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Chairperson Speech 2021-Final.Cdr Unwavering Purpose Chairperson’s AGM Speech 43rd Annual General Meeting Friday, July 23, 2021, Bengaluru, India Kiran Mazumdar-Shaw Executive Chairperson 2 Dear Shareholders, As we connued with our operaons, we also focused on protecng our people and ensuring It gives me great pleasure to welcome you their health and well-being. We invested in to the 43rd Annual General Meeting of implemenng strict safety protocols and your company. regularly engaged with our people to keep them movated. The leadership team constantly The pharmaceutical and healthcare monitored the fast-evolving situaon and took industry's fight against COVID-19 data-driven decisions for operaonal planning across our facilies. intensified over the past year as fresh waves of infections hit many countries REALIZING THE BIOSIMILARS PROMISE around the world. As the pandemic left societies and economies in disarray, Our Biosimilars business revenue at Rs 28,002 million, recorded a growth of 21% in FY21. We biotechnology-led companies quickly commercialized our third biosimilar, Insulin developed diagnostics, vaccines and Glargine, in the U.S. and obtained regulatory therapies to tilt the battle in favor of approvals for key biosimilars Bevacizumab and humanity. Insulin Aspart in the European Union. Our biosimilars benefited 3.1 million paents during India has been at the forefront of this the year. crusade, producing cost-effective As the only company from India to have three vaccines at scale for millions of people. biosimilars commercialized in the U.S. and among At the same time, the country has the select few globally to have five biosimilars approved in Europe, we are confident of enabling continued to supply the world with affordable access to expensive biologic drugs for generic and biosimilar therapies to millions of paents globally. prevent and treat non-COVID health Our diverse porolio of products straddling threats such as cancer, diabetes, heart monoclonal anbodies for cancer and attacks, HIV infections, malaria, autoimmune diseases and rh-insulin and insulin analogs for diabetes as well as our connued tuberculosis etc. commitment to quality and product safety, posion us to deliver robust and enduring growth BIOCON GROUP ENDURES COVID-19 in the coming years. CHALLENGE The market potenal for biosimilars remains solid, with biologics worth ~USD 90 billion in The unwavering purpose of our company to put originator sales losing exclusivity over the next 'paents first' enabled us to sustain the supply decade. of life-saving medicines, worldwide. The confidence of investors in Biocon Biologics' We also took up the challenge to find soluons growth story is reflected in the enty's post- to support India's fight against COVID-19 by money valuaon of ~USD 4.17 billion during the leveraging our deep scienfic experse and last round of fundraising from Abu Dhabi-based large-scale manufacturing capabilies. From ADQ. We have thus far raised ~USD 330 million diagnoscs to therapies, from tesng to from top global investors like True North, Tata vaccinaons, we did our best to make a Capital Growth Fund and Goldman Sachs. meaningful difference. 3 SERVING PATIENT NEEDS THROUGH class' an-CD6 monoclonal anbody, GENERICS Itolizumab, which has a unique 'mechanism of acon' in controlling The Generics business acted with agility to cytokine release syndrome (CRS). ensure supplies of much-needed generic APIs (Acve Pharmaceucal Ingredients) and The Drugs Controller General of India formulaons from India to the rest of the (DCGI) granted Restricted Emergency Use world, belying fears of large-scale medicine approval to Itolizumab in July 2020 to treat shortages due to the pandemic. CRS in paents experiencing moderate to severe acute respiratory distress syndrome We supply stans, immunosuppressants, (ARDS) due to COVID-19. We are gathering narrow-spectrum anbiocs and other APIs addional data as part of the Phase 4 post to over 100 countries and were able to serve markeng study for Itolizumab, which will our partners despite COVID-related further validate the potenal of this disrupons. Revenues from the Generics therapy in COVID-19. During the business grew by 6% over the previous year devastang second wave, Itolizumab was to Rs 23,359 million, supported by double- deployed to treat over 20,000 COVID-19 digit growth in Generic Formulaons and a paents affected with severe disease. modest single-digit growth in APIs. Results from the Phase 2 clinical trial, In FY21, Generics Formulaons achieved a which established Itolizumab as a key milestone with the launch of Tacrolimus promising, safe and effecve capsules, an immunosuppressant used to immunomodulatory therapy for COVID-19 treat organ transplant paents, in the U.S. with survival and recovery benefits, have We delivered ~2 billion stan pills for the been published in a presgious, peer- benefit of paents in the U.S. in FY21. reviewed scienfic journal in FY21. It also entered new partnerships to expand Equillium, our U.S.