Basilea reports 2009 financial results
(Thomson Reuters ONE) - Basilea Pharmaceutica AG / Basilea reports 2009 financial results processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. Basel, Switzerland, February 1, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)announces 2009 financial results reflecting first full year of Toctino® sales inits initial launch countries, and focused investments to support phase IIIdevelopment of isavuconazole globally and U.S. alitretinoin (Toctino®) trials.Combined cash and short-term investments amount to CHF 178.4 million as ofDecember 31, 2009.Business review 2009In 2009, Basilea reached a new milestone in its history reporting its first fullyear of Toctino® sales. Product sales of Toctino®, for the treatment of severechronic hand eczema, amounted to CHF 17.3 million in the first launch countries.By year-end, Toctino® had been launched in Denmark, France, Germany and theUnited Kingdom.Further regulatory approvals of Toctino® were obtained in five additionalEuropean Union countries plus Canada and Switzerland, as well as arecommendation for approval in another 15 European countries. Furthermore, theendorsement of Toctino® by pricing and reimbursement bodies in the UK and Francemarked important milestones confirming that Toctino® is an innovativecost-effective therapy that fills a high medical need. In addition, a phase IIIclinical trial program is ongoing in the U.S.As communicated at the end of 2009, the U.S. approval of ceftobiprole, ananti-MRSA broad-spectrum antibiotic, was delayed as the Food and DrugAdministration (FDA) requested new phase III studies for complicated skin andskin structure infections (cSSSI) from the sponsor Johnson & JohnsonPharmaceutical Research & Development, L.L.C. (Johnson & Johnson PRD).After a positive opinion from the European Committee for Medicinal Products forHuman Use (CHMP) in November 2008, the European Medicines Agency (EMEA) haltedthe European Commission decision process on ceftobiprole for complicated skinand soft tissue infections (cSSTI) early 2009 pending completion and assessmentof Good Clinical Practice (GCP) inspections at investigator sites.Early 2009 Basilea submitted a Request for Arbitration relating to substantialdamages suffered by Basilea as consequence of the delayed approval ofceftobiprole as well as delay in milestone payments.In 2009, patient recruitment in the international phase III program of Basilea'santifungal drug isavuconazole was interrupted due to manufacturing issues, whichhave been addressed to allow recruitment re-initiation.Basilea's research and development investments were focused on the phase IIIclinical trials of isavuconazole and the phase III program in the U.S. foralitretinoin during 2009. In addition, Basilea focused on advancing early-stageprograms such as BAL30072, a novel antibiotic against the mostdifficult-to-treat multidrug-resistant Gram-negative bacteria, and BAL27862, anovel anti-cancer compound with the potential to treat drug-resistant cancers.Ron Scott, Chief Financial Officer, said: "We are pleased to see first full yearproduct sales for Toctino with major contributions from the German market andadditional sales from Denmark and the UK. We also achieved first sales inFrance, a major European market, where the product was launched recently. During2010 we expect enhanced sales uptake of Toctino following further nationalapprovals and launches. We are committed going forward to take advantage of thestrategic flexibility that our rich and competitive product portfolio provides.""Basilea experienced successes as well as setbacks in 2009. We are very proud ofthe successful commercialization of Toctino in first key markets in the pastyear reflecting the innovation and pharmacoeconomic value of Toctino. We are,however, clearly disappointed with the delays following the review of the marketapplications for ceftobiprole," stated Dr. Anthony Man, Chief Executive Officer."We expect to resume the phase III recruitment of our second anti-infective,isavuconazole, in the first half of the year and anticipate to see firstclinical results from the phase III study of alitretinoin in the U.S. atyear-end. We will continue with high priority to seek solutions to makeceftobiprole available as quickly as possible to patients in need of newtreatment options to fight potentially deadly resistant bacterial infections."Management changesBasilea announces the appointment of Professor Achim Kaufhold, M.D., as ChiefMedical Officer and member of the Executive Committee. Prof. Kaufhold, aspecialist in Medical Microbiology and Infectious Diseases, has a long andsuccessful track record in the biotech and pharmaceutical industry. Prior tojoining Basilea he held executive positions at Pharmexa, Chiron, Berna Biotech,GlaxoSmithKline and was most recently President & CEO of Affitech A/S Denmark.Prof. Kaufhold will succeed Dr. Dieter G? who will leave the company.Dr. Anthony Man commented, "We thank Dr. G? for his contributions he made asChief Medical Officer to help advance our development programs. It is part ofour strategic intent to further enhance our R&D efforts in hospital basedtherapies. We welcome in particular the extensive anti-infectives and R&Dexperience that Professor Kaufhold brings to Basilea."Financial summaryRevenues and other income in 2009 amounted to CHF 26.8 million compared toCHF 12.0 million in 2008. Revenues included CHF 17.3 million (2008: CHF 1.9million) related primarily to product sales as a result of the commercializationof Toctino® in Germany, the United