-Record Net Product Sales of $544 Million in
2Q23, an Increase of 26% Over 2Q22, Contributing to Total Revenues
of $604 Million in 2Q23-
-Strong PADCEV® Growth Driven By Combination
First-Line Advanced Urothelial Cancer Launch; Record ADCETRIS®
Performance with Overall Survival Benefit Demonstrated in the
ECHELON-1 Trial Added to Label-
-Three Registrational Trial Readouts for
PADCEV, TUKYSA® and TIVDAK® Anticipated in 2H23-
-Initiated Phase 3 Trial for Disitamab Vedotin
and Expect to Initiate Phase 3 Trial of SGN-B6A by Year End-
-Proposed Acquisition by Pfizer Progressing
Towards Close in Late 2023 or Early 2024-
Seagen Inc. (Nasdaq:SGEN) (Seagen or the Company) reported
financial results today for the second quarter ended June 30, 2023,
highlighting record net product sales, with significant
year-over-year growth of 26 percent.
David Epstein, Chief Executive Officer of Seagen said, “I am
pleased to report an exceptional quarter with strong performance
and growth seen across our commercial portfolio. We remain focused
on optimizing the potential of our commercial portfolio, advancing
our innovative pipeline of targeted therapies with ADCs at our core
and innovating through next-generation technologies.” Highlights
include:
- PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda®
(pembrolizumab) received accelerated approval for first-line
treatment of locally advanced or metastatic urothelial cancer in
the U.S. and was added as a preferred regimen to NCCN treatment
guidelines. The robust launch helped drive 36% net product sales
growth for PADCEV over the first quarter of 2023;
- ADCETRIS (brentuximab vedotin) net product sales grew
sequentially for the last six quarters. The overall survival
benefit demonstrated in the ECHELON-1 trial has now been included
in the U.S. ADCETRIS label. Importantly, a phase 3 study of
ADCETRIS with a modified chemotherapy regimen conducted by German
Hodgkin Study Group demonstrated non-inferiority with an
unprecedented 3-year progression-free survival of 94.9% compared to
a more chemo-intensive international standard of care in advanced
classical Hodgkin lymphoma, reinforcing the powerful impact this
therapy has on patients’ lives;
- TUKYSA (tucatinib) performed well in the quarter, demonstrating
the critical role it has in the treatment of HER2-positive
metastatic breast and colorectal cancer.
“I am particularly proud of our team’s execution, demonstrating
our focus on our strategic priorities as we continue to deliver
transformative therapies. In May, Seagen's shareholders
overwhelmingly supported the acquisition by Pfizer, which we
believe will accelerate our ability to deliver transformative
cancer medicines to more patients in need around the world,”
concluded Epstein.
Roger Dansey, President of Research and Development and Chief
Medical Officer, added, “For our marketed therapies we expect
several important data readouts with congress presentations this
year, potentially broadening their utility. We are prioritizing
development of our most transformative pipeline assets, as
demonstrated by the recently initiated phase 3 trial for disitamab
vedotin in combination with pembrolizumab in previously untreated
metastatic HER2-positive urothelial cancer and soon to be initiated
phase 3 trial of SGN-B6A in previously treated, metastatic
non-small cell lung cancer. We also expect to file at least three
INDs for new medicines by the end of this year, including for
multiple ADCs that utilize next-generation drug linkers and
payloads, as we seek to develop future transformational
medicines.”
PRODUCTS HIGHLIGHTS
PADCEV
- Launched PADCEV with Keytruda for First-Line Treatment of
Locally Advanced or Metastatic Urothelial Cancer (la/mUC) in the
U.S.: In April 2023, Seagen, Astellas and Merck announced the
FDA granted PADCEV (enfortumab vedotin-ejfv) with Keytruda
(pembrolizumab) accelerated approval in the U.S. as a combination
therapy for the treatment of adult patients with la/mUC who are not
eligible to receive cisplatin-containing chemotherapy. It is the
first treatment option combining an ADC with a PD-1 inhibitor in
this patient population. Continued approval for this indication is
contingent upon verification and description of clinical benefit in
the EV-302 confirmatory trial.
