- Total Revenues of $637.2 million,
Cabozantinib Franchise U.S. Net Product Revenues of $437.6 million
- - GAAP Diluted EPS of $0.77, Non-GAAP Diluted EPS of $0.84 - -
U.S. Food and Drug Administration (FDA) Accepts Supplemental New
Drug Application (sNDA) for Cabozantinib in Advanced Neuroendocrine
Tumors (NET) - - Earned $150 million Cabozantinib Sales-Based
Milestone from Ipsen - - Completed $450 million Stock Repurchase
Program for 2024 - - Announced Additional Stock Repurchase Program
for up to $500 million through the End of 2025 - - Conference Call
and Webcast Today at 5:00 PM Eastern Time -
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results
for the second quarter of 2024, provided an update on progress
toward achieving key corporate objectives, and detailed its recent
and anticipated commercial, clinical and pipeline development
milestones.
“Exelixis is well positioned for an impactful second half of
2024 as we continue to grow the cabozantinib franchise, execute on
our regulatory and development objectives, and advance our
next-generation pipeline,” said Michael M. Morrissey, Ph.D.,
President and CEO, Exelixis. “Cabozantinib’s second quarter
commercial performance was strong both in the U.S. and globally,
with Ipsen’s success prompting a $150 million milestone payment to
Exelixis based on sales over the past four quarters. On the
regulatory front, the FDA accepted the sNDA for cabozantinib in
advanced NET, granted standard review and assigned a target action
date of April 3, 2025. We’re actively preparing for launch and
excited at the prospect of bringing this new treatment option to
previously treated advanced NET patients with high unmet medical
need. At the same time, we are prioritizing our clinical pipeline
with plans to initiate a new phase 3 pivotal trial for
zanzalintinib in NET, advance phase 1 efforts for XL309 and XB010,
and discontinue development of XB002. I’d like to thank the entire
Exelixis team for their hard work and contributions toward
achieving these important milestones for cabozantinib and advancing
our broad, differentiated pipeline of oncology therapeutics to help
the patients we serve.”
Second Quarter 2024 Financial
Results
Total revenues for the quarter ended June 30, 2024 were
$637.2 million, as compared to $469.8 million for the comparable
period in 2023.
Total revenues for the quarter ended June 30, 2024 included net
product revenues of $437.6 million, as compared to $409.6 million
for the comparable period in 2023. The increase in net product
revenues was primarily due to an increase in sales volume and
average net selling price.
Collaboration revenues, composed of license revenues and
collaboration services revenues, were $199.6 million for the
quarter ended June 30, 2024, as compared to $60.2 million
for the comparable period in 2023. The increase in collaboration
revenues was primarily related to an increase in milestone-related
revenues recognized in the quarter and higher royalty revenues for
the sales of cabozantinib outside of the U.S. generated by
Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and
Takeda Pharmaceutical Company Limited, partially offset by a
decrease in development cost reimbursements earned.
Research and development expenses for the quarter ended
June 30, 2024 were $211.1 million, as compared to $232.6 million
for the comparable period in 2023. The decrease in research and
development expenses was primarily related to decreases in license
and other collaboration costs and clinical trial costs, partially
offset by an increase in manufacturing costs to support our
development candidates.
Selling, general and administrative expenses for the
quarter ended June 30, 2024 were $132.0 million, as
compared to $141.7 million for the comparable period in 2023. The
decrease in selling, general and administrative expenses was
primarily related to a decrease in legal and advisory fees related
to the proxy contest in the prior year.
Provision for income taxes for the quarter ended June 30,
2024 was $66.7 million, as compared to $19.2 million for the
comparable period in 2023.
GAAP net income for the quarter ended June 30, 2024 was
$226.1 million, or $0.78 per share, basic and $0.77 per share,
diluted, as compared to GAAP net income of $81.2 million, or $0.25
per share, basic and diluted, for the comparable period in 2023.
