– Cabozantinib franchise achieves
approximately $1.805 billion in preliminary U.S. net product
revenues for fiscal year 2024 –
– Fiscal year 2025 net product revenues
guidance of $1.95 billion - $2.05 billion –
– Presentation and webcast at 43rd Annual
J.P. Morgan Healthcare Conference tomorrow, Monday, January
13th at 5:15 p.m. PT / 8:15 p.m. ET –
Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary
unaudited financial results for the fiscal year 2024, provided
financial guidance for fiscal year 2025 and delivered an update on
its business. Exelixis anticipates 2025 will be a year of clinical
and regulatory execution and continued growth for its cabozantinib
franchise, as well as multiple data readouts for zanzalintinib and
across its diversified pipeline of small molecules and
biotherapeutics with the potential to improve standards of care for
patients with cancer.
Preliminary Fiscal Year 2024 Financial
Results & 2025 Financial Guidance
Exelixis is providing the following preliminary unaudited 2024
financial results and financial guidance for 2025. Net product and
total revenues guidance do not currently reflect any revenues
resulting from a potential U.S. regulatory approval and commercial
launch of CABOMETYX® (cabozantinib) for the treatment of patients
with previously treated advanced neuroendocrine tumors (NET). The
U.S. Food and Drug Administration (FDA) is currently reviewing
Exelixis' supplemental New Drug Application (sNDA) for this
proposed indication, with a Prescription Drug User Fee Act (PDUFA)
target action date of April 3, 2025.
Fiscal Year 2024
Fiscal Year 2025
Guidance
Total revenues
~ $2.165 billion
$2.15 billion - $2.25 billion
Net product revenues
~ $1.805 billion
$1.95 billion - $2.05
billion(1)
Cost of goods sold
~ 4.2%
4% - 5% of net product
revenues
Research and development expenses
~ $910 million(2)
$925 million - $975
million(3)
Selling, general and administrative
expenses
~ $495 million(4)
$475 million - $525
million(5)
Effective tax rate
n/a(6)
21% - 23%
Ending cash and marketable
securities(7)
~ $1.75 billion
n/p
(1)
Exelixis’ 2025 net product
revenues guidance range includes impact of a U.S. wholesale
acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1,
2025.
(2)
Includes $30.7 million of
non-cash stock-based compensation expense.
(3)
Includes $40.0 million of
non-cash stock-based compensation expense.
(4)
Includes $63.2 million of
non-cash stock-based compensation expense.
(5)
Includes $60.0 million of
non-cash stock-based compensation expense.
(6)
Preliminary results not yet
available.
(7)
Cash and marketable securities
are composed of cash, cash equivalents and marketable securities.
Fiscal year 2025 guidance not provided (n/p).
The preliminary 2024 financial information presented in this
press release has not been audited and is subject to change. The
complete Exelixis Fourth Quarter and Fiscal Year 2024 Financial
Results are planned for release after market on Tuesday, February
11, 2025.
“Entering 2025, Exelixis stands at an inflection point as we
work toward our goal of building a multi-product, multi-franchise
oncology business,” said Michael M. Morrissey, Ph.D., President
& CEO, Exelixis. “Exelixis had a very successful 2024
highlighted by strong commercial and financial performance, the
favorable ruling on our cabozantinib patent litigation,
accelerating progress with the zanzalintinib pivotal trial program
and establishing our zanzalintinib clinical development
collaboration with Merck. We’re carrying that momentum into the new
year as we seek to grow cabozantinib franchise revenues, accelerate
and expand our zanzalintinib pivotal development program, and
advance our diversified therapeutic pipeline of small molecules and
biotherapeutics.”
Dr. Morrissey continued: “We expect 2025 to be a year of
regulatory, clinical and commercial execution as we work toward a
potential regulatory approval and launch for cabozantinib in
neuroendocrine tumors and prepare for multiple zanzalintinib and
pipeline data readouts throughout the year. As cabozantinib’s
commercial success drives the business forward in the near-term,
we’re excited by zanzalintinib’s potential to surpass
cabozantinib’s scope and scale in the coming years and to become an
important component of our mid- and long-term revenue growth. We’re
also optimizing our earlier stage pipeline, rapidly profiling
compounds and advancing only those with the highest probability of
success into full development. We look forward to providing more
detailed updates on our pipeline progress at an R&D Day later
this year. Finally, we’ll maintain our balanced approach to capital
allocation, leveraging our strong balance sheet to execute on
business development opportunities within the GU and GI oncology
space, while using free cash flows to fund our stock repurchase
program and return capital to shareholders.”