- The EV-302 Trial has Completed Patient Enrollment and
Topline Results are Expected by the End of 2023: The trial
enrolled patients regardless of their cisplatin-eligibility or
PD-L1 expression and offers a platinum-free combination regimen. An
extension study in China continues to enroll patients.
- NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Bladder Cancer Updated to Include PADCEV and
Keytruda Combination as Preferred Regimen: In April 2023, based
on the results of the EV-103 trial, the NCCN Guidelines were
updated to include PADCEV with Keytruda as a Preferred Regimen
(Category 2A) for first-line therapy for patients with la/mUC who
are not eligible to receive cisplatin-containing chemotherapy.
- Data Presented in Earlier Stages of Disease for
Muscle-Invasive and Non-Muscle Invasive Forms of Bladder Cancer and
in First-Line la/mUC at the American Society of Clinical Oncology
(ASCO) Annual Meeting: In June 2023, presentations included
long-term follow-up data from the EV-103 trial
dose-escalation/Cohort A, which is evaluating PADCEV in combination
with pembrolizumab as first-line treatment in patients with locally
advanced or metastatic urothelial carcinoma who are ineligible to
receive cisplatin-based chemotherapy, demonstrated a manageable
safety profile after approximately 4 years of follow-up and
clinically meaningful efficacy with a median survival exceeding 2
years.
ADCETRIS
- Label Updated with Overall Survival Benefit Demonstrated in
the Phase 3 ECHELON-1 Trial: In June 2023, the U.S. Prescribing
Information for ADCETRIS was updated to include six-year overall
survival results from the phase 3 ECHELON-1 clinical trial of
ADCETRIS plus combination chemotherapy in patients with previously
untreated Stage III or IV classical Hodgkin lymphoma compared to
chemotherapy alone. The update was based on statistically
significant 41% reduction in risk of death versus the previous
standard of care in patients with frontline advanced classical
Hodgkin lymphoma.
- Combination Regimen Data from Multiple Clinical Trials
Presented at the International Conference on Malignant
Lymphoma: In June 2023, updated results from Part C of a phase
2 single-arm trial (SGN35-027) evaluating the ADCETRIS in
combination with the PD-1 inhibitor nivolumab and standard
chemotherapy agents doxorubicin and dacarbazine (AN+AD) for the
frontline treatment of patients with early-stage classical Hodgkin
lymphoma showed a high overall response rate of 98% and a 93%
complete response rate. The regimen was well tolerated, with the
most frequently reported treatment-related adverse events of any
grade occurring in more than 30 percent of patients being nausea
(65%), peripheral sensory neuropathy (47%) and fatigue (44%).
Separately, a phase 3 trial, called HD21, from the clinical
research cooperative German Hodgkin Study Group was presented. The
results demonstrated that ADCETRIS with a modified chemotherapy
regimen showed non-inferiority with unprecedented 3-year
progression free survival of 94.9% versus a less tolerable
international standard of care in advanced classical Hodgkin
lymphoma. The 12-month post-treatment safety data were consistent
with previously presented HD21 data results at the American Society
of Hematology 2022 Annual Meeting.
TUKYSA
- Data Presented in HER2-positive Biliary Tract Cancer at the
ASCO Annual Meeting: In June 2023, data were presented from a
phase 2 basket study of TUKYSA and trastuzumab in previously
treated HER2-positive metastatic biliary tract cancer. The
combination had clinically meaningful antitumor activity with a
confirmed objective response rate of 46.7% and a median duration of
response of 6.0 months. The combination was well tolerated, with
the most common treatment-emergent adverse events being pyrexia
(43.3%) and diarrhea (40.0%).
- Topline Results for Phase 3 HER2CLIMB-02 Clinical Trial
Expected in 3Q23: The Company expects to report topline results
of the phase 3 HER2CLIMB-02 clinical trial evaluating TUKYSA versus
placebo, in combination with Kadcyla® (ado-trastuzumab emtansine),
for patients with locally advanced or metastatic HER2-positive
breast cancer, including those with brain metastases.
TIVDAK
- Data Presented from innovaTV 207 Trial in Solid Tumors at
the American Association for Cancer Research (AACR) Annual
Meeting: In April 2023, data were presented from an interim
analysis of Part C from the innovaTV 207 phase 2 study of TIVDAK
(tisotumab vedotin-tftv) given every 2 weeks in patients with
recurrent or metastatic squamous cell carcinoma of the head and
neck who have progressed on or after prior platinum combination,
immunotherapy and targeted therapy, if eligible. Preliminary data
based on the first 15 patients demonstrated encouraging antitumor
activity with a confirmed overall response rate of 40% and a
manageable safety profile.
