- Cabozantinib Franchise Net Product Revenue
of $96.4 million, Total Revenue of $152.5 million -
- Net Income of $81.4 million, Diluted EPS
of $0.26 per Share -
- Conference Call and Webcast Today at 5:00
PM Eastern Time -
Exelixis, Inc. (NASDAQ: EXEL) today reported financial results
for the third quarter of 2017 and provided an update on progress
toward fulfilling its key corporate objectives, as well as
commercial and clinical development milestones.
Exelixis is focused on maximizing the opportunity for its two
internally discovered compounds, cabozantinib and cobimetinib, to
improve care and outcomes for people with cancer around the world.
The company’s top priority remains the ongoing commercialization of
CABOMETYX® (cabozantinib) tablets as a treatment for patients with
advanced renal cell carcinoma (RCC) who have received prior
anti-angiogenic therapy. During the third quarter of 2017,
CABOMETYX generated $90.4 million in net product revenue, while
COMETRIQ® (cabozantinib) capsules for the treatment of patients
with progressive, metastatic medullary thyroid cancer generated an
additional $6.1 million in net product revenue, for a combined
$96.4 million in net product revenue for the cabozantinib
franchise.
“In addition to strong financial performance, the third quarter
of 2017 was marked by significant clinical and regulatory
milestones that continue to drive us forward in our mission to help
cancer patients recover stronger and live longer,” said Michael M.
Morrissey, Ph.D., President and Chief Executive Officer of
Exelixis. “In August, we completed the filing for CABOMETYX in
previously untreated advanced RCC, which has been accepted by the
FDA and granted Priority Review. With an upcoming FDA action date
of February 15, 2018, our commercial team is fully prepared for a
potential launch of CABOMETYX in this expanded indication to bring
this much needed option to even more patients with advanced RCC as
quickly as possible. In addition, based on the positive results
from the CELESTIAL pivotal trial, demonstrating that cabozantinib
provided a statistically significant and clinically meaningful
improvement in overall survival for patients with advanced
hepatocellular carcinoma, we are moving rapidly to complete our
U.S. regulatory filing in the first quarter of next year.”
Cabozantinib Highlights
Strong Growth in Cabozantinib Franchise Net Revenue.
Cabozantinib generated $96.4 million in net product revenue during
the third quarter of 2017, an increase of 10 percent from the
second quarter of 2017 and an increase of 126 percent
year-over-year.
Phase 3 CELESTIAL Trial Meets Primary Endpoint of Overall
Survival (OS), with supplemental New Drug Application (sNDA) Filing
Planned for Q1 2018. In October, Exelixis announced that the
CELESTIAL trial met its primary endpoint of OS, with cabozantinib
providing a statistically significant and clinically meaningful
improvement in OS compared to placebo in patients with advanced
hepatocellular carcinoma (HCC). The independent data monitoring
committee for the study recommended that the trial should be
stopped for efficacy following review of the second planned interim
analysis. CELESTIAL is a randomized, global phase 3 trial of
cabozantinib compared to placebo in patients with advanced HCC who
have been previously treated with sorafenib. The safety data in the
study were consistent with the established profile of cabozantinib.
Based on these results, Exelixis plans to submit an sNDA to the
U.S. Food and Drug Administration (FDA) in the first quarter of
2018. Detailed results from CELESTIAL will be submitted for
presentation at a future medical conference.
Submission and Acceptance of sNDA for CABOMETYX for the
Treatment of Previously Untreated Advanced RCC with FDA Priority
Review. In August, Exelixis announced it had completed the
submission of its sNDA to the FDA for CABOMETYX for the treatment
of previously untreated advanced RCC. The sNDA submission is based
on results from the CABOSUN randomized phase 2 trial of CABOMETYX
compared to sunitinib in patients with previously untreated
advanced RCC with intermediate- or poor-risk disease. After the
quarter ended, the company announced the FDA had accepted the sNDA
and granted Priority Review, assigning a Prescription Drug User Fee
Act (PDUFA) action date of February 15, 2018.
