– Company announces anticipated timelines
for data readouts from six cabozantinib potentially label-enabling
clinical studies and up to three new potential IND candidates
–
– Presentation and webcast at 2020 J.P.
Morgan Healthcare Conference on Tuesday, January 14th at 4:30 PM
Pacific Time –
Exelixis, Inc. (Nasdaq: EXEL) today announced its key priorities
and anticipated milestones for 2020-21, including generating
top-line data from key clinical trials, completing enrollment of
ongoing studies, initiating new pivotal trials, and progressing its
mid-stage and early pipeline. The company intends to make
appropriate investments to maximize the clinical development
opportunities for CABOMETYX® (cabozantinib), which Exelixis
believes could lead to as many as four additional approved
indications by year-end 2021, while concurrently working to advance
a pipeline of potential new Exelixis medicines through internal
drug discovery and business development.
“Exelixis is moving decisively to pursue important new
indications for our lead product, CABOMETYX, and potentially bring
new medicines to cancer patients in need of better treatment
options,” said Michael M. Morrissey, Ph.D., President and Chief
Executive Officer of Exelixis. “Cabozantinib is now an oncology
franchise with global net revenue of more than $1 billion on an
annual basis. Over the course of the next two years, we intend to
expand the depth and breadth of the cabozantinib development
program by obtaining top-line results from as many as six ongoing
trials with label-enabling potential and initiating at least three
new pivotal trials. If the data from these trials are market
differentiating and result in regulatory approvals, we believe we
could dramatically expand the number of patients that might benefit
from cabozantinib, addressing a potential patient population more
than four times greater in magnitude than our current opportunities
in advanced renal cell and previously treated hepatocellular
cancer. This result could have a significant impact on our business
as we continue to invest in a multi-product oncology portfolio with
the potential to lead to annual U.S. net product revenues
approaching $4 billion by 2025.”
Dr. Morrissey continued: “We continue to make strong progress in
building our pipeline. Between our internal discovery activities
and the four business development deals we’ve signed over the past
two years, there are approximately 20 ongoing discovery programs
focused on potentially adding novel and differentiated assets to
the Exelixis development portfolio. In 2020, we believe these
efforts could yield as many as three Investigational New Drug
filings, and we also expect to advance multiple additional programs
into preclinical development. As cabozantinib advances, we believe
this earlier stage work, which we intend to complement with
external strategic assets by leveraging our strong balance sheet,
could bring forth a new generation of Exelixis medicines with the
potential to strengthen our business and help cancer patients
recover stronger and live longer.”
Anticipated Cabozantinib Data Readouts in 2020
- CheckMate 9ER: Bristol-Myers Squibb (BMS) and Exelixis
anticipate results from CheckMate 9ER, the phase 3 pivotal trial
evaluating cabozantinib in combination with nivolumab in previously
untreated advanced or metastatic renal cell carcinoma (RCC), in the
first half of 2020. BMS is sponsoring this trial, which completed
enrollment in early 2019. If the data are positive, Exelixis, BMS
and their respective partners plan to expeditiously pursue
regulatory filings.
- COSMIC-311: In the first half of 2020, Exelixis
anticipates completing enrollment of the first 100 patients in this
phase 3 pivotal trial evaluating cabozantinib versus placebo in
patients with radioactive iodine-refractory differentiated thyroid
cancer who have progressed after up to two VEGF receptor-targeted
therapies. As planned, Exelixis expects to conduct an interim
analysis in these first 100 patients for the co-primary endpoints
of objective response rate and progression-free survival (PFS) and
reach total enrollment of 300 patients in the second half of
2020.
- COSMIC-312: Exelixis expects to complete enrollment in
the first half of 2020 and conduct the analysis for the co-primary
endpoint of PFS and an interim analysis for overall survival (OS)
for this phase 3 pivotal trial evaluating cabozantinib in
combination with atezolizumab (TECENTRIQ®), Genentech’s anti-PD-L1
immune checkpoint inhibitor (ICI), versus sorafenib in previously
untreated advanced hepatocellular carcinoma (HCC). The analyses are
event-driven and may occur as early as in the second half of
2020.
- COSMIC-021: COSMIC-021, the phase 1b trial evaluating
cabozantinib in combination with atezolizumab in patients with
locally advanced or metastatic tumors, enrolled more than 550
patients across the 24 expansion cohorts by the end of 2019.
