- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 11, 2015--
Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the
second quarter of 2015 and provided an update on progress toward
delivering upon its key 2015 corporate objectives and clinical
development milestones.
Key Priorities and Corporate Updates
Exelixis is focused on expediting its regulatory submissions for
cabozantinib in advanced renal cell carcinoma (RCC) based on the
positive outcome from the METEOR pivotal trial and building its
commercial infrastructure to support the launch of cabozantinib in
advanced RCC in the United States, pending approval. In addition,
Exelixis continues to support its partner Genentech, a member of the
Roche Group, as it prepares for the potential worldwide
commercialization of cobimetinib, a second Exelixis-discovered compound.
METEOR Trial Delivers Positive Top-Line Results in Advanced RCC.
In July 2015, Exelixis announced that METEOR met its primary endpoint,
demonstrating a statistically significant improvement in
progression-free survival (PFS) for cabozantinib versus everolimus in a
population of patients with advanced renal cell carcinoma who have
experienced disease progression following treatment with at least one
prior VEGFR tyrosine kinase inhibitor. The primary analysis was
conducted on the first 375 patients enrolled, and the hazard ratio (HR)
was 0.58 (95% CI 0.45-0.75, p<0.0001), equating to a 42% decrease in the
risk of disease progression or death for the cabozantinib arm. As
expected, data pertaining to overall survival (OS) for the entire
658-patient study population were not mature at the data cut-off, but a
pre-planned interim analysis showed a trend favoring cabozantinib
(HR=0.67, unadjusted 95 percent CI 0.51-0.89; p=0.005). At the time of
the interim analysis, the pre-specified p-value of 0.0019 to achieve
statistical significance was not reached. The trial will continue to the
final OS analysis anticipated in 2016. The frequency of serious adverse
events of any grade, regardless of causality, was approximately balanced
between study arms, and the rate of discontinuations for adverse events
was low (10%) in both arms.
U.S. and EU Regulatory Filings for Cabozantinib in Advanced RCC
Planned for Early 2016. Having obtained positive top-line results
for METEOR, Exelixis’ highest corporate priority is the completion of
regulatory filings for cabozantinib in advanced RCC. Based on the data
from the trial, the company intends to complete regulatory filings in
the U.S. and European Union in early 2016. Earlier this year,
cabozantinib received Fast Track designation by the U.S. Food and Drug
Administration.
Recently Initiated Trial Combines Cabozantinib with Immunotherapies. In
July 2015, Exelixis’ collaborators at the National Cancer Institute’s
Cancer Therapy Evaluation Program (NCI-CTEP) initiated a phase 1 trial
of cabozantinib in combination with nivolumab alone, or in combination
with nivolumab plus ipilimumab, in patients with genitourinary tumors,
including bladder cancer and RCC. The primary endpoint of the trial is
the determination of dose-limiting toxicities, and a recommended phase 2
dose, for the combinations. Exelixis believes that there is a strong
rationale for combining cabozantinib with immunotherapies, including
clinical evidence of cabozantinib’s ability to create a more
immune-permissive environment, as well as preclinical data suggesting
cabozantinib increases T-cell infiltration into tumors. Data from this
trial could have relevance in other disease settings, including
non-small cell lung cancer (NSCLC).
Data at ASCO Underscore Potential of Cabozantinib in NSCLC. Oral
presentations at the American Society of Clinical Oncology’s 2015 Annual
Meeting, May 29 - June 2, highlighted positive data from two trials of
cabozantinib in molecularly-defined subtypes of NSCLC. An
investigator-sponsored phase 2 trial of cabozantinib in RET-rearranged
NSCLC met its primary endpoint, exceeding the predefined number of
objective responses. A second trial, conducted by the ECOG-ACRIN Cancer
Research Group under Exelixis’ cooperative research and development
agreement with NCI-CTEP, also met its primary endpoint, extending PFS
for cabozantinib and the combination of cabozantinib and erlotinib
versus erlotinib alone in EGFR wild-type NSCLC. Exelixis is committed to
working with its collaborators at the NCI and at ECOG-ACRIN to explore
further development of cabozantinib in lung cancer.
Cobimetinib Commercialization Planning Continues Ahead of Anticipated
Regulatory Decisions. Also at ASCO, investigators presented updated
data from coBRIM, the phase 3 pivotal trial of cobimetinib in
combination with vemurafenib in patients with advanced melanoma
harboring a BRAF V600 mutation. coBRIM formed the basis for Genentech’s
and Roche’s regulatory filings in the U.S. and EU, respectively, for
which both companies anticipate decisions later this year. In the U.S.,
Genentech’s New Drug Application received priority review, and the
Prescription Drug User Fee Act action date is now November 11, 2015.
