- Total Revenues of $231.1 Million,
Cabozantinib Franchise Revenues of $168.6 Million -
- GAAP Diluted EPS of $(0.10), Non-GAAP
Diluted EPS of $0.04 -
- Conference Call and Webcast Today at 5:00
PM Eastern Time -
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results
for the third quarter of 2020 and provided an update on progress
toward fulfilling its key corporate objectives, as well as
commercial and clinical development milestones.
“In the third quarter of 2020, the Exelixis team built the
foundation to accelerate revenue growth with CABOMETYX®
(cabozantinib) in 2021,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer of Exelixis. “Based on the
positive results from the CheckMate -9ER phase 3 pivotal trial
evaluating cabozantinib in combination with nivolumab in previously
untreated patients with advanced renal cell carcinoma, we and
Bristol Myers Squibb completed our respective regulatory filings
for the combination in August. In September, the first detailed
results from the trial were presented during a Presidential
Symposium of the ESMO Virtual Congress 2020. And then just last
month, we announced the FDA accepted the filings, granted Priority
Review designation and assigned an action date of February 20th of
next year. Exelixis is launch-ready and prepared to immediately
support this important new combination regimen, pending FDA
approval.”
Dr. Morrissey continued: “As we continue working to maximize the
clinical and commercial potential for CABOMETYX, we’re moving
quickly in parallel to build a diversified pipeline behind it. In
October, we presented the preclinical profile and initial clinical
pharmacokinetic data for XL092, our next-generation oral tyrosine
kinase inhibitor that builds on the experience and target profile
of cabozantinib with improved characteristics, including a shorter
pharmacokinetic half-life. Encouraged by the data we’ve seen to
date, we expanded the phase 1 study to evaluate XL092 in
combination with atezolizumab in multiple solid tumors, with
enrollment now underway. The XL092 program is an important
component of our growing pipeline, as well as an opportunity to
drive growth into new and potentially larger indications with unmet
medical need. We further strengthened our pipeline during the
quarter through business development activities, with two
additional collaboration and license agreements focused on the
discovery and development of novel antibody-drug conjugates. Our
continued efforts to expand the breadth and depth of our discovery
pipeline beyond small molecules, along with a focused investment in
the development of cabozantinib and XL092, have the potential to
drive top-line growth significantly for Exelixis, and provide new
treatment options for the patients we serve.”
Third Quarter 2020 Financial
Results
Total revenues for the quarter ended September 30, 2020
were $231.1 million, compared to $271.7 million for the comparable
period in 2019.
Total revenues for the quarter ended September 30, 2020 included
net product revenues of $168.6 million, compared to $191.8 million
for the comparable period in 2019. The decrease in net product
revenues was due to a decrease in sales volumes driven by decreases
in prescriptions, which were in line with market trends, and lower
customer inventory.
Collaboration revenues, composed of license revenues and
collaboration services revenues, were $62.5 million for the quarter
ended September 30, 2020, compared to $79.9 million for the
comparable period in 2019. The decrease in collaboration revenues
was primarily related to a decrease in the recognition of milestone
related revenues, which was partially offset by increases in
development cost reimbursements earned, 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 (Takeda).
Research and development expenses for the quarter ended
September 30, 2020 were $176.8 million, compared to $97.3 million
for the comparable period in 2019. The increase in research and
development expenses was primarily related to increases in clinical
trial costs, license and other collaboration costs and personnel
expenses. The increase in clinical trial costs was primarily due to
costs associated with expanding clinical trial programs for
cabozantinib, which includes CONTACT-02, COSMIC-313, COSMIC-312 and
COSMIC-021. The increase in license and other collaboration costs
was primarily due to an increase in upfront license fee payments
from recent business development activities with two additional
collaboration and license agreements focused on the discovery and
development of novel antibody-drug conjugates (ADCs). The increase
in personnel expenses was primarily due to an increase in
stock-based compensation expense attributable to the
performance-based restricted stock units (PSUs) granted in 2019
that became probable of achievement during the third quarter of
2020 and an increase in headcount to support Exelixis’ expanding
discovery and development efforts.
Selling, general and administrative expenses for the
quarter ended September 30, 2020 were $88.2 million, compared to
$51.3 million for the comparable period in 2019. The increase in
selling, general and administrative expenses was primarily related
to increases in personnel expenses and marketing costs. The
increase in personnel expenses was primarily due to an increase in
stock-based compensation expense attributable to the PSUs granted
in 2019 that became probable of achievement during the third
quarter of 2020 and an increase in administrative headcount to
support Exelixis’ commercial and research and development
organizations.
