Biocon Investor Presentation Jan 2013


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Biocon Investor Presentation Jan 2013

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Biocon Investor Presentation Jan 2013

  1. 1. Innovative Science Affordable Medicine INVESTOR PRESENTATION January 2013
  2. 2. 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. Important factors that could cause actual results to differ materially from our expectations include, amongst others general economic and business conditions in India, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currencies, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither the company, nor its directors and any of the affiliates have any obligation to update or otherwise revise any statements reflecting circumstances arising after this date or to reflect the occurrence of underlying events, even if the underlying assumptions do not come to fruition. 2
  3. 3. Agenda Biocon: Aligned With Global Trends Growth Segments Partnerships Financial Highlights 3
  4. 4. Biocon: Aligned with Global Trends
  5. 5. Biocon: An Introduction Biocon is an emerging, global Bio-pharmaceutical enterprise, focused on innovation to develop affordable products and services for patients, partners and healthcare systems across the world. Biocon is committed towards: Reducing therapy costs of chronic diseases. (diabetes, cancer & auto-immune diseases) Strategic Research and marketing partnerships that provide global access Leveraging the India advantage to deliver high value, licensable R&D assets 5
  6. 6. 9M FY13 Highlights Group Revenue at ` 1,890 Crores (23% YoY growth) Financial Growth across all verticals: Performance Biopharma - 17% Branded Formulations - 35% Research Services - 34% EBITDA at ` 472 Crores (EBITDA Margin: 25% ) R&D Expense: 11% of Biopharma Revenue Itolizumab: Marketing Approval received from DCGI for plaque Psoriasis in Research & India Development Entered into an option agreement with BMS for our novel asset, a prandial Updates oral insulin: IN-105 Global Phase III trial initiated for Biosimilar Trastuzumab post the successful completion of its Global Phase I Part II of the EU Phase III trial for biosimilar rh-Insulin completed. Part 1 of the trial successfully established the efficacy endpoint with comparable safety & efficacy with innovator products. Global Phase I trial for Biosimilar Insulin Glargine successfully completed. 6
  7. 7. 9M FY13 Highlights GE Capital proposes Investment to the tune of `125 Crores in Corporate Syngene Milestones Commencement of Abbott Nutrition Research & Development Centre Inauguration of Biocon Research Centre Becomes the only Asian Company to feature in Science magazine’s global ‘Top 20 Employers’ in biotech & pharma 7
  8. 8. Business Structure & Holdings BIOPHARMA SUBSIDIARIES Biocon Research , India | 100% R&D- Novel Molecules Biocon Biopharmaceuticals | 100% MAbs and Biosimilars Biocon Sdn. Bhd, Malaysia | 100% Overseas subsidiary ~61% | Promoters Biocon SA, Switzerland | 100% Overseas subsidiary ~ 8 % | Employees & ESOP trust Biocon NeoBiocon, UAE | 50% ~31 % | Public Overseas subsidiary RESEARCH SERVICES Syngene International, India | 99% Custom research, drug discovery Clinigene International, India | 100% Clinical development Spanning the entire Value Chain with capabilities ranging from discovery to manufacturing 8
  9. 9. Growth Verticals: Aligned with Shifting Paradigms ANDAs & 505(b)(2) filings Small Molecules Insulins, MAbs & Integrated Other Biologics offerings Research Biosimilars Services (Biologics & Growth Insulins) Verticals Unlock Value Novel Branded Rapidly growing- through Molecules Formulations India-centric business Licensing 9 EMERGING MARKETS FOCUS EMERGING MARKETS FOCUS
  10. 10. Growth Segments: Snapshot
  11. 11. Growth Segment: Small Molecules APIs Formulations 505(b)(2) (Generic & Novel) & ANDAs Portfolio based Approach Product Portfolio which leverage our core fermentation capabilities and have a high degree of complexity Early mover in niche products coupled with economies of scale. Current Portfolio Constituents Statins Simvastatin, Atorvastatin, Lovastatin, Rosuvastatin, Fluvastatin & Pravastatin Immuno suppressants Tacrolimus, MMF & MPA Other Biopharma Orlistat, Fidaxomicin, 50+ other molecules 11
