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  1. 1. Uploaded: December 15, 2014 The Building Blocks of BIOPHARMACEUTICAL COMPETITIVE INTELLIGENCE Fundamentals of Primary Competitive Research Deconstructed
  2. 2. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 2 Uploaded: December 15, 2014 The Building Blocks of Biopharmaceutical Competitive Intelligence THE FUNDAMENTALS OF PRIMARY CI Purpose: The fundamental design and principles of primary competitive intelligence are to effectively garner informed data and intelligence otherwise unknown and not in the public domain regarding specified key intelligence topics and questions (“KIT/ Qs”) and a specific, highly targeted and defined universe of competitors. Focus: To actionably enable clients to surpass the competition via actionable, meaningful and robust competitive intelligence research, insights and strategically-driven implications. PRIMARY COMPETITIVE INTELLIGENCE PURPOSE & FOCUS BIOPHARMACEUTICAL COMPETITIVE INTELLIGENCE PERFORMANCE ANATOMY & PERFORMANCE OUTCOMES Robust & Actionable Implications Delivered: Actionable results are achieved via pragmatic and stepwise iterative competitive intelligence gathering and analytics, which are subsequently methodically resolved into their components and rationalized. Key intelligence hypotheses and theses are constructed, deconstructed and ultimately thoroughly vetted prior to being presented to our client partners as key intelligence findings, results and actionable implications. Distinctive capabilities of biopharmaceutical competitive intelligence Actionable, strategic & tactical insights Competitive maneuvering & outmaneuvering Robust insight- driven decision making & strategizing Transformational insights into clinical, commercial & regulatory manufacturing and supply chain/ logistics topics of interest Positive returns on investment in seminal business objectives & key business problems
  3. 3. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 3 Uploaded: December 15, 2014 FACT: Competitive Intelligence Persists Throughout THE BIOPHARMACEUTICAL LIFECYCLE PRE-CLINICAL A PHASE 1 PHASE 2 PHASE 3 MARKETED LCM B C D E F G A Primary & Secondary CI Conference Coverage Scenario Analysis Business Assessments Pipeline & Portfolio Optimization Corporate Strategy Products & Portfolio Strategy B Business Development & Licensing Technology & Product Evaluations C Generics & Biosimilars Product Marketing & LCM Brand Planning Market Analysis Brand Strategy Solutions D Clinical Development Support R&D Support E Comprehensive Landscape Monitoring Market Assessments Competitive Benchmarking F Asset Valuations G Strategy Workshops
  4. 4. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 4 Uploaded: December 15, 2014 Competitive Intelligence Allows One to See Through THE “FOG OF WAR” & WIN DECISIVELY The synthesis and actionability conferred by accurate and granular primary competitive intelligence in biopharmaceuticals enables key stakeholders to drive informed strategic initiatives thus enabling them to win, decisively. Leveraging secondary reports and data alone – in a vacuum – leads to measurable misconceptions, mistakes and missteps When rationalized and combined together, the sum total of primary competitive insights and implications become palpable, meaningful and actionable CI “If you know the enemy and know yourself, you need not fear the results of a hundred battles.” – Sun Tzu Aggregating multiple “high quality” triangulated primary human sources who have reason to know the information sought drives a level of informed understanding and insight
  5. 5. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 5 Uploaded: December 15, 2014 Big & Sustainable – THE MOLEKULE GLOBAL SOURCE NETWORK KEY OPINION LEADER (“KOL”)/CLINICAL/ACADEMIC/MEDICAL SOURCES REGULATOR/REGULATORY SOURCES OTHER SOURCES COMPETITOR EMPLOYEE SOURCES (CURRENT & RECENTLY FORMER) Molekule’s robust organic global source network continues to actively grow via the regular attendance of global medical congresses, industry trade shows and active worldwide consultancy project engagement. We foster long-standing “peer-to- peer” relationships with key industry, clinical/medical, regulatory and payer and pharmacy sources as a means of facilitating positive client outcomes and goals during our project engagements — small and large. International KOL National KOL Regional KOL Local KOL Academician Physician Scientist Global Regulators National Regulators Regional Regulators Local Regulators Payers Wholesalers Distributors Pharmacies (Retail & Hospital) Third-Party Enablers Sales & Marketing Commercialization Executive Leadership Manufacturing Research & Development Clinical/Medical Affairs Scientific Affairs Regulatory Affairs Brand Management/ Leadership Strategy & Operations Management Supply Chain/Logistics Business Development Market Research & Analytics Other Competitor Functional Roles Other Academic, Clinical, Scientific & Medical Sources
