Toripalimab is the only immuno-oncology drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others. In 2023, Dr. Reddy's entered into a license and commercialisation agreement with Shanghai Junshi Biosciences Co. Ltd for Toripalimab. Under this agreement, Dr. Reddy's obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally, the agreement allows Dr. Reddy's to expand the scope of the license to cover Australia, New Zealand and nine other countries. With this launch by Dr. Reddy's, India becomes the third country in the world after China and the United States to receive access to this next generation PD-1 inhibitor. Dr. Reddy's will market it under the brand name Zytorvi in India. The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. In India, there were 6,519 newly diagnosed cases of NPC in 20224. M.V. Ramana, chief executive officer, Branded Markets (India and Emerging Markets), Dr. Reddy's, said: The launch of Toripalimab is a significant milestone for patients diagnosed with nasopharyngeal carcinoma (NPC) in India. NPC is a rare form of head and neck cancer. However, the prognosis of the disease for patients in advanced stages is poor, and India is among the top five countries in the world in terms of disease burden. As the next generation PD-1 inhibitor, Toripalimab has demonstrated superior outcomes for RM-NPC versus standard of care, thereby meeting a significant unmet need for patients with NPC in India. Dr Reddy's Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products. The company's consolidated net profit declined 15.3% to Rs 1255.70 crore despite of 16.5% jump in revenue from operations to Rs 8016.10 crore in Q2 FY25 over Q2 FY24. The scrip shed 0.17% to currently trade at Rs 1198.45 on the BSE. Powered by Capital Market - Live

Dr Reddys Laboratories announced the launch of Toripalimab in India. Toripalimab is a New Biological Entity (NBE). It is the only immuno-oncology drug approved by various regulatory authorities around the world such as the United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). In 2023, Dr. Reddy's entered into a license and commercialisation agreement with Shanghai Junshi Biosciences Co. Ltd for Toripalimab. Under this agreement, Dr. Reddy's obtained exclusive rights to develop and commercialise Toripalimab in 21 countries including India, South Africa, Brazil and various countries in Latin America. Additionally, the agreement allows Dr. Reddy's to expand the scope of the license to cover Australia, New Zealand and nine other countries. With this launch by Dr. Reddy's, India becomes the third country in the world after China and the United States to receive access to this next generation PD-1 inhibitor. Dr. Reddy's will market it under the brand name Zytorvi' in India. The standard of care for RM-NPC in India before Toripalimab was chemotherapy (gemcitabine and cisplatin). Toripalimab is indicated as first-line treatment of adults with metastatic or recurrent locally advanced NPC in combination with gemcitabine and cisplatin. This combination has shown a 48% reduction in risk of progression or death. Additionally, Toripalimab has also been approved as monotherapy for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy.Powered by Capital Market - Live

The GMP inspection was conducted from 13 November 2024 to 19 November 2024. The USFDA issued Form-483 with 7 observations. Dr Reddy's Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products. The company's consolidated net profit declined 15.3% to Rs 1255.70 crore despite of 16.5% jump in revenue from operations to Rs 8016.10 crore in Q2 FY25 over Q2 FY24.Powered by Capital Market - Live

