETRIS net sales in
the U.S. and Canada, reflecting growth in frontline CD30-expressing
peripheral T-cell lymphomas as well as frontline advanced Hodgkin
lymphoma,” said Clay Siegall, Ph.D., President and Chief Executive
Officer of Seattle Genetics. “We are also making substantial
progress with our late-stage programs, delivering on several key
goals. The Biologics License Application for enfortumab vedotin was
submitted to the FDA for patients with locally advanced or
metastatic urothelial cancer, taking us another step closer to
becoming a multi-product oncology company. Additionally, we expect
to report topline data from the tucatinib pivotal trial, HER2CLIMB,
in HER2-positive metastatic breast cancer later this year and from
the tisotumab vedotin pivotal trial, innovaTV 204, in metastatic
cervical cancer in the first half of 2020.”
Program Highlights
ADCETRIS
- Ex-U.S. Approvals for ADCETRIS in Frontline Hodgkin Lymphoma
(HL): In May 2019, ADCETRIS in combination with AVD
(Adriamycin®, vinblastine and dacarbazine) was approved by Health
Canada for patients with previously untreated stage IV HL. Also, in
June 2019, Takeda received an additional approval for ADCETRIS in
frontline HL that resulted in a $7.5 million milestone payment to
Seattle Genetics.
- Additional Analyses of ECHELON-1 and ECHELON-2 Trials
Presented at 2019 American Society of Clinical Oncology (ASCO)
Annual Meeting: A three-year update of the ECHELON-1 trial
continued to show superior clinical activity of ADCETRIS in
combination with AVD compared to ABVD (Adriamycin, bleomycin,
vinblastine and dacarbazine) in frontline stage III and IV HL.
Separately, analyses of clinical trials in T-cell lymphomas,
including the ECHELON-2 trial, showed that responses were observed
in patients across all levels of CD30 expression.
Enfortumab Vedotin
- Enfortumab Vedotin Biologics License Application (BLA)
Submitted to FDA: In July 2019, Seattle Genetics and Astellas
Pharma, Inc. submitted a BLA to the U.S. Food and Drug
Administration (FDA) for enfortumab vedotin to treat patients with
locally advanced or metastatic urothelial cancer who have received
a PD-1/L1 inhibitor and who have received a platinum-containing
chemotherapy in the neoadjuvant/adjuvant, locally advanced or
metastatic setting. The submission is based on positive results
from the first cohort of the EV-201 clinical trial, which were
recently presented in a late-breaking oral session at the 2019 ASCO
Annual Meeting.
- Broad Clinical Development Program Underway: Seattle
Genetics and Astellas are evaluating enfortumab vedotin in several
ongoing trials. These include a phase 3 randomized clinical trial
(EV-301) that is intended to support global registrations. A phase
1 trial (EV-103) is also underway evaluating enfortumab vedotin in
earlier lines of treatment for patients with locally advanced or
metastatic urothelial cancer, including in combination with
pembrolizumab and/or platinum chemotherapy in newly diagnosed
patients as well as patients whose cancer progressed from
earlier-stage disease. The company expects to report initial data
from the EV-103 trial in 2019.
Tucatinib
- Tucatinib HER2CLIMB Pivotal Trial Data Expected in 2019:
The company previously announced enrollment of 480 patients in the
HER2CLIMB pivotal trial of tucatinib in HER2-positive metastatic
breast cancer to enable analysis of the primary endpoint of
progression-free survival (PFS). Topline data are expected to be
reported in 2019.
Tisotumab Vedotin
- Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected
in 2020: Seattle Genetics and Genmab previously reported the
completion of enrollment in the innovaTV 204 pivotal trial of
tisotumab vedotin in patients with recurrent and/or metastatic
cervical cancer who have relapsed or progressed after standard of
care treatment. Topline data from the trial are expected in the
first half of 2020.
Other Recent Activities
- Collaborator ADC Progress: In June 2019, the FDA
approved Polivy™ (polatuzumab vedotin-piiq) an antibody-drug
conjugate (ADC) targeting CD79b that utilizes Seattle Genetics’
technology. Polivy was developed and will be commercialized by
Genentech, a member of the Roche Group. As a result, Seattle
Genetics will receive a $5.0 million milestone payment and is
eligible to receive royalties on worldwide net sales.
- Robin Taylor, Ph.D., Appointed Chief Commercial Officer:
Dr. Taylor brings 18 years of biotechnology and pharmaceutical
company experience in the commercialization of oncology drugs,
including significant marketing, launch and global product strategy
roles at both Genentech/Roche and AstraZeneca. He contributed to
several leading global brands, including Tecentriq® (atezolizumab),
Alecensa® (alectinib), Avastin® (bevacizumab) and Herceptin®
(trastuzumab).
