Biocon Ltd Management Discussions

* LMIC: Low - and Middle- Income Countries

Despite progress, pricing pressures and cost controls threaten profitability and innovation. To adapt, the pharma industry must embrace value-based pricing, regional reimbursement models, and tech-driven solutions to ensure equitable, sustainable healthcare globally.

Importance of Environment, Social and Governance (ESG) Practices Continues to Evolve

ESG practices are crucial for long-term success, focusing on reducing carbon emissions, improving energy efficiency, and adopting renewable energy and sustainable transport.

Technological advances are enabling green chemistry, which reduces hazardous substances, waste, and promotes responsible sourcing. Focus areas also include sustainable packaging, water stewardship, recycling, and improved wastewater treatment. Digital tools optimize energy use and identify waste through data analytics. ESG also emphasizes social impact by improving access to medicines, supporting patient programs, and ensuring diversity in clinical trials.

Governance in ESG emphasizes accountability, transparency, and ethical sourcing. Companies can show commitment by setting measurable goals, publishing progress reports, and implementing risk management to address environmental, social, and financial risks. These practices build stakeholder trust and position the biopharma industry for long-term success, strengthening investor and patient relationships while promoting sustainability.

Business Review

Biocon operates four distinct business segments: A. Generics B. Novel Biologics C. Biosimilars (Under Biocon Biologics Limited)

D. Research Services (Under Syngene International Limited)

A. Generics

Our Generics business began with a fermentation-based, cholesterol-lowering statin API and has evolved into a robust portfolio of APIs and finished dosages. In 2013, we entered the generic formulations space by forward-integrating our complex and differentiated in-house APIs—enhancing value, reliability, quality, and supply for customers and patients.

We operate API manufacturing facilities at five locations across Bengaluru, Hyderabad, and Visakhapatnam, along with an oral solid dosage (OSD) facility in Bengaluru capable of producing both potent and non-potent tablets and capsules. To strengthen our U.S. presence, we acquired an OSD facility in Cranbury, New Jersey in 2023. We are also developing an injectable facility in Bengaluru to support sterile fill-finish and device assembly needs.

Our current manufacturing capacity includes 900 MT of APIs and 880 million oral solid dosages annually. We serve global demand for statins, immunosuppressants, and other products in our portfolio. As of March 31, 2025, we have received over 125 cGMP approvals from international regulatory agencies such as U.S. FDA, EMA, TGA Australia, Health Canada, ANVISA, Brazil and Cofepris, Mexico. We also leverage Contract Manufacturing Organizations (CMOs) for formulation production as needed.

In the Generics segment, we served over 420 customers and distributed products across more than 60 countries as of March 31, 2025.

Our Strategic Priorities

We had identified eight strategic priorities to drive our growth and expansion. These include Development Excellence, Operational Excellence, Quality Excellence, Commercial Excellence, Cost Leadership, Innovation Focus, Talent Development, and Digital Initiatives. The first four priorities are focused on execution excellence. Priorities five to eight complement, support and enable the first four. These eight priorities, given below encompass the entire business lifecycle with the objective of bringing our products to market at the right time and right cost.

Guided by these priorities, there is a continued focus on growing our product pipeline, with a clear priority on innovation and vertical integration. We continue to add capacities and niche capabilities in areas such as peptides, high potent drugs, and injectables. On-going efforts towards building strategic partnerships, to de-risk our supply chain and leveraging digital transformation initiatives should further aid in accomplishing our key strategic goals.

Generic API Business

Biocon has built a well-balanced API portfolio encompassing both synthetic and fermentation-based molecules, backed by strong regulatory credentials and coverage across more than 10 therapeutic areas. This has been achieved by leveraging our strengths in R&D and manufacturing technology platforms, especially fermentation, to develop complex and differentiated APIs.

As of March 31, 2025, our API portfolio comprised over 75 products, spanning therapeutic areas such as cardiovascular, anti-diabetics, immunosuppressants, and specialty molecules. This portfolio has been further strengthened with the addition of oncology-focused HPAPIs and peptides, including GLP-1 receptor agonists that target diabetes and weight management.

The portfolio includes 44 active APIs, covering a strategic mix of high-growth areas like oncology and peptides, as well as established segments such as cardiovascular (CVS) and central nervous system (CNS). Biocons global footprint is supported by 67 active U.S. Drug Master Files (USDMFs) and 29 valid Certificates of Suitability (CEPs)¹.

We are a key global supplier of fermentation-based APIs, including immunosuppressants and statins, and one of only two Indian companies with a measurable portfolio approved in regulated markets such as the U.S., Europe, and Japan.

Growth Drivers for the API Business

The global API market is witnessing strong growth, driven by rising demand for generics and the increasing prevalence of chronic diseases, which are boosting volume. At the same time, complex, specialty, and high-value molecules such as peptides and HPAIs are enhancing market value. Growth is fuelled by both volume demand from generics and value demand from specialty innovators.

Regulatory and commercial pressures are prompting a shift toward more reliable sourcing geographies, encouraging investment in emerging regional hubs. This diversification is strengthening supply chain resilience and ensuring consistent market supply. Additionally, technological advancements in manufacturing and process efficiency are improving yields, reducing costs, and raising quality standards—further enhancing the global competitiveness of the API segment.

The global API market reached approximately USD 263 billion in 2024 and is projected to grow at a CAGR of 7.2% between 2024 and 2029 to reach USD 373 billion by 2029.

Biocons API Portfolio*

Generic Formulations Business

In 2013, we entered the generic formulations space by forward-integrating our complex and differentiated in-house APIs—enhancing value, reliability, quality, and supply for customers and patients. We compete on quality, cost, and supply reliability for our generic products. Many of our products are vertically integrated, giving us better control over the value chain, thereby ensuring continuity of supplies to customers and eventually to patients. We manufacture oral solid dosages (OSDs) in various forms including tablets and capsules, in multiple dosage forms like immediate and modified release formulations. We also have injectables with complex APIs and formulations available in vials, drug-device combinations like pre-filled syringes (PFS), and pen devices and auto-injectors, for which we have built capabilities over the years.

Since the commercialization of our first generic formulation in the U.S. in 2017, we have launched 22 drug products in the U.S., five in Europe (including UK) and a few in most-of the-world markets leveraging the U.S. approvals.

Currently, our generics formulations portfolio comprises more than 80 products across cardiology, anti-diabetics, obesity, oncology, immunology, and autoimmune indications, and the business crossed USD 100 million in annual sales in Fiscal 2024 and USD 125 million in annual sales in Fiscal 2025. We anticipate commercializing products every year in the U.S. market and strengthening our presence in Europe and MoW markets.

Across our portfolio of launched and pipeline generic products, 18 of these formulations correspond to the top 100 generic molecules globally by sales, and 17 are classified as blockbuster products, each exceeding USD 1 billion in annual sales. (Source: Frost & Sullivan)

Peptides, particularly GLP-1s, are a key area of focus for Biocon. These are injectable formulations with a drug device combination and complex characterization. In the coming years, we expect GLP-1s to play a major role as a growth driver for the business. We are building our peptides technology capability and capacity to take advantage of this large and strategic opportunity, which is projected to grow from USD 11 billion in 2019 to around USD 144 billion by 2029.

As we had received approval for our GLP-1 Liraglutide in the UK in April 2024 and a decentralized procedure ("DCP") end of procedure in Europe in December 2024, we remain focused on the strategic expansion of our differentiated GLP-1 portfolio into new markets. We aim to launch GLP-1 products in Europe and the United States, with approval in the United States expected to be in the Fiscal 2026.

We continue to expand and invest in our portfolio and build in-house manufacturing capabilities and capacities that will drive our future growth.

