Addex Pharmaceuticals First Half 2010 Financial Results
Geneva, Switzerland, 28 July 2010 – Allosteric modulation company Addex Pharmaceuticals (SIX:ADXN) released today financial results for the first half of 2010. The company also updated the status of its allosteric modulator pipeline including its lead product, ADX48621, which is scheduled to start Phase II development for Parkinson’s disease levodopa induced dyskinesia (PD-LID) later this year.
• 1H10 net loss: CHF17.3 million
• 1H10 revenues: CHF2.7 million
• Cash and cash equivalents at 30 June 2010: CHF56.7 million
• Addex 2010 full year cash burn guidance maintained at CHF30-35 million
• Operating cash through early of 2012
Pipeline & Operating Highlights
• ADX48621, an mGluR5 negative allosteric modulator, on track to start Phase II PD-LID trial in 4Q 2010
• ADX71149, an mGluR2 positive allosteric modulator (PAM) being developed by Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJPI), is completing Phase I testing
• ADX71943 preclinical data confirm osteoarthritis as lead indication for GABA-B positive allosteric modulator
Tim Dyer, CFO, said: “Our cash reach has extended to early 2012 from late 2011, after streamlining our headcount and implementing cost control measures. We are pleased that we are on track to meet our cash burn guidance of CHF30-35 million for 2010 while continuing to advance our pipeline.”
Key Financial Data
|millions of Swiss francs||1H10||2H09||1H09|
|Net finance result||-||-||0.3|
|Net loss for the period||(17.3)||(23.1)||(19.6)|
|Basic and diluted net loss per share (CHF)||(3.01)||(4.02)||(3.42)|
|Cash and cash equivalents||56.7||76.6||94.5|
First Half 2010 Financial Summary
Revenues of CHF2.7 million consist primarily of CHF1.1 million of research funding and technology access fees received from Merck & Co., Inc. under the mGluR4 PAM research collaboration and license agreement, which are being recognized over the term of the research collaboration, as well as CHF1.6 million of French government research tax credits related to R&D expenses that were incurred in 2009 and 2010 at our French subsidiary.
Research & Development expenses decreased by 22% to CHF16.7 million in the first half of 2010 from CHF21.4 million in the second half of 2009 mainly due to reduced clinical development costs.
General and Administration expenses were slightly reduced to CHF3.3 million in the first half of 2010 compared to CHF3.4 million in the second half of 2009 as a result of headcount reductions.
Cash and Cash Equivalents amount to CHF56.7 million at 30 June 2010, a decrease of CHF19.9 million compared to the position at year-end 2009 primarily due to the cost of operations.
ADX48621 is scheduled to start Phase II testing in late 2010 in patients with Parkinson’s disease levodopa-induced dyskinesia (PD-LID) and Phase IIa testing in focal dystonia patients (who do not have PD). ADX48621 is an mGluR5 negative allosteric modulator (NAM) wholly owned by Addex. Inhibition of mGluR5 is a clinically validated mechanism in PD-LID and a variety of other indications.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) is completing Phase I testing of ADX71149, which is scheduled to start Phase IIa testing for schizophrenia and anxiety in 2010, subject to successful completion of Phase I testing and regulatory authorization. Addex is eligible for up to €112 million subject to successful completion of development and regulatory milestones. In addition, Addex is eligible for low double-digit royalties on sales of ADX71149, subject to regulatory approval and successful commercial launch. ADX71149 is an mGluR2 positive allosteric modulator (PAM) being developed by OMJPI. Activation of mGluR2 is a clinically validated mechanism in both schizophrenia and anxiety.
ADX71943 recently demonstrated effects on mechanical hyperalgesia (increased pain sensitivity) and mechanical allodynia (pain produced by a normally innocuous stimulus). These were assessed in the monosodium iodoacetate (MIA) model of osteoarthritis, a model of chronic nociceptive pain. ADX71943 significantly reduced mechanical hyperalgesia and showed a trend toward reducing mechanical allodynia after both acute and sub-chronic (8 days) dosing. Statistically significant antihyperalgesic activity was observed on the first day and was maintained on day 8, despite increased pain severity. Phase I testing of ADX71943 is scheduled to start in 2011.
Conference Call & Webcast
Title: Addex First Half 2010 Financial Results Conference Call
Date: 28 July 2010
Time: 16:00 CEST
Dial-in numbers: +41 91 610 56 00 (Europe)
+44 207 107 0611 (UK)
+1 866 291 4166 (USA)
A live webcast and slides, as well as the webcast replay and transcript, will be available at www.addexpharma.com.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health and is focused on validated therapeutic targets for diseases of the central nervous system, metabolic disorders and inflammation. Subject to the completion of Phase I testing and regulatory approvals, Phase II clinical trials are expected to start in 2010 in four indications for two lead products: ADX48621, an mGluR5 negative allosteric modulator (NAM), in dystonia and Parkinson’s disease levodopa-induced dyskinesia (PD-LID); and ADX71149, an mGluR2 positive allosteric modulator (PAM), in schizophrenia and anxiety. ADX71149 is licensed to Ortho-McNeil-Janssen Pharmaceuticals Inc. A third product, ADX71943, GABA-B receptor PAM with potential for chronic pain, is scheduled to enter Phase I testing around the end of 2010. In addition, Merck & Co., Inc. has licensed rights to two preclinical products: mGluR4 PAM for Parkinson's disease and mGluR5 PAM for schizophrenia. Additional preclinical discovery stage programs include: mGluR2 NAM, GLP1R PAM, IL1R1 NAM and TNFR1 NAM. Roche Venture Fund and SR-One, corporate venture arm of GlaxoSmithKline, are investors in Addex.
Investor Relations & Communications
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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, mGluR7 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, mGluR7 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, mGluR7 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, mGluR7 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.