– Cabozantinib franchise achieves
approximately $1.630 billion in preliminary U.S. net product
revenues for fiscal year 2023 –
– Fiscal year 2024 net product revenues
guidance of $1,650 million - $1,750 million; 2024 R&D expense
guidance of $925 million - $975 million –
– Appointment of two new board members, Mary
C. Beckerle, Ph.D., and Gail Eckhardt, M.D., with extensive drug
development and corporate governance expertise –
– Implementing corporate restructuring to
focus R&D resources on clinical stage and IND-enabling
activities to maximize pipeline success and operational efficiency
–
– Board of Directors authorized $450 million
share repurchase in 2024 after successful completion of $550
million share repurchase in 2023 –
– Presentation and webcast at 2024 J.P.
Morgan Healthcare Conference tomorrow, Monday, January 8th at 4:30
p.m. PT / 7:30 p.m. ET –
Exelixis, Inc. (Nasdaq: EXEL) today announced its preliminary
unaudited financial results for the fiscal year 2023, provided
financial guidance for fiscal year 2024 and delivered an update on
its business. Exelixis expects 2024 to be a year of pipeline
progress as it advances its portfolio of promising biotherapeutics
and small molecule candidates recently highlighted at its 2023
R&D Day and pursues potential near-term label expansion
opportunities for CABOMETYX® (cabozantinib).
Preliminary Fiscal Year 2023 Financial
Results & 2024 Financial Guidance
Exelixis is providing the following preliminary unaudited 2023
financial results and financial guidance for 2024:
Fiscal Year 2023
Fiscal Year 2024
Guidance
Total revenues
~ $1,830 million
$1,825 million - $1,925
million
Net product revenues
~ $1,630 million
$1,650 million - $1,750
million(1)
Cost of goods sold
~ 4.5%
4% - 5%
Research and development
expenses
~ $1,045 million(2)
$925 million - $975
million(3)
Selling, general and
administrative expenses
~ $545 million(4)
$425 million - $475
million(5)
Effective tax rate
n/a(6)
20% - 22%
(1)
Exelixis’ 2024 net product
revenues guidance range includes the impact of a U.S. wholesale
acquisition cost increase of 2.2% for both CABOMETYX® and COMETRIQ®
effective on January 1, 2024.
(2)
Includes $34 million of non-cash
stock-based compensation expense.
(3)
Includes $40 million of non-cash
stock-based compensation expense.
(4)
Includes $72 million of non-cash
stock-based compensation expense.
(5)
Includes $60 million of non-cash
stock-based compensation expense.
(6)
Preliminary results not yet
available.
The preliminary 2023 financial information presented in this
press release has not been audited and is subject to change. The
complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial
Results are planned for release after market on Tuesday, February
6, 2024.
“Supported by strong revenues from cabozantinib, our global
oncology franchise, Exelixis is advancing an innovative pipeline of
differentiated product candidates that can improve standards of
care for cancer patients,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer, Exelixis. “Our 2024 plans
include filing data-driven label expansions for CABOMETYX,
accelerating the development of zanzalintinib, XB002, and XL309,
and moving three promising preclinical programs into clinical
development. The success of our internal drug discovery efforts as
highlighted at our recent R&D Day compels a rebalancing of our
investment priorities from early-stage research to product
development activities. Exelixis will therefore implement a
corporate restructuring that will concentrate R&D resources to
advance our emerging pipeline, and maintain positive cash flow to
support an additional $450 million share repurchase following
successful completion of the $550 million share repurchase in 2023.
We are taking these steps with the conviction that they are
necessary for our continued progress toward the company’s goal of
delivering an innovative pipeline of biotherapeutics and small
molecules to help patients with cancer and create value for all of
our stakeholders.”
Corporate Updates
Corporate Restructuring to Rebalance Resources to Drive
Pipeline Success: Exelixis will implement a corporate
restructuring that will prioritize the advancement of the company’s
deep pipeline of clinical and near-clinical programs. As a result,
Exelixis is reducing its workforce by approximately 175 employees
or 13 percent. Exelixis expects to substantially complete the
restructuring in the first quarter of 2024 and recognize a
restructuring charge of approximately $25 million.
Appointment of Two New Board Members: As part of the
company’s continued board refreshment plan announced last year,
Exelixis is announcing two new appointments to its Board of
Directors, effective January 5, 2024:
Mary C. Beckerle, Ph.D., Chief Executive Officer of the Huntsman
Cancer Institute and Distinguished Professor of Biological and
Oncological Sciences at the University of Utah. Since 2006, Dr.
Beckerle has had responsibility for the vision, strategic
direction, and management of the University’s oncology programs,
including research, care, education, and community outreach. A
noted cell biologist and cancer researcher, Dr. Beckerle’s work on
cytoskeletal dynamics and cell adhesion has led to important
advances both in basic and translational science. In addition to
Exelixis, Dr. Beckerle serves as an independent director of Johnson
& Johnson and Huntsman Corporation.