Generic Formulations Portfolio*

* Sample portfolio as on March 31, 2025; does not include molecules under development ¹ MoW - Most of the World markets ² Select EU countries ³ Approved in select European countries TA – Tentative approval

Generics – FY25 Highlights:

New Launches in Generic Formulations Drive Full Year Performance: We concluded the fiscal year on a strong note, with a robust second-half performance driven by our generic formulations business, supported by key new product launches. The launch of Liraglutide in the UK stood out as a major milestone, while the Q4 launch of Lenalidomide in the U.S. was a significant contributor to overall performance. Revenue growth in formulations, coupled with a recovery in the API segment, helped drive operational revenue growth for the full year. Notably, the share of formulations in total product sales increased to over 40%, up from around 35% in FY24

Continued Focus on Geographical Diversification: In FY25, Biocon advanced its global expansion strategy through direct presence and strategic partnerships across key markets including the UK, Europe, Middle East, Latin America, Asia, and Australia. Notable progress was made in the GLP-1 portfolio:

• Brazil: Signed exclusive licensing and supply agreements with Biomm S.A. for Semaglutide for diabetes and with another leading specialty pharma company for gLiraglutide, for both diabetes and obesity indications.

• Middle East: Expanded partnership with Tabuk Pharmaceuticals to introduce complex GLP-1 formulations in markets including Saudi Arabia.

• Mexico: Partnered with Medix to launch gLiraglutide for obesity treatment.

• South Korea: Collaborated with Handok for commercialization of synthetic Liraglutide for weight management.

• United Kingdom: Achieved a major milestone with the launch of gLiraglutide injection pens—Liraglutide Biocon for diabetes and Biolide for obesity—becoming the first generic company to gain approval in a major regulated market.

Additionally, Biocon continued participating in international tenders, with a notable win for Everolimus tablets in a MoW market.

Portfolio expansion and Product Approvals: During FY25, we made 108 formulation filings and received 50 approvals for our drug products across the U.S., EU, the UK and other markets, which includes U.S. FDA approvals for Micafungin injection, Sacubitril + Valsartan tablets, Daptomycin injection, Lenalidomide capsules, Dasatinib tablets, Triamterne capsules, Everolimus tablets as prophylaxis of organ rejection and Norepinephrine Bitartrate injection. We also received tentative approval of our ANDA for Rivaroxaban Tablets. The year saw us filing of 66 drug master files (DMFs) in different markets, including six in the U.S.

We also obtained the EU De-centralized Procedure (DCP) approval for Liraglutide, together with our partner Zentiva, for both diabetes and obesity indications. The product is expected to be launched in FY26, marking another step forward in accelerating the availability of these innovative GLP-1 therapies across the EU, positioning the Company for strategic growth in the region.

Furthermore, we received approval for Tacrolimus capsules in China making it Biocons second significant drug product approval in this strategic market.

Manufacturing Capacities and Capabilities: We continued to invest in expanding our capacities and adding complementary capabilities to support our growth plans. A key milestone was the qualification of our oral solid dosage manufacturing facility in Cranbury, New Jersey—acquired to strengthen our manufacturing infrastructure and presence in the U.S.—by the U.S. FDA for three vertically integrated statin products. Commercial supplies from this site commenced during the year, and we secured a 5-year national contract for one of these products. We plan to continuously introduce new products from this facility and are actively investing to further expand its capacity.

Our greenfield immunosuppressant manufacturing facility in Visakhapatnam was successfully inspected and qualified by the U.S. FDA. We are progressing with the qualification of additional products from this site.

Additionally, in FY26, we expect to commission our injectables facility in Bengaluru, which will cater to our portfolio needs across vials, cartridges, prefilled syringes, and drug-device combinations.

To support global development and commercial API requirements, we are augmenting our peptide and non-immuno fermentation capacities in Bengaluru, alongside expanding synthetic API capacities in Hyderabad.

These investments in new, upgraded, and larger capacities and capabilities are fully aligned with our long-term strategic business objectives.

Key Operational and Digital Initiatives: In FY25, the Company maintained its strategic focus on operational excellence, advancing key cost and operational improvement initiatives (CIP, OIP). Several Lean Six Sigma Green Belt projects were successfully executed, resulting in enhanced process efficiency, expanded production capacity, and reduced manufacturing costs. These improvements contributed significantly to strengthening our competitive position across key product segments.

Process validation activities were completed for multiple products, reinforcing our commitment to quality and reliability in manufacturing operations.

On the innovation front, we achieved proof of concept in the laboratory for gene synthesis and in-house enzyme cloning, supporting the development of chemo-enzymatic peptides. Additionally, we initiated new biotransformation projects aimed at driving cost efficiencies and enhancing sustainability in our production processes

The Company continued to prioritize digital adoption and transformation as a key strategic focus. Significant progress was made in automation and digitization across core business functions, enhancing operational efficiency, data integrity, and decision-making capabilities.

Key initiatives implemented during the year included:

• Quality Dashboard – enabling real-time monitoring and analytics for quality metrics.

• Commercial Business Case Automation – streamlining evaluation and approval processes.

• Serialization Readiness – strengthening supply chain traceability and compliance.

• Regulatory Information Management System (RIMS) – improving regulatory data governance and lifecycle management.

• SAP Paperless Preventive Maintenance – digitizing maintenance workflows to enhance equipment reliability.

• Document Management System (DMS) – centralizing document control and access.

• Electronic Computer System Validation (eCSV) – ensuring compliance and validation of digital systems.

These initiatives reflect our commitment to leveraging technology to drive operational excellence and regulatory compliance, while laying the foundation for scalable and sustainable growth.

Focus on Quality Management: At Biocon, excellence remains our benchmark, and our unwavering commitment to quality and compliance continues to drive performance across all functions. During FY25, our manufacturing sites underwent multiple regulatory inspections, aligned with new product approvals and compliance verification processes. These inspections yielded successful outcomes, underscoring the robustness of Biocons quality systems.

In June 2024, the U.S. FDA conducted GMP and pre-approval inspections at Sites 5 and 6 of our API facilities in Visakhapatnam. Both inspections were successfully concluded with the receipt of Establishment Inspection Reports (EIRs). Subsequently, in September 2024, the U.S. FDA carried out GMP inspections at Sites 1 and 2 of our API facilities in Bengaluru. These inspections were also successfully closed, with EIRs issued and classified as Voluntary Action Indicated (VAI), marking another significant milestone for the year.

Additionally, the Brazilian Health Regulatory Agency (ANVISA) conducted an audit of our API facility in Hyderabad and the oral solid dosage facility in Bengaluru. The inspections concluded without any significant or critical observations, further validating our commitment to maintaining high standards of regulatory compliance and operational excellence.

Ensuring Supply Chain Continuity and Minimizing Environmental Footprint: At Biocon, ensuring supply continuity remains a strategic priority, and we have undertaken proactive measures to de-risk our supply chain, particularly for key APIs. This includes the development of alternate vendors both within India and internationally, facilitated through technology transfers, long-term partnerships, or a combination of both. On the drug product side, in addition to our in-house manufacturing capabilities, we continue to collaborate with Contract Manufacturing Organizations (CMOs) across geographies to further strengthen supply chain resilience. The earlier acquisition of the oral solid dosage facility in the United States represents a significant step toward ensuring uninterrupted supply to customers in that region.

Aligned with our sustainability roadmap, we have implemented several initiatives across the supply value chain to reduce our environmental footprint and enhance stakeholder engagement. During FY25, we conducted ESG awareness sessions for our top suppliers, delivered either in-person or virtually, and carried out ESG audits to assess and improve supplier performance. Our broader sustainability efforts included initiatives focused on circular economy-based waste management, company-wide strategies for water neutrality, decarbonization of Scope 1 and Scope 2 emissions, and plastic sustainability.

Notably, in FY25, 99% of the electricity requirements at our Bengaluru sites and 72% of the total electricity consumption across our India-based Generics operations were met through renewable energy sources such as wind and solar, reflecting our commitment to responsible and sustainable operations

Focus on Talent Development: Biocon remains deeply committed to the continuous growth and development of its employees. A wide range of training programs were conducted during FY25 to enhance technical expertise, industry knowledge, and leadership capabilities, fostering a culture of innovation and excellence. Our flagship leadership development initiatives—BioAspire, BioLeap, and BioEdge—continued to build strategic thinking, collaboration, and team leadership across organizational levels.

