- Conference Call and Webcast Today at 5:00 PM Eastern Time -
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb. 24, 2015--
Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the
fourth quarter and full year of 2014 and provided an update on progress
toward delivering upon its 2015 key corporate objectives and clinical
development milestones.
Corporate Updates and Key Priorities for 2015
In 2015, Exelixis will continue to focus its development efforts and
financial resources on the opportunities for cabozantinib in metastatic
renal cell carcinoma (mRCC) and advanced hepatocellular carcinoma (HCC),
and 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.
Top-Line Results for METEOR Trial in mRCC Expected in Q2 2015. The
company’s top clinical development priority is the delivery of top-line
data for METEOR, the phase 3 pivotal trial of cabozantinib in mRCC.
Enrollment in METEOR was completed in November 2014, and Exelixis
expects top-line results from the trial’s primary endpoint,
progression-free survival (PFS), in the second quarter of this year. Per
the trial protocol, the primary PFS endpoint analysis will be conducted
once 259 events have occurred among the first 375 patients enrolled.
Enrollment for the first 375 patients in METEOR was completed in June
2014.
Cobimetinib U.S. and EU Regulatory Progress. As announced earlier
this month, the U.S. Food & Drug Administration (FDA) has accepted for
review Genentech’s New Drug Application (NDA) for cobimetinib, an
Exelixis-discovered compound, to be used in combination with vemurafenib
as a treatment for patients with BRAF V600 mutation-positive advanced
melanoma. The FDA granted Priority Review to the NDA and assigned a
Prescription Drug User Fee Act Action Date of August 11, 2015. Cobimetinib
is the subject of a worldwide co-development agreement between Exelixis
and Genentech. Pursuant to this agreement, Exelixis is entitled to an
initial equal share of U.S. profits and losses, which share will
decrease 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. In the European
Union, Roche filed a Marketing Authorization Application for cobimetinib
used in combination with vemurafenib in September of 2014.
Genentech has also initiated a series of early clinical studies
evaluating the potential of cobimetinib in combination with other
compounds in its oncology pipeline, including the anti-PDL1 antibody
MPDL3280A, and in other solid tumor types, including non-small cell lung
cancer (NSCLC), colorectal cancer and triple-negative breast cancer.
Broad Cabozantinib Development Program Continues to Expand through
NCI and Independent Investigators. While Exelixis pursues
cabozantinib’s late-stage development in mRCC and advanced HCC,
earlier-stage investigation continues through the company’s
collaboration with the National Cancer Institute’s Cancer Therapy
Evaluation Program (NCI-CTEP), and its ongoing Investigator-Sponsored
Trial (IST) program. Key anticipated milestones for the NCI-CTEP program
expected to be reached in the first half of 2015 include: top-line data
from a randomized phase 2 trial of cabozantinib versus paclitaxel in
second or later line persistent or recurrent ovarian cancer; detailed
data from a randomized phase 2 trial of cabozantinib with and without
erlotinib compared to erlotinib alone in second or third line EGFR
wild-type NSCLC; completion of enrollment of a randomized phase 2 study
of cabozantinib versus sunitinib in first-line RCC; and the initiation
by the NCI of a combination phase 1b study of cabozantinib and nivolumab
with or without ipilimumab in urothelial cancer.
Advancing Other Pipeline and Partnered Programs. Beyond
cabozantinib and cobimetinib, other Exelixis-discovered compounds
continue to advance. In November, independent investigators at the
Moffitt Cancer Center (Tampa, Florida) presented positive preliminary
data from a phase 1 trial of XL888, the company’s wholly-owned small
molecule oral inhibitor of Heat Shock Protein 90 (HSP90), in combination
with vemurafenib in patients with BRAF V600 mutation-positive melanoma.
Based on those results, as well as the data from cobimetinib’s pivotal
trial, the investigators plan to initiate a phase 1b IST of vemurafenib,
cobimetinib, and XL888 in a similar population this year.