Kingdom, France and Denmark in 2009. Inaddition, revenues included CHF 8.4 million (2008: CHF 8.2 million) related toour licensing agreement for ZEFTERA(TM)/Zevtera(TM), mainly comprising therelease of deferred revenue in connection with upfront and milestone paymentsreceived.Research and development expenses decreased to CHF 77.2 million in 2009 comparedto CHF 97.4 million in 2008, largely as a result of a reduction in expenses dueto cost control measures, the temporary interruption of the isavuconazole phaseIII recruitment and a decrease in costs for clinical supply, which was largelyestablished in 2008 for the isavuconazole phase III program. The R&D expenses in2009 relate primarily to conducting the phase III clinical program forisavuconazole. In addition, they include costs for the phase III clinical trialsfor alitretinoin in the U.S. and costs for the advancement of our early-stageantibacterial and anti-cancer compounds.Selling, general and administrative expenses amounted to CHF 69.2 million in2009 (2008: CHF 66.8 million) and include expenses for the establishment andmaintenance of an international commercialization organization to prepare andsupport the launch of Toctino® as well as the co-promotion activities related toZEFTERA(TM)/Zevtera(TM). Operating loss totaled CHF 121.2 million in 2009compared to CHF 152.5 million in 2008 and net loss decreased to CHF 120.7million in 2009 (2008: CHF 143.5 million), as a consequence of the increasedproduct sales for Toctino® and reduced operating expenses. Basic and dilutedloss per share amounted to CHF 12.61 for 2009 as compared to CHF 15.02 in 2008.The cash out from operating activities decreased to CHF 114.5 million in 2009 ascompared to CHF 127.2 million. Combined cash and short-term investments amountedto CHF 178.4 million as of December 31, 2009, compared to CHF 293.6 million atyear-end 2008.Key Figures+--------------------------------------------+---------+---------+| | 2009 | 2008 || (in CHF million) | | |+--------------------------------------------+---------+---------+| Revenues and Other Income | 26.8 | 12.0 |+--------------------------------------------+---------+---------+| Cost of Sales | (1.6) | (0.3) |+--------------------------------------------+---------+---------+| Research & Development Expenses | (77.2) | (97.4) |+--------------------------------------------+---------+---------+| Selling, General & Administrative Expenses | (69.2) | (66.8) |+--------------------------------------------+---------+---------+| Operating Loss | (121.2) | (152.5) |+--------------------------------------------+---------+---------+| Net Loss | (120.7) | (143.5) |+--------------------------------------------+---------+---------+| Cash Flow from Operating Activities | (114.5) | (127.2) |+--------------------------------------------+---------+---------+| Basic and Diluted Loss per Share in CHF | (12.61) | (15.02) |+--------------------------------------------+---------+---------+Notes: Consolidated figures in conformity with US GAAPThe consolidated financial statements of Basilea Pharmaceutica Ltd. for 2009 canbe found on the company's website at http://annualreport.basilea.com.Financial outlookAnticipating further launches and increasing market penetration, Toctino® salesfor 2010 are estimated at CHF 35-45 million. Average monthly net operatinglosses in 2010 are estimated at approximately CHF 9 million.Product and pipeline updateToctino® (alitretinoin) - By year-end 2009, Toctino® had been introduced inDenmark, France, Germany and the United Kingdom. Initial regulatory approvalsfor Toctino® in ten European countries were complemented by national approvalsin Canada and Switzerland and recommendations for approval in an additional 15European countries. Following the issuance of national marketing authorizationsas well as pricing and reimbursement approvals, further launches are anticipatedthroughout 2010. Regulatory applications for further territories, e.g., MiddleEast, South America, are scheduled for early 2010 to expand Toctino®'scommercial availability. In the U.S., the first multi-centered, controlledclinical phase III study on alitretinoin for patients with severe refractorychronic hand eczema is ongoing and first results are anticipated at year-end2010.ZEFTERA(TM)/Zevtera(TM) (ceftobiprole) - At year-end 2009, ceftobiprole wasmarketed in Canada under the brand name ZEFTERA(TM) and in Switzerland underZevtera(TM). In the U.S., the FDA issued a Complete Response Letter indicatingthat it cannot approve the application on ceftobiprole for cSSSI in its presentform. The Agency recommended that two new, adequate, and well-controlled studiesshould be conducted and that the sponsor Johnson & Johnson PRD meets with theAgency to discuss the design of these trials. The regulatory review ofceftobiprole for the treatment of cSSTI in the EU is on-going. An opinion by theCHMP on the EU application is anticipated in Q1 2010.Isavuconazole - There are three phase III trials currently open investigatingisavuconazole, one targeting yeast infections, one targeting mold infections anda third trial targeting rare molds and renally impaired patients withaspergillosis.In 2009, over three quarters of the projected number of patients had beenenrolled in the aspergillosis study while the candidiasis study had recruited40% of patients when patient recruitment was temporarily interrupted due to theneed to produce new clinical trial material. The recruitment of new patients isexpected to resume in H1 2010 and data from the phase III clinical program isanticipated to be available