Gail Eckhardt, M.D., Associate Dean of Experimental Therapeutics
at Baylor College of Medicine and Associate Director of
Translational Research at the College’s Dan L. Duncan Comprehensive
Cancer Center. Dr. Eckhardt is a recognized leader in translational
medicine relative to oncology with a particular emphasis on
preclinical and early clinical development of molecularly targeted
therapies and combination regimens to treat colorectal and other
gastrointestinal cancers. She currently serves on the Board of
Syros Pharmaceuticals, and as an academic advisor for eleven
NCI-designated Cancer Centers, among other roles.
In addition, current Exelixis board member Alan M. Garber, M.D.,
Ph.D., has notified the company that he will not stand for
reelection at the company’s 2024 Annual Meeting of Stockholders
later this spring due to his expanded responsibilities at Harvard
University. Having served as Harvard’s provost and chief academic
officer since 2011, last week Dr. Garber became the University’s
interim president.
Announcement of $450 Million Share Repurchase Program for
2024: The Exelixis Board of Directors authorized the repurchase
of up to an additional $450 million of the company’s common stock
in 2024. As of the end of 2023, Exelixis completed the repurchase
of 26.2 million shares of the company’s common stock, or 8% of
shares outstanding, for a total of $550 million, fulfilling its
commitments under the 2023 Share Repurchase Program announced in
March 2023. Share repurchases under the 2024 program may be made
from time to time through a variety of methods, which may include
open market purchases, in block trades, accelerated share
repurchase transactions, exchange transactions, or any combination
of such methods. The timing and amount of any share repurchases
under the share repurchase program will be based on a variety of
factors, including ongoing assessments of the capital needs of the
business, alternative investment opportunities, the market price of
Exelixis’ common stock and general market conditions.
Anticipated 2024 Cabozantinib
Milestones
Cabozantinib Pivotal Trial Data Readouts and Anticipated U.S.
Regulatory Filings: Detailed data from CONTACT-02, the phase 3
pivotal trial evaluating the combination of cabozantinib and
atezolizumab versus a second novel hormonal therapy (NHT) in
patients with metastatic castration-resistant prostate cancer
(mCRPC) and measurable, extrapelvic soft tissue disease who have
been previously treated with one NHT, will be the subject of an
oral presentation at the American Society of Clinical Oncology 2024
Genitourinary Cancers Symposium on January 25, 2024. Positive
top-line results indicating that the trial met one of its primary
endpoints of progression-free survival (PFS) were announced in
August 2023, and the study continues toward the next analysis of
the second primary endpoint of overall survival (OS), which is
anticipated in 2024. Exelixis will continue its discussions with
the U.S. Food and Drug Administration (FDA) on a potential
regulatory path forward for cabozantinib in mCRPC. Also anticipated
in 2024 is a potential regulatory filing for cabozantinib in
advanced neuroendocrine tumors (NET) based on positive results from
the pivotal phase 3 CABINET study, which evaluates cabozantinib
versus placebo in patients with either advanced pancreatic NET
(pNET) or extra-pancreatic NET (epNET) and is conducted by The
Alliance for Clinical Trials in Oncology (The Alliance). Detailed
data presented at the European Society for Medical Oncology
Congress 2023 showed that the study met its primary endpoint,
demonstrating dramatic improvement in PFS for patients treated with
cabozantinib in both the pNET and epNET cohorts. Exelixis is
working with The Alliance to discuss a potential regulatory filing
with the FDA and will provide an update when appropriate.
Anticipated Outcome of Cabozantinib Abbreviated New Drug
Application (ANDA) Litigation with MSN Pharmaceuticals: The
second bench trial for Exelixis’ ongoing ANDA lawsuit against MSN
Pharmaceuticals, Inc. concluded in October 2023, and Exelixis
anticipates a ruling from the United States District Court for the
District of Delaware in the first half of 2024. Exelixis is
confident in its cabozantinib patent estate and is vigorously
defending the patents at issue.
Upcoming Development
Milestones
Zanzalintinib Clinical Progress Anticipated in 2024:
Zanzalintinib is a third-generation tyrosine kinase inhibitor (TKI)
that Exelixis believes can become the vascular endothelial growth
factor receptor TKI of choice as solid tumor therapeutic landscapes
continue to evolve. Exelixis is executing on three ongoing pivotal
trials of zanzalintinib, STELLAR-303, -304, and -305, in forms of
colorectal cancer, non-clear cell renal cell carcinoma, and
squamous cell carcinoma of the head and neck, respectively.
Zanzalintinib is also the subject of three ongoing earlier-stage
trials, STELLAR-001, -002, and -009, intended to evaluate its
potential in best-in-class combinations and identify indications
for future pivotal trials, with priorities defined by emerging data
and potential clinical co-funding opportunities.
