-Net Product Sales of $302.6 Million in 1Q21,
an Increase of 52 Percent Over 1Q20-
-Significant Regulatory Progress Across Diverse
Oncology Pipeline, Including European Commission Approval of
TUKYSA, Multiple Applications Under Review Globally for PADCEV, and
FDA Acceptance of Tisotumab Vedotin BLA-
-Conference Call Today at 4:30 p.m. ET-
Seagen Inc. (Nasdaq:SGEN) today reported financial results for
the first quarter and three months ended March 31, 2021. The
Company also highlighted ADCETRIS® (brentuximab vedotin), PADCEV®
(enfortumab vedotin-ejfv) and TUKYSA® (tucatinib) commercial and
development accomplishments, as well as progress with its lead
pipeline programs to treat cancer.
“Year-over-year quarterly net product sales growth of 52 percent
was driven by rapid adoption of our newest products, PADCEV and
TUKYSA, in addition to strong sales of ADCETRIS. We continue to
project 2021 total net product sales in our territories of
approximately $1.3 billion,” said Clay Siegall, Ph.D., President
and Chief Executive Officer of Seagen. “Looking ahead, we expect
continued global progress across the portfolio. This includes
TUKYSA launches in Europe following marketing authorizations
received in the first quarter. In collaboration with Astellas we
are pursuing several PADCEV marketing applications across the
United States, Europe, Japan and Latin America. In addition, we are
preparing for potential U.S. launch of a fourth drug following FDA
acceptance of our tisotumab vedotin BLA submission with Priority
Review. We are continuing to deliver cutting-edge innovation and
medicines that make a meaningful difference in the lives of cancer
patients.”
COMMERCIAL PRODUCTS HIGHLIGHTS
PADCEV
- Received European Medicines Agency (EMA) Acceptance of
Marketing Authorization Application (MAA): In March 2021,
Seagen and Astellas announced that the EMA accepted the PADCEV MAA
for the treatment of adult 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.
PADCEV will be reviewed under accelerated assessment, which means
the EMA’s Committee for Medicinal Products for Human Use can
shorten the MAA evaluation timeframe.
- Received FDA Filing Acceptance of Two Supplemental Biologics
License Applications (sBLAs): In April 2021, the FDA accepted
two PADCEV sBLA submissions for review under the Real-Time Oncology
Review pilot program. The applications were granted Priority Review
with a target action date of August 17, 2021. The review of both
applications will be conducted under Project Orbis, an initiative
of the FDA Oncology Center of Excellence. The first sBLA is based
on the phase 3 EV-301 trial and seeks to convert PADCEV’s
accelerated approval to regular approval. The second sBLA, based on
the pivotal trial EV-201’s cohort 2, requests an expansion of the
current indication to include patients with locally advanced or
metastatic urothelial cancer who have been previously treated with
a PD-1/L1 inhibitor and are ineligible for cisplatin.
- Submitted Several Additional Global Marketing Authorization
Applications: In addition to the MAA under review in the
European Union (EU), Seagen and Astellas have submitted
applications for PADCEV approval in Australia, Canada, Japan,
Singapore, Brazil and Switzerland.
- Reported Positive EV-201 Cohort 2 and EV-301 Results in
Patients with Previously Treated Advanced Urothelial Cancer: In
February 2021, results were presented from the phase 3 EV-301 trial
comparing PADCEV to chemotherapy in adult patients with locally
advanced or metastatic urothelial cancer who were previously
treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
The data showed significant improvements in overall and
progression-free survival among patients treated with PADCEV
compared to those who received chemotherapy. The findings were
published in the New England Journal of Medicine and presented
during the virtual scientific program of the 2021 American Society
of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU).
Data were also presented at ASCO-GU demonstrating durable tumor
responses experienced among patients previously treated with
immunotherapy in the second cohort of the pivotal EV-201
trial.
TUKYSA
- Received Approval in the EU and Great Britain: In
February 2021, TUKYSA was approved by the European Commission for
use in combination with trastuzumab and capecitabine for the
treatment of adult patients with HER2-positive locally advanced or
metastatic breast cancer who have received at least two prior
anti-HER2 treatment regimens. The approval of TUKYSA is valid in
all countries of the EU, as well as Norway, Liechtenstein, Iceland
and Northern Ireland. In addition, TUKYSA was granted marketing
authorization in Great Britain by the UK Medicines and Healthcare
products Regulatory Agency (MHRA) in the same patient population.
MHRA had previously granted TUKYSA a Promising Innovative Medicine
designation.
- Started Enrolling Multiple Clinical Trials: In the first
quarter of 2021, the first patient was enrolled in two new clinical
trials. The phase 3 CompassHER2 RD trial is evaluating TUKYSA in
combination with Kadcyla® (trastuzumab emtansine; T-DM1) compared
to Kadcyla alone in the adjuvant HER2-positive breast cancer
setting. The trial is being conducted by the Alliance for Clinical
Trials in Oncology, a U.S. cooperative group. The second is a phase
2 trial evaluating TUKYSA in combination with trastuzumab in
various metastatic solid tumors with HER2 alterations.
