Proteus Investor Presentation (2012)

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Proteus Venture Partners Proteus Venture Partners Transforming Healthcare through Regenerative Medicine Transforming Healthcare through Regenerative Medicine June 2009

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Transcript of Proteus Investor Presentation (2012)

Page 1: Proteus Investor Presentation (2012)

Proteus Venture PartnersProteus Venture PartnersTransforming Healthcare through Regenerative Transforming Healthcare through Regenerative MedicineMedicine

June 2009

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CONFIDENTIAL 2

Fund SummaryFund Summary

Regenerative Medicine Fund

Global reach Stage agnostic Top tier venture returns 1st mover advantage

Technology Focus Cell Therapies Regenerative Compounds Tissue Engineering Tools & Enabling Devices Aesthetic Medicine

Addressing Large Markets

Large unmet medical needs Aging population

World Class Team Core team with complementary skills

Deep domain expertise Outstanding SAB & strategic partners

Industry leadership

Disciplined Investment Approach Proprietary deal flow Rigorous due diligence Build value thru active management

Timely exits

Target Investments Outstanding technology & team Defensible IP Viable business model Near term path to clinic or revenues

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The Promise of Regenerative MedicineThe Promise of Regenerative Medicine (Select (Select Examples)Examples)

To Regenerate Heart MuscleTo Grow & Replace Entire Organs

Tissue EngineeredUrinary Bladder CONFIDENTIAL 3

Beating Cardiomyocytes •(double click to

see)

Paralyzed Rat(double click to see

video)

Paralyzed Rat Walks(double click to see

video)

Restricted Glial Cells for Remyelination* Untreated Transplant – 1 Year

Later

*Source: Steve

Goldman, Rochester

To Heal Acute Spinal Cord Injury

Geron receives FDA go ahead to initiate ESC therapy in clinical trials Jan 23, 2009

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CONFIDENTIAL 4

Agenda

I. Proteus Team

II.Proteus Coverage of Regenerative Medicine

III.Why Invest in Regenerative Medicine Now?

IV.Proteus Investment Strategy

V. Summary and Next Steps

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Proteus Team and Network of Relationships

1. Specialized Set of Skills

2. Industry Leadership

3. Worldwide Network / Discovery Relationships

4. Result: Early Access to Best Innovation, IP & Scientists

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Proteus’ Team

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Business Team

Greg, JDJeff, MBA

Ward, PhD, MBA

Business Team

Greg, JDJeff, MBA

Ward, PhD, MBAOperationsRegulatory

Science / Technology

Finance

Team Built to Succeed in RM

Finance

Builders of value

Deep knowledge of valuations, business models and deal structures

Structured many successful exits: M&A, IPO, Partnerships

Operations

Extensive Board & management experience

Understand RM commercialization strategies & biz models

Command of IP landscape

Science /

Technology

Broad expertise In RM

Conducted pioneering research

Deep ties to academia

Regulatory

Close and regular ties to regulatory agencies

Thorough knowledge of FDA and EMEA regulations

Nuanced understanding of clinical trial design within the context of RM

Technology Team

Alan, PhDAsma, PhD

Chris, FRCS, PhDDaniel, MDFayad, MD

Leonide, PhDMelissa, PhD

Susan, FRCS, PhD

Technology Team

Alan, PhDAsma, PhD

Chris, FRCS, PhDDaniel, MDFayad, MD

Leonide, PhDMelissa, PhD

Susan, FRCS, PhD

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CONFIDENTIAL 8

Proteus Team: Senior Partners

Gregory A. Bonfiglio, Managing Partner

- Early Investor in Regenerative Medicine- Senior Partner at Anthem Venture Partners- Stellar track record: Top 5% Returns - Senior Partner - Morrison & Foerster- Adjunct Professor - Stanford Law School - RM Industry Leader: Frequent Speaker- ISSCR Industry & ISCT Commercialization Committees

- Served on Numerous Boards

Jeffrey S. Karan, Senior Partner

- 25+ yrs building value in companies- 12 years with Morgan Stanley & Goldman Sachs- Managed Over $5B of equity, debt, and M&A deals