  12. 12. Growth Segment: Biosimilars Biosimilars Pipeline Process Development / Phase Phase Portfolio Biosimilar Molecule Scale-up / Preclinical 1/II b III MarketGlobal Trials rh- Insulin Biosimilar Glargine Insulins Lispro & Aspart Trastuzumab Biosimilar MAbs and other Bevacizumab, Adalimumab biologics Etanercept, Peg-filgrastim Emerging Markets First strategy coupled with a regional partnership commercialization approach Biosimilar Insulins Portfolio: Currently being commercialized in Emerging Markets Biosimilars MAbs & Other Biologics: Biosimilar Trastuzumab undergoing an ROW focused, India Phase III trial. 12
  13. 13. Growth Segment: Biosimilars Biosimilar Insulin & Analogs Registrations: rh-Insulin: 40+ countries Glargine Glargine: 5+ countries 34% Biosimilar rh Insulin: Part 2 of the EU Phase III trial completed. Total Insulins Part 1 of the study establishes the Market: Aspart Efficacy end-point (non inferiority to rh-Insulin ~ USD 18 Bn* 23% innovator product) 19% Immunogenicity & Safety data similar to innovator at 6 month time point. Detemir Lispro Biosimilar Glargine: 9% 14% Global Phase I (PK-PD) study successfully completed Established equivalence between our Glulisine biosimilar insulin glargine and the 1% innovator product 13 *Market Size of innovator products MAT Sept 2012
  14. 14. Growth Segment: Branded Formulations 14
  15. 15. Growth Segment: Branded Formulations Affordability Index* INDIA PRODUCT RANKINGS# Cardiology Basalog: 40% Clotide 1 Insugen: 13% Myokinase 2 Oncotherapeutics Bestor: 30% BioMAb EGFR 2 Statix: 25% Evertor 2 Advacan: 45% Abraxane 3 Tacrograf: 30% Immunotherapy Psorid 1 Evertor: 59% Picon 2 BioMAb EGFR: 53% Tbis 2 Picon: 38% Nephrology Tacrograf 2 Psorid: 28% Bioproducts Genpirome 2 15*: Compared to the top selling competitor brand; #: ORG IMS November MAT 2012, IPSOS
  16. 16. Growth Segment: Branded Formulations Biocon’s Volume Value Growth YoY* Biocon’s ranking* Market share* Fastest growing Insulin company #4 in overall insulin market 100 IU Insulin: 15% Biocon: 34% Sanofi Aventis: 17% #3 in the 40 IU Insulin market Glargine vials: 72% Novo Nordisk: 10% #1 in the Glargine vial market INSUPen® ease Reusable delivery device based on proprietary German technology, capable of delivering both InsugenTM & BasalogTM launched in India & Select Emerging Markets 16 * : ORG IMS MAT November 2012
  17. 17. Growth Segment: Novel Molecules Novel Pipeline Pre- Phase Phase Phase Therapeutic Area Molecule Discovery Clinical 1 II III Market Diabetes IN-105Oncology/ Autoimmune Itolizumab # Oncology Nimotuzumab Oncology Anti CD – 20 Oncology Fusion Proteins Itolizumab: Marketing Authorization for Psoriasis approved by the Indian drug regulator Anti CD 20 (BVx 20) has entered the clinic in India Multiple Global Trials planned for Oral Insulin in collaboration with BMS 17
  18. 18. Growth Segment: Novel Molecules Alzumab (Itolizumab- First-in-Class Anti CD6) Marketing Authorization for Itolizumab (IV First-in-Class Therapy :Novel MOA with an delivery) received from Indian Drug regulator excellent safety profile for Psoriasis Very low Infection rates vis-à-vis other Alzumab India launch in 2013 approved therapies 2nd Novel Biologic from Biocon’s repertoire: Promising preclinical and clinical efficacy data First Novel MAb for Psoriasis developed in in other auto immune diseases (RA, MS) India Partnership discussions initiated for global US IND to be filed in 2013 to facilitate global development of this late stage opportunity clinical trials in Psoriasis, RA and other indications as Sub Q Baseline 12 Weeks 28 Weeks Treatment Arm 18
  19. 19. Growth Segment: Research Services • Integrated Drug Discovery and Development • Biologics Discovery and Development Integrated • Syngene- Clinigene axis Platforms • Bioanalytical testing of small and large molecules • Antibody Drug Conjugate (ADC) development • Unique In-Vivo Models- Human tumour tissue Xenograft Niche • Early and rapid toxicology evaluation (Cardiomyocytes ) Offerings • Commercial scale production of NCEs Evolving • High potency (cytotoxic) API manufacturing Services • Formulation development • Dedicated/customized infrastructure Customized • End-to-end services models • Risk sharing: Milestone based • Incubation: IP sharing 19
  20. 20. Growth Segment: Research Services ` crore 410 o PE Investment of $ 25 Mn for a 7.7% stake, valuing Syngene at $ 325 Mn 318 o Investment aimed at enhancing 281 Syngene’s service offerings & fund future growth o Dedicated, India-centric nutrition R&D Centre o Focused on: • Maternal & Child Nutrition • Diabetes Care FY 10 FY 11 FY 12 20