- Topline Results for Phase 3 innovaTV 301 Clinical Trial
Anticipated As Early As YE23: The Company expects to report
topline results of the phase 3 innovaTV 301 clinical trial
evaluating TIVDAK monotherapy versus investigator choice
chemotherapy for patients with second- or third-line recurrent or
metastatic cervical cancer.
PIPELINE PROGRAMS
- Initiated a Phase 3 trial for Disitamab Vedotin for Patients
with HER2-Positive, Metastatic Urothelial Cancer: We initiated
a phase 3 trial evaluating disitamab vedotin in combination with
pembrolizumab versus chemotherapy in patients with previously
untreated locally advanced or metastatic HER2-positive urothelial
cancer in the third quarter of 2023.
- Planned Initiation of a Phase 3 trial for SGN-B6A for
Patients with Metastatic Non-Small Cell Lung Cancer: We plan to
initiate a phase 3 trial evaluating SGN-B6A monotherapy compared to
standard of care, docetaxel, in patients with previously treated
non-small cell lung cancer in the fourth quarter of 2023.
- Multiple Abstracts on Early-Stage Pipeline Presented at the
AACR and ASCO Annual Meetings: Early-stage pipeline data
presented at AACR included clinical, preclinical and discovery
research programs. The first clinical data was presented for
SEA-TGT that demonstrated a manageable and tolerable safety profile
with initial monotherapy antitumor activity in solid tumors and
lymphomas. In addition, data on multiple new ADC technologies were
presented. These included the first preclinical data from Seagen
and Sanofi for a novel topoisomerase I inhibitor ADC targeting
CEACAM5, which demonstrated potent antitumor activity in
patient-derived colorectal cancer models. Early-stage pipeline data
presented at ASCO included updated phase 1 data for SGN-B6A, a
wholly-owned, first-in-class vedotin ADC directed to integrin
beta-6, a novel target that is highly expressed in multiple solid
tumors.
For additional information on Seagen’s pipeline, visit
www.seagen.com/science/pipeline.
CORPORATE HIGHLIGHT
- Seagen Stockholders Approve Acquisition by Pfizer: In
May 2023, at a special meeting, Seagen stockholders voted to
approve a proposal to adopt the previously announced merger
agreement under which Pfizer will acquire Seagen for $229 per share
in cash. More than 99% of the shares that were voted at the
meeting, representing approximately 88% of the shares of Seagen
common stock issued and outstanding as of the record date for the
special meeting, were voted in favor of the proposal to adopt the
merger agreement. Subject to the fulfillment of customary closing
conditions, including receipt of required regulatory approvals, the
acquisition is expected to close in late 2023 or early 2024.
SECOND QUARTER AND SIX-MONTHS 2023 FINANCIAL RESULTS
Revenues: Total revenues for the second quarter and six
months ended June 30, 2023 were $604 million and $1.1 billion,
respectively, compared to $498 million and $924 million for the
same periods in 2022, primarily driven by growth in net product
sales.
Revenues included the following components:
Three months ended June
30,
Six months ended June
30,
(dollars in millions)
2023
2022
% Change
2023
2022
% Change
Total Net Product Sales
$
544
$
432
26
%
$
1,013
$
815
24
%
ADCETRIS
$
262
$
202
30
%
$
505
$
383
32
%
PADCEV
$
161
$
124
30
%
$
280
$
224
25
%
TUKYSA
$
99
$
89
11
%
$
187
$
179
4
%
TIVDAK
$
22
$
17
26
%
$
41
$
29
44
%
Royalty Revenues
$
51
$
39
31
%
$
81
$
67
21
%
Collaboration and License Agreement
Revenues
$
9
$
27
(68
)%
$
30
$
42
(29
)%
Note: Sum of product sales may not equal
total net product sales due to rounding. Percent change reflects
actual (unrounded) values.
- Net Product Sales: The increases in net product sales
for the second quarter and year-to-date of 2023 compared to the
same periods in 2022 were driven by continued commercial execution.
