-ADCETRIS® (Brentuximab Vedotin) Net Sales in
U.S. and Canada of $627.7 Million in 2019, Including $166.2 Million
in the Fourth Quarter-
-PADCEV™ (Enfortumab Vedotin-ejfv) Granted
Accelerated Approval by FDA for Patients with Locally Advanced or
Metastatic Urothelial Cancer Following Platinum-based Chemotherapy
and a PD-1 or PD-L1 Inhibitor; U.S. Commercial Launch Underway-
-Tucatinib Applications for Approval Submitted
to the FDA and EMA for Patients with Locally Advanced or Metastatic
HER2-Positive Breast Cancer-
-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, 2019.
The Company also highlighted ADCETRIS (brentuximab vedotin) and
PADCEV (enfortumab vedotin-ejfv) commercial, regulatory and
clinical development accomplishments and progress with its clinical
programs for cancer, including tucatinib.
“At the end of 2019, we became a multi-product oncology company
following the rapid FDA approval of PADCEV for previously treated
metastatic urothelial cancer patients, expanding our commercial
portfolio into solid tumors,” said Clay Siegall, Ph.D., President
and Chief Executive Officer of Seattle Genetics. “In addition, in
collaboration with Takeda, global sales of ADCETRIS exceeded $1
billion in 2019, underscoring its importance in the treatment of
multiple lymphomas. As we look ahead, subject to regulatory
reviews, we are well positioned to bring a third product to market
with the tucatinib marketing applications in the United States,
Europe and other countries for patients with metastatic
HER2-positive breast cancer. Importantly, across PADCEV, tucatinib
and ADCETRIS, we are advancing broad clinical development programs
intended to fully explore their potential. We are executing on our
mission to develop transformative cancer therapies that make a
meaningful difference in people's lives.”
ADCETRIS Program Highlights
- Achieved ADCETRIS Sales Milestone: Seattle Genetics
achieved a one-time $40 million milestone payment triggered by its
collaborator Takeda surpassing annual net sales of $400 million in
its territory during 2019. The milestone was recognized as royalty
revenue in the fourth quarter of 2019.
- Received New Indication in Canada: Health Canada
approved ADCETRIS in combination with chemotherapy as frontline
treatment for certain types of CD30-expressing peripheral T-cell
lymphomas based on results of the phase 3 ECHELON-2 clinical
trial.
- Presented Fifteen Abstracts at ASH: ADCETRIS was
featured in 15 data presentations at the 61st American Society of
Hematology (ASH) annual meeting from both corporate and
investigator-led clinical trials. A four-year update of the phase 3
ECHELON-1 clinical trial in advanced Hodgkin lymphoma demonstrated
a sustained progression-free survival benefit for ADCETRIS in
combination with AVD (Adriamycin [doxorubicin], vinblastine and
dacarbazine) when compared to ABVD, which includes bleomycin. The
presentations also highlighted data on ADCETRIS as monotherapy and
as part of combination regimens in a range of CD30-expressing
lymphomas.
PADCEV Program Highlights
- Received FDA Approval for PADCEV: In December 2019,
PADCEV received accelerated approval from the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with
locally advanced or metastatic urothelial cancer who have
previously received a PD-1/L1 inhibitor and a platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in
a locally advanced or metastatic setting. Continued approval may be
contingent upon verification and description of clinical benefit in
confirmatory trials. It is the first FDA-approved treatment for
these patients. Seattle Genetics and Astellas are jointly
commercializing PADCEV in the United States.
- Completed Enrollment in Phase 3 EV-301 Clinical Trial:
In January 2020, enrollment was completed in the phase 3 EV-301
clinical trial in metastatic urothelial cancer patients who
previously received both platinum chemotherapy and a PD-1/L1
inhibitor. EV-301 is intended to serve as a confirmatory trial in
the United States and support global marketing applications.
- Initiated Phase 3 Clinical Trial in First-line Metastatic
Urothelial Cancer: In January 2020, Seattle Genetics in
collaboration with Astellas and Merck initiated the phase 3 EV-302
clinical trial evaluating the combination of PADCEV and Keytruda®
(pembrolizumab) with or without chemotherapy versus chemotherapy
alone in patients with previously untreated locally advanced or
metastatic urothelial cancer. The trial is expected to enroll 1,095
patients and the dual primary endpoints are progression-free
survival and overall survival. The trial was initiated based on
positive preliminary results from the phase 1 EV-103 clinical
trial.
