Valuation of Life Sciences Companies

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Valuation of Life Sciences Companies Patrik Frei Sep 2017 BIO IP & Diagnostics Symposium (IPDx)

Agenda 1.Overview of valuation 2.rNPV product valuation 3.Deal structuring 2

Company Mission Independent assessment and valuation of technology driven companies / products in growth industries Biotechgate / Life Sciences Database Offices Employees Clients HQ: Zurich with representative offices in Europe, North America and Asia 30 people in Switzerland / UK / Ireland / Canada / USA Singapore / India / China Pharma, Biotech and Investors such as Novartis Venture Fund, GSK, European Investment Bank, 4SC, Arpida/Evolva, Celtic Pharma Biotech Associations / Governments like Ausbiotech, Medicon Valley, SwedenBio, BIOTECanada, Maryland 3

Biotechgate.com 45 000 company profiles in over 70 countries, 65 000 products, 19 000 licensing opportunities 1) Company / Asset Directory 2) Deals Database with financial information 3) Investors database Partial information can be found free on: www.swisslifesciences.com / www.ukbiotech.com / www.nordic-lifesciences.com/ www.germanbiotech.com / www.usalifesciences.com

Value vs. Price Value: implies the inherent worth of a specific thing Price: depending on the market (supply / demand); whatever somebody is prepared to pay Price is what you pay. Value is what you get. By Warren Buffett => Provide basis for negotiation, investment decision, licensing deal 5

Biotech Valuation - Valuation is key issue in development - Industry lacks transparency (private) - Very difficult (high uncertainties) - High potential for investors - Long investment cycle - Traditional valuation methods unsuited - Complex technology and IP situations 6

Valuation of what? 1. Valuation of a product Licensing deal Strategic development decision 2. Valuation of a company Investment / Financing round Merger / Acquisition Measure success of company development 7

Cash Flow www.venturevaluation.com rnpv Valuation 1. Development phase => investment 2. Product Risk (r) => success rate or attrition rate 3. Market phase => revenues Patent expiry => end of revenues (often no terminal value) 4. Discount => non-specific risk (General Risk) Time DevelopmentMarket PhasePhase 8

1.Overview of valuation 2.rNPV product valuation 3.Deal structuring 9

Five Step Process 1 2 Devel. Market Determine Cash Flows in Development Phase Determine Cash Flows in Market Phase 3 Discount rate Discount with Discount rate 4 Risk Adjust for Risk 5 $$$$$ Sum cash flows 10

rnpv Example - Phase 1 product - 20% discount rate - 11% Probability of success (p1 to market) CF: USD 2 269m DCF: USD 127m rnpv: USD 8m 400'000 350'000 300'000 250'000 200'000 150'000 100'000 50'000 - -50'000 Cash Flow Discounted CF rnpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 40'000 35'000 30'000 25'000 20'000 15'000 10'000 5'000 - -5'000-10'000 Discounted CF rnpv 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 11

Example Trial Inputs 1 2 3 4 Devel. Market Discount rate Risk In US$ 000 s Phase I Phase II Phase III Approval Time (Years) 1 2 3 1 Number of Patients ~10 ~200 ~3000 Cost per patient 7 7 7 Total Patient costs 70 1400 21000 Total patient costs as percentage of total costs* 30% 30% 30% Total non-patient costs 163 3267 49000 Total costs 233 4667 70000 2500 Total Development Costs (unadjusted) 77400 5 $$$$$ * To factor in other cost including animal studies, manufacturing, administration etc. 12

Product Life Cycle 1 Devel. Time to Peak sales Time at Peak sales Decay / Patent Expiry 120% 2 Market 100% 80% 3 Discount rate 60% 40% 4 Risk 20% 0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 5 $$$$$ A. Define Growth Phase (4-8 years) B. Define Mature Phase (1-4 years) C. Define Decay Phase (7-10 years) 13

Bottom up approach 1 2 3 Devel. Market Discount rate Sales Forecast Western EU 2018 2019 Population (000's) 300'000 306'000 Incidence rate (%) 0.020% 60.000 61.200 Diagnosed population 70% 42.000 42.840 Population treated with drugs 80% 33.600 34.272 Compliance rate 90% 30.240 30.845 Addressable population 30.240 30.845 Market penetration rate (%) 18% 34% Patient population 5.443 10.487 Market share 12% Price (EUR) 2000 Sales Western EU (EUR 000's) 1'306 2'517 USA Sales 2'540 4'798 Japan Sales 392 755 Rest of the World (RoW) Sales 1'270 2'399 4 Risk 5 $$$$$ Total sales (EUR 000's) 5'508 10'469 Peak Sales Value USD 1bn => USD 8m USD 0.7bn => USD 3m USD 2bn => USD 25m 14

