Takeda Pharmaceutical Co. Ltd. · TSE:4502
Takeda Pharmaceutical — Investor Day (November 2019)
49 slides from Takeda Pharmaceutical's investor day presentation, Nov 21, 2019
Slide 1: Realizing the Potential of Plasma-Derived Therapies
REALIZING THE POTENTIAL OF PLASMA‐DERIVED THERAPIES 21st November 2019 Julie Kim President, Plasma‐Derived Therapies Business Unit
Slide 2: Important Notice
IMPORTANT NOTICE For the purposes of this notice, “presentation” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this presentation. This presentation (i
Slide 3: Plasma Presents a Unique Opportunity
PLASMA PRESENTS A UNIQUE OPPORTUNITY 1 2 3 4 5 Plasma is a durable business with Products have Indication Not subject to Probability of Market lifecycle expansion patent cliffs success for demand compelling growth spanning continues R&D is continues to opportunity… decades generally high grow steadi
Slide 4: Demand for Key Plasma-Derived Therapies Continuously Increasing
DEMAND FOR KEY PLASMA‐DERIVED THERAPIES HAS BEEN CONTINUOUSLY INCREASING AND EXPECTED TO GROW Worldwide demand for plasma‐derived therapies is This trend is primarily driven by: expected to increase each year 30 Greater awareness and increasing rates of diagnosis 4 Other 25 +6% 2 Blood Factors 20 3
Slide 5: Takeda Organized and Uniquely Positioned to Realize Plasma Potential
TAKEDA IS NOW ORGANIZED – AND UNIQUELY POSITIONED ‐ TO REALIZE THE FULL POTENTIAL OF PLASMA‐DERIVED THERAPIES PLASMA‐DERIVED THERAPIES >20 DEDICATED BUSINESS UNIT PLASMA‐DERIVED THERAPIES Top 3 plasma company, investing to grow RARE DISEASE LEADER PLASMA‐ 8 Deep understanding of FOCUSED MANUFACTURIN
Slide 6: Building on a Long History of Bringing Innovative Therapies to Patients
WE ARE BUILDING ON A LONG AND SUCCESSFUL HISTORY OF BRINGING INNOVATIVE THERAPIES TO PATIENTS Hyland 1941 1952 1960 1968 1994 1996 2005 2006 2010 2013 2015 2016 2019 Albumin First commercial Albumin Only FVIII facilitated IG with up to 1/month infusions PLASMA‐VAC First commercial FVIII concentrate
Slide 7: Dedicated Business Unit to Steer Our Path
WE’VE ESTABLISHED A DEDICATED BUSINESS UNIT TO STEER OUR PATH, BRING FOCUS AND HARNESS OUR END‐TO‐END PLASMA CAPABILITIES Donors Plasma Strategy & Operations Commercial Strategy Hospitals & & Sales Patients Plasma Sourcing Manufacturing BioLife RESEARCH & DEVELOPMENT 6
Slide 8: PDT BU Leadership Team
OUR PDT BU LEADERSHIP TEAM DRAWS ON, AND BRINGS TOGETHER, TAKEDA’S EXTENSIVE PLASMA EXPERIENCE AND BROADER EXPERTISE Julie Kim Ingrid Hofström Emi Psachoulia Sue Brown Christopher Michael Shires Shady Annick Ramy Riad Luana Banu Deborah Hibbett Head of Plasma‐ Executive Chief of Staff Plasma Sourcin
Slide 9: Our Ambition
Our Ambition Build a respected, We have a singular, dedicated plasma focus and strategy sustainable plasma Responsibility for end‐to‐end plasma business business that reimagines the industry to best serve Dedicated R&D organization and budget patients worldwide We also benefit from the support of a
Slide 10: Strategy and Investments Across the Entire Value Chain
OUR STRATEGY AND TARGETED INVESTMENTS EXTEND ACROSS THE ENTIRE VALUE CHAIN PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 9
Slide 11: Video of Plasma Center and Manufacturing Facility
VIDEO OF PLASMA CENTER AND MANUFACTURING FACILITY 10
Slide 12: Plasma Sourcing
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 11
Slide 13: Accelerating the Rate of Plasma Collection
WE ARE ACCELERATING THE RATE OF PLASMA COLLECTION AND INCREMENTALLY INCREASING OVERALL VOLUME We are building momentum…. Increased plasma volumes by approximately 20% in 2018 Expanded European presence from 7 to 30 collection centers within past 12 months Completed 5 acquisitions in the past 12 mont
Slide 14: Enhancing and Digitalizing Facilities and Services