- Managing Partner of Woodside Capital Partners- Extensive experience raising capital, aggregating assets, and negotiating partnerships

- Structured numerous IPO and M&A Transactions - Dartmouth, BA; Tuck, MBA, Edward Tuck Scholar

Senior Partners have 50+

years of venture capital,operating and financialadvisory experience

Strong operational andentrepreneurial DNA

Complementary skill sets

Collaborative approach

Long-standing interpersonal relationship

Deep network with RM community, companies and scientists

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CONFIDENTIAL 9

Senior Scientific Advisors

Alan J. Russell, Ph.D.

Director of the McGowan Institute for Regenerative Medicine, Pittsburgh Professor of Surgery, UPMC Professor Chemical Engineering, Bioengineering, and Rehab Sciences & Technology Executive Director of the Pittsburgh Tissue Engineering Initiative (PTEI) Director of the National Tissue Engineering Center (NTEC) Founder of Agentase LLC

Chris Mason, MBBS, PhD, FRCS

Director, Regenerative Medicine & Stem Cell Bioprocessing Unit, UCL Fellow of the Royal College of Surgeons of England PhD in Stem Cell/Tissue Engineering (University College London) Cofounder of the London Regenerative Medicine Network (LRMN), Editorial Boards of the journals "Regenerative Medicine" and "Tissue Engineering" Founder + Member of the Steering Committee for the UK National Stem Cell Network Founder/Director of Stem Cell Translation Ltd

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Senior Scientific Advisors

Melissa Carpenter, PhD,

13+ years developing stem cell therapies

Leadership positions at CytoTherapeutics (StemCells Inc), Geron, and Novocell

Numerous publications and patents in the stem cell field

Experience in translating discovery research into regenerative medicine therapies

Experience in developing preclinical development strategies

Deep knowledge, experience and networks in RM

Created innovative stem cell related IP

Deep ties to academia

Access to early deal flow and technology

Extensive clinical work

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United States Venture Partners

Daniel Kraft, MD, Venture Partner

Stanford and UCSF Faculty Member Pioneering Stem Cell Research Multiple publications, inventions & patents

Extensive clinical work with stem cell transplantation

Founder & BOD of StemCor: RM Tools Company

Medical Training at Stanford & Harvard Boarded Certified in Internal Medicine, Pediatrics, and Hematology/Oncology

Kaufman Fellow

Deep knowledge, experience and networks in RM

Founded stem cell based companies

Created innovative stem cell related IP

Deep ties to academia

Access to early deal flow and technology

Extensive clinical work

Operational experience, SAB and BOD roles in RM focused companies

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CONFIDENTIAL 12

International Venture Partners

Dr. Susan ML Lim, FRCS, Ph.D. (Singapore)– Chairman, Susan Lim Surgery & Group of Practice, Consultant General Surgeon, Transplant Surgeon– Chairman & CEO, Stem Cell Technologies focused on human adult progenitor cells derived predominantly from adipose tissue– MBBS (Hons 1 Monash University); PhD (Cantab), FRCS (Edinburgh, Gold Medal); FRCS (Glasgow); M.Med Surg (Singapore), FACS,FAMS, HonMD (New Castle), Visiting Professor to the Institute of Cell & Molecular Sciences, Barts & University of London, Queen Mary College

Fayad A. Dandashi, M.D. (Kingdom of Saudi Arabia)– Founder and CEO of FutureMed, a leading Saudi biotechnology company– Formed the first private Umbilical Cord Blood Bank in KSA– Introduced mesenchymal stem cell banking services in Jeddah– Co-founder and Managing Partner of several specialty medical companies, including: MedLab KSA (diagnostic lab), The Eye Center (ophthalmology center), and Mashafi Group (Secondary Care Hospitals)– M.D. by training with strong business and entrepreneurial experience

Asma Ibrahim Al Asad, B.S. (UAE)– Business Development Manager, Dubai Cord Blood & Research Center (DCRC)– Project Manager, Dubai Cord Blood & Research Center (DCRC)– Chief Lab Technologist, Hematology Department, Department of Health & Medical Services– Co-founder of DCRC, the 1st UAE mixed (public & private) cord blood bank , 1st of its kind in the Middle East.– Engaged with Bone Marrow Donor registries worldwide