- Initiated Phase 2 Clinical Trial in Solid Tumors: In
January 2020, Seattle Genetics and Astellas initiated the phase 2
EV-202 clinical trial to evaluate single-agent PADCEV in a range of
solid tumors, including non-small cell lung, head and neck,
gastric/esophageal and breast cancers.
Tucatinib Program Highlights
- Presented and Published HER2CLIMB Data: In December
2019, results were presented from the HER2CLIMB pivotal trial,
which demonstrated that the combination of tucatinib with
trastuzumab and capecitabine was superior to trastuzumab and
capecitabine alone in patients with unresectable locally advanced
or metastatic HER2-positive breast cancer. The trial met the
primary endpoint of progression-free survival (PFS) and all
secondary endpoints, including improvement in overall survival and
improvement in PFS for patients with brain metastases at baseline.
The tucatinib regimen was generally well-tolerated with a
manageable safety profile. The results were presented at the 2019
San Antonio Breast Cancer Symposium and simultaneously published in
the New England Journal of Medicine.
- Received Breakthrough Therapy Designation: In December
2019, the FDA granted Breakthrough Therapy designation to
tucatinib, in combination with trastuzumab and capecitabine, for
treatment of patients with locally advanced unresectable or
metastatic HER2-positive breast cancer, including patients with
brain metastases, who have been treated with trastuzumab,
pertuzumab, and T-DM1 (ado-trastuzumab emtansine, Kadcyla®). The
designation was based on results from the HER2CLIMB pivotal
trial.
- Submitted Multiple Applications for Approval: In
December 2019, Seattle Genetics completed its New Drug Application
submission to the FDA under the Real Time Oncology Review (RTOR)
pilot program. In January 2020, the Company submitted a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) and the submission was recently validated by the EMA. In
addition, applications were recently submitted to regulators in
Australia, Canada, Singapore and Switzerland under the FDA's
Project Orbis pilot program. The applications request approval of
tucatinib based on positive results of the HER2CLIMB clinical
trial.
- Initiated Phase 3 HER2CLIMB-02 Clinical Trial: In
October 2019, Seattle Genetics initiated the phase 3 HER2CLIMB-02
clinical trial of tucatinib versus placebo in combination with
T-DM1 for patients with unresectable locally advanced or metastatic
HER2-positive breast cancer, including those with brain metastases,
who have had prior treatment with a taxane and trastuzumab.
HER2CLIMB-02 could support applications for potential approval in
first- or second-line metastatic breast cancer.
- Expanded MOUNTAINEER Clinical Trial: Seattle Genetics
expanded the phase 2 MOUNTAINEER trial of tucatinib in combination
with trastuzumab in metastatic colorectal cancer (CRC) to enroll up
to approximately 110 patients to support potential accelerated
approval of tucatinib in HER2-positive CRC.
Tisotumab Vedotin Program Highlights
- Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected
in 2020: Seattle Genetics and Genmab expect to report topline
data in the first half of 2020 from 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.
Other Recent Activities
- ADC Collaborators Clinical and Regulatory Progress:
- In January 2020, Roche received conditional marketing
authorization from the European Commission for Polivy® (polatuzumab
vedotin) to treat patients with relapsed or refractory diffuse
large B-cell lymphoma. Polivy utilizes Seattle Genetics’
proprietary antibody-drug conjugate (ADC) technology and as a
result Seattle Genetics will receive a milestone payment from
Roche. Seattle Genetics also receives royalties on global sales of
Polivy.
- In January 2020, GlaxoSmithKline (GSK) was granted priority
review by the FDA for its Biologics License Application (BLA) and
in February 2020 the EMA validated its MAA for belantamab mafodotin
for the treatment of patients with relapsed or refractory multiple
myeloma. Belantamab mafodotin utilizes Seattle Genetics' ADC
technology. Additionally, GSK initiated a phase 3 clinical trial of
belantamab mafodotin, triggering a development milestone payment to
Seattle Genetics that was recognized as collaboration revenues in
the fourth quarter of 2019.
- Entered into License Agreement with BeiGene: Under the
terms of the license agreement, BeiGene was granted exclusive
rights to develop and commercialize a product candidate in Asia
(except Japan) and the rest of the world. Seattle Genetics retained
rights to the product candidate in the Americas, Europe and Japan.
