Annual Report 2023-24

Contents

Driving sustainable growth

INTEGRATED REPORT

01-05

Introduction

2 About the report

4 Performance highlights

06-17

Corporate overview

1. Aurobindo Pharma at a glance

1. Product portfolio

1. Geographic footprint

45

Awards and recognition

46-97

Capital-wise performance

46 Financial capital

1. Manufactured capital

1. Intellectual capital

1. Human capital

1. Social and relationship capital

1. Natural capital

As a leading global generic pharmaceutical company, our focus on building large-scale manufacturing capabilities and backward integration have been instrumental in our growth journey. Our R&D played a key role in creating a distinctive and diverse product portfolio catering to emerging patient needs, complemented by a robust and expansive supply chain to ensure reliable access to essential medicines worldwide.

Our commitment to stringent quality assurance and disciplined risk management has not only fuelled growth but also positioned us as a trusted partner in the global pharmaceutical market.

In our pursuit of sustainable growth, we prioritise developing differentiated products, delivering on strategic objectives, and striving for excellence in all our endeavours.

18-23

Performance overview

1. Vice Chairman & Managing Director's message

1. Key performance indicators

1. Business segment review

24-39

Value creation approach

1. Value creation model

1. Operating landscape

1. Strategic priorities

1. Stakeholder engagement

1. Materiality assessment

1. Sustainability goals and progress

1. Contribution to UN SDGs

40-44

Governance

1. Ethics and corporate culture

1. Board of Directors

1. Risk management

STATUTORY REPORTS

98-253

98 Notice

118 Board's Report

1. Management Discussion and Analysis

1. Risk Management

1. Business Responsibility & Sustainability Report

1. Report on Corporate Governance

FINANCIAL STATEMENTS

254-455

1. Standalone

1. Consolidated

456

Commercial manufacturing units

Develop

Excel

We are committed to continuous improvement in everything

we do, ensuring operational excellence through optimised capacity utilisation and a high-performance supply chain while upholding high standards of quality.

About the report

Value creation through capitals

The report illustrates our integrated approach to value creation, depicting how each capital contributes to addressing material issues and creating value for stakeholders.

Our integrated approach

We at Aurobindo Pharma Limited, are delighted to present our second integrated annual report, providing stakeholders with a comprehensive overview of our financial and non-financial performance, strategy and outlook.

Capital

Financial capital

Demonstrating financial discipline, we allocate cash from operations, divestitures, and financing to sustain our business, invest in future capabilities, capitalise

on growth opportunities, and distribute profits to shareholders.

Material issues

Customer welfare and satisfaction, Business ethics & accountability, Governance and code of business conduct.

Stakeholders impacted

Page 46

Manufactured capital

Our investments in capacity expansion ensure supply chain resilience, operational flexibility, environmental control, and regulatory compliance, enabling the production of valuable products.

Material issues

Pharmacovigilance, Regulatory compliance, Sustainable supply chain management.

Stakeholders impacted

Page 50

Intellectual capital

Our competitive edge lies in our technological prowess, operational excellence, and digital initiatives, reinforcing our foundation.

Material issues

R&D, Intellectual property.

Stakeholders impacted

Page 56

We are focused on developing a strong pipeline and driving the commercialisation of our key projects, which gives us confidence in sustaining our growth trajectory.

The report will address key topics relevant to each stakeholder group, providing transparency in our ways of working, continuous and clear communication on all aspects, and maintaining ethical business practices.

Reporting Period:

April 1, 2023, to March 31, 2024

Framework and standards

Our reporting process is guided by the Integrated Reporting (IR) Framework, established by the International Integrated Reporting Council (IIRC). The preparation of this report involves a structured content-gathering exercise across the entire organisation, which is driven by cross-functional teams and emphasises interaction with multiple stakeholders. This comprehensive approach prioritises future business and societal objectives.

Scope and boundary

This report encompasses data from all our global product manufacturing facilities, research, and development centres and marketing operations.

It includes information on ingredient sourcing, patient management, product packaging, and warehousing facilities.

Sustainability performance is evaluated specifically for our manufacturing and R&D facilities, as well as initiatives undertaken by our corporate office in Hyderabad, India.

Human capital

Our workforce, diverse and innovative, drives continuous stakeholder value through skill retention, career development, and robust succession planning, fostering an inclusive environment.

