GENEVA, SWITZERLAND--(Marketwire - Feb 23, 2012) -
Addex Pharmaceuticals /
Addex Pharmaceuticals Reports 2011 Financial Results
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Financial Highlights
* Cash and cash equivalents of CHF36.1 million at 31 December 2011
* Cash can fund operations through to 3Q 2013
* Restructuring and pipeline prioritization successfully implemented
* CHF28 million cash used for operations, at the low end of CHF28-32
million guidance
Operating Highlights
* Dipraglurant Phase II Parkinson's disease trial fully enrolled in 2011
- top
line data around end of March
* ADX71149 Phase II trial in schizophrenia patients initiated 1H11 by
Janssen
Pharmaceuticals Inc.
* New CEO, Bharatt Chowrira, focuses on pipeline execution and partnering
Addex Pharmaceuticals (SIX: ADXN), a
leading company pioneering allosteric modulation-based drug discovery
and
development, announced today its 2011 financial results. A conference
call and
webcast will be presented to investors, analysts and media at 16:00 CET
(15:00
GMT/10:00 ET) today.
"Last year Addex made significant progress and breakthroughs on several
fronts,"
said Bharatt Chowrira, President and CEO of Addex. "We were pleased to
see two
of our orally active allosteric modulators enter Phase IIa testing. We
fine-
tuned our strategy, re-focused on our core strengths and took
measures to
enhance operational efficiency going forward. As a result, the company is
now on
a much stronger footing and well positioned to achieve our near- and
medium-term
objectives."
Commenting on the financials, Tim Dyer, CFO, said: "we are delighted to
see our
restructuring and operational efficiency initiatives result in cash
utilization
coming in at the low end of 2011 guidance. In 2012, we plan to
strengthen our
balance sheet through the execution of high value partnerships while
efficiently
advancing our pipeline. Cash utilization guidance is significantly
reduced in
2012 to CHF23-25 million."
Key 2011 Financial Data
CHF' thousands 2011 2010 Change 2H11 2H10 Change
---------------------------------------------------------------------------
Income 3 743 4 000 (6%) 570 1 300 (56%)
--------------------------------------------------------
R&D expenses (27 986) (31 165) (10%) (13 428) (14 479) (7%)
G&A expenses (6 731) (6 433) 5% (3 432) (3 144) 9%
--------------------------------------------------------
Total operating
loss (30 974) (33 598) (8%) (16 290) (16 323) -
--------------------------------------------------------
Finance result,
net (167) (47) 255% (24) (60) (60%)
--------------------------------------------------------
Net loss for the
period (31 141) (33 645) (7%) (16 314) (16 383) -
--------------------------------------------------------
Basic and diluted
net loss per share (4.19) (5.69) (26%) (2.12) (2.68) (21%)
Net cash used (cash
burn) (27 732) (12 763) 117% (14 165) 7 111 299%
Cash and cash
equivalents 36 065 63 797 (43%) 36 065 63 797 (43%)
Shareholders' equity 33 836 64 414 (47%) 33 836 64 414 (47%)
2011 Financial Summary
Income was CHF3.7 million in 2011 compared to CHF4.0 million in
2010 and
comprised mainly of a milestone payment of CHF2.6 million received from
Janssen
Pharmaceuticals Inc. (JPI) under our mGluR2 PAM license agreement and
CHF0.7
million from a grant received from The Michael J. Fox Foundation for
Parkinson's
Research to support our dipraglurant Phase II study in Parkinson's
disease
levodopa-induced dyskinesia.
Research & development expenses decreased by 10% to CHF28.0 million in
2011
compared to CHF31.2 million in 2010, primarily due to our reduced R&D
headcount
and laboratory consumables.
General and administration expenses increased by 5% to CHF6.7 million in
2011
compared to CHF6.4 million in 2010 mainly due to the net effect of our
reduced
G&A headcount, which was off-set by certain one-off restructuring costs.
Net loss decreased by 8% to CHF31.1 million for 2011 compared to CHF33.6
million
for 2010, mainly due to the decrease in our operating expenses.
Cash and cash equivalents amount to CHF36.1 million at 31 December
2011,
compared to CHF63.8 million at the end of 2010. Cash utilization in
2011 of
CHF27.7 million relates mainly to cash used in operations.
Outlook: Based on current expectations, which include the completion
of the
dipraglurant Phase IIa development and the progression of our
prioritized
discovery and preclinical programs, full year 2012 cash burn guidance is
CHF23-
25 million.
Pipeline Status Review
Dipraglurant is a novel oral small molecule, which inhibits the
metabotropic
glutamate receptor 5 (mGluR5), and has potential to be used in combination
with
levodopa or dopamine agonists for treatment of Parkinson's disease
(PD). Our
initial focus is on testing dipraglurant for the treatment of PD
levodopa-
induced dyskinesia (PD-LID). Together with a partner, we hope to
study
dipraglurant's potential for treatment of the non-motor symptoms of PD
(e.g.
anxiety, depression and impulse control disorders), motor symptoms of
PD and
also non-parkinsonian dystonias.
In the double-blind, placebo-controlled, EU and U.S. trial in PD-LID
patients,
the primary objective is safety and tolerability. In addition, the
trial was
designed to evaluate exploratory efficacy as a secondary objective.