Start of Phase 3 Trial of Cabozantinib in Combination with
Nivolumab or with Nivolumab and Ipilimumab in Previously Untreated
Advanced or Metastatic RCC. In July, Exelixis and Bristol-Myers
Squibb (BMS) announced the initiation of CheckMate 9ER, the pivotal
phase 3 trial evaluating cabozantinib in combination with two of
BMS’ leading immunotherapies, nivolumab and ipilimumab, compared to
sunitinib. The trial is planned to enroll 1,014 treatment-naïve
patients, with a primary endpoint of progression-free survival.
Cabozantinib and Cobimetinib Data Presentations at the
European Society for Medical Oncology (ESMO) 2017 Congress. In
September, Exelixis-discovered compounds were the subject of 10
presentations at the ESMO 2017 Congress held in Madrid, Spain. Data
from CABOSUN, the randomized phase 2 trial of cabozantinib compared
to sunitinib in patients with previously untreated advanced RCC
with intermediate- or poor-risk disease, were the subject of a
poster discussion which showed cabozantinib demonstrated a
clinically meaningful and statistically significant reduction in
the rate of disease progression or death. Other cabozantinib
presentations included an oral presentation of data from the phase
1b trial of cabozantinib, nivolumab, and ipilimumab in advanced
genitourinary malignancies, as well as additional analyses of the
phase 3 METEOR trial in advanced RCC. Cobimetinib presentations at
the Congress included two data sets concerning forms of metastatic
melanoma. The company, along with its collaboration partner Ipsen,
also hosted an investor and media event in Madrid to discuss the
data for cabozantinib presented at the Congress and to take part in
a question and answer session with Drs. Toni Choueiri, Sumanta Pal
and Thomas Powles.
Cobimetinib Highlights
Settlement of Arbitration between Exelixis and Genentech
Regarding Companies’ Collaboration Agreement for Cobimetinib.
In July, Exelixis announced a settlement of its arbitration with
Genentech concerning claims asserted by Exelixis against Genentech
related to the development and commercialization of cobimetinib,
the Exelixis-discovered medicine that is marketed as COTELLIC®. The
revised revenue and cost-sharing arrangement resolves the
companies’ dispute pursuant to the arbitration demand filed on June
3, 2016, and aligns both companies’ interests in advancing
cobimetinib as a promising therapy for patients with multiple forms
of cancer. Moving forward, the revenue applied to the profit and
loss statement for the COTELLIC collaboration (Collaboration
P&L) will now be calculated using the average of the quarterly
net selling prices of COTELLIC and any additional branded Genentech
product(s) prescribed with COTELLIC. Exelixis will continue to
share U.S. commercialization costs, while Genentech’s portion of
these costs will now be allocated to the Collaboration P&L in
proportion to the number of Genentech products in any given
combination including COTELLIC.
Corporate Highlights
Updates from Partnered Programs with Daiichi Sankyo and
BMS. In the third quarter and shortly after the quarter ended,
Exelixis announced milestones for compounds from two of its
partnered programs.
In September, collaborator Daiichi Sankyo announced positive
top-line results from ESAX-HTN, a phase 3 pivotal trial of
esaxerenone (formerly CS-3150) in patients with essential
hypertension in Japan. As a result, Daiichi Sankyo plans to submit
a Japanese regulatory application for esaxerenone for an essential
hypertension indication in the first quarter of 2018. Daiichi
Sankyo also announced the initiation of a pivotal trial of
esaxerenone in patients with diabetic nephropathy. ESAX-DN is a
phase 3 study in patients with type-2 diabetes with
microalbuminuria who are taking an angiotensin II receptor blocker
(ARB) or an angiotensin converting enzyme (ACE) inhibitor in
Japan.
