Medicamen Biotech Ltd Management Discussions

COMPANY OVERVIEW

MBL is a research-driven pharmaceutical company engaged in the development, manufacturing and marketing of finished dosage forms, catering to both domestic and international markets. With a presence in 35 countries across the Rest of the World (ROW), the Company excels in providing Finished Dosage Forms (FDFs) and liquid formulations. In India, MBL stands out as a prominent player in the oncology segment, backed by its dedicated salesforce and branding team that have successfully established a robust presence in the domestic market.

Medicamen Pharmaceuticals is a leading manufacturer of a diverse range of pharmaceutical products including tablets, capsules and syrups, with a strong commitment to quality and innovation. We operate three state-of-the-art manufacturing facilities in India:

• Bhiwadi Plant (Rajasthan): Features Six blocks for general formulations and a dedicated R&D block for formulation development.

• Haridwar Unit I (Uttarakhand): Specializes in general formulations with a robust quality control laboratory ensuring product safety and quality.

• Haridwar Unit II (Uttarakhand): Focused on oncology formulations, producing lyophilized and ready-to-use products for cancer treatment.

Our reach extends to both domestic and international markets, enhancing health outcomes worldwide. Medicamen is committed to providing high-quality medicine to improve patient care.

INDUSTRY OVERVIEW

Global Pharmaceutical Industry

The global pharmaceutical sector is poised for significant growth in Financial Year 2024-25, driven by innovations in drug development, increased healthcare investments and improved access to medications. Government support through streamlined regulatory processes is fostering a conducive environment for growth. Rising demand for specialty drugs, particularly in emerging markets is further fueling market expansion. Strategic partnerships and collaborations among industry players are optimizing drug development and distribution. The global pharmaceutical markets for Cardio-Vascular Disease (CVD), Oncology and Pain Management are all significant and growing. The CVD market is substantial, with a projected value of $200.9 bn by 2032. The oncology market is also experiencing rapid growth, expected to reach $401.4 bn by 2029. The pain management market, including cancer pain, is estimated at $109.9 bn in 2028.

Overall, the pharmaceutical industry is set for a transformative year, improving access to medicines worldwide.

Indian Pharmaceutical Industry

The Indian pharmaceutical market for cardiovascular diseases (CVD), oncology and pain management is experiencing significant growth, driven by increasing disease prevalence and a rising demand for effective treatments. The CVD market is projected to reach $6.44 bn by 2030, while the oncology market is expected to hit $10.6 bn by the same year. The cancer pain management market is also poised for growth, estimated to reach $224.39 mn by 2030, with a CAGR of 8.3%.

The increased healthcare budget will enhance accessibility to essential medicines and support innovation. The removal of custom duties on critical treatments underscores our commitment to patient-centric solutions, while expanded Patient Assistance Programs (PAPs) will help reach underserved populations.

Overall, our management will prioritize continued investment in research and development and strengthen manufacturing to fully leverage the growth potential of the pharmaceutical sector.

OUR FOCUS MARKET Africa

The pharmaceutical sector in the Middle East and Africa is projected to grow from $30.07 bn in 2024 to $42.42 bn by 2030, reflecting a CAGR of 6.10%. Key drivers of this growth include a rising population, increased prevalence of chronic diseases and heightened demand for advanced treatments.

Medicamen perceives significant opportunities in the African market for CVD (Cardiovascular Disease), pain management and oncology medicines, particularly due to the growing burden of non-communicable diseases and the increasing affordability of healthcare among the rising middle class.

Medicamen Biotech Limited (MBL) has recently entered into an agreement with a South African business conglomerate to register and market its products in the South African pharmaceutical market, which represents a $4 bn opportunity. This move is part of MBLs broader strategy to expand into regulated markets, leveraging the recent EU approval of its manufacturing plant. MBL is also exploring the Francophone African pharmaceutical market focused on exporting medicines and outsourcing branded products.

Regulated Market

The European pharmaceutical market is a large and competitive sector, with significant investment in research and development. Its the second-largest market globally,

with a strong trade surplus. Key drivers include an aging population, rising healthcare spending and the increasing prevalence of chronic diseases. The market is expected to grow significantly in the coming years with a projected value of USD 267.79 bn by 2032.

Indian Pharmaceutical Companies play a significant role in the European Union (EU) market. Europe is a major export destination for Indian Pharmaceuticals, accounting for roughly 21% of Indias total pharmaceutical exports.

Our Company is also expanding its presence in the European pharmaceutical market through strategic partnerships and EU GMP certification of its manufacturing facility. The Company has secured a CDMO agreement with XGX Pharma, a European pharmaceutical company and a distribution agreement for three products to be marketed in Europe. These initiatives, along with EU and USFDA approvals for their manufacturing plants, position Medicamen for growth in regulated markets, including the EU.

