STRATEGIC INTELLIGENCE CAPABILITIES CAPABILITIES MOLEKULE ALIGNED INTELLIGENCE. FOCUSED RESULTS. Molekule Firm Dossier: 2017 Perspectives CONFIDENTIAL Molekule Capabilities 2 The Molekule Difference Core Capabilities 70+ years combined experience "within-the-walls" of Blue Chip pharma and generics competitive insights functions, including group leadership R&D & Commercial Competitive Intelligence Services: • Focused launch logistics including go-to-market strategy assessments • Strategic pricing and access, contracting and reimbursement reseach • Launch prioritization and segmentation research • Pipeline Optimization and Competitive Assessments • Licensing and M&A Support Strategy & Competitive Scenario Planning • War Gaming • Positioning • Franchise strategy and FMEA (failure mode effects analysis) • Biopharmaceutical Strategic Consulting • Molekule delivers long-term consultative partnerships with insights, pricing and market access, franchise and brand partners across the global pharma matrix to develop and deliver insights against brand and franchise strategic imperatives • We maintain a broad and growing, actively managed, global persistent human source network • We offer highly customized CI training programs and help educate internal customers and contributors on the value of CI Generics and Biosimilars; Manufacturing and Supply Chain Logistics • Pre- and Peri-LOE Assessments • Manufacturing & COGS Analyses • Manufacturing and Technology Assessments of Competitor Facilities, Equipment and Technologies • Supply Chain Logistics Assessments • Regulatory Landscape Assessments Regarding Generics and Biosimilar Threats • Generic/Biosimilar Landscape Monitoring – Proactive research CONFIDENTIAL Molekule Capabilities Molekule Consulting, LLC By the Facts and Numbers O U R I N C O R P O R AT I O N O U R STA F F I N G M O D E L US footprint • HQ in Miami Florida 2012 • Chicago office • NJ Office Employs FTE subject matter experts and seasoned pharmaceutical and management consulting industry professionals. Contractor and affiliates on long-term and ad-hoc engagements as required EU business based in London, UK est. 2014 India operations launched in 2016 M O L E KU L E & C L I E N T PA RT N E RS M O L E KU L E & ACT I O N A B I L I T Y DELIVERED Molekule drives excellence in strategic competitive intelligence and competitive workshopping Continually devoted to client centricity O U R G LO BA L O P E R AT I O N S Subsidiaries: physical operations in the EU, CIS/ CEE, Asia-Pacific, LATAM and Israel “Boots-on-the- ground” in 7 core geographies, fluent in 17 languages M O L E KU L E & COMPETITIVE INTELLIGENCE Employs intelligence industry experts, MDs, Ph.D.s, Pharm.D.s, MBAs and experienced business professionals 3 CONFIDENTIAL Molekule Capabilities The Molekule Way OUR VISION: We aspire to be the premier competitive intelligence and strategy consulting company in the life science industry delivering actionable insights and recommendations to our clients, essential for decision making, strategy development, and execution. OUR VALUE PROPOSITION: Molekule Consulting is a proactive and dedicated partner that leverages its industry leading CI expertise, deep area knowledge and its extensive global network to provide world-class competitive intelligence and strategy services. As a trusted consultant, Molekule conducts its business in an ethical manner with the highest level of integrity. Molekule Consulting will never compromise on these values. 4 CONFIDENTIAL Molekule Capabilities 5 Molekule Consulting's Proprietary Ethical Research Methodology and Disclosures Code of Conduct Molekule Consulting is committed to the highest standard of ethics throughout its global offices and worldwide consulting staff. As a firm, Molekule strictly complies with all global, regional and local laws and regulations. Molekule complies with all SCIP rules, regulations and guidelines, globally, across all office locations and human capital resources. Molekule Consulting neither has active, pending, nor prior litigation or litigious activity against it as a legal entity. IN PARTICULAR We will CONDUCT all business according to the following standards unless the client requests more restrictive constraints, in which case, those standards take precedence. We will NOT LIE (by giving any false information, misrepresenting ourselves or using false pretexts). We will NOT CHEAT (by attempting to bypass any company’s attempts to protect their information). We will NOT STEAL (by misappropriating or fraudulently obtaining, intellectual property). We will NOT provide inducements (honoraria or gifts) of any kind in exchange for information since this could be interpreted as a bribe to violate confidentiality agreements. We will NOT tape source interviews without the source’s permission. We will NOT use intrusive methods (technical or surreptitious means to penetrate private space or private conversations). We will NOT engage in