Separately, Exelixis’ partner Daiichi-Sankyo has recently initiated two
large phase 2b trials of CS-3150 (XL550), from Exelixis-discovered
compounds, in Japanese patients with hypertension and diabetic
nephropathy, respectively. CS-3150 is a small molecule antagonist of the
mineralocorticoid receptor, a nuclear hormone receptor implicated in a
variety of cardiovascular and metabolic diseases. Exelixis out-licensed
the compounds to Daiichi-Sankyo in 2006 and is eligible to receive
additional development, regulatory and commercialization milestone
payments, as well as royalties on any potential product sales.
COMETRIQ Product Revenue and European Commercialization. Net
product revenue from COMETRIQ® (cabozantinib capsules) sales
was $7.4 million for the fourth quarter of 2014, an increase of 69
percent over the fourth quarter of 2013, reflecting the continued ramp
up in sales of the product following its commercial launch in the United
States in January 2013 and further uptake of COMETRIQ in certain
countries of the European Union following its approval in March 2014.
Net product revenue for the fourth quarter of 2014 includes the impact
of a project management fee of $0.5 million payable to Exelixis’
European distribution partner, Swedish Orphan Biovitrum AB (Sobi), upon
its achievement of a cumulative revenue goal.
Exelixis and Sobi continue to make progress on the European
commercialization of COMETRIQ following its EU approval in March 2014.
Last month, Exelixis and Sobi announced an extended and restructured
agreement to support the distribution and commercialization of COMETRIQ
for its medullary thyroid cancer indication in the EU, Switzerland,
Norway, Russia, and Turkey. The agreement, which was established in
February 2013 and due to expire on December 31, 2015, will now extend to
December 31, 2019. Moreover, the payment structure of the partnership
will transition from fixed fees paid by Exelixis to Sobi to support
initial build out of COMETRIQ European commercial infrastructure to a
sales margin-based approach. COMETRIQ is now commercially available
in Germany, Wales, England, Sweden, Finland, Denmark, Norway, Czech
Republic, Austria and The Netherlands, and Sobi anticipates additional
European launches during the course of 2015 and beyond as pricing and
reimbursement are achieved.
2015 Financial Guidance. Given that Exelixis anticipates key
clinical milestones in the second quarter of this year that will
influence operating expenses for the remainder of 2015, the company is
currently only providing guidance for the first six months of 2015. The
company anticipates that operating expenses for the first six months of
2015 to be in a range of $70 million to $80 million. This range includes
approximately $5 million in restructuring charges in the first half of
2015 primarily related to building exit costs. Taking into account the
expected extension of the maturity date of the company’s indebtedness
under its note purchase agreement with Deerfield to July 1, 2018 from
July 1, 2015, Exelixis expects that its current cash and cash
equivalents, short- and long-term investments and product revenues are
sufficient to fund its operations through the end of 2015. Exelixis has
until March 31, 2015 to exercise its option to extend the maturity date
of the Deerfield indebtedness, as provided for by the January 2014
amendment to the note purchase agreement. Any exercise of the extension
option by Exelixis will be subject to customary conditions set forth in
the note purchase agreement, as amended.
“In 2015, Exelixis anticipates multiple clinical development and
regulatory milestones that have the potential to significantly shape our
company’s path forward and positively impact the patients, clinicians
and other stakeholders we serve,” said Michael M. Morrissey, Ph.D., the
company’s president and chief executive officer. “In the second quarter,
we expect top-line results from the METEOR phase 3 pivotal trial, which,
if positive, would represent considerable progress for Exelixis towards
delivering a new and meaningfully differentiated therapeutic option for
patients with mRCC. In the third quarter, we anticipate an FDA decision
on Genentech’s NDA for cobimetinib for use in combination with
vemurafenib. Such an approval would represent both a substantial advance
for the melanoma community and a valuable opportunity for Exelixis to
work alongside Genentech to co-promote cobimetinib in the United States.”