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CONFIDENTIAL 13

Proteus Advisory Board & Key Academic Relationships

Tony Atala, MD Tissue Engineering; Director RM Inst, Wake Forest Jacqui Brandwynne, MBA Aesthetic Medicine; Yardley; Citicorp; Neutrogena Gordon Keller, PhD ESC Biology & In Vitro Tools; Dir of RM, Univ. of Toronto Arnold Kriegstein, MD, PhD Neural Stem Cells: Dir. UCSF Dev Bio & Stem Cell Program Robert Lanza, MD ESC Biology & Therapy; VP. R&D of ACT Michael Longaker, MD, MBA RM; Director- Stanford Institute of Regenerative Med Malcolm Moore, PhD Cell Therapy; Memorial Sloan Kettering, Inventor of Neupogen

Gail Naughton, PhD, MBA Business; Dean San Diego State B-School; Founder of ATS

Julia Polak, MD, DSc Tissue Engineering; Imperial College London Brock Reeve, MBA Executive Director, Harvard Stem Cell Institute Wolf Reik, PhD Epigenetics & Tools; Babraham Institute, UK Myron Spector, PhD Tissue Engineering; Orthopedics Research, Brigham &

Women's Hospital; Prof. at Harvard Medical School & MIT

Key Academic Relationships:Harvard, Stanford, MIT, University of Wisconsin, UCSF, UPMC, Wake Forest, Columbia, Univ. of Toronto, Burnham Institute, U Washington, MD Anderson, UCL, Oxford, Imperial College, King’s College London, Cambridge (England), Singapore MIT Alliance

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Proteus’ Coverage of RM

1. All Major RM Platforms

2. Across Medical Indications

3. Access Best Teams, IP & Innovations at Earliest Stage from around the World

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CONFIDENTIAL 15

Regenerative Medicine is Transforming Healthcare

CONFIDENTIAL 15

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CONFIDENTIAL 16

RM Is A Broad Field: 5 Key Sectors (Selected Applications)

Aesthetic Medicine Dermal Fillers Hair Restoration Anti-Aging/Anti-WrinkleTooth Regeneration

Cell Therapies Heart Disease Diabetes Vision Disorders Neurological Disorders

Tissue Engineering Organ Replacement Tissue Regrowth Bone & Cartilage Wound Healing

Regenerative Compounds Compounds that triggerendogenous regeneration Anemia Advanced Wound Healing Advanced Fracture Healing

Tools & Devices Delivery Devices Cells Assays for DD&D Predictive Toxicology Bioinformatics

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Breadth of RM Products In DevelopmentBreadth of RM Products In Development

CONFIDENTIAL 17

Cancer8%

Cardiac12%

Diabetes10%

Eye2%

Gastrointestinal1%

Liver3%

Muscle1%

Orthopedic23%

Periodontal1%

Respiratory1%

Skin17%

Vascular3%

Urinary2%

Wound3%

Blood3%

Neural10%

Proteus’ database covers 700+ RM products in development

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RM treatments cover large

markets of unmet medical needs with aim of curing vs. treating diseases

Cardiovascular diseases ex: Theregen (cell based patch to promote small blood vessels in heart muscle), Cytograft (dialysis shunt / coronary artery bypass graft), Cytori (adipose stem cells)

Cancer and Hematologic diseases

ex: Cellerant – Neutrapenia; Fate Therapeutics – first products likely to be in cancer; G-CSF (Neupogen and the newer Neulasta)

Central Nervous SystemEx: Geron – spinal cord; Q-Therapeutics - demyelinating diseases; California Stem Cell – motor neuronal diseases; ACT - macular degeneration

Orthopedic diseasesex: BMP – Infuse; CellCoTec (autologous cartilage), Genzyme - Carticel™ for cartilage repair; Tigenix (biopsy & implant); ISTO - cells & scaffold

