-ADCETRIS® (Brentuximab Vedotin) Net Sales in
U.S. and Canada of $476.9 Million in 2018, Including $132.1 Million
in the Fourth Quarter-
-ADCETRIS Approved by FDA in Combination with
Chemotherapy for Frontline CD30-Expressing PTCL-
-Top-line Data from Enfortumab Vedotin Pivotal
Trial in Metastatic Urothelial Cancer Expected in the First Quarter
of 2019-
-Conference Call Today at 4:30 p.m. ET-
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported
financial results for the fourth quarter and year ended
December 31, 2018. The company also highlighted ADCETRIS
(brentuximab vedotin) commercialization and clinical development
accomplishments and progress with its late-stage clinical programs
for cancer.
“During 2018, we received FDA approval for two ADCETRIS
frontline indications, a major accomplishment that significantly
expands the number of patients eligible to benefit from treatment.
These approvals for frontline advanced Hodgkin lymphoma and
CD30-expressing peripheral T-cell lymphoma (PTCL) were based on
phase 3 data showing superior efficacy of the ADCETRIS-containing
regimens compared to combination chemotherapy agents that have been
used for decades,” said Clay Siegall, Ph.D., President and Chief
Executive Officer of Seattle Genetics. “Additionally, we made
progress in 2018 with our late-stage clinical programs, leading to
important anticipated milestones this year. Notably, we expect to
report top-line data in the first quarter of 2019 from the pivotal
trial of enfortumab vedotin in metastatic urothelial cancer and to
report top-line data later in the year from the pivotal trial of
tucatinib in HER2-positive metastatic breast cancer. Taken
together, we are positioned to establish ADCETRIS as the standard
of care in the frontline setting in both advanced Hodgkin lymphoma
and CD30-expressing PTCL, and realize our vision of becoming a
company with multiple oncology products addressing unmet medical
needs.”
ADCETRIS Program Highlights
- New Indication for CD30-Expressing
Frontline PTCL: In November 2018, the U.S. Food and Drug
Administration (FDA) approved ADCETRIS in combination with
chemotherapy for adults with previously untreated systemic
anaplastic large cell lymphoma (sALCL) or other CD30-expressing
peripheral T-cell lymphomas (PTCL), including angioimmunoblastic
T-cell lymphoma and PTCL not otherwise specified. The approval is
based on the successful outcome of the ECHELON-2 phase 3 clinical
trial. The FDA granted Breakthrough Therapy Designation in this
setting and reviewed the application under the Real-Time Oncology
Review Pilot Program leading to approval less than two weeks after
submission of the supplemental Biologics License Application
(BLA).
- New Indication in Canada: Health
Canada approved ADCETRIS for the treatment of adult patients with
primary cutaneous ALCL or CD30-expressing mycosis fungoides who
have had prior systemic therapy.
- Multiple Abstracts at
ASH: In addition to the presentation of ECHELON-2 data,
which were also simultaneously published in The Lancet, ADCETRIS
was featured in more than 30 data presentations at the 60th
American Society of Hematology (ASH) annual meeting from both
corporate and investigator-led clinical trials. The trials
highlighted the potential application of ADCETRIS as monotherapy
and as part of combination regimens in a range of CD30-expressing
lymphomas.
Enfortumab Vedotin (EV) Program Highlights
- EV-201 Pivotal Trial Data in First
Quarter 2019: Seattle Genetics and Astellas expect to report
top-line data in the first quarter of 2019 from the ongoing EV-201
pivotal trial evaluating EV in patients with locally advanced or
metastatic urothelial cancer who previously received both platinum
chemotherapy and a checkpoint inhibitor (PD-1 or PD-L1). Data from
this trial could serve as the basis for a BLA submission under the
FDA’s accelerated approval pathway.
- Multiple Trials Enrolling:
Seattle Genetics and Astellas continue enrollment in the global
randomized phase 3 clinical trial called EV-301 for
patients with locally advanced or metastatic urothelial cancer who
were previously treated with a PD-1 or PD-L1 inhibitor and a
platinum-containing regimen. EV-301 is intended to support global
regulatory submissions for approval and serve as a confirmatory
trial in the United States. Additionally, enrollment is ongoing in
the phase 1 trial called EV-103 in earlier lines of locally
advanced or metastatic urothelial cancer, including first-line,
evaluating EV in combination with pembrolizumab and/or platinum
agents.
Tucatinib Program Highlights
- HER2CLIMB Pivotal Trial Data in
2019: Seattle Genetics achieved enrollment of 480 patients in
the HER2CLIMB pivotal trial to enable analysis of the primary
endpoint of PFS, with top-line data expected to be reported in
2019. In addition, HER2CLIMB enrollment is continuing up to 600
patients, to support the analyses of key secondary endpoints,
including overall survival as well as progression-free survival in
patients with brain metastases. The company anticipates completing
enrollment of the additional patients in mid-2019.