activities that will cause harm to individuals, companies, or markets. Code of Conduct We will NEVER reveal a client’s identity. We will ALWAYS protect the confidentiality of sources. We will SPEAK UP immediately regarding any legal or ethical concerns. We will NEVER accept work that would create a conflict of interest for the company or our clients. We will ALWAYS report truthfully and will provide honest conclusions and recommendations to clients. We UNDERSTAND that it is better to “fail” than to violate legal and ethical guidelines and thereby create risk for Molekule Consulting and its clients. MRK 55 Analog Assessment of the Competitive Vaccines Market Molekule Consulting & Competitive Intelligence ALIGNED INTELLIGENCE. FOCUSED RESULTS. CONFIDENTIAL 6 CONFIDENTIAL Molekule Capabilities Competitive Intelligence Enables Thorough “Drill Down” via Multiple Levels of Asking Key Intelligence Questions (“KIQs”) Analytics of the secondary domain Thorough interviews with competitors, key stakeholders and KOLs Multi-point and multiperspective interviews with high value and reliable stakeholders/sources Multiple iterative refinements of CI interviewing with multiple sources/stakeholders HIGH VISIBILITY • Publicly disclosed information • Non-proprietary data • Sales and revenue figures • Audits and reviews “A BOV E T H E R A DA R ” • Proprietary custom research elucidating theories and/or opinions. i.e.threat levels, impact factors, enthusiasm levels “ H I G H VA LU E TA RG E TS” – PA RT I A L I M M E RS I O N • Granular elucidation of specific competitor actions, deployments and/or manifestations • Real-time and/or near-term competitive insight and intelligence “ D E E P D I V E S” – F U L L I M M E RS I O N • Competitor initiatives, strategies and tactics • Forward-looking competitor logistics • Competitive long-range planning • Highly detailed depiction of the competitive landscape • Synthesis and translatability 7 CONFIDENTIAL Molekule Capabilities Molekule Consulting's Three-Step "CAS" Competitive Intelligence Refinement Funnel COMPETITIVE DATA ALONE IN A VACUUM ARE NOT INTELLIGENCE . . . ACTIONABLE PRIMARY COMPETITIVE INTELLIGENCE IS DERIVED FOR ROBUST CONTEXTUALIZATION, ANALYSIS AND SYNTHESIS. FILTER #1 CONTEXTUALIZATION FILTER #2 ANALYSIS KEY: FILTER #3 SYNTHESIS Intelligence Signal Potential Intelligence Signal Competitive Noise 8 CONFIDENTIAL Molekule Capabilities CI Strengthens One’s Competitive Position VIA Accurate, Timely and Actionable Insight TIME Accuracy & Precision of Intelligence Findings Timeliness of Competitive Insight Actionability of Intelligence Developed PharmaCo's Competitive Position Bolstered, Robustly Sustainable Success and Measurable ROIs Conferred in Support of PharmaCo 9 CONFIDENTIAL Molekule Capabilities Competitive Intelligence Dissipates the “Fog of War” & Enables One to 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 Aggregating multiple “high quality” triangulated primary human sources who have reason to know the information sought drives a level of informed understanding and insight When rationalized and combined together, the sum total of primary competitive insights and implications become palpable, meaningful and actionable competitive intelligence “If you know the enemy and know yourself, you need not fear the results of a hundred battles.” – Sun Tzu 10 CONFIDENTIAL Molekule Capabilities Competitive Forces Exerted Upon Biopharmaceutical Players Necessitates Robust Competitive Intelligence Assessments • Competitor Corporate Strategy • Innovation and R&D strategies • Competitor Brand Strategy, product positioning and repositioning • Co-development and technology transfers • 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 • IP and patents • Pricing and reimbursement strategies • Regulatory affairs • Overarching healthcare systems and payers • Sales and marketing • Marketing and branding strategies • Internal alliances, partnerships and M&As • Sales force effectiveness • R&D and licensing (both in- and out- licensing) • Competitive analysis and landscaping C OM PE T I T I V E FORC E S COMMONLY EXERT ED ON PHA RM AC OS 11 CONFIDENTIAL Molekule Capabilities Fact: Competitive Intelligence Persists Throughout The Pharmaceutical and Medical Device Lifecycle A Primary & Secondary CI Conference Coverage Scenario Analysis Business Assessments Pipeline & Portfolio Optimization Corporate Strategy Products & Portfolio Strategy PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 B Business Development & Licensing Technology & Product Evaluations MARKETED LCM 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 12 MRK 55 Analog Assessment of the Competitive Vaccines Market Sample Engagement Team Profiles ALIGNED INTELLIGENCE. FOCUSED RESULTS. CONFIDENTIAL 13 CONFIDENTIAL Molekule Capabilities 14 David L. Alderman President & Partner David founded Molekule Consulting with an ethos of strategic and actionable competitive insight combined with