In October, Exelixis earned a $10 million milestone from BMS as
part of the two companies’ worldwide collaboration for compounds
targeting retinoic acid-related orphan receptor (ROR), a family of
nuclear hormone receptors implicated in inflammatory conditions.
The milestone was triggered by BMS’ filing of a Clinical Trial
Authorization in Europe for a first-in-human study of a RORγt
inverse agonist.
Debut of New Mission-Driven Corporate Branding and
Website. In September, Exelixis introduced new corporate
branding aligned with its mission, growth strategy and commitment
to bring best-in-class oncology medicines to market. The new
branding included a redesigned logo crafted as a wordmark with an
extractable symbol that will become emblematic of Exelixis, as well
as the revised corporate tagline, Resilience.Results.Remission. The
new corporate branding celebrates the company’s unwavering
perseverance to deliver results, and its aspirational commitments
to the diverse audiences it serves.
Third Quarter 2017 Financial
Results
Total revenue for the quarter ended September 30,
2017 was $152.5 million, compared to $62.2 million for the
comparable period in 2016. Total revenue includes $96.4 million and
$56.1 million of net product revenue and collaboration revenue,
respectively, compared to $42.7 million and $19.5 million for the
comparable period in 2016. The increase in net product revenues
primarily reflects the growth in product sales of CABOMETYX since
the product’s launch in late April 2016. Collaboration revenues for
the quarter ended September 30, 2017 include two milestones
totaling $45.0 million resulting from Ipsen’s receipt of the
validation from the European Medicines Agency for the application
for variation to the CABOMETYX marketing authorization for the
addition of a new indication in first-line treatment of advanced
RCC in adults; we also recognized $11.1 million in additional
revenue from the company’s collaboration agreements with Ipsen,
Takeda and Genentech during the quarter. Collaboration revenues for
the comparable period in 2016 include the recognition of a $15.0
million milestone from Daiichi Sankyo and $4.5 million in revenue
from the company’s collaboration agreements with Ipsen, Takeda and
Genentech.
Research and development expenses for the quarter ended
September 30, 2017 were $28.5 million, compared to $20.3
million for the comparable period in 2016. The increase in research
and development expenses was primarily a result of increases in
personnel expenses, clinical trial costs and consulting and outside
services. The increase in personnel-related expenses was primarily
a result of an increase in headcount associated with the re-launch
of the company’s internal discovery program and the build-out of
the company’s medical affairs organization. The increase in
clinical trial costs was predominantly due to start-up costs
associated with CheckMate 9ER and start-up costs associated with
the phase 1b trial of cabozantinib and atezolizumab in locally
advanced or metastatic solid tumors; those increases were partially
offset by decreases in costs related to METEOR, the company’s
completed phase 3 pivotal trial comparing CABOMETYX to everolimus
in patients with advanced RCC. The increase in consulting and
outside services was primarily in support of the company’s medical
affairs organization.
Selling, general and administrative expenses for the
quarter ended September 30, 2017 were $38.1 million, compared
to $32.5 million for the comparable period in 2016. The increase in
selling, general and administrative expenses was primarily a result
of increases in consulting and outside services to support the
company’s marketing activities and in personnel expenses resulting
primarily from an increase in general and administrative headcount
to support the company’s commercial and research and development
organizations. Those increases were partially offset by a decrease
in losses under the collaboration agreement with Genentech driven
by Genentech’s change in cost allocation approach in December
2016.
Other income (expense), net for the quarter ended
September 30, 2017 was $3.4 million compared to $(18.5)
million for the comparable period in 2016. The increase in other
income (expense), net, was primarily due to a $13.8 million loss on
extinguishment of debt associated with the conversions of the 4.25%
Convertible Subordinated Notes due 2019 (2019 Notes) during the
third quarter of 2016, and a $7.8 million decrease in interest
expense due to the conversions and the redemption of the 2019 Notes
during the third and fourth quarters of 2016, the repayment of the
Silicon Valley Bank term loan in March 2017 and the repayment of
the Deerfield Notes in June 2017.
