Dr. Reddy's Laboratories (RDY) and China-based Bio-Thera Solutions announced that they have entered into commercialization and license agreements for BAT2206, a proposed biosimilar of Johnson & Johnson's (JNJ) Stelara (ustekinumab), and BAT2506, a proposed biosimilar candidate of JNJ's Simponi (golimumab). The impending licensing deal is expected to significantly enhance Dr. Reddy's biosimilar portfolio across emerging markets. By capitalizing on its well-established commercial presence, RDY aims to bridge ...

Core Viewpoint - Bio-Thera Solutions and Dr. Reddy's Laboratories have entered into exclusive commercialization and license agreements for two proposed biosimilars, BAT2206 and BAT2506, targeting Southeast Asia and Colombia [1][2][3] Group 1: Agreements and Responsibilities - Bio-Thera will handle the development, manufacturing, and supply of BAT2206 and BAT2506, while Dr. Reddy's will seek regulatory approvals and manage commercialization in Southeast Asia, including countries like Cambodia, Indonesia, Malaysia, Philippines, Thailand, and Vietnam [2][3] - Dr. Reddy's will also gain exclusive commercial rights to BAT2206 in Colombia [2] Group 2: Product Information - BAT2206 is a proposed biosimilar to Stelara®, targeting conditions like Crohn's disease and ulcerative colitis, and is currently approved in the EU for multiple indications including moderate to severe plaque psoriasis and active psoriatic arthritis [4] - BAT2506 is a proposed biosimilar to Simponi®, which is used for moderate to severe rheumatoid arthritis and carries a Boxed Warning for serious infections and malignancy [5] Group 3: Company Background - Bio-Thera Solutions is a biopharmaceutical company based in Guangzhou, China, focused on developing innovative therapies and biosimilars for various diseases, including cancer and autoimmune disorders [6][7] - Dr. Reddy's Laboratories, headquartered in Hyderabad, India, is a global pharmaceutical company committed to providing access to affordable medicines, with a diverse portfolio including APIs, generics, and biosimilars [8]

Core Viewpoint - Dr. Reddy's Laboratories and Alvotech announced the FDA's acceptance of a regulatory filing for AVT03, a proposed biosimilar of Amgen's Prolia and Xgeva, which could enhance patient access to affordable treatments for osteoporosis and other bone-related conditions [1][4][6]. Group 1: Product and Market Impact - Prolia generated $2.89 billion in sales in 2024, reflecting an 8% year-over-year increase, while Xgeva brought in $1.51 billion, marking a 5% growth compared to 2023 [3]. - The introduction of AVT03 could improve treatment accessibility for millions affected by osteoporosis in the United States [6]. Group 2: Partnership and Development - Dr. Reddy's and Alvotech signed a license and supply agreement for AVT03 in 2024, with Alvotech responsible for development and manufacturing, while Dr. Reddy's handles registration and commercialization in key markets [7]. - AVT03 is expected to be available in two formulations: a single-dose prefilled syringe containing 60 mg and a single-dose vial with 120 mg [8]. Group 3: Stock Performance - Year to date, Dr. Reddy's shares have lost 15.5%, while Alvotech shares have decreased by 14.3% [3][7]. - Both companies currently carry a Zacks Rank 3 (Hold) [9].

Core Insights - Shanghai Henlius Biotech, Inc. has entered into a license agreement with Dr. Reddy's Laboratories for the commercialization of its investigational daratumumab biosimilar HLX15 in 43 countries and regions, including 42 European countries and the U.S. [1] - The agreement allows Henlius to receive up to $131.6 million, which includes a $33 million upfront payment and additional milestone payments, along with potential royalties on annual net sales of HLX15 [2] Company Overview - Henlius will be responsible for the development, manufacturing, and commercial supply of HLX15, aiming to enhance its product reach in the European and U.S. markets [2] - Dr. Reddy's Laboratories operates in over 75 countries globally, providing a strong partnership for Henlius to expand its market presence [2]

Dr. Reddy's Laboratories Limited (RDY) reported third-quarter fiscal 2025 earnings of 20 cents per American Depositary Share (ADS), which matched the Zacks Consensus Estimate. The company reported earnings of 19 cents per ADS in the year-ago quarter.See the Zacks Earnings Calendar to stay ahead of market-making news.Revenues grew 16% year over year to $977 million, which surpassed the Zacks Consensus Estimate of $875 million. The year-over-year improvement was primarily driven by growth in global generics r ...