client centricity. He is responsible for numerous engagements with varied scopes and objectives in the competitive intelligence and primary market research areas. Project scopes range from preclinical through launch and lifecycle management (“LCM”) to supporting clients in clinical and commercial strategy development. His major therapy expertise is in oncology, ophthalmology, cardiovascular, diabetes, autoimmune, and CNS. David attends numerous major medical congresses and scientific congresses globally Prior to founding Molekule, David held progressive roles in biopharmaceutical and market intelligence executive leadership, conducting business development, managing projects and personnel, as well as developing primary intelligence in support of client engagements. David has extensive experience developing clinical and marketing strategies for both pharmaceutical and biotechnology companies, leveraging his skills in intelligence needs identification, collection, analysis and dissemination David holds a B.S. in Biology from Trinity College in Hartford, CT, and a M.Sc. in Biomedical Science from Columbia University College of Physicians and Surgeons in New York, NY. Additionally, David pursued doctoral study in Genetic Research, Genomics and the Molecular Biology of Disease at Emory University School of Medicine in Atlanta, GA. THERAPY AREA & SUBJECT MATTER EXPERTISE Generics & Biosimilars Pre- and Peri-LOE Strategy Manufacturing Intelligence Supply Chain Logistics Intelligence Oncology ACADEMIC QUALIFICATIONS Doctoral Training & Research Emory University School of Medicine M.Sc. Columbia University College of Physicians and Surgeons B.S. Trinity College CNS Ophthalmology Cardiovascular Competitive Simulation Workshops LANGUAGES SPOKEN English Spanish CONFIDENTIAL Molekule Capabilities Dr. Daniel Pascheles CEO & Partner Dr. Pascheles joined Molekule Consulting in early 2017 as Chief Executive Officer and has over 20 years of experience in building world-class global competitive intelligence. As manager of large CI teams, Daniel oversaw and led during his successful career in the biopharmaceutical industry hundreds of primary CI projects, competitive simulations and strategic planning sessions. Prior to joining Molekule Consulting, Dr. Pascheles was Vice President and Head of Global Competitive Intelligence at Merck & Co /MSD for the last 12 years. Before that he worked for Aventis and its predecessor company (Hoechst Marion Roussel, Marion Merrell Dow) for 14 years in various positions such as Global Head of CI, European Head of Sales and Marketing Administration, European Head of Strategic Planning and General Manager Switzerland. Dr. Pascheles studied Pharmacy at the Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland. He received his Ph.D. in Pharmaceutical Technology from the same university. He did additional studies at the University of Kansas in Lawrence, Kansas. Daniel is Past-President and a current Board member of the Pharmaceutical Business Intelligence & Research Group (PBIRG). He is also a member of the Society of Competitive Intelligence Professionals (SCIP) and the Licensing Executive Society (LES). He is a well-known speaker/chairman of International Conferences on Competitive Intelligence. He is a member of the Editorial Advisory Board member of the Pharmaceutical Executive magazine and publishes regularly in various trade magazines. Daniel is also Visiting Professor at the Rey Juan Carlos University in Madrid teaching a Master Class in CI. THERAPY AREA & SUBJECT MATTER EXPERTISE CI Process Consulting and CI Training Competitive Benchmarking Generics & Biosimilars Diabetes Competitive Simulations & Strategic Planning Early Warning Programs & Monitoring ACADEMIC QUALIFICATIONS Ph.D. Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland M.Sc. Swiss Federal Institute of Technology (ETH) in Zurich, Switzerland Harvard Business School Executive Education on Leadership and Strategy Pre- and Peri-LOE Strategy Cardiovascular LANGUAGES SPOKEN English German French 15 CONFIDENTIAL Molekule Capabilities Hezekiah Blake Vice President Hezekiah Blake is a competitive intelligence functional expert with over 15 years of relevant experience. He has extensive management experience at Novartis, and Bayer having built teams and managed multi-millions in support of blockbuster assets. Holding various global pharma roles and working across cultures while living in India, he is adept at building rapport and delivering value across culture and geography in the global, matrixed pharma environment. On the consulting side, Hezekiah has built, managed and delivered engagements against brand and franchise strategic imperatives. Typical projects include clinical assessments, competitive benchmarking, risk assessments, competitor opinion leader and publication heat-maps, strategic and tactical scenario planning workshops. Hezekiah’s therapeutic areas of expertise include