Cobimetinib, a selective MEK inhibitor discovered by Exelixis, is the
subject of a worldwide collaboration agreement between Exelixis and
Genentech. Pursuant to this agreement, Exelixis is entitled to an
initial equal share of U.S. profits and losses, with Exelixis’ share
decreasing as sales increase. The parties will share equally in the U.S.
marketing and commercialization costs, and, if approved, Exelixis will
co-promote the compound in the U.S. Outside the U.S., Exelixis is
entitled to receive royalties on sales of cobimetinib.
Christopher J. Senner Joins Exelixis as EVP and Chief Financial
Officer. In July 2015, Exelixis appointed Chris Senner to the role
of Executive Vice President and Chief Financial Officer. Mr. Senner has
nearly 25 years of experience in biopharmaceutical finance. He joined
Exelixis following five years at Gilead Sciences, where he most recently
served as Vice President, Corporate Finance. Prior to joining Gilead,
Mr. Senner spent eighteen years at Wyeth in a variety of financial roles
with increasing responsibility for many of the company’s divisions and
regions.
Extension of Maturity Date of Indebtedness Under the Note Purchase
Agreement with Deerfield. On July 1, 2015, Exelixis extended the
maturity date of the Deerfield Notes from July 1, 2015 to July 1, 2018.
The Deerfield Notes will bear interest on and after July 2, 2015, at the
rate of 7.5% per annum to be paid in cash, quarterly in arrears, and
7.5% per annum to be paid in kind, quarterly in arrears, for a total
interest rate of 15% per annum and will mature on July 1, 2018.
Public Offering of Stock Raises Net Proceeds of $146 Million. After
the second quarter ended, Exelixis launched and completed a public
offering of common stock. The company issued 28,750,000 shares,
including 3,750,000 shares issued under the underwriters’ 30-day option
to buy shares, at a price to the public of $5.40 per share, receiving
approximately $146 million in net proceeds after deducting the
underwriting discount and other estimated offering expenses payable by
Exelixis. Exelixis currently expects to use the net proceeds from the
offering for general corporate purposes, including for clinical trials,
build-out of commercial infrastructure, research and development,
capital expenditures and working capital.
“The second quarter, and the weeks following it, are some of the most
significant in Exelixis history,” said Michael M. Morrissey, Ph.D.,
President and Chief Executive Officer of the company. “As announced in
July, cabozantinib delivered impressive results in the METEOR trial,
including a statistically significant and clinically meaningful
improvement in PFS, along with a strong trend toward improving overall
survival, as compared to everolimus, a widely-used agent in the second
and later lines of advanced RCC treatment. The data will serve as the
foundation for regulatory filings in the U.S. and EU, which we intend to
complete in early 2016.”
Dr. Morrissey continued: “As we move into the third quarter with METEOR
data in hand, all of us at Exelixis share an even greater sense of
urgency and focus around maximizing the potential of our pipeline to
help patients with cancer. This is illustrated by our recent activities,
including the recruitment of a new chief financial officer with global
commercial finance expertise, advancement of our discussions around a
potential partnership for ex-U.S. rights to cabozantinib, and the
initiation of a new trial evaluating cabozantinib in combination with
immunotherapies. At the same time, alongside our partners Roche and
Genentech, we have completed our commercial readiness for the potential
U.S. regulatory approval of cobimetinib later this year.”
COMETRIQ Product Revenue. Net product revenue from COMETRIQ®
(cabozantinib capsules) sales was $8.0 million for the second quarter of
2015.
2015 Financial Guidance. The company anticipates that operating
expenses for the second six months of 2015 will be in a range of $80
million to $90 million, including approximately $10 million of
incremental non-cash stock-based compensation expense related to the
vesting of performance stock options tied to the read-out of METEOR
top-line results.
Second Quarter 2015 Financial Results
Net revenues for the quarter ended June 30, 2015 were $8.0
million, compared to $6.6 million for the comparable period in 2014. Net
revenues consisted entirely of product revenue related to the sale of
COMETRIQ.
Research and development expenses for the quarter ended June 30,
2015 were $24.5 million, compared to $51.0 million for the comparable
period in 2014. The decrease was primarily related to a net decrease in
clinical trial costs, predominantly due to decreases in costs related to
COMET-1 and COMET-2, the company’s phase 3 trials in metastatic
castration-resistant prostate cancer, and decreases in personnel related
expenses resulting from an overall reduction in headcount.
