-Net Product Sales $267.5 Million in 3Q20, an
Increase of 60 Percent Over 3Q19-
-Collaborations with Merck for Ladiratuzumab
Vedotin and TUKYSA; Seagen Received $725M in Upfront Payments and
$1B Equity Investment-
-Positive Data from Two PADCEV Clinical Trials
to Support Global Registration Applications and Expand U.S.
Indication-
-Positive Data from Tisotumab Vedotin Pivotal
Trial; BLA Planned to Support U.S. Accelerated Approval-
-Conference Call Today at 4:30 p.m. ET-
Seagen Inc. (Nasdaq:SGEN) today reported financial results for
the third quarter and nine months ended September 30, 2020. 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.
“Our third quarter and year-to-date strong financial performance
was driven by product sales across our diverse portfolio of three
marketed products as well as the positive financial impact of our
recent collaborations with Merck on ladiratuzumab vedotin and
TUKYSA,” said Clay Siegall, Ph.D., President and Chief Executive
Officer of Seagen. “We plan to report clinical and preclinical data
across our programs at several medical meetings during the
remainder of 2020. In addition, we are pursuing multiple regulatory
submissions, including our TUKYSA MAA that is under review by the
EMA, a planned tisotumab vedotin BLA in the U.S. and global
marketing applications for PADCEV. With our significant financial
resources, robust drug development pipeline, expanding footprint in
Europe and strategic oncology collaborations, we are
well-positioned to continue building Seagen to address the unmet
medical needs of cancer patients around the globe.”
COMMERCIAL PRODUCTS HIGHLIGHTS
ADCETRIS
- Presenting Data in Multiple Abstracts at ASH: ADCETRIS
will be featured in multiple abstracts at the 62nd Annual Meeting
of the American Society of Hematology (ASH), which will be a
virtual event taking place December 5-8, 2020. Data will include
five-year follow-up results from the ECHELON-1 trial in frontline
stage III and IV Hodgkin lymphoma and the ECHELON-2 trial in
frontline CD30-expressing peripheral T-cell lymphomas.
PADCEV
- Announced Positive Topline Results from EV-301 Phase 3
Trial: In September 2020, Seagen and Astellas announced that
PADCEV alone improved overall survival compared to chemotherapy in
patients with locally advanced or metastatic urothelial cancer who
were previously treated with platinum-based chemotherapy and a
PD-1/L1 inhibitor. The trial was stopped early due to efficacy at
the planned interim analysis. Data from EV-301 will be submitted
for presentation at an upcoming scientific congress. In addition,
the results will be submitted to the U.S. Food and Drug
Administration (FDA) as the confirmatory trial following PADCEV's
accelerated approval in 2019, and EV-301 is also intended to
support global registrations.
- Announced Positive Topline Results from Second Cohort in
EV-201 Phase 2 Pivotal Trial: In October 2020, Seagen and
Astellas reported durable objective responses in patients with
locally advanced or metastatic urothelial cancer who have been
previously treated with a PD-1/L1 inhibitor, have not received a
platinum-containing chemotherapy and are ineligible for cisplatin.
Data from this second cohort of the EV-201 trial will be submitted
for presentation at an upcoming scientific congress and may support
a supplemental Biologics License Application (BLA) to extend use of
PADCEV in the U.S.
- Entered Into Additional Clinical Trial Collaboration with
Merck: In October 2020, Seagen, Astellas and Merck entered into
a clinical trial collaboration and supply agreement under which
PADCEV and KEYTRUDA will be evaluated in a planned phase 3 trial to
be conducted by Merck in cisplatin-eligible muscle invasive bladder
cancer to complement the ongoing study in cis-ineligible patients
in the same setting.
TUKYSA
- Received Approval in Fifth Country Under the FDA's Project
Orbis Initiative: In August 2020, Seagen announced TUKYSA's
approval in Australia for patients with metastatic HER2-positive
breast cancer, including patients with brain metastases. Australia
joined the U.S., Switzerland, Canada and Singapore in approving
TUKYSA under Project Orbis, an initiative of the FDA Oncology
Center of Excellence. In April 2020, TUKYSA became the first new
medicine approved in the U.S. under Project Orbis. A TUKYSA
marketing authorization application (MAA) is currently under review
by the European Medicines Agency (EMA).
- Entered into Exclusive License and Co-Development Agreement
with Merck for TUKYSA: In September 2020, Seagen granted Merck
an exclusive license to commercialize TUKYSA in Asia, the Middle
East and Latin America and other regions outside of the U.S.,
Canada and Europe. The collaboration is intended to accelerate
global availability of TUKYSA. Seagen received an upfront payment
of $125 million and is eligible for progress-dependent milestones
of up to $65 million as well as tiered royalties on sales of TUKYSA
in Merck’s territory.