Hemophilia, Virology, Immunology, Oncology, MS & the orphan disease space. Prior to joining Molekule, at Bayer, Hezekiah was responsible for proactive CI defense including corporate security, formalizing partnership between legal and CI, develop and launch of an enterprise wide insight portal, and insights lead of $2B+ franchise. Previously, Hezekiah served Novartis as a Function Head for the CI group. There he directly managed a team of 14 associates and transitioned the organization to a service-based delivery system. Mr. Blake holds a Masters of Bioscience, Business of Bioscience focus, from The Keck Graduate Institute of Applied Life Sciences, a member of the Claremont Colleges and a Bachelor of Science in Biology from The University of California San Diego. Hezekiah served as the student body president for his graduating Masters class. THERAPY AREA & SUBJECT MATTER EXPERTISE Competitive Simulation Workshops Immunology Orphan Disease Arthritides ACADEMIC QUALIFICATIONS M.B.S. Keck Graduate Institute of Applied Life Science B.S. University of California, San Diego Hematology Virology Nephrology CNS LANGUAGES SPOKEN English Spanish 16 CONFIDENTIAL Molekule Capabilities Alexander Price Director - Europe Alexander Price is a competitive intelligence functional expert with over 20 years of relevant experience. He has extensive management experience in healthcare research consultancies, having supported numerous operational, project, and resource requirements. Furthermore, he has held various global pharma roles and is skilled at building high performing teams and delivering value across culture and geography in the global, matrixed pharma environment. On the consulting side, Alex has sold, managed and delivered engagements against brand and franchise strategic imperatives. Typical projects include clinical assessments, competitive benchmarking, risk assessments, quantitative market research, strategic and tactical scenario planning workshops. Alex’s therapeutic areas of expertise include Neurology (particularly MS, Alzheimer’s Disease, Parkinson’s Disease, and Dementia), Diabetes, Rheumatoid Arthritis, Psoriasis and related autoimmune diseases, Respiratory (COPD, Asthma, Allergic Rhinitis), Virology, and Generics. On the industry side, Alex has held CI functional expertise positions at Roche Pharma HQ (Switzerland), and GE Healthcare HQ (UK). Key initiatives delivered as part of these roles include supporting the role out of an organization wide insight portal, elevating CI processes to the corporate level including corporate security, development of a CI agency vetting program, and insights lead of $1B+ franchise. Mr. Price holds a Bachelors and Masters Degree in Health Administration from The Pennsylvania State University and participates in local CI chapter meetings. THERAPY AREA & SUBJECT MATTER EXPERTISE Neurology Arthritides Virology ACADEMIC QUALIFICATIONS M.S. Pennsylvania State University B.A. Pennsylvania State University Biopharmaceutical Intellectual Property Diabetes Respiratory (COPD, Asthma, Allergic Rhinitis) Generics and Biosimilars Competitive Analysis and Simulation Workshops LANGUAGES SPOKEN English Spanish 17 CONFIDENTIAL Molekule Capabilities 18 Dr. Michael Marlatt Associate Director Michael is a uniquely experienced competitive intelligence (CI) and therapeutic area expert, having led significant engagements with both pharmaceutical and biotechnology clients. A seasoned project manager, Michael has a breadth of experience with competitive landscaping, product differentiation, launch preparedness, l i fe c yc l e management, and organizational development. His major therapeutic expertise is in CNS, oncology, rare, and infectious diseases. He brings first-hand experience delivering clinical and commercial insights for pipeline and marketed products to a breadth of clients, ranging from Top-20 pharma companies to privately held biotech firms. Michael is a research scientist by training, who began his career with Merck Research Labs in Neuroscience Drug Discovery. Following his PhD, Michael joined Deallus Consulting, a global CI and strategy firm based in London, where he developed further as project manager and functional CI expert. At Deallus, he held major responsibility for delivering global CI and strategy projects across therapeutic areas and diagnostics. From Deallus, Michael was recruited to Occam Global, a retained executive search and strategy firm based in New York, specializing in organizational development for venture capital backed healthcare and technology companies. Michael completed his BS and MS at Case Western Reserve University in Biochemistry and Pathology respectively. He completed his PhD through a Marie Curie Fellowship at the University of Amsterdam (The Netherlands) and National Institutes of Health (USA). THERAPY AREA & SUBJECT MATTER EXPERTISE CNS Oncology Rare Disease Virology Immunology and Inflammation ACADEMIC QUALIFICATIONS Ph.D. University of