Seattle Genetics received a $20 million upfront payment and is
eligible to receive progress-dependent milestones for a total
potential deal value of up to $160 million and tiered royalties on
any product sales.
FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS
Revenues: Total revenues in the fourth quarter and year
ended December 31, 2019 increased to $289.8 million and $916.7
million, respectively, compared to $174.5 million and $654.7
million for the same periods in 2018. Revenues are comprised of the
following three components:
- Product Revenues: ADCETRIS net sales in the U.S. and
Canada for the fourth quarter were $166.2 million, a 26 percent
increase over net sales of $132.1 million in the fourth quarter of
2018. ADCETRIS net sales in the U.S. and Canada were $627.7 million
for the full year in 2019, a 32 percent increase over net sales of
$476.9 million in 2018. Growth over 2018 reflected ADCETRIS label
expansions in 2018, which led to increased use primarily in
frontline CD30-expressing PTCL following approval in November 2018.
PADCEV was approved in the U.S. in late December 2019 and net sales
for the fourth quarter were $0.2 million.
- Royalty Revenues: Royalty revenues in the fourth quarter
were $72.3 million, compared to $24.6 million in the fourth quarter
of 2018. The fourth quarter of 2019 included a $40 million
milestone from Takeda triggered by annual net sales exceeding $400
million in Takeda's territory during 2019. Royalty revenues were
$138.5 million for the full year in 2019, compared to $83.4 million
in 2018. Royalty revenues are primarily driven by sales of ADCETRIS
outside the U.S. and Canada by Takeda and, to a lesser extent,
sales of Polivy by Roche.
- Collaboration and License Agreement Revenues: Amounts
earned under the Company’s collaboration and license agreements
were $51.1 million in the fourth quarter and $150.2 million for the
full year in 2019, compared to $17.8 million and $94.4 million,
respectively, for the same periods in 2018. In the fourth quarter
of 2019, the Company recognized a milestone payment under its ADC
collaboration with GSK and an upfront payment from BeiGene upon
entering into a product licensing agreement.
Research and Development (R&D) Expenses: R&D
expenses in the fourth quarter were $201.1 million, compared to
$149.8 million in the fourth quarter of 2018. R&D expenses were
$719.4 million for the full year in 2019, compared to $565.3
million in 2018. The increase in 2019 primarily reflected increased
investment in the Company's late-stage pipeline.
Selling, general and administrative (SG&A) Expenses:
SG&A expenses in the fourth quarter were $115.2 million,
compared to $79.5 million in the fourth quarter of 2018. SG&A
expenses were $373.9 million for the full year in 2019, compared to
$261.1 million for the same period in 2018. The increases were
primarily attributed to costs to support commercialization efforts
related to ADCETRIS frontline indications, launch preparation for
PADCEV and tucatinib, as well as higher infrastructure costs to
support the Company's continued growth.
Cost of Sales: Cost of sales in the fourth quarter were
$9.6 million, compared to $30.2 million in the fourth quarter of
2018. Cost of sales were $34.9 million for the full year in 2019,
compared to $66.1 million for the same period in 2018. The 2018
periods reflected an inventory write-off of $18.1 million recorded
in the fourth quarter of 2018 related to ADCETRIS in-process
production that did not meet manufacturing specifications, as well
as a reduction in amounts owed to certain third-party technology
licensors.
Non-cash, share-based compensation cost for the full year in
2019 was $127.3 million, compared to $78.9 million for the same
period in 2018.
Net Income / Loss: Net income for the fourth quarter of
2019 was $25.8 million, or $0.14 per diluted share, compared to a
net loss of $119.8 million, or $0.75 per diluted share, for the
fourth quarter of 2018. Net income in the fourth quarter of 2019
included net investment income of $64.2 million primarily
associated with Seattle Genetics’ common stock holdings in
Immunomedics, which are marked-to-market. For the full year in
2019, net loss was $158.7 million, or $0.96 per share, compared to
a net loss of $222.7 million, or $1.41 per share, for the year in
2018. Net loss for the full year in 2019 included net investment
income of $61.9 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, 2019, Seattle
Genetics had $868.3 million in cash and investments. In addition,
the Company held stock investments, primarily in Immunomedics
common stock, valued at $163.9 million.