  6. 6. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 6 Uploaded: December 15, 2014 Primary CI Deconstructed – Where Engagements Align Across the BIOPHARMACEUTICAL ASSET LIFECYCLE EARLY PHASE RESEARCH 4–6 YEARS 1 YEAR CONTINUOUS1 YEAR 0.5–2 YEARS PRE-CLINICAL TESTING CLINICAL TRIALS REGULATORY REVIEW POST- MARKETING SURVEILLANCE SCALE-UP TO MANUFACTURING ONE MARKETED MEDICINE 5,000 –10,000 Compounds 250 Compounds New Drug Application Submitted Investigational New Drug Application Submitted Patent Application Filed 5 Compounds Phase I II III Actionable Competitive Intelligence and Consulting is Needed Across The Lifecycle of Biopharmaceutical Molecules
  7. 7. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 7 Uploaded: December 15, 2014 Commercial Analytics and Primary CI Across the Biopharmaceutical Brand Lifecycle MEASURABLE ROIs CONFERRED PHASE I PHASE II PHASE III FILING/PRE-LAUNCH LAUNCHED/POST-LAUNCH Comprehensive Landscape Analysis War Game Targeted Assessment of Market Potential Global NPV FC TPP Testing ATU, Patient Records Positioning Message Testing Customer Segmentation Patient Flow Concept Testing Patient Segmentation Story Flow Testing FC & Uptake Research Evaluation of Market Understanding Country eNPV FC Monthly Market Share DataRegional eNPV FC War Game Persistant Competitive Landscape Monitoring CA InvestmentCIBAPMR ROI
  8. 8. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 8 Uploaded: December 15, 2014 Competitive Forces that are Exerted on Biopharmaceutical Players NECESSITATE ROBUST PRIMARY CI Competitor Corporate Strategy Competitor Brand Strategy, product positioning and repositioning Emerging markets and growth opportunity identification Competitor M&As and Industry Consolidation Lifecycle Management Competitive Generics Growth Internal asset portfolio defense strategies and blunting tactics Internal alliances, partnerships and M&As R&D and licensing (both in- and out- licensing) Innovation and R&D strategies Co-development and technology transfers IP and patents Pricing and reimbursement strategies Regulatory affairs Overarching healthcare systems and payers Sales and marketing Marketing and branding strategies Sales force effectiveness Competitive analysis and landscaping REPRESENTATIVE BIOPHARMACEUTICAL PLAYER X
  9. 9. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 9 Uploaded: December 15, 2014 Competitive Intelligence Exercises and Assessments Enable PharmaCos to Position THEMSELVES FOR ROBUST SUCCESS 1 Discrete biopharmaceutical threat assessments 2 Manufacturing and Technology Assessments of Competitor Facilities, Equipment and Technologies 3 Competitive Landscape monitoring – Proactive research 4 Strategic Gaming Sessions (FKA “Wargaming”) 5 Regulatory Landscape Assessments 6 Manufacturing & COGS analyses, and Supply Chain/Logistics Assessments 7 Targeted Conference Coverage 6 7 4 3 2 1 5 High Relative Applicability Sustainable Success Conferred Low Relative Applicability Increasing Relative ROIs Conferred LOW MEDIUM HIGH VERY HIGH Low Relative Applicability Degree of Impact to Commissioning PharmaCo High Relative Applicability The proper planning and implementation of concerted biopharmaceutical competitive intelligence exercises drives sustainable ROIs, cost savings and measurable long-term success.
  10. 10. ALIGNED INTELLIGENCE. FOCUSED RESULTS. 10 Uploaded: December 15, 2014 Conclusions & KEY TAKE-AWAYS Primary Competitive intelligence in the biopharmaceutical vertical is not a snapshot in time – it persists throughout an asset’s lifecycle and is necessary to sustainable corporate, franchise and brand-level strategic success. Properly leveraging high quality and robust actionable primary competitive insights and intelligence leads PharmaCos and their key stakeholders down a path of concerted and enlightened success. Standing at the intersection of corporate strategy and tactical implementation, primary competitive intelligence is a key tool in biopharmaceutical executives’ toolboxes enabling them clear foresight and insights into competitor actions, movements and counter-movements. The translatability and applicability of primary competitive intelligence is measurable – when done properly, the intrinsic power of competitive intelligence is a prime vehicle for achieving marked and meaningful corporate strategic and tactical development.
  11. 11. Basel, CH PH +41 61 588 04 77 Boston, MA PH +1 617 752 3420 FX +1 617 463 9340 Brussels, BE PH +32 7 848 03 80 Chicago, IL PH +1 312 585 6040 FX +1 312 585 6780 London, UK PH +44 20 3318 4750 New York, NY PH +1 646 568 5400 FX +1 646 568 5170 Prague, CZ PH +420 576 880 005 San Francisco, CA PH +1 650 449 7680 FX +1 650 449 7447 São Paulo, BS PH +55 11 32301580 FX +55 11 32301680 Tel Aviv, IL PH +972 3 7208759 Tokyo, JP PH +81 345 789470 1395 Brickell Avenue Suite 800 Miami, FL 33131 TF +1 877 778 5110 PH +1 786 600 2410 FX +1 786 600 3140 EM DAVID ALDERMAN President CL +1 305 504 3030 EM ALIGNED INTELLIGENCE. FOCUSED RESULTS.

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