- 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 -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 1, 2017--
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/
Source: Exelixis, Inc.
Exelixis, Inc.
Chris Senner, 650-837-7240
Chief
Financial Officer
csenner@exelixis.com
or
Exelixis,
Inc.
Susan Hubbard, 650-837-8194
EVP, Public
Affairs and Investor Relations
shubbard@exelixis.com