Corporate Updates
Stock Repurchase Program Update. In August 2024, Exelixis
announced that the company’s Board of Directors authorized the
repurchase of up to $500 million of the company’s common stock
through the end of 2025, the third stock repurchase program
undertaken by Exelixis since March 2023. Under this program, as of
the end of fiscal year 2024, Exelixis has repurchased $205.6
million of the company’s common stock, at an average price of
$33.62 per share.
Anticipated Cabozantinib
Milestones
Potential Label Expansion and Commercial Launch into NET.
Exelixis is preparing for the potential commercial launch of
CABOMETYX for the treatment of patients with previously treated
advanced NET following the FDA’s acceptance of its sNDA and
assignment of a PDUFA target action date of April 3, 2025. In
January 2025, the FDA notified Exelixis that its sNDA will no
longer be the subject of discussion at an Oncologic Drugs Advisory
Committee meeting. The regulatory filing was based on positive
results from the phase 3 CABINET pivotal trial sponsored by the
National Cancer Institute (NCI), part of the National Institutes of
Health, and led by the NCI-funded Alliance for Clinical Trials in
Oncology. CABINET met its primary endpoint, demonstrating
statistically significant and clinically meaningful improvements in
progression-free survival (PFS) for patients treated with
cabozantinib as compared to placebo in both its pancreatic NET
(pNET) and extra-pancreatic NET (epNET) cohorts. Final results from
the trial were subsequently presented at the 2024 European Society
for Medical Oncology (ESMO) Congress and published in The New
England Journal of Medicine. In January 2025, the National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in
Oncology for NET were updated to include cabozantinib as category 1
for certain types of NET following specific treatments, and as a
category 2A preferred regimen for several other forms of advanced
NET, depending on site of origin and grade. A subgroup analysis
from CABINET detailing the experience of patients with advanced
gastrointestinal (GI) NET will also be presented at the American
Society of Clinical Oncology GI Cancers Symposium (ASCO GI 2025)
later this month. Exelixis’ partner Ipsen anticipates a decision
from the European Medicines Agency on its Marketing Authorization
Application for its own proposed NET label expansion in the EU for
cabozantinib in 2025. While Exelixis prioritizes supporting the
FDA’s ongoing review of its proposed NET indication, the company
will continue to evaluate the timing of its potential regulatory
filing for cabozantinib in metastatic castration-resistant prostate
cancer based on the phase 3 CONTACT-02 pivotal study.
Anticipated Development
Milestones
Expansion and Acceleration of the Zanzalintinib Pivotal Trial
Program. Zanzalintinib is a third-generation tyrosine kinase
inhibitor (TKI) that Exelixis believes can become the vascular
endothelial growth factor receptor TKI of choice as the solid tumor
therapeutic landscapes continue to evolve. The zanzalintinib
pivotal development program currently consists of six ongoing or
planned pivotal trials, with additional studies to be announced in
2025 and beyond:
- STELLAR-303 is evaluating zanzalintinib in combination with
atezolizumab compared with regorafenib in patients with metastatic,
refractory non-microsatellite instability-high or non-mismatch
repair-deficient colorectal cancer (CRC). The primary endpoint in
the study is overall survival (OS) in the patients without liver
metastases (NLM). If OS is positive in the NLM population, the
study will evaluate OS in the intent-to-treat population that
includes patients with and without liver metastases. The study
completed enrollment in the third quarter of 2024, and preliminary
results are expected in the second half of 2025, dependent on study
event rates.
- STELLAR-304 is evaluating zanzalintinib in combination with
nivolumab versus sunitinib in previously untreated patients with
advanced non-clear cell renal cell carcinoma. The primary endpoints
in the trial are PFS and objective response rate. Based on current
enrollment status in the trial, the primary endpoint of PFS is
expected to be available in the second half of 2025, dependent on
study event rates.
