- Total Revenues of $356.0 million,
Cabozantinib Franchise Revenues of $310.3 million -
- GAAP Diluted EPS of $0.21, Non-GAAP
Diluted EPS of $0.26 -
- Conference Call and Webcast Today at 5:00
PM Eastern Time -
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results
for the first quarter of 2022 and provided an update on progress
toward achieving key corporate objectives, as well as commercial,
clinical and pipeline development milestones.
“Exelixis had a strong start to 2022 as we continued to gain
momentum across all components of our business,” said Michael M.
Morrissey, Ph.D., President and Chief Executive Officer, Exelixis.
“We are pleased with the growth of the cabozantinib franchise,
driven by increased demand for CABOMETYX® (cabozantinib) in
combination with OPDIVO® (nivolumab) in the first-line renal cell
carcinoma setting, as well as by the initial impact of the drug’s
most recent U.S. label expansion into differentiated thyroid
cancer. As we strive to help as many eligible cancer patients as
possible benefit from cabozantinib, we look forward to top-line
results from the COSMIC-313, CONTACT-01 and CONTACT-03 pivotal
phase 3 clinical trials expected over the course of this year.”
Dr. Morrissey continued: “Cabozantinib franchise revenues fuel
the growth of our expanding pipeline, which now comprises four
differentiated clinical-stage programs. We are on track to initiate
the pivotal trial series for XL092 beginning in the second quarter
of 2022 with the first phase 3 trial, STELLAR-303, which will
evaluate the compound in combination with atezolizumab in a form of
colorectal cancer, and we expect to advance the ongoing phase 1
studies of XL092, XB002 and XL102, and to present initial data from
these trials later this year. Additionally, in April we initiated
the first-in-human phase 1 trial of XL114, our small molecule
inhibitor of the CARD11-BCL10-MALT1 complex. As our pipeline
advances, we are building out our infrastructure, both on our
Alameda campus as well as in the Greater Philadelphia area through
our Exelixis East expansion. I look forward to providing further
updates on our progress throughout the year and want to thank the
Exelixis team for their collective hard work and execution as we
advance our mission to help cancer patients recover stronger and
live longer.”
First Quarter 2022 Financial
Results
Total revenues for the quarter ended March 31, 2022 were
$356.0 million, compared to $270.2 million for the comparable
period in 2021.
Total revenues for the quarter ended March 31, 2022 included net
product revenues of $310.3 million, compared to $227.2 million for
the comparable period in 2021. The increase in net product revenues
was due to an increase in sales volume, primarily as a result of
the growth in the number of units sold following the FDA’s approval
of CABOMETYX in combination with OPDIVO as a first-line treatment
of patients with advanced RCC in January 2021 and in part due to
the longer duration of therapy for this combination. The increase
in net product revenues was partially offset by increases in
discounts and allowances, primarily from higher utilization by
covered entities in the 340B Drug Pricing Program, an increase in
Medicaid utilization and an increase in Exelixis’ co-pay assistance
for commercially insured patients.
Collaboration revenues, composed of license revenues and
collaboration services revenues, were $45.7 million for the quarter
ended March 31, 2022, compared to $43.0 million for the comparable
period in 2021. The increase in collaboration revenues was
primarily related to 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 (Takeda), which was partially offset
by a decrease in development cost reimbursements.
Research and development expenses for the quarter ended
March 31, 2022 were $156.7 million, compared to $159.3 million for
the comparable period in 2021. The decrease in research and
development expenses was primarily related to decreases in license
and other collaboration costs and stock-based compensation expense,
which was partially offset by increases in personnel expenses.
Selling, general and administrative expenses for the
quarter ended March 31, 2022 were $102.9 million, compared to
$102.4 million for the comparable period in 2021. The increase in
selling, general and administrative expenses was primarily related
to increases in personnel expenses and marketing costs, which was
partially offset by a decrease in stock-based compensation
expense.
Provision for (benefit from) income taxes for the quarter
ended March 31, 2022 was $16.7 million, compared to $(3.6) million
for the comparable period in 2021, primarily due to the change in
pre-tax income (loss).
GAAP net income for the quarter ended March 31, 2022 was
$68.6 million, or $0.21 per share, basic and diluted, compared to
GAAP net income of $1.6 million, or $0.01 per share, basic and
$0.00 per share, diluted, for the comparable period in 2021.
