About Biocon Ltd

Biocon Limited is India's largest and fully-integrated, innovation-led biopharmaceutical company. The Company is engaged in the manufacture of biotechnology products and research services. Biocon Limited was incorporated in the year 1978 as a joint venture between Biocon Biochemicals Limited of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw. Biocon manufactured and exported enzymes to USA and Europe during the year 1979, as first of its kind. In 1989, Unilever plc acquired the Biocon Biochemicals Limited in Ireland and merges it with its subsidiary, Quest International. Also in the same year, the company had received US funding for proprietary technologies. After a year, in 1990, Biocon had scaled up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level. Biocon's R&D and manufacturing facilities received ISO 9001 certification from RWTUV, Germany during the period of 1993. In the year 1994, the company had established the Syngene International Pvt. Ltd. as a Custom research Company (CRC) to address the growing need for outsourced R&D in the pharmaceutical sector. The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion during the year 1996 and also in the same year, the company had leveraged its technology platform to enter biopharmaceuticals and statins. Biocon had spearheads initiatives in human healthcare in the year 1997 through a dedicated manufacturing facility. During the year 1998, Unilever inked a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agreed to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity in same period. In the year 2000, Biocon had commissioned its first fully automated submerged fermentation plant to produce specialty pharmaceuticals and also in the same year, the company had established Clinigene, India's first Clinical Research Organisation (CRO) to pursue clinical research and development. During the year 2001, Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule. During the same year of 2001, the company's proprietary bioreactor, PlaFractor was granted a US 2001 and worldwide patent. Later on, in 2002, Clinigene's clinical laboratory of the company received CAP accreditation as the first in India. The Company had developed the human insulin on a Pichia expression system in the year 2003. Biocon created a buzz in the stock market in March of the year 2004 with its hugely successful IPO. Day 1 on the bourses closed with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing. During the same year 2004, the Syngene had established new research centre, launched INSUGEN, the new generation bio-insulin, manufactured in Asia's largest human insulin plant. Biocon Limited and Vaccinex, Inc, collectively announced a broad strategic partnership to discover and co-develop at least four therapeutic antibody products. Biocon had signed a commercial agreement for supply of insulin API to Asia, Africa and the Middle East during the period of 2005. During the year 2006, the company inaugurated Biocon Park, India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in KIADB (Karnataka Industrial Areas Development Board) industrial estate and also established Biocon Biopharmaceuticals, India's largest multi-product Biologics facility at Biocon Park. In the same year 2006, Biocon's Syngene and Innate Pharmaceuticals AB, Umea, Sweden conclude a cooperation agreement to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease and also launched India's first anti-cancer drug BIOMAb EGFR. Abu Dhabi based pharmaceutical company Neopharma had signed an MOU with the company to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council) in the year 2007. The Company launched its Nephrology Division and a comprehensive portfolio of renal therapy products. Syngene had entered into a research partnership with Bristol-Myers Squibb and completes the groundbreaking ceremony of new research facility at Biocon Park. During the identical year of 2007, Biocon signed Memorandum of Understanding with Deakin University, Australia to establish Deakin Research Institute in Bangalore. The Company divested its enzymes division for USD 115 million to Novozymes. Biocon and Neopharma signed an MOU in July of the year 2007 to establish Neobiocon, a joint venture company in Dubai's biotechnology and research park, Dubiotech. As at January 2008, Biocon Limited and IATRICa, Inc made a strategic partnership to co-develop an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. In February of the year 2008, the company had acquired 78% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of 30 million Euros. As at June 2008, Biocon launched a Safety Device in the form of pre-filled syringes for two of its life saving products, GCSF (granulocyte-colony stimulating factor) and EPO (Erythropoietin) in collaboration with Safety Syringes Inc. During the year, Biocon wass ranked among the top 20 global biotechnology companies and 7th largest biotech employer in the world (Med Ad News). Also during the year, Biocon announced the results of an ascending dose study on its oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome. In 2009, Biocon launched BASALOG - long lasting basal insulin for Type 1 & Type 2 Diabetics. During the year, the company inked partnership with ISB to launch the Biocon Cell for Innovation Management. During the year, Biocon announced Strategic Collaboration with Mylan to enter the Global Generic Biologics Market. During the year, Biocon Limited and Amylin Pharmaceuticals entered into a Global Development and Commercialization Agreement for a Novel Peptide Hybrid. The Program will focus on the potential treatment of diabetes. Also during the year, Biocon and HCG group of hospitals joined hands in fight against cervical. In 2010, Biocon and Bayer joined hands to create awareness for self monitoring for diabetics. During the year, Biocon acquired the stake of its Cuban partner CIMAB S.A. in their seven year old JV, Biocon Biopharmaceuticals Pvt. Ltd. In 2010, Biocon and Optimer Pharmaceuticals announced manufacturing and supply agreement for a novel API, first-in-class anti-infective (C. difficile). During the year, Biocon and the Center of Molecular Immunology (CIM), based in Havana, Cuba strengthened their existing research partnership by joining forces for an integrated antibody program in immunology. During the year, Biocon announced a strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp). In 2011, Biocon sold its stake in its German subsidiary, AxiCorp GmbH, to the existing group of promoter shareholders. AxiCorp was the licensee for Biocon's biosimilar Insulin and Glargine in Germany and had the sole responsibility for commercializing these products. As a consequence of this divestment, these rights revert to Biocon. In 2011, Biocon announced project commencement for first high-end biopharmaceutical manufacturing and R&D facility in Bio-XCell, Malaysia. During the year, Biocon launched INSUPen, a convenient and affordable reusable insulin delivery device.In 2012, Biocon announced positive results from its Global Phase 3 study with Recombinant Human Insulin. During the year, GE Capital announced investment in Syngene, Biocon's Research Services Subsidiary. During the year, Biocon announced Positive Efficacy Data from Phase 3 clinical study with its Novel Monoclonal Antibody, Itolizumab for Psoriasis. Biocon also announced positive results from its Phase 1 Comparative PK-PD Study with Biosimilar Insulin Glargine. During the year, Biocon entered into an agreement with Bristol-Myers Squibb for its IN-105, an Oral Insulin drug. In 2013, Biocon received Marketing Authorization from the Drugs Controller General of India (DCGI) for its Novel Biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque Psoriasis. During the year, Biocon expanded its partnership with Mylan through Strategic Collaboration for Insulin Products. In 2013, Biocon launched ALZUMAb- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India. During the year, Biocon partnered with CytoSorbents to Market CytoSorb - A 'First-in-Class' Therapy for Sepsis Management. During the year, Biocon and Mylan received Indian Regulatory Approval for Trastuzumab for Treating Breast Cancer. In 2013, Biocon and Quark Pharmaceuticals announced collaboration to Develop Novel siRNA based Therapeutics. In 2014, Biocon introduced CANMAb - Trastuzumab for treating Breast Cancer in India. During the year, Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors agreed to acquire a minority 10% stake in Syngene International Limited, Biocon's Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited, a wholly owned subsidiary of Biocon Limited at a valuation of Rs 3800 crore. During the year, Biocon expanded its Strategic Partnership with CytoSorbents to treat SIRS and Cardiac Surgery Patients. In 2015, Biocon commissioned Asia's largest integrated insulin manufacturing facility at the Biotech Park in Johor, Malaysia. During the year, Biocon received approval in Mexico for Insulin Glargine through its partner PiSA Farmaceutica. During the year, Biocon's Research Services subsidiary Syngene International was listed on the bourses after an initial public offer (IPO). In 2015, Biocon inaugurated a World Class devices facility in Bangalore and introduced Basalog One in India. In 2016, Mylan and Biocon announced USFDA submission for proposed Biosimilar Trastuzumab. Mylan and Biocon also announced that regulatory submission for Insulin Glargine and proposed Biosimilar Pegfilgrastim were accepted for review by European Medicines Agency. During the year, Biocon launched its Insulin Glargine in Japan. During the year, Biocon and Quark announced initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India. During the year, Biocon received its first generic formulation approval in European Union. Also during the year, Biocon signed Co-Development & Commercialization Agreement with Lab PiSA for rh-Insulin in USA. In 2017, USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Pegfilgrastim for review. During the year, Biocon started commercial operations at its Malaysia facility with MYR 300 million contract from MoH, Malaysia to supply rh-insulin. During the year, USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Trastuzumab. On 18 January 2018, Biocon and Sandoz, a Novartis division and a global leader in biosimilars, announced a global partnership to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company's strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU while Biocon will lead commercialization in Rest of the World. On 29 January 2018, Mylan N.V., one of the world's leading pharmaceutical companies, and Biocon announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Semglee, insulin glargine, a long-acting insulin analog used in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.Mylan and Biocon on 28 March 2018 announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission (EC) following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan's joint portfolio to be approved in Europe. The EC approval of Semglee applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia. On 11 April 2018, Biocon announced that the company and Mylan have agreed to accelerate introduction of adalimumab biosimilar in Europe through Mylan's in-licensing arrangement with Fujifilm Kyowa Kirin Biologics (FKB). FKB's product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018. Through this arrangement, Mylan could commercialize FKB's Adalimumab in EU around market formation. Biocon retains its economic interest in this arrangement vis-a-vis Mylan in line with its existing global collaboration with Mylan for monoclonal antibodies. During FY'19, Company's first Generic Formulations plant, commissioned in 2017, received U.S. FDA approval. It commercialized Ogivrir* (Trastuzumab) in Europe. It signed agreement with GSK to advance drug discovery in multiple therapy areas. It signed agreement with Biotechnology Industry Research Assistance Council (BIRAC) to set up a Centre for Advanced Protein Studies. In FY'21, Company launched Tacrolimus capsules, Biocon's first immunosuppressant formulation in the U.S., for the benefit of organ transplant patients. It also entered new partnerships to expand commercial footprint to Singapore, Thailand and Brazil. It received U.S. FDA approval for Everolimus (gAfinitor), an immunosuppressant formulation to prevent rejection of organ transplants, and treat renal cell cancer and other tumors. It entered into a partnership with Libbs Farmaceutica, marking the entry of Biocon's Generic Formulations into Latin America, starting with Brazil. It partnered with DKSH to expand access to Biocon's Generic Formulations portfolio in key South East Asian markets of Singapore and Thailand. It continued to build Generic Formulations portfolio through new regulatory filings in the U.S., EU and Most of World markets. It received a GMP compliance certificate from MHRA, UK, for Generic Formulations manufacturing facility at Biocon Park in Bengaluru. It extended till 2030, a long-standing partnership with Bristol Myers Squibb (BMS) for drug discovery research. It entered a 5-year pact with 3DC, the drug discovery and development unit of Deerfield Management Co, to advance therapeutic discovery projects. It helped partner Albireo Pharma advance their compound to regulatory filings in U.S. and Europe, putting it on track to be the first approved drug for treating specific genetic liver diseases, primarily in children. It continued to support clients on drug research projects for leukemia, Parkinson's disease, inflammatory disorders, fibrotic disorders and orphan diseases. It expanded research facility in Hyderabad by adding capacity for an additional 90 scientists. It commissioned a new microbial manufacturing facility to reduce dependency on external service providers. It commercialized third biosimilar, Insulin Glargine, in the U.S. and obtained regulatory approvals for key biosimilars Bevacizumab and Insulin Aspart in the European Union. Its biosimilars benefited 3.1 million patients during the year. In association with partner, Viatris, the Company commercialized bGlargine (Semglee) in the U.S. and Fulphila in Australia and Canada. Its product pipeline got a boost with approvals from European Commission for biosimilar Bevacizumab and biosimilar Insulin Aspart, co-developed with Viatris. It commenced a multiple ascending doses (MAD) study for Type 1 DM in Germany in FY20, in partnership with the U.S.-based Juvenile Diabetes Research Foundation (JDRF) for Insulin Tregopil. Itolizumab, was granted Restricted Emergency Use approval in July 2020 to treat Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients in India. The drug was subsequently made available in the domestic market, having benefited over 27,000 patients as of May 2021. BCA101, the lead program for Boston-based Bicara Therapeutics, a first-inclass EGFR / TGFß-trap bifunctional antibody, entered a Phase 1/2 study at leading U.S. and Canadian cancer centers in July 2020. It ceded control over the Board and operations of Bicara Therapeutics, which housed our immuno-oncology program focused on developing novel bifunctional fusion antibodies. It received approval for Bevacizumab from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia. In July 2021, the European Medicines Agency's Committee for Orphan Medicinal Products granted an orphan medical product designation to Itolizumab for the treatment of both acute and chronic GVHD. This was a milestone for the Company as it intend to develop this drug for patients in Europe upon regulatory approval. In FY'22, the Company launched five products in the U.S. It strengthened its U.S. formulations portfolio with the launch of Labetalol Hydrochloride tablets and Esomeprazole Magnesium Delayed-Release capsules. It received approval from the U.S. FDA for ANDA for Mycophenolic Acid, which is indicated for the prophylaxis of organ rejection in adult patients receiving kidney transplants. It commenced first Most of the World (MoW) market supply of Tacrolimus capsules to Mexico, and received its first approval for Tacrolimus in Singapore, and for Rosuvastatin and Tacrolimus in the UAE. It also obtained Marketing Authorization for Everolimus tablets in the Netherlands and Spain. It received a Certificate of Good Distribution Practice (GDP) Compliance of a Wholesale Distributor from the Maltese authorities for the import and marketing of drug products in the European Union. More recently, it received a Compliant rating from Health Canada for API manufacturing facility in Bengaluru. It signed a strategic alliance with Serum Institute Life Sciences, marking an asset-light' and accelerated entry into vaccines. It advanced two unpartnered antibody programs, bUstekinumab and bDenosumab, to the clinical phase. It executed a Day 1' U.S. launch of Everolimus 10 mg tablet, a generic formulation for treating certain cancers and tumors. In FY22, it completed 34 product filings globally for APIs, including five in the U.S., and 28 filings for formulations, out of which 11 were in the U.S. It signed a partnership deal with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group, to commercialize select specialty generic medicines in the Middle East region, expanding the global presence of the Generic Formulations business. It received several product approvals in Most of the World (MoW) markets in FY'22. During the year 2022, Company went through various regulatory audits at some of its key sites, with successful outcomes. At the Oral Solid Dosage (OSD) facility in Bengaluru, the U.S. FDA conducted a Remote Interactive Evaluation (RIE) in September 2021, which was a pre-approval review for ANDAs filed earlier. The facility also secured a certificate of Good Manufacturing Practice (GMP) from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. based on a remote inspection. The certificate included manufacturing and packaging of tablets and capsules in the nonpotent and potent blocks of the facility. Furthermore, the Maltese authorities conducted a Wholesale Dealer License (WDL) and Manufacturing/ Importation Authorization (MIA) inspection, and thereafter, granted Company a Certificate of Good Distribution Practice (GDP) of a Wholesale Distributor, that enabled to import and market products in the European Union. Towards the end of the fiscal, Health Canada also conducted a remote inspection of API manufacturing unit in Bengaluru and rated it as Compliant' It commenced clinical trials for two of its unpartnered assets, bUstekinumab for inflammatory conditions and bDenosumab to treat osteoporosis and cancer. It received favorable rulings from the U.S. Federal Circuit related to patents covering the originator's device and formulation for administering bGlargine. During 2022-23, the Company commissioned its greenfield, fermentation-based immunosuppressant API manufacturing facility in Visakhapatnam, Andhra Pradesh and peptides API manufacturing facility in Bengaluru. It began work on expanding synthetic and non-immunosuppressant fermentation capacities in addition to a new injectable facility. Two important APIs, Sitagliptin and Vildagliptin were launched in the European Union. bBevacizumab was launched in 12 countries; a new insulin analog from ' bAspart' portfolio was launched in Canada and Malaysia. In FY23, the Company launched five generic formulation products. In the UK, it launched Posaconazole and in the European Union, Rosuvastatin.

