- Total Revenues of $225.4 million -
- Cabozantinib Franchise Net Product Revenues of $162.9 million -
- Net Income of $126.6 million, Diluted EPS of $0.41 -
- Conference Call and Webcast Today at 5:00 P.M. Eastern Daylight
Time -
ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 1, 2018--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
third quarter of 2018 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 2018, we continued to grow our commercial
business and make significant clinical development and regulatory
progress for our pipeline,” said Michael M. Morrissey, Ph.D., President
and Chief Executive Officer of Exelixis. “Cabozantinib franchise net
product revenues during the quarter were $162.9 million, which
represents a 12 percent increase compared to the second quarter of 2018.
We also initiated the next wave of cabozantinib pivotal trials with the
announcement of the COSMIC-311 study in differentiated thyroid cancer
and expect additional pivotal trials launching later this year and into
2019. This will include studies evaluating cabozantinib in combination
with leading immunotherapies, an approach supported by encouraging
clinical data, including phase 1b dose escalation results of
cabozantinib plus atezolizumab in advanced renal cell carcinoma
presented at the 2018 European Society for Medical Oncology Congress
last month.”
Dr. Morrissey continued: “Our team’s hard work provides strong momentum
as we close out the year and move into 2019. In particular, we look
forward to the U.S. Food and Drug Administration’s upcoming decision on
our supplemental New Drug Application for CABOMETYX® in
previously-treated advanced hepatocellular carcinoma, which has a
January 14, 2019 action date, and for which we are fully launch ready.
We are also pleased with Ipsen’s regulatory progress, including gaining
a positive opinion in the European Union for previously-treated
hepatocellular carcinoma, and Canadian regulatory approval for advanced
renal cell carcinoma. Each of these milestones has the potential to
support broadened access to CABOMETYX in key regions, and underscores
our commitment to making Exelixis-discovered medicines globally
available to cancer patients in need.”
Third Quarter 2018 Financial Results
Total revenues for the quarter ended September 30, 2018 were
$225.4 million, compared to $152.5 million for the comparable period in
2017.
Total revenues include net product revenues of $162.9 million for the
quarter ended September 30, 2018, compared to $96.4 million for the
comparable period in 2017, representing a 69 percent increase
year-over-year. The increase in net product revenues reflects the
continued growth of CABOMETYX in the U.S. for the treatment of advanced
renal cell carcinoma (RCC).
Total revenues also include collaboration revenues of $62.5 million for
the quarter ended September 30, 2018 compared to $56.1 million for the
comparable period in 2017. Collaboration revenues for the quarter ended
September 30, 2018 included the recognition of milestone revenue of
$36.9 million and $5.0 million from our collaboration with Ipsen Pharma
SAS (Ipsen) for the anticipated approval of CABOMETYX for
previously-treated hepatocellular carcinoma (HCC) in the European Union
and the approval by Health Canada of CABOMETYX for previously-treated
RCC, respectively. Collaboration revenues also included $11.7 million in
royalties earned from Ipsen and Genentech and $6.9 million in
development cost reimbursements under our collaboration agreements with
Ipsen and Takeda Pharmaceutical Company Ltd. Collaboration revenues for
the quarter ended September 30, 2017 included two milestones totaling
$45.0 million from our collaboration with Ipsen.
Research and development expenses for the quarter ended
September 30, 2018 were $44.7 million, compared to $28.5 million for the
comparable period in 2017. The increase in research and development
expenses was primarily related to increases in clinical trial costs and
personnel expenses. The increase in clinical trial costs was primarily
due to increased costs associated with: CheckMate 9ER, a phase 3 pivotal
trial of cabozantinib plus immunotherapy in patients with
previously-untreated RCC that is being conducted with Bristol-Myers
Squibb Company; COSMIC-311, a phase 3 pivotal trial of cabozantinib in
patients with radioiodine-refractory differentiated thyroid cancer (DTC)
who have progressed after prior VEGFR-targeted therapy; and the
preparation for further pivotal phase 3 trials that are expected to be
initiated in the coming months. The increase in personnel expenses was
primarily due to increases in headcount to support our expanded
development and discovery efforts.
Selling, general and administrative expenses for the quarter
ended September 30, 2018 were $48.1 million, compared to $38.1 million
for the comparable period in 2017. The increase in selling, general and
administrative expenses was primarily related to increases in personnel
expenses and stock-based compensation. The increase in personnel
expenses was primarily due to increases in general and administrative
headcount to support the company’s commercial and research and
development organizations. The increase in stock-based compensation was
primarily due to the increase in headcount.