XB002 Clinical Progress Anticipated in 2024: XB002 is a
next-generation tissue factor (TF)-targeting antibody-drug
conjugate (ADC) that Exelixis believes has development potential as
a monotherapy and in combination regimens. In 2024, Exelixis is
focused on advancing JEWEL-101, the phase 1 study of XB002 alone
and in combination with immunotherapy in a variety of solid tumor
settings with the goal of prioritizing sensitive tumor types for
full development.
XL309 Clinical Progress Anticipated in 2024: XL309 is a
potentially best-in-class small molecule inhibitor of USP1, which
has emerged as a synthetic lethal target in the context of
BRCA-mutated tumors. Exelixis in-licensed XL309 from Insilico
Medicine in September 2023, and the process of transferring
stewardship of the program’s ongoing phase 1 trial to Exelixis was
completed in the fourth quarter of 2023. Exelixis’ clinical
development priorities for XL309 include accelerating its
development as a potential therapy for tumors that have become
refractory to PARP inhibitor (PARPi) therapy, including forms of
ovarian, breast, and prostate cancers, pursuing potential PARPi
combinations, and moving beyond the PARPi market into new
areas.
Anticipated Discovery
Milestones
Three Potential Investigational New Drug (IND) Applications
in 2024: Exelixis anticipates moving three programs into
clinical development this year, including two biotherapeutics and
one small molecule compound. The company expects to file an IND
application for the XB010 5T4-MMAE ADC program in the first half of
2024, and expects to file IND applications for the XB628
PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1
inhibitor programs in the second half of 2024 if preclinical data
continue to be supportive.
Current Development Candidate (DC) Programs and New DC
Designations expected in 2024: Exelixis has two DC programs
that may be the subjects of IND filings in 2025, including the
XB371 TF-Topoisomerase I inhibitor ADC and XB064 ILT-2 monoclonal
antibody programs, and the XB033 IL13Ra2-Topoisomerase I inhibitor
ADC that may be the subject of an IND filing in 2026. In 2024, the
company expects to designate two new programs to DC status,
including a small molecule PLK4 inhibitor and an additional
ADC.
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 2023 financial results, 2024
financial guidance, and key priorities and milestones for 2024
during the company’s presentation at the 42nd Annual J.P. Morgan
Healthcare Conference beginning at 4:30 p.m. PT / 7:30 p.m. ET on
Monday, January 8, 2024.
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’
expectation that 2024 will be a year of pipeline progress as it
advances its portfolio of promising biotherapeutics and small
molecule candidates and pursues potential near-term label-expansion
opportunities for CABOMETYX; Exelixis’ 2024 financial guidance;
Exelixis’ 2024 plans for filing data-driven label expansions for
CABOMETYX, accelerating the development of zanzalintinib, XB002 and
XL309, and moving three promising preclinical programs into
clinical development; Exelixis’ plans and expectations for
corporate restructuring in the first quarter of 2024 and for a new
$450 million share repurchase program in 2024; Exelixis’
anticipated cabozantinib milestones for 2024, including the
presentation of data from CONTACT-02 at ASCO GU later in January
2024, the next analysis of OS data from CONTACT-02, continued
discussions with the FDA regarding the potential regulatory path
forward for cabozantinib in mCRPC, a potential regulatory filing in
2024 for cabozantinib as a treatment for NET based on positive
results from CABINET, and an expected ruling in the ANDA lawsuit
against MSN Pharmaceuticals, Inc. in the first half of 2024;
Exelixis’ upcoming development milestones for 2024, including
clinical progress and priorities for zanzalintinib and Exelixis’
belief that zanzalintinib can become the vascular endothelial
growth factor receptor TKI of choice as solid tumor therapeutic
landscapes continue to evolve, clinical progress and priorities for
XB002 and Exelixis’ belief that XB002 has development potential as
a monotherapy and in combination regimens, and clinical progress
and priorities for XL309 and Exelixis’ belief that XL309 is a
potentially best-in-class small molecule inhibitor of USP1;
Exelixis’ anticipated discovery milestones for 2024, including
potential IND filings for XB010 in the first half of 2024 and for
XB628 and XL495 in the second half of 2024 if preclinical data
continue to be supportive, and the designation of two new programs
to DC status in 2024, as well as potential IND filings in 2025 for
XB371 and XB064; 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; 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 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 December 29, 2023.
Exelixis is currently in the process of finalizing its financial
results for the quarter and fiscal year ended December 29, 2023,
and the preliminary financial results presented in this press
release are based only upon preliminary information available to
Exelixis as of January 7, 2024. 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
December 29, 2023.
Exelixis, the Exelixis logo and CABOMETYX are
registered U.S. trademarks.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240107570082/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
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