ADCETRIS performance was primarily attributed to volume growth,
driven by greater use in frontline advanced Hodgkin lymphoma.
PADCEV growth was driven by use as first-line treatment for locally
advanced or metastatic urothelial cancer following its approval for
this indication in April 2023. Of note, PADCEV sales in the second
quarter of 2022 included $19 million in sales to another company
for a clinical trial they are conducting, while no such sales were
booked in the second quarter of 2023. TUKYSA performance reflects
the important role it serves in the treatment of HER2-positivive
metastatic breast cancer, competitive dynamics in this setting as
well as early contributions from its colorectal cancer indication.
TIVDAK growth reflects continued uptake in its current
indication.
- Royalty Revenues: Royalty revenues were primarily driven
by sales of ADCETRIS outside the U.S. and Canada by Takeda as well
as royalties from sales of Polivy® (polatuzumab vedotin) by Roche,
which is an ADC that uses Seagen technology.
- Collaboration and License Agreement Revenues: The
decrease in collaboration and license agreement revenues was
primarily driven by a prior period milestone payment and decreased
revenues from drug product supplied to collaborators.
Cost of Sales: Cost of sales for the second quarter and
year-to-date in 2023 were $181 million and $293 million,
respectively, compared to $106 million and $194 million for the
same periods in 2022. The increases reflect higher sales of our
medicines and the related gross profit share amounts owed to
collaboration partners, which were $82 million and $146 million in
the second quarter and year-to-date in 2023, respectively, compared
to $66 million and $118 million for the same periods in 2022. Cost
of sales also reflects amortization of TUKYSA acquired in-process
technology costs, third-party royalties owed for PADCEV and TUKYSA
net product sales, and cost of products sold. The second quarter of
2023 cost of sales included a $47 million inventory write-off
related to in-process production of one of our products that did
not meet a release specification that was updated in June 2023.
This inventory adjustment and new release specification are not
expected to impact availability of product supply required to meet
current or future demand.
Research and Development (R&D) Expenses: R&D
expenses for the second quarter and year-to-date in 2023 were $400
million and $756 million, respectively, compared to $304 million
and $602 million for the same periods in 2022 reflecting continued
investment in clinical development of the Company's approved drugs
and pipeline programs.
Selling, General and Administrative (SG&A) Expenses:
SG&A expenses for the second quarter and year-to-date in 2023
were $244 million and $480 million, respectively, compared to $220
million and $394 million for the same periods in 2022. The increase
2023 were driven by ongoing commercialization efforts, as well as
$36 million in expenses year-to-date associated with the pending
acquisition by Pfizer and other corporate activities.
Non-cash, share-based compensation expense for the six months
ended June 30, 2023 was $157 million, compared to $98 million for
the same period in 2022.
Net Loss: Net loss for the second quarter of 2023 was
$212 million, or $1.13 per diluted share, and net loss for the
year-to-date of 2023 was $386 million, or $2.06 per diluted
share.
Net loss for the second quarter of 2022 was $135 million, or
$0.73 per diluted share, and net loss for the year-to-date of 2022
was $271 million, or $1.48 per diluted share.
Cash and Investments: As of June 30, 2023, Seagen had
$1.3 billion in cash and investments.
CONFERENCE CALL
Given the pending acquisition of Seagen by Pfizer, Seagen is no
longer providing financial guidance for 2023 and will not be
hosting its quarterly conference call and does not expect to do so
for future quarters. Earnings materials are available publicly on
the Investor Relations page of our website at investor.seagen.com.
Please direct any questions to Seagen Investor Relations at the
contact information below.
About Seagen
Founded 25 years ago, Seagen Inc. is a global biotechnology
company that discovers, develops, manufactures, and commercializes
targeted cancer therapeutics, with antibody-drug conjugates (ADCs)
at our core. Our colleagues work together with urgency to improve
and extend the lives of people living with cancer. An ADC
technology trailblazer, approximately one-third of FDA-approved and
marketed ADCs use Seagen technology. Seagen is headquartered in
Bothell, Washington and has locations in California, Canada,
Switzerland and across Europe. For additional information, visit
www.seagen.com and follow us on Twitter and LinkedIn.