-based partner, reported commercial footprint to Singapore, Thailand encouraging developments on the clinical and Brazil. advancement of Itolizumab in treang acute gra-versus-host disease, lupus, We remain commied to invesng in lupus nephris, and uncontrolled asthma. building new capabilies and capacies We are expecng clinical data from all across funcons, including R&D, studies later in calendar year 2021. Manufacturing and Quality, and expanding our product porolio to deliver long-term, Boston-based Bicara Therapeucs is sustainable growth in our Generics business. spearheading the development of novel bi- funconal fusion anbodies in immuno- oncology. Its lead program, BCA101, is in MAKING A DIFFERENCE WITH OUR Phase 1/2 clinical trials in the U.S. and NOVEL BIOLOGICS Canada. Bicara started operang as a standalone company under an independent management team in FY21 Realizing the acute need for an effecve aer we ceded control to its Board and treatment for people hospitalized with Management. COVID-19 and those at risk of developing severe illness, we repurposed our 'first in 4 KEEPING RESEARCH PROJECTS ON To support the government's efforts to TRACK combat and contain the pandemic, Syngene has set up a Vaccinaon Center to provide Despite a challenging year, Syngene free vaccinaon for Biocon Group employees successfully delivered on its commitment to and their families. Through Biocon clients who depend on the Company for their Foundaon's eLAJ smart clinics, we are now research and development needs. It delivered providing COVID-19 vaccinaon for revenue of Rs 21,843 million, and an annual marginalised communies. growth of 9%. Syngene also built on its integrated drug discovery and development porolio during the year, signing on new We remain committed to clients and renewing contracts scienfic and investing in building new manufacturing capabilies during the year. capabilities and strengthening our product portfolio to deliver TACKLING COVID-19 long-term, sustainable growth The Biocon Group was able to pivot very in our Generics business. quickly its capabilies to fight against COVID- 19 in FY21. PAYING TRIBUTE TO OUR COLLEAGUES We have a comprehensive porolio of LOST TO COVID-19 products for treang COVID-19 paents at different stages of the disease spectrum, The second wave of COVID-19 in India has including RemWin (Remdesivir) for mild to tragically impacted us and we have lost some moderate paents, ALZUMAb-L (Itolizumab) of our dear colleagues across Biocon, Biocon for moderate to severe paents and CytoSorb Biologics and Syngene. We express our for crical paents. deepest condolences to the bereaved families. Biocon's Research Services subsidiary Syngene We understand we cannot compensate the manufactured Remdesivir under a license loss of a human life, however, we have taken from Gilead and distributed in India through steps to help their families rebuild their lives. Biocon Biologics and Sun Pharma to address Biocon Group has decided to pay the families paent needs for this life saving therapy. of the deceased, 50% of the employee's gross salary for two years, up to a maximum payout Syngene leveraged its deep scienfic experse of Rs 50 lakhs. We will also extend the to develop various soluons to support the educaon allowance support for two children naon's bale against COVID-19. unl the age of 18. We will also assist with job Syngene, through its repurposed, high-end hiring for either the spouse or child, in one of laboratory, conducted 185,000 RT-PCR tests, our group companies, or help them find of which 90% were free of cost, in FY21. The employment elsewhere, depending on their Company also developed an ELISA (Enzyme- educaon and eligibility. The above support is Linked Immunosorbent Assay) anbody in addion to the Group Term Life Insurance tesng kit for COVID-19. Currently, sciensts and other benefits applicable as per the at Syngene are engaged in developing an and Company's policy. We sincerely appreciate the validang several relevant assays for assessing contribuons made by our dear colleagues immune response against SARS-CoV-2. and earnestly share the grief of their families. 5 Our internaonal revenue contribuon grew to 81% in FY21 from 78% in FY20. * Includes exceponal items and loss from disconnuing operaons # Includes inter-segment revenue 6 FINANCIAL PERFORMANCE the pharmaceucals industry, having worked in India, France and Sub-Saharan Africa for leading Despite a tough and unpredictable year, Biocon global pharma companies. delivered a credible financial performance with consolidated revenue growing 14% to Rs I do believe we have a strong leadership team in 73,603 million and hit the $1 billion mark. place now to drive the future growth of our EBITDA grew 8% to Rs 19,071 million, Biosimilars business and return the Company to represenng an EBITDA margin of 26%. Net its high growth trajectory soon. I will also be Profit (before exceponal item and playing a more acve role as the Execuve disconnuing operaons) was at Rs 7,540 Chairperson of Biocon Biologics Limited.
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