Provision for (benefit from) income taxes for the quarter
ended September 30, 2020 was $(6.0) million, compared to $25.2
million for the comparable period in 2019, primarily due to the
change in pre-tax income (loss).
GAAP net income (loss) for the quarter ended September
30, 2020 was $(32.0) million, or $(0.10) per share, basic and
diluted, compared to GAAP net income of $97.5 million, or $0.32 per
share, basic and $0.31 per share, diluted, for the comparable
period in 2019. The change in GAAP net income was primarily related
to an increase in operating expenses and a decrease in total
revenues.
Non-GAAP net income for the quarter ended September 30,
2020 was $11.2 million, or $0.04 per share, basic and diluted,
compared to non-GAAP net income of $107.6 million, or $0.35 per
share, basic and $0.34 per share, diluted, for the comparable
period in 2019. Non-GAAP net income excludes stock-based
compensation, adjusted for the related income tax effect.
Cash and investments were $1.5 billion at September 30,
2020, compared to $1.4 billion at December 31, 2019.
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 (loss) (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.
2020 Financial Guidance
Exelixis is providing the following updated financial guidance
for fiscal year 2020:
Total revenues
$900 million - $950 million
Net product revenues (1)
$700 million - $725 million
Cost of goods sold (1)
Approximately 5% of net product
revenues
Research and development expenses
(1)(2)
$550 million - $575 million
Selling, general and
administrative expenses (1)(3)
$290 million - $300 million
Effective tax rate (1)
14% - 16%
Cash and investments (4)
$1.5 billion - $1.6 billion
(1)
Guidance updated on November 5, 2020 from
previously provided guidance on August 6, 2020.
(2)
Includes $40 million of non-cash
stock-based compensation expense.
(3)
Includes $70 million of non-cash
stock-based compensation expense.
(4)
This cash and investments guidance does
not include any potential new business development activity, which
remains a key priority for Exelixis as it continues to build toward
becoming a multi-product oncology company.
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and
Royalties. Net product revenues generated by the cabozantinib
franchise in the U.S. were $168.6 million during the third quarter
of 2020, with net product revenues of $159.6 million from
CABOMETYX® and $9.0 million from COMETRIQ® (cabozantinib). Based
upon cabozantinib-related revenues generated by Exelixis’
collaboration partner Ipsen in the third quarter of 2020, Exelixis
earned $19.9 million in royalty revenues.
Initiation of CONTACT-03 Phase 3 Pivotal Trial of
Cabozantinib in Combination with Atezolizumab in Previously Treated
Metastatic Renal Cell Carcinoma (RCC). In July 2020, Exelixis
announced the initiation of CONTACT-03, a global phase 3 pivotal
trial of cabozantinib in combination with atezolizumab in patients
with inoperable, locally advanced or metastatic RCC who progressed
during or following treatment with an immune checkpoint inhibitor
as the immediate preceding therapy. CONTACT-03 is part of a
clinical trial collaboration between Exelixis and F. Hoffmann-La
Roche Ltd. that includes two additional ongoing phase 3 pivotal
trials – CONTACT-01 in patients with metastatic non-small cell lung
cancer who have been previously treated with an immune checkpoint
inhibitor and platinum-containing chemotherapy and CONTACT-02 in
patients with metastatic castration-resistant prostate cancer
(mCRPC) who have been previously treated with one novel hormonal
therapy.
Completion of Patient Enrollment for EXAMINER Phase 4 Trial
of Cabozantinib in Metastatic Medullary Thyroid Cancer. In July
2020, Exelixis announced the completion of patient enrollment in
EXAMINER, the phase 4 trial evaluating the safety and efficacy of
the 60 mg tablet formulation of cabozantinib compared with the 140
mg capsule formulation, which is marketed as COMETRIQ, for the
treatment of patients with progressive, metastatic medullary
thyroid cancer. EXAMINER is a post-marketing requirement from the
U.S. Food and Drug Administration (FDA) and the European
Commission. The trial was designed to enroll up to 250 patients,
and top-line results from the trial are anticipated later this
year.
Submission of Supplemental New Drug Application (sNDA) to and
Acceptance by the FDA for Cabozantinib in Combination with
Nivolumab for Advanced Renal Cell Carcinoma. In August 2020,
Exelixis announced the submission of an sNDA to the FDA for
cabozantinib in combination with Bristol-Myers Squibb Company’s
(BMS) nivolumab for patients with advanced RCC. The sNDA submission
was based on the positive results of the CheckMate -9ER phase 3
pivotal trial, which met its primary endpoint of significantly
improving progression-free survival (PFS) and secondary endpoints
of overall survival (OS) and objective response rate. In October
2020, Exelixis and BMS announced that the FDA had accepted
Exelixis’ sNDA and BMS’ supplemental Biologics License Application
(sBLA), granted Priority Review to both applications and assigned a
Prescription Drug User Fee Act goal date, or target action date, of
February 20, 2021.
