Addex Pharmaceuticals 2010 Financial Results
Geneva, Switzerland, 23 February 2011 – Allosteric modulation company Addex Pharmaceuticals (SIX:ADXN) announced today 2010 financial results and reviewed the status of its pipeline. The results will be presented to investors, analysts and media at 4pm CET (3pm GMT/10am ET) today via a webcast and teleconference.
Tim Dyer, CFO, said: “2010 has been a year of streamlining the organization and project prioritization resulting in a 22% reduction in our operating loss and a significant reduction in operating cash burn. An extra CHF20 million of new capital from Biotechnology Value Fund has strengthened our balance sheet giving us CHF63.8 million of cash which should see us well into 2013. Cash burn guidance for 2011 is CHF28-32 million.“
Vincent Mutel, CEO, commented: “Even as we re-focus on our core strengths in allosteric discovery and development, our two most advanced products are entering clinical proof of concept studies: ADX48621, now named dipraglurant, for Parkinson’s disease levodopa-induced dyskinesia; and ADX71149 for schizophrenia. Both drug candidates have clinically validated mechanisms and have earned external support. ADX71149 is being developed by our partner Ortho-McNeil-Janssen, a Johnson & Johnson subsidiary. The Michael J. Fox Foundation for Parkinson’s Research awarded Addex a grant for dipraglurant testing.”
Key 2010 Financial Data
|Income||4 000||4 503||(11%)||1 300||1 692||(23%)|
|R&D expenses||(31 165)||(39 961)||(22%)||(14 479)||(21 417)||(32%)|
|G&A expenses||(6 433)||(7 596)||(15%)||(3 144)||(3 414)||(8%)|
|Total operating loss||(33 598)||(43 054)||(22%)||(16 323)||(23 139)||(29%)|
|Finance result, net||(47)||362||(113%)||(60)||45||(233%)|
|Net loss for the period||(33 645)||(42 692)||(21%)||(16 383)||(23 094)||(29%)|
|Basic and diluted net loss per share||(5.69)||(7.44)||(24%)||(2.68)||(4.03)||(33%)|
|Net cash used (cash burn)||(12 763)||(42 911)||(70%)||(7 111)||(17 977)||(140%)|
|Cash and cash equivalents||63 797||76 560||(17%)||63 797||76 560||(17%)|
|Shareholders’ equity||64 414||77 581||(17%)||64 414||77 581||(17%)|
Income was CHF4.0 million in 2010 compared to CHF4.5 million in 2009, and comprises mainly fees and research funding received from Merck & Co., Inc. under our mGluR4 PAM license agreement and French government research tax credits.
Research & Development expenses decreased by 22% to CHF31.2 million in 2010 compared to CHF40 million in 2009 primarily due to our lower headcount and clinical development activities.
General and Administration expenses decreased by 15% to CHF6.4 million in 2010 compared to CHF7.6 million in 2009 mainly due to our lower headcount.
Net Loss decreased by 21% to CHF33.6 million for 2010 compared to CHF42.7 million for 2009, mainly due to the significant decrease in our operating expenses.
Cash and cash equivalents amounted to CHF63.8 million at 31 December 2010, compared to CHF76.6 million at the end of 2009. 2010 cash burn of CHF12.8 million is mainly due to the cash used in operations offset by the CHF20 million of gross proceeds from a capital increase and convertible note issuance.
Outlook: Based on current expectations, which include the completion of a substantial part of dipraglurant Phase IIa development and the advancement of our prioritized discovery and preclinical projects, full year cash burn guidance is CHF28-32 million.
Pipeline status review
Dipraglurant (ADX48621) is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). An immediate-release formulation of dipraglurant, dipraglurant-IR, which has a pharmacokinetic profile that is similar to that of levodopa, is about to enter Phase II trials for Parkinson’s disease levodopa-induced dyskinesia (PD-LID). Addex already received European regulatory and ethical committee authorizations to initiate the trial and will start enrolling patients in the coming months. Results from the study are expected in the first half of 2012. The double-blind placebo-controlled Phase II study in 90 patients is partially funded by a USD900,000 grant from The Michael J. Fox Foundation for Parkinson’s Research.
Dipraglurant-IR was well tolerated and achieved satisfactory pharmacokinetics, safety and tolerability in Phase I testing.
Separately, a longer-acting extended-release formulation of dipraglurant, dipraglurant-ER, is being developed. Dipraglurant-ER will have a pharmacokinetic profile that is more appropriate for use in indications where a longer-acting once- or twice-daily form is advantageous including, non-Parkinsonian dystonia, fragile X syndrome, pain, anxiety, depression and gastroesophageal reflux disease (GERD), all of which have been validated using mGluR5 inhibitors. Phase I testing of dipraglurant-ER will commence mid-year. Phase IIa testing of dipraglurant-ER in dystonia patients now is scheduled to start in the first half of 2012.