Amsterdam, The Netherlands M.S. Case Western Reserve University B.S. Case Western Reserve University Diagnostics Regulatory Strategy Life Cycle Management (Pre- and Peri-LOE strategy) Competitive Simulation Workshops Sales Force Effectiveness LANGUAGES SPOKEN English CONFIDENTIAL Molekule Capabilities 19 Patricia Garcia Engagement Manager Patricia manages competitive intelligence engagements across the biopharmaceutical arena. She develops actionable insights based on analysis and synthesis of primary and secondary research findings. Patricia has extensive experience in the biopharmaceutical ecosystem. Prior to joining Molekule Consulting, she has been working as an independent consultant after a decades-long career in the pharmaceutical industry in positions of increasing responsibility. She has had significant roles in the drug development lifecycle, having worked across multiple functions from R&D to commercialization. Patricia worked for 15 years at Sanofi in market analytics and competitive intelligence roles across multiple therapy areas, where she was a valued member of early brand teams, joint ventures of varying complexities, and project teams. Prior to joining Sanofi, she launched a proprietary database in the US as Product Manager for IMS International. Her background includes market research at BristolMyers Squibb, business planning and clinical research at Wyeth (now Pfizer), and pre-clinical research at Roche. Patricia is skilled in understanding the needs of scientific and commercial stakeholders in bringing a new drug to market, and assisting them in understanding the competitive environment to optimize the performance of existing brands. THERAPY AREA & SUBJECT MATTER EXPERTISE New Product Launch Licensing Assessments Strategic Alliances Long-Term Strategic Planning ACADEMIC QUALIFICATIONS M.B.A. New York University, Stern School of Business B.S. Biology Pace University, New York Immunology and Inflammation Diabetes CNS Anti-Infectives Anti-Virals Biologics Cardiovascular LANGUAGES SPOKEN Neurology Psychiatry Drug delivery English Spanish French CONFIDENTIAL Molekule Capabilities 20 Jayant Rana Consultant Jayant is a Competitive Intelligence functional expert with significant blue chip pharma experience at Novartis, Abbott, and Eli Lilly. He is adept in generating market and competitor insights across global matrixed pharma organizations for brand, franchise and senior leadership. As part of the Global CI team at Novartis, Jayant delivered insights to global and country brand teams across the globe in support of multiple blockbuster brands. As part of the Commercial Excellence team at Abbott, Jayant supported the leadership team in diverse projects related to sales force effectiveness, customer relationship management, and business analytics to achieve strategic objectives profitably and sustainably. At Lilly, Jayant developed market research expertise in support of the Diabetes brand team. Jayant holds an MBA from the Indian Institute of Foreign Trade, with a concentration in International Business, and a Bachelor of Technology degree in Biotechnology from the Jacob School of Biotechnology & Bioengineering. THERAPY AREA & SUBJECT MATTER EXPERTISE Neurology Cardiology Diabetes Respiratory ACADEMIC QUALIFICATIONS M.B.A. Indian Institute of Foreign Trade B.TECH Biotechnology Jacob School of Biotechnology & Bioengineering Competitive Analysis Sales Force Effectiveness Emerging Markets Generics & Biosmilars LANGUAGES SPOKEN English Hindi MRK 55 Analog Assessment of the Competitive Vaccines Market Client Testimonials ALIGNED INTELLIGENCE. FOCUSED RESULTS. CONFIDENTIAL 21 CONFIDENTIAL Molekule Capabilities Client Testimonials “It takes a lot of coordination and effort to drive home consistency and quality in terms of high impact deliverables and high quality, accurate and precise intelligence. The folks over at Molekule Consulting have an amazing ability to do that time in and time out.” “I must compliment Molekule [Consulting] on their ability to develop sources and track down individuals, globally, who are difficult-to-reach. As a firm, Molekule [Consulting] can develop some of the best primary [competitive intelligence] out there and they synthesize it quite well. Their deliverables are well refined and to the point of a ‘MBB-style’ consultancy.” “It takes a lot of coordination and effort to drive home consistency and quality in terms of high impact deliverables and high quality, accurate and precise intelligence. The folks over at Molekule Consulting have an amazing ability to do that time in and time out.” – Associate Director, Global Commercial Strategy, MNC Biopharmaceutical Company, U.S. – Director, Global Commercial Insights, Top-5 Pharmaceutical Company, U.S. – Director, Business Analysis and Insights, Top-15 Biopharmaceutical, U.S. “Wargaming may no longer be politically correct – but let us be true – it is a war game. Strategy workshops conducted by Molekule