Selling, general and administrative expenses for the quarter
ended June 30, 2015 were $12.8 million, compared to $16.5 million for
the comparable period in 2014. The decrease was primarily related to a
decrease in personnel and stock-based compensation expenses resulting
from an overall reduction in headcount, consulting and outside services,
and legal and patent costs. Those decreases were partially offset by
higher marketing expenses, including expenses for cobimetinib under the
company’s collaboration agreement with Genentech.
Restructuring charge for the quarter ended June 30, 2015 was $1.3
million. The restructuring charge was primarily related to the exit of
certain facilities, the partial termination of one of Exelixis’ building
leases and subleasing activities during the period.
Other income (expense), net for the quarter ended June 30, 2015
was a net expense of ($12.1) million compared to ($11.7) million for the
comparable period in 2014. The net expense is comprised primarily of
interest expense which includes $7.2 million of non-cash expense related
to the accretion of the discounts on both the 4.25% Convertible Senior
Subordinated Notes due 2019 and the company’s indebtedness under the
Deerfield Notes for the quarter ended June 30, 2015, as compared to $7.3
million for the comparable period in 2014.
Net loss for the quarter ended June 30, 2015 was ($43.4) million,
or ($0.22) per share, basic, compared to ($73.4) million, or ($0.38) per
share, basic, for the comparable period in 2014. The decreased net loss
for the quarter was primarily due to decreases in research and
development expenses and selling, general and administrative expenses
and an increase in product revenues.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $167.0
million at June 30, 2015 compared to $242.8 million at December 31,
2014. The June 30, 2015 cash position was prior to the launch of the
company’s public offering of stock on July 21, 2015, as noted above.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
second quarter of 2015 and provide a general business update during a
conference call beginning at 5:00 p.m. EDT/2:00 p.m. PDT today, August
11, 2015. To join the call, participants may dial 855-793-2457
(domestic) or 631-485-4921 (international) and provide the conference
call passcode 94776699 to join by phone. To listen to a live webcast of
the conference call, visit the Event Calendar page under Investors &
Media at www.exelixis.com.
An archived replay of the webcast will be available on the Event
Calendar page under Investors & Media at www.exelixis.com
for one year. An audio-only phone replay will be available until 11:59
p.m. EDT on August 13, 2015. Access numbers for the phone replay are:
855-859-2056 (domestic) and 404-537-3406 (international); the passcode
is 94776699.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine
kinases. Another Exelixis-discovered compound, cobimetinib, a selective
inhibitor of MEK, is being evaluated by Roche and Genentech (a member of
the Roche Group) in a broad development program under a collaboration
with Exelixis. For more information, please visit the company’s web site
at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: Exelixis’ key 2015 corporate
objectives and clinical development milestones; Exelixis’ focus on
expediting regulatory submissions for cabozantinib for the treatment of
advanced RCC and building a commercial infrastructure to support the
launch of advanced RCC, pending approval; Exelixis’ continued support of
Genentech, as it prepares for the potential worldwide commercialization
of cobimetinib; the continuation of the METEOR trial to the final OS
analysis anticipated in 2016; Exelixis’ plan to complete regulatory
filings for cabozantinib for the treatment of advanced RCC in the U.S.
and EU in early 2016; Exelixis’ belief that there is a strong rationale
for combining cabozantinib with immunotherapies and that data from the
phase 1 trial of cabozantinib in combination nivolumab alone, or in
combination with nivolumab plus ipilimumab, in patients with
genitourinary tumors, including bladder cancer and RCC, could have
relevance in other disease settings; Exelixis’ commitment to working
with its collaborators at NCI and at ECOG-ACRIN to explore further
development of cabozantinib in lung cancer; the continued
commercialization planning for cobimetinib ahead of anticipated
regulatory decisions; the financial terms of Exelixis’ collaboration
with Genentech if cobimetinib successfully reaches the market, including
Exelixis’ entitlement to an initial equal share of U.S. profits and
losses, with Exelixis’ share decreasing as sales increase; the parties
plan to share equally in the U.S. marketing and commercialization costs,
Exelixis’ plans to co-promote the compound in the U.S. and Exelixis’
entitlement to receive royalties on sales of cobimetinib outside of the
U.S.; Exelixis’ expectations for use of the net proceeds from the
public offering; the strong trend toward improving OS, as compared to
everolimus, reflected in the METEOR trial results; Exelixis’ plan to use
the data from the METEOR trial results as the foundation for regulatory
filings in the U.S. and EU; Exelixis’ plan to maximize the potential of
its pipeline to help patients with cancer; Exelixis’ commercial
readiness for the potential U.S. regulatory approval of cobimetinib
later this year; and Exelixis’ financial outlook for the second six
months of 2015, including non-cash charges for stock-based compensation.