2020 FINANCIAL OUTLOOK
Seattle Genetics anticipates 2020 revenues, operating expenses
and other costs to be in the ranges shown in the table below.
ADCETRIS net product sales
$675 million to $700 million
Royalty revenues
$105 million to $115 million
Collaboration and license agreement
revenues
$30 million to $50 million
R&D expenses
$860 million to $950 million
SG&A expenses
$475 million to $525 million
ADCETRIS 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)
$180 million to $200 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 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
800-353-6461 (domestic) or 334-323-0501 (international). The
conference ID is 7290215. A replay of the live event and supporting
slides will be available starting on February 6, 2020 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 7290215. The
telephone replay will be available until 5:00 p.m. PT on February
9, 2020.
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that
discovers, develops and commercializes transformative medicines
targeting cancer to make a meaningful difference in people’s lives.
ADCETRIS® (brentuximab vedotin) and PADCEV™ (enfortumab
vedotin-ejfv) use the company’s industry-leading antibody-drug
conjugate (ADC) technology. ADCETRIS is approved in certain
CD30-expressing lymphomas, and PADCEV is approved in certain
metastatic urothelial cancers. In addition, investigational agent
tucatinib, a small molecule tyrosine kinase inhibitor, is in
late-stage development for HER2-positive metastatic breast cancer,
and in clinical development for metastatic colorectal cancer. The
company is headquartered in Bothell, Washington, and has offices in
California, Switzerland and the European Union. 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
2020 outlook, including anticipated 2020 revenues, costs and
expenses; the Company’s potential to achieve the noted development
and regulatory milestones in 2020 and future periods and to bring a
third product to market in the United States and other countries;
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 innovaTV 204, EV-301, EV-302, EV-202, HER2CLIMB-02,
MOUNTAINEER 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, PADCEV, 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 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 and
PADCEV due to competition, unexpected adverse events, regulatory
action, reimbursement, market adoption by physicians or other
factors. The Company may also be delayed in its planned clinical
trial initiations, enrollment in and conduct of its clinical
trials, obtaining data from clinical trials, planned regulatory
submissions, regulatory approvals and launch 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 and the pricing and reimbursement
process when applicable. 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, 2019 and future periodic reports filed by the
Company, including the Company's Annual Report on Form 10-K for the
year ended December 31, 2019. 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 December
31,
Years Ended December
31,
2019
2018
2019
2018
Revenues:
Net product sales
$
166,414
$
132,127
$
627,977
$
476,903
Collaboration and license agreement
revenues
51,117
17,833
150,245
94,357
Royalty revenues
72,273
24,553
138,491
83,440
Total revenues
289,804
174,513
916,713
654,700
Costs and expenses:
Cost of sales
9,639
30,222
34,882
66,085
Cost of royalty revenues
2,289
5,363
9,070
22,208
Research and development
201,061
149,772
719,374
565,309
Selling, general and administrative
115,229
79,467
373,932
261,096
Total costs and expenses
328,218
264,824
1,137,258
914,698
Loss from operations
(38,414
)
(90,311
)
(220,545
)
(259,998
)
Investment and other income (loss),
net
64,244
(53,180
)
61,895
13,652
Income (loss) before income taxes
25,830
(143,491
)
(158,650
)
(246,346
)
Income tax benefit
—
23,686
—
23,653
Net income (loss)
$
25,830
$
(119,805
)
$
(158,650
)
$
(222,693
)
Net income (loss) per share - basic
$
0.15
$
(0.75
)
$
(0.96
)
$
(1.41
)
Net income (loss) per share - diluted
$
0.14
$
(0.75
)
$
(0.96
)
$
(1.41
)
Shares used in computation of per share
amounts - basic
171,638
160,197
165,498
157,655
Shares used in computation of per share
amounts - diluted
178,501
160,197
165,498
157,655
Seattle Genetics, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
December 31,
2019
2018
Assets
Cash, cash equivalents and investments
$
868,338
$
459,866
Other assets
1,337,528
1,043,463
Total assets
$
2,205,866
$
1,503,329
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
259,357
$
191,472
Deferred revenue and long-term
liabilities
70,222
37,914
Stockholders’ equity
1,876,287
1,273,943
Total liabilities and stockholders’
equity
$
2,205,866
$
1,503,329
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200206005874/en/
Investors: Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Media: Monique Greer 425-527-4641 mgreer@seagen.com
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