WE ARE FURTHER ENHANCING AND DIGITALIZING FACILITIES AND SERVICES TO MEET GROWING NEEDS FOR THE FUTURE Improving the donor experience and Attracting new donors in the community improving cost‐per‐liter through omnichannel engagement Reaching new donors Increasing community engagement Mobile Website
Slide 15: Manufacturing
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 14
Slide 16: World-Leading Plasma Derived Therapies Manufacturing Network
WE HAVE A WORLD‐LEADING PLASMA DERIVED THERAPIES MANUFACTURING NETWORK IN WHICH WE CONTINUE TO SIGNIFICANTLY INVEST Covington, GA 8 STRATEGIC LOCATIONS Sanquin, NL Vienna, Austria plus four strategic partners, allowing Round Lake, IL Narita, Japan independent yet inter‐related Lessines, Belgium manu
Slide 17: Increasing Production Capacity
WE'RE INCREASING PRODUCTION CAPACITY BY ACCELERATING INVESTMENT, WHILE FURTHER ENHANCING OUR QUALITY STANDARDS Investing in manufacturing capacity Continually investing in technologies and processes to maximize yield Higher yield, lower cost fractionation techniques We plan to increase our Analytics
Slide 18: Domestic Manufacturing in Japan via Nihon Pharma
IN JAPAN TAKEDA HAS DOMESTIC MANUFACTURING CAPABILITIES THROUGH OUR SUBSIDIARY NIHON PHARMA Over 60‐year legacy in plasma‐derived therapies in Japan Fractionation capacity 400 KL Strong plasma‐derived therapies portfolio incl. Human IG, Hyper IG, Research Laboratory, Chiba Albumin, and Antithrombin
Slide 19: World-Class Safety Capabilities
TAKEDA HAS WORLD‐CLASS SAFETY CAPABILITIES AND AN UNSURPASSED REPUTATION IN BOTH PLASMA DONATION AND PATHOGEN SAFETY Donation safety standards Strict donation Donation Strong Plasma screening, criteria and frequency inspection inventory hold and look screening at management record back procedure eac
Slide 20: Commercialization
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 19
Slide 21: Broad and Differentiated Portfolio of Plasma-Derived Therapies
OUR BROAD AND DIFFERENTIATED PORTFOLIO OF PLASMA‐DERIVED THERAPIES TREATS RARE AND COMPLEX DISEASES WORLDWIDE ATIII 20 For illustrative purposes only, geographies and products do not correspond
Slide 22: In Japan, IG Growth Remains Strong
IN JAPAN, IG GROWTH REMAINS STRONG AND THERE IS OPPORTUNITY TO ENHANCE STANDARD OF CARE Japan Plasma Market ($M), 2015‐18 Japan PDT Revenue Market Share ‐2% 928 872 Company C 5% 259 21% 217 Other Nihon Pharma 23% 114 106 Coagulation Factors 130 106 Albumin 13% 443 IG Company A 425 Company B 38% 2015
Slide 23: Personalized, Innovative, Lifelong Care Throughout Patient Journey
OUR GOAL IS TO CONTINUE TO BRING PERSONALIZED, INNOVATIVE, LIFELONG CARE THROUGHOUT THE PATIENT JOURNEY Diagnosis Access Partnership with large hospital Sustainable pricing systems in the US to leverage Dedicated access support electronic medical records Patient assistance programs Co‐chairing the G
Slide 24: Significant Growth Opportunities Across Our Portfolio
WE ANTICIPATE SIGNIFICANT GROWTH OPPORTUNITIES ACROSS OUR PORTFOLIO Global Takeda Global plasma revenue market size Example Global Takeda products Japan Takeda products (OY, 2018) (OY, 2018) Immunoglobulin ~2,870 ~12,500 Last Liter Albumin ~580 ~5,000 Hemophilia ~890 ~2,800 products First Liter Othe
Slide 25: Trajectory to Improve PDT Business Performance
AND WE ARE EMBARKING ON A TRAJECTORY TO IMPROVE OVERALL PLASMA‐DERIVED THERAPIES BUSINESS PERFORMANCE Key Growth & Margin Drivers for PDT Key Financial Aspiration for PDT* • Focused sustainable, value‐based commercial Annual revenues strategies, including tenders (CAGR) Mid to high single digit • Pr
Slide 26: Key Takeaways
KEY TAKEAWAYS 132 At Takeda, plasma is a Our goal is to Our broad and long‐term strategic accelerate growth in differentiated portfolio focus, led by a capacity by >65% over brings personalized, dedicated business the next 5 years to innovative, lifelong unit investing to grow bring additional and c
Slide 27: A New Dedicated Focus on Innovative, Sustainable Solutions