ADX71149, an mGluR2 positive allosteric modulator (PAM), is expected to start Phase II clinical trials in schizophrenia patients during the first quarter of 2011. Our partner Ortho-McNeil-Janssen Pharmaceuticals Inc. is responsible for development and commercialization of ADX71149. Addex is eligible for development and regulatory milestones of up to a total of EUR112 million plus low double-digit royalties on mGluR2 PAM for schizophrenia, anxiety and undisclosed indications.
ADX68692, an orally active small molecule follicle stimulating hormone receptor (FSHR) NAM, has potential for the treatment of endometriosis and benign prostatic hyperplasia (BPH). Preclinical studies have demonstrated that ADX68692 had an anti-estrogenic effect and reduced uterine weight in females; similarly, it reduced circulating testosterone levels and prostate weight in males. Addex has initiated a preclinical proof of concept study of ADX68692 in a well-recognized model of endometriosis. Due to our project prioritization, we are not planning to initiate clinical testing of this program prior to out-licensing.
mGluR2 NAM have potential for Alzheimer’s disease and depression. In a preclinical proof of concept study, the orally available mGluR2 NAM dose-dependently reversed memory deficit exhibited after beta-amyloid protein administration. The statistically significant effect was similar to the active comparator used in the same experiment, donepezil (Aricept), the benchmark marketed drug currently used to treat symptoms of Alzheimer’s disease. Preclinical research from other groups suggest not only that mGluR2 NAM might slow the progression of Alzheimer’s*, an effect not seen with any marketed drug, but also that it may have a synergistic effect on cognition when combined with donepezil**. Alzheimer’s disease represents a large and growing market with unmet medical need. None of the currently marketed drugs for Alzheimer’s disease offer patients sustained life-changing benefits. Due to our project prioritization, we are not preparing to initiate clinical testing of this program prior to out-licensing.
*The Journal of Neuroscience, March 17, 2010; 30(11):3870-3875
**Bioorganic & Medicinal Chemistry Letters, Dec 1, 2010; 20(23):6969-6974
GABA-B PAM from Addex have demonstrated better tolerability compared to the marketed GABA-B agonist baclofen and have high potential value in a wide range of indications, including osteoarthritis pain as well as other indications such as fragile X syndrome, urinary incontinence and GERD. Our lead gamma-aminobutyric acid receptor subtype B (GABA-B) PAM, ADX71943, demonstrated efficacy and advantageous tolerability in number of preclinical models; however, its risk benefit profile was not acceptable and we are currently evaluating potential backup compounds. We will invest further in advancing a new lead program for out-licensing but due to our project prioritization, we are not preparing to initiate clinical testing of this program prior to partnering it.
ADX63365, a preclinical mGluR5 PAM, is licensed to Merck & Co., Inc. as a potential treatment for schizophrenia and undisclosed indications. Addex is eligible for up to USD680 million in milestones plus royalties.
mGluR4 PAM also licensed to Merck are entering late preclinical development. Our drug discovery collaboration to develop mGluR4 PAM to treat Parkinson’s disease was successfully completed in 2010 and Merck is advancing leads towards clinical candidate selection. Addex is eligible to receive up to a total of USD167.5 million in milestones plus royalties for mGluR4 PAM to treat Parkinson’s disease and undisclosed indications.
A webcast and conference call will be held at 4pm CET (3pm GMT/10am 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, will be available at www.addexpharma.com.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric modulators for human health. The company uses its proprietary discovery platform to target cell surface receptors that are recognized as having therapeutic potential for treating diseases of the central nervous system, metabolic disorders or inflammation. Several Phase II clinical trials are expected to start soon for two lead products: dipraglurant (ADX48621) and ADX71149. Dipraglurant is an mGluR5 negative allosteric modulator (NAM), which will be tested in Parkinson’s disease levodopa-induced dyskinesia (PD-LID) and, separately, non-Parkinsonian patients suffering from dystonia, a movement disorder also observed in PD. The PD-LID clinical trial is supported by a grant from The Michael J. Fox Foundation for Parkinson’s Research. ADX71149 is an mGluR2 positive allosteric modulator (PAM), which has potential for treatment of schizophrenia, anxiety and other indications. ADX71149 is licensed to Ortho-McNeil-Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. In addition, Merck & Co., Inc. has licensed rights to two preclinical programs: mGluR4 PAM for Parkinson's disease and mGluR5 PAM for schizophrenia. Unpartnered products in preclinical testing include: follicle stimulating hormone receptor (FSHR) NAM, with potential for endometriosis and benign prostatic hyperplasia; mGluR2 NAM for Alzheimer’s disease; and GABA-B receptor PAM with potential for chronic pain, Fragile X syndrome, urinary incontinence and GERD. Preclinical diabetes and inflammation discovery programs include GLP1R PAM, IL1R1 NAM, and TNFR1 NAM.
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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.