Dr. Morrissey continued: “While Exelixis maintains its close focus on
cabozantinib’s ongoing pivotal trials, our collaborators continue to
evaluate cabozantinib, and other Exelixis-discovered compounds, in a
variety of settings. We look forward to the planned readout and
presentation of trials evaluating cabozantinib in ovarian cancer and
EGFR wild type NSCLC this year, and to the Moffitt Cancer Center’s
initiation of the planned triple-combination trial of XL888,
vemurafenib, and cobimetinib. We are steadfast in our commitment to seek
to maximize the value of our oncology assets through our clinical and
commercial efforts, and we remain grateful for our stakeholders’ support
as we work to make meaningful contributions to improving cancer care.”
Fourth Quarter and Full Year 2014 Financial
Results
Net revenues for the quarter ended December 31, 2014 were $7.4
million, compared to $4.3 million for the comparable period in 2013; and
for the year ended December 31, 2014 were $25.1 million, compared to
$31.3 million for the comparable period in 2013. Net revenues in 2014
consisted entirely of product revenue related to the sale of COMETRIQ
and were net of a project management fee payable to Exelixis’ European
distribution partner of $0.5 million for the fourth quarter of 2014 and
$2.3 million for the year ended December 31, 2014; no such fees were
recognized during the comparable periods in 2013. Net revenues in 2013
consisted of $15.0 million of product revenue and $16.3 million of
license and contract revenue. The decrease in contract and license
revenue reflects the company’s full recognition of all revenues from its
collaboration agreements with Bristol-Myers Squibb Company in the third
quarter of 2013.
Research and development expenses for the quarter ended
December 31, 2014 were $39.7 million, compared to $49.6 million for the
comparable period in 2013; for the year ended December 31, 2014 were
$189.1 million, compared to $178.8 million for the comparable period in
2013. The decrease for the quarter ended December 31, 2014 as compared
to the same period in 2013 primarily related to a decrease in personnel
expenses resulting from an overall reduction in headcount and the
elimination of employee bonuses as well as a related reduction in
stock-based compensation expense; in addition, clinical trial costs
decreased predominantly due to a reduction in costs related to COMET-1,
which was offset in part by increases in costs related to METEOR and
CELESTIAL, Exelixis’ phase 3 pivotal trial in advanced HCC. The overall
increase in research and development expenses for the year ended
December 31, 2014 as compared to 2013 was primarily due to increased
clinical trial costs, and related temporary, consulting and outside
servicing costs in support of METEOR. These increased costs were
partially offset by a reduction in costs related to COMET-1 and were
further offset by decreases in personnel expenses resulting in part from
the elimination of employee bonuses and a reduction in stock-based
compensation expense.
Selling, general and administrative expenses for the quarter
ended December 31, 2014 were $9.8 million, compared to $13.6 million for
the comparable period in 2013; and for the year ended December 31, 2014
were $50.8 million, compared to $51.0 million for the comparable period
in 2013. The decrease for the quarter ended December 31, 2014, as
compared to 2013, was primarily related to a decrease in personnel
expenses resulting from an overall reduction in headcount and the
elimination of employee bonuses as well as lower consulting and outside
services fees. For the year ended December 31, 2014, as compared to
2013, decreases in consulting and outside services fees and legal costs
were offset by increased personnel expenses, the majority of which are
associated with the expansion of the company’s U.S. sales force and
higher marketing expenses, including an increase in expenses for
cobimetinib under the company’s collaboration agreement with Genentech.
Restructuring charge for the quarter ended December 31, 2014 was
$3.5 million compared to $0.4 million for the comparable period in 2013;
and for the year ended December 31, 2014 was $7.6 million compared to
$1.2 million for the comparable period in 2013. The restructuring charge
for the quarter and year ended December 31, 2014 was primarily related
to employee termination benefits and asset impairment charges resulting
from the restructuring plan initiated in September 2014.
Other income (expense), net for the quarter ended December 31,
2014 was a net expense of ($11.9) million compared to ($11.3) million
for the comparable period in 2013; and for the year ended December 31,
2014 was a net expense of ($44.3) million compared to ($44.1) million
for the comparable period in 2013. The slight increase in expense for
both the quarter and year ended December 31, 2014 is primarily due to
interest expense which includes $7.7 million and $29.5 million,
respectively, 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 its note purchase agreement
with Deerfield, as compared to $6.8 million and $26.3 million,
respectively, for the comparable periods in 2013.
