Addex Pharmaceuticals Reports 2011 Financial Results
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Addex Pharmaceuticals /
Addex Pharmaceuticals Reports 2011 Financial Results
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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
Geneva, Switzerland, 23 February 2012 - 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
?112 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.
Chris Maggos
Business Development & Communication
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos(at)addexpharma.com
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.
This announcement is distributed by Thomson Reuters on behalf of
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Addex Pharmaceuticals via Thomson Reuters ONE
[HUG#1588392]
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Datum: 23.02.2012 - 07:00 Uhr
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News-ID 117635
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