These efforts are part of our broader strategy to cultivate a high-performance culture driven by empowered and accountable teams. Reflecting the impact of these initiatives, our FY25 Employee Satisfaction (ESAT) survey recorded a 93% overall satisfaction score, with 89% participation from the Generics business workforce.

Building an Inclusive Work Culture - Diversity, Equity, Inclusion, and Belonging (DEIB): At Biocon, we foster innovation, collaboration, and high performance through a strong commitment to Diversity, Equity, Inclusion, and Belonging (DEIB). We hire based on merit, guided by our core values—integrity, performance, innovation, quality, and collaboration—while promoting a culture of inclusion tailored to global and regional priorities.

Inspired by our Founder Chairperson, Kiran Mazumdar-Shaw, our focus on gender diversity has intensified, with clear targets to increase womens representation across levels. In FY25, female representation in the Generics workforce rose to 21%, up from 17.6% in FY24.

Progressive policies and programs support women in non-traditional roles, while senior leaders have adopted department-specific diversity targets to ensure accountability. Our inclusive practices are designed to empower individuals from diverse backgrounds and perspectives.

Generics – FY25 Financial Performance:

The Generics business delivered a growth of 8% in FY25 over the previous year, contributing 19% to consolidated group revenues. Revenues were at

30,175 million in FY25 as compared to 27,985 million in FY24.

The growth resulted from new formulation launches in the second half of the fiscal year and a steady full-year performance from our API business, supported by cost and operational improvement initiatives that aided volume growth. While the full-years financial performance was supported by the launch of Lenalidomide in the U.S. in the fourth quarter, a key strategic highlight of the year was the launch of our first GLP-1 peptide formulation globally, with the introduction of Liraglutide in the UK.

Formulations share of product sales increased to over 40% in FY25 from ~35% in the previous fiscal. While U.S. remained the biggest market for the formulations business, efforts to diversify continued with improved contributions from MoW markets and Europe.

Generics – FY26 Outlook:

In FY26, Biocon will maintain its strategic focus on executing its GLP-1 programs, which are poised to be a key growth driver in the coming years. This will be supported by continued emphasis on fermentation-based products and injectable formulations. We expect growth to be driven by stronger core business performance, new product launches in key regions, continued global expansion, and increased in-house manufacturing capacity to support commercial operations.

Biocon aims to achieve cost leadership by proactively executing cost optimization and operational efficiency initiatives, ensuring long-term sustainability across its generics business. The Companys vertically integrated business model, focused on strategic product portfolios and supported by a strong track record in quality and regulatory compliance, positions it well to navigate the dynamic global landscape. This foundation enables Biocon to effectively capitalize on strategic opportunities across therapeutic areas, particularly in diabetes and obesity (diabesity).

B. Novel Biologics

Biocon has consistently fostered a culture of innovation, supported by strategic investments in R&D to build robust, end-to-end capabilities. Leveraging advanced science and technology, we have developed a diversified portfolio of Biosimilars and Generics, reinforcing our position as an innovation-led organization committed to affordable healthcare.

Our Novel Biologics business focused on addressing unmet patient needs, particularly in oncology and immunology. Biocon was the first to develop, manufacture, and launch novel biologics in India—Nimotuzumab (anti-EGFR mAb) for head and neck cancer in 2006, and Itolizumab (anti-CD6 mAb) for psoriasis in 2013.

We also incubated Bicara Therapeutics, a clinical-stage biopharmaceutical company focused on bifunctional therapies for solid tumors. Bicaras lead program, ficerafusp alfa, is a bifunctional antibody. Biocon holds a 10.1% stake in Bicara, which was listed on NASDAQ in September 2024.

As part of a strategic realignment, Biocon discontinued its Novel Biologics business in December 2023.

C. Biosimilars (Biocon Biologics Limited)

Biocon Biologics Limited (BBL) is a unique, fully integrated global biosimilars company with a proven track record across the value chain from R&D to manufacturing and commercialization. A subsidiary of Biocon Limited, BBL is the largest contributor to Biocon Groups revenues and continues to be its fastest-growing business segment.

Our journey into biosimilars began in the early 2000s, when we became the worlds first company to develop and launch biosimilar human insulin in 2004, leveraging our proprietary Pichia pastoris expression platform. Building on this foundation, we expanded into the development of monoclonal antibodies (mAbs) and therapeutic proteins aimed at treating cancer and autoimmune disorders, utilizing advanced mammalian cell culture systems. As a pioneer in the biosimilars space, we have committed ~USD 1 billion each to date towards establishing cutting-edge R&D infrastructure and large-scale global manufacturing capabilities.

As one of the very few global players with a comprehensive biosimilars portfolio, Biocon Biologics addresses key therapeutic areas such as oncology, diabetes and immunology. With an unwavering commitment to quality, affordability, and access, BBL is setting new benchmarks in its mission to advance health equity worldwide.

The year FY25 marked a transformative year for BBL as we celebrated the first anniversary as a fully integrated global biosimilars company. This milestone marks our evolution from a development and manufacturing-focused organization into a unique, fully integrated, patient-centric company with a strong commercial engine with presence in over 120 countries.

Our three-stage strategy—Preserve, Consolidate, Accelerate - continues to yield results. Having successfully completed the Preserve phase in FY2024, our focus in FY2025 shifted to Consolidation, laying the groundwork for sustainable growth. We ensured business continuity by enhancing efficiencies across our value chain, building trust with patients, customers, prescribers, and payors worldwide, and expanding our reach through a combination of our own field force and strategic partnerships.

We also demonstrated predictable and consistent financial performance over the past several quarters following the integration. Additionally, we substantially improved our liquidity profile by refinancing our acquisition loan through a successful USD bond listing and a new syndicated loan facility.

Over the year, we achieved notable market share gains across key geographies, launched over 60 new products, and established long-term commercial collaborations, all strong indicators of growing stakeholder confidence in both our products and our people

Biosimilar Market: Increased Adoption and Growth

The biosimilars segment is rapidly expanding within the global pharmaceutical industry, driven by rising incidences of non-communicable diseases such as diabetes and cancer, along with improved diagnostics, proven safety and efficacy, and growing prescriber confidence.

As exclusivity for major biologic drugs expire, biosimilars offer cost-effective alternatives. Developed with the same scientific rigor and quality standards, biosimilars are addressing the challenges of cost and access while keeping patient needs at the centre. Regulatory support, coupled with growing physician and patient confidence, is accelerating market penetration across key therapeutic areas.

Exhibit 1: Upcoming Opportunities in the Global Biosimilars Market, 2024-2032F

Source: Evaluate Pharma, Frost & Sullivan: Expected LoE between 2024 to 2032 and based on peak sales between 2019-2030

40+ blockbuster biologics set to lose exclusivity between now and 2032 with a cumulative USD 260 billion+ opportunity As a result, the uptake rate in the first year after biosimilar entry has surged from 5%-40% to nearly 75%. Currently, over 70 biosimilars have been approved in the U.S. across 21 molecules, and more than 80 biosimilars have been approved in Europe across 24 molecules.

Despite the U.S. being an advanced market, the entry of biosimilars often coincides with branded biologics becoming more affordable. Biosimilars adoption has not only reduced healthcare costs but has also significantly increased access.

Emerging markets are also witnessing rapid adoption of biosimilars, fueled by the growing demand for affordable healthcare solutions. As healthcare systems in these regions face the dual challenge of rising disease prevalence and limited resources, biosimilars provide a viable solution to reduce the financial burden on both patients and healthcare systems.

Biosimilars Market: Regulatory and Policy Trends

Policymakers around the world are increasingly recognizing the potential of biosimilars to address challenges related to healthcare affordability and access. In many countries, legislative efforts are focused on promoting biosimilars as a cost-effective alternative to expensive biologic drugs. By incentivizing biosimilar development through regulatory frameworks, lawmakers aim to foster competition and reduce overall healthcare spending.