Material issues

Talent Attraction and Retention, Training & Development, Human rights, Diversity & Inclusiveness.

Social and relationship capital

We are dedicated to fostering a supportive environment for operations and investments, engaging stakeholders to tackle challenges and achieve strategic objectives through a multi-stakeholder approach.

Material issues

Affordability (Pricing), CSR, Antimicrobial resistance, Access to healthcare.

Natural capital

Utilising natural resources responsibly, we develop health-promoting products while striving for self-sufficiency, resource efficiency, and renewable energy adoption to minimise environmental impact.

Material issues

Energy efficiency, GHG emission, Water management, Renewable energy.

Feedback and contact

We value your feedback, which helps us enhance our reporting.

Please email us at: jvnreddy@aurobindo.com| ir@aurobindo.com| cc@aurobindo.com

Stakeholders impacted

Stakeholders impacted

Stakeholders impacted

Note:

Aurobindo Pharma Limited is also referred to as Aurobindo Pharma, APL, the Company or Our Company across the Integrated Annual Report.

2

3

Performance highlights

FinancialNon-financial

Environment

5%

Reduction in energy intensity (GJ/Turnover) (baseline year FY20)

~23%

Reuse of waste water out of total waste water generated (232,373 KL)

~16%

Reduction in carbon emissions (237,455 tCO2e reduction compared to FY20)

~14% (power to power) Renewable energy used in operations (124,446 MWh)

y-o-y growth

Social

~24

Training hours per employee

12.54%

Women in workforce

8.59 Lakh

Lives impacted through CSR interventions

Governance

50%

Board comprises Independent Directors, of which two are women

8

Non-executive Directors, including Independent Directors

2

Executive Directors

14 years

Average tenure of the Directors on our Board

4

5

Aurobindo Pharma at a glance

Global leadership

#1 Largest Generic pharma company in the US by Rx dispensed*

Committed to healthier life

We are a leading, well-integrated global pharmaceutical company, dedicated to making medicines affordable and

Ranked among Top-10 Generic companies in eight countries

in Europe

2nd largest listed Indian pharma company by Revenue from operations

accessible for patients worldwide.

29

From conception to commercialisation, we have developed capabilities and capacities across formulations and active pharmaceutical ingredients (API) to deliver a wide product portfolio that caters to diverse market needs and continues to make a difference in the lives of millions of patients across the world.

State-of-the-art commercial manufacturing facilities, with export presence in 150+ countries

9

R&D centres with 1,500+ scientists and analysts driving development

Vision

To become a leading and an admired global pharma company, ranked within the top 25 by 2030.

Mission

To become the most valued pharma partner to the world pharma fraternity by continuously researching, developing, and manufacturing a wide range of pharmaceutical products that comply with the highest regulatory standards.

37,000+

Global workforce including both permanent employees and contractual workers

* As per IQVIA MAT March 2024.

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7

Aurobindo Pharma at a glance

Business Segments

Formulations

Our formulations business focuses on developing and manufacturing a diverse range of pharmaceutical products to meet the evolving needs of

patients worldwide.

With a strong emphasis on quality and continuous development, we specialise in creating medications in various dosage forms, including oral solids, liquids, and injectables. Our formulations

target key therapeutic areas, including:

* Excludes current capacity expansion plans.

Active Pharmaceutical Ingredients (API) & Intermediates

Leveraging our expertise in process chemistry and the advantages of large-scale production, we have positioned ourselves as a cost-effective provider of API, which caters to both captive requirement and external customers.

We manufacture 52% of

our API requirements in-house.

Our API business covers a wide range of therapeutic areas, contributing to the profitability and growth of our formulations segment. Additionally, we are among the few companies present across beta-lactams and non-beta lactams. Within beta lactams, we offer both sterile and non-sterile Penicillin, Cephalosporins, and Penems.

* Excludes current capacity expansion plans.

Segment-wise revenue breakup

Revenue (₹ in crores)

Segment-wise contribution

Total revenue (%)

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9

Product portfolio

Biosimilars

CuraTeQ Biologics

(a wholly owned subsidiary of Aurobindo Pharma) is a biopharmaceutical company focused on developing cost-effective biosimilars for treating patients affected by life-threatening and debilitating diseases.