Biocon Ltd Chairman Speech

<dhhead>CHAIRPERSON’S MESSAGE</dhhead>

Dear Shareholders,

Biocon’s pioneering journey of over four decades in biotechnology has an underlying theme of metamorphosis. From enzymes to biopharmaceuticals, from research services to integrated drug development and from active pharmaceutical ingredients (APIs) to finished formulations, the evolution has sustained and is now accelerating to an in_ection point of transformational advancement. Biocon 5.0 denotes our fifth decade which is poised for breakthrough growth derived from two decades of investing in advanced scientific research and global-scale bio-manufacturing. Each of our businesses is uniquely differentiated and has attained a leadership profile that prepares us for an exciting future.

Our endeavor to build global health equity through affordable access to essential and lifesaving therapeutics has brought in a patient-centric focus in all that we measure. From a fledgling biotech company in 1978, we are today among the largest in Asia with ~15,000* employees and consolidated revenues of USD 1.1 billion.

Biocon is exclusively positioned with three distinctive and diverse businesses that balance the headwinds of one business with tailwinds in others. Pricing pressure on generics, for example, is mitigated with preferential pricing both from contract manufacturing and market exclusivity.

Our relentless strategic intent to stand out and stand apart through research and innovation has steered us into new growth paths that include a mega acquisition and multiple new investments that will generate both inorganic and organic growth momentum in the decade ahead.

 

A Transformative Acquisition

Our landmark decision to acquire the global biosimilars business of our long-term partner Viatris for USD 3.335 billion in cash and stock, is a transformational inflection point that steers us into accelerated, inorganic business expansion.

This game-changing transaction will create a world leader in a space that is extremely attractive for investors. Biologic brands worth over USD 70_billion^{^} will lose exclusivity over the next five years, presenting multiple new opportunities for the biosimilars sector.

This acquisition by Biocon Biologics will enable the Company to seamlessly move from the current collaboration model to full ownership of Viatris’ rights in partnered and in-licensed biosimilars assets, allowing recognition of 100% of revenues and profits. Furthermore, it will enable full vertical integration across the biosimilars value chain from lab to market and take us closer to patients, payors and healthcare providers in developed and emerging markets.

The deal is a strategic fit for Biocon Biologics and valued fairly. By giving us visibility on the growth trajectory of our Biosimilars portfolio over the next decade, this deal is going to be highly value accretive to both Biocon and Biocon Biologics shareholders. Viatris’ biosimilar business is expected to generate over USD 1 billion in revenue in calendar year 2023.

 

Foraying into Vaccines and Infectious Diseases

Biocon’s quest to impact global healthcare has steered us towards a strategic expansion into adjacencies such as vaccines.

Biocon Biologics has entered into an alliance with Serum Institute Life Sciences (SILS) to join the effort of addressing the inequitable access to vaccines.

We expect a very attractive return on investment from this strategic transaction.

 

Strong Biosimilars Business Performance

Prudent investments over the years in advanced R&D and global manufacturing scale have led Biocon Biologics to build a unique biosimilars portfolio comprising basal and rapid acting insulins, as well as antibodies for cancer and inflammatory diseases.

The performance of our portfolio of commercialized biosimilars in both developed and emerging markets yielded a 24% growth in our Biosimilars business revenues this year.

The highlight of the year was the historic approval of the world’s first interchangeable biosimilar, our bGlargine, in the U.S. The launch of our interchangeable bGlargine in the U.S. by our partner Viatris is in line with our aspiration to provide our biosimilar insulins to ‘one in five’ insulin-dependent people with diabetes, globally. Post this launch, the market share of our bGlargine in the U.S. has moved up from a low single-digit share last year to a double-digit market share in March 2022.

As we commemorate 100 years of the discovery of Insulin, we are positioning ourselves to build global leadership through unlocking equitable access to insulin and meeting varied patient needs through our comprehensive portfolio.

We have also focused on best-in-class therapies for cancer patients worldwide through our biosimilars such as bTrastuzumab, bPegfilgrastim and bBevacizumab. Our bTrastuzumab, which was the first to receive U.S. FDA regulatory approval in the world, continued to witness good demand in both developed and emerging markets. We commercialized our bBevacizumab in selected European markets during the year to bolster our oncology franchise.

 

Saving Lives During the Pandemic

At the height of the pandemic, we were able to realize the potential of bio-therapeutics in the fight against COVID-19 induced cytokine storm. Our repurposed novel biologic ALZUMAb-L (Itolizumab) has benefited over 40,000 COVID-19 patients so far.

 

Good Progress in Generic Formulations

Our investments in our Generics business have translated into new DMF and ANDA filings as well as approvals globally, which led to our first ‘Day 1’ launch in the U.S. for generic Everolimus 10 mg tablets. We also have made steady progress in establishing a strong global footprint for our Generics business during the year.

We continue to build a strong pipeline of niche formulations such as injectables, as well as peptides and potent APIs. A key element of our investment is a large greenfield fermentation-based manufacturing plant, largely for immunosuppressants, in the Visakhapatnam SEZ that will be operational in_FY23.

We believe our API business stands to benefit from the ‘China Plus One’ strategy at a time when pharma MNCs are trying to diversify their supply chains to include sourcing from India to mitigate their dependence on China.

 

A Strong Year for Research Services

Our Research Services business, Syngene, which delivered a revenue growth of 19%, is well poised to capture opportunities arising from the growing global demand for CRO and CDMO services through its offering of integrated research, development and manufacturing services. Syngene is leveraging its existing relationships to provide forward integration on the discovery and development continuum by catering to its clients’ requirements for early-stage, late-stage and commercial launch supplies.

Syngene extended its long-standing research collaboration with Amgen this year. These contract extensions confirm the stability of the relationship with both key clients and provide a very clear perspective on the future of Syngene’s Dedicated Centers.

To capture a higher share of biologics manufacturing opportunities, Syngene is also investing in expanding both microbial and mammalian manufacturing capacities.

 

Embedding ESG at the Core of our Business

At Biocon Group, our key priorities of ‘patient centricity’ and ‘access to all’ drive our strategy and the way we operate. Our philosophy of ensuring health equity resonates with our Environmental, Social and Governance (ESG) aspirations, which have assumed a greater prominence in our business objectives. By serving patients, protecting the environment and promoting business integrity, we are reinforcing our commitment to building a sustainable future. Our recent entry in the prestigious Dow Jones Sustainability Index (DJSI) Emerging Markets Index, where we achieved a 93rd percentile position with a Total Sustainability Score of 45, is a testimony to our responsible and sustainable business practices.

We were also certified by Great Place to Work? India as a Workplace with Inclusive Practices, acknowledging our investment in our people and our inclusive culture. We are refining our policies and increasing career opportunities for women to improve gender diversity at the Group, where women currently constitute 21% of our workforce.

As a Group, we believe that health equity is synergistic with restoring the ecological balance. This belief is driving us in continuously identifying opportunities to increase the share of renewables in our energy mix, improving energy efficiency, innovating to drive productivity across our value chain, implementing the principles of a circular economy and adopting digital solutions that minimize inefficiencies. Onsite solar installations and sourcing of power from renewable sources have increased the share of ‘green power’ to 54%* of our total energy consumption for FY22 across Biocon Group. We reduced our total carbon footprint by 186,500* tCO2 during the year. Through our water conservation initiatives across the global manufacturing operations of Biocon and Biocon Biologics we achieved 680,000 liters of incremental water savings per day.

 

Ensuring Sustainable Social Change

Biocon Group’s corporate philanthropy aims to build resilient solutions that enable and empower disadvantaged communities to live better. In FY22, we implemented several initiatives targeted at increasing access to healthcare for underserved communities, improving the nutritional standing of school-age children, promoting science & technology and sponsoring urban afforestation initiatives.

Biocon Foundation supported the Government of Karnataka in the implementation of its ‘test, treat, track and vaccinate’ strategy at 20 Primary Health Centers across seven districts. We helped strengthen hospital infrastructure by installing a 2,000-liter Liquid Medical Oxygen (LMO) storage tank at the Anekal General Hospital in Karnataka. As a part of our healthcare initiatives, we contributed to the capacity building of frontline health workers and screened over 4,000 people using the mHealth oral cancer screening tool.

Continuing our partnership with the Akshaya Patra Foundation, we contributed to raising the nutrition profile of students in over 70 government schools through the PM Poshan, Mid Day Meal Scheme.

As a part of our environmental outreach program, the Foundation is developing a second Miyawaki micro-forest in Mangaluru.

The Foundation is funding construction of the proposed Biocon-Hebbagodi Metro Station. Metro connectivity will reduce traffic congestion in Bengaluru and help lower the environmental impact from vehicular pollution.

As a part of our commitment to strengthen the medical science ecosystem in the country, the Foundation signed a memorandum of understanding with the Indian Institute of Science to contribute funds for the construction of a not-for-profit, 490-bed multi-specialty hospital and medical school in Bengaluru. This hospital will offer an integrated dual degree MD-PhD program in clinical research. In recognition of the funding support, the General Medicine Block will bear the name of Biocon-Syngene.

Our flagship initiative, Biocon Academy, which aims to build the talent ecosystem for biotech-related skills, saw over 180 young life sciences students graduate this year.

 

A Technology-Enabled Organization for the Future

The digital transformation journey we embarked on in 2020 was further accelerated as we maneuvered through the COVID-19 pandemic.

The significant investments we are making in organization-wide digital transformation initiatives are going to transform the Biocon Group into a data and digital-led global biopharmaceuticals organization, spearheading Biocon 5.0. Digitalization, we firmly believe, can build higher standards of governance and deliver greater levels of trust to all our stakeholders.

