Slide 1: Exchange submission cover letter
Date of Submission: February 6, 2019 Biocon Biocon Limited 20th KM Hosur Road Electronics City Bengaluru 560 100, India 91 80 2808 2808 F91 80 2852 3423 CIN : L24234KA1978PLC003417 www.biocon.com Department of Corporate Services Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai — 400 001 Scrip Code -
Slide 2: Biocon Limited Investor Presentation February 2019
Biocon Limited BSE: 532523 │ NSE: BIOCON │ REUTERS: BION.NS │ BLOOMBERG: BIOS IN │ WWW.BIOCON.COM Investor Presentation February 2019
Slide 3: Safe Harbor
Safe Harbor 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: Agenda
Agenda Our Journey Business & Financial Highlights • Small Molecules Our Business • Biologics • Branded Formulations • Research Services - Syngene Five Year Financials Enduring 3 Edge
Slide 5: Biocon: Asia's Leading Biopharma Company
Biocon: Asia’s Leading Biopharma Company Our Vision To enhance global healthcare through innovative and affordable biopharmaceuticals for patients, partners and healthcare systems across the globe Our Mission To be an integrated Biotech enterprise of global distinction Our Values Integrity & Ethical
Slide 6: Committed to Affordable Access
Committed to Affordable Access Aiming to develop products that can potentially benefit a billion patients Enduring 5 Edge
Slide 7: The Biocon Journey: A Continuous Evolution
The Biocon Journey: A Continuous Evolution 1978-1999 2000-2004 2005-2009 2010-2015 2016 and beyond Focused on Biosimilar Transforming Building the Trastuzumab global An Enzymes into a Base Business approved by US FDA; development and Company Biopharma and expertise in Biosimilar PEG-GCSF strategic g
Slide 8: Key Innovations: Making a Difference
Key Innovations: Making a Difference Ogivri™, first Second Novel biosimilar Biologic Launches (Insulin Glargine Trastuzumab prefilled disposable approved by US KRABEVA® First Novel pen) FDA in India Biologic Launches Launches Basalog One™ ALZUMAb™ Launches (Itolizumab) Launches BASALOG® (Insulin Gla
Slide 9: Business & Financial Highlights
Business & Financial Highlights Enduring Edge
Slide 10: Business: Recent Highlights
Business: Recent Highlights Biosimilar Pegfilgrastim Fulphila®, co-developed by Biocon and Mylan, received marketing approval in the EU. It also received a Notice of Compliance (NOC) from Health Canada’s Biologics and Genetic Therapies Directorate. With this, Fulphila® is now approved in the U.S., E
Slide 11: Revenue Highlights
Revenue Highlights All Figures in ₹ Million except % Particulars Q3 FY19 Q3 FY18 Growth 9M FY19 9M FY18 Growth FY18 - Small Molecules 4,689 3,688 27% 13,009 10,822 20% 15,077 - Biologics 4,486 1,898 136% 10,658 5,294 101% 7,702 - Branded Formulations 2,122 1,561 36% 5,234 4,624 13% 6,115 - Syngene (
Slide 12: Financial Summary
Financial Summary All Figures in ₹ Million except % Growth Particulars Q3 FY19 Q3 FY18 Growth 9M FY19 9M FY18 FY18 (%) Revenue 15,664 10,918 43% 41,066 30,989 33% 43,359 EBITDA 4,063 2,556 59% 11,069 7,348 51% 10,353 Net Profit# 2,117 919 130% 5,154 2,420 113% 3,724 R&D Expenses in 767 529 45% 1,978
Slide 13: Our Business
Our Business Enduring Edge
Slide 14: Business Segments
Business Segments Branded Formulations Finished Dosage Business in India & Overseas Small Molecules Research Services Syngene Differentiated APIs CRO offering integrated service platform & Generic Formulations for novel molecule drug discovery & development for small & large molecules Biologics Nove
Slide 15: Small Molecule: APIs & Generic Formulations
Small Molecule : APIs & Generic Formulations Differentiated APIs Current Constituents Portfolio Product Portfolio leverages core fermentation technology strengths Simvastatin, Pravastatin, Atorvastatin, Statins Rosuvastatin, & Fluvastatin. Among world’s largest manufacturers of statins & immunosupre
Slide 16: Biologics: Biosimilars & Novel Biologics
Biologics: Biosimilars & Novel Biologics Biosimilars Novel Biologics 15+ years of experience Creating market leadership is developing biologics in Innovation e.g., Insulin with multiple biosimilars Tregopil, Itolizumab commercialized globally Strong scientific and Pipeline includes oral technical ca