Income tax benefit for the quarter and year ended December 31,
2014 of $0.2 million resulted from state tax benefit related to the
lapse of the applicable statute of limitations in California for the
2009 tax year, offset by current year state income tax expense.
Net loss for the quarter ended December 31, 2014 was ($58.0)
million, or ($0.30) per share, basic, compared to ($70.7) million, or
($0.38) per share, basic, for the comparable period in 2013; and for the
year ended December 31, 2014 was ($268.5) million, or ($1.38) per share,
basic, compared to ($244.8) million, or ($1.33) per share, basic, for
the comparable period in 2013. 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, which was partially offset by an increase in restructuring
charges. The increased net loss for the year was primarily due to
decreases in contract and license revenue, increases in research and
development expenses and restructuring charges, which was partially
offset by an increase in product revenues.
Cash and cash equivalents, short- and long-term investments and
short- and long-term restricted cash and investments totaled $242.8
million at December 31, 2014, compared to $415.9 million at December 31,
2013.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the
quarter and full year ended December 31, 2014 and provide a general
business update during a conference call beginning at 5:00 p.m. EST/2:00
p.m. PST today, February 24, 2015. To join the call, participants may
dial 1-877-546-5020 (domestic) or 1-857-244-7552 (international) and use
passcode 38677626. 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. EST on February 26, 2015. Access numbers for the phone replay are:
888-286-8010 (domestic) and 617-801-6888 (international); the passcode
is 64033209.
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
COMETRIQ® (cabozantinib), its wholly-owned inhibitor of
multiple receptor tyrosine kinases. Another Exelixis-discovered
compound, cobimetinib, a highly 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.
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 quarters and years ended
January 2, 2015 and December 27, 2013 are indicated as ended
December 31, 2014 and December 31, 2013, respectively. The quarter ended
January 2, 2015 is a 14-week fiscal quarter; all other interim periods
presented are 13-week fiscal quarters.
Forward-Looking Statements
This press release contains forward-looking statements, including,
without limitation, statements related to: the continued development and
clinical, therapeutic and commercial potential of, and opportunities
for, cabozantinib, cobimetinib and other Exelixis-discovered compounds;
anticipated developments and timing with respect to Exelixis’ ongoing
phase 3 pivotal trials of cabozantinib; future cobimetinib regulatory
filings and potential approvals; the progress of Exelixis’
commercialization planning and preparation efforts with Genentech; the
progress of the European commercialization of COMETRIQ®
(cabozantinib); continuing investigation of cabozantinib through
Exelixis’ collaborations with the NCI-CTEP and the ongoing IST program;
future data presentations and clinical trial planning; Exelixis’
financial outlook for the first six months of 2015, including projected
operating expenses; the sufficiency of Exelixis’ cash resources to fund
its operations through the end of 2015; the expected extension of the
maturity date of Exelixis’ indebtedness under its note purchase
agreement with Deerfield to July 1, 2018 from July 1, 2015; and the
timing of future reporting on Exelixis’ progress. Words such as
“continues,” “expects,” “anticipate,” “will,” “plan,” “initiate,”
“potential,” “focus,” “delivery,” “committed,” “look forward,” 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 availability of data at the expected times;
risks related to the potential failure of cabozantinib, cobimetinib and
other Exelixis-discovered compounds to demonstrate safety and efficacy
in clinical testing; the clinical, therapeutic and commercial value of
cobimetinib, cabozantinib and other Exelixis-discovered compounds;
Exelixis’ dependence on its relationship with Genentech/Roche with
respect to cobimetinib and Exelixis’ ability to maintain its rights
under the collaboration; the uncertainty of regulatory approval
processes; the sufficiency of Exelixis’ capital and other resources; the
uncertain timing and level of expenses associated with the development
of cabozantinib; Exelixis’ ability to conduct clinical trials of
cabozantinib sufficient to achieve a positive completion; Exelixis’
ability to extend the maturity date of its indebtedness under its note
purchase agreement with Deerfield in accordance with, and subject to,
the terms and conditions of the note purchase agreement; 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; risks and
uncertainties related to Exelixis’ compliance with applicable regulatory
requirements, including healthcare fraud and abuse laws and
post-marketing requirements; 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 November 4, 2014, as updated by Exelixis’
annual report on Form 10-K to be filed with the SEC not later than March
3, 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.