 

Good Financial Performance

Biocon’s consolidated revenues grew 14% to `83,967 million for the full year, led by Biosimilars and Research Services revenues increasing 24% and 19%, respectively. For the year, the Biosimilars business posted revenue of `34,643 million, Generics reported `23,409 million and Research Services turned in `26,042 million. Our EBITDA increased 14% to `21,829 million for the year, representing a healthy margin of 26%. Adjusted for licensing, forex, gain on dilution in Bicara, mark-to-market loss on investments and R&D expense, Core EBITDA for the year grew 18% to `26,690 million, representing a margin of 32%. Our Net Profit for the year was `6,484 million. Net Profit was impacted on account of certain exceptional items, mark-to-market losses on investments and gain on dilution in Bicara. Adjusted for these items, Net Profit grew by 23% for the full year.

 

Management & Board Updates

We have appointed Naina Lal Kidwai, an accomplished banker and business leader, as an Additional Director on the Board of Biocon Limited, with effect from April 28, 2022 for a period of three years. We also appointed Dr. Eric Mazumdar as a Non-Executive Director to the Board, with effect from November 1, 2021.

I would like to express my deep appreciation and gratitude to John Shaw for his stewardship and judicious guidance as a key member of the Board and the management team since 1999. He has contributed significantly to the transformation of Biocon from a small enzymes company to a globally recognized biopharmaceutical enterprise. He has played a critical role in building Biocon, ensuring the highest levels of corporate governance, as well as contributing to the financial and strategic development of the Group in his role as Vice Chairman for over two decades.

 

Dividend

The Company and its Board of Directors acknowledge with deep appreciation, the support received from the shareholders during the pandemic over the last two years. As we come out of the pandemic with a strong financial performance, the Board of Directors has recommended a dividend of 10% of the face value of each share for FY22.

 

Ushering in Transformative Change

We have demonstrated a clear commitment to the highest standards of corporate governance as we pursue our purpose and deliver on our promise to protect patients from both communicable and non-communicable diseases. We have invested with a clear focus on efficiency and end-to-end digital transformation, coupled with ambitious targets in exciting new growth avenues, namely, a comprehensive portfolio of generic formulations, complex APIs, biosimilars, vaccines and research services.

The year ahead holds tremendous promise for all our business segments. We expect strong growth from our Biosimilars business on the back of the strategic transactions with SILS and Viatris, which are progressing towards various regulatory approvals. We expect these deals to close by the second half of calendar year 2022.

I would like to appreciate the contribution of our employees, executives and Boards who have worked tirelessly and passionately throughout the pandemic to realize our core purpose of serving patients and partners.

I would also like to thank all our shareholders for trusting our uniquely differentiated Company, over the years. With your unstinted support, we will continue to make progress towards ushering in transformative change that will make our world a healthier place.

Thank You.

Yours sincerely,

Sd/-

 

Kiran Mazumdar-Shaw

Executive Chairperson

May 27, 2022

Biocon Ltd Company History

Biocon Limited is India's largest and fully-integrated, innovation-led biopharmaceutical company. The Company is engaged in the manufacture of biotechnology products and research services. Biocon Limited was incorporated in the year 1978 as a joint venture between Biocon Biochemicals Limited of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw. Biocon manufactured and exported enzymes to USA and Europe during the year 1979, as first of its kind. In 1989, Unilever plc acquired the Biocon Biochemicals Limited in Ireland and merges it with its subsidiary, Quest International. Also in the same year, the company had received US funding for proprietary technologies. After a year, in 1990, Biocon had scaled up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level. Biocon's R&D and manufacturing facilities received ISO 9001 certification from RWTUV, Germany during the period of 1993. In the year 1994, the company had established the Syngene International Pvt. Ltd. as a Custom research Company (CRC) to address the growing need for outsourced R&D in the pharmaceutical sector. The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion during the year 1996 and also in the same year, the company had leveraged its technology platform to enter biopharmaceuticals and statins. Biocon had spearheads initiatives in human healthcare in the year 1997 through a dedicated manufacturing facility. During the year 1998, Unilever inked a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agreed to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity in same period. In the year 2000, Biocon had commissioned its first fully automated submerged fermentation plant to produce specialty pharmaceuticals and also in the same year, the company had established Clinigene, India's first Clinical Research Organisation (CRO) to pursue clinical research and development. During the year 2001, Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule. During the same year of 2001, the company's proprietary bioreactor, PlaFractor was granted a US 2001 and worldwide patent. Later on, in 2002, Clinigene's clinical laboratory of the company received CAP accreditation as the first in India. The Company had developed the human insulin on a Pichia expression system in the year 2003. Biocon created a buzz in the stock market in March of the year 2004 with its hugely successful IPO. Day 1 on the bourses closed with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing. During the same year 2004, the Syngene had established new research centre, launched INSUGEN, the new generation bio-insulin, manufactured in Asia's largest human insulin plant. Biocon Limited and Vaccinex, Inc, collectively announced a broad strategic partnership to discover and co-develop at least four therapeutic antibody products. Biocon had signed a commercial agreement for supply of insulin API to Asia, Africa and the Middle East during the period of 2005. During the year 2006, the company inaugurated Biocon Park, India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in KIADB (Karnataka Industrial Areas Development Board) industrial estate and also established Biocon Biopharmaceuticals, India's largest multi-product Biologics facility at Biocon Park. In the same year 2006, Biocon's Syngene and Innate Pharmaceuticals AB, Umea, Sweden conclude a cooperation agreement to jointly develop, manufacture and market virulence blockers to counteract bacterial diarrhoeal disease and also launched India's first anti-cancer drug BIOMAb EGFR. Abu Dhabi based pharmaceutical company Neopharma had signed an MOU with the company to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC countries (Gulf Cooperation Council) in the year 2007. The Company launched its Nephrology Division and a comprehensive portfolio of renal therapy products. Syngene had entered into a research partnership with Bristol-Myers Squibb and completes the groundbreaking ceremony of new research facility at Biocon Park. During the identical year of 2007, Biocon signed Memorandum of Understanding with Deakin University, Australia to establish Deakin Research Institute in Bangalore. The Company divested its enzymes division for USD 115 million to Novozymes. Biocon and Neopharma signed an MOU in July of the year 2007 to establish Neobiocon, a joint venture company in Dubai's biotechnology and research park, Dubiotech. As at January 2008, Biocon Limited and IATRICa, Inc made a strategic partnership to co-develop an exclusive new class of immunoconjugates for targeted immunotherapy of cancers and infectious diseases. In February of the year 2008, the company had acquired 78% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of 30 million Euros. As at June 2008, Biocon launched a Safety Device in the form of pre-filled syringes for two of its life saving products, GCSF (granulocyte-colony stimulating factor) and EPO (Erythropoietin) in collaboration with Safety Syringes Inc. During the year, Biocon wass ranked among the top 20 global biotechnology companies and 7th largest biotech employer in the world (Med Ad News). Also during the year, Biocon announced the results of an ascending dose study on its oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome. In 2009, Biocon launched BASALOG - long lasting basal insulin for Type 1 & Type 2 Diabetics. During the year, the company inked partnership with ISB to launch the Biocon Cell for Innovation Management. During the year, Biocon announced Strategic Collaboration with Mylan to enter the Global Generic Biologics Market. During the year, Biocon Limited and Amylin Pharmaceuticals entered into a Global Development and Commercialization Agreement for a Novel Peptide Hybrid. The Program will focus on the potential treatment of diabetes. Also during the year, Biocon and HCG group of hospitals joined hands in fight against cervical. In 2010, Biocon and Bayer joined hands to create awareness for self monitoring for diabetics. During the year, Biocon acquired the stake of its Cuban partner CIMAB S.A. in their seven year old JV, Biocon Biopharmaceuticals Pvt. Ltd. In 2010, Biocon and Optimer Pharmaceuticals announced manufacturing and supply agreement for a novel API, first-in-class anti-infective (C. difficile). During the year, Biocon and the Center of Molecular Immunology (CIM), based in Havana, Cuba strengthened their existing research partnership by joining forces for an integrated antibody program in immunology. During the year, Biocon announced a strategic foreign direct investment in Malaysia with the Malaysian Biotechnology Corporation SdnBhd (BiotechCorp). In 2011, Biocon sold its stake in its German subsidiary, AxiCorp GmbH, to the existing group of promoter shareholders. AxiCorp was the licensee for Biocon's biosimilar Insulin and Glargine in Germany and had the sole responsibility for commercializing these products. As a consequence of this divestment, these rights revert to Biocon. In 2011, Biocon announced project commencement for first high-end biopharmaceutical manufacturing and R&D facility in Bio-XCell, Malaysia. During the year, Biocon launched INSUPen, a convenient and affordable reusable insulin delivery device.In 2012, Biocon announced positive results from its Global Phase 3 study with Recombinant Human Insulin. During the year, GE Capital announced investment in Syngene, Biocon's Research Services Subsidiary. During the year, Biocon announced Positive Efficacy Data from Phase 3 clinical study with its Novel Monoclonal Antibody, Itolizumab for Psoriasis. Biocon also announced positive results from its Phase 1 Comparative PK-PD Study with Biosimilar Insulin Glargine. During the year, Biocon entered into an agreement with Bristol-Myers Squibb for its IN-105, an Oral Insulin drug. In 2013, Biocon received Marketing Authorization from the Drugs Controller General of India (DCGI) for its Novel Biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque Psoriasis. During the year, Biocon expanded its partnership with Mylan through Strategic Collaboration for Insulin Products. In 2013, Biocon launched ALZUMAb- a 'First in Class' Novel Biologic Treatment for Psoriasis Patients in India. During the year, Biocon partnered with CytoSorbents to Market CytoSorb - A 'First-in-Class' Therapy for Sepsis Management. During the year, Biocon and Mylan received Indian Regulatory Approval for Trastuzumab for Treating Breast Cancer. In 2013, Biocon and Quark Pharmaceuticals announced collaboration to Develop Novel siRNA based Therapeutics. In 2014, Biocon introduced CANMAb - Trastuzumab for treating Breast Cancer in India. During the year, Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors agreed to acquire a minority 10% stake in Syngene International Limited, Biocon's Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited, a wholly owned subsidiary of Biocon Limited at a valuation of Rs 3800 crore. During the year, Biocon expanded its Strategic Partnership with CytoSorbents to treat SIRS and Cardiac Surgery Patients. In 2015, Biocon commissioned Asia's largest integrated insulin manufacturing facility at the Biotech Park in Johor, Malaysia. During the year, Biocon received approval in Mexico for Insulin Glargine through its partner PiSA Farmaceutica. During the year, Biocon's Research Services subsidiary Syngene International was listed on the bourses after an initial public offer (IPO). In 2015, Biocon inaugurated a World Class devices facility in Bangalore and introduced Basalog One in India. In 2016, Mylan and Biocon announced USFDA submission for proposed Biosimilar Trastuzumab. Mylan and Biocon also announced that regulatory submission for Insulin Glargine and proposed Biosimilar Pegfilgrastim were accepted for review by European Medicines Agency. During the year, Biocon launched its Insulin Glargine in Japan. During the year, Biocon and Quark announced initiation of Pivotal Phase II/III Study of QPI-1007 in Rare Eye Disease in India. During the year, Biocon received its first generic formulation approval in European Union. Also during the year, Biocon signed Co-Development & Commercialization Agreement with Lab PiSA for rh-Insulin in USA. In 2017, USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Pegfilgrastim for review. During the year, Biocon started commercial operations at its Malaysia facility with MYR 300 million contract from MoH, Malaysia to supply rh-insulin. During the year, USFDA accepted Biologics License Application (BLA) for Mylan and Biocon's proposed Biosimilar Trastuzumab. On 18 January 2018, Biocon and Sandoz, a Novartis division and a global leader in biosimilars, announced a global partnership to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company's strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU while Biocon will lead commercialization in Rest of the World. On 29 January 2018, Mylan N.V., one of the world's leading pharmaceutical companies, and Biocon announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Semglee, insulin glargine, a long-acting insulin analog used in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs.Mylan and Biocon on 28 March 2018 announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission (EC) following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan's joint portfolio to be approved in Europe. The EC approval of Semglee applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia. On 11 April 2018, Biocon announced that the company and Mylan have agreed to accelerate introduction of adalimumab biosimilar in Europe through Mylan's in-licensing arrangement with Fujifilm Kyowa Kirin Biologics (FKB). FKB's product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018. Through this arrangement, Mylan could commercialize FKB's Adalimumab in EU around market formation. Biocon retains its economic interest in this arrangement vis-a-vis Mylan in line with its existing global collaboration with Mylan for monoclonal antibodies. During FY'19, Company's first Generic Formulations plant, commissioned in 2017, received U.S. FDA approval. It commercialized Ogivrir* (Trastuzumab) in Europe. It signed agreement with GSK to advance drug discovery in multiple therapy areas. It signed agreement with Biotechnology Industry Research Assistance Council (BIRAC) to set up a Centre for Advanced Protein Studies. In FY'21, Company launched Tacrolimus capsules, Biocon's first immunosuppressant formulation in the U.S., for the benefit of organ transplant patients. It also entered new partnerships to expand commercial footprint to Singapore, Thailand and Brazil. It received U.S. FDA approval for Everolimus (gAfinitor), an immunosuppressant formulation to prevent rejection of organ transplants, and treat renal cell cancer and other tumors. It entered into a partnership with Libbs Farmaceutica, marking the entry of Biocon's Generic Formulations into Latin America, starting with Brazil. It partnered with DKSH to expand access to Biocon's Generic Formulations portfolio in key South East Asian markets of Singapore and Thailand. It continued to build Generic Formulations portfolio through new regulatory filings in the U.S., EU and Most of World markets. It received a GMP compliance certificate from MHRA, UK, for Generic Formulations manufacturing facility at Biocon Park in Bengaluru. It extended till 2030, a long-standing partnership with Bristol Myers Squibb (BMS) for drug discovery research. It entered a 5-year pact with 3DC, the drug discovery and development unit of Deerfield Management Co, to advance therapeutic discovery projects. It helped partner Albireo Pharma advance their compound to regulatory filings in U.S. and Europe, putting it on track to be the first approved drug for treating specific genetic liver diseases, primarily in children. It continued to support clients on drug research projects for leukemia, Parkinson's disease, inflammatory disorders, fibrotic disorders and orphan diseases. It expanded research facility in Hyderabad by adding capacity for an additional 90 scientists. It commissioned a new microbial manufacturing facility to reduce dependency on external service providers. It commercialized third biosimilar, Insulin Glargine, in the U.S. and obtained regulatory approvals for key biosimilars Bevacizumab and Insulin Aspart in the European Union. Its biosimilars benefited 3.1 million patients during the year. In association with partner, Viatris, the Company commercialized bGlargine (Semglee) in the U.S. and Fulphila in Australia and Canada. Its product pipeline got a boost with approvals from European Commission for biosimilar Bevacizumab and biosimilar Insulin Aspart, co-developed with Viatris. It commenced a multiple ascending doses (MAD) study for Type 1 DM in Germany in FY20, in partnership with the U.S.-based Juvenile Diabetes Research Foundation (JDRF) for Insulin Tregopil. Itolizumab, was granted Restricted Emergency Use approval in July 2020 to treat Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients in India. The drug was subsequently made available in the domestic market, having benefited over 27,000 patients as of May 2021. BCA101, the lead program for Boston-based Bicara Therapeutics, a first-inclass EGFR / TGFß-trap bifunctional antibody, entered a Phase 1/2 study at leading U.S. and Canadian cancer centers in July 2020. It ceded control over the Board and operations of Bicara Therapeutics, which housed our immuno-oncology program focused on developing novel bifunctional fusion antibodies. It received approval for Bevacizumab from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia. In July 2021, the European Medicines Agency's Committee for Orphan Medicinal Products granted an orphan medical product designation to Itolizumab for the treatment of both acute and chronic GVHD. This was a milestone for the Company as it intend to develop this drug for patients in Europe upon regulatory approval. In FY'22, the Company launched five products in the U.S. It strengthened its U.S. formulations portfolio with the launch of Labetalol Hydrochloride tablets and Esomeprazole Magnesium Delayed-Release capsules. It received approval from the U.S. FDA for ANDA for Mycophenolic Acid, which is indicated for the prophylaxis of organ rejection in adult patients receiving kidney transplants. It commenced first Most of the World (MoW) market supply of Tacrolimus capsules to Mexico, and received its first approval for Tacrolimus in Singapore, and for Rosuvastatin and Tacrolimus in the UAE. It also obtained Marketing Authorization for Everolimus tablets in the Netherlands and Spain. It received a Certificate of Good Distribution Practice (GDP) Compliance of a Wholesale Distributor from the Maltese authorities for the import and marketing of drug products in the European Union. More recently, it received a Compliant rating from Health Canada for API manufacturing facility in Bengaluru. It signed a strategic alliance with Serum Institute Life Sciences, marking an asset-light' and accelerated entry into vaccines. It advanced two unpartnered antibody programs, bUstekinumab and bDenosumab, to the clinical phase. It executed a Day 1' U.S. launch of Everolimus 10 mg tablet, a generic formulation for treating certain cancers and tumors. In FY22, it completed 34 product filings globally for APIs, including five in the U.S., and 28 filings for formulations, out of which 11 were in the U.S. It signed a partnership deal with Tabuk Pharmaceutical Manufacturing Company, a fully-owned subsidiary of Astra Industrial Group, to commercialize select specialty generic medicines in the Middle East region, expanding the global presence of the Generic Formulations business. It received several product approvals in Most of the World (MoW) markets in FY'22. During the year 2022, Company went through various regulatory audits at some of its key sites, with successful outcomes. At the Oral Solid Dosage (OSD) facility in Bengaluru, the U.S. FDA conducted a Remote Interactive Evaluation (RIE) in September 2021, which was a pre-approval review for ANDAs filed earlier. The facility also secured a certificate of Good Manufacturing Practice (GMP) from the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. based on a remote inspection. The certificate included manufacturing and packaging of tablets and capsules in the nonpotent and potent blocks of the facility. Furthermore, the Maltese authorities conducted a Wholesale Dealer License (WDL) and Manufacturing/ Importation Authorization (MIA) inspection, and thereafter, granted Company a Certificate of Good Distribution Practice (GDP) of a Wholesale Distributor, that enabled to import and market products in the European Union. Towards the end of the fiscal, Health Canada also conducted a remote inspection of API manufacturing unit in Bengaluru and rated it as Compliant' It commenced clinical trials for two of its unpartnered assets, bUstekinumab for inflammatory conditions and bDenosumab to treat osteoporosis and cancer. It received favorable rulings from the U.S. Federal Circuit related to patents covering the originator's device and formulation for administering bGlargine. During 2022-23, the Company commissioned its greenfield, fermentation-based immunosuppressant API manufacturing facility in Visakhapatnam, Andhra Pradesh and peptides API manufacturing facility in Bengaluru. It began work on expanding synthetic and non-immunosuppressant fermentation capacities in addition to a new injectable facility. Two important APIs, Sitagliptin and Vildagliptin were launched in the European Union. bBevacizumab was launched in 12 countries; a new insulin analog from ' bAspart' portfolio was launched in Canada and Malaysia. In FY23, the Company launched five generic formulation products. In the UK, it launched Posaconazole and in the European Union, Rosuvastatin.