For example, in the U.S., the FDAs Biosimilars Action Plan (BAP) seeks to streamline biosimilar development and approval processes. The BAP focuses on improving regulatory clarity, enhancing communication with stakeholders, and supporting biosimilar adoption by addressing misinformation and deterring anti-competitive behavior.

Similarly, in Europe, lawmakers are encouraging biosimilar adoption through policies that promote substitution and improve access to high- quality treatments.

There is also a growing global emphasis on the localization of pharmaceutical production within regional markets. This shift is driven by trade policies, regulatory changes, and strategic goals focused on enhancing supply chain resilience and ensuring consistent access to essential medicines. As a result, companies are increasingly forming partnerships with local entities to navigate complex regulatory environments and improve market penetration.

Moreover, the integration of digital technologies, such as artificial intelligence (AI) and digital twins, is revolutionizing biosimilar development. These tools enhance manufacturing precision and accelerate clinical trial processes, contributing to more efficient and cost-effective production. Leading biosimilars companies, including Biocon Biologics, are running AI pilots at various stages of the product value chain to improve operational efficacy and reduce development timelines.

There are also discussions about allowing biosimilar manufacturers to initiate patent litigation at the start of Phase 3 clinical trials in the U.S. This approach could align biosimilar launch timelines more closely with those of generic drugs.

Diabetes Portfolio- A Key Di_erentiator

Diabetes has emerged as one of the most pressing global health challenges of the 21st century. According to the International Diabetes Federations 2025 Diabetes Atlas, approximately 589 million adults aged 20–79 are living with diabetes worldwide—equating to about 1 in 9 individuals. The prevalence of diabetes has quadrupled since 1990, with projections indicating that the number of affected adults could soar to 853 million by 2050.

At the heart of the fight against diabetes is insulin therapy. Advances in insulin formulations and delivery methods have significantly improved the management of the disease, yet there remains a global disparity in access to these life-saving treatments.

Our insulin portfolio plays a crucial role in our broader mission to enhance access to critical medicines, especially in regions where healthcare resources are limited. By expanding the availability of affordable, high-quality insulin, we aim to bridge this gap and ensure that all patients, regardless of their location or income- have the opportunity to manage their diabetes effectively.

In 2024, Biocon Biologics, along with its partners, emerged as the third- largest supplier by biologic volume of both rh-Insulin and insulin glargine U100 worldwide. Moreover, the ranked among the top five suppliers by biologic volume in 2024 across the entire insulin market, including basal, rapid-acting, and premixed insulins. (Frost & Sullivan analysis using data from the following source: IQVIA MIDAS? quarterly volume sales data for the period MAT Q4 2023 and MAT Q4 2024.)

We are witnessing a surge in global demand for Insulins. Given our global scale manufacturing capacities, we are well placed to capitalize on this large opportunity. The Biocon Group is also uniquely positioned to address the growing global burden of ‘Diabesity through its portfolio and pipeline of Insulins and GLP-1s.

Biocon Biologics Commercial Performance

Advanced Markets - North America

Biocon Biologics demonstrated strong performance across its product portfolio in the United States. The Company continues to deliver market share increases in the oncology franchise, with Ogivri? (bTrastuzumab) and Fulphila? (bPeg_lgrastim) both gaining traction. Market shares for Ogivri? in the IV segment more than doubled, increased to 26% in Q4 CY 2024 from 12% in Q4 CY 2023, while Fulphila? increased to 30% in Q4 CY 2024 from 16% in Q4 CY 2023 over the past year. Market shares of our Semglee and Insulin Glargine franchise also continue to be in mid-to-high teens including all channels. The growth in the market reflects the solid foundation we have built in the U.S. and was driven by several key formulary wins, increased pull through at the physician level and a robust pricing strategy.

The company also entered into a strategic partnership with Civica, Inc., a U.S.-based nonprofit pharmaceutical organization, to enhance the accessibility and affordability of Insulin Aspart in the United States. This collaboration aims to address the critical need for affordable insulin among the approximately 38.4 million Americans living with diabetes.

We also launched YESINTEK™ (ustekinumab-kfce) in the United States which is one of the first Stelara? (ustekinumab) biosimilar market entrants in the country and the fifth product from our portfolio to be commercialized in the country. There has been strong uptake for the product with formulary coverage of over 100 million patient lives and strong adoption at the physician level. The health plans and insurers covering Yesintek™ include CVS Health, Express Scripts National Preferred Formulary (NPF), UnitedHealth, Cigna, Navitus, Med Impact, Costco Health Solutions, multiple Blue Cross Blue Shield Plans and several closed-door health systems.

In Canada, market shares have remained stable, with Ogivri, our biosimilar trastuzumab holding 29% and Hulio, our biosimilar adalimumab at 8% as of Q4 CY2024.

Advanced Markets - Europe

In Europe, our biosimilars continue to demonstrate steady growth. Ogivri? (bTrastuzumab) grew from 10% in Q4 CY 2023 to 15% in Q4 CY 2024 and Abevmy? (bBevacizumab) increased its market share to 9% in Q4 CY 2024, up from 6% in Q4 CY 2023. The growth is primarily driven by key markets such as the Germany, France, Italy, UK, and Spain. Our Adalimumab franchise in Europe remains a significant contributor to our revenue, reflecting sustained market performance and continued prescriber confidence. We have also expanded our Immunology offering with the launch of Yesintek™ (bUstekinumab) in Germany during the last financial quarter of FY25.

Advanced Markets – Japan, Australia and New Zealand

In the JANZ markets, we are seeing continuous momentum across our key products. In Australia, our oncology portfolio bTrastuzumab and bBevacizumab recorded considerable growth, driven by multiple hospital tender wins. The market share of Ogivri (bTrastuzumab) rose to 21% in Q4 CY2024, up from 16% in Q4 CY2024. Our commercial partner, Yoshindo Inc., has launched biosimilar Ustekinumab in Japan. Developed and manufactured by Biocon Biologics, the product is being commercialized and marketed in the region through this exclusive partnership.

We continue to work closely with our integrated partner network in the JANZ region to improve access to our portfolio and broaden the reach of high-quality biosimilars.

Emerging Markets

The Emerging Markets segment closed the year on a strong note, progressing steadily from a phase of consolidation to one of acceleration. We continue to maintain leadership positions across several geographies and continue providing affordable access to patients across Emerging Marekts. We remain at the forefront in providing access to both Human and Biosimilar Insulin in all major markets notably Malaysia, Mexico & India. We continue to focus on Oncology Biosimilars in both private and tender segments of the market and have leadership position in various markets in Latam, Africa and Asia like Brazil, Philippines, South Africa, Tunisia Turkey and others Our foray into immunology segment with the launch of bAdalimumab and bEtanercept has gone as per plan, seeing us generate market share in countries like Saudia Arabia and Latam. We remain steadfast in our commitment to expanding access to our lifesaving medicines for patients across Emerging Markets. Throughout the year, we launched over 40 products across multiple geographies in the Emerging Markets.

Exhibit 3: Market Shares by Volume for Commercialized products in key Emerging Markets

Exhibit 4: Launches across markets

Portfolio and Regulatory Milestones

During the year we achieved several key regulatory milestones while our pipeline continued to progress well, which will be a key driver of future growth.

bUstekinumab

YESINTEK?, a biosimilar of Ustekinumab, has received marketing authorisation from the European Commission (EC) for use across the European Union (EU). Simultaneously, the product has been approved by Japans Pharmaceuticals and Medical Devices Agency (PMDA). In the United Kingdom (UK), the Medicines and Healthcare products Regulatory Agency (MHRA) has also granted marketing authorization.

The Company has also signed a settlement and license agreement with Janssen (Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson

& Johnson), paving the way for commercialization of YESINTEK? in Europe, the UK, Canada, and Japan.