Exelixis expects to present data from the metastatic
castration-resistant prostate cancer (mCRPC) cohort of the trial at
the ASCO Genitourinary Cancers Symposium in February 2020, and from
the non-small cell lung cancer (NSCLC) cohort when data have
matured and at the appropriate time in 2020. Based on regulatory
feedback from the U.S. Food & Drug Administration (FDA) and if
supported by the data from the mCRPC expansion cohorts, Exelixis
intends to file with the FDA for accelerated approval in an mCRPC
indication as early as 2021.
- CheckMate 040, EXAMINER, and CANTATA: BMS and Exelixis
expect that results of a cohort from the phase 1/2 CheckMate 040
trial investigating the safety and efficacy of nivolumab plus
cabozantinib with or without ipilimumab in patients with advanced
HCC will be presented at the ASCO Gastrointestinal Cancers
Symposium in January 2020. In addition, the PFS results for the
medullary thyroid cancer EXAMINER trial, which compares the 140 mg
capsule formulation with the 60 mg tablet formulation of
cabozantinib, are expected in 2020. Finally, Calithera expects the
analysis of CANTATA, a randomized phase 2 pivotal study of
cabozantinib plus glutaminase inhibitor telaglenastat (CB-839)
versus cabozantinib in previously treated RCC patients, to take
place in the second half of 2020. CANTATA completed enrollment in
October 2019 and is sponsored by Calithera; Exelixis provides
cabozantinib for the trial.
Based on the milestones for trial enrollment and data readout,
and if supported by the results, the current pivotal trials could
support regulatory filings for cabozantinib in various additional
tumor types and settings beginning in 2020.
Anticipated New Pivotal Trials in 2020
In 2020, based on emerging data from the COSMIC-021 trial,
Exelixis and its collaboration partner Roche expect to initiate
three new pivotal trials of cabozantinib in combination with
atezolizumab under the companies’ expanded clinical development
collaboration announced on December 19, 2019. The clinical program,
which Roche and Exelixis will co-fund, is expected to include three
phase 3 pivotal trials in advanced NSCLC, mCRPC and RCC. Additional
details will be provided when the individual trials are
initiated.
Additional Clinical Updates
- COSMIC-021: In late 2020, Exelixis anticipates
completing enrollment in COSMIC-021, which currently includes a
total of 24 expansion cohorts and a projected target enrollment of
up to 1,700 patients, pending the initiation of additional cohorts
or expansion of selected existing cohorts. Since its initiation in
2017, data from COSMIC-021 have been instrumental in guiding
Exelixis’ clinical development strategy for cabozantinib plus ICIs,
including supporting the initiation of COSMIC-312 and the
additional future trials described above.
- COSMIC-313: Exelixis expects to complete enrollment for
COSMIC-313, the phase 3 pivotal trial evaluating the triplet
combination of cabozantinib, nivolumab and ipilimumab versus the
combination of nivolumab and ipilimumab in patients with previously
untreated advanced intermediate- or poor-risk RCC, in early 2021
and to report top-line results of the event-driven analyses from
the study in the 2022 timeframe.
- XL092: The dose escalation phase 1 trial for this next
generation MET, AXL and VEGFR targeting tyrosine kinase inhibitor
is ongoing, and Exelixis anticipates that dose expansion cohorts
and potential combination cohorts with ICIs will begin to enroll in
2020.
Anticipated Discovery Milestones in 2020
Exelixis and its partners are currently advancing three
compounds through preclinical development. If the data are
supportive, Exelixis believes there is the potential for these
compounds to reach Investigational New Drug (IND) filing status
before the end of 2020. The programs are anticipated to include
both small molecules (a CDK7 inhibitor and a TAM kinase inhibitor)
and a next generation antibody-drug conjugate targeting tissue
factor. In addition, multiple development candidates from internal
and collaborative efforts are expected to reach preclinical
development in 2020, and Exelixis believes these candidates have
the potential to move into clinical trials starting in 2021.
Preliminary Fourth Quarter and Full Year 2019 Financial
Results
Exelixis is providing the following unaudited preliminary 2019
financial results:
- Total revenues for 2019 are approximately $972 million for the
full year and approximately $245 million for the fourth quarter
2019.
- Net product revenues for 2019 are approximately $765 million
for the full year and approximately $200 million for the fourth
quarter 2019.
- Research and development expenses for 2019 are approximately
$340 million for the full year and approximately $98 million for
the fourth quarter 2019.
- Selling, general and administrative expenses for 2019 are
approximately $230 million for the full year and approximately $60
million for the fourth quarter 2019.
- Cash and investments at year-end 2019 were approximately $1.4
billion.