Biocon Ltd Directors Reports

Dear Shareholders,

We are pleased to present the Forty-Fifth (45^th) Annual Report on the business and operations along with the audited standalone and consolidated financial statements and the Auditor's Report of the Company, for the financial year ended March 31, 2023.

Financial Highlights

Particulars	Standalone		Consolidated
	FY23	FY22	FY23	FY22
Total Income	22,643	19,254	115,501	83,967
Expenses	21,559	17,857	101,946	70,956
Share of loss of joint venture and associate, net	-	-	(1,670)	(2,069)
Profit before tax and exceptional items	1,084	1,397	11,885	10,942
Exceptional items, net	28,628	-	(2,914)	(1,111)
Profit before tax	29,712	1,397	8,971	9,831
Income tax	1,288	536	2,541	2,115
Non-controlling interest	-	-	1,803	1,232
Profit for the year	28,484	861	4,627	6,484
Other comprehensive income, net	9	80	1,138	967
Total comprehensive income	28,493	941	5,765	7,451
Earnings per Share (EPS) after exceptional items	23.87	0.72	3.88	5.44

Standalone and Consolidated Financial Statements

The standalone and consolidated financial statements of the Company have been prepared in accordance with the Indian Accounting Standards ('Ind AS') as notified under the Companies (Indian Accounting Standards) Rules, 2015, as amended. The financial highlights and the results of the operations, including major developments have been further discussed in detail in the Management Discussion and Analysis Report.

Further, a statement containing the salient features of the financial statements of our subsidiaries pursuant to sub-section 3 of Section 129 of the Companies Act, 2013 in the prescribed form AOC-1 is appended as Annexure 1 to the Board's Report. The statement also provides the details of performance and the financial positions of each of the subsidiaries, associates and joint venture.

State of Affairs

The highlights of your Company's Consolidated Financial performance are as under:

• During the year, our consolidated revenues registered a growth of 38% to Rs.115,501 mn from Rs.' 83,967 mn in

FY22. From a segment perspective, Biologics recorded an annual growth of 61% and Research services grew by 23% while Generics registered a growth of 13%.

• Core operating margins (EBITDA margins net of licensing, forex and R&D) increased to 34% compared to 32% in FY22 mainly due to higher contribution from Biologics and Research.

• Profit for the year including non-controlling interest stood at Rs.' 6,430 mn compared to ' Rs. 7,716 mn for FY22.

• The effective tax rate (ETR) for the year before the exceptional item was 15% (22% in FY22). ETR is down by 7% due to lower tax led by tax holidays in Biosimilar business.

Exceptional items (Consolidated):

• During the year, Group obtained services of professional experts (like advisory, legal counsel, valuation experts etc.) for the acquisition of Viatris biosimilar business and proposed merger of Covidshield Technologies Private Limited. The Group recorded ' 2,374 mn as an expense under Exceptional items in the financial statements.

Consequential tax impact of ' 231 mn is included within tax expense during the year ended March 31, 2023.

• Pursuant to acquisition of Viatris biosimilar business, the Group re-assessed the value of certain licensed products for development and commercialisation and recorded an impairment of certain intangible assets amounting to ' 470 mn. The impairment has been recognised as an exceptional item in the financial statements. Consequential tax impact of '62 mn is included within tax expense during the year ended March 31, 2023.

Corporate Events:

• Biocon Limited has sold 15.39% shares held in Syngene International Limited (Syngene), subsidiary company, in the market in tranches to meet its funding commitment to Biocon Biologics Limited (BBL) pursuant to the acquisition of biosimilars assets of Viatris Inc. by BBL.

• The Company has issued Commercial Papers (CP) of Rs.' 22,500 million on November 23, 2022, to SBI Mutual Fund and ICICI Prudential Mutual Fund which was redeemed at its maturity date i.e., February 22, 2023.

• BBL has allotted equity shares to Biocon Limited and Biocon Pharma Limited, subsidiary of Biocon Limited, for an amount of ~USD 650 million on rights issue basis during November 2022.

• Biocon Biologics Limited completed the acquisition of the global biosimilars business of Viatris Inc. through (i) Purchase of 100% stake in Biosimilar NewCo Limited ('BNCL'); and (ii) Subscription to 100% stake in Biosimilar Collaborations Ireland Limited ('BCIL')

• The Company has raised funds by issuance and allotment of Non-Convertible Debentures aggregating to ' 10,700 million to Kotak Special Situations on February 21, 2023.

• The Company has raised funds by issuance and allotment of Non-Convertible Debentures aggregating to ' 5,000 million to ESOF III Investment Fund and Edelweiss Alternative Asset Advisors Limited on May 19, 2023. The Company further invested the said funds for acquisition of Optionally Convertible Debentures (OCDs) issued by BBL.

The highlights of the Company's Standalone Financial

performance are as under:

• Revenue from operations for FY23 stood at ' Rs. 19,929 mn compared to Rs.' 17,382 mn for FY22. Other income for FY23 amounted to Rs. ' 2,714 mn as against Rs. 1,872 mn in FY22.

• Core operating margins (EBITDA margins net of licensing, impact of forex, R&D and dividend from subsidiaries) was 14% compared to 17% in the previous financial year, primarily due to price erosion in Generics business.

• Profit before tax and exceptional items stood at ' Rs. 1,084 mn compared to ' Rs. 1,397 mn in FY22. Decrease in standalone profit is mainly due to price erosion in our base business products specifically statins.

• Effective tax rate (ETR) for the year was 27% (excluding Minimum Alternate Tax (MAT) charge on adoption of new tax regime and dividend income with nil tax charge) against 38% in FY22. ETR is down in FY23 mainly due to adoption of new tax regime under section 115BAA of the Income Tax Act, 1961.

• Effective April 1, 2022, the Company decided to elect its option to adopt the new tax regime notified u/s 115BAA of the Income Tax Act, 1961 and consequently, has written off MAT balance of ' 1,071 mn in its financial statements for the year ended March 31, 2023, which can no longer be carried forward.

• Profit for the year stood at Rs. ' 28,484 mn compared to Rs. ' 861 mn for FY22. This includes MAT write off of ' 1,071 mn and exceptional gain of ' 28,628 mn on Syngene stake sale as mentioned below.