|
|
|
|
|
|
|
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except per share data) (unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
|
Year Ended December 31,
|
|
|
|
2014
|
|
2013
|
|
|
2014
|
|
2013 (1)
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
|
$
|
7,353
|
|
|
$
|
4,347
|
|
|
|
$
|
25,111
|
|
|
$
|
15,017
|
|
License and contract revenues
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
16,321
|
|
Total revenues
|
|
|
7,353
|
|
|
4,347
|
|
|
|
25,111
|
|
|
31,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
|
684
|
|
|
263
|
|
|
|
2,043
|
|
|
1,118
|
|
Research and development
|
|
|
39,650
|
|
|
49,597
|
|
|
|
189,101
|
|
|
178,763
|
|
Selling, general and administrative
|
|
|
9,766
|
|
|
13,635
|
|
|
|
50,829
|
|
|
50,958
|
|
Restructuring charge
|
|
|
3,461
|
|
|
366
|
|
|
|
7,596
|
|
|
1,231
|
|
Total operating expenses
|
|
|
53,561
|
|
|
63,861
|
|
|
|
249,569
|
|
|
232,070
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(46,208
|
)
|
|
(59,514
|
)
|
|
|
(224,458
|
)
|
|
(200,732
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and other, net
|
|
|
555
|
|
|
293
|
|
|
|
4,341
|
|
|
1,223
|
|
Interest expense
|
|
|
(12,482
|
)
|
|
(11,621
|
)
|
|
|
(48,607
|
)
|
|
(45,347
|
)
|
|
Total other income (expense), net
|
|
|
(11,927
|
)
|
|
(11,328
|
)
|
|
|
(44,266
|
)
|
|
(44,124
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(58,135
|
)
|
|
(70,842
|
)
|
|
|
(268,724
|
)
|
|
(244,856
|
)
|
|
Income tax benefit
|
|
|
(182
|
)
|
|
(96
|
)
|
|
|
(182
|
)
|
|
(96
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(57,953
|
)
|
|
$
|
(70,746
|
)
|
|
|
$
|
(268,542
|
)
|
|
$
|
(244,760
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
|
$
|
(0.30
|
)
|
|
$
|
(0.38
|
)
|
|
|
$
|
(1.38
|
)
|
|
$
|
(1.33
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
195,536
|
|
|
184,376
|
|
|
|
194,299
|
|
|
184,062
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Derived from the audited consolidated financial statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXELIXIS, INC. CONDENSED CONSOLIDATED BALANCE SHEET
DATA (in thousands)
|
|
|
|
|
|
|
|
|
|
December 31, 2014 (unaudited)
|
|
December 31, 2013 (1)
|
Cash and investments (2)
|
|
|
$
|
242,760
|
|
|
$
|
415,862
|
|
|
|
|
|
|
|
Working capital
|
|
|
$
|
(4,619
|
)
|
|
$
|
178,756
|
|
|
|
|
|
|
|
Total assets
|
|
|
$
|
327,960
|
|
|
$
|
503,287
|
|
|
|
|
|
|
|
Total stockholders’ (deficit) equity
|
|
|
$
|
(114,829
|
)
|
|
$
|
66,238
|
|
|
|
|
|
|
|
|
|
(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 $16.9 million and $29.1 million as of December 31, 2014 and
December 31, 2013, respectively.
|
Source: Exelixis, Inc.
Exelixis, Inc.
Deborah Burke, 650-837-7835
Chief
Financial Officer
dburke@exelixis.com
or
Susan
Hubbard, 650-837-8194
Investor Relations & Corporate
Communications
shubbard@exelixis.com