- STELLAR-305 is evaluating zanzalintinib in combination with
pembrolizumab versus pembrolizumab alone in patients with
previously untreated PD-L1-positive recurrent or metastatic
squamous cell carcinoma of the head and neck. The study was
designed to enroll approximately 250 eligible patients in the phase
2 portion of the trial to be randomly assigned to zanzalintinib in
combination with pembrolizumab or pembrolizumab alone to evaluate
the activity of the combination therapy. Data from the phase 2
portion are expected be available in the second half of 2025, which
would inform whether the data support expansion into the phase 3
portion of the trial, during which an additional 350 patients would
be randomized for a total of 600 patients. The primary endpoints in
the study are PFS and OS.
- Exelixis also expects to initiate STELLAR-311, a phase 3
pivotal trial evaluating zanzalintinib compared with everolimus as
a first oral therapy in patients with advanced NET, regardless of
site of origin, in the first half of 2025.
- Additionally, as part of Exelixis’ clinical development
collaboration with Merck, two pivotal renal cell carcinoma (RCC)
studies are planned for 2025. The companies will provide further
details on these trials closer to their initiation.
Earlier Stage Zanzalintinib Data Readouts Expected This
Year. Exelixis anticipates initial clinical data readouts from
zanzalintinib’s phase 1b/2 STELLAR-001 and STELLAR-002 clinical
studies in the first half of 2025, including data from CRC and RCC
cohorts. STELLAR-001 and -002 are evaluating zanzalintinib as a
monotherapy and in potentially best-in-class combination regimens
across various tumor types. In the nearest term, at ASCO GI 2025
later this month, investigators will present preliminary results
from a randomized expansion cohort of STELLAR-001 designed to
assess the contribution of atezolizumab to zanzalintinib in
patients with previously treated metastatic CRC.
Advance XL309 Phase 1 Program in PARP Inhibitor Refractory
Setting and Beyond. XL309, Exelixis’ potentially best-in-class
small molecule inhibitor of USP1, is currently being evaluated in a
phase 1 study as a single agent and in combination with olaparib, a
PARP1/2 inhibitor, in patients with advanced solid tumors.
Enrollment in the dose escalation cohorts for XL309 monotherapy and
olaparib combination are ongoing. The mechanism of action of XL309
and its potential to combine with PARP-inhibitors (PARPi) provide
optionality for a robust development program in a variety of solid
tumors. Exelixis’ clinical development plans for XL309 include its
development as a potential therapy for tumors that have become
refractory to PARPi therapy, including forms of ovarian, breast and
prostate cancers, pursuing potential PARPi combinations, and moving
beyond the PARPi market into new areas. Exelixis plans to present
data from the XL309 program at a scientific meeting in 2025.
Progress of Phase 1 Clinical Trials for XB010 and XL495.
Exelixis initiated clinical development of its XB010 and XL495
pipeline programs in 2024. The company plans to rapidly profile
each compound to determine if early clinical data support further
advancement toward full development. XB010 is an antibody-drug
conjugate (ADC) consisting of a monomethyl auristatin E payload
conjugated to a monoclonal antibody targeting the tumor antigen 5T4
and is the first custom ADC generated through Exelixis’
biotherapeutics collaboration network. The first-in-human, global
phase 1 trial of XB010 is evaluating the compound in patients with
locally advanced or metastatic solid tumors. The dose-escalation
stage of the study is evaluating XB010 as a single agent and in
combination with pembrolizumab to inform the cohort-expansion
stage. The expansion cohorts are designed to further assess the
tolerability and activity of monotherapy and of the combination in
specific indications. XL495 is a novel, potent, small molecule
inhibitor of PKMYT1. The first-in-human phase 1 clinical trial of
XL495 is evaluating the compound in patients with advanced solid
tumors; the dose-escalation stage of the study is designed to
determine the maximum tolerated dose of XL495. The expansion
cohorts are designed to further assess the tolerability and
activity of XL495 both as monotherapy and in combination with
select cytotoxic agents in tumor-specific indications. Exelixis
plans to present preclinical data from the XL495 program at a
scientific meeting in 2025.
Anticipated Discovery
Milestones
Three Potential Investigational New Drug (IND) Applications
in 2025. Exelixis anticipates advancing three biotherapeutics
programs into clinical development this year, including the XB628
PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody
and XB371 TF-topoisomerase I inhibitor ADC. The company expects to
file the IND applications for these compounds in 2025 if
preclinical data continue to be supportive. Exelixis plans to
present preclinical data from one or more of these programs at a
scientific meeting in 2025.