A NEW DEDICATED FOCUS ON INNOVATIVE, SUSTAINABLE SOLUTIONS FOR PLASMA‐DERIVED THERAPIES Christopher Morabito, M.D. Head of R&D, Plasma‐Derived Therapies
Slide 28: PDT R&D's Credentials and Infrastructure
PDT R&D’S CREDENTIALS AND INFRASTRUCTURE ARE WELL‐ESTABLISHED Partobulin Albumin (Austria, Health Ministry Approval) 1941 1952 1968 1968 1986 1994 1998 1999 2001 2002 2005 2006 2008 2010 2013 2016 Tetabulin Antithrombin III (Canada, Health Ministry Endobulin S/D Approval) Partobulin S/D Pathogen Pha
Slide 29: Independence Bolstered by Access to Broader R&D
OUR INDEPENDENCE BRINGS FOCUS ON PLASMA AND IS BOLSTERED BY ACCESS TO BROADER R&D CAPABILITIES AND RESOURCES Focused entirely on plasma‐derived therapies Lean and agile team PDT Based in Cambridge, MA and Vienna, Austria R&D Separate R&D prioritization Dedicated budget Global R&D Common Takeda value
Slide 30: PDT R&D Leadership Team
THE PDT R&D LEADERSHIP TEAM IS WELL‐INTEGRATED AND BRINGS DEEP AND DIVERSE FUNCTIONAL EXPERTISE Christopher Morabito MD R&D Head Boston, MA Catherine Parham MD Rory Bukofzer Leman Yel MD Chris Tremblay Bagirath Gangadharan PhD Andreas Liebminger PhD Sascha Haverfield DPhil Program Leadership Program
Slide 31: Two R&D Engines Driving Innovation
WE ARE DRIVING A CULTURE OF INNOVATION THROUGH TWO R&D ENGINES Research/Early Development Late Development Translational Integrated Pharmaceutical Care Solutions Sciences Translational Research Pharm Sci and Devices Early Development Innovation Engine Late Development Innovation Engine Generate new
Slide 32: PDT R&D Strategy
PDT R&D Strategy Maximize the therapeutic Realize full potential of in‐line First and Last Liter products value of plasma‐derived Expanded indications and benefit‐risk datasets therapies for patients with Device‐driven solutions for diagnosis, management, rare and complex diseases and long‐term foll
Slide 33: Prioritizing Near-Term Late Development
WE ARE PRIORITIZING NEAR‐TERM LATE DEVELOPMENT… RESEARCH / NON‐CLINICAL DEVELOPMENT LATE DEVELOPMENT CUVITRU HYQVIA HYQVIA Halozyme Halozyme Wearable Device US ‐ Pediatric PID EU ‐ Pediatric PID HYQVIA HYQVIA ‐ HyHub Halozyme Flextronics Chronic inflammatory demyelinating Delivery Device polyneuropa
Slide 34: Enabling Discovery of Next Generation Therapeutics
… WHILE ENABLING DISCOVERY OF NEXT GENERATION THERAPEUTICS RESEARCH / NON‐CLINICAL DEVELOPMENT LATE DEVELOPMENT TAK 881 CUVITRU HYQVIA HYQVIA Facilitated 20% SC IgG Halozyme Halozyme Wearable Device Halozyme US ‐ Pediatric PID EU ‐ Pediatric PID Primary Immunodeficiency (PID) TAK 880 Alpha‐1 Antitry
Slide 35: Allocating Resources to Research and Early Development
OVER THE NEXT 3 YEARS, WE PLAN TO ALLOCATE RESOURCES TO RESEARCH AND EARLY DEVELOPMENT Estimated % of PDT R&D spend for FY2023 Distribution of PDT R&D spend for FY2019 60% ~70% of resources will be allocated to improving in‐line products and production efficiencies 95% 10% Optimizing value of in‐lin
Slide 36: Realize Full Potential of In-Line First and Last Liter Products
OUR GOAL IS TO REALIZE THE FULL POTENTIAL OF IN‐LINE FIRST AND LAST LITER PRODUCTS Estimated % of PDT R&D spend for FY2023 Expanded indications and benefit‐risk datasets 60% Device‐driven solutions for diagnosis, management, and long‐term follow‐up Global expansion New formulations 10% Optimizing va
Slide 37: Immunoglobulins Provide the Scaffold for PDT Innovation
IMMUNOGLOBULINS PROVIDE THE SCAFFOLD FOR PDT INNOVATION Current State US & EU IgG use by indication* Exploring efficacy and safety of HYQVIA in patients with PID and other neuro‐immune diseases (e.g. CIDP) immunology Ongoing delivery device development SID Other SID 4% PID 15% Opportunities 26% Indi
Slide 38: Facilitated 20% SCIG Potential Value
FACILITATED 20% SCIG HAS THE POTENTIAL TO PROVIDE FURTHER VALUE TO PATIENTS WHO REQUIRE HIGHER VOLUME ADMINISTRATIONS Pig model, sequentially administered recombinant human hyaluronidase (rHuPH20) and 20% IgG (CUVITRU)* Pre Injection Post Injection Next Day 400 Control + Ig rHuPH20 + Ig 300 Control