Tisotumab Vedotin (TV) Program Highlights
- innovaTV 204 Pivotal Trial
Enrollment: Seattle Genetics and Genmab expect to complete
enrollment by mid-2019 in the pivotal innovaTV 204 trial evaluating
TV in patients with recurrent and/or metastatic cervical cancer who
have relapsed or progressed after standard of care treatment.
- Broad Development Program:
Seattle Genetics and Genmab are evaluating TV in multiple ongoing
or planned clinical trials, including trials in earlier-stage
cervical cancer and in multiple types of other solid tumors.
Other Recent Activities
- Initiated Phase 1 Trial of
SEA-BCMA: Seattle Genetics announced the dosing of the first
patient in a phase 1 trial evaluating the safety and tolerability
of SEA-BCMA in relapsed or refractory multiple myeloma. SEA-BCMA is
an empowered antibody using the company’s proprietary Sugar
Engineered Antibody (SEA) technology designed to enhance antibody
dependent cellular cytotoxicity.
- ADC Collaborator Regulatory
Submission: In December 2018, Roche submitted regulatory
applications in the U.S. and the European Union for approval of
polatuzumab vedotin to treat patients with relapsed or refractory
diffuse large B-cell lymphoma. Polatuzumab vedotin utilizes Seattle
Genetics’ proprietary antibody-drug conjugate (ADC)
technology.
FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS
Revenues: Total revenues in the fourth quarter and year
ended December 31, 2018 increased to $174.5 million and $654.7
million, respectively, compared to $129.6 million and $482.3
million for the same periods in 2017. Revenues are comprised of the
following three components:
- Product Revenues: ADCETRIS net
sales in the U.S. and Canada for the fourth quarter were $132.1
million, a 58 percent increase over net sales of $83.7 million in
the fourth quarter of 2017. ADCETRIS net sales in the U.S. and
Canada were $476.9 million for the full year in 2018, a 55 percent
increase over net sales of $307.6 million for the same period in
2017. Growth over 2017 reflects ADCETRIS label expansions in 2018,
most notably in frontline Stage III and IV Hodgkin lymphoma in
March 2018 and to a lesser degree in frontline CD30-expressing PTCL
in November 2018.
- Royalty Revenues: Royalty
revenues in the fourth quarter were $24.6 million, compared to
$20.0 million in the fourth quarter of 2017. Royalty revenues were
$83.4 million for the full year in 2018, compared to $66.1 million
for the same period in 2017. Royalty revenues are primarily driven
by sales of ADCETRIS outside the U.S. and Canada by Takeda.
- Collaboration and License Agreement
Revenues: Amounts earned under the company’s ADCETRIS and ADC
collaborations were $17.8 million in the fourth quarter and $94.4
million for the full year in 2018, compared to $25.9 million and
$108.6 million, respectively, for the same periods in 2017.
Research and Development (R&D) Expenses: R&D
expenses in the fourth quarter were $149.8 million, compared to
$110.5 million in the fourth quarter of 2017. R&D expenses were
$565.3 million for the full year in 2018, compared to $456.7
million for the same period in 2017. The increase in 2018 reflects
increased investment in the company's late-stage pipeline and
technology acquisition costs in the first quarter of 2018.
Selling, general and administrative (SG&A) Expenses:
SG&A expenses in the fourth quarter were $79.5 million,
compared to $48.5 million in the fourth quarter of 2017. The
increase in SG&A expenses for the fourth quarter of 2018 was
primarily driven by the rapid approval and launch of ADCETRIS for
frontline CD30-expressing PTCL. SG&A expenses were $261.1
million for the full year in 2018, compared to $167.2 million for
the same period in 2017. The increase for the full year in 2018 was
primarily related to costs to support the launch of ADCETRIS in the
frontline indications as well as transaction costs associated with
the acquisition of Cascadian Therapeutics.
Cost of Sales: Cost of sales in the fourth quarter were
$30.2 million, compared to $10.2 million in the fourth quarter of
2017. Cost of sales were $66.1 million for the year in 2018,
compared to $34.8 million for the same period in 2017. The
increases in 2018 reflect an inventory write-off of $18.1 million
recorded in the fourth quarter of 2018 related to in-process
production that did not meet manufacturing specifications and did
not impact availability of product supply required to meet demand
for ADCETRIS.
Non-cash, share-based compensation cost for the full year
in 2018 was $78.9 million, compared to $63.8 million for the same
period in 2017.
