Strategic & Commercial Due Diligence - Bionest Partnersbionest.com/wp-content/uploads/2015/10/Bionest-Partners-Due... · Other Relevant Case Studies ... beginning with the founding

Strategic & Commercial Due Diligence

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Bionest Capabilities


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Bionest Partners General Overview1.

Bionest is a Global Consulting Firm with Experienced Management Team

San Diego New York

London

Paris

Munich

Catharine StaughtonFounder

Kerstin WaterlohSenior Adviser

Tokyo


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Bionest Professional Staff Majority of team have a Ph.D. and / or MBA degree

Mary KotoFounder

Bob EastonCo-Chairman

Olivier LesueurManaging Director

Rachel LaingManager

New York

Alain GilbertCo-Chairman

Anne-Sophie DemangeManager

Yasuhiro Komatsu

Senior Adviser

Tokyo

South America

Strategic Partner

China

Strategic Partner

Focused Exclusively on Life Sciences

Medical

Pharmaceuticals

DiagnosticsBioPharma

TEAM EXPERTISE


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Medical

Devices

Healthcare

Services

Animal

Health

Vaccines

OTC

Over the Past 10 Years

Labs /

Contract Manufacturing

� Not linked to downstream M&A or financing

� Guaranteed objectivity

Bionest is Uniquely Positioned for Buy / Sell Side Clients

What makes us unique to our clients?

Broad Network

� Leverage global key expert network:

- Medical opinion leaders

- Industry experts(i.e., R&D, Commercial, Access)

- Regulatory experts

- Other experts including IP and

Independant80%80%Repeat business


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� Understand key business issues / challenges for buy / sell side

� Quick and efficient turnaround time

� Personal relationship: always staff the “A Team”

Responsive and Dedicated

- Other experts including IP and manufacturing / supply chain

� Bring healthcare expertise to enhance financial evaluation

� World-class topline revenue forecasting

� Gold standard valuation methodology for healthcare industry

Strategy and Finance


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Specific Expertise in Due Diligence2.

Overview of Due Diligence Approach and Critical Components

� Markets and Segments

� Competition

REVENUE (MARKET SHARE, PRICE, ACCESS, UPSIDE/DOWNSIDE POTENTIAL)