Exceptional items (Standalone):

• During the year, the Company sold 6,17,89,164 equity shares of ' Rs. 10 each of Syngene in the open market. The gain arising from sale of aforesaid equity shares amounting to Rs. ' 28,628 mn has been recorded as exceptional item in the Standalone Financial Statements.

Subsidiaries, Associates and Joint Ventures

The Company has 26 subsidiaries, 1 joint venture and 2 associates as on March 31, 2023. A report on the performance and financial position of each subsidiary and joint venture is outlined in AOC-1 which is annexed to this report as Annexure - 1.

In accordance with the provisions of Section 136 of the Companies Act, 2013, and the amendments thereto, read with the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 ('SEBI Listing Regulations'), the audited financial statements, including the consolidated financial statements and related information of the Company and financial statements of the subsidiary companies will be available on our website www.biocon.com.

The Company has also formulated a policy for determining 'material' subsidiaries pursuant to the provisions of the SEBI Listing Regulations. The policy is available at the website of the Company at https://www.biocon.com/investor-relations/ corporate-governance/governance-documents-policies/.

A report of the salient features and a summary of the financial performance of each of the subsidiaries is presented as below:

Syngene International Limited, India

Syngene International Limited (Syngene), subsidiary of the Company, is an innovation-focused global discovery, development and manufacturing organisation providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Its services include integrated drug discovery and development capabilities in chemistry, biology, in vivo and in vitro pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with clinical development services. Syngene is a public limited company incorporated and domiciled in India and has its registered office in Bengaluru, Karnataka, India. The Company's shares are listed on the BSE Limited (BSE) and the National Stock Exchange of India Limited (NSE) in India.

During the year ended March 31, 2023, Syngene (consolidated) registered total revenue growth of 23% to ' 32,638 mn (FY22 - Rs. ' 26,570 mn). EBITDA margin for the year was 31% with the operating margin at ' 10,053 mn (FY22 - Rs. ' 8,490 mn), registering a growth of 18%.

Syngene USA Inc., USA

Syngene USA Inc. is a wholly owned subsidiary of Syngene, incorporated on August 24, 2017, with its registered office in the State of Delaware, United States of America (USA). It provides sales and business support services to the operations of Syngene in USA. During FY23, Syngene USA Inc., posted total revenue of ' 453 mn and reported a net profit of ' 28 mn against a total revenue of ' 280 mn and net profit of ' 19 mn in FY22.

Syngene Scientific Solutions Limited, India

Syngene Scientific Solutions Limited ('SSSL') is a wholly owned subsidiary of Syngene, incorporated on August 10, 2022, with its registered office in the State of Karnataka, India. SSSL shall be engaged in Contract Research and Manufacturing Services (CRAMS) and Clinical research services. During FY23, there was no revenue generated as SSSL was yet start its operations.

Syngene Manufacturing Solutions Limited, India

Syngene Manufacturing Solutions Limited ('SMSL') is a wholly owned subsidiary of Syngene, incorporated on August 26,

2022, with its registered office in the State of Karnataka, India. SMSL shall be engaged in the business of manufacturing of pharmaceutical, biopharmaceutical and biological products of any kind. During the FY23, there was no revenue generated as SMSL was yet to start its operations.

Biocon Biologics Limited, India (formerly known as Biocon Biologics India Limited)

Biocon Biologics Limited ('BBL'), was incorporated on June 08, 2016, in India with the objective of building a biologics focused business with strong R&D and global scale manufacturing capabilities.

BBL, a subsidiary of Biocon Ltd., is a unique, fully integrated, leading global biosimilars company committed to transforming healthcare and patient lives by enabling affordable access to high quality biologics worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world class quality systems to lower the cost of lifesaving biologics and improve health outcomes.

BBL recently acquired the global biosimilars business of its longstanding strategic partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in several key Emerging Markets as well as Advanced Markets like U.S., EU, Australia, Canada and Japan.

The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other noncommunicable diseases. It has a proven track record of success and has achieved several 'firsts' in the biosimilars industry. BBL is also committed to environmental, social and governance (ESG) goals in-line with global norms such as the UN Sustainable Development Goals (SDGs) and remains focused on manging ESG performance and improving outcomes.

During the year, BBL completed its multi-billion-dollar acquisition of the global biosimilars business of its partner Viatris Inc on November 29, 2022 after obtaining all applicable approvals from relevant global regulators including the U.S. Federal Trade Commission, the Competition Commission of India and the Reserve Bank of India, and its investors. The acquisition created a unique, fully integrated, leading global biosimilars enterprise with direct commercialization capabilities in both Advanced Markets and several key Emerging Markets. As a part of the transaction, BBL has issued Compulsorily Convertible Preference Shares (CCPS) in the Company valued at USD 1 billion and made an upfront cash payment of USD 2 billion to Viatris. In consideration of this issuance of securities, the BBL purchased 100% stake in Biosimilar Newco Limited ("BNCL"), a company incorporated in the United Kingdom; and subscribed to 100%

stake in Biosimilar Collaborations Ireland Limited ("BCIL"), a company incorporated in Ireland, indirectly through Biocon Biologics UK Limited.

During the previous year 2021-22, BBL Board of Directors approved the scheme of Merger by Absorption (the Scheme) of Covidshield Technologies Private Limited ("CTPL"), a wholly owned subsidiary of Serum Institute Life Sciences Private Limited ("SILS"). While BBL had received approval from the National Company Law Tribunal (NCLT) in Karnataka, SILS was awaiting approval from the NCLT in Maharashtra to complete the merger. BBL and SILS entered into new strategic alliance, wherein they have reached an agreement to withdraw from the original equity structure contemplated under their Strategic Alliance announced in September, 2021.

During the year ended March 31,2023, BBL posted a standalone revenue of ' 21,893 mn (FY22 - ' 23,728 mn) and a standalone net loss of ' 4,453 mn (FY22 - Net profit of ' 860 mn).

During the year ended March 31,2023, BBL posted consolidated revenue growth of 61% to ' 55,958 mn (FY22 - ' 34,747 mn) and a consolidated net profit of ' 1,335 mn (FY22 - ' 3,825 mn).

Biocon Biologics UK Limited, UK (formerly known as Biocon Biologics Limited)

Biocon Biologics UK Limited, (formerly known as Biocon Biologics Limited) ('BUK') which was incorporated in the United Kingdom in March, 2016, is a wholly owned subsidiary of BBL.

During the year, BBUK reported a total revenue of ' 19,754 mn and net profit of ' 4,190 mn in FY23 against a total revenue of ' 16,034 mn and profit of ' 2,524 mn in FY22.

Biosimilars Newco Limited, United Kingdom

Biosimilars Newco Limited ('BNCL') is a wholly owned subsidiary of BBL, registered in the United Kingdom, which was acquired from Viatris on November 29, 2022, as part of acquisition of Viatris' Biosimilars assets / business.

BNCL undertakes biosimilars businesses, i.e. w.r.t. Trastuzumab, Bevacizumab, Pegfilgrastim, Glargine, Aspart, Pertuzumab and Toujeo across the globe.

BNCL reported total revenues of ' 14,524 mn and net loss of ' 3,237 mn in FY23.

Biosimilar Collaborations Ireland Limited, Ireland

Biosimilar Collaborations Ireland Limited ('BCIL') is a wholly owned subsidiary of Biocon Biologics UK Limited, registered in Ireland, which was acquired from Mylan Ireland Limited, an Irish private limited company and wholly owned subsidiary of Viatris

Inc. on November 29, 2022 as part of acquisition of Viatris' Biosimilars assets / business.

BCIL undertakes biosimilars businesses w.r.t Adalimumab, Eternacept and Aflibercept.

BCIL reported total revenues of ' 7,835 mn and net profit of ' 1,258 mn in FY23.

Biocon Sdn. Bhd., Malaysia

Biocon Sdn. Bhd. ('BSB') is a wholly owned subsidiary of BUK and is a step-down subsidiary of BBL. BSB was established as the group's first overseas manufacturing facility at Malaysia. BSB is engaged in the manufacturing of insulins and insulin analogues for global markets and is located within BioXcell, a biotechnology park in Iskandar Puteri, Johor. The facility is Asia's largest integrated insulins manufacturing facility with approvals from several global agencies including National Pharmaceutical Regulatory Authority ('NPRA'), Malaysia, cGMP certification from HPRA ('EMA') and cGMP certification from the U.S. Food and Drug Administration ('USFDA'). With over US$ 350 mn investment, 800 strong workforce, BSB is the single largest biotech facility in Malaysia and holds the commercial and development rights of insulin and insulin analogues.

BSB reported total revenue of ' 12,686 mn and net profit of ' 1,905 mn in FY23 against total revenue of ' 7,869 mn and net loss of ' 1,080 mn in FY22.

Biocon Biologics Healthcare Malaysia Sdn. Bhd., Malaysia (formerly known as Biocon Healthcare Sdn. Bhd.)

Biocon Biologics Healthcare Malaysia Sdn. Bhd. ('BBHMSB') is a wholly owned subsidiary of BUK, registered in Malaysia. BBHMSB was established with an objective of undertaking operations for biologics in Malaysia. BBHMSB was set up to carry on the business as importers and distributors of drugs and devices in the Malaysian market.

BBHMSB did not have any operations during the FY23 and FY22.

Biocon Biologics Inc., USA

Biocon Biologics Inc., USA ('BBIU') is a wholly owned subsidiary of Biocon Biologics UK Limited, registered in the State of Delaware, United States of America (USA). BBIU was established with an objective to undertake all activities relating to pharmaceuticals, biopharmaceuticals and biologics products, i.e. commercialization, etc. in USA and other geographies.

During the year, BBI reported a total revenue of ' 382 mn and net profit of ' 14 mn in FY23 against loss of ' 110 mn in FY22.

Biocon Biologics Do Brasil Ltda, Brazil

Biocon Biologics Do Brasil Ltda, Brazil ('BBDBL') is a wholly owned subsidiary of BUK, registered in Brazil. BBDBL was established with an objective to undertake direct marketing services and representatives' activities and intermediation in general.

BBDBL reported total revenues of ' 48 mn and net profit of ' 1 mn in FY23 against a net loss of ' 49 mn in FY22.

Biocon Biologics FZ-LLC, UAE

Biocon Biologics FZ-LLC, UAE ('BBFL') is a wholly owned subsidiary of BUK, registered in Dubai, UAE. BBFL was established with an objective to undertake import and export, marketing and sales promotion, research and development, storage, support services activities related to therapeutics.

During the year, BBFL reported total revenues of ' 261 mn and net profit of ' 5 mn in FY23 against a net profit of ' 1 mn in FY22.

Biocon Biologics Canada Inc., Canada

Biocon Biologics Canada Inc. ('BBCI'), a wholly owned subsidiary of BUK was incorporated on March 20, 2023, registered in Ontario, Canada. BBCI was established with an objective to undertake activities such as commercialisation, sale and distribution etc. related to pharmaceuticals, biopharmaceuticals and biologics products.

There was no business or any operations conducted during the year.

Biocon Biologics Germany GmbH, Germany

Biocon Biologics Germany GmbH, a wholly-owned subsidiary of BUK, was incorporated on March 29, 2023, to carry out activities such as commercialisation, sale and distribution etc. related to pharmaceuticals, biopharmaceuticals and biologics products.

There was no business or any operation conducted during the year.

Biocon Pharma Limited, India

Biocon Pharma Limited ('BPL') is a wholly owned subsidiary of the Company with its registered office situated in Bengaluru, Karnataka. The Company was incorporated under the Companies Act, 2013 on October 31, 2014, and is engaged in the development and manufacture of generic formulations for sale in global markets, with a focus on opportunities in the US and EU. BPL has setup its formulations manufacturing facility for oral solid dosages at Bengaluru.

During the year under review, the Board of Directors have approved scheme of amalgamation of Biofusion Therapeutics Limited, wholly owned subsidiary of Biocon Limited with Biocon Pharma Limited. The scheme of amalgamation has been filed with National Company Law Tribunal (NCLT), Bangalore Bench and the same is in process.

During the year under review, BPL has also taken a loan equivalent to ' 12,400 mn from Serum Institute Life Sciences Private Limited (Serum) to subscribe to the rights issue of BBL. Further, BPL has acquired 4,33,34,580 shares of BBL on right issue basis on November 16, 2022.

Further, BPL acquired 8,34,402 shares of BBL from Biocon Limited, holding company and repaid the loan equivalent to ' 12,400 mn availed from Serum.

During the year ended March 31, 2023, BPL reported a total revenue of ' 6,232 mn and a net profit of ' 452 mn as against revenue of ' 6,314 mn and net profit of ' 1,056 mn in FY22. This growth was driven by launch of inhouse developed molecules in US, EU, UK and most-of-the-world markets.