Presentation and Webcast
Exelixis President and Chief Executive Officer Michael M.
Morrissey, Ph.D., will provide a corporate overview and discuss the
company’s preliminary fiscal year 2024 financial results, 2025
financial guidance and key priorities and milestones for 2025
during the company’s presentation at the 43rd Annual J.P. Morgan
Healthcare Conference beginning at 5:15 p.m. PT / 8:15 p.m. ET on
Monday, January 13, 2025.
To access the webcast link, log onto www.exelixis.com and
proceed to the Event Calendar page under the Investors & News
heading. A replay will also be available at the same location for
at least 30 days.
About Exelixis
Exelixis is a globally ambitious oncology company innovating
next-generation medicines and regimens at the forefront of cancer
care. Powered by drug discovery and development excellence, we are
rapidly evolving our product portfolio to target an expanding range
of tumor types and indications with our clinically differentiated
pipeline of small molecules, antibody-drug conjugates and other
biotherapeutics. This comprehensive approach harnesses decades of
robust investment in our science and partnerships to advance our
investigational programs and extend the impact of our flagship
commercial product, CABOMETYX® (cabozantinib). Exelixis is driven
by a bold scientific pursuit to create transformational treatments
that give more patients hope for the future. For information about
the company and its mission to help cancer patients recover
stronger and live longer, visit www.exelixis.com, follow
@ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and
follow Exelixis on LinkedIn.
Forward-Looking Statements and
Preliminary Financial Results
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
anticipation that 2025 will be a year of clinical and regulatory
execution and continued growth for its cabozantinib franchise as
well as multiple data readouts for zanzalintinib and across its
diversified pipeline of small molecules and biotherapeutics with
the potential to improve standards of care for patients with
cancer; the regulatory review process with respect to Exelixis’
sNDA for cabozantinib in previously treated advanced pNET and
advanced epNET, including the Prescription Drug User Fee Act target
action date assigned by the FDA; Exelixis’ 2025 financial guidance;
Exelixis’ goal of building a multi-product, multi-franchise
oncology business and to grow cabozantinib franchise revenues,
accelerate and expand its zanzalintinib pivotal development
program, and advance its diversified therapeutic pipeline of small
molecules and biotherapeutics; Exelixis’ expectation for 2025 to be
a year of regulatory, clinical and commercial execution including a
potential regulatory approval and launch for cabozantinib in
neuroendocrine tumors and multiple zanzalintinib and pipeline data
readouts; Exelixis’ belief in zanzalintinib’s potential to surpass
cabozantinib’s scope and scale in the coming years and to become an
important component of the company’s mid- and long-term revenue
growth; Exelixis’ plans to execute on business development
opportunities or a stock repurchase program; Exelixis’ anticipated
cabozantinib milestones, including potential label expansion and
commercial launch into NET, the presentation of data from CABINET
at ASCO GI 2025, and the potential regulatory path forward for
cabozantinib in mCRPC; Exelixis’ upcoming development milestones,
including expansion and acceleration of the zanzalintinib pivotal
trial program and Exelixis’ belief that zanzalintinib can become
the vascular endothelial growth factor receptor TKI of choice as
solid tumor therapeutic landscapes continue to evolve; Exelixis’
expectation for initial clinical data readouts from STELLAR-001 and
STELLAR-002 in 2025 and the presentation of data from STELLAR-001
at ASCO GI 2025; clinical progress and priorities for XL309, the
presentation of XL309 data at a scientific meeting in 2025 and
Exelixis’ belief that XL309 is a potentially best-in-class small
molecule inhibitor of USP1; clinical progress of phase 1 clinical
trials for XB010 and XL495; Exelixis’ anticipated discovery
milestones, including the advancement into clinical development of
the XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal
antibody and XB371 TF-topoisomerase I inhibitor ADC and potential
IND filings for these compounds if preclinical data continue to be
supportive, and the presentation of preclinical data from one of
more of these programs at a scientific meeting in 2025; Exelixis’
scientific pursuit to create transformational treatments that give
more patients hope for the future; and other statements that are
not historical facts. Any statements that refer to expectations,
projections or other characterizations of future events or
circumstances are forward-looking statements and are based upon
Exelixis’ current plans, assumptions, beliefs, expectations,
estimates and projections. Forward-looking statements involve risks
and uncertainties. Actual results and the timing of events could
