Addex Pharmaceuticals SA : Addex Pharmaceuticals Reports 2011 Financial Results

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	3743		4000		(6%)		570		1300		(56%)
R&D expenses	(27986)		(31165)		(10%)		(13428)		(14479)		(7%)
G&A expenses	(6 731)		(6433)		5%		(3432)		(3144)		9%
Total operating loss	(30974)		(33598)		(8%)		(16290)		(16323)		-
Financeresult, net	(167)		(47)		255%		(24)		(60)		(60%)
Net loss for the period	(31141)		(33645)		(7%)		(16314)		(16383)		-
Basic and diluted net loss per share	(4.19)		(5.69)		(26%)		(2.12)		(2.68)		(21%)
Net cash used (cash burn)	(27732)		(12763)		117%		(14165)		7111		299%
Cash and cash equivalents	36065		63 797		(43%)		36065		63 797		(43%)
Shareholders' equity	33836		64 414		(47%)		33836		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 & developmentexpenses 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 administrationexpenses 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 lossdecreased 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 equivalentsamount 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

Dipraglurantis 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.

ADX71149is 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 callwill 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 (<stockticker w:st="on">RTK</stockticker>) 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

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.

Partner Area