Biocon Pharma Inc., USA

Biocon Pharma Inc. ('BPI'), a wholly owned subsidiary of BPL was incorporated in July, 2015 in USA. BPI is engaged in the commercialization of generic formulations in the United States.

BPI registered total revenue of ' 5,249 mn and net profit of ' 21 mn in FY23 against total revenue of ' 4,707 mn and net profit of ' 207 mn in FY22.

Biocon Pharma UK Limited, UK

Biocon Pharma UK Limited ('BPUK'), a wholly owned subsidiary of BPL was incorporated in December, 2018 in the United Kingdom. BPUK is engaged in the commercialization of generic formulations in the United Kingdom.

BPUK commenced its commercial operations in FY23 and recorded a total revenue of ' 70 mn. During the Financial Year ended March 31, 2023 and March 31, 2022, BPUK reported Nil loss.

Biocon Pharma Ireland Limited, Ireland

Biocon Pharma Ireland Limited ('BPIL'), a wholly owned subsidiary of BPL was incorporated in December, 2018 in Ireland. BPIL is engaged in commercialization of generic formulations in Ireland.

As on March 31, 2023, BPIL has not commenced its commercial operations. During the financial year ended March 31, 2023, BPIL reported a loss of ' 3 mn against ' 1 mn in FY22.

Biocon Pharma Malta Limited (BPML) & Biocon Pharma Malta I Limited (BPMIL)

BPML is a wholly owned subsidiary of BPL and BPMIL is a wholly owned subsidiary of BPML, which were incorporated on January 25, 2021 in Malta. BPMIL is engaged in commercialization of generic formulations and has commenced its commercial operations as on March 31, 2023.

During the year under review, BPMIL has recorded a total revenue of ' 116 mn and reported a profit of ' 2 mn against loss of ' 1 mn in FY22. During the financial year ended March 31, 2023, BPML has reported loss of ' 1 mn similar to FY22.

Biocon Biosphere Limited, India

Biocon Biosphere Limited ('BBSL') is a wholly owned subsidiary of Biocon Limited with its registered office situated in Bengaluru, Karnataka. The Company was incorporated under the Companies Act, 2013 on December 12, 2019 for undertaking similar business to that of Biocon Limited vide a Greenfield facility in Vizag to de-risk fermentation manufacturing at Bengaluru. As on March 31, 2023, BBSL has not commenced commercial operations and has capital work in progress of ' 5,988 mn as against ' 3,707 mn in FY22.

Biofusion Therapeutics Limited, India

Biofusion Therapeutics Limited ('BTL') is a wholly owned subsidiary of Biocon Limited with its registered office situated in Bengaluru, Karnataka. The Company was incorporated under the Companies Act, 2013 on March 18, 2021, for undertaking Contract Research and Manufacturing Services (CRAMS) and other R & D in the field of pharmaceuticals, including but not restricted to drug discovery, biotechnology pharmaceuticals, medicinal sciences etc.

During the year under review, the Board of Directors at its meeting held on July 27, 2022, approved the transfer of business of Contract Research Services of the Company on a going concern basis by way of slump sale to Syngene International Limited, along with employees, liabilities, approvals, registrations, licenses, agreements relating to the business etc. as per the Business Transfer Agreement, subject to the approval of the shareholders of the Company. Further, the shareholders of BTL at its Extra-Ordinary General Meeting held on July 28, 2022, approved for the sale and transfer of business of Contract Research Services of the Company on a going concern basis by way of slump sale to Syngene International Limited.

During the year under review, the Board of Directors has approved the scheme of amalgamation of Biofusion Therapeutics Limited with Biocon Pharma Limited, wholly owned subsidiary of Biocon Limited. The scheme of amalgamation has been filed with National Company Law Tribunal ('NCLT'), Bangalore Bench and the same is in process.

During the year ended March 31, 2023, Biofusion Therapeutics Limited reported a total revenue of ' 565 mn and a net profit of ' 259 mn as against total revenue of ' 402 mn and a net profit of ' 9 mn in FY22.

Biocon Academy, India

Biocon Academy spearheads Biocon Group's CSR initiatives in technical and professional education. The Academy was established as a Centre of Excellence for Advanced Learning in Biosciences in 2014. Biocon Academy leverages the rich industry experience of Biocon, its subject matter expertise alongside international Education Partners such as Keck Graduate Institute of Claremont, California (USA) and BITS- Pilani, India to deliver industry-oriented advanced learning and skill building programs for pharma and biotech graduates. Biocon Academy is dedicated exclusively to industry-oriented biosciences education. The programs offered by the Academy aim to empower the Biotechnology and Engineering graduates with advanced learning, industrial proficiency and job-skills development, the essential building blocks for a promising career in the Biotech industry.

Biocon SA, Switzerland

Biocon SA ('BSA'), a wholly owned subsidiary of the Company, is primarily engaged in identifying and developing novel molecules into commercial products or licensable assets through strategic partnerships.

In the current year, BSA registered a net profit of ' 5 mn against a loss of ' 1 mn in FY22.

Biocon FZ LLC, Dubai

Biocon FZ LLC is a wholly owned subsidiary of the Company, based in Dubai. Incorporated in June 2015, Biocon FZ LLC was established as a marketing entity for pharmaceutical products to target markets in the Middle East and GCC. During the year ended March 31, 2023, Biocon FZ LLC earned ' 204 mn in revenue and reported a net profit of ' 12 mn against a revenue of ' 419 mn and a net profit of ' 2 mn in FY22.

Neo Biocon FZ LLC, UAE

Neo Biocon FZ LLC, UAE ('NB') is a joint venture based in Dubai. Incorporated in 2007, NB was established as a market entity for the pharmaceutical products to target markets in the Middle East and GCC. During the year ended March 31, 2023, Neo Biocon FZ LLC recorded total revenue of ' 160 mn as revenue and a net loss of ' 75 mn as against a revenue of ' 404 mn and a net profit of ' 78 mn in FY22. The entity continued to face regulatory challenges.

Bicara Therapeutics Inc., USA

Bicara Therapeutics Inc., USA ('Bicara') was incorporated in December, 2018 in the United States of America as a subsidiary of the Company. Bicara is anchoring the development of

a pipeline of functional antibodies that exploit the recent advances in immuno-oncology. The Group accounts for its investments in Bicara using the equity method as it continues to have significant influence over the investee.

Bicara is currently in R&D phase and during the Financial Year ended March 31, 2023, Bicara recorded Nil revenue (FY22- Nil) and reported a net loss of ' 2,910 mn (FY22 - loss of ' 2,564 mn). The Group accounted a share of loss of ' 1,633 mn (FY22 - loss of ' 2,106 mn).

Biocon Limited holds 39% shareholding in Bicara. Hence, Bicara has been classified as an Associate Company of Biocon Limited.

Hinduja Renewables Two Private Limited

During the financial year ended March 31, 2021, the Company had acquired 26% equity stake in Hinduja Renewables Two Private Limited towards enhancing the renewable based power consumption. The Company does not consolidate the associate since it does not exercise significant influence over it.

Dividend

In line with the Dividend Distribution Policy of the Company, we recommend a final dividend of ' 1.50 per equity share (i.e. 30 % of face value) for the financial year ended March 31, 2023. The dividend, if approved at the ensuing 45^th Annual General Meeting ('AGM'), will be paid to those members whose names appear in the Register of Members as on close of July 07, 2023. The total dividend payout will be approximately ' 1,800 million.

Dividend Distribution Policy

In terms of Regulation 43A of the SEBI Listing Regulations, the Board has formulated and adopted the Dividend Distribution Policy. The Policy is available on the website of the Company at https://www.biocon.com/investor-relations/ corporategovernance/governance-documents-policies/.

Transfer to reserves

No amount is proposed to be transferred to reserves for the financial year ended March 31, 2023.

Share Capital

During the year under review, there has been no change in the share capital of the Company. The share capital of the Company as on March 31, 2023, is as follows:

Particulars	FY23 Amount in '
Authorized Equity Share Capital (Equity shares of ' 5/- each)	6,250,000,000
Paid up Equity Share Capital (Equity shares of ' 5/- each)	6,003,000,000

Human Resource Development

We, at Biocon, give paramount importance to our employees, who we believe to be our greatest assets. Attracting and retaining the best talents have been the cornerstone of the Human Resource function at Biocon. We strive to create a diverse and inclusive environment that is value driven, collaborating and growth inducing. The total head count as on March 31, 2023 stood at 3,408.

Management's Discussion and Analysis

Pursuant to Regulation 34 of the SEBI Listing Regulations, the Management Discussion and Analysis Report for the year under review, is forming part of the Annual Report.

Corporate Governance

The Company is committed to maintain the highest standards of corporate governance. We believe in adherence to good corporate practices, implementing effective policies and guidelines and developing a culture of the best management practices and compliance with the law at all levels. Our corporate governance practices strive to foster and attain the highest standards of integrity, transparency, accountability and ethics in all business matters to enhance and retain investor trust, long-term shareholder value and respect minority rights in all our business decisions.

A separate section on Corporate Governance as stipulated under Schedule V (C) of the SEBI Listing Regulations forms part of this report. The Corporate Governance Report along with the requisite certificate from the statutory auditors of the Company confirming compliance with the conditions of corporate governance as stipulated under SEBI Listing Regulations forms part of this Annual Report.

Business Responsibility and Sustainability Reporting

The Business Responsibility and Sustainability Reporting ('BRSR'), originating from the MCA report on Business Responsibility Reporting, had found its way into the regulatory provisions by way of an amendment to the Regulation 34(2)(f) of the SEBI Listing Regulations, notified on May 05, 2021.

The BRSR has replaced the existing Business Responsibility Reporting ('BRR') format w.e.f. the Financial Year 2022-23. SEBI has made BRSR mandatory for the top 1000 (one thousand) listed entities by market capitalization with effect from Financial Year 2022-23. The Company had voluntarily prepared and published its 1^st BRSR Report for the Financial Year 2021-22.

Pursuant to Regulation 34(2)(f) of the SEBI Listing Regulations, the BRSR Report for the year under review, is forming part of the Annual Report.

Employee Stock Option Plan (ESOP)

The Board of Directors of the Company had formulated the Biocon Employees Stock Option Plan, 2000 (hereinafter referred to as the 'ESOP Plan'), administered by the Biocon India Limited Employees' Welfare Trust ('ESOP Trust') under the instructions and supervision of the Nomination and Remuneration Committee ('NRC'). The Plan is implemented through a trust route in accordance with the Securities and Exchange Board of India (Share Based Employee Benefits and Sweat Equity) Regulations, 2021 ('SEBI SBEBSE Regulations') with a view of attracting and retaining the best talent, encouraging employees to align individual performances with Company's objectives, and promoting increased participation by them in the growth of the Company.

Subsequently, the Company had also introduced Biocon Restricted Stock Unit Long Term Incentive Plan FY 2020-24 (hereinafter referred to as 'the RSU Plan'), administered by the ESOP Trust under the instructions and supervision of the NRC, which was approved by the shareholders at the 42^nd Annual General Meeting ('AGM') of the Company held on July 24, 2020. The RSU Plan is designed to drive performance towards achieving the Board approved strategic objectives for the Financial Year 2020-24. The RSU Plan covers key employees who, by virtue of their roles, influence the accomplishment of the strategic objectives.

During the year under review, based on the recommendation of NRC and approval of the Board, the members at the 44^th AGM of the Company held on July 28, 2022, have approved the amendment in the ESOP Plan and RSU plan to align with the SEBI notification dated August 13, 2021, w.r.t. exercise of options through cashless route. The members have also approved the termination of the ESOP Plan and the cash and shares (existing or future) lying under the ESOP Plan shall be transferred to other share benefit schemes/ plans (existing or future) implemented by the Company under the SEBI SBEBSE Regulations. Further, the termination of the ESOP Plan shall not affect the options already offered and granted under this ESOP Plan to any grantee and such options shall remain in full force. The members have also approved the acquisition of shares through secondary market by the Trust under the RSU Plan.

During the year, a total of 23,86,260 and 5,21,787 shares were transferred from the ESOP Trust to the eligible employees under the Company's prevailing ESOP Plan and RSU Plan, respectively.

As on March 31, 2023, the ESOP Trust cumulatively held 6,612,268 equity shares of the Company under both the ESOP and RSU Plans of the Company.

The applicable disclosures as stipulated under the SEBI SBEBSE Regulations as on March 31, 2023, are appended herewith as

Annexure 2 to the Board's Report. The details of the Plan forms a part of the notes to accounts of the Financial Statements in this Annual Report. The Company has received a certificate from the Practicing Company Secretary, that the ESOP and RSU schemes have been implemented in accordance with SEBI SBEBSE Regulations and the resolutions passed by the shareholders. The certificate would be placed at the AGM for inspection by the members.

