Xenon Pharmaceuticals Reports Third Quarter 2015 Financial Results and Provides Corporate Update
November 10 2015 - 4:30PM
Progress Includes Initiation of XEN801
Phase 1 Clinical Trial and Achievement of Milestones in Genentech
Nav1.7 Clinical Program and Pain Genetics
Collaboration
Conference Call/Webcast Today at 5:00
p.m. Eastern Time
Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage
biopharmaceutical company, today reported its financial results for
the quarter ended September 30, 2015 and provided a corporate
update.
Dr. Simon Pimstone, Xenon's President and Chief Executive
Officer, said, "We are pleased with our progress in the third
quarter in advancing both our partnered and proprietary programs.
We have achieved important milestones that underscore the
therapeutic potential and breadth of our pipeline and the value of
our Extreme Genetics platform. We have achieved two recent
milestones in our collaboration with Genentech including
advancement of a second Nav1.7 inhibitor into clinical testing and
identification of a novel pain gene in our pain genetics
collaboration. In addition, we advanced XEN801 into clinical
development and a Phase 1 trial is ongoing. We believe that we are
well positioned to continue to build on this momentum, with
additional development stage milestones anticipated for the
remainder of this year and into 2016, and that we have sufficient
resources and capabilities to achieve our near-term goals."
2015 Achievements to Date
Partnered Pain Programs with Teva and Genentech
- Xenon's partner Teva Pharmaceutical Industries Ltd. is
conducting a randomized, double-blind, placebo-controlled Phase 2b
clinical trial for TV-45070 in patients with post-herpetic
neuralgia, with results expected in the second half of 2016.
- Xenon's partner Genentech Inc., a member of the Roche Group, is
currently conducting a Phase 1 clinical trial for GDC-0276, which
is expected to complete patient enrollment by the end of 2015.
GDC-0276 is a selective, oral Nav1.7 small-molecule inhibitor being
developed for the treatment of pain.
- Genentech recently advanced a second selective, oral Nav1.7
small-molecule inhibitor, GDC-0310, into a Phase 1 clinical
trial.
- Xenon and Genentech also have an active research collaboration
focused on other selective, oral small molecule inhibitors of
Nav1.7.
- Xenon and Genentech's second collaboration is focused on the
discovery of novel pain targets in rare human pain disorders where
individuals have either an inability to perceive pain or where
individuals have non-precipitated spontaneous severe pain. Xenon
met a key goal of this collaboration by identifying a new pain
target, triggering a milestone payment in September 2015.
Xenon's Proprietary Programs
- XEN801, is a stearoyl Co-A desaturase, or SCD1 inhibitor, for
the treatment of acne. Xenon initiated a Phase 1 clinical trial for
XEN801 in September 2015. If supported by positive data from the
Phase 1 trial, Xenon plans to initiate a Phase 2 clinical trial by
the end of 2015 or early 2016 in patients with moderate to severe
acne. SCD1 is an enzyme involved in lipid synthesis that is
expressed in sebaceous glands in the skin. By inhibiting SCD1,
XEN801 represents a novel approach to treat acne with a dual
mechanism of action expected to reduce both sebum production and
the size and number of sebaceous glands.
- Xenon's development of a Nav1.6 sodium channel inhibitor for
the treatment of Dravet Syndrome, an orphan disease of severe
childhood epilepsy, continues to progress and Xenon expects to file
an investigational new drug application in the second half of 2016.
Xenon's approach to treating Dravet Syndrome is to develop
selective and potent inhibitors of Nav1.6 which have demonstrated
efficacy for seizures in a pre-clinical animal model.
- Xenon also anticipates announcing its next drug discovery
program in 2015 by leveraging its Extreme Genetics discovery
platform and expertise in ion channel chemistry and biology.
Glybera
- Xenon's Glybera licensee, uniQure Biopharma B.V. (Nasdaq:QURE),
has reported that its commercialization partner, Chiesi
Farmaceutici S.p.A., has submitted price and reimbursement dossiers
in key European countries in order to make Glybera accessible to
patients. Chiesi has sole control over commercialization in Europe
and neither uniQure nor Xenon will be providing additional guidance
regarding commercialization progress. Glybera is the first gene
therapy product approved in the European Union for the treatment of
the orphan disorder lipoprotein lipase deficiency, and is the first
product whose active ingredient was derived from Xenon's platform
to receive commercial approval. Xenon is eligible to receive a
royalty on commercial sales.