Completion of Patient Enrollment for the COSMIC-312 Phase 3
Pivotal Trial in Previously Untreated Hepatocellular Carcinoma
(HCC). In August 2020, Exelixis announced the completion of
patient enrollment in COSMIC-312, a global phase 3 pivotal trial
evaluating cabozantinib in combination with atezolizumab versus
sorafenib as a treatment for patients with previously untreated
advanced HCC, providing the patient population for the event-driven
analyses of the study’s endpoints. Separately, patient enrollment
remains open in China in order to enroll a sufficient number of
patients to enable local registration, if supported by the clinical
data. The co-primary endpoints of the trial are PFS and OS for the
combination of cabozantinib and atezolizumab versus sorafenib.
Based on current event rates, Exelixis anticipates announcing
top-line results in the first half of 2021.
Presentation of Positive Results from CheckMate -9ER Phase 3
Pivotal Trial during Presidential Symposium I at the
European Society for Medical Oncology Virtual Congress 2020 (ESMO
2020). In September 2020, Exelixis and BMS announced the first
presentation of results from the CheckMate -9ER phase 3 pivotal
trial as part of Presidential Symposium I at ESMO 2020, in which
cabozantinib in combination with nivolumab demonstrated significant
improvements across all efficacy endpoints, including OS, in
previously untreated advanced RCC, with a favorable tolerability
profile versus sunitinib.
Validation of Regulatory Filings for Cabozantinib plus
Nivolumab in the European Union (EU). In September 2020,
Exelixis, BMS, and Ipsen announced that the European Medicines
Agency (EMA) had validated BMS' and Ipsen’s type II variation
applications for cabozantinib plus nivolumab, which confirmed the
submissions were complete and began the EMA’s centralized review
process. Like BMS' and Exelixis’ own regulatory filings in the
United States, BMS' and Ipsen’s EU filings were based on positive
data from the CheckMate -9ER phase 3 pivotal trial.
Presentation of Positive Results from Two RCC Cohorts of the
COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab
at ESMO 2020. In September 2020, Exelixis presented positive
phase 1b clinical trial results for the combination of cabozantinib
and atezolizumab in patients with locally advanced or metastatic
solid tumors at ESMO 2020. Data from the clear cell RCC and
non-clear cell RCC expansion cohorts of the COSMIC-021 trial were
presented as part of the GU Proffered Paper Session and as part of
a poster presentation, respectively, and showed that cabozantinib
in combination with atezolizumab demonstrated promising preliminary
efficacy and a favorable safety profile.
Announcement of Submission of Supplemental Application for
Cabozantinib in Combination with Nivolumab in Japan for the
Treatment of Unresectable, Advanced or Metastatic RCC. In
October 2020, Exelixis announced that its collaboration partner
Takeda, and Ono Pharmaceuticals Co., Ltd. (Ono), submitted a
supplemental application to the Japanese Ministry of Health, Labour
and Welfare for Manufacturing and Marketing Approval of
cabozantinib in combination with nivolumab for the treatment of
patients with unresectable, advanced or metastatic RCC. The
application is also based on the results from the CheckMate -9ER
study. Takeda has licensed the exclusive rights to cabozantinib
from Exelixis for development and commercialization in Japan, while
Ono jointly develops and commercializes nivolumab, in collaboration
with BMS, in Japan, South Korea and Taiwan. Takeda previously
received approval in March 2020 to market single-agent cabozantinib
for the treatment of patients with curatively unresectable or
metastatic RCC in Japan.
Pipeline Highlights
Presentations of Data for XL092 and AUR102 at the 32nd
EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer
Therapeutics. In October 2020, Exelixis presented the
preclinical profile and initial clinical pharmacokinetics (PK) for
XL092 at the ENA Symposium. The poster discussion presentation
included preclinical results demonstrating robust target and tumor
growth inhibition, as well as increased efficacy for XL092 when
combined with an immune checkpoint inhibitor. PK data from the
ongoing phase 1 trial suggested a significantly shorter PK
half-life for XL092 as compared to cabozantinib. Also at the ENA
Symposium, Aurigene presented promising preclinical data for
AUR102, its novel inhibitor of cyclin-dependent kinase 7, including
potent anti-tumor activity in a large panel of cancer cell lines.