Net income for the quarter ended September 30, 2018 was $126.6
million, or $0.42 per share, basic and $0.41 per share, diluted,
compared to $81.4 million, or $0.28 per share, basic and $0.26 per
share, diluted, for the comparable period in 2017. The increase in net
income was primarily the result of increases in net product revenues and
collaboration revenues, which was partially offset by the increases in
research and development and selling, general and administrative
expenses.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $750.3
million at September 30, 2018, as compared to $457.2 million at
December 31, 2017.
2018 Financial Guidance
The company is updating its guidance that total costs and operating
expenses for the full year will be between $410 million and $420
million. This guidance includes approximately $50 million of non-cash
costs and expenses related primarily to stock-based compensation expense.
Cabozantinib Highlights
Strong Growth in Cabozantinib Franchise Net Revenues. Net product
revenues generated by the cabozantinib franchise were $162.9 million
during the third quarter of 2018, an increase of 69 percent
year-over-year. During the third quarter of 2018, CABOMETYX generated
$158.3 million in net product revenues and COMETRIQ®
(cabozantinib) capsules for the treatment of patients with progressive,
metastatic medullary thyroid cancer generated an additional $4.7 million
in net product revenues.
CELESTIAL Phase 3 Pivotal Trial Results Published in The New
England Journal of Medicine (NEJM). In July, Exelixis
announced that NEJM published positive results from the CELESTIAL
phase 3 pivotal trial of cabozantinib in patients with
previously-treated advanced HCC. As previously announced and presented,
the data demonstrate that cabozantinib provided a statistically
significant and clinically meaningful improvement in overall survival
versus placebo.
National Comprehensive Cancer Network (NCCN) Updates Clinical
Practice Guidelines with New Recommendations for CABOMETYX. In
September, the NCCN updated its Clinical Practice Guidelines to
recommend CABOMETYX for the treatment of advanced RCC regardless of
patient risk status (favorable-, intermediate-, and poor-risk). With the
updates, CABOMETYX is the only tyrosine kinase inhibitor (TKI) indicated
for the treatment of advanced RCC with NCCN-preferred status for
intermediate- and poor-risk groups in the first-line setting, and the
only TKI with preferred status for patients who have progressed on prior
therapy.
In a separate update to the Clinical Practice Guidelines for
Hepatobiliary Cancers, the NCCN also added cabozantinib as a Category 1
option for the treatment of patients with HCC (Child-Pugh Class A only)
who have been previously treated with sorafenib. CABOMETYX is not a U.S.
Food and Drug Administration (FDA) approved therapy for
previously-treated advanced HCC. In May 2018, the FDA accepted Exelixis’
supplemental New Drug Application (sNDA) for CABOMETYX in this disease
setting, assigning a Prescription Drug User Fee Act date of January 14,
2019.
Health Canada Approves CABOMETYX for Previously-treated Advanced RCC.
In September, Ipsen announced approval by Health Canada of CABOMETYX for
the treatment of adults with advanced RCC who have received prior
vascular endothelial growth factor-targeted therapy. Health Canada had
granted CABOMETYX priority review status, which provided an accelerated
review of Ipsen’s new drug submission. Under the collaboration agreement
with Ipsen, Exelixis is eligible to receive a $5.0 million milestone for
the Health Canada approval, which was recognized as revenue in the third
quarter of 2018.
Positive Committee for Medicinal Products for Human Use (CHMP)
Opinion for CABOMETYX for Previously-treated HCC. In September,
Ipsen announced that it received a positive opinion from the CHMP, the
scientific committee of the European Medicines Agency, for CABOMETYX as
a monotherapy for the treatment of HCC in adults who have been
previously treated with sorafenib. The positive CHMP opinion will now be
reviewed by the European Commission (EC), which has the authority to
approve medicines for the European Union. The CHMP opinion was based on
results from the CELESTIAL phase 3 pivotal trial. Under the
collaboration agreement with Ipsen, Exelixis is eligible to receive a
milestone payment of $40.0 million for the approval of CABOMETYX for
previously-treated HCC, of which $36.9 million was recognized as revenue
in the third quarter of 2018. Payment of the full $40.0 million is
expected to be received within 70 days of an approval decision by the EC.