Slide 17: Strategic Partnership with Mylan for Biosimilars: Insulins & mAbs
Strategic Partnership with Mylan for Biosimilars: Insulins & mAbs BIOCON MYLAN • Global-scale, complex biologics • Strength in Regulatory/ filings manufacturing capabilities strategy • Facilities accredited by • Strong commercialization international regulatory agencies capability in US and EU. • De
Slide 18: Strategic Partnership with Sandoz for next generation Biosimilars
Strategic Partnership with Sandoz for next generation Biosimilars Deal Structure Portfolio addresses next wave of immunology and oncology biosimilars Both companies share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of biosimilars Costs & prof
Slide 19: Status of Biocon's Global Biosimilars Portfolio
Status of Biocon’s Global Biosimilars Portfolio* Therapeutic Molecule Status Area Oncology Trastuzumab Approved in U.S., EU & Australia. Under review in Canada. Launched in emerging markets Diabetes Insulin Glargine Launched in the EU. Approved in Australia. Under review in U.S. and Canada. Launched
Slide 20: Biocon Well Placed in Competitive Global Landscape (1)
Biocon Well Placed in Competitive Global Landscape (1) Molecule Biosimilar Development Pipeline$ Phase I Phase 3 Regulatory Submission Approved/ Marketed EMA FDA EMA FDA adalimumab DM Bio, Alvotech Coherus, Momenta, Fresnius/ Samsung, Pfizer Amgen, Samsung, Amgen, BI, Celltrion, BIOCON DRL^, Pfizer*
Slide 21: Biocon Well Placed in Competitive Global Landscape (2)
Biocon Well Placed in Competitive Global Landscape (2) Molecule Biosimilar Insulin Development Pipeline$ Phase I Phase 3 Regulatory Submission Approved/ Marketed EMA FDA EMA FDA insulin glargine Gan Lee /Sandoz BIOCON* BIOCON, Eli Lilly, Eli Lilly, Merck Merck (TA) insulin aspart Sanofi, BIOCON insu
Slide 22: Biosimilars Manufacturing: Building Global Scale
Biosimilars Manufacturing: Building Global Scale Biocon Malaysia: Asia’s largest integrated insulins manufacturing facility Biocon’s First Manufacturing expansion overseas in Iskandar, Johor. Investment of over US$275mn in the first phase. Sales commenced in E.U. & Emerging Markets; include OTA awar
Slide 23: Novel Molecules - Pipeline & Therapeutic Area Focus
Novel Molecules - Pipeline & Therapeutic Area Focus Insulin Tregopil * India Phase II/III in DIABETES First-in-Class Oral, Prandial Insulin T2D commenced Itolizumab* IND Approved for Novel, humanized CD6 Antibody orphan indications BVX-20# INFLAMMATION Novel, humanized CD20 Antibody Path to IND mapp
Slide 24: Novel Molecules: Progressing to key milestones
Novel Molecules: Progressing to key milestones Asset Details Insulin Tregopil USP: Oral, Ultra Rapid-Acting Post- prandial glycemic control; Liver specific- portal delivery, Weight neutral Phase II/III Ongoing Safety & tolerability established in Phase 1 studies in US – DDI, Food Effect, PK/PD Dat
Slide 25: Branded Formulations: India & UAE
Branded Formulations: India & UAE Specialty business with regional ambitions; strong value builder for Biocon. Biologics-led specialty products focused on chronic therapy areas. Comprehensive offering of products, patient and physician support programs INDIA UAE India’s largest Insulins & leading On
Slide 26: Research Services Business: Syngene
Research Services Business: Syngene One of leading India based CROs, a global high growth CRO company Offers an integrated drug discovery and development platform for both small and large molecules, antibody- drug conjugates and oligonucleotides backed by best- in-class bioinformatics services End-t
Slide 27: Five Year Financials
Five Year Financials All Figures in ₹ Million except EPS Business Segment FY13 FY14 FY15 FY16 FY17$ Biopharmaceuticals 18,705 21,382 22,367 23,908 26,259 - Biopharma 15,231 17,468 18,071 19,534 20,764 - Branded Formulations 3,474 3,914 4,296 4,374 5,495 Contract Research 5,572 7,146 8,225 10,599 11,
Slide 28: Investor Relations contact
Investor Relations contact: Saurabh Paliwal Tel : +91 80 6775 2040 Email: investor.relations@biocon.com For further information, please visit www.biocon.com 27