Slide 1: Exchange filing cover letter: Investor Presentation
June 11, 2020 Biocon Biocon Limited 20th KM Hosur Road Electronics City Bangalore $60 100, India T91 80 2808 2808 F91 80 2852 3423, CIN : L24234KA1978PLC003417 www.biocon.com To The Secretary BSE Limited Department of Corporate Services Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai — 400 001 To Th
Slide 2: Biocon Biologics Investor Presentation
Biocon Biologics Investor Presentation Transforming Healthcare. Transforming Lives June 2020 1
Slide 3: Safe Harbour
Safe Harbour Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those contemplated in such forward-looking statements
Slide 4: Introduction
es Introduction gS Biocon Biologics
Slide 5: Biocon Biologics
Biocon Biologics Uniquely positioned as fully integrated player for biosimilars 2 Development Partnerships 740+ Registered 28 Products 5 Products taken (Mylan, Sandoz) Trademarks* in pipeline from Lab to Market 4000+ High Quality, Diverse ~860 Patents granted ~120 Countries where our Employees (Biol
Slide 6: Our Vision
Our Vision Biocon Biologics ‘Transforming Healthcare, Transforming Lives.’ Most inspiring global leader in Biologics delivering affordable access to innovative and inclusive healthcare solutions, transforming patient lives. PRIVILEGED AND CONFIDENTIAL 5
Slide 7: We transform healthcare
We transform healthcare Example: Diabetes – a global epidemic Graphic Source: International Diabetes Federation 6
Slide 8: Committed to make a difference to patients' lives
Biocon Biologics Committed to make a difference to patients’ lives served 2.1 million patients* in FY 20 touch over 5 million patient lives* by FY 22 We are serving global patient needs with high quality, affordable Biosimilars * Calculated basis standard dosing and drug substance expected to be man
Slide 9: Biocon Biologics - Set Up For Success
Biocon Biologics - Set Up For Success Well positioned in therapeutic areas like diabetes and oncology and inflammatory diseases Business & commercial strategy tailored to market archetypes, aim to be disruptive As a committed stakeholder of the United Nation’s Sustainable Development Goals* (SDG)
Slide 10: Foundation based on over years of experience in science and manufacturing
Biocon Biologics Foundation based on over 40 years of experience in science and manufacturing 1978– 2000– 2005– 2010– 2016– 2020 and 1999 2004 2009 2015 2019 beyond Foundation of Biocon Transforming into a Building expertise in Expanding strategic Commercializing Foundation of Biocon as an enzymes B
Slide 11: Biocon Biologics Holding Structure
Biocon Biologics Holding Structure Independent and international management team with top talents Biocon Limited, India (BL) 96.07%* Biocon Biologics India Limited, India (BBIL) 100% Biocon Biologics Limited, UK 100% 100% 100% Biocon Healthcare SDN BHD, Biocon SDN BHD, Biocon Biologics Inc, Malaysia
Slide 12: Market overview
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Slide 13: Nature of Biosimilars
Nature of Biosimilars High investments, quality focus and scale needed to deliver biosimilars across the world A biosimilar is highly A biosimilar has no clinically A biosimilar is approved by A biosimilar is a similar to a reference meaningful differences from FDA after rigorous evaluation biologic
Slide 14: Biologics Market
Biologics Market Significant opportunity for biosimilars 196 SIZE OF MARKET ($B) Including originators and biosimilars1 49 46 16 10 USA Europe Japan China Others Population ~330M ~750M ~130M ~1420M ~5000M 1. Excludes vaccines; 2. As of 2019 Note: size of market is indicative Source: IMS, FDA, gabion
Slide 15: Biocon Biologics – Biosimilars is our only focus
Biocon Biologics – Biosimilars is our only focus Major player with 28 molecules in pipeline PRODUCT BIOCON BIOLOGICS PFIZER AMGEN SAMSUNG SANDOZ CELLTRION COHERUS LILLY SANOFI Pegfilgrastim TUMOUR OFFERING UNIQUE SOLID Trastuzumab Bevacizumab Adalimumab Etanercept STRONG INSULINS Glargine FRANCHISE
Slide 16: Biocon Biologics Pipeline
Biocon Biologics Pipeline Undisclosed: US Undisclosed: US Steady stream of launches every year^ in developed markets Bevacizumab*: US Undisclosed: US, EU FY25 Insulin Glargine*: US Pegfilgrastim*: EU Etanercept*: EU FY23 Pegfilgrastim*: US Insulin Glargine*: EU FY21 FY24 Insulin Glargine: Adalimumab
Slide 17: Business
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Slide 18: Biocon Biologics footprint across the world
Biocon Biologics footprint across the world Serving patient needs in emerging & developed markets London Boston Bangalore Dubai Johor Singapore Manufacturing Commercial offices Sao Paulo Headquarter 17
Slide 19: ~2M patients reached in FY20
Biocon Biologics footprint across the world ~2M patients reached in FY20 FY20 FY20 Product Planned Estimated Reach Reach* RHI 2.0M 1.7M Glargine 479k 283k Pegfilgrastim 26k 20k Adalimumab 24k 24k Trastuzumab 20k 18k Total 2.6M 2.0M Number of patients = (Volume supplied in FY20) / (Dose per patient p
Slide 20: Global Product Portfolio
Biocon Biologics Global Product Portfolio BIOCON BIOLOGICS is independently developing many biosimilar assets With MYLAN, 11 biosimilars being co-developed for global markets With SANDOZ, set of next-gen 28 immunology, oncology biosimilars MOLECULES being co-developed for global markets 19