Initiation of COSMIC-311, Phase 3 Pivotal Trial of Cabozantinib in
Patients with Radioiodine-refractory DTC Who Have Progressed After Prior
VEGFR-Targeted Therapy. After the quarter ended, in October,
Exelixis announced the initiation of COSMIC-311, a multicenter,
randomized, double-blind, placebo-controlled phase 3 pivotal trial that
aims to enroll approximately 300 patients at approximately 150 sites
globally. The co-primary endpoints of the trial are progression-free
survival and objective response rate. The American Cancer Society
estimates that approximately 54,000 new cases of thyroid cancer will be
diagnosed in the United States in 2018.1 DTC accounts for
approximately 90 percent of all thyroid cancers.2
Cabozantinib Data at the 2018 European Society for Medical Oncology
(ESMO) Congress. After the quarter ended, in October, data from
clinical trials of cabozantinib were featured in 13 presentations at the
2018 ESMO Congress in Munich, Germany. Notable results included further
analyses from the CELESTIAL phase 3 pivotal trial, as well as
single-agent and combination data for cabozantinib in a variety of tumor
types and disease settings. One poster presentation highlighted results
from the dose escalation stage of the phase 1b COSMIC-021 study of
cabozantinib in combination with atezolizumab in previously-untreated
advanced RCC, demonstrating that this therapy combination was well
tolerated and showed encouraging anti-tumor activity in advanced RCC. A
second poster presentation, reviewed during a discussion session,
evaluated the effect of PD-L1 status on clinical outcomes with
cabozantinib in advanced RCC in the CABOSUN and METEOR trials, and
showed improved outcomes regardless of PD-L1 expression relative to
sunitinib or everolimus, the respective comparator arms for each trial.
Another poster presentation evaluated the activity of cabozantinib in
patients with advanced RCC who had progressed on immune checkpoint
inhibitor (ICI) therapy, finding that cabozantinib was active in
patients previously-treated with ICIs, either alone or in combination
with anti-VEGF or other therapies.
CABOMETYX as a Treatment for Advanced RCC Approved in Brazil and
Taiwan. After the quarter ended, in October, Ipsen received
approvals from both the Agência Nacional de Vigilância Sanitária in
Brazil for CABOMETYX as a treatment for both previously-treated and
previously-untreated advanced RCC and from the Taiwan Food and Drug
Administration for CABOMETYX as a treatment for patients with advanced
RCC who have received prior anti-angiogenic therapy.
Corporate Highlights
Inclusion on Standard & Poor’s (S&P) MidCap 400 Index. On
July 2, Exelixis began trading as a member of the S&P MidCap 400®
classified under S&P’s Global Industry Classification Standard
Biotechnology Sub-Industry index. The index, which is distinct from the
large-cap S&P 500®, measures the performance of
profitable mid-sized companies, reflecting the distinctive risk and
return characteristics of this market segment.
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
September 28, 2018, December 29, 2017 and September 29, 2017 are
indicated as being as of and for the periods ended September 30, 2018,
December 31, 2017 and September 30, 2017, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
third quarter of 2018 and provide a general business update during a
conference call beginning at 5:00 p.m. EDT / 2:00 p.m. PDT today,
Thursday, November 1, 2018.
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 1043999 to join
by phone.
A telephone replay will be available until 8:00 p.m. EDT / 5:00 p.m. PDT
on November 3, 2018. Access numbers for the telephone replay are:
855-859-2056 (domestic) and 404-537-3406 (international); the passcode
is 1043999. 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
genetic systems, 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. We discovered our three
commercially available products, CABOMETYX® (cabozantinib),
COMETRIQ® (cabozantinib) and COTELLIC® (cobimetinib),
and 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. In July 2018, Exelixis was
added to 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’ expectation to
launch additional pivotal clinical trials later in 2018 and in 2019,
including studies evaluating cabozantinib in combination with leading
immunotherapies; the impact of the FDA’s upcoming decision on Exelixis’
sNDA for CABOMETYX as a treatment option for patients with
previously-treated advanced HCC; the potential of regulatory approval
milestones outside the U.S. to support broadened access to CABOMETYX in
key regions and Exelixis’ commitment to making its discovered medicines
globally available to cancer patients in need; Exelixis’ guidance for
2018 total costs and operating expenses, including non-cash costs and
expenses; eligibility for and the expected timing of receipt of
milestone payments from Ipsen; 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, COMETRIQ and COTELLIC and the
availability of sufficient coverage and adequate reimbursement for these
products; the level of costs associated with Exelixis’
commercialization, research and development, in-licensing or acquisition
of product candidates, and other activities; the potential failure of
cabozantinib and cobimetinib, 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; risks and uncertainties related to regulatory
review and approval processes, including that regulatory authorities may
not approve Exelixis’ products as treatments for the indications in
which approval has been sought; Exelixis’ 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 or cobimetinib;
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 August 1, 2018, 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 1, 2018. 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.
Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are
registered U.S. trademarks.
1American Cancer Society, Key Statistics for Thyroid
Cancer, https://www.cancer.org/cancer/thyroid-cancer/about/key-statistics.html,
accessed October 2018.
2 Cooper DS, et al, 2009, Revised American Thyroid
Association management guidelines for patients with thyroid nodules and
differentiated thyroid cancer, The American Thyroid Association
(ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid
Cancer, Thyroid, 19:1167-1214.
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
162,946
|
|
|
$
|
96,416
|
|
$
|
443,054
|
|
|
$
|
253,297
|
|
Collaboration revenues
|
|
62,451
|
|
|
56,094
|
|
182,170
|
|
|
79,108
|
|
Total revenues
|
|
225,397
|
|
|
152,510
|
|
625,224
|
|
|
332,405
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
7,360
|
|
|
4,658
|
|
18,996
|
|
|
10,875
|
|
Research and development
|
|
44,741
|
|
|
28,543
|
|
124,986
|
|
|
79,967
|
|
Selling, general and administrative
|
|
48,120
|
|
|
38,129
|
|
153,989
|
|
|
113,084
|
|
Total operating expenses
|
|
100,221
|
|
|
71,330
|
|
297,971
|
|
|
203,926
|
|
Income from operations
|
|
125,176
|
|
|
81,180
|
|
327,253
|
|
|
128,479
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income
|
|
3,507
|
|
|
1,133
|
|
8,099
|
|
|
3,497
|
|
Interest expense
|
|
(1
|
)
|
|
—
|
|
(1
|
)
|
|
(8,679
|
)
|
Other, net
|
|
272
|
|
|
2,275
|
|
369
|
|
|
(3,638
|
)
|
Total other income (expense), net
|
|
3,778
|
|
|
3,408
|
|
8,467
|
|
|
(8,820
|
)
|
Income before income taxes
|
|
128,954
|
|
|
84,588
|
|
335,720
|
|
|
119,659
|
|
Provision for income taxes
|
|
2,324
|
|
|
3,206
|
|
5,739
|
|
|
3,921
|
|
Net income
|
|
$
|
126,630
|
|
|
$
|
81,382
|
|
$
|
329,981
|
|
|
$
|
115,738
|
|
Net income per share, basic
|
|
$
|
0.42
|
|
|
$
|
0.28
|
|
$
|
1.11
|
|
|
$
|
0.39
|
|
Net income per share, diluted
|
|
$
|
0.41
|
|
|
$
|
0.26
|
|
$
|
1.05
|
|
|
$
|
0.37
|
|
Shares used in computing net income per share, basic
|
|
298,416
|
|
|
294,269
|
|
297,700
|
|
|
292,776
|
|
Shares used in computing net income per share, diluted
|
|
312,346
|
|
|
312,940
|
|
313,200
|
|
|
311,555
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
September 30, 2018
|
|
December 31, 2017 (1)
|
Cash and investments (2) |
|
$
|
750,320
|
|
$
|
457,176
|
Working capital
|
|
$
|
696,056
|
|
$
|
369,704
|
Total assets
|
|
$
|
1,024,366
|
|
$
|
655,294
|
Total stockholders’ equity
|
|
$
|
915,966
|
|
$
|
284,961
|
_______________________________________
|
|
|
|
|
(1)
|
|
Derived from the audited consolidated financial statements.
|
|
|
|
|
|
(2)
|
|
Cash and investments include cash and cash equivalents, short- and
long-term investments and short- and long-term restricted cash and
investments. Short- and long-term restricted cash and investments
totaled $1.6 million as of September 30, 2018 and $5.2 million as of
December 31, 2017.
|
|
|
|
|
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20181101006090/en/
Source: Exelixis, Inc.
Exelixis, Inc.
Chris Senner, 650-837-7240
Chief
Financial Officer
csenner@exelixis.com
or
Susan
Hubbard, 650-837-8194
EVP, Public Affairs & Investor
Relations
shubbard@exelixis.com