Addex Pharmaceuticals Reports First Half 2009 Financial Results
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Addex 1H09 Financial ResultsAddex 1S09 Résultats FinanciersAddex 1H09 Finanzergebnis Addex Pharmaceuticals Reports First Half 2009 Financial Results Operating loss reduced by 30%; with current cost control measures, Addex is holding over 2 years of cashGeneva, Switzerland, 28 July 2009 - Allosteric modulation companyAddex Pharmaceuticals (SIX:ADXN) released today financial results forthe first half of 2009 and reiterated the status of its allostericmodulator pipeline including lead product, ADX10059, which is inPhase IIb development for both gastroesophageal reflux disease (GERD)and migraine prevention.Financial Highlights * 1H09 net loss: CHF19.6 million * 1H09 revenues: CHF2.8 million * Cash and cash equivalents at June 30, 2009: CHF94.5 million * Addex 2009 full year cash burn guidance revised to CHF43-47 millionPipeline & Operating Highlights * ADX10059 on track to deliver Phase IIb results in GERD in Q4 2009 and in migraine prevention in Q1 2010 * Platform adapted to discover allosteric modulators of cytokine receptors, including TNF-R1 and IL-1R1 * Operating loss reduced by 30% as cost control measures take effectTim Dyer, CFO, said: "Thanks to cost control measures and continuedrevenues from partnerships, we are pleased to report a 30% reductionin our operating loss while making exceptional progress in expandingour proprietary platform technology and advancing our productportfolio, especially the Phase IIb trials of ADX10059 for GERD andmigraine prevention. As a result of the implementation of cashpreservation measures, spending in the first half of 2009 was in linewith our expectations and our full year cash burn guidance is revisedto CHF43-47 million."Key Financial Data 1H09 2H08 1H08 millions of Swiss francsRevenues 2.8 1.0 25.8R&D expenses (18.5) (25.3) (18.9)G&A expenses (4.2) (4.1) (3.5)Operating (loss) / profit (19.9) (28.4) 3.4Net finance result 0.3 3.6 (0.8)Net profit (loss)/ profit for the period (19.6) (24.8) 2.6Basic and diluted net (loss) / earnings pershare (CHF) (3.42) (4.30) 0.45Cash and cash equivalents 94.5 119.5 142.8First Half 2009 Financial SummaryRevenues of CHF2.8 million consist primarily of a CHF1.5 millionmilestone receivable from Ortho-McNeil-Janssen Pharmaceuticals Inc.under the mGluR2 PAM license agreement and CHF1.0 million of upfrontfees, milestones and technology access fees received from MerckSharpe & Dohme Research Ltd under the mGluR4PAM researchcollaboration and license agreement which are being recognized overthe term of the research collaboration.Research & Development expenses decreased by 26.9% to CHF18.5 millionin the first half of 2009 from CHF25.3 million in the second half of2008 reflecting the effect of a number of cost control strategieswhich were implemented at the end of 2008.General and Administration expenses remained stable at CHF4.2 millionin the first half of 2009 compared to CHF4.1 million in the secondhalf of 2008 mainly due to the net effect of cost control strategiesoff-set by a strengthening of the business development and HRfunctions.Net Finance Result decreased to CHF0.3 million in the first half of2009 from CHF3.6 million primarily due to lower interest rates andthe absence of unrealized exchange gains which had been recorded inthe second half of 2008.Cash and Cash Equivalents amount to CHF94.5 million at the 30 June2009, a decrease of CHF25.0 million compared to the position atyear-end 2008 mainly due to the cost of operations and to a lesserextent capital expenditure.Pipeline updateAddex reiterates the status of its pipeline, given during its R&D Dayheld on 16 July. Recordings of the webcasts and slides from the R&DDay are available at www.addexpharma.com.Enrollment in the three Phase IIb trials of ADX10059 in both GERD andmigraine prevention is proceeding as planned. The data from the twoGERD studies are expected in the fourth quarter of 2009. The datafrom the migraine prevention study are expected in the first quarterof 2010.Preclinical data, reported for the first time at the 2009 Addex R&DDay, show that both ADX10059 and ADX48621 reversed haloperidolinduced catalepsy in a rodent model of Parkinson's disease (PD). Datafrom ongoing studies in a primate monkey model of PD are expected inthe coming months. ADX10059 and ADX48621 are metabotropic glutamatereceptor 5 (mGluR5) negative allosteric modulators (NAM). ADX48621completed Phase I testing in healthy volunteers earlier this year andis scheduled to start Phase IIa testing in PD patients around the endof 2009.Addex partner Ortho-McNeil-Janssen Pharmaceuticals Inc., a Johnson &Johnson company, started last month Phase I testing of ADX71149, anmGluR2 positive allosteric modulator (PAM) with potential fortreatment of schizophrenia and anxiety. Addex received ?1 million forthe milestone and is eligible for further undisclosed milestones androyalties. To date, Addex also has received an upfront fee of ?3million and ?4.3 million in research funding during the drugdiscovery collaboration period.Earlier this month, Addex achieved the second research milestones of$500,000 under its collaboration with partner Merck & Co., Inc. todiscover mGluR4 PAM drugs to treat Parkinson's disease bringing thetotal amount earned to $4 million. Addex is eligible for up to $106.5million in