Takeda Pharmaceutical Co. Ltd. · TSE:4502
Takeda Pharmaceutical — Investor Day (November 2019)
67 slides from Takeda Pharmaceutical's investor day presentation, Nov 15, 2019
Slide 1: Realizing the Potential of Plasma-Derived Therapies
Realizing the Potential of Plasma‐Derived Therapies Investor Relations Day, Covington, GA 15th November 2019 Julie Kim President, Plasma‐Derived Therapies Business Unit (PDT BU)
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: Thank you to the Georgia BioScience Training Center
Thank you to the Georgia BioScience Training Center Front Entrance Room 139 Room 125 Room 124 Back Entrance 2
Slide 4: Agenda
Agenda PDT Overview Julie Kim, President, PDT BU Lunch buffet PDT R&D Overview Christopher Morabito, Head, R&D, PDT Covington Site Introduction Carlos Soto, Covington Site Head Q&A Sue Brown, Head, Global BioLife Operations Julie Kim, President, PDT BU Christopher Morabito, Head, R&D, PDT Adrian Mur
Slide 5: Introducing Takeda's Plasma-Derived Therapies Business
Introducing Takeda’s Plasma‐Derived Therapies Business Julie Kim President, Plasma‐Derived Therapies Business Unit
Slide 6: Plasma-derived therapies are critical, life-saving medicines
Plasma‐derived therapies are critical, life‐saving medicines, relied upon by thousands of people worldwide with rare and complex diseases Lynayah’s Family I probably wouldn’t have lived to see six months, which is why my family and I are eternally grateful for you. Your time, and your donation helpe
Slide 7: 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 8: Demand for key plasma-derived therapies has been 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 9: Plasma still has significant untapped therapeutic potential
And plasma still has significant untapped therapeutic potential Multiple factors influence plasma protein By advancing our understanding metabolism and effects in individuals of plasma proteins, we can: • Predict how different patients metabolize plasma proteins, and drive Health individualization o
Slide 10: Takeda is uniquely positioned to realize the potential of plasma
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 11: Long and successful 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 12: Dedicated business unit across end-to-end plasma capabilities
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 11
Slide 13: PDT BU leadership team
Our PDT BU leadership team draws on, and brings together, Takeda’s extensive plasma experience and broader expertise across our business 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
Slide 14: 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 15: 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 14
Slide 16: Plasma Sourcing
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 15
Slide 17: BioLife is an industry leader in plasma sourcing
BioLife, part of Takeda’s Plasma‐Derived Therapies Business Unit, is an industry leader in the sourcing of high‐quality plasma Broad global footprint Recognized expertise 140+ collection centers across Trained medical staff at each center four countries Dedicated quality, regulatory and Plasma sourc
Slide 18: BioLife centers offer an exceptional donor experience
Our BioLife centers offer an exceptional donor experience Efficiency & convenience central to our approach • Repeat donors spend just ~1 hour at the center • Appointment‐based process with digital scheduling Staff committed to the well‐being of our donors Modern, high quality facilities, with free W
Slide 19: Accelerating the rate of plasma collection
We are accelerating the rate of plasma collection and incrementally increasing overall volume through third parties and acquisition 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 Comple
Slide 20: 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 21: Manufacturing
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 20
Slide 22: 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 23: Global network builds on the strengths of each location
The global network builds on the strengths of each location while leveraging operational excellence across the sites Mass Capture, Fractionation Los Angeles, USA Rieti, Italy Vienna, Austria Sanquin, NL Covington, USA Downstream Processing Lessines, Belgium Covington, USA Round Lake, USA Pisa, Italy
Slide 24: Increasing production capacity while enhancing quality standards
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 25: World-class safety capabilities in donation and pathogen safety
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 26: Commercialization
PLASMA SOURCING MANUFACTURING COMMERCIALIZATION RESEARCH & DEVELOPMENT 25
Slide 27: Broad and differentiated portfolio of plasma-derived therapies
Our broad and differentiated portfolio of plasma‐derived therapies treats rare and complex diseases worldwide ATIII 26 For illustrative purposes only, geographies and products do not correspond
Slide 28: Two SCIG brands complement each other
Our two SCIG brands complement each other and address different patient needs • Similar efficacy to IVIG and IV‐like • Well tolerated administration features • Limited volumes (up to 60ml per • High volumes (up to 600ml per site) and site) through frequent infusions monthly infusions (every 3‐4 week