Additionally, Biocon Biologics announced positive results from a pivotal Phase 3 randomized, double-blind, parallel group, multicenter study comparing YESINTEK? to Stelara? in adults with moderate to severe chronic plaque psoriasis, with data being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida

bDenosumab

We received positive CHMP opinions in Europe for our biosimilar Denosumab candidates across distinct therapeutic indications. Additionally, the U.S. FDA also validated our Biologics License Application (BLA) filing for biosimilar Denosumab.

bBevacizumab

The U.S. FDA has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin? (bevacizumab). The approval of JOBEVNE expands Biocon Biologics biosimilar oncology portfolio in the U.S., which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb).

bA_ibercept

Biocon Biologics has signed a settlement and license agreement with Regeneron, clearing the way to commercialize YESAFILI™ (aflibercept- jbvf ), an interchangeable biosimilar of aflibercept, in the United States. This agreement enables the Company to launch the product in the U.S. in the second half of calendar year 2026, or earlier under certain circumstances.

Additionally, Biocon Biologics has secured a settlement agreement in Canada with Bayer Inc. and Regeneron Pharmaceuticals, Inc., allowing for the launch of YESAFILI™ no later than July 1, 2025.

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmology conditions, is a biosimilar of the reference product EYLEA? (aflibercept). The product has already received approvals from several key regulators, including the U.S. FDA, MHRA, EMA, and provisional approval from Health Canada.

Exhibit 5: Approvals across markets

Facility and Audit Updates

The U.S. Food and Drug Administration (FDA) has classified all of our facilities in Bengaluru, India, as Voluntary Action Indicated (VAI).

Similarly, our facility in Malaysia has received a VAI classification from the U.S. FDA. As a next step, we are awaiting the approval of our bAspart product from the agency.

These classifications have paved the way for launching several products in the U.S and enhanced access to our life-saving medicines. In the near term, we expect to launch five products in the U.S. market including bUstekinumab, bBevacizumab, bAspart.

The European Medicines Agency has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility at Bengaluru and its insulin facility in Malaysia following routine GMP inspections, and as a result, none of our products require a pre-licensing inspection for the next three years.

In addition, the Company also received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its mabs site in Bangalore.

To date, our facilities have secured more than 90 cGMP approvals from over 25 regulatory agencies, including the U.S. FDA and EMA. These approvals underscore Biocon Biologics compliance to the highest international regulatory standards and unlock significant additional capacity to cater to the needs of patients well as our pipeline products.

ESG

ESG is core to our business operations. As part of our environmental, social, and governance (ESG) commitment, we are advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). At the heart of our mission is the commitment to providing access to life-saving medicines for patients, and we remain steadfast in our efforts to increase product approvals and launches in LIC/LMIC countries.

Over the year, we made significant progress across several key sustainability parameters, including reductions in carbon emissions, waste generation, and freshwater consumption. We also launched a global volunteering policy to promote employee engagement and social responsibility.

Biocon Biologics made its first independent submission to the Dow Jones Sustainability Indices (DJSI) and earned recognition in the S&P Global Sustainability Yearbook. Additionally, Biocon Biologics is a signatory to the United Nations Global Compact.

We also advanced our human capital initiatives by strengthening employee engagement and improving gender diversity. Notably, we released our Gender Pay Gap report, which demonstrated a global pay parity of over 95% - indicating an immaterial gap overall.

In FY25, we also initiated projects to align our emissions targets with the Science Based Targets initiative (SBTi) guidelines (work in progress) to make our ESG approach more global and reflective of the evolved nature of our business.

Financial Update

In FY25, we recorded revenue of 90,174 million, a strong 15% year-on-year growth on a like-to-like basis² driven by robust performance in Advanced and Emerging markets.

The business delivered 30,274 million in EBITDA. This includes proceeds from the strategic business transfer agreement with Eris Lifesciences for the BFI segment. Adjusting for the income from the Eris transaction, business achieved 19,710 million in EBITDA representing a healthy margin of 22%. We have continued to invest in our pipeline to support future growth with our R&D spending at 7% of revenues.

We ended the year on a strong note and remain focused on delivering profitable and sustainable growth.

During the year, we successfully completed a debut USD 800 million Senior Secured Notes issuance, listed on the Singapore Exchange, alongside securing a new USD 320 million syndicated debt facility. Proceeds from these transactions were utilized to refinance existing debt of USD 1.1 billion (INR 93,468 million). This strategic refinancing strengthens our financial flexibility and positions Biocon Biologics for long-term growth as we consolidate our business operations.

Biosimilars FY26 Outlook

In summary, this has been a year of advancing our reach, strengthening our position as a global biopharmaceutical organization, and sustaining growth momentum.

Looking ahead, we are committed to the next phase of our strategic journey — accelerating growth of our existing portfolio, broadening our geographical footprint, and gearing for a series of new product launches. These upcoming launches are expected to serve as key catalysts for driving sustainable and profitable growth in the years ahead.

D. Research Services (Syngene International Ltd.)

Syngene is a contract research, development, and manufacturing services company that offers a broad range of scientific services from the earliest stages of discovery to commercial supplies. With more than 5,600 skilled scientists, advanced technological capabilities and in-depth scientific expertise, Syngene stands out as a preferred partner for biopharmaceutical companies seeking integrated drug discovery, development and manufacturing services. Although its primary focus is on the pharmaceutical sector, Syngene also collaborates with companies in nutrition, animal health, consumer products, and specialty chemicals. The Company has worked with around 400 clients primarily situated in the United States, Europe and the UK.

Syngene provides end-to-end services as a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) for large and small molecules. The Company offers different collaboration models ranging from long-term relationships with dedicated R&D facilities to Full-Time Equivalent (FTE) and Fee-for-Service (FFS) arrangements.

Contract Research Organization (CRO)

Syngene is a contract research, development, and manufacturing services company that offers a broad range of scientific services from the earliest stages of discovery to commercial supplies. With more than 5,600 skilled scientists, advanced technological capabilities and in-depth scientific expertise, Syngene stands out as a preferred partner for biopharmaceutical companies seeking integrated drug discovery, development and manufacturing services. Although its primary focus is on the pharmaceutical sector, Syngene also collaborates with companies in nutrition, animal health, consumer products, and specialty chemicals. The Company has worked with around 400 clients primarily situated in the United States, Europe and the UK.

Syngene provides end-to-end services as a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) for large and small molecules. The Company offers different collaboration models ranging from long-term relationships with dedicated R&D facilities to Full-Time Equivalent (FTE) and Fee-for-Service (FFS) arrangements.

CRO Market

Contract Research Organization (CROs) provides research services to pharmaceutical, biotechnology, medical device, and other industries in the form of services outsourced on a contract basis. The contract research industry has experienced rapid growth over the past decade with the pharmaceutical industry continuing to invest heavily in R&D, in order to develop innovative therapies that address unmet medical needs.

The global CRO market size was valued at USD 23 billion in 2023 and is expected to grow at a CAGR of 10% to USD 37 billion in 2028³. The growth of the CRO market is driven by factors such as increasing R&D activities in the pharmaceutical and biotechnology industries, rising demand for outsourcing activities and improving technological capabilities and global expertise

FY25 was a challenging year for the research services industry as a whole as Biotech funding challenges in the U.S. impacted client spend for research services. Funding slowdown in 2022 and 2023 had pushed biotech companies to prioritize their spending towards development / late-stage assets, as these were most likely to be attractive immediately to potential acquirers. With overall funding in 2024 around pre-Covid levels, its flow towards research and preclinical work are showing signs of gradual recovery, resulting in higher requests for proposals and enquiries for CROs. However, the recovery of business has been uneven with many customers taking longer for decision making and looking to commission smaller work packages to prioritize programs and extend cash funds. Biotech funding in Jan-March 2025 was down both y-o-y and sequentially. The pace of recovery in Biotech funding will be a key variable for growth in the CRO segment.

The pandemic and recent geopolitical events highlight the risks associated with relying on a single supply route. As a result, many companies are looking to build resilience in their supply chains by expanding and diversifying their suppliers to mitigate the risks. In addition, the geopolitical shifts and China + 1 strategy are encouraging companies to consider outsourcing to countries like India. Considering these demand drivers for the CRO industry, we believe the long-term fundamentals of the industry are intact.