Non-GAAP net income for the quarter ended March 31, 2022
was $83.9 million, or $0.26 per share, basic and diluted, compared
to non-GAAP net income of $28.5 million, or $0.09 per share, basic
and diluted, for the comparable period in 2021.
Cash, cash equivalents, restricted cash equivalents and
investments were $2.0 billion at March 31, 2022, compared to
$1.9 billion at December 31, 2021.
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.
2022 Financial Guidance
Exelixis is maintaining the following previously provided
financial guidance for fiscal year 2022:
Total revenues
$1.525 billion - $1.625
billion
Net product revenues
$1.325 billion - $1.425
billion
Cost of goods sold
5% - 6% of net product
revenues
Research and development expenses (1)
$725 million - $775 million
Selling, general and administrative
expenses (2)
$400 million - $450 million
Effective tax rate
20% - 22%
____________________
(1) Includes $45 million of non-cash
stock-based compensation expense.
(2) Includes $50 million of non-cash
stock-based compensation expense.
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and
Royalties. Net product revenues generated by the cabozantinib
franchise in the U.S. were $310.3 million during the first quarter
of 2022, up 3% over the prior quarter, with net product revenues of
$302.8 million from CABOMETYX and $7.5 million from COMETRIQ®
(cabozantinib). Exelixis earned $27.0 million in royalty revenues
during the quarter ended March 31, 2022, pursuant to collaboration
agreements with its partners, Ipsen and Takeda.
Completion of Enrollment in CONTACT-03 Pivotal Trial of
Cabozantinib in Combination with Atezolizumab in Previously Treated
Metastatic Renal Cell Carcinoma (RCC). In January 2022,
Exelixis announced that enrollment was complete for CONTACT-03, the
global phase 3 pivotal trial evaluating cabozantinib in combination
with atezolizumab versus cabozantinib alone in patients with
locally advanced or metastatic clear cell or non-clear cell RCC who
progressed during or following treatment with an immune checkpoint
inhibitor (ICI). CONTACT-03 enrolled 523 patients who were
randomized 1:1 to the experimental arm of cabozantinib in
combination with atezolizumab and the control arm of cabozantinib
alone. The primary endpoints of the trial are progression-free
survival (PFS) per Response Evaluation Criteria in Solid Tumors v.
1.1 as assessed by independent radiology review and overall
survival (OS). Secondary endpoints include PFS, objective response
rate (ORR) and duration of response as assessed by study
investigators. CONTACT-03 is sponsored by F. Hoffmann-La Roche
Limited and co-funded by Exelixis. Interim data from the trial are
anticipated in the second half of 2022.
Cabozantinib Data at the 2022 American Society of Clinical
Oncology (ASCO) Gastrointestinal Cancers Symposium (ASCO GI
2022). In January 2022, investigators presented encouraging
data from two trials of cabozantinib in combination with ICIs for
the treatment of advanced colorectal cancer (CRC) at ASCO GI 2022.
The results reinforce Exelixis’ decision to pursue clinical
development of XL092, which pairs a target profile similar to
cabozantinib with a potentially significantly improved safety
profile, in advanced CRC through the STELLAR-303 global phase 3
pivotal trial expected to initiate in the second quarter of
2022.
Cabozantinib Data at the 2022 ASCO Genitourinary Cancers
Symposium (ASCO GU 2022). In February 2022, cabozantinib was
the subject of multiple data presentations at ASCO GU 2022. Notable
presentations include two additional data sets from the phase 3
pivotal CheckMate -9ER study providing final OS analysis and
organ-specific target lesion assessments with two-year follow-up,
and updated health-related quality of life results.
Announcement of Final OS Results from Phase 3 COSMIC-312
Trial in Patients with Previously Untreated Advanced Hepatocellular
Carcinoma (HCC). In March 2022, Exelixis announced results from
the final analysis of the second primary endpoint of OS from the
phase 3 COSMIC-312 trial, which evaluated cabozantinib in
combination with atezolizumab versus sorafenib in patients with
previously untreated advanced HCC. The final analysis showed
neither improvement nor detriment in OS for cabozantinib in
combination with atezolizumab versus sorafenib. Based on this
outcome for OS and the rapidly evolving treatment landscape for
previously untreated advanced HCC, Exelixis decided not to submit a
supplemental New Drug Application to the U.S. FDA.