GAAP net income per share for the quarter ended June 30, 2024 was
favorably impacted by lower weighted-average common shares
outstanding for the quarter ended June 30, 2024, as compared to the
comparable period in 2023, as a result of the stock repurchase
programs.
Non-GAAP net income for the quarter ended June 30, 2024
was $245.6 million, or $0.85 per share, basic and $0.84 per share,
diluted, as compared to non-GAAP net income of $100.3 million, or
$0.31 per share, basic and diluted, for the comparable period in
2023.
Non-GAAP Financial
Measures
To supplement Exelixis’ financial results presented in
accordance with U.S. Generally Accepted Accounting Principles
(GAAP), Exelixis presents non-GAAP net income (and the related per
share measures), which excludes from GAAP net income (and the
related per share measures) stock-based compensation expense,
adjusted for the related income tax effect for all periods
presented.
Exelixis believes that the presentation of these non-GAAP
financial measures provides useful supplementary information to,
and facilitates additional analysis by, investors. In particular,
Exelixis believes that these non-GAAP financial measures, when
considered together with its financial information prepared in
accordance with GAAP, can enhance investors’ and analysts’ ability
to meaningfully compare Exelixis’ results from period to period,
and to identify operating trends in Exelixis’ business. Exelixis
has excluded stock-based compensation expense, adjusted for the
related income tax effect, because it is a non-cash item that may
vary significantly from period to period as a result of changes not
directly or immediately related to the operational performance for
the periods presented. Exelixis also regularly uses these non-GAAP
financial measures internally to understand, manage and evaluate
its business and to make operating decisions.
These non-GAAP financial measures are in addition to, not a
substitute for, or superior to, measures of financial performance
prepared in accordance with GAAP. Exelixis encourages investors to
carefully consider its results under GAAP, as well as its
supplemental non-GAAP financial information and the reconciliation
between these presentations, to more fully understand Exelixis’
business. Reconciliations between GAAP and non-GAAP results are
presented in the tables of this release.
2024 Financial Guidance
Exelixis is providing the following updated financial guidance
for fiscal year 2024 (1):
Total revenues
$1.975 billion - $2.075
billion
Net product revenues (2)
$1.650 billion - $1.750
billion
Cost of goods sold
4% - 5% of net product
revenues
Research and development expenses (3)
$925 million - $975 million
Selling, general and administrative
expenses (4)
$450 million - $500 million
Effective tax rate
20% - 22%
____________________
(1) 2024 financial guidance excludes
expenses related to the restructuring plan announced in January
2024.
(2) 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.
(3) Includes $40 million of non-cash
stock-based compensation expense.
(4) Includes $60 million of non-cash
stock-based compensation expense.
Cabozantinib and Pipeline
Highlights
Cabozantinib Franchise Net Product Revenues and
Royalties. Net product revenues generated by the cabozantinib
franchise in the U.S. were $437.6 million during the second quarter
of 2024, with net product revenues of $433.3 million from
CABOMETYX® (cabozantinib) and $4.2 million from COMETRIQ®
(cabozantinib). Based upon cabozantinib-related net product
revenues generated by Exelixis’ collaboration partners during the
quarter ended June 30, 2024, Exelixis earned $41.2 million in
royalty revenues.
Achievement of Cabozantinib Sales-Based Milestone from
Ipsen. Today, Exelixis announced it earned and recognized in
license revenues a $150 million commercial milestone from Ipsen
during the second quarter of 2024 based on Ipsen achieving $600
million in cumulative net sales of cabozantinib in its related
license territory over four consecutive quarters. Exelixis expects
to receive the milestone payment during the third quarter of
2024.
