Slide 1: Biocon Limited Investor Presentation
Biocon Limited Investor Presentation September 2017 BSE: 532523 │ NSE: BIOCON │ REUTERS: BION.NS │ BLOOMBERG: BIOS IN │ WWW.BIOCON.COM
Slide 2: 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 3: Agenda
Agenda Biocon: Who are we? Highlights • Business Highlights • Financial Highlights Business Segments • Small Molecules • Biosimilars • Branded Formulations • Novel Molecules • Research Services - Syngene Five Year Financial Summary Outlook 3
Slide 4: Who are we?
Who are we? 4
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 5
Slide 6: The Biocon Journey: A continuous evolution
The Biocon Journey: A continuous evolution Transforming into a Building the Base Business Poised for global impact with Biopharma company and expertise in biologics Biosimilar insulins & Antibodies Revenues: ₹5,490 Million Revenue: ₹ 11,940 Million Target US$1bn in sales by FY19 People: 700+ People:
Slide 7: Evolution of Key Innovations: Making a Difference
Evolution of Key Innovations: Making a Difference 1979 - First Indian company to manufacture and export enzymes to US and Europe 2001 - First Indian company to be approved by US FDA for the manufacture of lovastatin from solid state fermentation 2004 - First company worldwide to commercialize generi
Slide 8: Recent Highlights
Recent Highlights U.S. Food and Drug Administration (USFDA) Oncologic Drug Advisory Committee (ODAC) recommended for approval Biocon‐Mylan's proposed biosimilar Trastuzumab in all eligible indications; first biosimilar Trastuzumab to be recommended by the Committee. Proposed biosimilars of Trastuzum
Slide 9: Revenue Highlights
Revenue Highlights All Figures in ₹ Million except % Growth Particulars Q1 FY18 Q1 FY17 FY17 FY16 (%) - Small Molecules 3,629 4,354 (17) 16,405 14,583 - Biologics 1,839 1,606 15 7,018 5,296 - Branded Formulations 1,304 1,580 (17) 5,489 4,409 - Syngene (Research Services) 2,911 2,745 6 11,925 11,070
Slide 10: Financial Summary
Financial Summary All Figures in ₹ Million except % Growth Particulars Q1 FY18 Q1 FY17 FY17 FY16 (%) Revenue 9,877 10,329 (4) 40,787 34,602 EBITDA 2,461 3,040 (-19) 11,366 8,470 Net Profit# 813 1,666 (51) 6,199 4,021 R&D Expenses in P&L 582 514 13 2,662 2,742 Gross R&D Spends 956 915 4 4,019 4,267 E
Slide 11: Business Segments
Business Segments 11
Slide 12: Growth Segments: Aligned with Shifting Paradigms
Growth Segments: Aligned with Shifting Paradigms Small Molecules – APIs and Generic Formulations Biologics – Biosimilars & Novel Biologics Branded Formulations - Formulations Business in India & UAE Research Services - Contract Research & Manufacturing 12
Slide 13: Small Molecule APIs
Small Molecule APIs Product Portfolio which leverages our core fermentation capabilities and have a high degree of complexity. Early mover in niche products at commercial scale. One of the largest producers of various fermentation based statins and immunosuppressant API in India and across the globe
Slide 14: Small Molecule Generic Formulations
Small Molecule Generic Formulations Vertically integrated business model with a nascent pipeline. Target to file ~10-15 dossiers in the next few years. Pipeline includes solid oral & parenteral products in both potent & non-potent categories of compounds. Focus therapeutic segments – Metabolics, Onc
Slide 15: Biosimilars
Biosimilars U.S. Food and Drug Administration (USFDA) Oncologic Drug Advisory Committee (ODAC) recommended for approval Biocon‐Mylan's proposed biosimilar Trastuzumab in all eligible indications; first biosimilar Trastuzumab to be recommended by the Committee. Proposed biosimilars of Trastuzumab and