Forward-Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to Pfizer’s proposed
acquisition of the Company; the anticipated timing of completion of
the proposed acquisition; the Company’s potential to achieve the
noted development and regulatory milestones in 2023, in future
periods or at all; the Company’s pipeline and technologies;
anticipated activities related to the Company’s planned and ongoing
clinical trials, including the timing of topline results; 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 potential for the
EV-302 clinical trial to serve as a confirmatory trial to support
the continued approval of PADCEV in its first-line la/mUC
indication; the opportunities for, and the therapeutic and
commercial potential of ADCETRIS, PADCEV, TUKYSA, TIVDAK, the
Company’s product candidates and the products and product
candidates of its licensees and collaborators; plans with respect
to regulatory submissions; 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: risks related to the satisfaction or waiver of
the conditions to closing the proposed acquisition (including the
failure to obtain necessary regulatory approvals) in the
anticipated timeframe or at all, including the possibility that the
proposed acquisition does not close; disruption from the
transaction making it more difficult to maintain business and
operational relationships; significant transaction costs; unknown
liabilities; the risk of litigation and/or regulatory actions
related to the proposed acquisition or Seagen’s business; risks
related to the financing of the transaction; the risks that the
Company’s ADCETRIS, PADCEV, TUKYSA and TIVDAK 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, TUKYSA and TIVDAK due to
competition, adverse events, regulatory action, reimbursement,
market adoption by physicians, drug pricing reform, 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, including with respect to reimbursement,
compliance, operational or other matters; the possibility of delays
or setbacks in obtaining pricing and reimbursement approvals or
otherwise commercializing PADCEV and TUKYSA in Europe and other
jurisdictions; risks relating to the Company’s collaboration
agreements and its ability to achieve progress dependent milestones
thereunder; risks related to the COVID-19 pandemic and resulting
economic, financial and healthcare system disruptions; risks
associated with the ongoing military conflict between Russia and
Ukraine, related sanctions imposed against Russia, and related
economic, financial and geopolitical disruptions; other business
effects and uncertainties, including the effects of industry,
market, business, economic, political or regulatory conditions;
future exchange and interest rates; and changes in laws,
regulations, rates and policies. 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-Q for the quarter ended March 31, 2023 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Revenues:
Net product sales
$
543,974
$
431,714
$
1,012,613
$
814,800
Royalty revenues
51,189
39,109
81,367
67,290
Collaboration and license agreement
revenues
8,669
26,679
29,571
41,872
Total revenues
603,832
497,502
1,123,551
923,962
Costs and expenses:
Cost of sales
180,753
106,100
292,529
193,726
Research and development
399,868
304,254
755,883
601,913
Selling, general and administrative
243,932
220,259
480,373
394,484
Total costs and expenses
824,553
630,613
1,528,785
1,190,123
Loss from operations
(220,721
)
(133,111
)
(405,234
)
(266,161
)
Investment and other income (loss),
net
12,084
(1,609
)
26,484
(3,799
)
Loss before income taxes
(208,637
)
(134,720
)
(378,750
)
(269,960
)
Provision for income taxes
2,891
107
7,515
1,361
Net loss
$
(211,528
)
$
(134,827
)
$
(386,265
)
$
(271,321
)
Net loss per share - basic and diluted
$
(1.13
)
$
(0.73
)
$
(2.06
)
$
(1.48
)
Shares used in computation of per share
amounts - basic and diluted
187,559
184,145
187,226
183,897
Seagen Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands)
June 30, 2023
December 31, 2022
Assets
Cash, cash equivalents and investments
$
1,292,119
$
1,735,070
Other assets
2,203,263
1,939,462
Total assets
$
3,495,382
$
3,674,532
Liabilities and Stockholders’
Equity
Accounts payable and accrued
liabilities
$
762,898
$
818,404
Long-term liabilities
113,425
52,309
Stockholders’ equity
2,619,059
2,803,819
Total liabilities and stockholders’
equity
$
3,495,382
$
3,674,532
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230802149112/en/
Seagen Contacts: For Investors Douglas Maffei, Ph.D. Vice
President, Investor Relations (425) 527-4881 dmaffei@seagen.com
For Media David Caouette Vice President, Corporate
Communications (310) 430-3476 dcaouette@seagen.com
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