DOES YOUR COMPANION DIAGNOSTIC STRATEGY BEST P OSITION YOU FOR SUCCESS?
History has Demonstrated that Sub-optimal CDx Strategies can Impact Drug Success Real-World Examples 1 st Year Sales Increased complexity of current testing + Unclear benefit of testing * $225M $123M Xalkori + ALK NSCLC = High Confusion Around Test Quality & Low Testing Rates Expected Sales Actual Sales Keytruda + PD-L1 NSCLC Required PD-L1 CDx on label vs. competitor s (BMS Opdivo) informative only CDx = Unexpected Lower Drug Prescription vs. Competitor 2015 Sales * $2.1B $566M Selzentry + EGFR HIV Source: Company Websites, Press Releases, Bionest Partners Misalignment between Pfizer and its Dx partner (e.g., on data, level of resources to involve) = Overall Poor Market Perception + Insufficient Field Force * Note: Facts described are potential contributors to the sales figures; other factors may have contributed May 2016 Slide 2 1 st Year Sales * $150M Expected Sales $24M Actual Sales
Keys to a Successful CDx Strategy BUILD COMPETITIVE DIFFERENTIATION THROUGH YOUR CDX STRATEGY CDx strategy can be a potential differentiator in a crowded competitive space ENSURE CDX FITS SEAMLESSLY WITHIN PATIENT JOURNEY Unhindered drug prescription requires a clear understanding of how the journey for all key stakeholders will evolve and the identification of potential barriers to the use of your CDx BUILD CLEAR COMMERCIALIZATION PLAN, FROM GLOBAL TO LAB LEVEL Development of a robust, integrated, commercialization strategy with functional initiatives that address CDx-related challenges will maximize test penetration from global to lab level May 2016 Slide 3
What Can Bionest Do For You? Bionest Can Provide Insights to Address all Key Aspects of Your CDx Strategy SUCCESS KEY Build CDx Competitive Advantage SUCCESS KEY Ensure Seamless Fit in Patient Journey SUCCESS KEY Build Clear CDx Commercialization Plan Bionest Project: CDx Competitive Landscape Key Insights Bionest Project: Testing Journey and Scenario Planning Key Insights Bionest Project: CDx Commercialization Roadmap Key Insights Competitor biomarker / CDx strategies Biomarker / CDx future scenarios & impact on drug positioning Avenues to leverage CDx to support competitive differentiation Current & future testing journey How testing for can be integrated in the current / future journey Identification of various biomarker and future journey scenarios Potential CDx-related barriers to drug prescription by country Global to local countryspecific initiatives to alleviate potential barriers Action items assigned by function and with associated timing Responsibility breakdown between Rx company and CDx partner Definition of key success measurements May 2016 Slide 4
What is Our Track Record? Bionest Has Worked Extensively on CDx Strategies In Various Therapeutic Areas... And Across Multiple Technology Platforms CNS Oncology Infectious Diseases Immunology Next Generation Sequencing ImmunoHisto- Chemistry Polymerase Chain Reaction Signature Panels POC Testing FISH / CISH Orphan Diseases Hand-held Testing ELISA Respiratory Metabolic Circulating Tumor DNA Etc. Numerous Companies Have Trusted Bionest With Their CDx Projects Companion Diagnostics Projects over the Past Few Years Bionest also leverages its expertise in diagnostics from projects with Dx companies: Projects with Dx Companies in Recent Years May 2016 Slide 5
Selected Project Examples CDx Strategic Planning in Breast Cancer CDx Competitive Advantage CDx competitive landscape in breast cancer Profile of each biomarker scenario and potential impact on drug prescription CDx prioritization options Competitive Landscape Prioritization Approach Current and Future Testing Journey and Scenario Planning in Asthma Fit in Patient Journey CDx Commercialization Plan Current testing journey in asthma Potential future testing journey scenarios and CDx-related barriers associated with each scenario Roadmap with action points and triggers for the team Testing Journey Roadmap of Key Initiatives Commercial Lab Strategy for PD-L1 Testing in NSCLC & Melanoma CDx Competitive Advantage Fit in Patient Journey CDx Commercialization Plan Lab visits to understand lab level testing journey and lab landscape mapping Critical success factors for PD-L1 test Risk mitigation plan for critical commercial scenarios Lab Landscape Lab Testing Processes May 2016 Slide 6
Bionest has Developed Specific Expertise in Companion Diagnostics Bionest s Key Published Articles When Illumina Buys Roche: the Dawning of the Era of Diagnostics Dominance IN VIVO, Jul. 2014 A great opportunity is at hand to turn data acquisition and analysis into medical knowledge. But few if any pharma or diagnostics companies appear poised to take advantage How to Optimize Personalized Medicine R&D & Commercialization Decision-Making Science, Dec. 2011 Quantifying factors for the success of stratified medicine Nature, Nov. 2011 Will CDx Save the Next-Generation IOs? 2016 In Progress To read these articles and more, visit http://bionest.com/publications/publications/ May 2016 Slide 7
Bionest is a Global Consulting Firm with an Experienced Management Team Bob Easton Co-Chairman, New York Bob has a deep Dx background with managing / development positions within IVD companies, followed by 30+ years consulting for wide range of Dx companies & pharma developing drugs with CDx, on market entry, scenario planning, target selection, etc. Alain Gilbert Co-Chairman, Paris Alain offers the unique combination of experience as a leader and manager of businesses in a cross- section of pharma, medical devices, and diagnostic areas, including top management positions within Abbott and Medtronic Olivier Lesueur Managing Director, New York Olivier has been helping biopharma clients tackle CDx challenges for 5+ years, across various areas (oncology, respiratory, CNS, etc.) with expertise ranging from long-term Dx transformative trends to CDx commercial strategy at lab level Mary Koto Founder, San Diego Mary has contributed to CDx projects in oncology, CNS, and respiratory. She has also worked on numerous Dx assignments across various areas. Mary also has operating experience in Dx as Vice President of Marketing at Accumetrics Melinda Kutzing Manager, New York Melinda leverages expertise from PhD in Biomedical Engineering to address key aspects of CDx strategy for a variety of clients in various therapeutic areas, including commercialization strategy and fit in patient journey Additional Strategic partners in South America, Japan & China Bionest Professional Staff Majority of team have a Ph.D. and / or MBA degree May 2016 Slide 8
380 Lexington Avenue 43rd Floor New York, NY 10168 USA Tel: +1 646 619 8717 19, rue du Général Foy 75008 Paris France Tel: +33 1 58 05 14 00 Fax: +33 1 58 05 14 09 info@bionest.com www.bionest.com 9 9