Slide 1: Exchange filing cover letter
Biocon Biocon Limited 20th KM Hosur Road Electronics City Bangalore 560 109, India T 91 80 2808 2808 F 91 80 2852 3423 CIN : 124234KA1978PLCO03417 December 11, 2019 WR SIGCOTICOnT To To The Secretary The Secretary BSE Limited National Stock Exchange of India Limited Department of Corporate Services
Slide 2: Biocon Biologics Investor Presentation
Biocon Biologics Investor Presentation Transforming Healthcare. Transforming Lives December 2019 PRIVILEGED AND CONFIDENTIAL 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
Introduction PRIVILEGED AND CONFIDENTIAL 3
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: 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 FY1999* FY2004* FY2009* FY2015* FY2019* 250 ₹318 Mn 700+ ₹5,493 Mn 3,500+ ₹11,937 Mn 7,500+ ₹31,429 Mn 11,000+ ₹56,588 Mn 1978– 2000– 2005– 2010– 2016– 2020 and 1999 2004 2009 2015 2019 beyond Foundation of
Slide 7: Biocon Biologics Holding Structure
Biocon Biologics Holding Structure Independent and international management team with top talents Biocon Limited, India 100% 93.27% Biocon Research Limited, Biocon Biologics India Limited, India India 100% Biocon Biologics Limited, UK 100% 100% Biocon SDN BHD, Biocon Biologics Inc, Malaysia USA % de
Slide 8: Market overview
Market overview PRIVILEGED AND CONFIDENTIAL 7
Slide 9: 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 10: Biologics Market
Biologics Market Significant opportunity for biosimilars SIZE OF MARKET ($B) 178 Including originators and biosimilars1 47 42 14 9 USA Europe Japan China Others Population ~330M ~750M ~130M ~1420M ~5000M 1. Excludes vaccines; 2. As of 2018 Note: size of market is indicative Source: IMS, FDA, gabionl
Slide 11: Biologics – Biosimilars is our only focus
Biocon Biologics – Biosimilars is our only focus One of the major players from a portfolio perspective with 28 molecules in pipeline PRODUCT BIOCON BIOLOGICS PFIZER AMGEN SAMSUNG SANDOZ CELLTRION COHERUS LILLY SANOFI TUMOUR OFFERING Filgrastim UNIQUE SOLID Pegfilgrastim Trastuzumab Bevacizumab Infli
Slide 12: Biocon Biologics Pipeline
Biocon Biologics Pipeline Undisclosed: EU, US Undisclosed: EU Steady stream of launches every year^ in developed markets Undisclosed: EU, US Undisclosed: US Bevacizumab*: EU, US 2025 Aspart*: EU, US 2023 Ogivri*: EU, US, Australia Insulin Glargine*: Australia 2021 2024 Undisclosed*: EU Undisclosed:
Slide 13: Strategic overview
Strategic overview PRIVILEGED AND CONFIDENTIAL 12
Slide 14: Biologics' unique approach
Biocon Biologics’ unique approach It is not about drug cost cutting, it is about finding innovative ways to transform the patient ecosystem Re-Imagining the Patient ecosystem in an innovative way Task shifting 70% Spend for Technology driven personalized care services & others • New partners in disr
Slide 15: We transform healthcare
We transform healthcare Diabetes – a global epidemic Graphic Source: International Diabetes Federation PRIVILEGED AND CONFIDENTIAL 14
Slide 16: Biocon Biologics presents at US FDA Public Hearing on Increasing Insulins Access
Biocon Biologics presents at US FDA Public Hearing on Increasing Insulins Access A unique opportunity for accelerating approval of biosimilar human insulin – the most important insulin for patients struggling to afford their medicines Biocon presented at the US FDA public hearing held in May 2019 Di
Slide 17: Biocon Biologics Policy Engagement
Biocon Biologics Policy Engagement Initial steps towards greater focus on global policy engagement and visibility US-India Leaders Summit at National Press Club in Washington DC • Attended by business leaders from US & India, senior US legislative staffers representing committees including trade, he
Slide 18: Business
Business PRIVILEGED AND CONFIDENTIAL 17
Slide 19: 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 SDG framework, Biocon Biologics is committed to UNIVE
Slide 20: Biocon Biologics footprint across the world
Biocon Biologics footprint across the world Serving patient needs in emerging & developed markets PRIVILEGED AND CONFIDENTIAL 19
Slide 21: 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 PRIVILEGED A
Slide 22: 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 AREA MOLECULE STATUS Launched in US, EU, Australia & Emerging Markets. Approved in Trastuzumab Canada Biocon’s strong Pegfilgrastim Launched in US. Approved in EU, Canada & Au
Slide 23: Pegfilgrastim - Fulphila
Pegfilgrastim - Fulphila Pegfilgrastim biosimilars still only at 25%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
Slide 24: 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 countrie
Slide 25: 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 26: Bevacizumab
Bevacizumab Launched in India in Nov 2017; global trial complete and on-track for US filing in Dec’19 Market Dynamics BBL’s Bevacizumab 2 players approved by FDA, Amgen was first to launch Krabeva launched in India in Nov 2017 – Amgen launched in Jul’19 US filing expected in Dec’19 – Pfizer pl
Slide 27: 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 28: R&D and manufacturing
R&D and manufacturing PRIVILEGED AND CONFIDENTIAL 27
Slide 29: 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 30: Research & Development
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 31: 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 32: 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 33: Outlook
Outlook PRIVILEGED AND CONFIDENTIAL 32
Slide 34: Biocon Biologics
Biocon Biologics Committed to make a difference to patients’ lives serve ~2.6 million patients* in FY 20 touch over 5 million patient lives* by FY 22 Crossing a revenue milestone of US$ 1 billion We are serving global patient needs with high quality, affordable Biosimilars * Calculated basis standar
Slide 35: FY22 Aspiration of $1Bn Unlocking market opportunity
FY22 Aspiration of $1Bn Unlocking market opportunity The opportunity expected to increase ~2x as new products are commercialized • Glargine US • Beva EU, US • rHI US* • Aspart EU • Aspart US • Undisclosed EU • Adalimumab MoW • Pegfil US • Trastuzumab US • Pegfil EU, MoW • Glargine EU, MoW • Trastuzu
Slide 36: 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 70 Neupogen (filgrastim) 67 Neupogen (filgrastim) 90 Epogen (epoetin) 60
Slide 37: FY22 Aspiration of $1Bn The future has already started
FY22 Aspiration of $1Bn The future has already started Based solidly on actual performance E X P E C TAT I O N S F O R H 2 FY20 AND BEYOND 97% 63% • Performance in H2 FY20 to be even stronger, driven by new launches and availability of new capacities, helping both revenue growth as well as margin FY
Slide 38: 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 US launches of trastuzumab and glargine markets While US is biggest growth driver, ROW Continued growth in existing developed growth is
Slide 39: 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 40: Questions
Questions PRIVILEGED AND CONFIDENTIAL 39