新药技术转让背景和发展趋势课件

新药技术转让背景和发展趋势

2010年12月上海新药技术转让概要国外行情案例示范资本市场近期动态如何应对疑问解答

NumberofDealsandTotalValuebyYear(1999-2008)Source:DeloitteRecapLLC,2009生物技术公司价值回升中期项目交易案例晚期项目交易案例临床二期项目交易案例晚期临床项目交易条款生物技术股权投资

不同阶段技术许可的典型签约条款13Pre-clinicalPhaseIPhaseIIPhaseIIIvs.5yearsagoUpfront$3-10M$5-15M$10-25M$40-100M3xIND$2-5MNANANA3xPhIIStart$3-8M$5-10MNANAPhIIIStart$10M$10-15M$25MNANDAFiling$5M$5M$10M$30M1stApproval$5M$10M$30M$50M2-3x2nd–3rdApproval$10M$20M$45M$70MRoyaltyTiers9-13%12-15%14-20%18-26%1.2xSource:DeloitteRecapLLC,2009BiggestGrowthinValuehasbeenatClinicalProofofConcept14Source:Windhover’sStrategicTransactionsDatabase,June2007Upfrontonly(nomilestonesorroyalties):avg.of$35MNo.ofTransactions$Millions全球生物医药并购案10年统计数字

010203040506070809Unit$亿药物研究+开发+销售费用基础研究

BasicResearch§$0.5–5millionperYear§Upto$25millionTotalforaProject临床前研究和早期临床

PreclinicalandEarlyClinical§$1–10millionperYear§Upto$30millionTotalforaProject晚期临床

LateClinical§$10–200millionperYear§Upto$1billionTotalforsomeProducts药品申报审批

Regulatory§$10millionormore药品生产制造

Manufacturing§Hundredsofmillionstobillions市场营销

Marketing§Hundredsofmillionstobillions

10年+10亿美元多数无法收回$$

研发效率下降审批门槛在提高失败几率增大产品被告几率增大早期投资缺乏生物技术公司融资路径Startup/SeedFunding($500K-$5M)–AngelsandFriends&FamilyprovideSeedcapitalandIntellectualCapitalGrantFunding($500K-$5M)–NIHandNSFSBIRGrantsVentureCapital($5-50M)–Preferredsharestructure–Syndicateroundsamongmultipleinvestors/funds–Typicallyprovide2-3yearsofcapital–Lookforexitin3-4years,fundsseektoaverage3XreturnInvestmentBanks,MutualFunds,HedgeFunds($60M+)–PublicOfferings–IPO,SPO(CommonShares)–PrivateOfferings–PIPEdeals(PreferredShares)àInaddition,partneringdealsprovidessignificantamountsofnon-dilutivefinancingtofundbiotechcompanies生物医药投资者看中什么?TheDisappearanceofSmallCapBiotech($200M-$1B)Overthepastthreeyearsthiscategoryhasshrank

Companiesthatareshortofcashandwithoutnewsflowhavebeen

punishedinthemarketplaceandmovedintomicro-capterritoryIndustryconsolidationeliminatedmanycompaniesPharmaandBiotechacquisitionsatbargainpricesMergersofequalsinthehopesofsurvivingthestormInstitutionalInvestorsaretypicallylookingtoinvest$10-50MTheycan’tdothatwithmicro-capswithoutaffectingthestockpriceInvestorswanttoseemoresmallcapBiotechsInvestorswanttobuyintoBiotechs’riskIdeallyPhaseII/IIIdataoutcomeswithin6-12monthsPharma/BiotechBiotech/Biotech73dealsbetween2004-0838PublicCompanies(52.1%)35PrivateCompanies(47.9%)44ProductCompanies(60.3%)29PlatformCompanies(39.7%)29LargeMoleculeFocus(39.7%)44SmallMoleculeFocus(60.3%)AverageValuation$1,853.4MMedianValuation$387.0MTotalValue$135,295.9M90dealsbetween2004-0833PublicCompanies(36.7%)57PrivateCompanies(63.3%)72ProductCompanies(80.0%)18PlatformCompanies(20.0%)22LargeMoleculeFocus(24.4%)68SmallMoleculeFocus(75.6%)AverageValuation$340.9MMedianValuation$105.0MTotalValue$30,677.9MDefiningBigCorpsofBioPharmaLicensingDefiningthe‘BigCos’IntegratedBiopharmacompaniesRevenuegeneratingandprofitableValuationinexcessof$1billionTop40BigCossign90%ofdeals,bytotaldollarvalueBiotechTherapeuticOut-licenseDealswithBigCorp(2004-Q32009)70distinctBigCorps1,237alliances$139billionannouncedtotalvaluePaymentsinalliances($M)UpfrontEquityAnnouncedTotal2005-09Total$12,159$2,857$139,238AnnualAverage$2,559$601$29,313BiotechAllianceswithBigCorpsAlliancefrom2005–Q320091,237dealsannouncedStageatSigningofDealDiscovery72551%LeadMolecule624%Preclinical14010%PhaseI786%PhaseII1168%PhaseIII1259%Approved17312%国外已公开的部分数据AggregatePaymentsinAnnouncedNewAlliances($M)

UpfrontEquityAnnouncedTotal2005-09Average$2,559

$601$29,3132008$3,572$299$37,2962009YTD$1,448$533$17,1502009est.$1,931$711$22,867如何准备和谈判技术合作GettingPreparedtoPartnerGatherinformationfrompotentialpartnersWhatarethecriticalquestionsaboutyourprogram?Howcanyouanswer/addressthesequestions?SupportwithR&D,marketresearch,KOLs,reimbursementandregulatoryPreparepartneringmaterialsandrunanefficientprocessWhatroledoestheassethaveincorporatedevelopment?Whatstructureareyoulookingfor?Summarizeandpreparea5minutepitchUtilizeatopd