� Differentiation / Positioning

� Pricing Strategy

INVESTMENTS

RISK AND IDENTIFICATION OF RED FLAGS

� Research and Development

� Sales and Marketing

� Manufacturing / Supply Chain

� Taxes


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VALUATION AND EXIT

� Technical / Clinical

� Regulatory

� Commercial

� Access / Reimbursement

� Discounted Cash Flow

� Decision Tree Analysis

� Comparable Analysis

� Upside and Exit Strategy

� One-on-one Interviews

� Reference Checking

� Benchmarking

MANAGEMENT AND ORGANIZATION ROLES, REQUIREMENTS AND GAPS

� EUSA Pharma launched a sale process of the

company after US approval of "Asparaginase,” its

main asset

� Bionest conducted a strategic opportunity

assessment and developed a WW forecast

� Bionest characterized risks, uncertainty and critical

success factors

� Bionest performed full valuation for buy side client

� Jazz pharmaceutical won the auction for $ 650 MM

Other Relevant Case Studies

EUSA PharmaDue Diligence Cases

Track Record: Strategic Due Diligence

Due diligence

for

Due diligence

for

Merck Generics

� Merck KGaA desired to divest its generics unit to

pay down debt and focus on branded drugs

� Bionest performed an in-depth assessment of the

portfolio and specific markets / countries

� Bionest developed top-line revenue forecast,

margins analysis and valuation

� Bionest provided independent valuation to guide

bidding process to buy side client

� Mylan Labs won the auction for $ 6.6 B


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Due diligence

for Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for Due diligence

for


Due diligence

For

Undisclosed

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

Due diligence

for

13 tail products from

Due diligence

for

Due diligence

for

� EyeGate Pharma is a privately-held, venture-backed specialty

pharmaceutical company focused on new approaches for eye diseases

� Independent valuation of the Company to raise $12m in order to finance

the Phase III of EGP-437, EyeGate’s core asset, in dry eyeOphthalmology

Corporate Valuation


Assignment OverviewEYEGATE – Corporate Valuation

Track Record: Asset / Corporate Valuation to Support Deal Making


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Adenobio

Cardiovascular

Asset Valuation

Confidential

Animal Health

Corporate Valuation

Confidential

Drug Delivery

Corporate Valuation

Ginkor Fort

Asset Valuation

Anti-Infectious

Corporate Valuation

Oncology

Asset Valuation

Distribution

Corporate Valuation

Anti-infectious

Asset Valuation

Oncology

Asset Valuation

Niche Products

Corporate Valuation

Type I Diabetes

Corporate Valuation

Oncology

Corporate Valuation

Confidential

Cardiometabolic

Asset Valuation

Melyatis

Drug Delivery

Corporate Valuation

Pleiotherapy

Corporate Valuation


Cardiometabolic

Corporate Valuation


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Team Biographies3.

Before co-founding Bionest in 2003, Alain J. Gilbert was European Founding President of Biogen Inc. (BGEN), where he was

responsible for the launch of Avonex®, a biotech breakthrough treatment for MS. He held several positions at the senior

management level such as European founder of IDEXX Labs Inc. (IDXX), involved in veterinary diagnostic, water and food

contaminant testing products, and President of Medtronic Europe, world leader in cardiovascular devices (pacemakers,

valves, etc.). Alain J. Gilbert started his career in sales and marketing at Abbott's Diagnostic Division and remained there

for 17 years, holding key executive positions in the US and in Europe. At Bionest, Alain J. Gilbert is mostly involved in

Biopharmaceutical, Animal Health, Product Launch, Clinical Development strategy and Private Equity, all with a primary

focus on the US.

Alain J. Gilbert – Co-Chairman - Paris & New York

Co-Chairmen


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For over 25 years, Bob Easton has been recognized as a leader in healthcare business consulting. He has built and led two

top firms, beginning with the founding of The Wilkerson Group in 1985. He has led scores of market development and

strategic advisory assignments for clients, including large and specialty pharmaceutical companies, early-stage through

publicly traded biopharmaceutical companies, and diagnostics businesses. He has influenced the decision-making of

numerous healthcare professionals and supported hundreds of client executives in Australia, Japan, Canada, U.S., Europe,

and Israel. His interest in healthcare began when he managed a medical diagnostics business for Union Carbide.

Over a long career, Bob Easton has been highly visible in the industry, having written and spoken about multiple industry

issues in scores of venues. He is Chairman-Elect of the New York Biotechnology Association (NYBA), after having served as

Director. He has served on eight medical company Boards including Apex Bioventures, CollaGenex, and Cepheid. Bob

Easton holds two degrees in Chemical Engineering from Rice University and an MBA from the Harvard Business School.

Bob J. Easton – Co-Chairman - New York

Managing Director / Founders

Mary Koto, Ph.D. – Founder – San Diego

Mary has more than 25 years of healthcare experience in both operating companies and in consulting. Prior to joining

Olivier joined Bionest in 2004 and moved to the New York office in 2008 to develop US operations. He gained significant

experience in strategic planning (franchise and product), commercialization strategy (US and ex-US), portfolio management

and strategic due diligence. Before Bionest, Olivier was a consultant at Celerant Consulting. Olivier has an MS in

Management from EM-Lyon Business School and an MS in Molecular Biology from Polytech Clermont-Ferrand.

Olivier Lesueur – Managing Director – New York & Paris


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Catharine’s consulting career began at The Wilkerson Group (later part of IBM Consulting) in 1993 and she has led

numerous strategy and marketing projects for clients across the globe. Before then she worked in business development in

the pharmaceutical industry and as a financial analyst forecasting new product sales. Catharine has substantial project

experience in a wide range of medical products and has worked in diagnostic and surgical equipment as well as prescription

and OTC pharmaceutical products. Catharine graduated in Natural Sciences (Genetics) from the University of Cambridge

and has an MBA from INSEAD in France. She speaks excellent French.

Catharine Staughton – Founder – London

Mary has more than 25 years of healthcare experience in both operating companies and in consulting. Prior to joining

Bionest, she was a founding partner at Scisive Consulting where she worked on strategy assignments in a broad range of

therapeutic areas. Prior to that, she worked +17 years in marketing and strategic planning in pharmaceutical and medical

device companies including Agouron Pharmaceuticals and Gensia Sicor, launching products in hospitals and physician

offices. Mary has a Ph.D. from Yale University and an MBA from Stanford.