- Expanded Clinical Development Program in HER2-Positive
Cancers: Seagen initiated multiple trials to broadly evaluate
TUKYSA in combination with other agents, including in
gastrointestinal and other solid tumors.
PIPELINE HIGHLIGHTS
- Entered into a Global Co-Development and
Co-Commercialization Agreement with Merck for Seagen’s
Ladiratuzumab Vedotin (LV): In September 2020, Seagen and Merck
entered into an agreement under which the companies will jointly
develop and equally share future costs and profits worldwide for
LV, Seagen's investigational antibody-drug conjugate (ADC). Merck
made an upfront payment to Seagen of $600 million. In October 2020,
following expiration of the waiting period under the
Hart-Scott-Rodino Act, Merck made a $1.0 billion equity investment
in 5.0 million shares of Seagen at $200 per share. In addition,
Seagen is eligible for progress-dependent milestone payments of up
to $2.6 billion.
- Presented Results from Tisotumab Vedotin (TV) Pivotal Trial
at ESMO: In September 2020, Seagen and Genmab presented
positive results at the European Society for Medical Oncology
(ESMO) Virtual Congress 2020 from the phase 2 single-arm clinical
trial known as innovaTV 204. The trial is evaluating TV for the
treatment of patients who have relapsed or progressed on or after
prior treatment for recurrent or metastatic cervical cancer. The
companies plan to submit a BLA to the FDA, which could support
accelerated approval in the U.S.
- Presenting Multiple Preclinical Abstracts at SITC:
Several Seagen programs will be featured in presentations at the
Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary
Annual Meeting 2020, taking place virtually November 9-14, 2020.
Abstracts encompass preclinical findings on the ADCs ADCETRIS, TV
and LV, as well as the Company’s novel empowered antibody programs
SEA-TGT and SEA-CD40.
For additional information on Seagen’s pipeline, visit
www.seagen.com/science/pipeline.
OTHER CORPORATE HIGHLIGHTS
- Received Milestone Payments Under ADC Collaboration with
GlaxoSmithKline (GSK): In August 2020, Seagen achieved two
milestones totaling $26 million under its ADC collaboration with
GSK, triggered by FDA and EMA approval of BlenrepTM (belantamab
mafodotin) for multiple myeloma.
- Announced Seagen R&D Day to be Held on November 16:
The R&D day will highlight the broad clinical development of
Seagen’s marketed products as well as provide an overview of its
deep pipeline of innovative cancer therapies.
THIRD QUARTER AND NINE-MONTHS 2020 FINANCIAL
RESULTS
Revenues: Total revenues for the third quarter and nine
months ended September 30, 2020 increased to $1.1 billion and $1.6
billion, respectively, compared to $213.3 million and $626.9
million for the same periods in 2019. Growth over 2019 was driven
by the addition of PADCEV and TUKYSA to the Company's commercial
portfolio and impact of the Company's recent collaborations with
Merck. Revenues are composed of the following three components:
Three months ended September
30,
Nine months ended September
30,
(dollars in millions)
2020
2019
% Change
2020
2019
% Change
Total Net Product Sales
$
267.5
$
167.6
60
%
$
706.5
$
461.6
53
%
ADCETRIS
163.3
167.6
(3
)%
494.9
461.6
7
%
PADCEV
61.8
—
N/A
153.5
—
N/A
TUKYSA
42.4
—
N/A
58.1
—
N/A
- Royalty Revenues: Royalty revenues for the third quarter
and year-to-date in 2020 were $35.9 million and $87.5 million,
respectively, compared to $27.3 million and $66.2 million for the
same periods in 2019. Royalty revenues are primarily driven by
sales of ADCETRIS outside the U.S. and Canada by Takeda. To a
lesser extent, royalty revenues include sales of Polivy®
(polatuzumab vedotin) by Roche, which is an ADC that uses Seagen
technology.
- Collaboration and License Agreement Revenues: Amounts
earned under the Company’s product, development and technology
collaborations were $758.3 million and $780.3 million in the third
quarter and year-to-date in 2020, respectively, compared to $18.4
million and $99.1 million for the same periods in 2019. The 2020
periods included $725 million in upfront license revenue related to
the Merck collaborations for LV and TUKYSA that were entered into
in September 2020. In addition, during the third quarter of 2020
Seagen received $26 million in total milestone payments from GSK,
triggered by FDA and EMA approvals of Blenrep.
Research and Development (R&D) Expenses: R&D
expenses for the third quarter and year-to-date in 2020 were $217.7
million and $610.9 million, respectively, compared to $196.1
million and $518.3 million for the same periods in 2019. The
increases in 2020 primarily reflect continued investment in the
Company's pipeline.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the third quarter and year-to-date in 2020
were $127.6 million and $375.5 million, respectively, compared to
$96.1 million and $258.7 million for the same periods in 2019. The
increases were primarily attributed to increased field sales
personnel in the U.S. for Seagen's recently commercialized
products, PADCEV and TUKYSA, as well as higher infrastructure costs
to support the Company's continued growth and international
expansion.