Our CRO Business:

The Company offers its Research Services through various flexible models, which include shared resources and infrastructure as well as the option of a dedicated facility. The newly formed Research Services division comprises the legacy Discovery Services, Dedicated centres and Translational & Clinical Research.

Discovery services span the entire spectrum of early-stage research from target identification to delivery of drug candidates for further development across small and large molecules. Syngenes flexible approach provides its clients with a choice of individual functional services or integrated drug discovery solutions. Functional services include chemistry, biology, safety assessment and toxicology, and computational and data sciences. Integrated Drug Discovery services

– Synvent, encompasses the functional domains with a program management approach across various stages of the drug discovery process.

Dedicated Centres are built on long term strategic partnerships, offering dedicated multi-disciplinary scientific teams, support personnel, and a tailormade ring-fenced infrastructure to support the clients R&D goals.

Contract Development and Manufacturing Organization (CDMO) CDMO Market:

CDMOs specialize in the development, scale-up and manufacturing of drug products both for clinical trials and commercial distribution. CDMOs offer a range of services that include drug development, process development, analytical testing, formulation development, scale-up, manufacturing, packaging, and distribution. These services can be provided on a stand- alone basis or as part of a complete end-to-end service offering.

The global CDMO (Small molecule + Large molecule) market was valued at ~USD 120 billion in 2023 and expected to grow at a CAGR of 8% to reach a market size of USD 176 billion by 2028³. Strong technical and R&D infrastructure capabilities, availability of skilled scientific talent and quality manufacturing with strong track record of regulatory compliance, are some of the key success factors for a CDMO. The reliance on CDMOs will further increase going forward as they continue to offer innovator pharmaceutical companies commercially feasible solutions for a range of drug development and manufacturing services, such as pharmaceutical formulation, analytical development, process optimization, and scale-up manufacturing.

Small Molecule CDMO Market

A typical small molecule CDMO offers services in clinical scale drug substance and drug product development, clinical scale manufacturing services and commercial scale development and manufacturing services. The global small molecule CDMO market was ~USD 99 billion in the year 2023 and is expected to grow at a CAGR of 7% to reach a market size of ~USD 137 billion by 2028⁴.

Our Small Molecule CDMO Business:

We restructured our operating model with the integration of small molecule development and manufacturing into a single division. It now mirrors how our clients approach their commercial manufacturing requirements. To support this, we have consolidated our drug substance (DS) and drug product (DP) salesforce and strengthened our leadership team with step up hires.

In Small Molecule CDMO Development Services, Syngene offers preclinical development, API and drug product development. We engage in drug development services from lead generation to clinical supplies of drug substance and drug product. We also support our clients in drug filing with US FDA and other regulatory authorities.

The Company has an integrated small molecule offering including process development, nGMP supplies and clinical and commercial supplies. The Company has a state-of-the-art small molecule commercial manufacturing facility in Mangalore which is US FDA approved.

In the financial year 2025, Syngenes primary focus was on expanding capabilities through modifications to existing facilities, the construction of new ones, and strengthening our team by bringing in subject matter experts for emerging modalities.

Large Molecule CDMO Market

The large molecule market size is currently estimated at USD 22 billion and is forecast to grow at a CAGR of 12% to reach the market size of USD 39 billion in 2028⁴ Drug development for large molecules can be divided into two sections: drug substance (DS) development, which includes the development of master and working cell banks, manufacturing process development, and scale-up; and drug product (DP) development, which includes filling the drug substance into the primary containers.

Our Large Molecule CDMO Business:

The Company is a fully integrated custom biomanufacturer. Our solutions include mammalian and microbial capabilities for clinical and commercial supplies. We have a strong track record in terms of experience and know-how across monoclonal antibodies, bispecific, antibody fragments, recombinant proteins, glycoproteins, mRNA, microbial (E. coli and Pichia) and microbiome Live Biotherapeutic Product (LBP).

Our biologics manufacturing facility can accommodate multi-product production campaigns simultaneously, based on a single-use technology platform. It is designed to support clients during long-term commercial manufacturing campaigns. Our facility has a wide range of the latest technology combined with rich experience in handling cell culture-based products.

We intend to expand the portfolio in new growth areas by continuing progress in niche microbial and emerging Advanced Therapy Medicinal Products (ATMP) areas, expand portfolio with capability investments including ADC market via investment in commercial scale bioconjugation capability and drug product market.

The Company aims to enhance the business through further improving Syngenes biologics brand and commercial reach in human and animal health. Syngene acquired Unit 3 and recently entered the US market through the acquisition of the Emergent Baltimore facility. The focus now is to build a pipeline of projects that generate recurring revenue and expand our integrated development pipeline to feed future commercial launches. We will continue to expedite building our capabilities and focus on deriving efficiencies in the business.

Research Services (Syngene) - FY25 Highlights:

The Company continued to add capacity and capabilities in Discovery Services at its Bangalore and Hyderabad campuses in areas such as antibody-drug conjugates, peptides and oligonucleotides. Within Research services, Syngene continued to receive pilot projects from large and medium sized pharma companies and successfully converted majority of these programs into full-fledged contracts. Syngene continued technology upgrades and automation in its operations to enhance scientific excellence.

In small molecule CDMO, a new, dedicated laboratory for the synthesis of potent molecules has been established. A state-of-the-art facility for handling molecules under OEB-4 conditions has been set up at the Mangalore site. The Company has also been focusing on executing process development projects to build further on follow-the-molecule approach.

Syngene acquired its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines. The state-of-the-art biologics facility, acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC (a subsidiary of Emergent BioSolutions Inc.), will expand Syngenes growing global biologics footprint to better serve its customers across both human and animal health market segments. It enables Syngene to expand its footprint in the largest US market and comply with requirements of clients looking for USDA approvals for their products. The new site will increase Syngenes total single-use bioreactor capacity to 50,000L for large molecule discovery, development and manufacturing services.

During the year, the Company introduced a protein production platform, which reduces development timelines by months for a variety of biologics. Syngene progressed with repurposing the biologics manufacturing facility (Unit III) acquired in FY25. The facility has recently got local regulatory approvals. During the year, Syngene achieved a milestone by becoming the first company in the Indian pharma and life sciences industry to earn the 5S certification (5S is a cyclical methodology: sort, set in order, shine, standardize, sustain the cycle) for the biologics quality control laboratory.

Research Services (Syngene) - FY25 Financial Performance:

Syngene generated operating revenues of 36,424 million, contributing to 23% of Biocons overall revenues and reflecting a growth of 4% over FY24, underpinned by growth in Research Services and Large Molecule CDMO business partially offset by decline in Small Molecule CDMO business.

The growth in Research services was led by pipeline build of pilot programs in discovery services deriving from large- and medium-sized pharma companies as they rebalance their China+1 supply chain network. Syngene has been successful in converting the majority of those pilots into full program contracts. Dedicated centers delivered at sustained pace.

Syngenes large molecule biologics business has delivered another strong year performance with FY25 growth of over 20% primarily driven by the ramp-up in commercial volumes. In the second half of the year, the company concluded several new collaborations with clients to execute integrated biologics development and manufacturing projects across both human and animal health that have the potential to feed into the pipeline for future commercial manufacturing.

Talking about the revenue breakup, Research Services remained stable, contributing to 61% of the total revenue, consistent with last year. Our large molecule CDMO business saw a solid uptick with its revenue share increasing to 25% in FY25 from 21% in FY24. On the other hand, small molecule CDMO contributed 12% this year, down from 16% in the prior year.

The consolidated financial performance of Syngene for FY25 is available in its Annual Report.

Research Services (Syngene) – FY26 Outlook:

We expect FY26 to be a transient year with uncertain short-term macro environment including pace of recovery in biotech funding, big pharma restructuring and tempering of urgency on the Biosecure Act. However, our underlying business growth remains strong with revenue growth in the early teens, driven by performance across research and CDMO businesses.