Consulting are standout – they are well prepared and facilitated. The level of engagement with our internal key stakeholders was extreme and the key takehomes was solid. Overall, I was very impressed with the job the Molekule group did and would definitely re-engage with them” “There are few and far between [competitive intelligence] agencies that do the job ethically and right - collecting solid intelligence findings and reporting it properly, strategically and actionably. Molekule Consulting does just that - after 23 years in the industry on the client-side, inside the walls of Pharma, I can wholeheartedly endorse the Molekule [Consulting] team.” “The dedication and real, two-way communication between the Molekule team and us was stellar - and helped better fulfill the engagement objectives, significantly. Communication is key in any services industry - even down to the consultancy level - and they knocked it out of the park in terms of the intelligence and deliverables - when you get that synergized with the communication, it is great!” – Sr.Manager, Top 5 Global Pharmaceutical Company, Switzerland – Sr. Director, Global Competitive Intelligence, Major Pharma, Europe – Associate Director, Competitive Strategic Insights, Top-10 Biotech, U.S. 22 MRK 55 Analog Assessment of the Competitive Vaccines Market Sample Framework ALIGNED INTELLIGENCE. FOCUSED RESULTS. CONFIDENTIAL 23 CONFIDENTIAL Molekule Capabilities 24 Rationalizing Therapy Area Competitive Landscapes Elucidates Strengths, Opportunities, Weaknesses and Threats EXHIBIT Q High Impact of Competitor New Commercial Offerings 1. CompetitorA 2. Competitor B 3. Competitor C 4. Competitor D 5. Competitor E 6. Competitor F 7. Competitor G 1 6 2 In-line RA Player Pipeline RA Player (Note: approved for nonRA indications) Note: Competitor 1 and 2 are considered standouts among rheumatologists due to overt initiatives performed to garner enthusiasm. Although their respective RA assets in the EU28 are considered “mature…” rheumatologists claim Competitor 1 and 2 continue to drive measurable excitement via new initiative develo ment on a yearly basis Low Impact of Competitive Asset Label Expansion 7 5 Low Impact of Competitor New Commercial Offerings 4 High Impact of Competitive Asset Label Expansion 3 “Competitor 1 just seems to get what I want to have happen and every year they drive new and transformational programming for prescribers who treat RA. Humira is a great drug and when they [Competitor 1] come to the gate with new offerings and programs to boot, how can they be beat?” – KOL, The Netherlands CONFIDENTIAL Molekule Capabilities Competitive Commercial Manufacturing and Scalability Dashboard EXHIBIT X The approximate tonnage of API 1 produced globally by competitors is ~175 metric tons COMMENTS • Competitor 7 produces API 1 at its Montreal, Canada based facility, but sources a bulk of its API 1 from Competitor 3 • Competitor 5 produces API 1 in Andhra Pradesh, India at a facility with approximately 300% up-scalability relative to current capacity • • Competitor 12’s API 1 is produced in Reykjavik, Iceland at a facility with approximately 125% up-scalability relative to current capacity • Competitor 13’s API 1 is produced in Andhra Pradesh at a facility with ~65% up-scalability MAX I MUM AP I 1 CAP ACI TY Competitor 2 ~25 MT Competitor 10 ~7.5 MT Competitor 3 ~50 MT Competitor 12 ~30 MT Competitor 5 ~25 MT Competitor 9 ~10 MT Competitor 7 ~10 MT Competitor 13 ~5 MT 25 CONFIDENTIAL Molekule Capabilities 26 KOL Mapping Dashboard NEEDS • Reduce relative cost of psoriasis biologics to a more “reasonable,” customer-friendly price • Drive long-term investment into public/academic psoriasis clinical and translation research • Foster the growth of overall psoriasis disease state awareness and understanding among non-medical professionals N EED S WANTS Understanding the interplay among pharmacos and striving for industry-psoriasis HCP transparency • Facilitating novelty in terms of initiatives and programs sponsored by leading psoriasis pharmacos will “bridge the gap” for prescribers • Leverage an EU28 centralized model for psoriasis biologics than a geography- or country- variant model WA N TS ASPIRATIONS • Seek better overall relationship with industry – necessitates “partnership for tomorrow” • Wants to link data transparency via open-access psoriasis clinical data consortium • Keen on understanding pharmacos’ lifecycle management and long-range planning to be aligned in terms of how to better manage patients in the long-term A SPIR ATION S “Psoriasis pharmaceutical companies are not all bad, but they certainty are not all good. I personally and we as dermatologists have multiple unmet needs to care well for the psoriatic patient, but so too do we have dimensions we strive for. Pharma, please help us!” – KOL, Belgium CONFIDENTIAL Molekule Capabilities Competitor 1’s Sources its Insulins in a Ready - Made Form From Denmark Across all EM-8 