Biosimilars can be a safe alternative by providing the same benefits as already licensed biologic drugs and have

the potential to democratise access to life saving therapies. CuraTeQ's portfolio of 14 biosimilars, primarily in oncology and immunology segments, can deliver long-term and sustainable benefit to patients, health care systems, and shareholders. CuraTeQ has completed licensure clinical trials for three oncology biosimilars, which are filed with the European Medicines Agency. Four more biosimilars are in global Phase 3 clinical trials, of which at least two biosimilars will complete their clinical study requirements and will enter the filing phase in the next year. CuraTeQ has received marketing authorisation from the

Central Drugs Standard Control Organisation (CDSCO, India) for biosimilar trastuzumab, a humanised monoclonal antibody that is used in the treatment of early-stage and metastatic breast cancers. Our trastuzumab biosimilar product was developed using a "totality of evidence approach" to establish equivalence in terms of quality, safety, and efficacy to the originator product. The biosimilar was subjected to extensive analytical comparability testing, PK/PD assessment in healthy volunteers, and an efficacy clinical trial in 690 metastatic breast cancer patients.

Enhancing patient care through continuous development

Diverse product portfolio

We are expanding and diversifying our product pipeline, particularly in specialty and complex generics, leveraging our in-house development capabilities and through targeted acquisitions. Our development programs for biosimilars and vaccines will further serve evolving patient needs.

14

Biosimilars are in our product pipeline

Immunology and oncology

Target therapeutic segments

4

Products in global phase 3 clinical trials

Product portfolio

Dermatology

In our pursuit of developing advanced formulations, we are dedicated to developing drug delivery solutions through the dermal route, including topical and transdermal products.

Topical products

Topical formulations are essential in dermatological care, offering targeted treatment directly to affected areas of the skin. These formulations include creams, foams, shampoos, and specialised products tailored to address various skin conditions. Our in-house capabilities enable efficient in-vitro studies, reducing development timelines while ensuring efficacy.

44

Products in the portfolio including those under development

Transdermal Patches

Transdermal patches deliver medications directly through the skin for systemic effects. These patches provide a controlled, sustained release of medications into the bloodstream. Our portfolio includes patches

for diverse indications, backed by successful pharmacokinetic studies. We anticipate regulatory submissions for these patches soon, aiming to address unmet medical needs.

8

Products in the portfolio including those under development

Outlook

With a robust pipeline and a strategic focus on continuous development, we are poised for significant growth in topical products. Our ongoing efforts aim to bring effective and accessible topical drug products to patients worldwide, driving positive clinical outcomes.

Respiratory

Respiratory disorders demand precise delivery of medications directly to the affected areas.

Nasal sprays and inhalers provide targeted treatment, offering relief from symptoms and improving patient outcomes.

Nasal Sprays

Nasal sprays offer a rapid and efficient route for delivering medications directly to the nasal cavity. Our ongoing efforts are focused on enhancing our portfolio through new device-based nasal products.

Inhalers

Inhalers are crucial in respiratory therapy, facilitating the delivery of medications directly into the lungs. With a focus on metered dose inhalers (MDI) and dry powder inhalers (DPI), we aim to address respiratory

disorders through rigorous clinical trial requirements and adherence to reference-listed drug standards. Our state-of-the-art manufacturing facility in Raleigh, USA, ensures quality and efficiency in the production of the inhaler drug device combination.

16

Products in the portfolio including those under development

Outlook

Our commitment to respiratory health drives continuous development and advancement in nasal spray and inhaler formulations. With ongoing efforts and regulatory submissions, we anticipate meeting the evolving needs of patients with acute and chronic respiratory conditions.

Depot injections

Depot injections represent a vital segment of our pharmaceutical development, offering sustained-release formulations for prolonged therapeutic effects. Our focus on continuous development has led to significant progress in this area. Leveraging a nano-suspension platform, we have successfully manufactured exhibit batches for one of our depot injectables. Currently, we are in the process of finalising the clinical strategy for the product to ensure its efficacy and safety profile.

Vaccines

We have managed to achieve momentum in our vaccine portfolio with four development programs. We are focused on developing vaccine candidates that can help address public health problems in low-andmiddle-income countries. In September 2023, our Company entered into a license agreement with Hilleman Laboratories Singapore Pte. Ltd. to develop, manufacture, and commercialise a pentavalent vaccine candidate used for vaccination in children against meningitis.

