-Net Product Sales of $1 Billion in 2020, an
Increase of 59 Percent Over 2019-
-European Medicines Agency's CHMP Adopted
Positive Opinion Recommending Approval of TUKYSA for Patients with
Locally Advanced or Metastatic HER2-Positive Breast Cancer-
-PADCEV U.S. and Global Marketing Applications
Planned for 1Q 2021-
-Tisotumab Vedotin Biologics License
Application Submitted to FDA for Recurrent or Metastatic Cervical
Cancer-
-Conference Call Today at 4:30 p.m. ET-
Seagen Inc. (Nasdaq:SGEN) today reported financial results for
the fourth quarter and year ended December 31, 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.
“In 2020, we generated record product revenues of more than $1
billion driven by successful launches of PADCEV and TUKYSA, as well
as continued growth of ADCETRIS,” said Clay Siegall, Ph.D.,
President and Chief Executive Officer of Seagen. “These strong
results are in addition to several significant business, regulatory
and development accomplishments during the year. Looking ahead, we
are focused on maximizing the global potential of our approved
medicines, advancing our late-stage programs towards securing
approvals of new products, and expanding our innovative early-stage
pipeline. In collaboration with our partner Genmab we submitted a
BLA for tisotumab vedotin to the FDA, positioning it to be our
fourth commercial product. We are on track for several other
milestones across our pipeline over the course of 2021, and are in
a strong financial position to continue executing against our
goals.”
COMMERCIAL PRODUCT HIGHLIGHTS
ADCETRIS
- Presented 5-year Follow-up Results for ECHELON-1 and
ECHELON-2 Trials at the ASH Annual Meeting: Key long-term
updates for two phase 3 ADCETRIS trials were presented at the 62nd
American Society of Hematology (ASH) annual meeting. Notably, the
five-year update of the phase 3 ECHELON-1 clinical trial 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.
PADCEV
- Reporting Phase 3 EV-301 and EV-201 Cohort 2 Data in Oral
Presentations at ASCO GU; Regulatory Submissions Planned: Full
results from the phase 3 EV-301 trial and the second cohort of the
pivotal phase 2 EV-201 trial will be presented at the 2021 American
Society of Clinical Oncology's Genitourinary Cancers Symposium
(ASCO-GU) being held February 11-13. Both trials were conducted in
patients with previously treated locally advanced or metastatic
urothelial cancer. The EV-301 data are intended to support global
registration submissions planned for the first quarter of 2021. The
results from the second cohort of EV-201 will support a
supplemental Biologics License Application (BLA) submission with
the U.S. Food and Drug Administration (FDA) planned for the first
quarter of 2021.
- Initiated Second Phase 3 Trial in Muscle Invasive Bladder
Cancer (MIBC): In collaboration with Astellas and Merck, the
randomized phase 3 EV-304/KEYNOTE-B15 trial was initiated to
evaluate PADCEV in combination with KEYTRUDA® (pembrolizumab) in
cisplatin-eligible MIBC. This is in addition to the ongoing
randomized phase 3 study, EV-303/KEYNOTE-905, in
cisplatin-ineligible MIBC patients.
TUKYSA
- Received Positive CHMP Opinion for TUKYSA: In December
2020, the European Medicines Agency adopted a positive opinion
recommending the approval of TUKYSA 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 2 prior anti-HER2 treatment regimens. The CHMP
positive opinion is now being considered by the European
Commission, which has the authority to approve medicines in the
European Union.
- Presented Multiple TUKYSA Abstracts at SABCS: In
December 2020, eight abstracts highlighted Seagen's commitment to
addressing unmet needs in breast cancer at the San Antonio Breast
Cancer Symposium (SABCS). One presentation provided new exploratory
analyses from the pivotal HER2CLIMB trial in metastatic
HER2-positive breast cancer that demonstrated progression-free
survival, overall survival and objective response rate improvements
with TUKYSA were observed consistently across hormone receptor
status subgroups, including in patients with brain metastases.