Exelixis has an exclusive option for AUR102 under its July 2019
exclusive collaboration, option and license agreement with
Aurigene. Exelixis’ option window extends up until the time of
Investigational New Drug application (IND) acceptance; AUR102 could
be the subject of an IND later this year.
Enrollment of First Patient in Phase 1 Trial Cohort
Evaluating XL092 in Combination with Atezolizumab in Patients with
Advanced Solid Tumors. In October 2020, Exelixis announced
enrollment of the first patient into the dose-escalation cohort of
the combination arm of the phase 1 trial evaluating the safety,
tolerability, PK and preliminary anti-tumor activity of XL092 alone
and in combination with atezolizumab in patients with advanced
solid tumors. Initiated in February 2019, the dose-escalation
evaluation of the XL092 monotherapy arm of the phase 1 trial is
ongoing. Once the recommended doses of both single-agent XL092 and
XL092 in combination with atezolizumab are established, the trial
will begin to enroll expansion cohorts for patients with clear cell
and non-clear cell RCC, hormone-receptor positive breast cancer and
mCRPC.
Corporate Updates
FDA Approves TECENTRIQ® (Atezolizumab) Plus COTELLIC®
(Cobimetinib) and ZELBORAF® (Vemurafenib) for Previously Untreated
BRAF V600 Mutation-Positive Advanced Melanoma. In July 2020,
the FDA approved the sBLA submitted by Genentech, Inc. (a member of
the Roche Group) (Genentech), for TECENTRIQ plus COTELLIC and
ZELBORAF for the treatment of BRAF V600 mutation-positive advanced
melanoma in previously untreated patients. The approval is based on
positive results from the phase 3 IMspire150 study, which
demonstrated that adding TECENTRIQ to COTELLIC and ZELBORAF helped
to reduce the risk of disease worsening or death, compared to
placebo plus COTELLIC and ZELBORAF. This was the second FDA
approval for a regimen including COTELLIC, which was discovered by
Exelixis and is being developed and commercialized by Genentech as
part of a worldwide collaboration agreement between the two
companies.
Exelixis and Catalent, Inc. (Catalent) Enter into Exclusive
Collaboration and License Agreement to Develop ADCs Leveraging
SMARTag® Bioconjugation Technology. In September 2020, Exelixis
and Catalent announced a partnership under which Catalent’s Redwood
Bioscience subsidiary will develop multiple ADCs for Exelixis using
Catalent’s proprietary SMARTag® site-specific bioconjugation
technology. Under the terms of the agreement, Exelixis made an
upfront payment of $10.0 million to Catalent in exchange for the
ability to nominate and have the exclusive option to license target
programs.
Exelixis and NBE-Therapeutics AG (NBE) Enter into Exclusive
Collaboration and License Agreement to Discover and Develop Novel
ADCs for the Treatment of Cancer. In September 2020, Exelixis
and NBE announced a partnership to discover and develop multiple
ADCs for oncology applications by leveraging NBE’s unique expertise
and proprietary platforms in ADC discovery, including NBE’s
SMAC-Technology™ (a site-specific conjugation technology) and novel
payloads. Under the terms of the agreement, Exelixis made an
upfront payment of $25.0 million to NBE in exchange for the ability
to nominate and have the exclusive option to license target
programs.
Exelixis and Iconic Therapeutics, Inc. (Iconic) Announce
Promising Preclinical Data for ICON-2 in Treatment of Solid Tumors
at the World ADC Digital Conference. In September 2020,
Exelixis and Iconic announced new preclinical data that support the
continued development of ICON-2, an ADC comprised of an anti-Tissue
Factor antibody and a proprietary linker-payload developed by
Zymeworks Inc., for the treatment of diverse solid tumors. Exelixis
has an exclusive option to license ICON-2 in oncology indications
under its May 2019 option and license agreement with Iconic.
Inclusion in Fortune’s 100 Fastest-Growing Companies
List. In November 2020, Exelixis was named to Fortune’s 100
Fastest-Growing Companies list, which ranks companies that are
traded on a major U.S. stock exchange by their revenue growth rate,
EPS growth rate and three-year annualized total return for the
period ended June 30, 2020. In its first year on the list, Exelixis
ranked 17th overall and was the third-highest biopharmaceutical
company.
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 October 2, 2020, January 3, 2020 and September 27, 2019 are
indicated as being as of and for the periods ended September 30,
2020, December 31, 2019 and September 30, 2019, respectively.
Conference Call and
Webcast
Exelixis management will discuss the company’s financial results
for the third quarter of 2020 and provide a general business update
during a conference call beginning at 5:00 p.m. EST / 2:00 p.m. PST
today, Thursday, November 5, 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 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 6945239 to join by phone.