Net income for the quarter ended September 30, 2017
was $81.4 million, or $0.28 per share, basic and $0.26 per share,
diluted, compared to a net loss of $(11.3) million, or $(0.04) per
share, basic and diluted, for the comparable period in 2016. The
transition to profitability was primarily due to the increase in
net product revenues, reflecting the growth in product sales of
CABOMETYX since the launch in late April 2016, which was
supplemented by the growth in our collaboration revenues and
partially offset by the increase in operating expenses.
Cash and cash equivalents, short- and long-term investments
and long-term restricted cash and investments totaled $422.3
million at September 30, 2017, as compared to $479.6 million
at December 31, 2016.
2017 Financial Guidance
The company is updating its guidance that total costs and
operating expenses for the full year will be between $285 million
and $295 million. This guidance includes approximately $25
million of non-cash costs and expenses related primarily to
stock-based compensation expense.
Basis of Presentation
Exelixis 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 29, 2017, December 30, 2016 and September
30, 2016 are indicated as being as of and for the periods
ended September 30, 2017, December 31, 2016 and September 30,
2016, respectively.
Conference Call and
Webcast
Exelixis management will discuss the company’s financial results
for the third quarter of 2017 and provide a general business update
during a conference call beginning at 5:00 p.m. EDT / 2:00 p.m. PDT
today, Wednesday, November 1, 2017.
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 96645455 to join by phone.
A telephone replay will be available until 8:00 p.m. EDT on
November 3, 2017. Access numbers for the telephone replay are:
855-859-2056 (domestic) and 404-537-3406 (international); the
passcode is 96645455. 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 lead compounds, cabozantinib and
cobimetinib, and advanced them into clinical development before
entering into partnerships with leading biopharmaceutical companies
in our efforts to bring them to patients globally. With growing
revenues from the three resulting commercialized products -
CABOMETYX®, COMETRIQ®, and COTELLIC® - we are reinvesting in our
business to maximize the potential of our pipeline, which we intend
to supplement 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. For more information about Exelixis, please visit
www.exelixis.com or follow
@ExelixisInc on Twitter.
Forward-Looking
Statements
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
focus on maximizing the opportunity for cabozantinib and
cobimetinib to help patients with cancer around the world; the
commercialization of CABOMETYX as Exelixis’ top priority; the
impact of the FDA’s grant of Priority Review for Exelixis’ sNDA for
CABOMETYX as a treatment for patients with previously untreated
advanced RCC and the positive results from the CELESTIAL pivotal
trial on Exelixis’ ability to improve treatment outcomes for
patients with cancer; a potential commercial launch of CABOMETYX as
a treatment for patients with previously untreated advanced RCC;
Exelixis’ plan to submit an sNDA in the first quarter of 2018 for
cabozantinib as a treatment for HCC; data results from CELESTIAL at
a future medical conference; Daiichi Sankyo’s plans to submit a
Japanese regulatory application for esaxerenone for an essential
hypertension indication in the first quarter of 2018 and initiate a
pivotal trial of esaxerenone in patients with diabetic nephropathy;
the impact of Exelixis’ new corporate branding; Exelixis’ guidance
for 2017 total costs and operating expenses, including non-cash
costs and expenses; growing revenues from CABOMETYX, COMETRIQ, and
COTELLIC 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; and Exelixis’ mission to deliver the next generation of
Exelixis medicines and help patients recover stronger and live
longer. Words such as “focused,” “priority,” “mission,” “upcoming,”
“potential,” “moving,” “plans,” “planned,” “future,” “will,”
“forward,” “promising,” “guidance,” “intend,” “commitment,” or
other similar expressions identify forward-looking statements, but
the absence of these words does not necessarily mean that a
statement is not forward-looking. In addition, any statements that
refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements.