PIPELINE HIGHLIGHTS
- Submitted Tisotumab Vedotin BLA to FDA: In February
2021, Seagen and Genmab submitted a BLA to the FDA seeking
accelerated approval of tisotumab vedotin for the treatment of
patients with recurrent or metastatic cervical cancer with disease
progression on or after chemotherapy. Results from the innovaTV 204
trial formed the basis of the submission.
- Initiated Phase 3 Trial of Tisotumab Vedotin: A phase 3
trial, called innovaTV 301, was initiated to evaluate tisotumab
vedotin compared to chemotherapy in patients with recurrent or
metastatic cervical cancer who have received one or two prior lines
of therapy. innovaTV 301 is intended to support global regulatory
applications and potentially serve as a confirmatory trial in the
U.S.
- Treated First Patient in Phase 1 Trial of SGN-STNV: In
January 2021, the first patient was dosed in a phase 1 trial of
SGN-STNV, a novel antibody-drug conjugate (ADC) targeting Sialyl
Thomsen-nouveau (STN). STN is highly expressed across multiple
solid tumors.
For additional information on Seagen’s pipeline, visit
www.seagen.com/science/pipeline.
FOURTH QUARTER AND FULL YEAR 2020 FINANCIAL RESULTS
Revenues: Total revenues in the fourth quarter and year
ended December 31, 2020 increased to $601.3 million and $2.2
billion, respectively, compared to $289.8 million and $916.7
million for the same periods in 2019. Revenues were comprised of
the following three components:
Three months ended December
31,
Full years ended December
31,
(dollars in millions)
2020
2019
% Change
2020
2019
% Change
Total Net Product Sales
$
294.1
$
166.4
77%
$
1,000.6
$
628.0
59%
ADCETRIS
163.7
166.2
(2)%
658.6
627.7
5%
PADCEV
69.0
0.2
—
222.4
0.2
—
TUKYSA
61.4
—
N/A
119.6
—
N/A
Note: Sum of product sales may not equal
total net product sales due to rounding.
- Royalty Revenues: Royalty revenues in the fourth quarter
were $39.2 million, compared to $72.3 million in the fourth quarter
of 2019. 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
$126.8 million for the full year in 2020, compared to $138.5
million in 2019. Royalty revenues are primarily driven by sales of
ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser
extent, also include 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 collaboration and license agreements
were $267.9 million in the fourth quarter and $1.0 billion for the
full year in 2020, compared to $51.1 million and $150.2 million,
respectively, for the same periods in 2019. The fourth quarter of
2020 included $250.1 million in revenue related to the premium over
market price paid by Merck under a $1 billion stock purchase that
closed in October 2020 as part of the ladiratuzumab vedotin
collaboration agreement. The full year in 2020 included $975.1
million in license revenue related to the Merck collaborations for
ladiratuzumab vedotin and TUKYSA that were entered into in
September 2020.
Cost of Sales: Cost of sales in the fourth quarter were
$61.8 million, compared to $11.9 million in the fourth quarter of
2019. Cost of sales were $217.7 million for the full year in 2020,
compared to $44.0 million for the same period in 2019. The
increases in 2020 were primarily due to the gross profit share
payment to Astellas based on PADCEV sales, which were $32.1 million
and $104.6 million in the fourth quarter and full year,
respectively. Cost of sales for the periods in 2020 also reflect
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.
Cost of sales for the year in 2020 included a payment owed to a
third-party technology licensor related to the TUKYSA license
agreement with Merck reflected in the third quarter of the
year.
Research and Development (R&D) Expenses: R&D
expenses in the fourth quarter were $216.2 million, compared to
$201.1 million in the fourth quarter of 2019. R&D expenses were
$827.1 million for the full year in 2020, compared to $719.4
million in 2019. The increase in 2020 primarily reflected continued
investment in the Company's pipeline.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses in the fourth quarter were $158.4 million,
compared to $115.2 million in the fourth quarter of 2019. SG&A
expenses were $533.8 million for the full year in 2020, compared to
$373.9 million for the same period 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.
Non-cash share-based compensation cost for the full year in 2020
was $147.2 million, compared to $127.3 million for the same period
in 2019.