FDA Accepts for Standard Review the sNDA for Cabozantinib for
Patients with Advanced NET; Updated Results from Phase 3 CABINET
Study to be Presented during an Oral Presentation at the European
Society for Medical Oncology (ESMO) Congress 2024. Today,
Exelixis announced that the FDA accepted its sNDA for cabozantinib
for patients with previously treated advanced pancreatic NET
(pNET), and for patients with previously treated advanced
extra-pancreatic NET (epNET). The FDA assigned a standard review
with a Prescription Drug User Fee Act (PDUFA) target action date of
April 3, 2025. The FDA also granted orphan drug designation to
cabozantinib for the treatment of pNET. The application was based
on results from the phase 3 CABINET trial, which evaluated
cabozantinib compared with placebo in patients with previously
treated pNET and epNET. The CABINET study is 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. Updated results from CABINET, including final results on
the primary efficacy endpoint of progression-free survival by
Blinded Independent Central Review, will be presented during the
ESMO Congress 2024 in September.
Exelixis Partner Ipsen Opts into Phase 3 CABINET Pivotal
Trial in Advanced NET. In July, Ipsen announced it opted into
the phase 3 CABINET pivotal trial, expanding the existing
collaboration and license agreement with Exelixis and permitting
Ipsen to seek potential marketing authorizations for CABOMETYX in
advanced pNET and epNET from regulatory authorities outside of the
U.S. and Japan. As part of the agreement, Exelixis is eligible to
receive a reimbursement of a portion of costs related to the trial,
as well as milestone payments for potential future regulatory
action by the European Medicines Agency. The decision to expand the
existing agreement was based on detailed results from the CABINET
trial, which were first presented at the ESMO Congress 2023.
Phase 3 CONTACT-02 Metastatic Castration-Resistant Prostate
Cancer (mCRPC) Study Update and Intention to Submit sNDA in
2024. Today, Exelixis announced that the final overall survival
(OS) analysis for the phase 3 CONTACT-02 trial has been completed.
This study is evaluating cabozantinib in combination with
atezolizumab compared with a second novel hormonal therapy (NHT) in
patients with mCRPC and measurable soft-tissue disease who have
progressed after treatment with one prior NHT. As previously
reported, the CONTACT-02 study met one of its two primary
endpoints, demonstrating a statistically significant benefit in
progression-free survival (PFS) (hazard ratio: 0.65; 95% confidence
interval: 0.50–0.84; p=0.0007) in the predefined PFS
intent-to-treat population (i.e., the first 400 randomized
patients). While final OS continued to favor the combination of
cabozantinib and atezolizumab, it did not achieve statistical
significance. The safety profile of the combination regimen was
reflective of the known safety profiles for each single agent and
was consistent with the known tolerability profile of approved
immune checkpoint inhibitor-tyrosine kinase inhibitor combinations
in advanced solid tumors. Exelixis intends to submit an sNDA to the
FDA this year and to present these final data at a future medical
meeting.
Enrollment Completion for Zanzalintinib Phase 3 STELLAR-303
Study and Announcement of New Pivotal Trial for Zanzalintinib in
Neuroendocrine Tumors. Today, Exelixis announced that
enrollment has been completed in the STELLAR-303 phase 3 pivotal
study. STELLAR-303 is evaluating zanzalintinib in combination with
atezolizumab compared with regorafenib in patients with metastatic
refractory colorectal cancer that is not microsatellite
instability-high or mismatch repair-deficient. The primary endpoint
in the study is OS in the patients without liver metastases.
Exelixis anticipates preliminary results from the study to readout
in 2025. Additionally, Exelixis intends to initiate a new phase 3
pivotal trial, STELLAR-311, evaluating zanzalintinib compared with
everolimus as a first oral therapy in patients with pNET and epNET,
in the first half of 2025.
Initiation of Phase 1 Clinical Trial Evaluating XB010 in
Patients with Advanced Solid Tumors. Today, Exelixis announced
the initiation of the dose-escalation stage of the first-in-human
phase 1 clinical trial of XB010 in patients with locally advanced
or metastatic solid tumors. XB010, an antibody-drug conjugate (ADC)
consisting of a monomethyl auristatin E payload conjugated to a
monoclonal antibody targeting the tumor antigen 5T4, is the first
custom ADC generated through Exelixis’ biotherapeutics
collaboration network. The dose-escalation stage of this phase 1,
global, open-label study will evaluate 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.