in 2011. In Q1 2010, the Independent Data SafetyMonitoring Board (IDSMB) recommended the continuation of the phase III clinicaltrial of isavuconazole for the treatment of invasive Aspergillus infectionsbased on a futility analysis of 180 patients.Early-stage programs - BAL30072, a novel antibiotic against the mostdifficult-to-treat multi-drug-resistant Gram-negative bacteria, and BAL27862, anovel anti-cancer compound with activity against a broad range of tumor types,including those unresponsive to standard therapeutics, are currently undergoingpre-IND (Investigational New Drug) studies. Subject to successful completion ofpre-IND studies, the initiation of phase I clinical trials is planned for thesecond half of 2010. Both programs represent potential significant futurebusiness opportunities.Key events for the twelve-month period in 2009 included:Toctino® (alitretinoin) - The only therapy approved for severe chronic handeczema unresponsive to topical corticosteroids· December 14: Toctino® is recommended for regulatory approval in 13additional European Union Member States as well as in Norway and Iceland.· October - November: Health Canada and the Swiss regulatory authoritySwissmedic grant marketing authorization for Toctino®.· August 26: The UK National Institute for Health and ClinicalExcellence (NICE) issues its final guidance on Toctino®, recommending its usewithin the licensed indication.· March 31: Basilea submits Marketing Authorization Applications forToctino® in 13 additional European Union Member States as well as in Norway andIceland.· March 26: The German Society of Dermatology incorporates Toctino® inthe new treatment guidelines for the management of hand eczema.· March 9: The Scottish Medicines Consortium (SMC) accepts Toctino® foruse within the National Health Service.· March to May: Toctino® receives approval in Austria, Belgium,Luxemburg, the Netherlands and Spain.ZEFTERA(TM)/Zevtera(TM) (ceftobiprole) - Anti-MRSA broad-spectrum antibiotic· December 30: FDA issues a Complete Response Letter on ceftobiprole forthe treatment of cSSSI and recommends that new phase III clinical studies shouldbe conducted.· September 1: FDA accepts for review the complete response submitted byJohnson & Johnson PRD.· February 24: Basilea files arbitration claims against Johnson &Johnson over its handling of ceftobiprole clinical studies and related to delaysin approval of ceftobiprole.· February 24 and 26: The EMEA halts the European Commission decisionprocess on ceftobiprole pending completion of GCP inspections.Conference callBasilea Pharmaceutica Ltd. invites you to participate in a conference call onMonday, February 1, 2010, 4 p.m. (CET), during which the company will discusstoday's press release.Dial-in numbers are:+41 (0) 91 610 56 00 (Europe and ROW)+1 (1) 866 291 4166 (USA)+44 (0) 207 107 0611 (UK)A playback will be available 1 hour after the conference call until Wednesday,February 3, 2010, 6 p.m. (CET). Participants requesting a digital playback maydial:+41 (0) 91 612 4330 (Europe)+1 (1) 866 416 2558 (USA)+44 (0) 207 108 6233 (UK)and will be asked to enter the ID 17906 followed by the # sign.Note to shareholdersThe shareholders of Basilea Pharmaceutica Ltd. are kindly reminded that theOrdinary General Meeting of Shareholders of Basilea Pharmaceutica Ltd. will takeplace on Tuesday, March 30 at 2 pm at the Hilton Hotel in Basel, Switzerland.The invitation will be published in the Swiss Official Gazette of Commerce(Schweizerisches Handelsamtsblatt). Shareholders who are recorded in the shareregister with voting rights on March 18, 2010 will be entitled to participateand exercise their voting rights.About BasileaBasilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed onthe SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and developmentoperations are currently focused on new antibacterial, antifungal and oncologyagents to fight drug resistance and on the development of dermatology drugs.Basilea's products are targeted to satisfy high medical and patient needs in thehospital and specialty care setting.The company owns a diversified portfolio including two commercialized drugs(Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug(isavuconazole) in phase III clinical development. Basilea has set up commercialorganizations in Canada, France, Germany, the Nordics and the United Kingdom,while it is building sales and marketing organizations in other countries tocommercialize alitretinoin and to co-promote ceftobiprole, subject to approval.DisclaimerThis communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition, performanceor achievements of Basilea Pharmaceutica Ltd. to be materially different fromany future results, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providing thiscommunication as of this date and does not undertake to update anyforward-looking statements contained herein as a result of new information,future events or otherwise.For further information, please contact:+----------------------------------------+-------------------------------------+|Media Relations |Investor Relations |+----------------------------------------+-------------------------------------+|Adesh Kaul |Barbara Zink, Ph.D., MBA ||Head Public Relations & |Head Corporate Development ||Corporate Communications | ||+41 61 606 1460 |+41 61 606 1233 ||media_relations(at)basilea.com |investor_relations(at)basilea.com ||
P.O Box Basel SwitzerlandWKN: A0B9GA;ISIN: CH0011432447; Press release (PDF): http://hugin.info/134390/R/1378930/339238.pdf
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