The headline equity benchmarks traded with substantial losses in early trade. The Nifty dropped below the 23,400 level. Barring the IT index, all the other sectoral indices on the NSE were traded in red. At 09:26 IST, the barometer index, the S&P BSE Sensex declined 419.26 points or 0.54% to 77,159.12. The Nifty 50 index lost 142.95 points or 0.61% to 23,375.55. In the broader market, the S&P BSE Mid-Cap index shed 0.52% and the S&P BSE Small-Cap index fell 0.58%. The market breadth was weak. On the BSE, 1,068 shares rose and 1,879 shares fell. A total of 140 shares were unchanged. Foreign portfolio investors (FPIs) sold shares worth Rs 3,411.73 crore, while domestic institutional investors (DIIs) were net buyers to the tune of Rs 2,783.89 crore in the Indian equity market on 19 November 2024, provisional data showed. Stocks in Spotlight: Dr Reddy's Laboratories (DRL) slipped 2.46% after the company informed that on Tuesday, 19 November 2024, US Food and Drug Administration (USFDA) completed its Good manufacturing practice (GMP) inspection at API manufacturing facility located in Bollaram, Hyderabad. Garden Reach Shipbuilders & Engineers (GRSE) rose 0.79%. The company has signed a contract with the Transport Department, Government of West Bengal, for the delivery of 13 hybrid ferries for total consideration of Rs 226.18 crore. Godrej Properties shed 0.42%. The company has announced the acquisition of a 53-acre land parcel in Joka, Kolkata. The company plans to develop a residential plotted development project on this land, with an estimated development potential of 1.3 million square feet and a revenue potential of approximately Rs 500 crore. Numbers to Track: The yield on India's 10-year benchmark federal paper added 1.87% to 6.938 as compared with previous close 6.810. In the foreign exchange market, the rupee edged higher against the dollar. The partially convertible rupee was hovering at 84.4200, compared with its close of 84.4275 during the previous trading session. MCX Gold futures for 5 December 2024 settlement rose 0.20% to Rs 76,189. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.14% to 106.53. The United States 10-year bond yield shed 0.05% to 4.408. In the commodities market, Brent crude for January 2024 settlement gained 17 cents or 0.23% to $72.98 a barrel. Global Markets: Asian markets declined on Thursday, dampened by mixed signals from Nvidia's earnings report and heightened geopolitical tensions. Investors remained cautious, with concerns over Russia-Ukraine conflict weighing on sentiment. U.S. stocks closed mixed on Wednesday, with Target's disappointing earnings and Nvidia's tempered guidance impacting investor sentiment. While the Dow Jones Industrial Average gained 0.32%, the S&P 500 index ended flat%, and the NASDAQ Composite index fell 0.11%. Investors were rattled by a nearly 22% slide in Target after the retailer missed expectations for its September quarter earnings. Target steadied in evening trade, although its earnings also raised some questions over weakening retail spending. Nvidia shares fell more than 1% in aftermarket trade to around $144.0, trimming some losses after falling as much as 2% just after its earnings. Earnings per share rose to $0.81 on revenue of $35.1 billion, higher than expectations of $0.75 in EPS and $33.09 billion in revenue. Nvidia's quarterly results, while exceeding expectations, fell short of some analysts' hopes for a more significant beat. The company's guidance for the fourth quarter, though slightly above estimates, hinted at a slower pace of revenue growth, raising questions about the sustainability of AI-driven demand. This cautious outlook tempered investor enthusiasm and contributed to the broader market's subdued performance. Market participants are now focused on a series of U.S. economic indicators, including jobless claims, home sales data, and the Purchasing Managers' Index (PMI). Additionally, several Federal Reserve officials are scheduled to speak, providing insights into the central bank's monetary policy outlook. Powered by Capital Market - Live

The GMP inspection was conducted from 13 November 2024 to 19 November 2024. The USFDA issued Form-483 with 7 observations. Dr Reddy's Labs is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products. The company's consolidated net profit declined 15.3% to Rs 1255.70 crore despite of 16.5% jump in revenue from operations to Rs 8016.10 crore in Q2 FY25 over Q2 FY24. The scrip rose 1.73% to settle at Rs 1213.95 on Tuesday, 19 November 2024. The market will remain shut today on account of Maharashtra Assembly polls.Powered by Capital Market - Live

Dr Reddys Laboratories has received an order dated 12 November 2024, from COFEPRIS (Comisi'n Federal para la Protecci'n Contra Riesgos Sanitarios) health department of Mexico. The drug regulatory body of Mexico (Comisi'n Federal para la Protecci'n contra Riesgos Sanitarios) has imposed a penalty of MXN 651, 420 (~Rs 27 Lakh) on the Company for deviation from prescribed guidelines in filing intimation of import of a reference standard for one of the company's APIs. Additionally, the fine was imposed due to an error in the date of the invoice and also name of the reference standard Vs import license. Powered by Capital Market - Live

Dr Reddys Laboratories Ltd is up for a third straight session in a row. The stock is quoting at Rs 1300.85, up 2.25% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is up around 0.85% on the day, quoting at 24419.55. The Sensex is at 80155.08, up 0.85%. Dr Reddys Laboratories Ltd has dropped around 1.6% in last one month. Meanwhile, Nifty Pharma index of which Dr Reddys Laboratories Ltd is a constituent, has dropped around 0.45% in last one month and is currently quoting at 22661.25, up 0.94% on the day. The volume in the stock stood at 29.93 lakh shares today, compared to the daily average of 6.7 lakh shares in last one month. The benchmark November futures contract for the stock is quoting at Rs 1301, up 2.14% on the day. Dr Reddys Laboratories Ltd is up 20.35% in last one year as compared to a 25.83% spurt in NIFTY and a 49.79% spurt in the Nifty Pharma index.The PE of the stock is 25.77 based on TTM earnings ending June 24.Powered by Capital Market - Live