Portfolio Prioritization Update. Today, Exelixis
announced it will discontinue the development of XB002, the
company’s tissue factor (TF)-targeting ADC, as part of its
portfolio prioritization efforts. Based on available data, the
compound is unlikely to improve upon tisotumab vedotin or other
competitor TF-targeting ADCs currently in development. The company
plans to disclose data from the phase 1 JEWEL-101 study, evaluating
XB002 in advanced solid tumors, at a later date. Preclinical
development of XB371, its ADC consisting of a topoisomerase payload
conjugated to a TF-targeting monoclonal antibody, is ongoing.
Exelixis plans to reallocate resources to new pivotal trials with
zanzalintinib, advancing XL309 and its growing pipeline.
Corporate Highlights
Settlement of CABOMETYX Patent Litigation with Cipla Limited
and Cipla USA. In May, Exelixis entered into a Settlement and
License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc.
(individually and collectively referred to as Cipla) resolving two
patent litigations brought by Exelixis in response to Cipla’s
Abbreviated New Drug Application (ANDA) seeking approval to market
generic versions of CABOMETYX tablets (20 mg / 40 mg / 60 mg) prior
to the expiration of the applicable patents. Pursuant to the terms
of the Agreement, Exelixis will grant Cipla a license to market
generic versions of CABOMETYX in the United States beginning on
January 1, 2031, if approved by the FDA and subject to conditions
and exceptions common to agreements of this type. The U.S. District
Court for the District of Delaware dismissed the case without
prejudice in July 2024 per the parties’ joint request, effectively
terminating all ongoing Hatch-Waxman litigation between Exelixis
and Cipla regarding CABOMETYX patents
Completion of the $450 million 2024 Stock Repurchase
Program. As of June 30, 2024, Exelixis completed the
repurchase of 20.3 million shares of the company’s common stock for
a total of $450 million, fulfilling its commitment under the stock
repurchase program announced in January 2024. With the completion
of this 2024 stock repurchase program, the company has returned $1
billion to shareholders since the initial $550 million stock
repurchase program was authorized in March 2023.
Announcement of Additional Stock Repurchase Program for up to
$500 million through the End of 2025. Today, Exelixis announced
that the company’s Board of Directors has authorized the repurchase
of up to an additional $500 million of the company’s common stock
through the end of 2025. The newly authorized stock repurchase
program is the third such program undertaken by Exelixis since
March 2023. Stock repurchases under the newly authorized 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 stock
repurchases under the stock 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.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally
ends on the Friday closest to December 31. For convenience,
references in this press release as of and for the fiscal periods
ended June 28, 2024 are indicated as being as of and for the
periods ended June 30, 2024.
Conference Call and
Webcast
Exelixis management will discuss the company’s financial results
for the second quarter of 2024 and provide a general business
update during a conference call beginning at 5:00 p.m. ET / 2:00
p.m. PT today, Tuesday, August 6, 2024.
To access the conference call, please register using this link.
Upon registration, a dial-in number and unique PIN will be provided
to join the call. To access the live webcast link, log onto
www.exelixis.com and proceed to the Event Calendar page under the
Investors & News heading. A webcast replay of the conference
call will also be archived on www.exelixis.com for one year.