The preliminary 2019 financial information presented in this
press release has not been audited and is subject to change. The
complete Exelixis Fourth Quarter and Full Year 2019 Financial
Results are planned for release after market on Wednesday, February
26, 2020.
2020 Financial Guidance
Exelixis is providing the following financial guidance for
2020:
- Total revenues are expected to be between $850 million and $900
million.
- Net product revenues from the cabozantinib franchise (COMETRIQ®
and CABOMETYX) are anticipated to be between $725 million and $775
million, reflecting the continued evolution of the metastatic RCC
and HCC treatment landscapes.
- Cost of goods sold are expected to be between 4 percent and 5
percent of net product revenues.
- Research and development expenses are expected to be between
$460 million and $500 million corresponding with the expected
initiation and completion of numerous late-stage cabozantinib
trials as outlined previously and are expected to include non-cash
expenses related to stock-based compensation expense of $25
million.
- Selling, general and administrative expenses are expected to be
between $230 million and $250 million with the continued commercial
investment in CABOMETYX and the broader organization and are
expected to include non-cash stock-based compensation expense of
$30 million.
- Guidance for the effective tax rate in 2020 is between 20
percent and 22 percent.
- Cash and investments at year end 2020 are expected to be in the
$1.5 billion to $1.6 billion range, reflecting our continued focus
on balancing the appropriate level of investment in the business
with a continued emphasis on generating free cash flow.
Importantly, this cash guidance does not include any potential new
business development activity, which remains a key priority for
Exelixis as we continue to build toward becoming a multi-product
oncology company.
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 fourth quarter and full year 2019 financial
results, 2020 financial guidance, and key priorities and milestones
for 2020-21 during the company’s presentation at the J.P. Morgan
Healthcare Conference beginning at 4:30 p.m. PT on Tuesday, January
14, 2020.
To access the webcast link, log onto www.exelixis.com and
proceed to the News & Events / Event Calendar page under the
Investors & Media heading. Please connect to the company’s
website at least 15 minutes prior to the presentation to ensure
adequate time for any software download that may be required to
listen to the webcast. A replay will also be available at the same
location for 14 days.
About Exelixis
Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially
successful, oncology-focused biotechnology company that strives to
accelerate the discovery, development and commercialization of new
medicines for difficult-to-treat cancers. Following early work in
model system genetics, we established a broad drug discovery and
development platform that has served as the foundation for our
continued efforts to bring new cancer therapies to patients in
need. Our discovery efforts have resulted in four approved
products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib),
COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have
entered into partnerships with leading pharmaceutical companies to
bring these important medicines to patients worldwide. Supported by
revenues from our marketed products and collaborations, we are
committed to prudently reinvesting in our business to maximize the
potential of our pipeline. We are supplementing our existing
therapeutic assets with targeted business development activities
and internal drug discovery — all to deliver the next generation of
Exelixis medicines and help patients recover stronger and live
longer. Exelixis is a member of Standard & Poor’s (S&P)
MidCap 400 index, which measures the performance of profitable
mid-sized companies. For more information about Exelixis, please
visit www.exelixis.com, follow
@ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Forward-Looking Statements, Good Faith
Revenue Estimate and Preliminary Financial Results
This press release contains forward-looking statements,
including, without limitation, statements related to: the clinical,
therapeutic and commercial potential of CABOMETYX; Exelixis’ key
priorities and anticipated milestones, including Exelixis’ priority
to become a multi-product oncology company; Exelixis’ intention to
expand the depth and breadth of the cabozantinib development
program; Exelixis’ expectations for, and the related anticipated
timelines for, initiating and completing enrollment in, conducting
analyses of and obtaining top-line results from its ongoing
potential label-enabling clinical studies and initiating new
pivotal trials evaluating cabozantinib, and if supported by the
data, pursuing potential regulatory approvals; the potential for as
many as four additional approved indications for CABOMETYX by
year-end 2021; Exelixis’ belief that if the data from ongoing and
new trials evaluating cabozantinib are market differentiating and
result in regulatory approvals, it could dramatically expand the
number of patients that might benefit from cabozantinib and
potentially lead to annual U.S. net product revenues approaching $4
billion by 2025; Exelixis’ belief that its discovery efforts could
yield as many as three IND filings and result in multiple
additional programs advancing into preclinical development in 2020,
as well as its belief that certain preclinical candidates have the
potential to move into clinical trials starting in 2021; Exelixis’
expectations that results from various trials evaluating
cabozantinib will be presented at upcoming conferences; Exelixis’
anticipation that dose expansion cohorts in the phase 1 trial of
XL092, as well as potential cohorts combining XL092 with ICIs, will
begin to enroll in 2020; Exelixis’ 2020 financial guidance;
Exelixis’ plans to reinvest in its business to maximize the
potential of the company’s pipeline, including through targeted
business development activities and internal drug discovery; 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. In some cases, you can
identify forward-looking statements by terms such as “may,” “will,”
“should,” “could,” “would,” “expect,” “plan,” “anticipate,”
“believe,” “build,” “estimate,” “project,” “predict,” “propose,”
“intend,” “continue,” “potential,” “possible,” and similar
expressions intended to identify forward-looking statements.
