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Strategic & Commercial Due Diligence
Page 1
Strategic & Commercial Due Diligence
Bionest Capabilities
Bionest is a Global Consulting Firm with Experienced Management Team
San Diego New York
London
Paris
Munich
Catharine StaughtonFounder
Kerstin WaterlohSenior Adviser
Tokyo
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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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
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
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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Other Relevant Case Studies
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� 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
Other Relevant Case Studies
Assignment OverviewEYEGATE – Corporate Valuation
Track Record: Asset / Corporate Valuation to Support Deal Making
Strategic & Commercial Due Diligence
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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
Other Relevant Case Studies
Cardiometabolic
Corporate Valuation
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
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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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
Strategic & Commercial Due Diligence
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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
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