Words such as “objectives,” “focused,” “continues,” “potential,” “will,”
“anticipated,” “planned,” “priority,” “intends,” “believes,” “could,”
“committed,” “entitled,” “expects,” “trend,” 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. Exelixis’ 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 uncertainties of the regulatory review and
approval processes and Exelixis’ compliance with applicable legal and
regulatory requirements; Exelixis’ ability to correctly judge the
proper size and level of experience of the sales and marketing force
required to support the launch of advanced RCC, if approved; Exelixis’
dependence on its relationship with Genentech/Roche with respect to
cobimetinib and Exelixis’ ability to maintain its rights under the
collaboration; the availability of data at the expected times; risks
related to the potential failure of cabozantinib or cobimetinib to
demonstrate safety and efficacy in clinical testing; the clinical,
therapeutic and commercial value of cabozantinib and cobimetinib; the
sufficiency of Exelixis’ capital and other resources; the uncertain
timing and level of expenses associated with the development of
cabozantinib; Exelixis’ ability to enter into new collaborations on
acceptable terms; Exelixis’ ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; the risk that
unanticipated developments could adversely affect the commercialization
of COMETRIQ; the degree of market acceptance of COMETRIQ and the
availability of coverage and reimbursement for COMETRIQ; Exelixis’
dependence on third-party vendors; 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 Securities and Exchange Commission (SEC) on August 11, 2015 and
in Exelixis’ other filings with the SEC. 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, and COMETRIQ are registered U.S.
trademarks.
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EXELIXIS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
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2015
|
|
2014
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$
|
7,992
|
|
|
$
|
6,562
|
|
|
$
|
17,380
|
|
|
$
|
11,467
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
686
|
|
|
477
|
|
|
1,452
|
|
|
786
|
|
Research and development
|
|
24,506
|
|
|
50,976
|
|
|
46,788
|
|
|
105,823
|
|
Selling, general and administrative
|
|
12,789
|
|
|
16,466
|
|
|
22,320
|
|
|
31,157
|
|
Restructuring charge
|
|
1,291
|
|
|
331
|
|
|
860
|
|
|
377
|
|
Total operating expenses
|
|
39,272
|
|
|
68,250
|
|
|
71,420
|
|
|
138,143
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(31,280
|
)
|
|
(61,688
|
)
|
|
(54,040
|
)
|
|
(126,676
|
)
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
(123
|
)
|
|
359
|
|
|
(130
|
)
|
|
2,490
|
|
Interest expense
|
|
(11,959
|
)
|
|
(12,081
|
)
|
|
(24,362
|
)
|
|
(23,843
|
)
|
Total other income (expense), net
|
|
(12,082
|
)
|
|
(11,722
|
)
|
|
(24,492
|
)
|
|
(21,353
|
)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(43,362
|
)
|
|
$
|
(73,410
|
)
|
|
$
|
(78,532
|
)
|
|
$
|
(148,029
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$
|
(0.22
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(0.40
|
)
|
|
$
|
(0.77
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
196,201
|
|
|
194,929
|
|
|
196,052
|
|
|
193,323
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET DATA
(in thousands)
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014 (1)
|
|
|
(unaudited)
|
|
Cash and investments (2)
|
|
$
|
166,988
|
|
|
$
|
242,760
|
|
|
|
|
|
|
Working capital (deficit)
|
|
$
|
31,487
|
|
|
$
|
(4,619
|
)
|
|
|
|
|
|
Total assets
|
|
$
|
248,778
|
|
|
$
|
327,960
|
|
|
|
|
|
|
Total stockholders’ deficit
|
|
$
|
(188,188
|
)
|
|
$
|
(114,829
|
)
|
_______________________________________
(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 $8.8 million and $16.9 million as of June 30, 2015 and
December 31, 2014, respectively.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150811006381/en/
Source: Exelixis, Inc.
Exelixis, Inc.
Chris Senner, 650-837-7240
Chief
Financial Officer
csenner@exelixis.com
Susan
Hubbard, 650-837-8194
Investor Relations & Corporate
Communications
shubbard@exelixis.com