Discount rate 1 Devel. Used discount rate in rnpv: 2 3 4 Market Discount rate Risk 5 $$$$$ Early stage 12% - 28% Mid stage 10% - 22% Late stage 9% - 20% Source. www.biostrat.dk Discount rate depends on non-development associated risks 20% => USD 8m 25% => USD 2m 15% => USD 21m 15

Risk Factors 1 2 Devel. Product development specific risk: Failure / success in clinical trial 3 4 Market Discount rate Risk Non-product development specific risk: Finance risk Management risk Market / Competitive risk IP risk 5 $$$$$ 16

Risk Factors IP 1 2 3 Devel. Market Rating Criteria patent protection 6 Very good possibility Example Key intellectual property in target markets is protected by issued patents 5 Good possibility Patent applications have been filed, and are in advanced prosecution stage 4 Sufficient possibility Few, minor patents provide only minimal protection (method patents) 4 Discount rate Risk 5 $$$$$ 3 Insufficient possibility Likelihood to receive patents that will really help the company gain a competitive advantage is small. 2 Poor possibility Key patents have been rejected or drastically reduced in scope of claims covered 1 No possibility Patent protection is not likely in target market i.e. prior art 17

How IP is reviewed 1 2 3 Devel. Market Discount rate Scope of coverage (claims) to ensure that the IP covers the technology and product Patent life, expiry, potential for extension, or data exclusivity protection IP review includes patents, know-how / trade secrets and trade marks Freedom to operate / prior art search 4 Risk 5 $$$$$ Source: State of IP (www.epo.org / company) Competitive IP (worldwide.espacenet.com) But we do not do a patent due diligence 18

Adjust for risk (I) 1 2 3 4 Devel. Market Discount rate Risk 5 $$$$$ Source: Clinical Development Success Rates 2006-2015; BIO; June 2016 19

Adjust for risk (II) 1 2 3 4 Devel. Market Discount rate Risk Finish Phase I 64% Finish Phase II 32% 18 Finish Phase III 61% 125 Market entry 86% 11% 672 477 Does not enter the market 14% 2% -77.0 Does not finish Phase III 39% 8% -72.0 Does not finish Phase II 68% 44% -12.0 5 $$$$$ 8 Does not finish Phase I 36% 36% -2.0 20

Value www.venturevaluation.com Adjust for Risk (III) 1 2 3 Devel. Market Discount rate The relation between Risk and Value Completion of a phase Direct value increase m USD 672 477 Cumulative Sucess rate: 11% 86% 4 Risk 125 61% 5 $$$$$ 18 8 64% 32% Phase I Phase II Phase III NDA/BLA Approval/Market 21

1.Overview of valuation 2.rNPV product valuation 3.Deal structuring 22

Timing of payments Front/ back-loading a deal can heavily influence deal structure Deal terms dependent on needs of both parties In USD m Payment of rnpv* (or up-front) Up-front 1 m 1 m Finish Pre-clinical 1 m 0.44 m Finish Phase I 1 m 70 000 Finish Phase II 1 m 17 000 Finish Phase III 1 m 8 000 Approval / Enter market 1 m 5 000 Royalties 1% 0.70 m * Time value of money and Risk adjusted 23

Timing of payments (II) Two very different deal structures can look identical Cash Flow Pharma Biotech Non-discounted, non-risk adjusted rnpv 1 Pharma Biotech 25 million upfront 300 million milestones 5% royalties rnpv 2 Pharma Biotech 5 million upfront 50 million milestones 12% royalties OVERVIEW rnpv PRODUCT VALUATION COMPANY VALUATION DEAL STRUCTURE CASE STUDY 24

Conclusion Valuation is key in the development of Life Sciences companies Value = future risk & potential Valuation is not an exact science Its all about the assumptions Q&A 25

Thank you for listening! Tel.: +41 43 321 86 60 Venture Valuation Inc. www.venturevaluation.com p.frei@venturevaluation.com Asia Europe North America