Dr Reddys Labs - RDY STOCK NEWS

Aurigene Oncology , a subsidiary of Dr. Reddy's Laboratories, has announced promising Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study - India's first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed/refractory multiple myeloma. The study reported:

• 100% clinical response in 8 heavily pre-treated patients
• 62.5% achieved stringent complete response
• No high-grade events of Cytokine Release Syndrome or neurotoxicity

The Indian Regulatory Agency (DCGI) has approved the commencement of the Phase 2 trial. These results were presented at the 21st annual meeting of the International Myeloma Society in Brazil. Ribrecabtagene autoleucel is manufactured at Aurigene Oncology's CAR-T GMP facility in Bangalore.

Dr. Reddy's Laboratories (RDY) has entered into a royalty-free non-exclusive voluntary licensing agreement with Gilead Sciences Ireland UC for the manufacture and commercialization of Lenacapavir in India and 120 other countries. Lenacapavir is an FDA-approved drug for treating HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1. The agreement covers both the current approved indication and potential future use in HIV prevention (PrEP).

Dr. Reddy's will be responsible for technology transfer, manufacturing, clinical studies, product registration, and launch in the agreed markets. This collaboration aims to improve patient access and affordability for HIV treatment and prevention in primarily low- and lower-middle-income countries with high HIV disease burden.

Dr. Reddy's Laboratories, Aurigene Pharmaceutical Services, and Kainomyx have signed a non-binding MoU for the joint development of an affordable anti-malarial drug. This potential partnership aims to combine Kainomyx's novel drug discovery expertise, Aurigene's integrated drug development capabilities, and Dr. Reddy's commercialization abilities in low and middle-income countries, the US, and Europe.

The collaboration addresses the critical need for effective, affordable, and accessible malaria prevention and treatment, especially in vulnerable populations. With 249 million malaria cases and 608,000 deaths reported in 2022, this initiative aligns with Dr. Reddy's goal of reaching 1.5 billion patients by 2030. The partnership will leverage each company's strengths to accelerate the development of innovative medicines targeting cytoskeletal proteins of parasites, a novel mechanism of action.

Dr. Reddy's Laboratories (NYSE: RDY) has received a positive opinion from the European Medicines Agency's CHMP for its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI®). This recommendation paves the way for potential marketing authorization in EU and EEA member states. The biosimilar is being developed as an alternative to MabThera® (Rituximab), with intended indications including Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukaemia, Rheumatoid Arthritis, and other conditions.

This development is part of Dr. Reddy's strategic biosimilars program, which has been a key focus for the company over the past 25 years. The company has already launched biosimilar products in India and over 25 other countries, with plans for global expansion in regulated and emerging markets.

Dr. Reddy's Laboratories reported strong Q1FY25 financial results, with revenues of ₹76,727 Mn, up 14% YoY and 8% QoQ. Key highlights include:

- Gross Margin improved to 60.4%
- EBITDA at ₹21,599 Mn (28.2% of Revenues)
- Profit after Tax at ₹13,920 Mn (down 1% YoY, up 7% QoQ)

The growth was primarily driven by the Global Generics business, particularly in North America and India. The company made strategic investments in biologics, consumer healthcare, and innovation. Notable developments include the acquisition of Nicotinell® brands, a joint venture with Nestlé India, and partnerships with Novartis and Alvotech for product commercialization.

Dr. Reddy's Laboratories announced the acquisition of Haleon's Nicotinell and related NRT brands for GBP 500 million. The acquisition includes Nicotinell's global portfolio, comprising Nicabate, Thrive, and Habitrol, across Europe, Asia, and Latin America. The deal features an upfront payment of GBP 458 million and performance-based payments of up to GBP 42 million. Nicotinell, the second-largest NRT brand globally, generated GBP 217 million in revenue in CY'23. Dr. Reddy's aims to expand its OTC business and strengthen its global consumer healthcare presence. The transaction is expected to close in early Q4 2024.

Aurigene Pharmaceutical Services, a subsidiary of Dr. Reddy’s Laboratories, has announced the opening of a new 70,000 sq.ft. biologics facility in Hyderabad, India. The facility offers process and analytical development, along with small-scale manufacturing of antibodies and recombinant proteins for preclinical and early phase clinical requirements. While the laboratories are now operational, the manufacturing capacity will be commissioned by 2024. This new facility aims to provide seamless transitions to larger commercial CGMP manufacturing, complementing Aurigene's current capabilities in recombinant proteins and antibody drug conjugates. The initiative aligns with Aurigene's strategic growth in biologics and small molecules, supported by recent collaborations and investments in AI/ML-led drug discovery.

Dr. Reddy's Laboratories has appointed Milan Kalawadia as CEO of the North America division. Kalawadia, a veteran of the company with 18 years of experience, will be based in Princeton, New Jersey. He has held roles in Finance, Investor Relations, Corporate Development, Marketing, and most recently served as Chief Commercial Officer. Under his leadership, the North American division achieved three consecutive years of growth, surpassing $1 billion in revenue and setting record sales for FY24. Kalawadia's extensive industry knowledge and innovative approach are expected to propel the North American business to new heights.

Dr. Reddy’s Laboratories released its Q4 & Full Year FY24 Financial Results. In Q4FY24, revenues were ₹70,830 Mn, up 12% YoY, and FY24 revenues were ₹279,164 Mn, up 14% YoY. Gross margin was 58.6%. SG&A expenses increased by 14% YoY, R&D expenses were 9.7% of revenues. EBITDA was 26.4% of revenues. Profit before tax increased by 21% YoY in Q4FY24, and by 19% YoY for FY24. Profit after tax grew by 36% YoY in Q4FY24 and 24% YoY for FY24.