-ADCETRIS® (Brentuximab Vedotin) Net Sales in
U.S. and Canada Were $135.0 Million in the First Quarter, an
Increase of 42 Percent Over the First Quarter of 2018-
-Positive Topline Results from Pivotal Trial of
Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial
Cancer Support Planned 2019 Submission of Biologics License
Application-
-Target Enrollment Reached in HER2CLIMB Pivotal
Trial of Tucatinib in HER2-Positive Metastatic Breast Cancer;
Topline Results Expected in 2019-
-Conference Call Today at 4:30 p.m. ET-
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported
financial results for the first quarter ended March 31, 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 first quarter we achieved an important milestone toward
becoming a multi-product oncology company with the announcement of
positive topline results from the pivotal trial of enfortumab
vedotin in patients with locally advanced or metastatic urothelial
cancer, and we plan to submit an application for approval to the
FDA in 2019,” said Clay Siegall, Ph.D., President and Chief
Executive Officer of Seattle Genetics. “We continue to execute on
expanding ADCETRIS use in the two frontline indications, and
maintain our 2019 net sales guidance of $610 million to $640
million in the U.S. and Canada. We have also advanced our other
late-stage programs, including reaching target enrollment in the
HER2CLIMB pivotal trial of tucatinib in HER2-positive metastatic
breast cancer. We expect to report topline results from HER2CLIMB
in 2019.”
ADCETRIS and Late-Stage Pipeline Highlights
- ADCETRIS Ex-U.S. Regulatory
Activities in Frontline Hodgkin Lymphoma: In February
2019, Takeda received approval from the European
Commission to extend the marketing authorization for ADCETRIS
to include ADCETRIS in combination with AVD (Adriamycin®,
vinblastine and dacarbazine) in adult patients with previously
untreated CD30-positive stage IV classical Hodgkin lymphoma. As a
result, Seattle Genetics received a $30 million milestone
payment from Takeda.
- Enfortumab Vedotin (EV) Pivotal
Trial Positive Topline Results; Data Selected for Oral Presentation
at the American Society of Clinical Oncology (ASCO) 2019 Annual
Meeting: In March 2019, Seattle Genetics and Astellas announced
positive topline results from the first cohort of the EV-201
clinical trial that enrolled 128 patients with locally advanced or
metastatic urothelial cancer who previously received both platinum
chemotherapy and a PD-1 or PD-L1 inhibitor. Results showed a 44
percent objective response rate per blinded independent central
review. The duration of response was consistent with that recently
reported in the previous phase 1 study (EV-101). The most common
treatment-related adverse events included fatigue, alopecia,
decreased appetite, rash and peripheral neuropathy. The companies
plan to submit a Biologics License Application under the U.S. Food
and Drug Administration’s (FDA) accelerated approval pathway in
2019.
- Tucatinib HER2CLIMB Pivotal Trial
Update: Seattle Genetics previously announced enrollment of 480
patients in the HER2CLIMB trial to enable analysis of the primary
endpoint of progression-free survival (PFS), with topline data
expected to be reported in 2019. In April 2019, Seattle Genetics
achieved enrollment of 120 additional patients in HER2CLIMB to
reach the target enrollment of 600 patients to support the analyses
of key secondary endpoints, including overall survival as well as
PFS in patients with brain metastases.
- Tisotumab Vedotin (TV) innovaTV 204
Pivotal Trial Update: In March 2019, Seattle Genetics and
Genmab completed enrollment in the innovaTV 204 pivotal trial
evaluating TV in patients with recurrent and/or metastatic cervical
cancer who have relapsed or progressed after standard of care
treatment. The trial is designed to support a potential
regulatory submission under the FDA’s accelerated approval
pathway.
FIRST QUARTER 2019 FINANCIAL RESULTS
Revenues: Total revenues in the first quarter ended
March 31, 2019 increased to $195.2 million, compared to $140.6
million for the same period in 2018. Revenues are comprised of the
following three components:
- Net Product Sales: ADCETRIS net
sales for the U.S. and Canada in the first quarter were $135.0
million, a 42 percent increase over net sales of $95.4 million in
the first quarter of 2018.
- Royalty Revenues: Royalty
revenues in the first quarter were $15.6 million, compared to $15.7
million in the first quarter of 2018. Royalty revenues are
primarily driven by sales of ADCETRIS outside the U.S. and Canada
by Takeda. First quarter 2019 net sales of ADCETRIS in Takeda’s
territories increased over the comparable period in 2018; however,
royalty revenues for the period in 2018 included additional amounts
attributable to Takeda’s portion of certain third-party royalty
obligations that expired at the end of 2018.