Diabetes ex: Novocell- encapsulated islet cells; BetaCell – encapsulated xenograft; diabetic complications: Stratatech for diabetic foot ulcers

Applications of Regenerative Medicine

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Regenerative Compounds: already 50% of Biotech Sales

Cytokines (Some Interferons and Interleukins (Avonex, Rebit, Betaseron)

9%Human Growth Hormones

(Except insulin)2%

Tissue Growth Factors (BMPs mostly,

neurotrophic GF, wound healing GF)

2%

Blood Growth Factors (led by CSF, EPO, derivatives)

35%

Other Biotech (monoclonal antibodies, insulin, other)

52%

Biotech Sales (2006) – Regenerative

Compounds on Right Half

$3.4b

$21b$14.1b

$0.8b

$0.8b

Expected CAGR: 15-20%

Source: Frost & Sullivan and Aggarwal, Nature 2007

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Why Invest in Regenerative Medicine Now?

1. Technology is Maturing After 30 Years of Development

2. Addressable Market is Enormous and Growing

3. Big Pharma is Very Active

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CONFIDENTIAL 21

Why the Time to Invest is Now

400+ Companies Research programs proliferating: 80+

Technology maturing

Clinical activity accelerating (800+ FDA trials)

Increased Government Funding

Demographics: aging populations

Large unmet medical needs

Pharma pipeline diminishing

Public markets receptive

The Market is at a Crucial Inflection Point

Technology Push Market Pull

Healthcare Spend is 17% of US GDP Heading Towards 23%

RM is Maturing after 40 Years of Development

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CONFIDENTIAL 22

Development of Regenerative Medicine

1968 – ALL patient irradiated, infused with identical twin BMT

1968 – ALL patient irradiated, infused with identical twin BMT

1973 – First unrelated bone marrow transplant

1973 – First unrelated bone marrow transplant

2001 – RhBMP-7 approved

2001 – RhBMP-7 approved

Dermagraft - FDA Approval 2001Dermagraft - FDA Approval 2001

1997 – Dolly the Sheep clonedLate 1990’s – Multiple FDA Approvals

Carticel (1997)

Apligraf (1999)

1997 – Dolly the Sheep clonedLate 1990’s – Multiple FDA Approvals

Carticel (1997)

Apligraf (1999)

1960s 1990s1970s 1980s 2000s

Source: Company websites, NIH, Pubmed

2005 Use of unrelated cord blood in BMT

2005 Use of unrelated cord blood in BMT

1963 – Mouse ASCs isolated1963 – Mouse ASCs isolated

1981 – Mouse ESCs isolated1981 – Mouse ESCs isolated

1986 – First Mouse Cloned1986 – First Mouse Cloned

1998 – Human ESCs isolated

1998 – Human ESCs isolated

2006 – hESCs produced w/out harming the embryo

2006 – hESCs produced w/out harming the embryo

Current technologies build on 40 years of research

1993 – ViaCell Begins Banking Cord Blood

1993 – ViaCell Begins Banking Cord Blood

1990 – Geron Founded1990 – Geron Founded

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Technology Push: Beginning the 2nd Half of the Gartner Curve

CONFIDENTIAL 23

Stage of Development

Visibility

Technology Trigger

Peak of Inflated Expectations

Trough of Disillusionment

Slope of Enlightment

Plateau of Productivity

1980 Early TE research (MIT)

1985 Term “TE” coined1986 ATS & Organogenesis founded

1988 SyStemix founded

1992 Geronfounded

1997 First cell therapyFDA approved (Carticel)

1997 Dolly the sheep

1998 Human ESCs first derived

1998 Plan to build human heart in 10 years

1999 First TE product FDA approved (Apligraf)

1999 TE bladders in clinic

1999 Intercytex founded

2000 Time Magazine:TE No. 1 job

2001 Bush “partial ban” on HESCs

2001 Dermagraft FDA approved2001 TE blood vessel enters clinic

2001 Ortec FDA approved

2001: 3300 jobs, 73 firms, mkt cap > $2.5B

2002 ISSCR founded

2002 ATS + Organogenesis file Chapter 11

2003 UK Stem Cell Bank set up2005 CIRM founded2006 Carticel - 10,000 patients2006 hESCs derived without harming embryo2006 Batten’s Disease trial2006 Reneuron file IND for stroke trial2007 Apligraf - 200,000 patient therapies2007 Human iPSCs Derived2007 Intercytex start Phase 3 ICX-PRO2007 1.2M+ Patients Treated 2007 $1.5B RM Product Revenues2007 800 FDA Clinical Trials Ongoing 2007 50 Public Companies: $4.7B Mrkt Cap