The Company has been making strides in expanding its reach into regulated markets like the US and Middle East through successful audits and approvals of its manufacturing facilities. Our Haridwar Oncology Plant received a USFDA audit and their Bhiwadi facility secured EU GMP approval. Furthermore, our parent company, Shivalik Rasayan, has a USFDA-approved API facility. These achievements position Medicamen Biotech for potential growth in regulated markets.

OUR BUSINESS SEGMENTS

Medicamen Biotech Limited has made significant steps during the year under review in establishing itself as a reputable player in the global pharmaceutical landscape. As we enter the fiscal year, we are pleased to report on key developments that underscore our commitment to expanding our footprint and delivering high-quality products to healthcare providers and patients worldwide.

Regulatory Approvals and Product Registrations

In September 2024, Medicamen achieved a significant milestone with EU approval for our manufacturing facility located in Bhiwadi. This approval paves the way for our continued expansion into the European market. Following this, in October 2024, we secured US FDA approval for our oncology plant, enhancing our ability to cater to the growing demand for oncology products in the United States.

Our ongoing efforts in product registration have also yielded positive results. We have successfully registered 70 products in Ethiopia and 50 in Ghana. Notably, we have laid the groundwork for a strong presence in several West African countries, with registrations procured for 31 products across

Cameroon, Mali, Niger, Burkina Faso, Benin and Senegal. Additionally, we are currently processing 300 products for registration in Francophone regions, further diversifying our market presence.

European Union Portfolio Development

In line with our strategy to strengthen our EU portfolio, we anticipate two product registrations by October 2025. Our research and development team is diligently working on seven additional products for our EU operations and fifteen Stock Keeping Units (SKUs) are under development for filing, demonstrating our commitment to innovation and responding to market needs.

US FDA Engagement

The Company marked a significant achievement in June 2025, receiving our first ANDA approval, which will enhance our market competitiveness in the US. We have also entered into an agreement with a US company for third-party manufacturing of oncology products, which will enable us to leverage existing market channels.

In addition, we have submitted documents for Therapeutic Goods Administration (TGA) approval in Australia, filed for plant approval in Canada and commenced dossier filings in Vietnam. Our partnership with a Canadian company for the supply and marketing of our products further solidifies our commitment to expanding our product reach.

FINANCIAL OVERVIEW

Medicamen Biotech Limited

On a consolidated basis, the revenue for 2024-25 was 16,254.72 Lakhs, lower by 9.35% over the previous years revenue of 17,930.62 Lakhs. The profit after tax (PAT) attributable to shareholders for 2024-25 and 2023-24 was 655.56 Lakhs and 949.40 Lakhs respectively. The PAT attributable to shareholders for 2024-25 was experiencing a regression of -30.95% over the PAT of 2023-24.

On standalone basis, the revenue for 2024-25 was 15146.33 Lakhs, lower by 12.13% over the previous years revenue of 17,238.63 Lakhs. The profit after tax (PAT) attributable to shareholders for 2024-25 and

2023- 24 was 944.75 Lakhs and 1329.80 Lakhs respectively. The PAT attributable to shareholders for

2024- 25 was experiencing a regression of (28.95)% over the PAT of 2023-24.

Medicamen Life Sciences

As Medicamen Life Sciences approaches the two-year anniversary of its incorporation, we are proud to report that our products have gained acclaim among the medical community, reflecting our dedication to quality and efficacy.

The management is optimistic break even in the current year, demonstrating our strong operational foundations and strategic growth trajectory.

In conclusion, Medicamen Life Sciences is positioned for robust growth as we continue to expand our product portfolio to establish brand value for Medicamen.

HUMAN RESOURCES

Medicamen Biotech Limited prioritizes its employees, fostering a safe, inclusive, and supportive work environment. The Company provides clear employee handbooks and a strong Code of Conduct to ensure awareness of rights and responsibilities. Safety is paramount, supported by a robust Environmental, Health, and Safety (EHS) policy. Regular communication and performance management align employees with company goals, while teamwork and crossfunctional collaboration nurture a shared sense of purpose.

The Company also emphasizes employee growth through skill development workshops and engagement activities.

INTERNAL CONTROL SYSTEM

MBL has a robust internal financial control system that aligns with its operational size and complexity, ensuring accurate financial reporting and compliance with policies and regulations. During the assessment period, internal auditors reported no major issues. The finance team consistently monitors control effectiveness across all locations, while statutory auditors, M/s. Rai Qimat & Associates, review the system to confirm adherence to accounting practices. The Audit Committee receives reports on major findings and corrective actions taken. Additionally, the Company fully complies with Indian Accounting Standards in its financial management.

Financial

Statements