-Total Revenues of $278.0 Million in the Second
Quarter, Including Record Net Product Sales of $240.5 Million
Driven by Three Marketed Products: ADCETRIS®, PADCEV® and
TUKYSA™-
-Reported Positive Topline Results from Pivotal
Trial of Tisotumab Vedotin-
-Conference Call Today at 4:30 p.m. ET-
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial
results for the second quarter and six months ended June 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.
“We generated record product sales of $240.5 million in the
second quarter driven by ADCETRIS, PADCEV and now a third
commercial product, TUKYSA, following the FDA approval in mid-April
for metastatic HER2-positive breast cancer,” said Clay Siegall,
Ph.D., President and Chief Executive Officer of Seattle Genetics.
“We successfully launched TUKYSA in the United States and are
building our international capabilities to support global launches.
In addition, we reported another quarter of strong PADCEV sales
with revenues of $91.6 million in its first two full quarters on
the market. Our total revenues are on track to exceed $1 billion in
2020.”
PRODUCT SALES SUMMARY
- ADCETRIS: Continued growth with net sales in the U.S.
and Canada of $167.5 million in the second quarter of 2020, an
increase of five percent over the second quarter of 2019.
- PADCEV: U.S. net sales in the second quarter were $57.2
million, an increase of 66 percent over the first quarter of
2020.
- TUKYSA: Second quarter net sales of $15.8 million
following U.S. approval in mid-April.
Dr. Siegall continued, “We also made substantial progress in the
second quarter across our pipeline of more than a dozen programs.
We reported positive results from the innovaTV 204 trial of
tisotumab vedotin in recurrent or metastatic cervical cancer and
plan to discuss with the FDA the potential submission of a
Biologics License Application to support an accelerated approval.
In addition, we advanced two novel drug candidates into phase 1
trials. We plan to host an investor R&D day later in 2020 to
highlight the breadth of opportunities across our programs.”
COMMERCIAL PRODUCT HIGHLIGHTS
ADCETRIS
- Announced Partner's Ex-U.S. Regulatory Progress: In May
2020, Takeda received approval from the European Commission for
ADCETRIS for the treatment of patients with previously untreated
systemic anaplastic large cell lymphoma (sALCL) in combination with
CHP (cyclophosphamide, doxorubicin, prednisone). Also in May 2020,
Takeda received approval from China's National Medical Products
Administration for ADCETRIS for the treatment of relapsed or
refractory sALCL and Hodgkin lymphoma. This marks the first
approval of ADCETRIS in China.
- Expanded Clinical Program: Seattle Genetics recently
initiated a phase 3 trial in relapsed and refractory diffuse large
B-cell lymphoma and expanded a trial in frontline Hodgkin lymphoma
to evaluate stage I and II patients.
PADCEV
- Completed Enrollment in Second Cohort of EV-201 Trial:
In April 2020, Seattle Genetics and Astellas completed enrollment
in the second cohort of the EV-201 trial for patients who
previously received a PD-1 or PD-L1 inhibitor, are platinum naive
and are not candidates for treatment with cisplatin chemotherapy.
Data from the second cohort could potentially serve as the basis
for a second PADCEV indication.
- PADCEV Added to Merck Trial in Muscle Invasive Bladder
Cancer (MIBC): In July 2020, Merck expanded its ongoing phase 3
KEYNOTE 905 trial to include an arm evaluating PADCEV in
combination with KEYTRUDA for patients with cisplatin-ineligible
MIBC. The expansion is being conducted under a clinical trial
collaboration and supply agreement among Seattle Genetics, Astellas
and Merck.
TUKYSA
- Received FDA Approval: In April 2020, TUKYSA was
approved by the FDA in combination with trastuzumab and
capecitabine for the treatment of adult patients with advanced
unresectable or metastatic HER2-positive breast cancer, including
patients with brain metastases, who have received one or more prior
anti-HER2-based regimens in the metastatic setting. Approval was
granted four months ahead of the PDUFA target action date under the
FDA's Real-Time Oncology Review pilot program.
- Received Ex-US Regulatory Approvals: TUKYSA received
approval in Canada, Singapore and Switzerland under the Project
Orbis initiative of the FDA Oncology Center of Excellence that
provides a framework for concurrent submission and review of
oncology products among international partners.
- Presented and Published HER2CLIMB Analyses in Brain
Metastases Patients: Announced positive results from
exploratory analyses of the treatment effect of the TUKYSA regimen
in metastatic HER2-positive breast cancer patients with brain
metastases in the HER2CLIMB trial. Results demonstrated that the
addition of TUKYSA to trastuzumab and capecitabine in patients with
brain metastases delayed progression in the brain, doubled the
intracranial response rate (tumor shrinkage in the brain) and
reduced the overall risk of death by nearly half. In the HER2CLIMB
trial, the tucatinib regimen was generally well-tolerated with a
manageable safety profile. Results were featured in an oral
presentation during the virtual scientific program of the 2020
American Society of Clinical Oncology (ASCO) Annual Meeting held in
June 2020 and simultaneously published in the Journal of Clinical
Oncology.