Exelixis’ Partner Ipsen Receives European Commission (EC) and
Health Canada Approvals for CABOMETYX for Patients with Previously
Treated Radioactive Iodine (RAI)-Refractory Differentiated Thyroid
Cancer (DTC). In May 2022, Exelixis announced its partner Ipsen
received approval from the EC for CABOMETYX as a monotherapy for
the treatment of adult patients with locally advanced or metastatic
DTC, refractory or not eligible to RAI who have progressed during
or after prior systemic therapy. This approval allows for the
marketing of CABOMETYX in this indication in all 27 member states
of the European Union, Norway, Liechtenstein and Iceland.
Similarly, in late April 2022, Ipsen received approval from Health
Canada to market CABOMETYX for a similar DTC indication in Canada.
Both approvals were based on the positive results of the phase 3
COSMIC-311 pivotal trial.
Cabozantinib Data Presentations at the 2022 ASCO Annual
Meeting. In June 2022, cabozantinib will be the subject of 13
presentations at this year’s ASCO Annual Meeting, being held from
June 3-7 in Chicago. Notable presentations will include results
from cohorts 7 and 20 in non-small cell lung cancer and cohorts 3,
4 and 5 in urothelial carcinoma from the ongoing COSMIC-021 study
evaluating cabozantinib in combination with atezolizumab across
multiple tumor types, and a phase 2 investigator-sponsored trial
from the Emory Winship Cancer Institute evaluating the combination
of cabozantinib and pembrolizumab in recurrent metastatic head and
neck squamous cell carcinoma.
Pipeline Highlights
Amendment of Option and License Agreement for XB002, an
Antibody-Drug Conjugate (ADC) Targeting Tissue Factor (TF). In
January 2022, Exelixis and Iconic Therapeutics, Inc. (Iconic)
announced amended terms to their May 2019 exclusive option and
license agreement for XB002, a next-generation TF-targeting ADC.
Under the amended agreement, Exelixis acquired broad rights to use
the anti-TF antibody incorporated into XB002 for any application,
including conjugated to other payloads, as well as rights within
oncology to a number of other anti-TF antibodies developed by
Iconic, including for use in ADCs and multispecific
biotherapeutics. Based on early clinical data supportive of a
potentially differentiated and best-in-class profile, Exelixis
intends to aggressively expand development of XB002, both as a
monotherapy and in combination with ICIs and other targeted
therapies, across a wide range of tumor types, including
indications other than those currently addressed by commercially
available TF-targeted therapies. Exelixis expects to provide
clinical updates from the ongoing phase 1 study of XB002 in the
second half of 2022.
Initiation of First-In-Human Phase 1 Trial Evaluating XL114
Monotherapy in Patients with Non-Hodgkin’s Lymphoma (NHL). In
April 2022, Exelixis announced the initiation of the
dose-escalation stage of the first-in-human phase 1 trial of XL114,
a novel anti-cancer compound that inhibits the CARD11-BCL10-MALT1
complex, as a monotherapy in patients with NHL who have received
prior standard therapies. The objectives of the study are to
determine the recommended dose and/or the maximum tolerated dose of
XL114 and to evaluate the safety and preliminary efficacy of XL114
in patients with NHL. The dose-escalation stage will determine the
recommended dose of XL114 in patients with advanced B- and T-cell
NHL. In the cohort-expansion stage, the safety and preliminary
efficacy of XL114 will be further evaluated in various B-cell
NHL-specific expansion cohorts. The primary endpoint of the
expansion stage will be ORR based on lymphoma-specific response
criteria as assessed by the investigator. Exelixis in-licensed
XL114 from Aurigene Discovery Technologies Limited under the
companies’ July 2019 collaboration, option and license agreement
and assumed responsibility for the future clinical development,
commercialization and global manufacturing of XL114.
Corporate Updates
Appointment of Vicki L. Goodman, M.D., as Executive Vice
President, Product Development & Medical Affairs and Chief
Medical Officer (CMO). In January 2022, Exelixis announced the
appointment of Vicki L. Goodman, M.D., as Executive Vice President,
Product Development & Medical Affairs and CMO. Dr. Goodman has
more than 20 years of oncology experience as a drug development
leader at global biopharmaceutical organizations, regulator and
clinician. She joined from Merck & Co., where she served as
Vice President, Clinical Research and Therapeutic Area Head, Late
Stage Oncology. Dr. Goodman is based in the Greater Philadelphia
area. As part of her role overseeing the company’s product
development operations, she is leading the buildout of a new
Exelixis team that will expand the company’s development activities
on the East Coast. Exelixis’ East Coast presence will complement
the company’s growing West Coast development team and enable the
company to lay additional groundwork for potential future growth
outside the U.S.