Managers

Anne-Sophie joined Bionest in 2010. Since her arrival, she mainly contributed to projects focused on strategic issues:

Market access, strategic & franchise planning, strategy operational implementations, corporate development including

business opportunity assessments, and entry in Europe for American biotech companies. She has mainly worked for

American and European clients including biotech and big pharma companies.

Prior to joining Bionest, Anne-Sophie worked at Sanofi in Singapore. Anne-Sophie holds a graduate degree in Chemistry

from ENSIC (Nancy) and holds a Master in Management from ESCP-Europe (Paris). Anne-Sophie speaks French, English and

German fluently.

Anne-Sophie Demange – Manager - Paris


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Prior to joining Bionest, Rachel completed a Ph.D. in Medical and Molecular Pharmacology at the University of California, Los

Angeles. Her doctoral research was focused on tumor metabolism, with a focus on cancer immunotherapy and PET imaging

biomarkers. Rachel has extensive project experience in oncology, including solid and hematology-oncology indications,

neurology, orphan diseases, biologics, novel antibody platforms and specialty markets, and her work has focused on clinical

and commercial assessments, qualitative and quantitative analysis, decision making, personalized medicine and primary

market research. Rachel also holds an MS in Neuropharmacology from the University of Oxford, and a BS in Molecular and

Cell Biology from UCLA.

Rachel Laing, Ph.D. – Manager – New York

Bionest Senior Advisers

Claude focuses mainly on Pharma activities and Strategy. Before co-founding Bionest in 2003, Claude was an ISO

HealthCare Consulting VP in Paris (1998-2002), responsible for the European healthcare services and Senior Consultant in

healthcare for Arthur D. Little (1991-1998). Claude held Corporate positions for 14 years with Glaxo PLC International,

Rhône-Poulenc Santé International and Parke-Davis. Claude graduated from ESSEC and is a member of SFAF (CEFA,

France).

Claude Allary – Senior Adviser - Paris

Scott has 18 years of experience building international CROs. During a 10 year career with Quintiles, Scott served as the

President of Quintiles France and Spain and also as global business affairs manager of two of Quintiles largest operating

units – CNS and Anti-Infectives. Subsequent to Quintiles, Scott was the President of CAC Oncology, where he grew the

company from one subsidiary in Paris to a 14 office niche oncology CRO with operations in Europe, US and Latin America,

before selling it to AAIPharma. Most recently he served as the European President of Siro Clinpharm. Prior to his life in

CROs, Scott held various senior management positions in consumer goods companies and media companies.

Scott Spector – Senior Adviser - Paris


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CROs, Scott held various senior management positions in consumer goods companies and media companies.

Yasuhiro has 40 years of pharmaceutical and life sciences industry experience. He has held several positions in research

and development, product management, business development and licensing and strategic consulting. Yasuhiro began his

career at Eisai Co. Ltd. and has founded / been one of the beginning members of several consulting and Life Sciences

companies including Kansai Research Institute (KRI Inc.), Komatsu Associates, and H. Holstein GmbH & Co. KG. Yasuhiro

graduated with a B.S. in Marine Biochemistry from the University of Tokyo and holds an MBA in Quantitative Methods from

the University of Washington graduate business program.

Yasuhiro Komatsu – Senior Adviser - Tokyo

Dr. Kerstin Waterloh has more than fifteen years experience in consulting to the healthcare industry. Her expertise spans

across the value chain of a pharmaceutical company, covering corporate, market and product strategy development,

process optimization and also market access (particularly pricing and reimbursement). Previously Kerstin headed the

Private Equity and Venture Capital Life Sciences Team at IKB Private Equity, a German fund. Kerstin holds a BSc and a

Ph.D. in Molecular Biology from the University of Southampton and an MBA from Manchester Business School. She is based

near Munich and is bilingual in German and English.

Kerstin Waterloh, Ph.D. – Senior Adviser – Munich

380 Lexington Avenue

43rd Floor

New York, NY 10168

USA

Tel: +1 646 619 8717


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19, rue du Général Foy

75008 Paris

France

Tel: +33 1 58 05 14 00

Fax: +33 1 58 05 14 09

[email protected]

www.bionest.com

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