PIPELINE HIGHLIGHTS
- Reported Positive Topline Results from Tisotumab Vedotin
Pivotal Trial: In June 2020, Seattle Genetics and Genmab
announced positive topline results from the phase 2 single-arm
clinical trial known as innovaTV 204 evaluating tisotumab vedotin
administered every three weeks for the treatment of patients who
have relapsed or progressed on or after prior treatment for
recurrent or metastatic cervical cancer. Results from the trial
showed a 24 percent confirmed objective response rate (ORR) by
independent central review with a median duration of response of
8.3 months. The most common treatment-related adverse events
(greater than or equal to 20 percent) included alopecia, epistaxis
(nose bleeds), nausea, conjunctivitis, fatigue and dry eye. The
companies plan to discuss with the FDA a potential Biologics
License Application (BLA) submission to support accelerated
approval.
- Initiated Phase 1 Trials of Two Novel Drug Candidates:
In June 2020, the first patient was dosed in a phase 1 trial of
SEA-TGT, an anti-TIGIT antibody for patients with solid tumors and
lymphomas. SEA-TGT employs the Company’s proprietary Sugar
Engineered Antibody (SEA) technology. Seattle Genetics also
announced dosing of the first patient in a phase 1 clinical trial
evaluating SGN-B6A, an antibody-drug conjugate (ADC) targeting
integrin beta-6, which is overexpressed in a variety of solid
tumors and has been shown to be a negative prognostic indicator
across a diverse range of cancers.
- Presented Early Pipeline and ADC Technology:
Advancements in the Company's drug linker and payload components of
ADCs as well as preclinical data on multiple investigational drug
candidates were presented at the American Association for Cancer
Research (AACR) Virtual Meeting II held in June 2020.
For additional information on Seattle Genetics’ pipeline, visit
www.seattlegenetics.com/pipeline.
CORPORATE HIGHLIGHTS
- Named Tuomo Pätsi Executive Vice President, Commercial
International: In July 2020, Tuomo Pätsi joined Seattle
Genetics in the newly created position of Executive Vice President,
Commercial International. In this role, he will lead the Company's
commercial organization in Europe, Canada and the rest of the world
outside of the United States. Mr. Pätsi brings extensive commercial
leadership experience, including from Celgene where he was
President, Worldwide Markets. Mr. Pätsi also has experience most
recently from Bristol-Myers Squibb, and previously from Human
Genome Sciences and Amgen. The U.S. commercial organization will
continue to be led by Chip Romp, Executive Vice President,
Commercial U.S.
SECOND QUARTER AND SIX-MONTHS 2020 FINANCIAL
RESULTS
Revenues: Total revenues for the second quarter and six
months ended June 30, 2020 increased to $278.0 million and $512.5
million, respectively, compared to $218.4 million and $413.6
million for the same periods in 2019. Revenues are composed of the
following three components:
Three months ended June
30,
Six months ended June
30,
(dollars in millions)
2020
2019
% Change
2020
2019
% Change
Total Net Product Sales
$
240.5
$
159.0
51%
$
439.0
$
294.0
49%
ADCETRIS
167.5
159.0
5%
331.6
294.0
13%
PADCEV
57.2
—
N/A
91.6
—
N/A
TUKYSA
15.8
—
N/A
15.8
—
N/A
- Royalty Revenues: Royalty revenues for the second
quarter and year-to-date in 2020 were $31.2 million and $51.6
million, respectively, compared to $23.3 million and $39.0 million
for the same periods in 2019. 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™ (polatuzumab vedotin-piiq) by
Roche.
- Collaboration and License Agreement Revenues: Amounts
earned under the Company’s ADCETRIS and ADC collaborations were
$6.3 million and $21.9 million in the second quarter and
year-to-date in 2020, respectively, compared to $36.1 million and
$80.7 million for the same periods in 2019. Collaboration revenues
for the first half of 2019 included $37.5 million in milestones
from Takeda triggered by additional approvals of ADCETRIS in
combination with chemotherapy for frontline Hodgkin lymphoma.
Research and Development (R&D) Expenses: R&D
expenses for the second quarter and year-to-date in 2020 were
$198.1 million and $393.3 million, respectively, compared to $163.9
million and $322.2 million for the same periods in 2019. The
increase in 2020 primarily reflected increased investment in the
Company's pipeline.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the second quarter and year-to-date in 2020
were $125.6 million and $247.9 million, respectively, compared to
$82.3 million and $162.6 million for the same periods in 2019. The
increase was primarily attributed to increased field sales
personnel for Seattle Genetics' 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 second quarter and
year-to-date in 2020 were $48.2 million and $77.7 million,
respectively, compared to $10.9 million and $21.2 million for the
same periods in 2019. The increase in 2020 was primarily due to the
gross profit share with Astellas based on PADCEV sales, which were
$27.1 million and $43.5 million in the 2020 second quarter and
year-to-date, respectively. Cost of sales also increased due to
amortization of acquired in-process technology costs that began
with the approval of TUKYSA in April 2020, as well as royalties
owed for PADCEV and TUKYSA net product sales.