During the year ended March 31, 2023, there has been no other changes in the Company's existing plans and they both are in compliance with SEBI SBEBSE Regulations.

Deposits

The Company has not accepted any deposit, including from the public, and as such no amount of principal and interest were outstanding as at March 31, 2023.

Particulars of Loans, Guarantees or Investments

Details of loans, guarantees and investments covered under the provisions of Section 186 of the Companies Act, 2013 forms part of the notes to the Financial Statements provided in this Annual Report.

Policy on Directors' Appointment and Remuneration

The Company's current policy centralises on having an appropriate mix of Executive, Non-Executive and Independent Directors to maintain the independence of the Board and separate its functions of governance and management. Assessment and appointment of Directors to the Board are based on a combination of criterion that includes ethics, personal and professional stature, domain expertise, gender diversity and specific qualifications required for the position.

For the purpose of selection of any Director, the Nomination and Remuneration Committee ('NRC') identifies persons of integrity who possess relevant expertise, experience and leadership qualities required for the position. A potential board member is also assessed based on independence criteria defined in Section 149(6) of the Companies Act, 2013 and Regulation 16(1)(b) of the SEBI Listing Regulations.

In accordance with Section 178(3) of the Companies Act, 2013 and Regulation 19(4) of the SEBI Listing Regulations, as amended from time to time, and on recommendation of the NRC, the Board had adopted a remuneration policy for Directors, Key Managerial Personnel, Senior Management and other employees. This policy is available at the website of the Company at https://www.biocon.com/investor-relations/ corporate-governance/governance-documents-policies/.

As on March 31, 2023, the Board comprised of 9 (nine) members, consisting of 2 (two) Executive Directors, 2 (two) Non-

Executive Non-Independent Directors and 5 (five) Independent Directors. Out of the total members, 2 (two) are women Directors. The Board periodically evaluates the need for change in its composition and size.

Board Diversity

The Company recognises and embraces the importance of a diverse board in contributing to its success. Adequate diversity on the Board is essential to meet the challenges of business globalisation, rapid deployment of technology, greater social responsibility, increasing emphasis on corporate governance and enhanced need for risk management. The Board enables efficient functioning through differences in perspective and skill, and fosters differentiated thought processes at the back of varied industrial and management expertise, gender, knowledge and geographical backgrounds. The Board has adopted the Board Diversity Policy which sets out the approach to diversity of the Board. The policy is available at the website of the Company at https://www.biocon.com/investor-relations/ corporate-governance/governance-documents-policies/.

Declaration by Independent Directors

All Independent Directors of the Company have submitted the requisite declarations confirming that they meet the criteria of independence as prescribed under Section 149(6) of the Companies Act, 2013 read with Regulation 16 and 25(8) of the SEBI Listing Regulations. The Independent Directors have also confirmed that they have complied with Schedule IV of the Companies Act, 2013 and the Company's Code of Conduct.

They have further confirmed that they are not aware of any circumstances or situations which exist or may be reasonably anticipated that could impair or impact their ability to discharge their duties and that they are independent of the management. Further, the Independent Directors have also submitted their declaration in compliance with the provision of Rule 6(3) of the Companies (Appointment and Qualification of Directors) Rules, 2014, which mandated the inclusion of an Independent Director's name in the data bank of the Indian Institute of Corporate Affairs ('IICA') for a period of one year or five years or life-time till they continue to hold the office of an independent director. All the Independent Directors are exempted from appearing the Online Proficiency Self-Assessment Test conducted by IICA.

In the opinion of the Board, all the Independent Directors have integrity, expertise and experience.

Board Evaluation

Pursuant to the provisions of Section 134 of the Companies Act, 2013 and Regulation 19 of the SEBI Listing Regulations, the annual performance evaluation of the Board, Board level Committees and individual directors was conducted during

the year, in order to ensure that the Board and Board level Committees are functioning effectively and demonstrating good governance. Once in every 3 (three) years, the Board evaluation is done by an external agency. For the current Financial Year 2022-23, the Board had undertaken this exercise through selfevaluation questionnaires.

The evaluation was carried out based on the criteria and framework approved by the NRC. A detailed disclosure on the parameters and the process of Board evaluation has been provided in the Report on Corporate Governance.

Directors

As on March 31, 2023, the Board of Directors comprised of 9 (nine) members including 2 (two) women members. The Board has an appropriate mix of Executive Directors, Non-Executive Non-Independent Directors and Independent Directors , which is compliant with the Companies Act, 2013, the SEBI Listing Regulations and is also aligned with the best practices of Corporate Governance.

Appointment

The Board of Directors at its meeting held on April 28, 2022, based on the recommendation of NRC, had approved the appointment of Naina Lal Kidwai as an Additional Director categorised as Non-Executive and Independent Director of the Company with effect from April 28, 2022. Further, the shareholders at the 44^th Annual General Meeting ('AGM') held on July 28, 2022 have approved the appointment of Naina Lal Kidwai as an Independent Director of the Company for a period of 3 (three) years till the conclusion of 47^th AGM proposed to be held in the year 2025.

Further, the Board of Directors at its meeting held on November 14, 2022, based on the recommendation of NRC, had approved the appointment of Peter John Bains as an Additional Director categorised as Non-Executive and Independent Director of the Company. Further, pursuant to the provisions of Sections 108 and 110 of the Companies Act, 2013, Peter John Bains was appointed as an Independent Director of the Company with effect from December 12, 2022, till the conclusion of 48^th AGM of the Company to be held in the year 2026, by way of shareholder's approval to the Postal Ballot Notice dated December 19, 2022.

Re-appointment

As per the provisions of the Companies Act, 2013 and Articles of Association of the Company, Prof. Ravi Rasendra Mazumdar is liable to retire by rotation at the ensuing AGM and being eligible, seeks re-appointment. Once he is re-appointed by the members at the ensuing AGM, he will continue as a NonExecutive Director of the Company.

The Board at its meeting held on May 23, 2023, had recommended above re-appointment and separate resolution shall be placed before the members for their approval at the ensuing AGM.

In the opinion of the Board, all the Directors, as well as the Directors proposed to be appointed/ re-appointed possess the requisite qualifications, experience, expertise and hold high standards of integrity and relevant proficiency.

Completion of tenure of Directors

During the year under review, Daniel Bradbury and Mary Harney, Independent Directors of the Company, have completed their second term of tenure with the Company on July 27, 2022. Accordingly, they ceased to be the Directors of the Company with effect from that date. The Board placed on record its

appreciation for the extensive contribution rendered by Daniel Bradbury and Mary Harney during their tenure at Biocon.

Key Managerial Personnel

The Key Managerial Personnel(s) of the Company as on March 31, 2023, are Kiran Mazumdar-Shaw, Executive Chairperson, Siddharth Mittal, Managing Director & CEO, Indranil Sen, Chief Financial Officer and Mayank Verma, Company Secretary & Compliance Officer.

Kiran Mazumdar-Shaw, Executive Chairperson of the Company, is also the Non-Executive Chairperson of Syngene International Limited ('Syngene') and Executive Chairperson of Biocon Biologics Limited ('BBL'), both being subsidiaries of the Company and is in receipt of remuneration from the respective companies for the Financial Year 2022-23.

Committees of the Board

Currently, the Company has 5 (five) Board level Committees: Audit Committee ('AC'), Risk Management Committee ('RMC'), Nomination and Remuneration Committee ('NRC'), Stakeholders Relationship Committee ('SRC') and Corporate Social Responsibility and ESG Committee ('CSR & ESG'). The composition of the above committees, as on March 31, 2023, is disclosed as under:

S. Name of Members No.	Category	AC		RMC		NRC		SRC		CSR & ESG
		C	M	C	M	C	M	C	M	C	M
1 Kiran Mazumdar-Shaw	Executive Chairperson				•
2 Siddharth Mittal	Managing Director & CEO				•						•
3 Prof. Ravi Rasendra Mazumdar	Non-Executive Director						•	•			•
4 Eric Vivek Mazumdar	Non-Executive Director				•						•
5 Bobby Kanubhai Parikh	Independent Director	•		•					•
6 Meleveetil Damodaran	Independent Director		•		•
7 Dr. Vijay Kumar Kuchroo	Independent Director						•		•		•
8 Naina Lal Kidwai	Independent Director					•				•
9 Peter John Bains	Independent Director		•		•				•

C: Chairperson and M: Member.

Meetings of the Board

The meetings of the Board are scheduled at regular intervals to discuss and decide on matters of business performance, policies, strategies and other matters of significance. The schedule of the meetings is circulated in advance, to ensure proper planning and effective participation. In certain exigencies, decisions of the Board are also accorded through circulation.

During the financial year 2022-23, the Board met 4 (four) times on April 28, 2022, July 27, 2022, November 14, 2022 and February 14, 2023. The maximum interval between any two meetings did not exceed 120 days, as prescribed in the Companies Act, 2013. Detailed information regarding the meetings of the Board is included in the report on Corporate Governance, which forms part of this annual report.

Related Party Contracts or Arrangements

There were no materially significant related party transactions entered between the Company, Directors, management and their relatives, except for those disclosed in the financial statements. All the contracts/ arrangements/ transactions entered by the Company with the related parties during the Financial Year 2022-23 were in the ordinary course of business and on an arm's length basis, and whenever required the Company has obtained necessary approval as per the related party transaction policy of the Company.

Accordingly, particulars of contracts or arrangements with related parties referred to in Section 188(1) of the Companies Act, 2013 along with the justification for entering into such contract or arrangement in Form AOC-2 does not form a part of the Report.

The Company formulated the policy on 'Materiality of Related Party transactions and on dealing with Related Party Transactions', and the same is available at the website of the Company at https://www.biocon.com/investor-relations/ corporate-governance/governance-documents-policies/. The details of related party disclosures forms part of the notes to the Financial Statements provided in the Annual Report.

Credit Ratings

ICRA Limited vide its letter dated November 17, 2022 continued to rate the Company 'watch with Developing Implications' on the long-term bank facilities of the Company. The short-term rating was removed from 'watch with developing implications' and reaffirmed rating of 'ICRA A1+' on the banking facilities and Commercial Paper of the Company.

During the year, CRISIL vide its letter dated November 30, 2022 removed 'watch with Developing Implications' and reaffirmed rating of 'CRISIL AA+' rating on the long-term bank facilities of the Company. The rating on the short-term bank facilities has been reaffirmed at 'CRISIL A1+'.

During the year under review, India Ratings and Research (Ind- Ra) has vide letters dated February 07, 2023 assigned its 'IND AA+/ Stable' ratings on Non-convertible Debentures, Term Loans and 'IND A1+' rating on Commercial Paper.

Conservation of Energy, Technology Absorption, Foreign Exchange Earnings & Outgo

The particulars as prescribed under sub-section (3)(m) of Section 134 of the Companies Act, 2013, read with the Companies (Accounts) Rules, 2014, is appended herewith as Annexure 3 to the Boards' Report.

AUDITORS Statutory Auditors

M/s. B S R & Co. LLP, Chartered Accountants (ICAI Registration No. 101248W/W-100022) were appointed as the Statutory Auditors of the Company for a term of 5 (five) years, to hold office from the conclusion of the 43^rd AGM held on July 23, 2021, till the conclusion of the 48^th AGM, on such remuneration as may be decided by the Board in consultation with the Statutory Auditors of the Company.

The Auditors' Report on the financial statements of the Company for the financial year ended March 31, 2023, is unmodified i.e. it does not contain any qualification, reservation or adverse remark or disclaimer. The Auditors' Report is enclosed with the financial statements forming part of the Annual Report.

Cost Auditors

The Cost Records of the Company are maintained in accordance with the provisions of Section 148(1) of the Companies Act, 2013 as specified by the Central Government. The Cost Audit Report, for the financial year ended March 31, 2022, was filed with the Central Government within the prescribed time. The Board, on recommendation of the Audit Committee, had appointed M/s. Rao & Murthy, Cost Accountants (Firm Registration Number 000065) as the Cost Auditors to conduct the audit of Company's cost records for the financial year ended March 31, 2023. The Cost Auditors will submit their report for the Financial Year 2022-23 on or before the due date.

The Board, on recommendation of the Audit Committee, has appointed M/s. Rao & Murthy, Cost Accountants (Firm Registration Number 000065) as the Cost Auditors of the Company to conduct the audit of Company's cost records for the Financial Year 2023-24. The Cost Auditors have confirmed that their appointment is within the limits of Section 141(3) (g) of the Companies Act, 2013 and have also certified that they are free from any disqualifications specified under Section 141(3) and proviso to Section 148(3) read with Section 141(4) of the Companies Act, 2013. The Audit Committee has also received a certificate from the Cost Auditors certifying their independence and arm's length relationship with the Company.