12

13

Product portfolio

Peptides

Peptide-based drugs, which are short chains of amino acids with molecular weights typically ranging from 500 to 5,000 Da, have gained traction in the pharmaceutical industry due to advancements in chemical synthesis techniques.

AuroPeptides is our subsidiary developing peptide-based generic APIs with a focus on oncology and diabetology segments. We expect GLP-1 receptor agonists to have a steady increase in market demand as this class of drugs will be increasingly used in treating diabetes and obesity. To that effect, we are continuing our focus on our three products in the GLP-1 API portfolio and are aligning additional new capacities to support their manufacturing.

By the end of FY24, we have filed 14 peptide API DMFs with the US FDA. Out of which, our DMFs have contributed to five ANDA approvals thus far. The peptides' manufacturing facility was inspected by the US FDA during the year, and the inspection concluded with zero observations. Subsequently, the facility received an Establishment Inspection Report (EIR) from

the US FDA with a classification of 'No Action Indicated (NAI)'.

Oncology

and Hormones

Eugia Pharma has witnessed significant growth in its business operations, marked by robust financial performance and strategic expansions. Eugia Pharma has been expanding its manufacturing footprint with capacity expansions at

Key Highlights FY24

Commercialisation of new sterile facility

Eugia Pharma commercialised its sterile facility in Anakapally district with an estimated peak utilisation capacity of 285 million units. This facility is expected to cater to Europe, the US, and Growth Markets. The facility was recently inspected by the US FDA.

Product approvals

Eugia Pharma obtained approvals for over 20 products during FY24 across

approvals. Eugia Pharma commenced commercialisation activities in Australia, leveraging its growing product portfolio.

Audit performance

Unit-III of Eugia Pharma faced certain regulatory challenges. We are in the process of addressing the issues raised by the US FDA and have promptly engaged third-party consultants for the implementation of the proposed CAPA. The operations of the plant were temporarily impacted, and all the lines were restarted in a phased manner after addressing the issues and

14 DMFs

Submitted with the US FDA

the existing plants as well as greenfield expansion towards building the new sterile facility. Despite certain regulatory challenges, Eugia Pharma has maintained a strong trajectory of growth and efficiency across its operations.

various therapeutic segments, underscoring its commitment to continuous development and expanding its portfolio.

Geographic expansion

Eugia Pharma has strategically expanded its presence into new markets, notably Australia and New Zealand, where it has initiated product filings and received

Outlook

Eugia Pharma is set to continue its growth trajectory, aided by capacity enhancements, new plant commercialisation and new product approvals, despite Eugia unit-III audit challenges. It continues to focus on efficiency improvements and cost optimisation initiatives to drive long-term success and shareholder value.

ensuring the quality of the product.

Notably, the Eugia-I facility received an outstanding outcome of the audit with zero observations, reflecting Company's commitment to quality and compliance. Further, in June 2024, the injectable facility of Eugia SEZ Pvt. Ltd. was classified as Voluntary Action Indicated (VAI) by the US FDA.

Facility operations

Eugia Pharma's plants have been running at full capacity, although there were certain temporary shutdowns taken at Eugia Unit-III for reassessment and corrective measures to address the issues highlighted during the regulatory inspection. With reasonable assurance, the unit has resumed operations. Further, the sterile unit

at Anakapally has commenced its operations, which will support the increased volume demand and growth plans across the markets.

Financial growth

Specialty and Injectables has experienced substantial revenue growth, with a 35% increase over the previous year, amounting to a total revenue of ₹4,480 crores. Further, increased volumes, on the back of improved plant utilisation, and a focus on operational efficiencies have aided the margins of the specialty business.

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Geographic footprint

Enhancing accessibility through global reach

Our extensive geographic coverage across developed and developing markets enables us to serve patients globally. This gives us a competitive advantage in understanding customer needs and ensuring faster delivery.

This extensive reach not only enhances our capability to understand and meet diverse consumer needs but also strengthens our ability to deliver novel and agile solutions promptly.

150+

Countries export presence

Countries export presence

Commercial plants

Non-operatinal/Under construction project

Map not to scale.

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