- Collaboration and License Agreement
Revenues: Amounts earned under the company’s ADCETRIS and ADC
collaborations were $44.6 million in the first quarter of 2019,
compared to $29.6 million for the same period in 2018.
Collaboration revenues for the first quarter of 2019 included the
earned portion of a $30.0 million milestone from Takeda triggered
by European Commission approval of ADCETRIS in combination with AVD
in adult patients with previously untreated CD30-positive stage IV
classical Hodgkin lymphoma.
Research and Development (R&D) Expenses: R&D
expenses in the first quarter were $158.3 million, compared to
$152.5 million in the first quarter of 2018. The increase reflects
additional investment in the company’s late-stage pipeline
including EV, tucatinib and TV.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses in the first quarter were $80.3 million, compared
to $66.2 million in the first quarter of 2018. The increase was
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 three
months of 2019 was $25.7 million, compared to $16.8 million for the
same period in 2018.
Net Loss
Net loss for the first quarter of 2019 was $13.3 million, or
$0.08 per diluted share, compared to a net loss of $111.7 million,
or $0.73 per diluted share, for the first quarter of 2018. Net loss
in the first quarter of 2019 included a non-cash net investment
gain of $38.1 million associated with Seattle Genetics’ common
stock holdings in Immunomedics, which are marked-to-market.
Cash and Investments
As of March 31, 2019, cash and investments were $418.3
million. In addition, the company held stock investments, primarily
in Immunomedics common stock, valued at $151.9 million.
2019 FINANCIAL OUTLOOK
The company’s 2019 financial guidance is detailed below,
including updates to its expectations for R&D and SG&A
expenses driven primarily by positive results from the EV-201
pivotal trial.
Current Previous Revenues
ADCETRIS net product sales $610 million
to $640 million Unchanged Collaboration and license agreement
revenues $95 million to $110 million Unchanged Royalty revenues $85
million to $90 million Unchanged
Operating Expenses and other
costs R&D expenses $650 million to $700 million $600
million to $650 million SG&A expenses $300 million to $335
million $280 million to $310 million Cost of sales 5 percent to 6
percent Unchanged Cost of royalty revenues
Low single-digit percenton ex-US sales
Unchanged
Non-cash costs (primarily attributable
toshare 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 first 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 on the Seattle Genetics website at
www.seattlegenetics.com, under the Investors section. Investors may
also participate in the conference call by
calling 877-260-1479 (domestic)
or 334-323-0522 (international). The conference ID is
6169352. A replay of the live event and supporting slides will be
available for at least 30 days. A replay of the audio only will be
available by calling 888-203-1112 (domestic)
or 719-457-0820 (international), using conference ID
6169352. The telephone replay will be available until 5:00 p.m. PT
on April 29, 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
to submit a Biologics License Application for enfortumab vedotin
under the U.S. Food and Drug Administration’s (FDA) accelerated
approval pathway and to report topline data for tucatinib for the
HER2CLIMB trial in 2019; anticipated activities related to the
company’s planned and ongoing clinical trials, including clinical
trial enrollment and data availability and the expected timing
thereof; 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
anticipation 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, or
market adoption by physicians. The company may also be delayed 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 Annual Report on Form 10-K for the year
ended December 31, 2018 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 March 31, 2019 2018 Revenues:
Net product sales $ 135,001 $ 95,357 Collaboration and license
agreement revenues 44,578 29,559 Royalty revenues 15,620
15,674 Total revenues 195,199 140,590 Costs
and expenses: Cost of sales 7,911 10,358 Cost of royalty revenues
2,389 5,377 Research and development 158,265 152,502 Selling,
general and administrative 80,271 66,182 Total costs
and expenses 248,836 234,419 Loss from operations
(53,637 ) (93,829 ) Investment and other income (loss), net 40,308
(17,886 ) Net loss $ (13,329 ) $ (111,715 ) Net loss per
share - basic and diluted $ (0.08 ) $ (0.73 ) Shares used in
computation of per share amounts - basic and diluted 160,657
152,049
Seattle Genetics, Inc. Condensed
Consolidated Balance Sheets (Unaudited) (In
thousands) March 31, 2019
December 31, 2018 Assets Cash, cash
equivalents and investments $ 418,295 $ 459,866 Other assets
1,174,309 1,043,463 Total assets $ 1,592,604 $ 1,503,329
Liabilities and Stockholders’ Equity Accounts payable and
accrued liabilities $ 180,959 $ 191,472 Deferred revenue and
long-term liabilities 98,234 37,914 Stockholders’ equity
1,313,411 1,273,943 Total liabilities and stockholders’
equity $ 1,592,604 $ 1,503,329
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190425005884/en/
Investors:Peggy Pinkston425-527-4160ppinkston@seagen.com
Media:Monique Greer425-527-4641mgreer@seagen.com
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