Cost of Sales: Cost of sales for the third quarter and
year-to-date in 2020 were $78.3 million and $156.0 million,
respectively, compared to $10.8 million and $32.0 million for the
same periods in 2019. The increases in 2020 were primarily due to
the gross profit share with Astellas based on PADCEV sales, which
were $29.1 million and $72.6 million in the third quarter and
year-to-date, respectively. Cost of sales also increased in 2020
due a payment owed to a third-party technology licensor related to
the TUKYSA license agreement with Merck, 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.
Non-cash, share-based compensation cost for the first nine
months of 2020 was $107.5 million, compared to $79.7 million for
the same period in 2019.
Net Income (Loss): Net income for the third quarter of
2020 was $636.2 million, or $3.50 per diluted share, compared to
net loss of $91.9 million, or $0.55 per diluted share, for the
third quarter of 2019. Net income for the nine months ended
September 30, 2020 was $446.6 million, or $2.47 per diluted share,
compared to net loss of $184.5 million, or $1.13 per diluted share,
for the same period in 2019. Net income for the periods in 2020 is
the result of the upfront license payments received from Merck.
This includes an income tax provision of $3.2 million in the third
quarter of 2020. Seagen utilized federal net operating loss
carryforwards as allowed, however the Company incurred income taxes
in some states that did not have deferred tax assets available.
Cash and Investments: As of September 30, 2020, Seagen
had $1.7 billion in cash and investments. The $1.0 billion equity
investment by Merck, which closed in October 2020, will be
reflected in the Company's December 31, 2020 cash and
investments.
2020 FINANCIAL OUTLOOK
Seagen's 2020 financial guidance is shown below, which includes
the impact of the Company's collaborations with Merck.
Current
Previous
Revenues
ADCETRIS net product sales
$650 million to $660 million
$675 million to $700 million
PADCEV net product sales
$215 million to $235 million
Unchanged
Royalty revenues
$125 million to $130 million
$105 million to $115 million
Collaboration and license agreement
revenues
$1.03 billion to $1.04
billion
$30 million to $50 million
Operating expenses and other
costs
R&D expenses
$820 million to $870 million
Unchanged
SG&A expenses
$475 million to $525 million
Unchanged
Cost of Sales
$205 million to $225 million
$185 million to $205 million
Non-cash costs1 (primarily attributable
to
share-based compensation)
$180 million to $200 million
Unchanged
- Non-cash costs 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 third quarter 2020 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 and supporting
slides 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 10148256. 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 Seagen is
contained under the caption “Risk Factors” included in the
Company’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2020 filed with the Securities and Exchange Commission (SEC),
and the Company’s subsequent periodic and current reports filed
with the SEC. 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 September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Revenues:
Net product sales
$
267,494
$
167,582
$
706,473
$
461,563
Royalty revenues
35,924
27,261
87,520
66,218
Collaboration and license agreement
revenues
758,313
18,420
780,250
99,128
Total revenues
1,061,731
213,263
1,574,243
626,909
Costs and expenses:
Cost of sales
78,296
10,827
155,962
32,024
Research and development
217,670
196,119
610,945
518,313
Selling, general and administrative
127,579
96,101
375,470
258,703
Total costs and expenses
423,545
303,047
1,142,377
809,040
Income (loss) from operations
638,186
(89,784)
431,866
(182,131)
Investment and other income (loss),
net
1,223
(2,129)
17,951
(2,349)
Income (loss) before income taxes
639,409
(91,913)
449,817
(184,480)
Provision for income taxes
(3,242)
—
(3,242)
—
Net income (loss)
$
636,167
$
(91,913)
$
446,575
$
(184,480)
Net income (loss) per share - basic
$
3.65
$
(0.55)
$
2.58
$
(1.13)
Net income (loss) per share - diluted
$
3.50
$
(0.55)
$
2.47
$
(1.13)
Shares used in computation of per share
amounts - basic
174,460
168,109
173,409
163,428
Shares used in computation of per share
amounts - diluted
181,877
168,109
180,939
163,428
Seagen Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
September 30, 2020
December 31, 2019
Assets
Cash, cash equivalents and investments
$
1,718,375
$
868,338
Other assets
1,286,586
1,337,528
Total assets
$
3,004,961
$
2,205,866
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
342,688
$
259,357
Deferred revenue
250,450
—
Long-term liabilities
153,793
70,222
Stockholders’ equity
2,258,030
1,876,287
Total liabilities and stockholders’
equity
$
3,004,961
$
2,205,866
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201029006128/en/
Investors: Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Media: Monique Greer 425-527-4641 mgreer@seagen.com
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