A telephone replay will be available until 8:00 p.m. EST on
November 7, 2020. Access numbers for the telephone replay are:
855-859-2056 (domestic) and 404-537-3406 (international); the
passcode is 6945239. 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. In November 2020, the company was named to Fortune’s 100
Fastest-Growing Companies list for the first time, ranking 17th
overall and the third-highest biopharmaceutical company. 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’
belief that recent activities, specifically positive results from
CheckMate -9ER and related data presentations and regulatory
filings, are a foundation to accelerate revenue growth with
CABOMETYX in 2021; Exelixis’ belief that the XL092 program is an
opportunity to drive growth into new and potentially larger
indications with unmet medical need; the potential for Exelixis’
ongoing efforts to expand the pipeline and drive top-line growth
significantly for Exelixis, and provide new treatment options for
patients; Exelixis’ updated 2020 financial guidance; Exelixis’
anticipated timelines for top-line results from COSMIC-312 and
EXAMINER; Exelixis' plans to file an IND for AUR102 later in 2020;
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 continuing COVID-19 pandemic and its impact
on Exelixis’ clinical trial, drug discovery and commercial
activities; 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, cobimetinib or
esaxerenone; 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 discussed under the caption “Risk Factors” in Exelixis’
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on August 6, 2020, 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 November 5, 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, except as required by law.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks.
MINNEBRO is a registered Japanese
trademark.
-see attached financial tables-
EXELIXIS, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Revenues:
Net product revenues
$
168,587
$
191,768
$
541,197
$
565,024
License revenues
33,205
69,137
113,318
132,443
Collaboration services revenues
29,300
10,798
62,971
29,998
Total revenues
231,092
271,703
717,486
727,465
Operating expenses:
Cost of goods sold
8,725
7,537
27,235
22,577
Research and development
176,762
97,295
393,572
242,516
Selling, general and administrative
88,185
51,265
210,916
170,218
Total operating expenses
273,672
156,097
631,723
435,311
Income (loss) from operations
(42,580
)
115,606
85,763
292,154
Interest income
3,994
7,191
16,376
20,253
Other income (expense), net
565
(140
)
571
688
Income (loss) before income taxes
(38,021
)
122,657
102,710
313,095
Provision for (benefit from) income
taxes
(5,981
)
25,205
19,317
60,826
Net income (loss)
$
(32,040
)
$
97,452
$
83,393
$
252,269
Net income (loss) per share:
Basic
$
(0.10
)
$
0.32
$
0.27
$
0.84
Diluted
$
(0.10
)
$
0.31
$
0.26
$
0.80
Weighted-average common shares
outstanding:
Basic
309,116
303,268
307,437
301,999
Diluted
309,116
315,453
317,495
315,046
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEET DATA
(in thousands)
(unaudited)
September 30, 2020
December 31, 2019
Cash and investments
$
1,545,960
$
1,388,628
Working capital
$
1,206,465
$
868,444
Total assets
$
2,111,043
$
1,885,670
Total stockholders’ equity
$
1,852,031
$
1,685,970
EXELIXIS, INC.
RECONCILIATION OF GAAP NET
INCOME TO NON-GAAP NET INCOME
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
GAAP net income (loss)
$
(32,040
)
$
97,452
$
83,393
$
252,269
Adjustments:
Stock-based compensation - research and
development expenses (1)
18,936
4,301
30,134
13,745
Stock-based compensation - selling,
general and administrative expenses (1)
36,719
8,838
55,657
27,002
Income tax effect of the above
adjustments
(12,406
)
(2,954
)
(19,195
)
(9,148
)
Non-GAAP net income
$
11,209
$
107,637
$
149,989
$
283,868
GAAP net income (loss) per share:
Basic
$
(0.10
)
$
0.32
$
0.27
$
0.84
Diluted (2)
$
(0.10
)
$
0.31
$
0.26
$
0.80
Non-GAAP net income per share:
Basic
$
0.04
$
0.35
$
0.49
$
0.94
Diluted
$
0.04
$
0.34
$
0.47
$
0.90
Weighted-average common shares
outstanding:
Basic
309,116
303,268
307,437
301,999
Diluted (2)
318,501
315,453
317,495
315,046
____________________
(1)
Non-cash stock-based compensation
expense used for GAAP reporting in accordance with Accounting
Standards Codification Topic 718, Compensation—Stock
Compensation.
(2)
The dilutive effect of shares
related to employee stock plans are not included in the calculation
of GAAP diluted loss per share in the third quarter of 2020 as the
effect would be anti-dilutive.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105006159/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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