Net Loss: Net loss for the fourth quarter of 2018 was
$119.8 million, or $0.75 per share, compared to a net loss of $59.2
million, or $0.41 per share, for the fourth quarter of 2017. Net
loss in the fourth quarter of 2018 includes a net investment loss
of $53.2 million primarily associated with Seattle Genetics’ common
stock holdings in Immunomedics, which are marked-to-market. For the
full year in 2018, net loss was $222.7 million, or $1.41 per share,
compared to a net loss of $125.5 million, or $0.88 per share, for
the year in 2017. Net loss for the full year in 2018 includes net
investment income of $13.7 million primarily associated with
Seattle Genetics’ common stock holdings in Immunomedics. Net loss
for both the fourth quarter and the full year in 2018 included a
non-cash income tax benefit of $23.7 million related to acquired
intangible assets as part of the acquisition of Cascadian
Therapeutics.
Cash and Investments: As of December 31, 2018,
Seattle Genetics had $459.9 million in cash and investments. In
addition, the company held stock investments, primarily in
Immunomedics common stock, valued at $113.8 million.
2019 FINANCIAL OUTLOOK
Seattle Genetics anticipates 2019 total revenues to be in the
range of $790 million to $840 million, driven by the following
components:
ADCETRIS net product sales $610 million
to $640 million Collaboration and license agreement revenues $95
million to $110 million Royalty revenues $85 million to $90 million
Operating expenses and other costs are expected to be within the
following ranges for the year in 2019:
R&D expenses $600 million to $650
million SG&A expenses $280 million to $310 million Cost of
sales 5 percent to 6 percent Cost of royalty revenues
Low single digit percent on ex-US
sales
Non-cash costs (primarily attributable to share based compensation)
$135 million to $145 million
Conference Call Details
Seattle Genetics’ management will host a conference call and
webcast with supporting slides to discuss its fourth quarter and
full year 2018 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
1660553. A replay of the live event and supporting slides will be
available starting on February 7, 2019 on the Seattle Genetics
website at www.seattlegenetics.com, under the Investors section,
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
1660553. The telephone replay will be available until 5:00 p.m. PT
on February 11, 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 and to
establish ADCETRIS as the standard of care in the frontline setting
in both advanced Hodgkin lymphoma and CD30-expressing PTCL and
become a multi-product oncology company; anticipated activities
related to the company’s planned and ongoing clinical trials,
including clinical trial enrollment and data availability and the
expected timing thereof, including with respect to EV-201,
HER2CLIMB and other 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; 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, revenue, expense, 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, u, 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 periodic reports
filed with the Securities and Exchange Commission, including the
company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2018 and future periodic reports filed by the
company, including the company's Annual Report on Form 10-K for the
year ended December 31, 2018.
Seattle Genetics, Inc. Condensed
Consolidated Statements of Operations (Unaudited) (In
thousands, except per share amounts) Three Months
Ended December 31, Year Ended December 31, 2018
2017 2018 2017 Revenues: Net
product sales $ 132,127 $ 83,721 $ 476,903 $ 307,562 Collaboration
and license agreement revenues 17,833 25,853 94,357 108,632 Royalty
revenues 24,553 20,031 83,440 66,056
Total revenues 174,513 129,605 654,700 482,250 Costs and expenses:
Cost of sales 30,222 10,213 66,085 34,768 Cost of royalty revenues
5,363 5,450 22,208 19,350 Research and development 149,772 110,504
565,309 456,700 Selling, general and administrative 79,467
48,450 261,096 167,233 Total costs and
expenses 264,824 174,617 914,698 678,051
Loss from operations (90,311 ) (45,012 ) (259,998 ) (195,801
) Investment and other income (loss), net (53,180 ) (42,131 )
13,652 36,914 Loss before income taxes (143,491 )
(87,143 ) (246,346 ) (158,887 ) Income tax benefit 23,686
27,942 23,653 33,357 Net loss $ (119,805 ) $
(59,201 ) $ (222,693 ) $ (125,530 ) Net loss per share - basic and
diluted $ (0.75 ) $ (0.41 ) $ (1.41 ) $ (0.88 ) Shares used in
computation of per share amounts - basic and diluted 160,197
144,061 157,655 143,174
Seattle Genetics, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands) December 31, 2018
2017 Assets Cash, cash equivalents and investments $
459,866 $ 413,171 Other assets 1,043,463 464,778 Total
assets $ 1,503,329 $ 877,949
Liabilities and
Stockholders’ Equity Accounts payable and accrued liabilities $
191,472 $ 132,672 Deferred revenue and long-term liabilities 37,914
67,708 Stockholders’ equity 1,273,943 677,569 Total
liabilities and stockholders’ equity $ 1,503,329 $ 877,949
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version on businesswire.com: https://www.businesswire.com/news/home/20190207005747/en/
Investors:Peggy Pinkston425-527-4160ppinkston@seagen.com
Media:Monique Greer425-527-4641mgreer@seagen.com
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