Third Quarter 2015 Financial Results
Cash and cash equivalents and marketable securities as of
September 30, 2015 were $65.5 million, compared to $84.0 million as
of December 31, 2014. There were 14,344,267 shares outstanding as
of September 30, 2015.
For the quarter ended September 30, 2015, Xenon reported total
revenue of $4.3 million, compared to $13.2 million for the same
period in 2014. Revenue in both periods was primarily derived from
Xenon's collaboration agreements with Teva and Genentech. The
decrease of $8.9 million was primarily attributable to an $8.0
million milestone payment from Genentech in the third quarter of
2014 and revenue recognized relating to the upfront payment from
the December 2011 collaborative development and license agreement
with Genentech which was fully recognized by December 2014. The
remaining decrease was due to less full time equivalent funding
from Genentech and Teva and the change in the foreign exchange rate
between the U.S. and Canadian dollar.
Research and development expenses for the quarter ended
September 30, 2015 were $3.8 million, compared to $3.2 million for
the same period in 2014. The increase of $0.6 million was primarily
attributable to an increase in spending on XEN801 in preparation
for clinical development which began in September 2015 and the
Nav1.6 sodium channel inhibitor program, partially offset by
decreases in Teva and Genentech collaboration expenses.
General and administrative expenses for both the quarter ended
September 30, 2015 and the same period in 2014 were $1.3 million.
For the three months ended September 30, 2015, we recognized a
recovery of $1.0 million due to the change in fair value of our
liability classified stock options granted to directors and certain
consultants until the options were reclassified back to equity in
September 2015. Offsetting the recovery was an increase primarily
attributable to additional expenses incurred as a public company
and acceleration of stock based compensation expense for certain
consultants.
Other expense for the quarter ended September 30, 2015 was $3.0
million, compared to other income of $0.5 million for the same
period in 2014. The change of $3.5 million was primarily
attributable to $3.1 million of unrealized foreign exchange losses
arising from the translation of Canadian denominated balances to
U.S. dollars as a result of the functional currency change to U.S.
dollars from Canadian dollars on January 1, 2015.
Net loss for the quarter ended September 30, 2015 was $3.8
million, compared to net income of $9.2 million for the comparative
period in 2014. The decrease was primarily attributable to lower
revenue, higher operating expenses and unrealized foreign exchange
losses recorded in the quarter ended September 30, 2015.
Conference Call Today at 5:00 p.m. Eastern
Time
Xenon will host a conference call and live audio webcast today
at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss third
quarter 2015 financial results and to provide a business
update.
To participate in the call, please dial (855) 779-9075 for
domestic callers or (631) 485-4866 for international callers, and
provide conference ID number 74074102. The webcast will be
broadcast live on the investors section of Xenon's website at
www.xenon-pharma.com and will be available for replay following the
call for 30 days.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering
and developing a pipeline of differentiated therapeutics for orphan
indications that it intends to commercialize on its own and for
larger market indications that the company intends to partner with
global pharmaceutical companies. Xenon has built a core enabling
discovery platform, referred to as Extreme Genetics®, for the
discovery of validated drug targets by studying rare human diseases
with extreme traits, including diseases caused by mutations in ion
channels, known as channelopathies. Xenon's Extreme Genetics®
platform has yielded the first approved gene therapy product in the
European Union and a broad development pipeline and multiple
pharmaceutical partnerships, including with Teva and Genentech. For
more information, please visit www.xenon-pharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and the Private
Securities Litigation Reform Act of 1995 and Canadian securities
laws. These forward-looking statements are not based on historical
fact, and include statements regarding the timing of IND or IND
equivalent submissions with regulatory agencies; the initiation of
future clinical trials; potential efficacy, future development
plans and commercial potential of our product candidates; the
timing of the completion of and results from additional clinical
trials and pre-clinical development activities; our achievement of
certain milestones under our collaboration agreements; the plans of
our collaboration partners and their interactions with regulatory
agencies; the results of research and development efforts; the
timing for identifying new pain targets in our existing
collaboration with Genentech and announcing another proprietary
drug discovery program and the sufficiency of our resources and
capabilities to achieve our near-term goals. These forward-looking
statements are based on current assumptions that involve risks,
uncertainties and other factors that may cause the actual results,
events or developments to be materially different from those
expressed or implied by such forward-looking statements. These
risks and uncertainties, many of which are beyond our control,
include, but are not limited to: clinical trials may not
demonstrate safety and efficacy of any of our or our collaborators'
product candidates; our Extreme Genetics discovery platform or
ongoing collaborations may not yield additional product candidates;
any of our or our collaborators' product candidates may fail in
development, may not receive required regulatory approvals, or may
be delayed to a point where they are not commercially viable;
Glybera may have its conditional regulatory approval revoked or
modified or may not attain adequate reimbursement coverage from
third party payers; we may not achieve additional milestones
pursuant to our collaboration agreements; the impact of
competition; the impact of expanded product development and
clinical activities on operating expenses; adverse conditions in
the general domestic and global economic markets; as well as the
other risks identified in our filings with the Securities and
Exchange Commission and the securities commissions in British
Columbia, Alberta and Ontario. These forward-looking statements
speak only as of the date hereof and we assume no obligation to
update these forward-looking statements, and readers are cautioned
not to place undue reliance on such forward-looking statements.