Adjusted for the need to balance client inventory in the large molecule commercial manufacturing, our reported revenue growth is likely to be in the mid-single digits. We have invested in building capabilities both in India and the acquisition of the biologics facility in the U.S. to strengthen our leading position in the biologics market. With the new facilities coming online and the ramp-up over the couple of years, we expect margins to moderate in the near term. We will continue to strategically invest in areas that strengthen our position as a leading integrated provider of research, development and manufacturing services. We will continue to add new niche capabilities and capacities that position us an integrated, differentiated and valued service provider for our clients.

Financial Performance - An Overview Consolidated Statement of Profit and Loss

The following table highlights key components of the statement of Profit and Loss for the fiscal years ended March 31, 2025 (FY25) and March 31, 2024 (FY24).

Total income

During the year, Total income grew by 5% from 156,212 million to 164,699 million. Revenue from operations in Generics, Biosimilars and Research Services was up 8%, 2% and 4% respectively. Our Total income number includes 10,573 million of stake dilution and fair valuation gain in Bicara, pursuant to fund raise during the year.

Our Biosimilar revenues have increased by 2% over last year to 90,174 million. Adjusted for sales from Branded Formulations Unit, India (BFI), BFI divestment gain, licensing income and forex/ derivative accounting, revenues have grown 15% over last year. Growth in revenues has come from an increase in market shares of products in the U.S., EU and Emerging markets and new launches.

Generics revenues grew 8% to 30,175 million. Formulations business saw encouraging growth, driven by new product launches, strengthening of our US business footprint, further traction in our wider geographic expansion initiatives through both our direct-to-market and strategic partnership models. Momentum in our formulations business, the API sales uptick in the second half balanced the challenges we faced in pricing pressures on our API business, which witnessed modest year-on-year growth.

The Research services grew 4% at 36,424 million on strong performance in the large molecule CDMO business and recovery of performance in discovery services in the second half that was impacted due to slowdown in biotech funding. Dedicated centers and small molecule delivered at sustained pace.

The Total Income composition for FY25 and FY24 is detailed below:

Cost of material costs consumed.

Material costs include raw materials, packing materials and change in inventories. In FY25, material costs, as a percentage of revenue from operations stood at 34%, up by 85 bps from FY24.

Employee benefit expense

Employee costs comprise of the following items:

• Salaries, wages, allowances, and bonuses

• Contributions to provident fund

• Contributions to gratuity

• Amortisation of employees stock compensation expenses; and

• Employee welfare expenses including employee insurance.

These expenses increased by 38% in FY25, driven by increased cost on headcount (transition from Viatris with corresponding decline in overheads from Viatris transition services under other expenses), new facilities moving to operational phase and annual increments.

Interest and Finance charges

The finance cost for FY25 decreased to 8,974 million from 9,744 million in FY24 primarily due to debt reduction in second half of FY24.

Depreciation and Amortisation

During the fiscal, the depreciation and amortisation cost increased 8% at 16,870 million from 15,688 million in FY24 on new facilities across generics and biosimilars.

Research and development expenses

The net R&D expenditure for FY25 decreased by 26% to 8,585 million ( 11,540 million in FY24). Net R&D was at 7% of revenue ex-Syngene. The R&D spend decreased due to reduced clinical spends in biosimilar development programs.

Other expense

Other expenses comprise power and fuel costs, professional fees, overheads from Viatris biosimilar business, and other selling expenses such as freight outwards and general overheads. Other expenses for FY25 decreased by 5% to 30,952 million ( 32,681 million in FY24). Other expenses as a percentage of revenue reduced from 21% to 19% in FY25 driven by movement of overheads on Viatris acquisition to employee benefit expenses.

Tax expenses

The effective tax rate (ETR) for the year before the exceptional item and deferred tax charge on withdrawal of indexation benefit was 23% compared to 15% in FY24. Increase is mainly due to higher ETR in Biosimilars and Research services.

Exceptional items (net)

The Exceptional items include the following:

a. BBL liquidated inventory provided as exceptional in the previous year for 885 million. Hence, the related provision has been reversed in the financial results. Consequential tax impact 147 million is included within tax expense.

b. Syngene received its final claim of 320 million from the insurance company for the loss of fixed assets in fire incident on December 12, 2016.

c. Pursuant to repayment of the acquisition debt, BBL has written off the unamortized portion of such debt raise cost amounting to

1,216 million pertaining to such acquisition debt. Consequent tax impact of 304 million is included within tax expense.

d. BBL was settled with 2,518 million towards working capital under the existing arrangements, which was recorded at fair value of 1,136 million. The resulting difference of 1,185 million is recorded as a gain in the financial results. Consequential tax impact of 284 million is included within tax expense.

e. Biocon Pharma Inc (‘BPI) pursuant to the uncertainty in commercialization of product in certain territories, recorded an impairment of the carrying value of the intangible asset amounting to 86 million as impairment of the carrying value of the intangible asset during the year.

f. The Group has fair valued equity shares issued by Indian Foundation for Quality Management (‘IFQM) and has recorded fair value charge of 75

Other comprehensive income

Other comprehensive income includes re-measurement gains/ losses on defined benefit plans, gains/losses on hedging instruments designated as cash flow hedges and exchange differences on translation of foreign operations, gains/losses on the fair value of the investment in equity through Fair Value through Other Comprehensive Income (FVOCI).

Consolidated Balance Sheet

The following table highlights the Consolidated Balance Sheet as on March 31, 2025 (FY25) and March 31, 2024 (FY24)

Tangible assets

Tangible assets grew 12%, primarily due to additions in Biosimilars facility expansion in Malaysia and India, Generics peptides facility and Research Services in Hyderabad and acquisition of Emergent facility in US, partly offset by depreciation during the year.

Goodwill and intangible assets

Goodwill and intangible assets are primarily on account of the acquisition of Viatris biosimilars business and intangibles under development in Biosimilars.

Inventories

Inventories stood at 49,311 million (March 24 - 49,439 million). Increase was on account of inventory built up in Generics to support new launches partly offset by inventory optimisation in Biosimilars and Research.

Financial assets

Financial assets primarily include Trade and other receivables, derivative assets, and other financial assets. Decrease is primarily due to improvement in collection from customers in Generics and Biosimilars business.

Other assets

Other assets comprise of Balance with statutory / government authorities, capital and other supplier advances, prepayments. Increase is on account of PLI receivable and other balances with government authorities.

Share Capital and other equity

Other equity majorly comprises of securities premium, treasury shares, retained earnings, and further reserves. The Companys total other equity increased by 9% in FY25. Increase is mainly due to earnings and other comprehensive income for the year.

Non-controlling interests

The profit attributable to minority shareholders increased due to current years profit accumulation and issue of shares by Subsidiary.

Borrowings

Total Borrowings stood at 177,555 million (March 31, 2024: 157,296 million). During the year ended March 31, 2025. Net Debt stood at

128,300 million (March 31, 2024: 126,280 million)

Financial liabilities

Other financial liabilities primarily comprise 14,186 million of gross liability on written put options to enable investors of our subsidiary, Biocon Biologics Limited, to exit over a period of time and 5,126 million of deferred compensation payable for Viatris acquisition. Further, it also includes trade and capital goods payables, lease, derivative liabilities, and other liabilities.

Provisions and other non-current liabilities

Provisions and other non-current liabilities primarily include deferred revenue, deferred tax liability and provision for gratuity and compensated absences.

Key financial ratios

# Operating margin is defined as Profit before taxes, interest and depreciation

* Net Profit before exceptional item and tax thereon

^ Net Profit before exceptional income and tax thereon to average equity

Risks, Threats, and Concerns Risk Management:

Risk, as defined by ISO 31000:2018 (Risk Management - Principles and Guidelines), "is the effect of uncertainty on objectives". A risk is a potential event or non-event, the occurrence or non-occurrence of which can adversely affect the objectives or strategy of the company or result in opportunities being missed. Risk is measured in terms of likelihood of occurrence and potential impact if it materializes. Risks can be categorized as Strategic, Regulatory and Statutory, Sectoral, Geo-political, Information technology, Catastrophic, Executional/ Operational, and Sustainability (ESG).