These forward-looking statements 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 coverage and
reimbursement for these products; the risk that unanticipated
developments could adversely affect the commercialization of
CABOMETYX, COMETRIQ, and COTELLIC; Exelixis’ dependence on its
relationship with its collaboration partners, including the
level of their investment in the resources necessary to
successfully commercialize cabozantinib and cobimetinib in the
territories where they are approved; risks and uncertainties
related to regulatory review and approval processes and Exelixis’
compliance with applicable legal and regulatory
requirements; Exelixis’ ability and the ability of its
collaborators to conduct clinical trials of cabozantinib and
cobimetinib both alone and in combination with other therapies
sufficient to achieve a positive completion; risks related to the
potential failure of cabozantinib and cobimetinib, both alone and
in combination with other therapies, to demonstrate safety and
efficacy in clinical testing; the level of costs associated with
Exelixis’ commercialization, research and development and other
activities; Exelixis’ dependence on its relationship with
Genentech/Roche with respect to cobimetinib and Exelixis’
ability to maintain its rights under the collaboration;
Exelixis’ dependence on third-party vendors; Exelixis’ ability
to protect the company’s intellectual property rights; market
competition; 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 SEC
on August 2, 2017, 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, 2017. The forward-looking statements made in this press release
speak only as of the date of this press
release. Exelixis expressly disclaims any duty,
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Exelixis’ expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Exelixis, the Exelixis logo, CABOMETYX,
COMETRIQ and COTELLIC are registered U.S. trademarks.
EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended September 30, Nine Months Ended
September 30, 2017 2016 2017
2016 Revenues: Net product revenues $ 96,416 $ 42,742 $
253,297 $ 83,459 Collaboration revenues 56,094 19,452
79,108 30,414 Total revenues 152,510 62,194
332,405 113,873 Operating expenses: Cost of
goods sold 4,658 2,455 10,875 4,700 Research and development 28,543
20,256 79,967 72,166 Selling, general and administrative 38,129
32,463 113,116 103,143 Restructuring (recovery) charge —
(244 ) (32 ) 871 Total operating expenses 71,330
54,930 203,926 180,880 Income (loss) from
operations 81,180 7,264 128,479 (67,007 )
Other income (expense), net: Interest income and other, net 3,408
3,059 6,098 4,010 Interest expense — (7,834 ) (8,679 ) (28,575 )
Loss on extinguishment of debt — (13,773 ) (6,239 ) (13,773
)
Total other income (expense), net
3,408 (18,548 ) (8,820 ) (38,338 ) Income (loss) before
income taxes 84,588 (11,284 ) 119,659 (105,345 ) Income tax expense
3,206 — 3,921 — Net income (loss) $
81,382 $ (11,284 ) $ 115,738 $ (105,345 ) Net income
(loss) per share, basic $ 0.28 $ (0.04 ) $ 0.39 $ (0.44 ) Net
income (loss) per share, diluted $ 0.26 $ (0.04 ) $ 0.37 $ (0.44 )
Shares used in computing basic net income (loss) per share 294,269
256,319 292,776 238,024 Shares used in computing diluted net income
(loss) per share 312,940 256,319 311,555 238,024
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
DATA
(in thousands)
(unaudited)
September 30, 2017
December 31,2016
(1)
Cash and investments (2) $ 422,317 $ 479,554 Working capital $
361,968 $ 200,215 Total assets $ 609,772 $ 595,739 Total
stockholders’ equity
$
238,715 $ 89,318 _______________________________________ (1)
Derived from the audited consolidated financial statements. (2)
Cash and investments include cash and cash equivalents, short- and
long-term investments and long-term restricted cash and
investments. Long-term restricted cash and investments totaled $4.7
million as of September 30, 2017 and $4.2 million as of December
31, 2016.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171101006786/en/
Exelixis, Inc.Chris Senner, 650-837-7240Chief Financial
Officercsenner@exelixis.comorExelixis,
Inc.Susan Hubbard, 650-837-8194EVP, Public Affairs and Investor
Relationsshubbard@exelixis.com
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