ADCETRIS
- Expect Publication of 5-year Follow-up Results for
ECHELON-1: The five-year update of the phase 3 ECHELON-1
clinical trial have been accepted for publication and should be
published in the second quarter 2021. Data showed treatment with
ADCETRIS in combination with AVD (Adriamycin [doxorubicin],
vinblastine and dacarbazine) resulted in superior long-term
outcomes when compared to ABVD, which includes bleomycin, in
frontline advanced Hodgkin lymphoma.
PIPELINE HIGHLIGHTS
- Received FDA Filing Acceptance of Tisotumab Vedotin BLA for
Priority Review: In April 2021, Seagen and Genmab announced the
FDA had accepted for Priority Review the tisotumab vedotin BLA for
the treatment of patients with recurrent or metastatic cervical
cancer with disease progression on or after chemotherapy. The FDA
has set a target action date of October 10, 2021 submission is
based on the results of the innovaTV 204 pivotal phase 2 trial,
which were presented at the European Society for Medical Oncology
(ESMO) Virtual Congress 2020 and published in The Lancet Oncology
in April 2021.
- Presented Data Highlighting Pipeline of Novel Targeted
Therapies at the American Association for Cancer Research (AACR)
Annual Meeting: In April 2021, Seagen presented preclinical
data on three pipeline programs that support the rationale for
clinical development. SEA-TGT, an anti-TIGIT antibody using the
Company’s sugar-engineered antibody (SEA) technology, and two
vedotin-based ADCs, SGN-B6A and SGN-STNV, were highlighted. All of
the programs are currently in phase 1 clinical trials.
For additional information on Seagen’s pipeline, visit
www.seagen.com/science/pipeline.
FIRST QUARTER 2021 FINANCIAL RESULTS
Revenues: Total revenues for the first quarter ended
March 31, 2021 increased to $332.0 million, compared to $234.5
million for the same period in 2020. Growth over 2020 was driven by
higher sales of PADCEV and the addition of TUKYSA to the Company's
commercial portfolio. Revenues are composed of the following three
components:
Three months ended March
31,
(dollars in millions)
2021
2020
% Change
Total Net Product Sales
$
302.6
$
198.5
52%
ADCETRIS
162.6
164.1
(1)%
PADCEV
69.8
34.5
102%
TUKYSA
70.3
—
N/A
Note: Sum of product sales may not equal
total net product sales due to rounding.
- Royalty Revenues: Royalty revenues for the first quarter
in 2021 were $27.2 million, compared to $20.4 million for the same
period in 2020. Royalty revenues are primarily driven by sales of
ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser
extent, royalties from sales of Polivy® (polatuzumab vedotin) by
Roche and Blenrep® (belantamab mafodotin) by GlaxoSmithKline, which
are ADCs that use Seagen technology.
- Collaboration and License Agreement Revenues: Amounts
earned under the Company’s product, development and technology
collaborations were $2.2 million in the first quarter in 2021,
compared to $15.6 million for the same period in 2020.
Collaboration revenues for the first quarter of 2020 included a
regulatory milestone related to Polivy under the collaboration with
Roche.
Cost of Sales: Cost of sales for the first quarter in
2021 were $64.1 million, compared to $29.4 million for the same
period in 2020. The increase was primarily due to the gross profit
share with Astellas based on PADCEV sales, which was $32.5 million
in the first quarter of 2021, compared to $16.4 million for the
same period in 2020. The increase in cost of sales also reflected
amortization of acquired in-process technology costs that began
with the approval of TUKYSA in April 2020, and third-party
royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales,
in addition to cost of products sold.
Research and Development (R&D) Expenses: R&D
expenses for the first quarter in 2021 were $230.4 million,
compared to $195.2 million for the same period in 2020. The
increase in 2021 primarily reflected continued investment in the
Company's pipeline to evaluate new potential indications for the
Company’s commercial drugs and to advance novel product candidates
and technologies.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the first quarter in 2021 were $159.8
million, compared to $122.2 million for the same period in 2020.
The increase was primarily attributed to increased field sales
personnel and external spend to support our recently commercialized
products, PADCEV and TUKYSA, and higher infrastructure costs to
support our continued growth in the U.S. and Europe.
Non-cash, share-based compensation expense for the first three
months of 2021 was $38.2 million, compared to $33.6 million for the
same period in 2020.
Net Loss: Net loss for the first quarter of 2021 was
$121.4 million, or $0.67 per diluted share, compared to net loss of
$168.4 million, or $0.98 per diluted share, for the first quarter
of 2020. Net loss in the first quarter of 2020 included a non-cash
net investment loss of $59.1 million primarily associated with
Seagen's common stock holding in Immunomedics, which was
marked-to-market.
Cash and Investments: As of March 31, 2021, Seagen had
$2.5 billion in cash and investments.