research, development and regulatory milestones for thefirst product developed for multiple indications. Additionalmilestones of up to $61 million would be payable if a second andthird product is developed. Addex is eligible to receive undisclosedroyalties on sales of any products resulting from this collaboration,signed in late 2007. Merck is responsible for clinical development.Data on ADX68692, a follicle stimulating hormone (FSH) NAM, reportedat the 2009 Addex R&D Day have led Addex to begin preclinical testingof the product for treatment of hormone refractory prostate cancer.Addex also announced at its R&D Day that it has adapted its discoveryplatform to allow discovery of orally available small molecule drugstargeting cytokine receptors and other type 1 transmembrane proteins.In addition, Addex announced that initial screenings of itsallosteric modulator biased library have been performed for severalnew targets, including Tumor Necrosis Factor receptor 1 (TNF-R1),Gastric Inhibitory Peptide receptor (GIPR), Adenosine 2A receptor andOrexin 2 receptor. Primary hits have been identified for all threetargets and the assays have been adapted to screen the Addex libraryagainst interleukin-1 receptor 1 (IL-1R1).Conference Call & WebcastTitle: Addex First Half 2009 Financial Results Conference CallDate: 28 July 2009Time: 16:00 CESTDial-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 andtranscript, will be available at www.addexpharma.com.Addex Pharmaceuticals (www.addexpharma.com) discovers and developsallosteric modulators for human health. Allosteric modulators are adifferent kind of orally available small molecule therapeutic agent,which we believe will offer a competitive advantage over classicaldrugs. Our lead allosteric modulator product, ADX10059, has achievedclinical proof of concept and is in Phase IIb testing in twoindications. Phase IIb data for ADX10059 to treat gastroesophagealreflux disease (GERD) are expected in the fourth quarter of 2009.Phase IIb data for ADX10059 as a migraine prevention therapy inpatients with frequent migraine are expected in the first quarter of2010. ADX10059 is a first-in-class mGluR5 inhibitor, a therapeuticstrategy that also is being pursued in multiple indications by largepharma competitors.Our products and technology already have proven their value throughour relationships with four of the top 10 pharmaceutical companies inthe world. Specifically, under an agreement with Ortho-McNeil-JanssenPharmaceuticals Inc., a Johnson & Johnson company, ADX71149, apositive allosteric modulator (PAM) of mGluR2 with potential for thetreatment of schizophrenia and anxiety, is undergoing Phase Iclinical testing. Under two separate agreements with Merck & Co.,Inc., we are developing mGluR4 PAM and mGluR5 PAM as drugs to treatParkinson's disease and schizophrenia, respectively. In addition,GlaxoSmithKline and Roche have made equity investments in Addex.Chris MaggosHead of IR & CommunicationsAddex Pharmaceuticals+41 22 884 15 11chris.maggos(at)addexpharma.comDisclaimer: The foregoing release may contain forward-lookingstatements that can be identified by terminology such as "notapprovable", "continue", "believes", "believe", "will", "remainedopen to exploring", "would", "could", or similar expressions, or byexpress or implied discussions regarding Addex Pharmaceuticals Ltd,its business, the potential approval of its products by regulatoryauthorities, or regarding potential future revenues from suchproducts. Such forward-looking statements reflect the current viewsof Addex Pharmaceuticals Ltd regarding future events, future economicperformance or prospects, and, by their very nature, involve inherentrisks and uncertainties, both general and specific, whether known orunknown, and/or any other factor that may materially differ from theplans, objectives, expectations, estimates and intentions expressedor implied in such forward-looking statements. Such may in particularcause actual results with allosteric modulators of mGluR2, mGluR4,mGluR5, mGluR7 or other therapeutic targets to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7 will beapproved for sale in any market or by any regulatory authority. Norcan there be any guarantee that allosteric modulators of mGluR2,mGluR4, mGluR5, mGluR7 or other therapeutic targets will achieve anyparticular 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 affectedby, among other things, unexpected actions by our partners,unexpected regulatory actions or delays or government regulationgenerally; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existingclinical data; competition in general; government, industry andgeneral public pricing pressures; the company's ability to obtain ormaintain patent or other proprietary intellectual propertyprotection. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Addex Pharmaceuticals Ltd is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise, except as may be required by applicablelaws.http://hugin.info/138017/R/1330953/314832.pdfhttp://hugin.info/138017/R/1330953/314833.pdfhttp://hugin.info/138017/R/1330953/314834.pdf --- End of Message ---Addex Pharmaceuticals12, chemin des Aulx Plan-les-Ouates, Geneva SwitzerlandISIN: CH0029850754; Index: SLIFE, SPI, SPIEX, SSCI;Listed: Main Market in SIX Swiss Exchange;
Datum: 28.07.2009 - 07:00 Uhr
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