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
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
belief that it is well-positioned for an impactful second half of
2024; the regulatory review process with respect to Exelixis’ sNDA
for cabozantinib in advanced NET, including the PDUFA target action
date assigned by the FDA, and the potential to bring cabozantinib
as a new treatment option for these patients with high unmet
medical need; Exelixis’ plans to reallocate resources to new
pivotal trials in zanzalintinib and to advancing phase 1 efforts
for XL309 and XB010, as well as to the rest of the company’s
growing pipeline; Exelixis’ updated 2024 financial guidance; the
anticipated timing for receipt of a $150 million milestone payment
from Ipsen; Exelixis’ plans to present updated results from
CABINET, including final results for the primary efficacy endpoint
of PFS, at the ESMO Congress 2024 in September; Exelixis’
expectation to receive reimbursement payments from Ipsen relating
to CABINET, as well as milestone payments for potential future
regulatory actions by the European Medicines Agency; Exelixis’
plans to submit an sNDA for the combination of cabozantinib and
atezolizumab in mCRPC to the FDA this year based on the results of
CONTACT-02, and to present final data from CONTACT-02 at a future
medical meeting; Exelixis’ expectation that preliminary results
from STELLAR-303 will readout in 2025; Exelixis’ plans to initiate
STELLAR-311 in the first half of 2025; Exelixis’ plans to disclose
data from JEWEL-101 at a later date; Exelixis’ future obligations
under the Agreement settling the company’s patent litigation with
Cipla; Exelixis’ plans to repurchase up to an additional $500
million of its common stock before the end of 2025; and Exelixis’
scientific pursuit to create transformational treatments that give
more patients hope for the future. 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.
Exelixis, the Exelixis logo, CABOMETYX and
COMETRIQ are registered trademarks of Exelixis, Inc.
EXELIXIS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Revenues:
Net product revenues
$
437,581
$
409,646
$
816,104
$
773,046
License revenues
194,986
52,747
239,662
91,039
Collaboration services revenues
4,611
7,455
6,638
14,551
Total revenues
637,178
469,848
1,062,404
878,636
Operating expenses:
Cost of goods sold
17,667
17,705
38,923
32,020
Research and development
211,147
232,570
438,836
466,816
Selling, general and administrative
132,015
141,723
245,999
273,120
Restructuring
475
—
33,310
—
Total operating expenses
361,304
391,998
757,068
771,956
Income from operations
275,874
77,850
305,336
106,680
Interest income
17,258
22,541
37,152
42,043
Other expense, net
(287
)
(5
)
(376
)
(59
)
Income before income taxes
292,845
100,386
342,112
148,664
Provision for income taxes
66,729
19,208
78,679
27,458
Net income
$
226,116
$
81,178
$
263,433
$
121,206
Net income per share:
Basic
$
0.78
$
0.25
$
0.89
$
0.37
Diluted
$
0.77
$
0.25
$
0.88
$
0.37
Weighted-average common shares
outstanding:
Basic
289,216
324,205
294,986
324,312
Diluted
293,974
327,305
299,752
326,792
EXELIXIS, INC.
RECONCILIATION OF GAAP NET
INCOME TO NON-GAAP NET INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
GAAP net income
$
226,116
$
81,178
$
263,433
$
121,206
Adjustments:
Stock-based compensation - research and
development expenses (1)
9,178
9,589
13,070
12,841
Stock-based compensation - selling,
general and administrative expenses (1)
16,176
15,311
31,397
28,720
Income tax effect of the above
adjustments
(5,841
)
(5,781
)
(10,289
)
(9,642
)
Non-GAAP net income
$
245,629
$
100,297
$
297,611
$
153,125
GAAP net income per share:
Basic
$
0.78
$
0.25
$
0.89
$
0.37
Diluted
$
0.77
$
0.25
$
0.88
$
0.37
Non-GAAP net income per share:
Basic
$
0.85
$
0.31
$
1.01
$
0.47
Diluted
$
0.84
$
0.31
$
0.99
$
0.47
Weighted-average common shares
outstanding:
Basic
289,216
324,205
294,986
324,312
Diluted
293,974
327,305
299,752
326,792
____________________
(1) Non-cash stock-based compensation
expense used for GAAP reporting in accordance with Accounting
Standards Codification Topic 718, Compensation—Stock
Compensation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240806336755/en/
Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240
csenner@exelixis.com
Susan Hubbard EVP, Public Affairs & Investor Relations
Exelixis, Inc. 650-837-8194 shubbard@exelixis.com
Grafico Azioni Exelixis (NASDAQ:EXEL)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Exelixis (NASDAQ:EXEL)
Storico
Da Gen 2024 a Gen 2025