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally
ends on the Friday closest to December 31st. For convenience,
references in this press release as of and for the fiscal periods
ended April 1, 2022, and April 2, 2021, are indicated as being as
of and for the periods ended March 31, 2022, and March 31, 2021,
respectively.
Conference Call and
Webcast
Exelixis management will discuss the company’s financial results
for the first quarter of 2022 and provide a general business update
during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT
today, Tuesday, May 10, 2022.
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 conference call to ensure
adequate time for any software download that may be required to
listen to the webcast. Alternatively, please call 855-793-2457
(domestic) or 631-485-4921 (international) and provide the
conference call passcode 6282616 to join by phone.
A telephone replay will be available until 8:00 p.m. ET on
Thursday, May 12, 2022. Access numbers for the telephone replay
are: 855-859-2056 (domestic) and 404-537-3406 (international); the
passcode is 6282616. A webcast replay will also be archived on
www.exelixis.com for one year.
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 commercially
available 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 the 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
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
expectations and anticipated timelines for top-line results from
the COSMIC-313, CONTACT-01 and CONTACT-03 pivotal phase 3 clinical
trials during 2022; Exelixis’ plans to initiate the pivotal trial
series for XL092 beginning in the second quarter of 2022 with
STELLAR-303, as well as to advance the ongoing phase 1 studies of
XL092, XB002 and XL102, and to present initial data from these
trials later in 2022; Exelixis’ 2022 financial guidance; Exelixis’
planned cabozantinib presentations at the 2022 ASCO Annual Meeting;
the potentially differentiated and best-in-class profile of XB002
and Exelixis’ intention to aggressively expand development of
XB002, both as a monotherapy and in combination with ICIs and other
targeted therapies, into indications other than those currently
addressed by commercially available TF-targeted therapies;
Exelixis’ clinical development plans for XL114; Exelixis’ plans to
expand its development activities on the East Coast and for
potential future growth outside the U.S.; and 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. 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 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 products;
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, including as
a result of the COVID-19 pandemic and other global events; and
other factors discussed under the caption “Risk Factors” in
Exelixis’ Annual Report on Form 10-K filed with the Securities and
Exchange Commission (SEC) on February 18, 2022, and in Exelixis’
future filings with the SEC, including, without limitation,
Exelixis’ Quarterly Report on Form 10-Q expected to be filed with
the SEC on May 10, 2022. 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.
COTELLIC is a registered trademark of
Genentech, Inc.
MINNEBRO is a registered trademark of Daiichi
Sankyo Company, Limited.
OPDIVO is a registered trademark of
Bristol-Myers Squibb Company.
EXELIXIS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended March
31,
2022
2021
Revenues:
Net product revenues
$
310,298
$
227,212
License revenues
32,067
27,528
Collaboration services revenues
13,615
15,490
Total revenues
355,980
270,230
Operating expenses:
Cost of goods sold
13,203
13,198
Research and development
156,671
159,288
Selling, general and administrative
102,863
102,351
Total operating expenses
272,737
274,837
Income (loss) from operations
83,243
(4,607
)
Interest income
1,822
2,682
Other income (expense), net
164
(90
)
Income (loss) before income taxes
85,229
(2,015
)
Provision for (benefit from) income
taxes
16,656
(3,616
)
Net income
$
68,573
$
1,601
Net income per share:
Basic
$
0.21
$
0.01
Diluted
$
0.21
$
0.00
Weighted-average common shares
outstanding:
Basic
319,582
312,473
Diluted
323,289
321,287
EXELIXIS, INC.
RECONCILIATION OF GAAP NET
INCOME TO NON-GAAP NET INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended March
31,
2022
2021
GAAP net income
$
68,573
$
1,601
Adjustments:
Stock-based compensation - research and
development expenses (1)
8,899
12,396
Stock-based compensation - selling,
general and administrative expenses (1)
10,860
22,257
Income tax effect of the above
adjustments
(4,439
)
(7,789
)
Non-GAAP net income
$
83,893
$
28,465
GAAP net income per share:
Basic
$
0.21
$
0.01
Diluted
$
0.21
$
0.00
Non-GAAP net income per share:
Basic
$
0.26
$
0.09
Diluted
$
0.26
$
0.09
Weighted-average common shares
outstanding:
Basic
319,582
312,473
Diluted
323,289
321,287
____________________
(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/20220509006077/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
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