differ materially from those anticipated in the forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation: the degree of market acceptance of
CABOMETYX and other Exelixis products in the indications for which
they are approved and in the territories where they are approved,
and Exelixis’ and its partners’ ability to obtain or maintain
coverage and reimbursement for these products; the effectiveness of
CABOMETYX and other Exelixis products in comparison to competing
products; complexities and the unpredictability of the regulatory
review and approval processes in the U.S. and elsewhere, including
the risk that the FDA may not approve cabozantinib as a treatment
for pNET or epNET in a timely fashion, if at all; the level of
costs associated with Exelixis’ commercialization, research and
development, in-licensing or acquisition of product candidates, and
other activities; Exelixis’ ability to maintain and scale adequate
sales, marketing, market access and product distribution
capabilities for its products or to enter into and maintain
agreements with third parties to do so; the availability of data at
the referenced times; the potential failure of cabozantinib,
zanzalintinib and other Exelixis product candidates, both alone and
in combination with other therapies, to demonstrate safety and/or
efficacy in clinical testing; uncertainties inherent in the drug
discovery and product development process; Exelixis’ dependence on
its relationships with its collaboration partners, including their
pursuit of regulatory approvals for partnered compounds in new
indications, their adherence to their obligations under relevant
collaboration agreements and the level of their investment in the
resources necessary to complete clinical trials or successfully
commercialize partnered compounds in the territories where they are
approved; complexities and the unpredictability of the regulatory
review and approval processes in the U.S. and elsewhere; Exelixis’
continuing compliance with applicable legal and regulatory
requirements; unexpected concerns that may arise as a result of the
occurrence of adverse safety events or additional data analyses of
clinical trials evaluating cabozantinib, zanzalintinib and other
Exelixis product candidates; Exelixis’ dependence on third-party
vendors for the development, manufacture and supply of its products
and product candidates; Exelixis’ ability to protect its
intellectual property rights; market competition, including the
potential for competitors to obtain approval for generic versions
of Exelixis’ marketed products; changes in economic and business
conditions; and other factors detailed from time to time under the
caption “Risk Factors” in Exelixis’ most recent Annual Report on
Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in
Exelixis’ other future filings with the Securities and Exchange
Commission. All forward-looking statements in this press release
are based on information available to Exelixis as of the date of
this press release, and Exelixis undertakes no obligation to update
or revise any forward-looking statements contained herein, except
as required by law.
In addition, this press release includes Exelixis’ preliminary
financial results for the fiscal year ended January 3, 2025.
Exelixis is currently in the process of finalizing its financial
results for the quarter and fiscal year ended January 3, 2025, and
the preliminary financial results presented in this press release
are based only upon preliminary information available to Exelixis
as of January 12, 2025. Exelixis’ preliminary financial results
should not be viewed as a substitute for audited financial
statements prepared in accordance with U.S. GAAP, and undue
reliance should not be placed on Exelixis’ preliminary financial
results. Exelixis’ independent registered public accounting firm
has not audited or reviewed the preliminary financial results
included in this press release or expressed any opinion or other
form of assurance on such preliminary financial results. In
addition, items or events may be identified or occur after the date
of this press release due to the completion of operational and
financial closing procedures, final audit adjustments and other
developments may arise that would require Exelixis to make material
adjustments to the preliminary financial results included in this
press release. Therefore, the preliminary financial results
included in this press release may differ, perhaps materially, from
the financial results that will be reflected in Exelixis’ audited
consolidated financial statements for the fiscal year ended January
3, 2025.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250112148606/en/
Investor Contacts: Susan Hubbard EVP, Public Affairs
& Investor Relations Exelixis, Inc. 650-837-8194
shubbard@exelixis.com
Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240
csenner@exelixis.com
Media Contact: Hal Mackins For Exelixis, Inc.
415-994-0040 hal@torchcommunications.com
Exelixis (NASDAQ:EXEL)
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Exelixis (NASDAQ:EXEL)
過去 株価チャート
から 1 2024 まで 1 2025