Time

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Public Markets Are Rewarding Clinical Progress

CONFIDENTIAL 24

Company Product / Stage

Market Revenue Mkt Cap (as of 12/31/07) / M&A

AnorMED Mozobil, Phase III Hematopoietic stem cell transplantation

< $1M Acquisition by Genzyme: $580M

(10/2006)

Cell Genesys(CEGE:NASDAQ)

GVAX Cancer Immunotherapy / Phase III

LeukemiaPancreatic CancerProstate Cancer

$1M $190M

Dendreon(DNDN:NASDAQ)

Provenge;:FDA review (prostrate cancer)Neuvenge: Ph I (breast, ovarian, colon cancer)

Cellular immunotherapy, monoclonal antibody, and small molecule product candidates to treat various cancers

< $1M $530M

Geron(GERN:NASDAQ)

Filing IND for spinal cord early 2008

treatment of cancer,spinal cord injury, heart failure, diabetes, and HIV/AIDS

< $4M $440M

Intercytex(ICX.L:LSE/AIM)

ICX-PRO, Ph III – in Ph III for VLUs & Ph II for DFUsVAVELTA®, Ph IIICX-TRC, Ph II

Stimulate active repair in chronic woundsFacial rejuvenationHair regeneration

< $1M $75M

LifeCell (LIFC:NASDAQ)

AlloDerm ; GraftJacket; AlloCraft

Tissue-based prods for reconstructive, orthopedic, and urogynecologic surgical procedures

$166M $1.4B

Osiris (OSIR:NASDAQ) Prochymal, Ph III & II Provacel, a phase I

GVHD & Crohn’s DiseaseAcute MI

$10M $410M

ViaCell UC storagePre-clinical work in cancer, cardiac & diabetes

Collecting and preserving stem cells from umbilical cord blood

$59M Acquisition by Perkin Elmer

$300M 10/07 – 52% premium)

Page 25: Proteus Investor Presentation (2012)

Brand Name Company Generic Name Indication

Patent Expiratio

nFDA

ApprovalSales 3Q 2007 ($MM)

Actos  Eli Lilly / Takeda  Pioglitazone  Type 2 diabetes   2011   1999  $180  

Advair/Seretide  GlaxoSmithKline  Fluticasone Asthma  2010  

1998/1999 $1,721  

Aprovel Sanofi-Aventis / Bristol-Myers Squibb   Irbesartan  Hypertension 2011   1998  $392  

Aricept  Pfizer / Eisai Donepezil HCI  Alzheimer’s 2010   1996  $100  

Avandia  GlaxoSmithKline Rosiglitazone  Type 2 diabetes   2012   1999  $463  

Cozaar  Merck  Losartan  Hypertension 2010   1995  $814  

Crestor  AstraZeneca  Rosuvastatin  Cholesterol  2012   2003  $691  

Diovan/Co-Diovan  Novartis 

Valsartan+hydrochlorothiazide 

Hypertension (high blood pressure)   2012   1996  $1,267  

Levaquin  Johnson & Johnson  Levofloxacin  Antibiotic   2010   1996  $366  

Lipitor  Pfizer  Atorvastatin  Cholesterol   2011*  1996  $3,170  

Plavix Sanofi-Aventis / Bristol-Myers Squibb  Clopidogrel  Anticoagulant   2011   1998  $1,250  