In accordance with the provisions of Section 148 of the Companies Act, 2013 read with the Companies (Audit and Auditors) Rules, 2014, since the remuneration payable to the Cost Auditor is required to be ratified by the members, the Board recommends the same for approval by members at the ensuing AGM.

Secretarial Auditors

Pursuant to the provisions of Section 204 of the Companies Act, 2013 and rules thereunder, M/s. V. Sreedharan & Associates, Practicing Company Secretaries were appointed to conduct the secretarial audit of the Company for the Financial Year 202223. The Secretarial Audit Report for the Financial Year 202223 does not contain any qualification, reservation or adverse remark or disclaimer and is appended herewith as Annexure 4 to the Boards' Report.

Pursuant to the provisions of Regulation 24A of the SEBI Listing Regulations, Biocon Biologics Limited, a material unlisted subsidiary of the Company undertook the secretarial audit for the Financial Year 2022-23. The Secretarial Audit Report for the Financial Year 2022-23 given by M/s. V. Sreedharan & Associates, Practicing Company Secretaries is appended herewith as Annexure 4A of the Boards' Report.

Pursuant to the SEBI circular vide no. CIR/CFD/CMD/1/27/2019 dated February 08, 2019, the Annual Secretarial Compliance

Report for the Financial Year 2022-23, issued by M/s. V. Sreedharan & Associates, Practicing Company Secretaries shall be submitted with the stock exchanges where shares of the Company are listed, within stipulated timeline.

Reporting of fraud by Auditors

During the year, the statutory auditors have not reported to the Audit Committee any material fraud on the Company by its officers or employees under Section 143(12) of the Companies Act, 2013, the details of which need to be provided in this report.

Risk Management Policy / Framework

The Company has formed a Risk Management Committee and has put in place an enterprise wide Risk Management Framework and Risk Management Policy with an objective of timely identification of risks (existing and upcoming), assessment and evaluation of such risks in line with the overall business objectives or strategies and define adequate mitigation strategies to reduce the impact of risk exposure. On a quarterly basis, the Risk Management Committee reviews critical risks on a rotation basis in line with the risk management plan to assess effectiveness of mitigation actions defined against critical risks and its impact on overall risk exposure of the Company. All the critical risk areas are covered at least once a year. All critical risk areas as identified by the Company are re-evaluated annually. During the course of year, appropriate changes were made to the risk register, considering internal and/or external changes.

Internal Financial Control

The Company has laid down guidelines, processes and structures, which enable implementation of appropriate internal financial controls across the organisation. Such internal financial controls encompass policies, processes and procedures adopted by the Company for ensuring the orderly and efficient conduct of business, including adherence to its policies, safeguarding of its assets, prevention and detection of frauds and errors, the accuracy and completeness of accounting records and the timely preparation of reliable financial information. These include controls in the nature of manual or automated (IT applications including the ERP applications wherein the transactions are approved and recorded). Appropriate review and control mechanisms are put in place to ensure that such control systems are adequate and are operating effectively on an ongoing basis.

Because of the inherent limitations of internal financial controls, including the possibility of collusion or improper management override of controls, material mis-statements in financial reporting due to error or fraud may occur and not be detected. Also, evaluation of the internal financial controls are subject to the risk that the internal financial control may become inadequate because of changes in conditions, or that the compliance with the policies or procedures may deteriorate.

The Company has, in all material respects, an adequate internal financial control system and such internal financial controls which were operating effectively based on the internal control criteria established by the Company considering the essential components of internal control stated in the guidance note on audit of internal control over financial reporting issued by the Institute of Chartered Accountants of India.

Vigil Mechanism

The Vigil Mechanism as envisaged in the Companies Act, 2013, the rules prescribed thereunder, and the SEBI Listing Regulations is implemented through the Whistle Blower Policy of the Company to enable the Directors, employees and all stakeholders (internal and external) of the Company to report genuine concerns, to adequately safeguard against victimisation of persons who use such mechanism and make provision for direct access to the Chairperson of the Audit Committee.

Whistle Blower Policy of the Company is available on the Company's website and can be accessed at https://www. biocon.com/investor-relations/corporate-governance/ governancedocuments-policies/.

Directors' Responsibility Statement

Pursuant to the requirement under Section 134(3)(c) of the Companies Act, 2013, the directors confirm that:

a. In the preparation of the annual accounts, the applicable accounting standards have been followed along with proper explanation relating to material departures;

b. they have selected such accounting policies and applied them consistently and made judgements and estimates that are reasonable and prudent so as to give a true and fair view of the state of affairs of the Company at the end of the financial year and of the profit and loss of the Company for that period;

c. they have taken proper and sufficient care for the maintenance of adequate accounting records in accordance with the provisions of the Companies Act, 2013 for safeguarding the assets of the Company and for preventing and detecting fraud and other irregularities;

d. they have prepared the annual accounts on a going concern basis;

e. they have laid down internal financial controls based on the internal controls framework established by the Company, which were adequate and are operating effectively; and

f. they have devised proper systems to ensure compliance with the provisions of all applicable laws and that such systems were adequate and operating effectively.

Particulars of Employees

The statement containing particulars in terms of Section 197(12) of the Companies Act, 2013 read with rule 5(1) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 forms part of this report and is appended herewith as Annexure 5 to the Boards' Report.

The statement containing particulars in terms of Section 197(12) of the Companies Act, 2013 read with rule 5(2) and 5(3) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014, forms part of this report. The above statement is available on the website of the Company at www. biocon.com.

However, considering the first proviso to Section 136(1) of the Companies Act, 2013, the Annual Report, excluding the aforesaid information, is being sent to the members of the Company and others entitled thereto. The said information is available for inspection at the registered office of the Company during business hours on working days of the Company up to the date of the ensuing AGM. Any shareholder interested in obtaining a copy thereof, may write to the secretarial team of the Company in this regard.

Corporate Social Responsibility (CSR)

At Biocon, CSR has been an integral part of our business since its inception. With the incorporation of Biocon Foundation in 2004, the Company formally structured its CSR activities. Today, the Company span its CSR efforts through Biocon Foundation, Biocon Academy and select partnership programs with like- minded private organizations and Government, aimed at promoting social and economic inclusion for the marginalized communities. In the year under consideration, the CSR programs of the Company were focused on providing financial assistance for sustainable urban public transport system and high-quality vocational training for youth in biosciences.

Environmental Sustainability

Air pollution levels continue to be a serious public health concern in Bengaluru. Traffic congestions and abysmally slow commute speed have tremendous adverse impacts on the quality of life of the residents in the city.

In keeping with the unwavering commitment to ecological balance and sustainability, the Company has supported a people-oriented and environment-friendly transport alternative. Mass rail transit systems lessen the usage of individual vehicles thereby reducing toxic emissions and greenhouse gases. Biocon Foundation signed a memorandum of understanding with Bengaluru Metro Rail Corporation (BMRCL) in 2020 to fund the construction of the proposed Metro Station at Hebbagodi. In the year under consideration, we continued our funding support towards the Biocon-Hebbagodi Metro station. The

station will form part of the new line of 18.82 KM connecting R V Road to Bommasandra, being constructed under Phase II of the Bengaluru Metro Rail Project. The line will be fully elevated with 16 stations. The Metro connectivity would provide a sustainable, safe and faster travel alternative to residents and business commuters from all parts of Bengaluru, reducing traffic congestion on Hosur Road and helping lower the environmental impact from vehicular pollution.

The project is progressing in full swing and is likely to be completed by the year 2023.

Promoting Education

Biocon Academy is dedicated exclusively to industry-oriented biosciences education which aims to address the skill deficit in the Biopharma sector, by developing high-end talent through advanced learning. The programs offered by the Academy aim to empower the Biotechnology and Engineering graduates with advanced learning, industrial proficiency and job-skills development, the essential building blocks for a promising career in the Biotech industry.

In compliance with the provisions of Section 135 of the Companies Act, 2013, the Board has formed a Corporate Social Responsibility and ESG Committee, which monitors and oversees various CSR initiatives and activities of the Company. As on March 31, 2023, the CSR & ESG Committee comprises of Naina Lal Kidwai (Chairperson), Dr. Vijay Kumar Kuchroo, Prof. Ravi Rasendra Mazumdar, Eric Vivek Mazumdar and Siddharth Mittal.

A detailed report regarding Corporate Social Responsibility is appended herewith as Annexure 6 to the Boards' Report. The Policy on Corporate Social Responsibility and Annual Action Plan have been uploaded on to the website of the Company and is available at https://www.biocon.com/investor-relations/ corporate-governance/governance-documents-policies/.

Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013

The Company has in place an Anti-Sexual Harassment Policy in line with the requirements of the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013. An Internal Complaints Committee ('ICC') has been set up to redress complaints received regarding sexual harassment. All employees (permanent, contractual, temporary, trainees) are covered under this Policy. The Policy is gender neutral.

During the financial year under review, 8 (eight) complaints with allegations of sexual harassment were filed and all 8 (eight) complaints were disposed-off and no complaint is pending for closure as per the timelines of the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013.

Transfer of Unpaid and Unclaimed Amounts to Investor Education and Protection Fund ('IEPF')

Pursuant to the provisions of Section 124(5) of the Companies Act, 2013, read with the IEPF Authority (Accounting, Audit, Transfer and Refund) Rules, 2016, all dividends which remains unpaid or unclaimed for a period of 7 (seven) years from the date of their transfer to the unpaid dividend account are required to be transferred by the Company to the Investor Education and Protection Fund ('IEPF'), established by the Central Government. Further, as per IEPF Rules, the shares on which dividend has not been paid or claimed by the members for 7 (seven) consecutive years or more shall also be transferred to the demat account of the IEPF Authority. Further, as per Rule 6(8) of IEPF Rules, all benefits such as bonus shares, split, consolidation except right issue, accruing on shares which are transferred to IEPF, shall also be credited to the demat account of the IEPF authority.

During the year ended March 31, 2023, the Company has transferred unpaid and unclaimed dividends of ' 1,106,320 for the financial year 2014-15 and 4,867 corresponding equity shares on which dividends were unclaimed for 7 (seven) consecutive years were transferred as per requirements of the IEPF Rules.

Significant and Material Orders

There are no significant and material orders passed during the year by the regulators, courts or tribunals impacting the going concern status and Company's operations in the future.

Statutory Disclosures

None of the Directors of the Company are disqualified as per the provisions of Section 164(1) and (2) of the Companies Act, 2013. The Directors have made necessary disclosures, as required under various provisions of the Companies Act, 2013 and the SEBI Listing Regulations.

Material Changes and Commitments

No material changes and commitments affecting the financial position of the Company have occurred between March 31, 2023, and the date of this report.

Change in Nature of Business

The Company continues to be a pioneer biopharmaceutical company engaged in manufacturing active pharmaceutical ingredients and formulations, including biosimilar drugs for diabetics, oncology and autoimmune diseases with sales in markets across the globe.

There has been no change in the nature of the business of the Company.

Annual Return

The Annual Return of the Company as per the provisions of Section 134(3)(a) and 92(3) of the Companies Act, 2013, is available on the website of the Company at www.biocon.com.

Secretarial Standards issued by the Institute of Company Secretaries of India ('ICSI')

In terms of Section 118(10) of the Companies Act, 2013, the Company has complied with the applicable Secretarial Standards

i.e. SS-1, SS-2 and SS-4, relating to the 'Meetings of the Board, 'General Meetings' and 'Report of the Board of Directors', respectively, as specified by the Institute of Company Secretaries of India (ICSI) and approved by the Central Government.

Green Initiative

We request all the shareholders to support the 'Green Initiative' of the Ministry of Corporate Affairs and Biocon's continuance towards greener environment by enabling the service of the Annual Report, AGM Notice and other documents electronically to your email address registered with your Depository Participant/ Registrar and Share Transfer Agent.

Acknowledgement

We place on record our appreciation for the committed services by every member of the Biocon family globally whose contribution was significant to the growth and success of the Company. We would like to thank all our clients, partners, vendors, investors, bankers and other business associates for their continued support and encouragement during the year.

We also thank the Government of India and Malaysia, Government of Karnataka, Government of Telangana, Government of Andhra Pradesh, Ministry of Information Technology and Biotechnology, Ministry of Health, Ministry of Commerce and Industry, Ministry of Finance, Department of Pharmaceuticals, Department of Scientific and Industrial Research, Ministry of Corporate Affairs, Central Board of Indirect Taxes and Customs, Income Tax Department, CSEZ, and all other regulatory agencies for their assistance and cooperation during the year and look forward to their continued support in the future.

For and on behalf of the Board

		Sd/-
		Kiran Mazumdar-Shaw
Place:	Bengaluru	Executive Chairperson
Date:	May 23, 2023	DIN: 00347229