January 23, 2025 1 Safe Harbor Statement This presentation contains forward-looking statements and information that involve risks, uncertainties and assumptions. Forward-looking statements are all statements that concern plans, objectives, goals, strategies, future events or performance and underlying assumptions and other statements that are other than statements of historical fact, including, but not limited to, those that are identified by the use of words such as "anticipates", "believes", "estimates", ...

Financial Data and Key Metrics - The company has released its Q3 FY 2025 results, which are available on its website [4] Business Performance and Strategy - The CEO, Erez Israeli, will provide insights into the business performance following the financial highlights presentation by the CFO, M V Narasimham [4] Management Commentary - The leadership team, including the CEO and CFO, is present during the earnings call to discuss the results and address questions [3] Q&A Session - The conference call will include a Q&A session after the initial presentations by the CFO and CEO [4] Other Important Information - The call is copyrighted material of Dr Reddy's and cannot be rebroadcasted or attributed in press or media outlets without the company's permission [4]

Core Viewpoint - Dr. Reddy's Laboratories is positioned as a strong player in the generic drugs market, with a robust pipeline and strategic initiatives that may enhance its growth prospects in fiscal 2025 [1]. Group 1: Financial Performance and Market Position - As of September 30, 2024, Dr. Reddy's has 80 generic filings pending FDA approval, including 75 abbreviated new drug applications (ANDAs) and five new drug applications, with 44 of the ANDAs being Para IVs [2]. - In fiscal 2024, the company launched 21 products in North America and continued to see positive traction in its base business and recent launches [3]. - Year-to-date, shares of Dr. Reddy's have gained 1.6%, while the industry has seen a growth of 12.5% [8]. Group 2: Product Pipeline and Innovations - Dr. Reddy's has expanded its biosimilars facility in India and launched Versavo, a biosimilar of Avastin, in the UK during the fourth quarter of fiscal 2024 [4]. - The company received a positive opinion for its biosimilar candidate DRL_RI, which is expected to be marketed as Ituxredi in the EU, further contributing to revenues [5]. - Recent launches include Ivermectin Tablets in the US and a biosimilar of Loqtorzi in India, indicating a focus on expanding its biosimilars portfolio [6]. Group 3: Strategic Initiatives - Dr. Reddy's has modernized its infrastructure and implemented a new quality management system to enhance efficiency and regulatory compliance [9]. - The company divested non-core dermatology brands and launched a new division, RGenX, to focus on India's trade generics market [10]. - Strategic partnerships include collaborations with Sanofi for vaccine distribution and Bayer for heart failure drugs, as well as a licensing deal with Gilead Sciences for HIV treatment [12]. Group 4: Earnings Estimates and Market Outlook - The Zacks Consensus Estimate for Dr. Reddy's fiscal 2025 earnings per share (EPS) has increased from 81 cents to 83 cents, with a similar increase for fiscal 2026 EPS from 82 cents to 86 cents [13]. - Despite facing competition from major players in the generics market, Dr. Reddy's deep pipeline and strategic efforts are expected to provide a competitive edge [14]. - Analysts maintain an optimistic outlook for the company, suggesting that investors consider buying Dr. Reddy's stock for long-term gains [15].

Dr. Reddy’s Laboratories (RDY) announced that it has launched a biosimilar of Coherus BioSciences’ (CHRS) Loqtorzi (toripalimab) in India under the brand name Zytorvi for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), a rare form of head and neck cancer.Loqtorzi, a novel anti-PD-1 monoclonal antibody, is a new biological entity that has been developed by Coherus in collaboration with China-based Junshi Biosciences. In October 2023, CHRS announced the FDA’s approval o ...

Dr. Reddy's Laboratories Limited (NYSE:RDY) Q2 2025 Earnings Conference Call November 5, 2024 9:00 AM ET Company Participants Richa Periwal - Head of Investor Relations MV Narasimham - Chief Financial Officer Erez Israeli - Chief Executive Officer Conference Call Participants Kunal Dhamesha - Macquarie Neha Manpuria - Bank of America Amey Chalke - JM Financial Mikaela Franceschina - Barclays Harith Ahmad - Avendus Spark Damayanti Kerai - HSBC Bino Pathiparampil - Elara Capital Surya Patra - PhillipCapital T ...