Net Income / Loss: Net income for the fourth quarter of
2020 was $167.1 million, or $0.90 per diluted share, compared to
net income of $25.8 million, or $0.14 per diluted share, for the
fourth quarter of 2019. For the full year in 2020, net income was
$613.7 million, or $3.37 per diluted share, compared to a net loss
of $158.7 million, or $0.96 per diluted share, for the year in
2019. Net income for 2020 was driven by the revenue recognized in
the third and fourth quarters under the Merck collaborations.
Seagen utilized federal net operating loss carryforwards as
allowed, however the Company incurred income taxes in certain
states which resulted in an income tax provision of $2.0 million
for the year in 2020.
Cash and Investments: As of December 31, 2020, Seagen had
$2.7 billion in cash and investments. This includes proceeds from a
$1.0 billion equity investment by Merck, which closed in October
2020.
2021 FINANCIAL OUTLOOK
Seagen anticipates 2021 revenues, operating expenses and other
costs to be in the ranges shown in the table below.
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 costs1 (primarily attributable
to
share-based compensation)
$225 million to $245 million
1. 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 fourth quarter and full year 2020
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
(U.S.) or 412-717-9224 (international). The conference ID is
10150708. A webcast replay will be archived on the Company's
website www.seagen.com, under the Investors section.
About Seagen
Seagen 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
the company’s 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
2021 outlook, including anticipated 2021 revenues, costs and
expenses; the Company’s potential to achieve the noted development
and regulatory milestones in 2021 and in future periods and to
bring a fourth product to market in the United States; anticipated
activities related to the Company’s planned and ongoing clinical
trials; the opportunities for, and the therapeutic and commercial
potential of ADCETRIS, PADCEV, TUKYSA, tisotumab vedotin and the
Company’s other product candidates and those of its licensees and
collaborators; the potential for data from the innovaTV 204 trial
to support an 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 Company to commercialize TUKYSA in Europe; 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, government pricing
and/or reimbursement actions, market adoption by physicians,
impacts associated with COVID-19 or other factors; the risks 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; 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 Exhibit
99.1 to the Company’s Current Report on Form 8-K, filed with the
Securities and Exchange Commission (SEC) on December 29, 2020, and
the Company’s subsequent periodic 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 December
31,
Years Ended December
31,
2020
2019
2020
2019
Revenues:
Net product sales
$
294,125
$
166,414
$
1,000,598
$
627,977
Royalty revenues
39,236
72,273
126,756
138,491
Collaboration and license agreement
revenues
267,932
51,117
1,048,182
150,245
Total revenues
601,293
289,804
2,175,536
916,713
Costs and expenses:
Cost of sales
61,758
11,928
217,720
43,952
Research and development
216,184
201,061
827,129
719,374
Selling, general and administrative
158,365
115,229
533,835
373,932
Total costs and expenses
436,307
328,218
1,578,684
1,137,258
Income (loss) from operations
164,986
(38,414
)
596,852
(220,545
)
Investment and other income, net
898
64,244
18,849
61,895
Income (loss) before income taxes
165,884
25,830
615,701
(158,650
)
Income tax benefit (expense)
1,211
—
(2,031
)
—
Net income (loss)
$
167,095
$
25,830
$
613,670
$
(158,650
)
Net income (loss) per share - basic
$
0.93
$
0.15
$
3.51
$
(0.96
)
Net income (loss) per share - diluted
$
0.90
$
0.14
$
3.37
$
(0.96
)
Shares used in computation of per share
amounts - basic
179,078
171,638
174,834
165,498
Shares used in computation of per share
amounts - diluted
186,040
178,501
182,287
165,498
Seagen Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
December 31,
2020
2019
Assets
Cash, cash equivalents and investments
$
2,660,250
$
868,338
Other assets
1,340,656
1,337,528
Total assets
$
4,000,906
$
2,205,866
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
388,138
$
259,357
Long-term liabilities
124,668
70,222
Stockholders’ equity
3,488,100
1,876,287
Total liabilities and stockholders’
equity
$
4,000,906
$
2,205,866
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210211005849/en/
Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Seagen (NASDAQ:SGEN)
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