Slide 21: Biocon – Mylan Partnered Product Pipeline
Biocon – Mylan Partnered Product Pipeline Early mover in first wave of biosimilar launches in the next 3–5 years THERAPEUTIC STATUS MOLECULE AREA US EU RoW Launched in Australia Canada & Trastuzumab $ 2.8 B $ 1.5 B Biocon’s strong Emerging Markets. development and Pegfilgrastim $ 3.4 B $ 0.4 B Launc
Slide 22: Pegfilgrastim - Fulphila
Pegfilgrastim - Fulphila Pegfilgrastim biosimilars at 28%1 of total US market; with the additional approval of a new manufacturing facility, Fulphila is well-positioned to grow rapidly in the US and expand in other markets Biocon/ Mylan first to launch in US Expanded capacity to drive U.S. growth, e
Slide 23: Trastuzumab
Trastuzumab First biosimilar trastuzumab approval globally with CANMAb™ in India; OgivriTM launched in the US, EU and Australia; Biocon Biologics has sufficient manufacturing capacity to fulfil demand for global markets Emerging Markets Developed Markets Regulatory approval in more than 80 countri
Slide 24: Insulins Portfolio
Insulins Portfolio Equitable access to more affordable insulins is critical to address the growing incidence of diabetes globally Biocon Biologics is among the Top 5 insulins players globally, vertically integrated and cost competitive Recombinant Human Insulin Insulin Glargine Insulin Aspart (rh-in
Slide 25: Bevacizumab
Bevacizumab Launched in India in Nov 2017; global trial complete, US filing done in Dec’19 Market Dynamics BBL’s Bevacizumab US - 2 players approved by FDA, biosimilar share ~28%1 Krabeva launched in India in Nov 2017 – Amgen was first to launch, Amgen launched in Jul’19, Filed in US and EU in
Slide 26: Biocon – Sandoz exclusive partnership
Biocon – Sandoz exclusive partnership Co-development of next-generation biosimilars Shared responsibility for… Broader Biocon participation in end-to-end development Development and commercialization Manufacturing Global regulatory approvals Various assets are in early stage development stage for gl
Slide 27: R&D and manufacturing
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Slide 28: Research & Development
Research & Development World class research talents and infrastructure FACILITIES TALENT • 85,000 sq. ft. state of the art research facility in BLR • 450+ employees • 8,000 sq. ft. microbial and cell culture pilot plants • 20% with MDs or PhD’s • 60,000 sq. ft research center in Chennai • 60% with M
Slide 29: Research & Development: Capabilities and Structure
Research & Development Capabilities and Structure C A PA B I L I T I E S P L AT F O R M E X P E RT I S E • Drug Discovery • Analytical Sciences • Pichia pastoris • NS0 • Process Development • Bioanalytical Sciences • E. Coli • Fusion Proteins • Scale Up & TT to • Intellectual Property Rights • CHO m
Slide 30: Global Scale Manufacturing Expertise
Global Scale Manufacturing Expertise Largest Biologics manufacturing capacity in India State-of-the-art manufacturing facilities – mammalian & microbial Facilities conform to most stringent cGMP guidelines Regulatory approvals - EMA, US FDA, Health Canada, ANVISA, COFEPRIS, PMDA, TGA, MCC etc. Secon
Slide 31: Manufacturing Sites
Manufacturing Sites Largest Biotech Hub in India CAMPUS PA R K JOHOR 1978 25 acres 2006 90 acres 2016 40 acres • U.S. FDA • U.S. FDA • EMA • EMA • Health Canada • TGA (Australia) • COFEPRIS (Mexico) • TGA (Australia) • NPRA Regulatory • TGA (Australia) • COFEPRIS (Mexico) approvals • MCC (South Afri
Slide 32: Outlook
Outlook gS Biocon Biologics
Slide 33: Unlocking Market Opportunity
Unlocking Market Opportunity The opportunity expected to increase ~2.5x as new products are commercialized • Adalimumab US • Undisclosed US • Glargine US • Aspart US, EU • Undisclosed US, EU • Undisclosed US • Beva US • RHI US • Adalimumab MoW • Beva EU • Pegfil US • Pegfil EU, MoW • Glargine EU, Mo
Slide 34: Context of global leadership: Biosimilar penetration
Context of global leadership Biosimilar penetration 80%+ total biosimilar market shares open the door to leadership-level shares EU biosimilar market share (by standard units) US biosimilar market share (by standard units) 100% 100% Neupogen (filgrastim) 80% Filgrastim, 78% Epogen (epoetin) 80% Remi
Slide 35: FY22 Aspiration of $1Bn
FY22 Aspiration of $1Bn Multiple levers to further accelerate growth in the next 2 years GROWTH DRIVER GEOGRAPHIC MIX Diversified mix across developed and emerging Ramp up of pegfilgrastim and trastuzumab and markets glargine While US is biggest growth driver, MOW growth is also significant Launch o
Slide 36: What to Expect In The Next Decade?
What to Expect In The Next Decade? Only a few players will succeed in the BS market and we will be one of them! Accelerating the growth path Further strengthening the broad pipeline Ability to further differentiate Leveraging our affordable innovation and disrupt healthcare model & global scale R&D
Slide 37: Conclusion
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Slide 38: Key Investment Highlights
Key Investment Highlights Highest quality, differentiated, transformative, pure play, scaled biosimilars company Global biosimilar market presents a large and attractive opportunity; Biocon Biologics is the best suited to tap into this opportunity Best-in-class platform with a de-risked first wa
Slide 39: Questions
(@ Questions gS Biocon Biologics