Addex Pharmaceuticals 2009 Financial Results
Geneva, Switzerland, 23 February 2010 – Allosteric modulation company Addex Pharmaceuticals (SIX:ADXN) announced today 2009 financial results and reviewed the status of its pipeline.
Tim Dyer, CFO, said: “We are pleased to report cash burn of CHF42.9 million, at the low end of our guidance. We currently have a cash balance of CHF76.6 million. Our cash burn guidance for 2010 is CHF30-35 million. We look forward to positive news in 2010 from our three partnered programs and our business development initiatives as we focus on rebuilding value for our shareholders. While we were disappointed with the termination of ADX10059, we feel we are well positioned to continue developing our proprietary platform and advance a number of promising product candidates toward important value inflection points.”
“We will continue to deliver on our business development objectives and advance our proprietary drug candidates; ADX48621, ADX71943 and ADX68692 which are in development for Parkinson’s disease, osteoarthritis and benign prostatic hyperplasia, respectively,” added Vincent Mutel, CEO. “The breakthrough discoveries we have made in the field of allosteric modulation provide us with the opportunity to drive business development, even at early stages, as we have demonstrated in our collaborations with J&J and Merck & Co. Our goals going forward will focus on advancing our own internal products and to continue actively pursuing further collaborations with quality partners.”
Key 2009 Financial Data
|Total operating loss||(43054)||(24872)||73%||(23139)||(28305)||(18%)|
|Finance result, net||362||2806||(87%)||45||3638||(99%)|
|Net loss for period||(42692)||(22066)||93%||(23094)||(24667)||(6%)|
|Basic and diluted net loss per share||(7.44)||(3.85)||93%||(4.03)||(4.30)||(6%)|
|Net cash used (cash burn)||(42911)||(20574)||(109%)||(17977)||(23325)||(23%)|
|Cash and cash equivalents||76560||119471||(36%)||76560||119471||(36%)|
2009 Financial Summary
Revenues consist primarily of amounts received from collaboration partners. Revenues decreased to CHF4.5 million in 2009 from CHF26.9 million in 2008, mainly due to the one-time upfront payment of CHF24.8 million from the out-licensing of our mGluR5 PAM schizophrenia program to Merck & Co., Inc. in January 2008.
Research & Development expenses slightly decreased to CHF40 million in 2009 from CHF44.2 million in 2008 reflecting the measures taken to control costs associated with our discovery and development programs which included delaying the entry of certain preclinical programs into man.
General and Administration expenses remained stable at CHF7.6 million in 2009 and 2008.
Net Finance Result amounted to CHF0.4 million for 2009 compared to CHF2.8 million for 2008 due to a combination of lower interest rates on short-term deposits being applied to our lower average cash balance.
Cash and cash equivalents amount to CHF76.6 million at 31 December 2009, a decrease of CHF42.9 million compared to CHF 119.5 million at 31 December 2008.
Outlook: Based on current expectations, which include the preparation of ADX48621 Phase II development scheduled to start Q4 2010 and the advancement of our current discovery and preclinical portfolio, full year cash burn guidance is CHF30-35 million.
Pipeline status review
ADX48621 is an mGluR5 NAM that is being developed for Parkinson’s disease levodopa induced dyskinesia (PD-LID). This mechanism, inhibition of mGluR5, is clinically validated for PD-LID. In a Phase I study, ADX48621 was well tolerated in older subjects, and achieved satisfactory pharmacokinetics, safety and tolerability with single and repeat dose administration.
In late 2009, Addex disclosed that ADX48621 showed strong efficacy in the MPTP model of PD-LID. Furthermore, ADX48621 appears to be highly differentiated from other products in development for PD-LID by the fact that it displayed efficacy on both components of dyskinesia: chorea (e.g. trembling) and dystonia (e.g. cramping). No other product in development or on the market has been reported to have efficacy on dystonia. A Phase IIb study of ADX48621 is scheduled to begin during Q4 2010.
ADX71943, a gamma-aminobutyric acid receptor subtype B (GABAB) PAM, is in late preclinical development and is scheduled to start Phase I testing in Q4 2010. While efficacy of ADX71943 was similar in preclinical models of pain compared to the marketed GABAB agonist baclofen, ADX71943 demonstrated markedly fewer side effects in the same models.
ADX68692 is an orally active, follicle stimulating hormone (FSH) NAM that has potential for the treatment of endometriosis and benign prostatic hyperplasia (BPH). Preclinical studies have demonstrated that ADX68692 reduces estradiol levels, testosterone production and prostate weight.
In June 2009, our partner Ortho-McNeil-Janssen Pharmaceuticals Inc., a Johnson & Johnson company, initiated Phase I trials with ADX71149, an mGluR2 PAM in development for the treatment of schizophrenia. Ortho McNeil Janssen is responsible for all future development and commercialization of ADX71149.
ADX63365, an mGluR5 PAM being developed in late preclinical studies by partner Merck & Co. ADX63365 is being evaluated as a potential treatment for schizophrenia.
In November 2009, Merck & Co. and Addex extended the mGluR4 PAM Parkinson’s disease research agreement for an additional year, with Merck & Co. agreeing to cover research costs at Addex. The decision followed the achievement of the first two preclinical milestones, showing that the collaboration had yielded orally available mGluR4 PAM with efficacy in an animal model of Parkinson’s disease.
Addex Pharmaceuticals (www.addexpharma.com) utilizes its unique proprietary platform technologies to discover and develop allosteric modulators for human health. Allosteric modulators are a different kind of orally available small molecule therapeutic agent, which we believe will offer a competitive advantage over classical drugs. With 15 programs in development, the Addex pipeline demonstrates the productivity and broad potential of our unparalleled platform technologies. The most advanced product, ADX48621, an mGluR5 negative allosteric modulator (NAM), has completed Phase I testing and is scheduled to start Phase II testing for Parkinson’s disease levodopa associated dyskinesia (PD-LID) later this year.
Our products and technology already have proven their value through our relationships with four of the top 10 pharmaceutical companies in the world. Specifically, under an agreement with Ortho-McNeil-Janssen Inc., a Johnson & Johnson company, ADX71149, an mGluR2 positive allosteric modulator (PAM), is undergoing Phase I clinical testing and has potential for treatment of schizophrenia and anxiety. Under two separate agreements with Merck & Co., Inc., we are developing PAMs of mGluR4 and mGluR5 as drugs to treat Parkinson's disease and schizophrenia, respectively. In addition, SR-One, the corporate venture arm of GlaxoSmithKline, and Roche Venture Fund have made equity investments in Addex.
Head of IR & Communications
+41 22 884 15 11
Disclaimer: The foregoing release contains 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, and involve known and unknown risks, uncertainties and other factors that may cause actual results with allosteric modulators of mGluR7, mGluR5, mGluR4, mGluR2, GABAB, FSH, GLP-1 or other receptors 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 mGluR7, mGluR5, mGluR4, mGluR2, GABAB, FSH, GLP-1 or other receptors will be approved for sale in any market or by any regulatory authority. Nor can there be any guarantee that allosteric modulators of mGluR7, mGluR5, mGluR4, mGluR2, GABAB, FSH, GLP-1 or other receptors will achieve any particular levels of revenue (if any) in the future. In particular, management's expectations regarding allosteric modulators of mGluR7, mGluR5, mGluR4, mGluR2, GABAB, FSH, GLP-1 or other receptors 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 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.