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, risks
and uncertainties associated with: the degree of market acceptance
of CABOMETYX and other Exelixis products in the territories where
they are approved, and Exelixis’ 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,
including the risk that Exelixis may not properly judge the
requisite size and experience of its commercialization teams or the
level of distribution necessary to market and sell CABOMETYX
successfully in multiple indications; the availability of data at
the referenced times; the potential failure of cabozantinib 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, including evolving regulatory
requirements, slower than anticipated patient enrollment or
inability to identify a sufficient number of clinical trial sites;
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; the regulatory review and
approval processes, including the risk that regulatory authorities
may not approve Exelixis’ products as treatments for the
indications in which approval has been sought, if at all, as well
as the related risk that regulatory authorities may not approve the
labeling claims that are necessary or desirable for the successful
commercialization of CABOMETYX in any additional indications or of
any newly-approved product; 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 products; Exelixis’ dependence on
third-party vendors for the manufacture and supply of its products;
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 discussed under the caption “Risk Factors” in Exelixis’
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on October 30, 2019, and in Exelixis’
future filings with the SEC, including, without limitation,
Exelixis’ Annual Report on Form 10-K expected to be filed with the
SEC on February 26, 2020. 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.
This press release includes an estimate for Exelixis’ potential
annual U.S. net product revenue by 2025, which is a forward-looking
statement. While this revenue estimate was prepared in good faith,
no assurance can be made regarding future events. This revenue
estimate is a projection based on historical performance trends and
management outlook that is dependent in principal part on the
successful outcomes of ongoing and planned clinical trials, the
related anticipated scope and nature of potential labeling updates
for CABOMETYX and approvals from regulatory authorities, and
management assumptions and estimates regarding pricing, coverage
and reimbursement of CABOMETYX over time, estimates of the size of
the eligible patient populations that may ultimately be served by
CABOMETYX in the future, new patient market share, duration of
therapy, and the safety and efficacy profiles of therapies
competing with CABOMETYX, all of which are inherently uncertain.
The estimates and assumptions underlying this revenue estimate
involve significant judgments with respect to, among other things,
future economic, competitive, regulatory, market and financial
conditions, as well as future clinical and regulatory outcomes and
future business decisions that may not be realized, and that are
inherently subject to significant business, economic, competitive
and regulatory risks and uncertainties, including, among other
things, the inherent uncertainty of the clinical development and
regulatory approval process, CABOMETYX’s perceived benefit/risk
profile as compared to the benefit/risk profiles of other
competitive treatments now available or in development, obtaining
and maintaining coverage and reimbursement for CABOMETYX, and
business and economic conditions affecting the biotechnology
industry generally, all of which are difficult to predict and many
of which are outside the control of Exelixis. There can be no
assurance that the underlying assumptions will prove to be accurate
or that the projected results will be realized and actual results
likely will differ, and may differ materially, from those reflected
in this revenue estimate. This revenue estimate is not fact, should
not be construed or relied upon as financial guidance, and should
not otherwise be relied upon as being necessarily indicative of
future results, and investors are cautioned not to place undue, if
any, reliance on this information. Exelixis undertakes no
obligation, except as required by law, to update or otherwise
revise this revenue estimate to reflect circumstances existing
since its preparation or to reflect the occurrence of unanticipated
events, even in the event that any or all of the underlying
assumptions and estimates are shown to be in error, or to reflect
changes in general economic or industry conditions.
In addition, this press release includes Exelixis’ preliminary
financial results for the quarter and fiscal year ended January 3,
2020. Exelixis is currently in the process of finalizing its full
financial results for the quarter and fiscal year ended January 3,
2020, and the preliminary financial results presented in this press
release are based only upon preliminary information available to
Exelixis as of January 12, 2020. Exelixis’ preliminary financial
results should not be viewed as a substitute for full 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, 2020.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks.
MINNEBRO is a Japanese trademark.
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version on businesswire.com: https://www.businesswire.com/news/home/20200112005055/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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