Geographies Competitor 1: Supply Chain for Emerging Markets Russia China Competitor 1 plans to build a fill/finish production facility for insulins, which will be completed within 3-4 years Competitor 1’s Tianjin plant produces competitor 1 Pen 3 and fill/finish capacity for China and AP region years Poland Turkey Mexico Finished Product API/bulk insulin Source site for Insulin and/ orAPI Brazil Competitor 1 is constructing a new manufacturing facility north of Minas Gerais which will have cartridge fillingcapacity 27 CONFIDENTIAL Molekule Capabilities Manufacturing Capacity Investments Target China, Russia and Brazil with Major LongTerm R&D Investment in India Competitor 1: Planned Headcount Expansions Country Country CHINA 2012/2013 Expansion Plans 2014 or beyond expansion plans No expansion plans Sales Force Marketing R&D Mfg Comments • Plans to expand overall headcount from 1700 (2008) to 3000 by 2012 • Beijing R&D staff to increase to 150 staff • Tianjin manufacturing headcount to increase from 350 to 500 staff by 2012 INDIA Competitor 1’s sales force in India is to increase headcount by 50 to support Victoza launch RUSSIA Competitor 1 intends to increase its investment in Russia manufacturing; however, d oes not intend to increase headcount across sales, marketing and R&D POLAND There are no plans to increase headcount in the Polish market S. KOREA Competitor 1 plans to increase sales force headcount to increase share of voice for Levemir TURKEY There are no plans to increase headcount in the Turkish market MEXICO Presently, there are no plans to increase headcount in the Mexican market BRAZIL Brazilian manufacturing facility is actively expanding headcount throughout 2012-2013 28 MRK 55 Analog Assessment of the Competitive Vaccines Market Molekule Case Studies ALIGNED INTELLIGENCE. FOCUSED RESULTS. CONFIDENTIAL 29 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Top - 10 Ethical MNC Biopharma S I T UAT I O N Our client faced near-term direct competition from both generic and novel FDC HIV ARV assets ACT I O N In support of a Top-10 ethical MNC biopharma player, Molekule conducted a comprehensive landscape monitoring of the HIV market for FDC ARV generics – either direct ANDA competitors to established brands of novel FDCs of generics components. We worked with a Director of Strategic Planning to assess the impact and implications of generic threats to established ARV agents, as well as novel FDC ARV agents. MOLEKULE CONDUCTED COMPREHENSIVE LANDSCAPE MONITORING Inclusive of: – Congress Coverage – KOL Interviews – Competitor interviews – Regulatory Stakeholder Interviews – Payer Interviews R E SU LTS Molekule accurately identified a short list of key generic competitors poised to enter the FDC ARV market. Accordingly, our client was able to correlate its manufacturing of product to scale with the forthcoming genericization, conterring significant cost savings to our client. 30 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Top - 5 MNC Ethical Pharma S I T UAT I O N Our client sought high value antibiotic targets for in-licensing, acquisition and/or partnership. ACT I O N Molekule was engaged by a Top-5 MNC U.S.-based ethical pharmaceutical player to conduct a targeted assessment of the market dynamics and associated implications of novel antibiotics and associated potential licensing partnerships/ agreements in select markets including the U.S., Big-5 EU and Japan. Our client was an Associate Director of Business Development and Licensing and the overall engagement enabled our client to elucidate BD&L opportunities in the U.S., Big-5 EU and Japan markets for key antibiotic assets. MOLEKULE CONDUCTED A BUSINESS DEVELOPMENT & LICENSING DUE DILIGENCE TARGETED CI ASSESSMENT Inclusive of: – KOL Interviews – BD&L Target Interviews – Congress Coverage R E SU LTS Molekule accurately identified a short list of key generic competitors poised to enter the FDC ARV market. Accordingly, our client was able to correlate its manufacturing of product to scale with the forthcoming genericization, conterring significant cost savings to our client. 31 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Specialty Biopharma S I T UAT I O N Our client is engaged in the highly competitive IBD space and needed a focused and robust universe of KIT/Qs answered to better address emerging competitive dynamics. ACT I O N Molekule was engaged by a specialty gastroenterology player to conduct comprehensive congress coverage of the UEGW and ACG congresses in support of a blockbuster anti-TNF asset. Our client was a Senior Manager of Global Competitive Intelligence; engaging together, Molekule depicted clear answers to the client’s high, medium and low priority KIT/Qs, enabling the client company to position itself for robust success in the gastroenterology space, forward-looking in the U.S. and EU. MOLEKULE WAS ENGAGED TO CONDUCT COMPREHENSIVE CONGRESS COVERAGE Inclusive of: – Congress Coverage – Competitor interviews – KOL Interviews R E SU LTS Molekule furnished our client high impact, accurate, timely and actionable strategic insight and intelligence leveraging congressess as venues flush with high value human source resulted in our client hardening competitive pinch points and elucidating blind spots. 