Slide 39: PROTHROMPLEX TOTAL for Variety of Bleeding Disorders
PROTHROMPLEX TOTAL CAN BE DEVELOPED TO TREAT A VARIETY OF BLEEDING DISORDERS Changing Treatment Paradigm (EU Total Prescriptions) 37% 31% 53% 45% Current State 70% 62% Many different mechanisms used for prophylactic and surgical anti‐ coagulant therapy 63% 69% 47% 55% PROTHROMPLEX TOTAL use is limit
Slide 40: ARALAST & GLASSIA in Alpha-1 Antitrypsin Deficiency
ARALAST & GLASSIA PROVIDE OPPORTUNITIES TO IMPROVE OUTCOMES IN PATIENTS WITH ALPHA‐1 ANTITRYPSIN DEFICIENCY (A1ATD) Healthcare Resource Utilization in A1ATD‐Emphysema 15 Current State Current standard of care does not adequately treat A1ATD 10 10.12 8.48 Opportunities Mean Number 5 5.57 Of Events Pe
Slide 41: Investigational A1AT-Replacement Formulations
INVESTIGATIONAL A1AT‐REPLACEMENT FORMULATIONS MAY OFFER ADDITIONAL VALUE TO PATIENTS Short term Mid term In Vivo Model Highly purified post‐ Protein Modification PK parameters for a modified A1AT fractionations site‐specific modification leading to have been assessed in vivo Statistically significan
Slide 42: Optimizing Efficiencies of Plasma-Derived Therapy Production
WE ARE OPTIMIZING EFFICIENCIES OF PLASMA‐DERIVED THERAPY PRODUCTION Estimated % of PDT R&D spend for FY2023 Optimizing value of in‐line products Plasma production efficiencies 60% New plasma‐derived therapies 10% Pharmaceutical science support for manufacturing 30% 41
Slide 43: Improving Manufacturing Efficiencies to Increase Yield
WE ARE FURTHER IMPROVING MANUFACTURING EFFICIENCIES TO INCREASE YIELD High yield high throughput initiatives will improve delivery of last liter products to patients globally A new high yield & high throughput process: Process development to shorten IgG upstream and total albumin cycle times Capture
Slide 44: Identifying and Developing New Plasma-Derived Therapies
WE ARE IDENTIFYING AND DEVELOPING NEW PLASMA‐DERIVED THERAPIES Estimated % of PDT R&D spend for FY2023 Optimizing value of in‐line products Plasma production efficiencies 60% New plasma‐derived therapies 10% 30% New targeted therapies for diverse therapeutic areas 43
Slide 45: Untapped Potential in Plasma Proteins
WE BELIEVE THERE IS A TREMENDOUS AMOUNT OF UNTAPPED POTENTIAL IN PLASMA PROTEINS Homeostasis >3000 plasma proteins control balance, some with health promoting effects and other with disease associated effects Disease Generally, PDTs have been developed to replace functional deficiencies in health pr
Slide 46: Well-Positioned to Create Near-Term and Sustainable Growth
We are well‐positioned to create near‐term and sustainable growth NEAR TERM CATALYSTS SUSTAINED GROWTH TARGET FY19 – FY22 FY23 – FY24 FY25 AND BEYOND APPROVAL FY HYQVIA CUVITRU GLASSIA Halozyme HYPERIMMUNE IGx Kamada GENERATION Chronic inflammatory demyelinating Japan PID (FPI Q4 2019) A1ATD‐emphyse
Slide 47: Treatment Paradigms Are Dynamic and We Are Innovating
TREATMENT PARADIGMS OF RARE AND COMPLEX DISEASES ARE DYNAMIC AND WE ARE INNOVATING CONTINUOUSLY Uncertainties PDT Innovation Deepening understanding of underlying Directed most appropriate uses of PDTs mechanisms of diseases and co‐morbidities With Takeda Global R&D, investigate plasma‐drug combinat
Slide 48: Key Takeaways for Plasma-Derived Therapies R&D
KEY TAKEAWAYS FOR PLASMA‐DERIVED THERAPIES R&D 132 Dedicated PDT R&D Poised to deliver near‐ Committed to creating organization focused on term value by long‐term value by – and investing in – optimizing our in‐line unlocking the full reimagining plasma, portfolio and potential of plasma to while le
Slide 49: Realizing the Potential of Plasma-Derived Therapies
REALIZING THE POTENTIAL OF PLASMA‐DERIVED THERAPIES 21st November 2019 Julie Kim President, Plasma‐Derived Therapies Business Unit