Biocon Corporate Presentation

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Biocon

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Technology

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FY22

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#1* Biocon Investor Presentation Q1 FY22 Biocon Biologics#2Safe Harbor Statement Biocon 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#3Biocon is a global biopharmaceutical company that is leveraging its affordable innovation model to reduce disparities in access to safe, high-quality medicines, as well as, address the gaps in scientific research to find innovative solutions to impact a billion lives. GENOMIC INSPIRATION gary trakke Biocon 3#4The Biocon Manifesto As a committed stakeholder of the global health agenda under the UN Sustainable Development Goals (SDGs), Biocon has drawn up a manifesto to deliver on its commitment to universal healthcare. Ⓡ accessibility • • Use our science, scale and expertise to enhance access to essential drugs for patients on the lowest rung of the economic ladder Uncover new medical insights aimed at expanding the scope of therapy to address unmet needs affordability • Focus on the kind of innovation that adds the condition of affordability to accessibility Bring competition for expensive innovator medicines through our generics and biosimilars Biocon • • availability Build strategic global and regional partnerships to make high-quality biopharmaceuticals available to the maximum number of people Create a robust portfolio of 'blockbuster' drugs with the potential to benefit a billion patients 00 assurance Demonstrate the highest levels of ethics, compliance and governance Assure continuous supply of high-quality products conforming to international regulatory standards 4#5The Biocon Journey: A Continuous Evolution 1978- 1999 2000- 2004 2005- 2009 2010- 2016- 2015 2018 2019 & Beyond Transforming into An Enzymes Company a Biopharma Company Successful IPO, Biocon listed in India (2004) Building the Base Business and Expertise in Biologics Enzymes Business Divested (2007) Global Development of Biosimilars in Partnership with Mylan (2009) Strategic Global Alliance with Mylan for Biosimilars Expanded (2013) Generic Formulations Business Unit set up (2013) IPO of Syngene (2015) Commercialized Biosimilars for Diabetes & Cancer in Japan, U.S., EU Global Partnership with Sandoz for Next-Gen Biosimilars (2018) Poised for Global Impact with Biosimilars Investments in complex Generic Formulations Unwavering focus through the years on innovation & difficult to make, niche products to create tangible differentiators for sustainable growth ✓ Biocon 5 LO#6Biocon Today: Strategically poised for a strong global play ✓ Biocon 0 P *Fiscal year 2020-21 Rs 7,360 Cr Revenue* 12,000+ Total Employees* 1,200+ Patents 120+ Countries where our products are available 吣 25+ CGMP approvals from International regulatory agencies Ranked 5 Among Top 10 Global Biotech Employers by Science magazine CO 6#7Battling the pandemic! ✓ Biocon Mounting 'on-site' infections coupled with lockdown posed significant operational challenges 20,000+ COVID-19 vaccines administered to employees, their families and our neighbouring communities When I came off the ventilator, I was told to be prepared for convalescent plasma therapy. But its need was mitigated by the administration of ALZUMAB-L (Itolizumab), which foiled the life- threatening impact of cytokine storm due to COVID-19. My turnaround was miraculous. - Dr. Belani, Mumbai Ramped up production of Itolizumab to serve patients in the second wave: 27,000+ lives impacted With vaccinations picking up pace, we are hopeful of the situation improving I was admitted in the ICU when the doctors administered Itolizumab, following which my condition improved. I was moved out of the ICU the next day. Within a few days, I was helping other patients, even those in wheelchairs. - - Sanjai Rai, Mumbai ワ 7#8Biocon Business Segments EAM DEVIC 8#9Growth Verticals: Aligned With Shifting Paradigms Biocon From pipeline to production, from drug discovery to drug delivery, we bring differentiated, high-quality and affordable healthcare products & services globally. Biocon GENERICS Biocon Biologics BIOSIMILARS Syngene RESEARCH SERVICES BICARA therapeutics NOVEL BIOLOGICS Ensuring access through quality, affordability, reliability Expanding access through innovative, inclusive healthcare solutions Partnering to deliver innovative scientific solutions Pushing scientific boundaries to deliver impactful innovations 6#10Generics: Investing into capacities and capabilities for the future growth -TH 罩 $ Biocon Differentiated API business 5 state-of-the-art facilities across Bangalore, Hyderabad and Visakhapatnam in India to manufacture high quality products with reliability and efficiency. Expertise in fermentation technology, large scale chromatography and synthetic chemistry gives us a key competitive edge in APIs. Among the world's largest manufacturers of immunosuppressant and statin APIs 1,000+ customers in 100+ countries including the U.S, Europe and large emerging markets, with a track-record of excellence for over 20 years. 