32 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Major EU Biopharma S I T UAT I O N Our client wanted to understand competitive commercial strategies across global mid-sized biopharmaceutical players. ACT I O N Molekule was engaged by a large cap EU-based biopharmaceutical player to conduct a targeted assessment of novel strategic implementation models across mid-sized (i.e.- $300MM – $750MM market capitalization) biopharmaceutical players approaches to global market access and go-to-market strategy. Our client was a Senior Director of Marketing Analytics and Business insights. MOLEKULE WAS ENGAGED TO CONDUCT A TARGETED CI ASSESSMENT MARKET ACCESS & GO-TO-MARKET STRATEGY ASSESSMENT Inclusive of: – Competitor interviews – Internal Stakeholder Interviews – KOL Interviews R E SU LTS Partnered together, Molekule and client developed keen insights and market intelligence regarding middle market capitalization competitors’ global market access and go-to-market access strategies, worldwide. 33 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Top - 3 MNC Biopharma S I T UAT I O N Our client sought market intelligence regarding competitive blunting strategies and tactics across key players and markets ACT I O N Molekule was engaged by a global Top-3 ethical MNC biopharmaceutical player to conduct an elucidation of competitor strategies and tactics that are leveraged to driver and/or blunt market uptake and traction of novel biopharmaceutical products in North America, LATAM and the Big-5 EU markets. Our client was a Senior Manager of Global Commercial Insights. MOLEKULE CONDUCTED COMPETITIVE LANDSCAPE MONITORING & CONGRESS COVERAGE Inclusive of: – Competitor interviews – Internal Stakeholder Interviews – KOL Interviews R E SU LTS Molekule developed clear, concise and actionable intelligence regarding the drivers and key factors leverageable to blunt market uptake and traction of competitor novel biopharmaceutical assets in North America, LATAM and Big-5 EU markets. 34 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Boutique Biotech S I T UAT I O N Our client sought overall firm-wide diversification via a new business and commercial model. ACT I O N Molekule was engaged by a niche/specialist U.S.-based biopharmaceutical company with a mid-sized market capitalization to develop a new business plan for strategic diversification from a “one-stop-shop” biopharmaceutical player into a diversified specialty pharmaceutical company. Our client was a VP of Global Strategy. MOLEKULE CONDUCTED A COMPETITIVE CORPORATE STRATEGY ASSESSMENT Inclusive of: – Internal Stakeholder Interviews – External Competitor Stakeholder Interviews – Subject Matter Expert Interviews – Therapy Area Expert Interviews R E SU LTS Partnered together, Molekule and client developed a concerted growth and development plan including decisive diversification for the client across three (3) key therapeutic areas of potential pipeline growth opportunity. 35 CONFIDENTIAL Molekule Capabilities Molekule Case Studies: In Support Of A Product Protection Department at Leading Japan Pharma S I T UAT I O N Our client sought a comprehensive assessment of pharmaceutical counterfeiting and illegal diversion of several key products throughout the globe ACT I O N Molekule was engaged by a major MNC pharmaceutical player to understand and elucidate the scope, scale and impact of global biopharmaceutical counterfeiting, parallel trade and illegal diversion as it pertains to several of its high profile products in Emerging Markets in A-P, EEMA and LATAM. Our client was a Director of Global Product Protection. MOLEKULE CONDUCTED COMPREHENSIVE LANDSCAPE MONITORING Inclusive of: – Review of secondary domain – Primary interviews with relevant stakeholders – Global product flow mapping R E SU LTS Molekule developed a comprehensive assessment of product security issues affecting the client’s key products globally. The assessment highlighted the impact of illicit activities for each product, listed the main players involved, and provided illicit product flow mapping to better understand regional risks. The report was used by the client to prioritize and focus its investigative efforts as well as plan out appropriate supply chain security measures to mitigate risks. 36 n ew yor k • san fr an d o • n h l n o sc c o • ci ic a g i • o mi am • bo • sto • tokyo n o • u pa lo • base l ew sã n r • je s 1395 Brickell Avenue, Suite 800 Miami, FL 33131 TEL e y • zu ri ch te • brussels l av iv • FAX ALIGNED INTELLIGENCE. FOCUSED RESULTS. / +1 786 600 2410 / +1 786 600 3140 [email protected]
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