SECOND QUARTER AND SIX-MONTHS 2019 FINANCIAL RESULTS
Revenues: Total revenues in the second quarter and
six-month periods ended June 30, 2019 increased to $218.4 million
and $413.6 million, respectively, compared to $170.2 million and
$310.8 million for the same periods in 2018. Revenues are comprised
of the following three components:
- Net Product Sales: ADCETRIS net sales for the U.S. and
Canada in the second quarter were $159.0 million, a 30 percent
increase over net sales of $122.4 million in the second quarter of
2018. ADCETRIS net sales for the U.S. and Canada were $294.0
million for the year-to-date in 2019, a 35 percent increase over
net sales of $217.8 million for the same period in 2018.
- Royalty Revenues: Royalty revenues in the second quarter
were $23.3 million, compared to $20.6 million in the second quarter
of 2018. Royalty revenues were $39.0 million for the year-to-date
in 2019, compared to $36.2 million for the same period in 2018.
Royalty revenues are primarily driven by sales of ADCETRIS outside
the U.S. and Canada by Takeda, which increased for the periods in
2019 compared to the same periods in 2018.
- Collaboration and License Agreement Revenues: Amounts
earned under the company’s ADCETRIS and ADC collaborations
increased to $36.1 million in the second quarter of 2019, compared
to $27.2 million for the same period in 2018. Collaboration
revenues were $80.7 million for the year-to-date in 2019, compared
to $56.7 million for the same period in 2018. Collaboration
revenues included the earned portion of $12.5 million and $42.5
million for milestones achieved in the second quarter of 2019 and
first half of 2019, respectively. These milestones were based on
Takeda’s additional approvals of ADCETRIS in frontline HL and
Genentech’s FDA approval of Polivy.
Research and Development (R&D) Expenses: R&D
expenses in the second quarter were $163.9 million, compared to
$122.9 million in the second quarter of 2018. R&D expenses were
$322.2 million for the year-to-date in 2019, compared to $275.4
million for the same period in 2018. The increases reflect
additional investment in the company’s late-stage pipeline
including enfortumab vedotin, tucatinib and tisotumab vedotin.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses in the second quarter were $82.3 million,
compared to $58.3 million in the second quarter of 2018. SG&A
expenses were $162.6 million for the year-to-date in 2019, compared
to $124.5 million for the same period in 2018. The increases were
primarily attributed to costs to support commercialization efforts
related to frontline ADCETRIS indications, the company's late-stage
programs and higher infrastructure costs to support the company's
continued growth.
Non-cash, share-based compensation cost for the first six months
of 2019 was $51.9 million, compared to $32.4 million for the same
period in 2018.
Net Loss
Net loss for the second quarter of 2019 was $79.2 million, or
$0.49 per diluted share, compared to net income of $76.3 million,
or $0.47 per diluted share, for the second quarter of 2018. Net
loss in the second quarter of 2019 included a net investment loss
of $40.5 million primarily associated with Seattle Genetics’ common
stock holdings, which are marked-to-market, compared to a net
investment gain of $106.6 million in the second quarter of 2018.
For the six months ended June 30, 2019, net loss was $92.6 million,
or $0.57 per share, compared to a net loss of $35.4 million, or
$0.23 per share, for the six months ended June 30, 2018. Net loss
for the six months ended June 30, 2018 included an investment gain
of $88.7 million.
Cash and Investments
As of June 30, 2019, cash and investments were $376.1 million.
In addition, the company held stock investments, primarily in
Immunomedics common stock, valued at $109.2 million.
2019 FINANCIAL OUTLOOK
The company's 2019 financial guidance is detailed below,
including updates to its expectations for collaboration revenues
driven by recent milestones and SG&A expenses driven primarily
by pre-commercialization activities for the potential launch of
enfortumab vedotin in connection with the recent BLA
submission.
Current
Previous
Revenues
ADCETRIS net product sales
$610 million to $640 million
Unchanged
Collaboration and license agreement
revenues
$110 million to $125 million
$95 million to $110 million
Royalty revenues
$85 million to $90 million
Unchanged
Operating expenses and other
costs
R&D expenses
$650 million to $700 million
Unchanged
SG&A expenses
$335 million to $360 million
$300 million to $335 million
Cost of sales
5 percent to 6 percent
Unchanged
Cost of royalty revenues
Low single-digit percent on ex-US
sales
Unchanged
Non-cash costs (primarily attributable to
share based compensation)
$135 million to $145 million
Unchanged
Conference Call Details
Seattle Genetics’ management will host a conference call and
webcast with supporting slides to discuss its second quarter 2019
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 and supporting slides will be
simultaneously webcast and available for replay from the Seattle
Genetics website at www.seattlegenetics.com, under the Investors
section. Investors may also participate in the conference call by
calling 800-458-4121 (domestic) or 323-794-2093 (international).