By effectively managing the risks that may have a material impact on the business either financially or otherwise, one can create sustainable value for all stakeholders. Therefore, identifying, assessing, and effectively managing key risks that matter is critical to attaining strategic objectives and to protect the interest of the stakeholders.

Enterprise Risk Management (ERM) is an integrated approach to proactively managing risks which affect the achievement of vision, mission, and objectives. Risk management does not aim at eliminating the risks, as that would simultaneously eliminate all chances of rewards/ opportunities. Risk Management is instead focused on ensuring that these risks are known and addressed through a pragmatic and effective risk management process.

At Biocon Limited we follow a robust Risk Management framework that ensures business operations continue uninterrupted. The key objectives are:

? Better understand the Companys risk profile.

? Increased certainty and fewer surprises.

? Ensure that the Executive Leadership team can make informed business decisions based on risk assessment.

? Sound business opportunities are identified and pursued without exposing the business to an unacceptable level of risk.

? Contribute to safeguard Company value and interest of shareholders.

? Improve compliance with good corporate governance guidelines and practices as well as laws and regulations.

Our Risk Management Process:

Once a risk is identified, there are four different ways in which a risk can be handled – Treat, Terminate, Transfer, Take. At Biocon, a responsive action plan is initiated for treating or managing the key risks identified and bringing them to a tolerable level.

The risk management process at Biocon involves the following four steps:

1. Risk Identification and Assessment

2. Risk Prioritization

3. Risk Mitigation

4. Risk Monitoring and Reporting

The organizations risks are identified, assessed, and prioritized on a periodic basis. The risk monitoring and reporting process aims to provide assurance to the Management that risks have been adequately identified, assessed, prioritized based on its impact on business and the likelihood of occurrence, and mitigation strategies put in place and regularly monitored for their effectiveness. The Risk Management Committee reviews the key risks that matter with respect to their gross exposure, mitigation action status, and net exposure periodically.

Our Risk Management Structure:

Biocon Limiteds Board of Directors has direct oversight of the Companys overall risk management framework. The Board has formed a Risk Management Committee which reviews key existing and emerging risks, monitors the adequacy of mitigation strategies as well as the progress on implementing such strategies. The Risk Management Committee, which comprises of the Chairperson, Independent Directors and Managing Director and CEO meet once every quarter, and invites senior business leaders, who are essential to the discussions, to these meetings.

An enterprise-wide risk evaluation and validation process is conducted regularly and reviewed by the Risk Management Committee and the Board of Directors. The three lines of defense model lays out clear risk management responsibilities and accountabilities to ensure a company?s risk-related objectives are achieved. In this model, the first line i.e., Departments/ Functions (risk owners, risk managers and business unit heads) are responsible for executing and implementing the risk management initiatives set and assigned by the second line; the second line i.e., the Risk Management Committee and Executive Leadership Team with the support of Chief Risk Officer establishes the framework sets approach, provides direction and monitors risk management activities. The third line, i.e., the internal audit/ Governance, Risk, and Compliance (GRC) team or an external auditor, provides independent assurance that organizational practices are aligned with the companys risk strategy and policies, as implemented by the first and second lines.

Collaboration: With time, the practice of risk management has shifted in a fundamental way. In the past, risks were managed in "silos". Over time, risk management framework recognized that risks, by their nature, are highly interconnected and interdependent. This evolved approach views all risks together, within a coordinated and strategic framework, which is integrated throughout the organization cutting across functions. To formalize and communicate its approach to risk management, the Company has put in place an enterprise-wide Risk Management Framework. This holistic approach provides the assurance that, to the best of its capabilities, the Company and all its business units identify, assess, and mitigate risks that could materially impact on its performance in achieving the stated objectives. Our Chief Risk Officer works closely with all key functional heads who are the Risk and Mitigation plan owners.

Our integrated approach to risk management encompasses both business risks and ESG-related risks. This comprehensive view acknowledges the interconnected nature of risks across the Company, its stakeholders. and the value chain.

Our risk universe covers the entire gamut of risk exposure categorized under Sectoral, Strategic, Information Technology, Catastrophic, ESG/ Sustainability, Geo-political, Regulatory and Statutory, and Executional/ Operational risks. From this risk library the key risks that matter are arrived at based on the high impact on business and the high likelihood of occurrence. For the key risks that matter, mitigation strategies are developed, implemented, and assessed on a periodic basis.

Risk Culture: To strengthen the risk culture across the Organization, we undertake awareness programs with relevant stakeholders to educate them on the significance of risk management and encourage a culture of constant feedback to drive continuous improvement in our risk management systems and processes.

Key Business Risks and Opportunities:

Our established risk management framework addresses risks that are inherent to the pharma business and any others that may impact on our strategic goals. The following summary indicates some of our key risks and mitigation measures drawn from management reviews and deliberations with the Risk Management Committee:

A keen eye to identify and understand Significant Emerging Risks and Opportunities is also placed from time to time. This enables the company to manage these risks and safeguard our business proactively.

Currently the Generics industry faces two opposing forces that complicate profitability and growth. While demand for generics continues to increase globally and there will be an increase in number of blockbusters and other small molecule drugs going off-patent globally in next 5 years, buyers consolidation/ consortia may further add to the existing price pressure and limit generics manufacturers pricing power, reduce profitability and force to exit markets.

Geopolitical risks include the collapse of a multilateral institution, interstate conflicts, global trade wars and tariffs, terrorist attacks, etc. Any occurrence of this nature has the potential to severely disrupt our operations along with irreparable damage to life, access to medicines, livelihood and the ecosystem. Consistent monitoring of the regional policies and statutes in different countries where our products are marketed and sold is undertaken to ensure compliance.

An early alert to such risk events and scenarios provides us with the ability to plan, prepare for and respond against adverse impact and based on the assessment, it will be taken either as a placeholder in our risk library or if rated high, included in the key risks that matter for mitigation and monitoring.

AI and ML-driven drug discovery startups are transforming the traditional generics industry by speeding up the discovery process and bringing innovative medications and therapies to market. While these technologies can expedite R&D, improve productivity and lower costs, they pose risks in terms of data governance, bias, and IP disputes.

The World Economic Forums Global Risks Report 2023 identifies misinformation as the fifth most severe long term global risk. As the internet continues to evolve, pharmaceutical companies face increasing vulnerability to misinformation campaigns that can disseminate unreliable information about their products, ultimately undermining public trust in both the brand and the industry as a whole.

Our way forward plan is to further embed these risk management practices into the wider organization, by taking measures to educate and incentivize employees at all levels of the business, thereby nurturing a strong and effective risk culture. Creating a strong risk culture is important for integrating risk processes, procedures, and employee awareness throughout the organization. Such an approach ensures risk management is not just a compliance exercise but a fundamental part of the companys operational mindset.

Internal Controls

The Company has laid down guidelines, processes, and structures, which enable implementation of appropriate internal control systems commensurate with the business requirements, scale of operations and applicable statutes. Such internal financial controls encompass policies, processes and key activities or 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 fraud 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).

The Company is staffed by experienced, qualified professionals who play an important role in designing, implementing, maintaining, and monitoring our internal control systems. Appropriate review and self-certification mechanisms have been put in place to ensure that such control systems are adequate and are operating effectively on an ongoing basis.

The Corporate Internal Audit team is an independent assurance and advisory function, responsible for evaluating and improving the effectiveness of controls, risk management practices and governance processes. This function helps to enhance and protect organizational value by providing risk-based objective assurance, advice and insights.

The internal audit team prepares annual audit plans based on risk assessment, which are approved by the Audit Committee of the Board. Audit execution is done in a co-sourcing model, partly in-house and partly by an Audit Firm. Such independent audits provide reasonable assurance of internal control effectiveness and benchmark on industry-wide best practices.

The firm representative and the Head of Internal Audit present an update on a quarterly basis on their respective areas of scope to the Audit Committee. The Audit Committee, consisting of Independent Directors, reviews important issues raised by the auditors regularly, alongside the remediation actions to ensure the control environment stays strong and risks are mitigated appropriately on a timely basis.