2021 FINANCIAL OUTLOOK
Seagen anticipates 2021 revenues, operating expenses and other
costs to be in the ranges shown in the table below, unchanged from
the Company's previous financial guidance provided on February 11,
2021.
Revenues
ADCETRIS net product sales
$675 million to $700 million
PADCEV net product sales
$310 million to $325 million
TUKYSA net product sales
$300 million to $315 million
Royalty revenues
$125 million to $135 million
Collaboration and license agreement
revenues
Less than $20 million
Operating expenses and other
costs
Cost of Sales
$270 million to $300 million
R&D expenses
$900 million to $1,000
million
SG&A expenses
$650 million to $725 million
Non-cash expenses1 (primarily attributable
to
share-based compensation)
$225 million to $245 million
1. Non-cash expenses include share-based compensation,
depreciation and amortization of intangible assets.
Conference Call Details
Seagen management will host a conference call and webcast with
supporting slides to discuss its first quarter 2021 and
year-to-date 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
simultaneously webcast and available for replay from the Seagen
website at www.seagen.com, under the
Investors section. Investors may also participate in the conference
call by calling 844-763-8274 (domestic) or 412-717-9224
(international). The conference ID is 10153242. Supporting slides
are available on the Seagen website at www.seagen.com under the Investors section. A
webcast replay will be archived on the Company's website
www.seagen.com, under the Investors
section.
About Seagen
Seagen Inc. is a global biotechnology company that discovers,
develops and commercializes transformative cancer medicines to make
a meaningful difference in people’s lives. Seagen is headquartered
in the Seattle, Washington area, and has locations in California,
Canada, Switzerland and the European Union. For more information on
our marketed products and robust pipeline, visit www.seagen.com and
follow @SeagenGlobal 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 in future periods; the
Company’s pipeline; 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 in the
U.S. and in other countries; the opportunities for, and the
therapeutic and commercial potential of ADCETRIS, PADCEV, TUKYSA,
tisotumab vedotin and ladiratuzumab vedotin and the Company’s other
product candidates and those of its licensees and collaborators;
the potential to submit a BLA for accelerated approval of tisotumab
vedotin; the potential for data from the EV-301 and EV-201 cohort 2
clinical trials to support additional regulatory approvals of
PADCEV; the potential for the approval of TUKYSA by the EMA; the
Company’s global expansion; potential future milestone payments and
royalties under the Company’s collaborations; as well as other
statements that are not historical fact. 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 without limitation: the risks that the Company’s
ADCETRIS, PADCEV and TUKYSA net sales, revenues, expenses, costs,
and other financial guidance may not be as expected; risks and
uncertainties associated with maintaining or increasing sales of
ADCETRIS, PADCEV and TUKYSA due to competition, unexpected adverse
events, regulatory action, reimbursement, market adoption by
physicians, impacts associated with COVID-19 or other factors; the
risk that the Company or its collaborators may be delayed or
unsuccessful in planned clinical trial initiations, enrollment in
and conduct of clinical trials, obtaining data from clinical
trials, planned regulatory submissions, and regulatory approvals in
the U.S. and in other countries 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 actions and the
inherent uncertainty associated with the regulatory approval
process; the possibility that the Company may encounter challenges
in commercializing its therapeutic agents outside of the United
States, including with respect to reimbursement, compliance,
operational or other matters; risks relating to the Company’s
collaboration agreements and its ability to achieve progress
dependent milestones thereunder; and risks related to the duration
and severity of the COVID-19 pandemic and resulting global
economic, financial and healthcare system disruptions. More
information about the risks and uncertainties faced by the Company
is contained under the caption “Risk Factors” included in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2020 and the Company’s subsequent periodic reports filed with
the Securities and Exchange Commission. Seagen 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.
Seagen Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
(In thousands, except per
share amounts)
Three Months Ended March
31,
2021
2020
Revenues:
Net product sales
$
302,588
$
198,514
Royalty revenues
27,219
20,360
Collaboration and license agreement
revenues
2,176
15,640
Total revenues
331,983
234,514
Costs and expenses:
Cost of sales
64,135
29,421
Research and development
230,426
195,199
Selling, general and administrative
159,842
122,249
Total costs and expenses
454,403
346,869
Loss from operations
(122,420
)
(112,355
)
Investment and other income (loss),
net
1,000
(56,047
)
Net loss
$
(121,420
)
$
(168,402
)
Net loss per share - basic and diluted
$
(0.67
)
$
(0.98
)
Shares used in computation of per share
amounts - basic and diluted
181,150
172,350
Seagen Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
March 31, 2021
December 31, 2020
Assets
Cash, cash equivalents and investments
$
2,531,156
$
2,660,250
Other assets
1,411,829
1,340,656
Total assets
$
3,942,985
$
4,000,906
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
389,616
$
388,138
Long-term liabilities
128,745
124,668
Stockholders’ equity
3,424,624
3,488,100
Total liabilities and stockholders’
equity
$
3,942,985
$
4,000,906
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210429005996/en/
Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Seagen (NASDAQ:SGEN)
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