223 1000+ Customers ה ווווי Growing Formulations Footprint Solid oral & parenteral products in both potent & non-potent categories Focus therapeutic segments - Metabolics, Oncology, Immunology & Auto-immune indications Generic Tacrolimus, Rosuvastatin, Simvastatin & Atorvastatin launched in the United States Entered partnerships to expand Generic Formulations footprint in China, Singapore, Thailand Regulatory licenses received from MHRA for import and distribution of our formulations in UK 280+ Patents Obtained 50% Global MS in orlistat API & world's leaders in immunosuppressants Investments for future growth Expanding our R&D capabilities for newer fermentation-derived and chemical synthesis- based molecules. Focus on developing niche, difficult-to-make, complex molecules with relatively higher entry barriers. Investing Rs. 6 billion in greenfield, fermentation-based manufacturing facility in Visakhapatnam, Andhra Pradesh Focus on adopting best-in-class quality practices and implement digital processes in our quality and related functions Retaining leadership in key APIs with structured cost improvement programs 800+ Metric ton cumulative weight of APIs supplied annually 10#11Generics: Q1 FY22 Biocon KEY HIGHLIGHTS COVID-19 led operational and supply chain challenges in API manufacturing, expected to normalize in the coming quarter Gradual ramp-up of Tacrolimus in US while statins' market share was resilient Q1 FY22 Q 1 F Y 21 Revenue *621Cr *486Cr 22% YoY decrease Entered Labetalol and Esomeprazole in the US with estimated market size* of $63m and $230m, respectively Delay in site inspections, consequently launches, due to travel restrictions On track to commission greenfield Immunosuppressant API facility in Visakhapatnam in FY 2022 *US Market value based on IQVIA Profit Before Tax *29Cr *96Cr 6% of revenue 15% of revenue 11#12Biosimilars: Developing biologics for global markets at all scale Biocon Biologics Biosimilars are an attractive opportunity Robust biosimilar portfolio coupled with adjacent biologics (e.g., ADG20) Fully integrated - lab to market Global Footprint (120+ countries) Strong partners e.g., Viatris, Sandoz and Adagio Branded Formulations India (BFI) forms a robust commercial platform in India Therapeutic Areas Molecule Pegfilgrastim¹ Trastuzumab¹ Oncology Bevacizumab¹ Pertuzumab¹ 1,2 Immunology Diabetes Undisclosed 8 HE Approved Products6 Adalimumab¹ Etanercept¹,2 Glargine 100U¹,3 Glargine 300U¹ Aspart¹ RHI4 7 Assets 2 Research & Product Status S US Dev. Markets: ex-US MoW5 EU, CANZ EU, CANZ EU EU, CA, Japan EU EU, ANZ, Japan EU EU Early Dev./ Preclinical Clinical Filed Approved 30 Manufacturing sites Development sites (2 Bengaluru, 1 Malaysia) 25+ 1 CGMP approvals (incl. FDA & EMA) 1 In partnership with Viatris; 2 Partner Viatris has in-licensed product (Biocon benefits from economic interest); 3 Japan is outside of Viatris partnership; 4 RHI non-partnered asset completed Ph 1 and considering potential Ph 3 waiver to be confirmed with US FDA advice, shown as Planned submission; 5 MoW represents Most of the World markets. Chart represents the status of the country where the product is in most advanced stage. Every country has a different status; 6 Includes Adalimumab and Etanercept which have been in-licensed by Viatris and Biocon Biologics has economic interest. 12#13Biosimilars: Key updates in Q1 FY22 Biocon Biologics KEY HIGHLIGHTS Strong growth in BFI business with significant contribution from COVID-19 portfolio, serving 50,000+ patients Q1 FY22 Q 1 F Y 21 Revenue *758Cr *692Cr Steady performance of non-COVID products Continued improvement in market share for commercial products in the US Additional growth in US expected by launch of bBevacizumab and bAspart, and bGlargine interchangeability Near-term growth in EU to be driven by entry in new markets and product launches (bBevacizumab) 10% YoY increase Core EBITDA¹ *271Cr *249Cr 36% of revenue Profit Before Tax *101Cr *105Cr 1 Core EBITDA defined as EBITDA before R&D, forex and licensing income 13% of revenue 15% of revenue 13#14Novel Molecules: Pushing scientific boundaries to deliver impactful innovations Biocon Disease Area ៨ Diabetes Inflammation Immuno-oncology Asset Insulin Tregopil- a first-in-class oral, prandial Insulin Itolizumab- A novel humanized CD6 antibody BCA101- (formerly FmAb2, a first-in-class EGFR/ TGFB-trap bifunctional antibody).This asset is part of Bicara Therapeutics, a clinical-stage biotechnology company based in US* Current Progress • Phase I multiple ascending dose studies in Type 1 DM patients making progress in Germany. This trial is in partnership with the US-based Juvenile Diabetes Research Foundation (JDRF), a leading non-profit organization. . Phase 1 component of this trial expected to be completed in FY22 US, Canada, Australia and New Zealand rights out-licensed to the US-based Equillium Inc. Currently, Equillium