Dr Reddys Labs Stock Price, News & Analysis

Bio-Thera Solutions and Dr. Reddy's Laboratories have announced an exclusive commercialization agreement for two biosimilar products: BAT2206 (proposed Stelara® biosimilar) and BAT2506 (proposed Simponi® biosimilar). Under the partnership, Bio-Thera will handle development, manufacturing, and supply, while Dr. Reddy's (RDY) will manage regulatory approvals and commercialization in Southeast Asian territories including Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam.

Additionally, Dr. Reddy's has secured exclusive commercial rights for BAT2206 in Colombia. This marks Bio-Thera's first partnership focused exclusively on Southeast Asia, aiming to expand access to affordable medicines in emerging markets.

The FDA has accepted a Biologic License Application (BLA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab), jointly announced by Dr. Reddy's Laboratories and Alvotech. AVT03 aims to treat osteoporosis in post-menopausal women and prevent bone complications in cancer patients.

Under a License and Supply Agreement from May 2024, Alvotech will handle development and manufacturing, while Dr. Reddy's will manage registration and commercialization in applicable markets, including the U.S. Upon FDA approval, AVT03 will be available in two formulations: a 60 mg/1 mL single-dose prefilled syringe and a 120 mg/1.7 mL single-dose vial.

Dr. Reddy's Laboratories (NYSE: RDY) has initiated a nationwide recall of one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection in the United States due to critical mislabeling. The infusion bags are incorrectly labeled as containing 500 mg/100 mL when they actually contain 1,000 mg/100 mL.

The affected batch was distributed nationwide between November 4-6, 2024. This mislabeling could result in patients receiving double the intended dose, potentially leading to serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, and respiratory depression. Patients receiving high doses for status epilepticus treatment are at highest risk.

While no adverse events have been reported, Dr. Reddy's is instructing wholesalers, distributors, hospitals, and pharmacies to immediately stop use, quarantine, and return affected products. The medication is indicated for adjunct therapy in adults with partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures when oral administration isn't feasible.

Dr. Reddy's Laboratories has entered into a license agreement with Shanghai Henlius Biotech for HLX15, a biosimilar candidate to Darzalex® & Darzalex Faspro®. The agreement grants Dr. Reddy's exclusive commercialization rights for both subcutaneous and intravenous formulations in the U.S. and Europe.

Under the agreement, Henlius will handle development, manufacturing, and commercial supply. The deal includes an upfront payment of $33 million, with potential milestone payments bringing the total to $131.6 million, plus royalties on annual net sales. HLX15 is a recombinant anti-CD38 human monoclonal antibody injection developed for multiple myeloma treatment.

This collaboration strengthens Dr. Reddy's biosimilars portfolio in regulated markets, following their recent pegfilgrastim launch in the U.S. and bevacizumab in the UK, as well as their denosumab biosimilar partnership with Alvotech.

Henlius Biotech has entered into a license agreement with Dr. Reddy's Laboratories for HLX15, an investigational daratumumab biosimilar. The deal grants Dr. Reddy's exclusive commercialization rights in 43 countries, including 42 European regions and the United States.

Under the agreement terms, Henlius will handle development, manufacturing, and commercial supply. The deal includes a $33 million upfront payment and potential additional milestone payments totaling up to $131.6 million, plus royalties on annual net sales.

The partnership aims to leverage Henlius' biosimilar development and manufacturing capabilities with Dr. Reddy's global commercialization experience. The collaboration focuses on expanding access to affordable oncology treatments in the U.S. and European markets.

Dr. Reddy's Laboratories (RDY) reported Q3FY25 financial results with revenues of ₹83,586 Mn, up 16% YoY and 4% QoQ. The growth was primarily driven by the recently acquired Nicotine Replacement Therapy (NRT) business, which contributed ₹6,049 Mn. Underlying YoY growth excluding NRT was 7.5%.

Key highlights include:

• Gross Margin at 58.7%
• EBITDA at ₹22,982 Mn (27.5% of revenues)
• Profit after Tax at ₹14,133 Mn (up 2% YoY, 13% QoQ)

Geographic performance showed:

• North America revenues at ₹33,834 Mn (1% YoY growth)
• Europe revenues at ₹12,096 Mn (143% YoY growth, including NRT)
• India revenues at ₹13,464 Mn (14% YoY growth)
• Emerging Markets at ₹14,358 Mn (12% YoY growth)

Dr. Reddy's Laboratories has launched Toripalimab (brand name Zytorvi®) in India, making it the third country after China and the US to access this new biological entity for treating nasopharyngeal carcinoma (NPC). The drug is the first and only immuno-oncology treatment approved by major regulatory authorities worldwide for adults with recurrent or metastatic NPC. When combined with standard chemotherapy, Toripalimab showed a 48% reduction in risk of progression or death. The launch follows Dr. Reddy's exclusive licensing agreement with Shanghai Junshi Biosciences for development and commercialization rights in 21 countries.

Dr. Reddy's Laboratories and Senores Pharmaceuticals announced the launch of Ivermectin Tablets USP, 3 mg in the US market. The product is bioequivalent to STROMECTOL® Tablets of Merck Sharp and Dohme Dr. Reddy's will market the product, with Senores being the second generic manufacturer to receive approval. The Ivermectin Tablets market, including both brand and generic products, had US sales of approximately $20 million for the twelve months ending September 2024, according to IQVIA data.

Dr. Reddy's Q2FY25 financial results show revenue growth of 17% YoY to ₹80,162 Mn, with a gross margin of 59.6%. The company reported EBITDA of ₹22,803 Mn (28.4% of revenues) and profit after tax of ₹13,415 Mn, down 9% YoY. Global Generics segment grew 17% YoY to ₹71,576 Mn, while PSAI revenues increased 20% to ₹8,407 Mn. Key developments include completing the Nicotine Replacement Therapy portfolio acquisition and operationalizing the Nestlé Health Science joint venture. The company maintained growth momentum across businesses despite increased SG&A expenses and R&D investments.