OneStart 2015 London Bootcamp: Ilan Zipkin, Takeda Ventures - Development Paths in the Life Sciences
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Ilan Zipkin, PhD, Senior Investment Director, Takeda Ventures
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OneStart 2015 London Bootcamp: Ilan Zipkin, Takeda Ventures - Development Paths in the Life Sciences
- 1. © 2012 Takeda Ventures, Inc. | COMPANY CONFIDENTIAL Development Paths in the Life Sciences Ilan Zipkin, Ph.D. Takeda Ventures Inc.
- 2. COMPANY CONFIDENTIAL | 2 StarBng point with mulBple potenBal avenues Process Goal with modified or improved funcBonality Development “You know where it ends usually depends on where you start” – Everlast, What It’s Like Organism development, drug development, and business development are all processes of transformaBon from one state to another All companies begin development with a market need and a product concept – the trick is figuring out where to go and how to get there! What it looks like What it feels like
- 3. COMPANY CONFIDENTIAL | 3 3 Defining the Space Very different paths, goals and business models TherapeuAcs ModulaBng molecular pathways Extensive clinical tesBng Medical Devices Mechanical intervenBon Precedent with proof Research Tools Enabling experimentaBon Lower barrier to entry DiagnosAcs Rapid quanBficaBon Centralized market Healthcare IT Data processing/analysis SBll fragmented
- 4. COMPANY CONFIDENTIAL | 4 4 Business Goals Barrier to entry defines revenue expectaBons TherapeuAcs IP, Clinical, Regulatory Huge cost and huge payoff Medical Devices IP, InvenBon, IteraBon Shorter development cycle Research Tools First mover, Cost, Speed Rapid uptake / obsolesence DiagnosAcs Ease, Relevance, Format Access and cost Healthcare IT So`ware, ImplementaBon AdopBon and value The harder it is for someone else to compete, the larger the revenue genera6on poten6al
- 5. COMPANY CONFIDENTIAL | 5 Discovery and opBmizaBon Animal tesBng and toxicology IND Phase I safety Phase II efficacy Phase III target populaBon NDA Design and prototyping Animal tesBng and opBmizaBon IDE Pilot tesBng Pivotal tesBng 510(k) with precedent PMA or TherapeuAcs NCEs require New Drug ApplicaBon (NDA) with evidence of safety and efficacy from well controlled, randomized clinical trials Medical Devices FDA regulates as devices; 510(k) with clinical sample data or PMA with data on impact on paBent health DiagnosAcs FDA regulates as devices; 510(k) with clinical sample data or PMA with data on impact on paBent health Research Tools Not regulated, open market compeBBon Healthcare IT HIPAA paBent privacy and data security compliance 5 Key Hurdles Along the Way
- 6. COMPANY CONFIDENTIAL | 6 6 Key Features for Investors What will it take to get to an exit? TherapeuAcs InnovaBve science versus expensive clinical development Medical Devices Sales ramp ahracBve in acquirer markets Research Tools Sales cycle and capital infrastructure / reagents DiagnosAcs Value add to clinical decision making; reimbursement Healthcare IT Magnitude of benefit to purchaser to jusBfy cost The more capital and 6me required to develop a product, the larger the exit valua6on must be Revenue genera4on drives earnings per share, either as a public company or upon acquisi4on, which determines exit value for investors
- 7. COMPANY CONFIDENTIAL | 7 7 Main Issues Return on Investment = Exit value/Capital invested TherapeuAcs ValidaBon Medical Devices Sales ramp ahracBve in acquirer markets Research Tools Sales cycle and capital infrastructure / reagents DiagnosAcs Value add to clinical decision making; reimbursement Healthcare IT Magnitude of benefit to purchaser to jusBfy cost Time and money needed to address these issues and start genera6ng that expected revenue is the denominator in the return equa6on • May be different for different investors even in the same company • ROI = absolute cash on cash or IRR, which takes 4me value of money into account
- 8. COMPANY CONFIDENTIAL | 8 8 QuesAons Every Business Plan Must Address Degree of market saAsfacAon How well is this going to address the need? DifferenAaAon from compeAAon (or compeBBve advantage) MoneAzaAon Who will pay for this? How will product development be translated into shareholder value? StarBng point Process / Path Goal Team Who are the people involved? Why are they the right founders/management for this company? Market opportunity Broadly defined Expected/PotenBal share Development acAviAes Requirements Risks Knowns/Unknowns Budget required Money Time People Company Z Summary Development Plan Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Program 1 Assay development $500,000 Compound screening $650,000 Lead optimization $650,000 Manufacturing $1,500,000 GMP toxicology $1,000,000 IND $250,000 Phase I $2,200,000 FTEs 3 3 3 5 7 7 10 12 Total $250,000 $575,000 $650,000 $1,075,000 $1,250,000 $750,000 $1,100,000 $1,100,000 $6,750,000
- 9. COMPANY CONFIDENTIAL | 9 9 NavigaAng the Path Cars now have “acBve headlights”… Companies need acBve investors who have been down the road many Bmes before! You know the curves are coming, but line of sight is limited and slow reacBon Bmes can be deadly Data reproducibility Capital efficiency Handling delays Something didn’t work Targeted partnering RecruiAng management IP strategy