is conducting clinical trials on the use of Itolizumab in the treatment of acute graft-versus-host disease (aGVHD), uncontrolled asthma and lupus nephritis. ⚫ The European Commission granted an 'Orphan Medical Product' designation to Itolizumab in the treatment of Graft versus Host disease in July 2021 ⚫ In 2020, Itolizumab was repurposed for the prevention and treatment of COVID-19 complications and we were granted Restricted Emergency Use approval in September 2020 for the treatment of Cytokine Release Syndrome (CRS) in moderate to Severe Acute Respiratory Distress Syndrome (ARDS) patients in India. Phase 4 studies are making good progress. • Entered a Phase 1/2 study at leading US and Canadian cancer centers in July 2020. Under evaluation, both as a single agent and in combination with the checkpoint inhibitor Pembrolizumab, in patients with advanced EGFR-driven solid tumors, who no longer respond to the standard of care. Bicara anticipates transitioning to dose expansion studies in the second half of 2021. *In Q4FY21, Biocon ceded control over the Board of Directors and Operations of Bicara Therapeutics Inc. to enable it to operate independently under a US based leadership team and raise funds to advance its development programs. As a result of this change, Bicara was classified as an Associate from a Subsidiary under IND-AS. 14#15Novels: Q1 FY22 KEY HIGHLIGHTS Equillium had Positive End-of-Phase 1 meeting with the US FDA on Itolizumab for acute GvHD* To initiate a Phase 3 pivotal study on Itolizumab in first-line acute GvHD* in Q4 CY 2021 COMP** approved an Orphan Designation for Itolizumab for the treatment of acute and chronic GVHD* in EU Completed dosing for Phase 4 study of Itolizumab for treating CRS^ in moderate to severe ARDS* patients due to Covid-19 *Graft-versus-host disease ** Committee for Orphan Medicinal Products ^Cytokine Release Syndrome #Acute Respiratory Distress Syndrome ✓ Biocon 15#16Research Services (Syngene): A global CRO delivering innovative solutions Offering integrated research, development and manufacturing services for both small and large molecules, antibody-drug conjugates and oligonucleotides backed by best-in-class bioinformatic services Combining world class research expertise, technology and infrastructure to reduce costs and time to market Talented scientific and techno-commercial teams, led by experienced management, moving beyond cost arbitrage to innovation World class infrastructure audited successfully by US FDA, EMA, AAALAC and major life sciences partners 400+ active marquee clients across multiple sectors World-class R&D and manufacturing infrastructure spread over 1.9 million square feet 4700+ talented team of scientists, including ~490 PhDs Strong track record of top-line growth with best-in-class EBITDA margins and Net Profit margin Listed in India on BSE and NSE in 2015 Syngene 22 16#17Research Services: Q1 FY22 KEY HIGHLIGHTS Growth across all divisions - Discovery, Development and Manufacturing services Significant contribution of Remdesivir in topline growth Syngene Q1 FY22 Q 1 F Y 21 Revenue *595Cr *422Cr 41% YoY increase Mangalore API facility successfully completed ISO 9001:2015 certification audit Profit Before Tax *95Cr *66Cr 16% of revenue Signed a five-year agreement with IAVI for manufacturing three anti-HIV mAbs for use in Phase 1 and 2 clinical trials 17#18Biocon Financial Highlights EAM DEVIC 18#19Annual Financial Highlights FY 21 FY20 Revenue +13% 7,360Cr *6,462Cr Core EBITDA¹ +15% 2,430Cr *2,108Cr % margin 33% 33% EBITDA +8% 1,907Cr *1,765Cr % margin 26% 27% Profit Before Tax² (11) % 1,077Cr *1,215Cr % margin 15% 19% Net Profit # (4)% *754Cr *789Cr % margin 5% 9% 1 Core EBITDA defined as EBITDA before R&D, forex and licensing income; 2 from continued operations Biocon Biosimilars +21% | Research Services +9% | Generics +6% Forex loss of 9Cr in FY21 vs *65Cr of Forex gain in FY20 Gross R&D spends at *627Cr in FY21 (13% of ex-Syngene revenues) R&D spends in P&L #533Cr for FY21 Excluding Bicara Fair Valuation gain of 160 Cr: Core EBITDA 32%, dn 1% EBITDA *1,747Cr at 24% Net profit at *594Cr 19#20Quarterly Financial Highlights Biocon Q 1 FY22 Q 1 FY21 Revenue +6% 1,808Cr *1,712Cr Biosimilars +10% | Research Services +41% | Generics (22)% Core EBITDA* (1)% *531Cr *532Cr % margin 30% 31% EBITDA +1% *437Cr *432Cr % margin 24% 25% Forex Gain of 17Cr in Q1 FY22 vs *4Cr of Forex loss in Q1 FY21 Gross R&D spends at #136Cr in Q1 FY22 vs 142Cr in Q1FY21 R&D spends in P&L *120Cr for Q1 FY22 Profit Before Tax (33)% *166Cr *249Cr PBT ex Bicara of 224Cr in Q1 FY22 % margin 9% 15% Net Profit (44)% €84Cr *149Cr Net Profit ex Bicara of *142Cr in Q1 FY22 % margin 5% 9% *Core EBITDA defined as EBITDA before R&D, forex and licensing income 20 20#21Thank You INVESTOR RELATIONS CONTACT: Chirag Dalal, Biocon Limited Tel: +91 897 197 4732 Email: [email protected] Nikunj Mall, Biocon Biologics Limited Tel: +91 998 777 4078 Email: [email protected] ✓ Biocon 21

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