The conference ID is 3271918. A replay of the audio only will be
available by calling 888-203-1112 (domestic) or 719-457-0820
(international), using conference ID 3271918. The telephone replay
will be available until 5:00 p.m. PT on July 19, 2019.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes
transformative therapies targeting cancer to make a meaningful
difference in people’s lives. ADCETRIS® (brentuximab vedotin)
utilizes the company’s industry-leading antibody-drug conjugate
(ADC) technology and is currently approved for the treatment of
multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company
has established a pipeline of novel targeted therapies at various
stages of clinical testing, including three in ongoing pivotal
trials for solid tumors. Enfortumab vedotin for metastatic
urothelial cancer and tisotumab vedotin for metastatic cervical
cancer utilize our proprietary ADC technology. Tucatinib, a small
molecule tyrosine kinase inhibitor, is in a pivotal trial for
HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a
portfolio of proprietary immuno-oncology agents in clinical trials
targeting hematologic malignancies and solid tumors. The company is
headquartered in Bothell, Washington, and has a European office in
Switzerland. For more information on our robust pipeline, visit
www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
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
2019 outlook, including anticipated 2019 revenues, costs and
expenses; the company’s potential to achieve the noted development
and regulatory milestones in 2019 and in future periods including
the potential approval by the FDA of the BLA for enfortumab vedotin
to treat patients with locally advanced or metastatic urothelial
cancer who have received a PD-1/L1 inhibitor and who have received
a platinum-containing chemotherapy in the neoadjuvant/adjuvant,
locally advanced or metastatic setting; the anticipated reporting
of topline data for tucatinib for the HER2CLIMB trial in 2019 and
for tisotumab vedotin for the innovaTV 204 trial in the first half
of 2020; anticipated activities related to the company’s planned
and ongoing clinical trials; the potential for the company’s
clinical trials to support further development, regulatory
submissions and potential marketing approvals; the opportunities
for, and the therapeutic and commercial potential of ADCETRIS,
enfortumab vedotin, tucatinib, and tisotumab vedotin and the
company’s other product candidates and those of its licensees and
collaborators; the company’s aspiration to become a multi-product
oncology company; 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
risks that the company’s ADCETRIS net sales, revenues, expenses,
costs, and other financial guidance may not be as expected, as well
as risks and uncertainties associated with maintaining or
increasing sales of ADCETRIS due to competition, unexpected adverse
events, regulatory action, reimbursement, market adoption by
physicians or other factors. The company may also be delayed or
unsuccessful in its planned clinical trial initiations, the
enrollment in and conduct of its clinical trials, obtaining data
from clinical trials, planned regulatory submissions, and
regulatory approvals in each case for a variety of reasons
including the difficulty and uncertainty of pharmaceutical product
development, negative or disappointing clinical trial results,
unexpected adverse events or regulatory discussions or actions and
the inherent uncertainty associated with the regulatory approval
process. 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, 2019 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 except as
required by applicable law.
Seattle Genetics, Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Revenues:
Net product sales
$
158,980
$
122,443
$
293,981
$
217,800
Collaboration and license agreement
revenues
36,130
27,179
80,708
56,738
Royalty revenues
23,337
20,551
38,957
36,225
Total revenues
218,447
170,173
413,646
310,763
Costs and expenses:
Cost of sales
8,609
13,157
16,520
23,515
Cost of royalty revenues
2,288
6,148
4,677
11,525
Research and development
163,929
122,860
322,194
275,362
Selling, general and administrative
82,331
58,292
162,602
124,474
Total costs and expenses
257,157
200,457
505,993
434,876
Loss from operations
(38,710
)
(30,284
)
(92,347
)
(124,113
)
Investment and other income (loss),
net
(40,528
)
106,557
(220
)
88,671
Net income (loss)
$
(79,238
)
$
76,273
$
(92,567
)
$
(35,442
)
Net income (loss) per share - basic
$
(0.49
)
$
0.48
$
(0.57
)
$
(0.23
)
Net income (loss) per share - diluted
$
(0.49
)
$
0.47
$
(0.57
)
$
(0.23
)
Shares used in computation of per share
amounts - basic
161,436
158,381
161,049
155,525
Shares used in computation of per share
amounts - diluted
161,436
163,382
161,049
155,525
Seattle Genetics, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
June 30, 2019
December 31, 2018
Assets
Cash, cash equivalents and investments
$
376,129
$
459,866
Other assets
1,191,436
1,043,463
Total assets
$
1,567,565
$
1,503,329
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
204,950
$
191,472
Deferred revenue and long-term
liabilities
90,789
37,914
Stockholders’ equity
1,271,826
1,273,943
Total liabilities and stockholders’
equity
$
1,567,565
$
1,503,329
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190716005943/en/
Investors: Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Media: Monique Greer 425-527-4641 mgreer@seagen.com
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