Non-cash, share-based compensation cost for the first six months
of 2020 was $68.4 million, compared to $51.9 million for the same
period in 2019.
Net Loss: Net loss for the second quarter of 2020 was
$21.2 million, or $0.12 per diluted share, compared to net loss of
$79.2 million, or $0.49 per diluted share, for the second quarter
of 2019. Net loss for the six months ended June 30, 2020 was $189.6
million, or $1.10 per diluted share, compared to net loss of $92.6
million, or $0.57 per diluted share, for the same period in 2019.
Net loss in the second quarter and the year-to-date in 2020
included a net investment gain of $72.8 million and $16.7 million,
respectively, primarily associated with Seattle Genetics’ common
stock holdings in Immunomedics, which was sold in April 2020 for
$174.7 million.
Cash and Investments: As of June 30, 2020, Seattle
Genetics had $895.7 million in cash and investments.
2020 FINANCIAL OUTLOOK
The Company's 2020 financial guidance is shown below, including
PADCEV net sales guidance.
Current
Previous
Revenues
ADCETRIS net product sales
$675 million to $700 million
Unchanged
PADCEV net product sales
$215 million to $235 million
N/A
Royalty revenues
$105 million to $115 million
Unchanged
Collaboration and license agreement
revenues
$30 million to $50 million
Unchanged
Operating expenses and other
costs
R&D expenses
$820 million to $870 million
$860 million to $950 million
SG&A expenses
$475 million to $525 million
Unchanged
Cost of Sales
$185 million to $205 million
N/A
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
Seattle Genetics’ management will host a conference call and
webcast with supporting slides to discuss its second 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 Seattle Genetics website at www.seattlegenetics.com, under the Investors
section. Investors may also participate in the conference call by
calling 866-248-8441 (domestic) or 720-452-9102 (international).
The conference ID is 1128188. A webcast replay will be archived on
the Company's website www.seattlegenetics.com, under the Investors
section.
About Seattle Genetics
Seattle Genetics, Inc. is a global biotechnology company that
discovers, develops and commercializes transformative cancer
medicines 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. TUKYSATM (tucatinib), a small
molecule tyrosine kinase inhibitor, is approved in certain
HER2-positive metastatic breast cancers. The Company is
headquartered in the Seattle, Washington area, with locations 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 in future periods; the
potential to submit a BLA for accelerated approval of tisotumab
vedotin; 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 and tisotumab
vedotin and the Company’s other product candidates and those of its
licensees and collaborators; the potential for data from the EV-103
trial to potentially support registration under accelerated
approval regulations in the U.S.; intended expansion of commercial
operations in Europe; 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, PADCEV and TUKYSA net sales,
revenues, expenses, costs, and other financial guidance may not be
as expected, as well as 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 Company may also be delayed or
unsuccessful 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, 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2020 filed with the Securities and Exchange
Commission (SEC), and the Company’s subsequent periodic and current
reports filed with the SEC. 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 June
30,
Six Months Ended June
30,
2020
2019
2020
2019
Revenues:
Net product sales
$
240,465
$
158,980
$
438,979
$
293,981
Royalty revenues
31,235
23,337
51,595
38,957
Collaboration and license agreement
revenues
6,298
36,130
21,938
80,708
Total revenues
277,998
218,447
512,512
413,646
Costs and expenses:
Cost of sales
48,244
10,897
77,665
21,197
Research and development
198,077
163,929
393,276
322,194
Selling, general and administrative
125,642
82,331
247,891
162,602
Total costs and expenses
371,963
257,157
718,832
505,993
Loss from operations
(93,965)
(38,710)
(206,320)
(92,347)
Investment and other income (loss),
net
72,775
(40,528)
16,728
(220)
Net loss
$
(21,190)
$
(79,238)
$
(189,592)
$
(92,567)
Net loss per share - basic and diluted
$
(0.12)
$
(0.49)
$
(1.10)
$
(0.57)
Shares used in computation of per share
amounts - basic and diluted
173,406
161,436
172,878
161,049
Seattle Genetics, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
June 30, 2020
December 31, 2019
Assets
Cash, cash equivalents and investments
$
895,668
$
868,338
Other assets
1,268,888
1,337,528
Total assets
$
2,164,556
$
2,205,866
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
282,615
$
259,357
Long-term liabilities
67,864
70,222
Stockholders’ equity
1,814,077
1,876,287
Total liabilities and stockholders’
equity
$
2,164,556
$
2,205,866
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200730005885/en/
Investors: Peggy Pinkston 425-527-4160 ppinkston@seagen.com
Media: Monique Greer 425-527-4641 mgreer@seagen.com
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