Seroquel  AstraZeneca  Quetiapine  Antipsychotic  2011   1997  $1,055  

Singulair  Merck  Montelukast  Asthma  2012   1998  $1,018  

Symbicort  AstraZeneca Budesonide /Formoterol  Asthma  2012   2000  $371  

Taxotere  Sanofi-Aventis  Docetaxel  Cancer   2010   1995  $694  

Xalatan  Pfizer  Latanaprost  Glaucoma   2011   1995  $402  

Zometa  Novartis Zoledronic acid  Cancer   2012   2001  $318  

Big Pharma Faces Tidal Wave of Patent Expirations

* Estimate – Sources: Datamonitor; Dolphin; WSJ.com research

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Big Pharma is Actively Engaged

CONFIDENTIAL 26

• GSK & HSCI: $25M Deal

•Merck, Pfizer & Lily Launch Enlight BioScience

•Pfizer Forms Regenerative Medicine Division

•GSK, AZN & Roche Help Launch Stem Cells for Safer Medicine in UK

•Johnson & Johnson Invests in Tengion & NovoCell

Page 27: Proteus Investor Presentation (2012)

Proteus’ Investment Strategy

1. Substantial Proprietary Deal Flow2. Rigorous Due Diligence Process3. Build Value through Active Management4. Timely Exits

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CONFIDENTIAL 28

2. Due Diligence and Deal Structuring

3. Build Company Value and Maximize Exits

1. Proprietary Deal Flow

Proteus’ systematic approach leads to…

…greater value for our portfolio companies and higher returns for our LPs

Proteus Value Add

Industry Leadership,Extensive Network

ProprietaryDatabases

Identify Best Opportunities

Initial Screen &Primary DueDiligence

Deep DueDiligence

Structure Deal toMaximize Returns& Minimize Risk

Build Team &Construct Optimal

Biz Model

Drive Execution &Manage Risk

Structure Exitto Maximize Value

Investment Process Overview

Page 29: Proteus Investor Presentation (2012)

Proteus Investment Approach: Deal Flow Due Diligence

Build Value

CONFIDENTIAL 29

Top DownStrategy

Bottom Up

Strategy

EXTERNAL ECOSYSTEM ANALYSIS

OPTIONS TO ENHANCE VALUE

INTERNAL COMPANY ANALYSIS

DRIVERS OF VALUE

BUILDCOMPANYVALUE!

Proprietary Data Bases

Company Selection

Size of Market

Competitive Land- scape

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CONFIDENTIAL 30

Optimal Exit At Phase II On Risk Adjusted NPV

FM

V /

Co

st o

f T

ota

l C

om

po

un

ds

in P

has

e

Source: ADIS, Pharma Projects, Fortis Bank, Paraexel, Jagle, Lehman Brothers, Journal of Health Economics 22:151-185 (2003), TFG Estimates

FMV = ~5x peak year revenues of $500M discounted by probability of launching

1,399

4,453

12,214

18,700

520 865 738 9882,458

-2,000

2,000

6,000

10,000

14,000

18,000

22,000

Entering Late-StagePre-Clinical

Entering Phase I Entering Phase II Entering Phase III Entering Launch

FMV of Compounds

Total Cost of Development($M)

57100

31

39% 180% 208%Cumulative ROI**: 19%

Phase of Development

Ind. Period ROI*: 23% 112% 25%19%

11

7

No. of Compounds:

22 months

18 months

31 months

26 months

PHASE II EXIT STRATEGY

Page 31: Proteus Investor Presentation (2012)

Summary of Proteus Value Proposition

RM Technologies Are Transforming Healthcare Science moving at an extraordinarily rapid pace Technologies at a key inflection point Large and growing markets driven by demographics

Only VC Firm Built From Ground Up To Focus Exclusively On RM Complementary skills address all the major challenges to commercialization Unparalleled domain expertise Proven records of success Established RM industry leadership Fund already has a robust pipeline 1st mover advantage (critical for IP, Freedom to Operate, knowledge base, best teams & deals)

Superior Investment Strategy

Substantial Proprietary Deal Flow Rigorous, Comprehensive Due Diligence Process Build Value thru Active Management Develop Big Pharma Relationships from the Earliest Stages Timely Exits

CONFIDENTIAL 31

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Proteus Team & Friends