The Xenon logo and "Extreme Genetics" are registered trademarks
or trademarks of Xenon Pharmaceuticals Inc. in various
jurisdictions.
|
Xenon Pharmaceuticals
Inc. |
Condensed balance
sheets |
(Unaudited) |
(Expressed in thousands
of U.S. dollars except share data) |
|
|
|
|
September 30, |
December 31, |
|
|
2015 |
2014 |
|
|
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents and marketable
securities |
$65,469 |
$84,041 |
Other current assets |
645 |
901 |
Other assets |
3,830 |
2,476 |
|
|
|
Total assets |
$69,944 |
$87,418 |
|
|
|
|
|
|
Liabilities |
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$2,823 |
$2,664 |
Deferred revenue, current portion |
2,513 |
11,622 |
Non-current liabilities |
149 |
353 |
|
|
|
Total liabilities |
$5,485 |
$14,639 |
|
|
|
Shareholders'
equity |
64,459 |
72,779 |
|
|
|
Total liabilities and shareholders'
equity |
$69,944 |
$87,418 |
|
Xenon Pharmaceuticals
Inc. |
Condensed statements of
operations |
(Unaudited) |
(Expressed in thousands
of U.S. dollars except share and per share
data) |
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
September
30, |
September
30, |
|
2015 |
2014 |
2015 |
2014 |
|
|
|
|
|
Revenue: |
|
|
|
|
Collaboration revenue |
$4,293 |
$13,192 |
$12,347 |
$23,489 |
Royalties |
1 |
1 |
3 |
3 |
|
4,294 |
13,193 |
12,350 |
23,492 |
Operating expenses: |
|
|
|
|
Research and development |
3,793 |
3,216 |
10,889 |
8,315 |
General and administrative |
1,321 |
1,316 |
8,219 |
4,106 |
Total operating expenses |
5,114 |
4,532 |
19,108 |
12,421 |
|
|
|
|
|
Income (loss) from operations |
(820) |
8,661 |
(6,758) |
11,071 |
Other income (expense) |
(3,007) |
530 |
(5,057) |
723 |
|
|
|
|
|
Net income (loss) |
(3,827) |
9,191 |
(11,815) |
11,794 |
Net income attributable to participating
securities |
-- |
5,596 |
-- |
8,199 |
Net income (loss) attributable to common
shareholders |
$(3,827) |
$3,595 |
$(11,815) |
$3,595 |
|
|
|
|
|
Net loss per share attributable to common
shareholders: |
|
|
|
|
Basic |
$(0.27) |
$2.67 |
$(0.83) |
$2.67 |
Diluted |
$(0.27) |
$1.69 |
$(0.83) |
$1.71 |
|
|
|
|
|
Weighted-average shares outstanding: |
Basic |
14,298,612 |
1,348,417 |
14,251,006 |
1,346,989 |
Diluted |
14,298,612 |
2,122,766 |
14,251,006 |
2,108,403 |
CONTACT: Ian Mortimer
Chief Financial Officer and Chief Operating Officer
Xenon Pharmaceuticals Inc.
Phone: 604.484.3300
Email: investors@xenon-pharma.com
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