Slide 16: Biosimilars: Growth through partnership
Biosimilars: Growth through partnership 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. • Decade-long experience & • M
Slide 17: Global Biosimilars Pipeline – US$61bn opportunity
Global Biosimilars Pipeline – US$61bn opportunity Market Size* Molecule Type Status (US$ bn) Rh Insulin Regular Acting Insulin Pre-clinical (US), Marketed in EM 3.2 INSULINS Filed in EU, Australia & Canada. Glargine Long Acting Insulin 6.4 Marketed in Japan (since Jul-16) & EM Aspart Rapid Acting In
Slide 18: Biosimilar Pipeline: Biocon well placed in the competitive landscape
Biosimilar Pipeline: Biocon well placed in the competitive landscape Molecule Biosimilar Development Pipeline@ Phase I Phase 3 Regulatory Submission Approved/ Marketed EMA FDA EMA FDA pegfilgrastim Dr. Reddy’s, Biocon, Apotex, Cinfa, Coherus Biocon None None Pfizer Sandoz, trastuzumab Biocon, Hanwha
Slide 19: 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$275mn in the first phase. Commercial supplies initiated with OTA award by Ministry of
Slide 20: Branded Formulations
Branded Formulations A Specialty Business with regional ambitions, currently in India and UAE. Strategy focused around biologics and differentiated products as anchor brands. The UAE business sells Branded generics and in-licensed Branded products. India business organized into 5 divisions aro
Slide 21: Novel Molecules - Pipeline & Therapeutic Area Focus
Novel Molecules - Pipeline & Therapeutic Area Focus Insulin Tregopil * Phase II Ready DIABETES T1D/ T2D First-in-Class Oral, Prandial Insulin Itolizumab* Phase I Ongoing Novel, humanized CD6 Antibody BVX-20# IND Ready Novel, humanized CD20 Antibody INFLAMMATION QPI-1007$ Phase III Initiated SiRNA fo
Slide 22: Novel Molecules – Progressing to key milestones
Novel Molecules – Progressing to key milestones Asset Details Tregopil USP: Oral, Ultra Rapid-Acting Phase II Ready Post- prandial glycemic control; Liver specific- portal delivery, Weight neutral Safety & tolerability established in Phase 1 studies in US – DDI, Food Effect, PK/PD Data available
Slide 23: Syngene (Research Services Business)
Syngene (Research Services Business) Global High Growth CRO Company Established in 1994, as India’s first Contract Research Organization – 23 years of unparalleled experience in novel molecule discovery and development services One of the leading India-based contract research organizations (CRO) Int
Slide 24: Outlook
Outlook 24
Slide 25: Aspiring for $1 Billion in Revenues by FY19
Aspiring for $1 Billion in Revenues by FY19 Key Focus Areas o Small Molecules & Generic Formulations - Improved product mix incl. ANDAs o Biosimilars - Meaningful near term growth to be driven 25% by emerging markets, ramp up post developed market entry 30% o Branded Formulations –Strategy focused a
Slide 26: Appendix
Appendix 26
Slide 27: Business Holdings Structure
Business Holdings Structure Biocon Limited, India Small Molecules & ANDA Biocon Pharma, India (100%) Branded Formulations Biocon Pharma, US (100%) Biocon FZ LLC (100%)/ NeoBiocon, UAE (49%) Biocon Biologics, UK Biocon SA, Switzerland Syngene, India (100%) (100%) (73.54%)* Biocon Sdn Bhd, Biocon Biol
Slide 28: Five Year Financial Performance Summary (FY13-17)
Five Year Financial Performance Summary (FY13-17)# All Figures in ₹ Million except EPS Business Segment FY13 FY14 FY15 FY16 FY17$ 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 Researc
Slide 29: For further information, please visit www.biocon.com
For further information, please visit www.biocon.com Investor Relations contact: Saurabh Paliwal Tel : +91 80 6775 2040 Email: saurabh.paliwal@biocon.com 29