  21. 21. Partnerships
  22. 22. STRATEGIC PARTNERSHIPS BMS Diabetology Oral Insulin (IN-105) Discovery & CIMAb Oncology BioMAb EGFR, Itolizumab Development IATRICa Oncology Immuno-conjugated MAbs Vaccinex Oncology Biobetter MAbs Co-Development & Oncology & Biosimilar MABs & Mylan Commercialization Auto Immune Biologics First in Class Commercialization Optimer Fidaxomicin Anti Infective Discovery to BMS Integrated DD Services Commercialization Research Services Integrated discovery Abbott Nutrition R&D services 22
  23. 23. IN-105 Option Agreement: BMSFirst-in-class oral prandial insulin Combines Biocons novel asset and development experience with BMS’ novel drug development, regulatory & commercialization capabilities. Biocon will continue global development of the molecule through Phase II via redesigned trials. . Partnership encompasses Financial, Strategic and Clinical Support throughout the development phase BMS will have an exclusive option post phase II to further develop & commercialise the asset worldwide (excl. India) Biocon will receive licensing fee in addition to potential regulatory & commercialization milestones, when BMS exercises its option. 23
  24. 24. Fidaxomicin Partnership: OptimerFirst-in-class Anti-Infective Combines Biocons R&D and manufacturing prowess of novel biologics with Optimer’s proprietary molecule technology Collaboration for manufacture & supply of Fidaxomicin API : DIFICIDTM & DIFICLIRTM tablets . Extension of prior relationship where Biocon assisted Optimer with product development Launched in US & select East European nations in first phase; Alliances established for Japan, LATAM & 24
  25. 25. Biosimilars Commercialization Partnership: MylanMonoclonal Antibodies (MAbs) Combines Biocons R&D and manufacturing prowess of biologics with Mylan’s regulatory & commercialization capabilities in the US and Europe Market Value of Portfolio : ~33 Bn USD Exclusive collaboration for development and commercialization of . complex biosimilars. Basket of Products with patent expiries 2015 onward (Trastuzumab, Peg-filgrastim, Bevacizumab, Adalimumab, Eternacept) Mylan and Biocon to share development and capital costs. Mylan will have exclusive commercialization rights in the regulated markets; profits to be shared Biocon and Mylan to have co-exclusive commercialization rights in other markets. 25*Market Size of innovator products MAT Sept 2012
  26. 26. Financial Highlights
  27. 27. Financial Performance ` crore / USD mn FY08 FY09 FY10 FY11 FY12 Revenue 1,090 273 1,194 260 1,493 318 1,858 407 2,148 445 EBITDA 335 83 372 81 455 97 573 125 579 120 Net profit* 225 56 238 52 273 58 340 74 338 70 9M FY13 9M FY12 Revenue 1,890 | 346 1,537 | 324 EBITDA 472 | 86 423 | 89 25% 27% PAT 260| 48 241 | 51 14% 16% EPS 13.3 12.3 FY08-12: Avg.exch.rate in that fiscal ; 9M FY13: USD 1 = ` 54.64; 9M FY12: USD 1= ` 47.39 * Net profit is pre-exceptional in table 1.No exceptional items in FY10, FY11 and FY12. 27
  28. 28. Leveraging Challenges For Sustained Growth 25% FY 18 E 20% 20% $1 Billion + 25% 5% 20% 30% FY 15 E 10% ~ $700 Mn 5% 20% 10% Small Molecules 5% 10% 40% FY 12 A Biosimilars (Insulins + MAbs) ~ $450 Mn Research Services Branded Formulation 55% Licensing & Other Income 28
  29. 29. Innovative Science Affordable Medicine Thank You
  30. 30. APPENDIX
  31. 31. Global Pharma Growth Catalyst: Emerging Markets Emerging Markets to contribute ~ 75% of the Total Pharma Growth by 2016 USD Bn ~180 ~1,205 Global Pharma Spending expected to cross $1.2 Trillion by 2016 ~70 Emerging Markets projected growth CAGR: ~10% ~955 Developed Markets expected growth Global Pharma Market CAGR: ~2% ~ 5% CAGR Emerging Markets growth driven by: Increased Government Healthcare Spending Growing Affluence 2011 A Developed Emerging Markets 2016 E Markets 31Source: IMS Institute of Healthcare informatics,The Global Use of Medicines: Outlook Through 2016
  32. 32. Global Pharma Growth Catalyst: Generics & Biosimilars Generic Spending to Increase by ~75% in the next 5 years vs. Branded drugs’ growth of 9% USD Bn Biosimilars Biosimilars will grow 5 fold to $5 Bn ~5 ~1,205 Biosimilars 956 ~1 Generic 430 Generic 242 Small Molecules, Small ~ 425 Molecules, ~ 241 Branded* Branded* 714 745 Back 2011 2016 E *includes: OTC, diagnostics and non-therapeutics sales worth $118 Bn in 2011 and $145 Bn in 2016 E 32Source: IMS Institute for Healthcare Informatics, IMS Market Prognosis, May 2012