Slide 29: Global supply is not keeping up with demand for IG therapies
Currently, global supply is not keeping up with demand for IG therapies STRONG & CONTINUED IG DEMAND The Global Polyvalent IG Market (IVIG/SCIG) IG is increasingly recognized for its diverse from 2000 to 2016, with Projected Global Demand Through 2024 therapeutic value, and is expected to grow in Mi
Slide 30: Commitment to sustainable patient care during supply-demand imbalance
Takeda’s commitment during times of supply‐demand imbalance is to focus on sustainable patient care Consider the global Support for those Focus on existing Partner to explore community with highest need to patients first and and implement gain treatment responsibly pursue policies and practices new
Slide 31: Personalized, innovative, lifelong care throughout the patient journey
Our goal is to continue to bring personalized, innovative, lifelong care to as many people as possible 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 assista
Slide 32: Significant growth opportunities across our portfolio
We anticipate significant growth opportunities across our portfolio Global plasma Takeda revenue market size Example Takeda products (OY, 2018) (OY, 2018) Immunoglobulin ~2,870 ~12,500 Last Liter Albumin ~580 ~5,000 Hemophilia ~890 ~2,800 products First Liter Other products ~660 ~3,700 Antithrombin
Slide 33: 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 • P
Slide 34: 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 35: A New Dedicated Focus on Innovative, Sustainable Solutions for PDT
A New Dedicated Focus on Innovative, Sustainable Solutions for Plasma‐Derived Therapies Christopher Morabito, M.D. Head of R&D, Plasma‐Derived Therapies
Slide 36: 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 37: Independence brings focus on plasma
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 38: 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 39: Culture of innovation through two R&D engines
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 40: 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 41: 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 42: 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 43: 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 44: Realize the 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 45: 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 46: Facilitated 20% SCIG potential for higher volume administrations
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 47: PROTHROMPLEX TOTAL for a 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 48: 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 49: 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 significa
Slide 50: 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% 49
Slide 51: 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 52: 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 51
Slide 53: 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 54: 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 55: Treatment paradigms are dynamic and we are innovating continuously
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 56: Key takeaways for PDT 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 57: Introducing our Covington Manufacturing Facility
Introducing our Covington Manufacturing Facility Carlos Soto Covington Site Head 56
Slide 58: This was our starting place in October 2012
This was our starting place in October 2012 57
Slide 59: Vision and plans for Covington
Our vision and plans for Covington enable us to serve more patients as we continue to ramp up our operations Increases capacity for Investment of Manufacturing Takeda will employ $1 BILLION+ campus covers ~1,500 EMPLOYEES PLASMA‐DERIVED 2 THERAPIES 1 MILLION+ FT in Georgia at full ramp up 2012 2014
Slide 60: How our site looks today - November 2019
This is how our site looks today ‐ November 2019 59
Slide 61: Our current footprint allows for further expansion
Our current footprint allows for further expansion
Slide 62: Therapies manufactured from plasma proteins
Today, we manufacture these therapies from plasma proteins GAMMAGARD Liquid FLEXBUMIN 61
Slide 63: Our facility is vertically integrated
Our facility is vertically integrated Fully integrated end-to-end production site • ~1000 employees today Plasma testing Fractionation Purification Filling Packaging / ramp up plan in place • Site includes already approved BioLife testing and storage facility Flexible design for future expansion Fra
Slide 64: Video of Covington Manufacturing Facility
Video of Covington Manufacturing Facility 63
Slide 65: Creating impact together
Creating impact together Through a dedicated plasma business unit, we will reimagine the plasma industry and uncover the full potential of plasma‐ derived therapies to benefit patients worldwide 64
Slide 66: 65
65
Slide 67: Speakers
Sue Brown Julie Kim Christopher Adrian Murphy Costa Saroukos Carlos Soto Head, Global President, PDT BU Morabito Head of Plasma Chief Financial Officer Covington Site Head BioLife Operations Head R&D, PDT Operating Unit, Global Manufacturing & Supply 66