Efficacy is
being measured using: the modified Abnormal Involuntary Movement Scale;
patient
diaries documenting on time (with/without dyskinesias), off time and sleep
time;
the Unified Parkinson's Disease Rating Scale; the Clinician & Patient
Global
Impression of Change; and finally, an evaluation of the patients' mood,
using
the Hospital Anxiety & Depression Score.
The study, which is partially funded by a $900,000 grant from The Michael
J Fox
Foundation for Parkinson's Research, has completed enrollment of 72
patients.
Top line data will be disclosed around the end of March, 2012.
ADX71149 is undergoing a 105-patient Phase IIa trial for the
treatment of
schizophrenia. The orally available small molecule mGluR2 positive
allosteric
modulator (PAM) was discovered and developed in collaboration with our
partner,
Janssen Pharmaceuticals, Inc. (JPI), which is responsible for all
clinical
development and commercialization of ADX71149. Under the licensing
agreement,
Addex is eligible for development and regulatory milestones of up to a
total of
EUR112 million plus low double-digit royalties.
Addex is prioritizing preclinical programs for GABABR PAM for
osteoarthritis
pain and overactive bladder; mGluR4 PAM for Parkinson's disease,
anxiety and
other diseases. Prioritized discovery programs are: receptor tyrosine
kinase
(RTK) superfamily members, including TrkB PAM for treating
neurodegenerative
diseases (e.g. Alzheimer's, Parkinson's and Huntington's diseases); TNF
receptor
superfamily members, including TNFR1 NAM for inflammation (e.g.
rheumatoid
arthritis) and other diseases; and GLP1R PAM for Type 2 diabetes.
A webcast and conference call will be held today at 16:00 CET (15:00
GMT/10:00
ET) today. To participate, please listen to the webcast or call one of the
following telephone numbers. RSVP is not necessary.
Dial-in numbers: +41 91 610 56 00 (Europe)
+44 203 059 58 62 (UK)
+1 866 291 4166 (USA)
The live webcast, slides, webcast replay and transcript, as well as the
2011
annual report will be available at www.addexpharma.com.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops an
emerging
class of small molecule drugs, called allosteric modulators, which
have the
potential to be more specific and confer significant therapeutic advantages
over
conventional "orthosteric" small molecule or biological drugs. The Company
uses
its proprietary discovery platform to address receptors and other proteins
that
are recognized as attractive targets for modulation of important diseases
with
unmet medical needs. The Company's two lead products are being
investigated in
Phase IIa clinical testing: dipraglurant (ADX48621, an mGluR5
negative
allosteric modulator or NAM) is being developed by Addex to treat
Parkinson's
disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2
positive
allosteric modulator or PAM) is being developed by our partner
Janssen
Pharmaceuticals Inc. to treat schizophrenia. Addex also is advancing
several
preclinical programs including: GABA-BR PAM for pain, overactive
bladder and
other disorders; mGluR4 PAM for Parkinson's, anxiety and other diseases;
GLP1R
PAM for type 2 diabetes; mGluR2 NAM for treating Alzheimer's
disease and
depression; and FSHR/LHR NAM for sex hormone dependent tumors &
reproductive
system disorders. In addition, Addex has discovery programs to
identify
allosteric modulators of: receptor tyrosine kinase (RTK) superfamily,
including
TrkB PAM for treating neurodegenerative diseases (e.g. Alzheimer's,
Parkinson's
and Huntington's diseases); and TNF receptor superfamily, including
TNFR1 NAM
for inflammation (e.g. rheumatoid arthritis) and other diseases.
Disclaimer: The foregoing release may contain forward-looking statements
that
can be identified by terminology such as "not approvable", "continue",
"believes", "believe", "will", "remained open to exploring", "would",
"could",
or similar expressions, or by express or implied discussions regarding
Addex
Pharmaceuticals Ltd, its business, the potential approval of its products
by
regulatory authorities, or regarding potential future revenues from such
products. Such forward-looking statements reflect the current views of
Addex
Pharmaceuticals Ltd regarding future events, future economic performance or
prospects, and, by their very nature, involve inherent risks and
uncertainties,
both general and specific, whether known or unknown, and/or any other
factor
that may materially differ from the plans, objectives, expectations,
estimates
and intentions expressed or implied in such forward-looking statements.
Such may
in particular cause actual results with allosteric modulators of mGluR2,
mGluR4,
mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1, RTK, TrkB or other therapeutic
targets
to be materially different from any future results, performance or
achievements
expressed or implied by such statements. There can be no guarantee that
allosteric modulators of mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R,
TNFR1,
RTK, TrkB or other therapeutics targets will be approved for sale in any
market
or by any regulatory authority. Nor can there be any guarantee that
allosteric
modulators of mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1,
RTK,
TrkB or other therapeutic targets will achieve any particular levels of
revenue
(if any) in the future. In particular, management's expectations regarding
allosteric modulators of mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R,
TNFR1, RTK, TrkB or other therapeutic targets could be affected by, among
other
things, unexpected actions by our partners, unexpected regulatory actions
or
delays or government regulation generally; unexpected clinical trial
results,
including unexpected new clinical data and unexpected additional analysis
of
existing clinical data; competition in general; government, industry and
general
public pricing pressures; the company's ability to obtain or maintain
patent or
other proprietary intellectual property protection. Should one or more of
these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated,
believed,
estimated or expected. Addex Pharmaceuticals Ltd is providing the
information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise, except as may be
required
by applicable laws.
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