Total revenue from operations stood at Rs 8,038.2 crore in Q2 FY25, up 16.45% as agasint Rs 6,902.6 crore posted in Q2 FY24. The revenue growth was primarily driven by growth in global generics revenues. Consolidated profit before tax rose marginally to Rs 1,917.4 crore in the second quarter of FY25 as against Rs 1916.7 crore posted in Q2 FY24. EBITDA grew 4.53% to Rs 2,280.3 crore in Q2 FY25 as against Rs 2,181.3 crore recorded in the corresponding quarter previous year. EBITDA margin reduced to 28.4% in Q2 FY25 as against 31.7% posted in Q2 FY24. Q2 FY25 gross margin stood at 59.6%, up 92 bps YoY, primarily of improvement in product mix and overhead leverage, partly offset by price erosion. Selling, general & administrative (SG&A) expenses for Q2 FY25 were at Rs 2,300.7 crore, YoY increase of 22.41%. Research & development (R&D) expenses in second quarter of FY25 stood at Rs 727.10 crore, 28.7% of revenue. During the quarter, revenues from Emerging Markets segment stood at Rs 1,455.4 crore, year on year increase of 19.65%, growth is attributable to market share expansion as well as new product launches. Revenues from India market during the quarter stood at Rs 1,397.1 crore, year on year increase of 17.79%, growth was led by revenues from the vaccine portfolio in-licensed from Sanofi, new products launched as well as price increases. During the quarter, company launched three new brands in the country, taking the year-to-date total to 16. Revenues from North America market was at Rs 3,728.1 crore, year on year rise of 17.32%. The growth was largely on account of increase in sales volumes, partly offset by price erosion. During the quarter, revenue from Europe market was at Rs 577 crore, year on year growth of 9.15%. The growth was primarily on account of leveraging the portfolio to launch new products, partly offset by price erosion. Revenues from Global Generics (GG) during the quarter grew 17.17% YoY to Rs 7,157.6 crore, primarily driven by improved sales volumes and new product launches. Sequential growth was primarily driven by Emerging Markets and Europe. Revenues from Pharmaceutical Services and Active Ingredients (PSAI) rose 19.51% to Rs 840.70 crore in Q2 FY25, mainly driven by momentum in base business volumes, growth in services business and revenues from new products. Free cash-flow for Q2 FY25 stood at Rs 200 crore while net cash surplus for the company was at Rs 1,890 crore as on 30 September 2024. Capital expenditure for second quarter of FY25 stood at Rs 740 crore. On half year basis, the company's net profit declined 8.28% to Rs 2,648.1 crore on 15.18% rise in total revenue from operations to Rs 15,734 crore in H1 FY25 over H1 FY24. Commenting on the results, co-chairman & MD, G V Prasad said, We delivered another good quarter and maintained the growth momentum across businesses. We made progress on our future growth drivers, operationalized our venture with Nestle and completed the acquisition of Nicotinell and related brands. We will continue to drive efficiency, strengthen our core businesses, and positively impact patient lives through science and innovation. Meanwhile, the company's board approved fund infusion by way of investment in equity shares of Dr. Reddy's Laboratories LLC, Russia, a step-down wholly-owned subsidiary, upto an amount of Rs 600 crore. The fund will be used for working capital requirements. Dr Reddy's Laboratories is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products. The scrip rose 0.36% to close at Rs 1,272.55 on the BSE.Powered by Capital Market - Live

Net profit of Dr Reddy's Laboratories declined 15.28% to Rs 1255.70 crore in the quarter ended September 2024 as against Rs 1482.20 crore during the previous quarter ended September 2023. Sales rose 16.51% to Rs 8016.10 crore in the quarter ended September 2024 as against Rs 6880.20 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales8016.106880.20 17 OPM %25.9029.19 - PBDT2314.402292.20 1 PBT1917.401916.70 0 NP1255.701482.20 -15 Powered by Capital Market - Live

Aurigene Oncology, a wholly-owned subsidiary of Dr. Reddy's Laboratories has announced the 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 initial results from the first 8 patients. All patients were heavily pre-treated with median of 5.5 previous lines of treatment. Most patients had also received transplant in the past and had disease progression post-transplant. All 8 patients (100%) achieved clinical response, with 5/8 (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients. After reviewing the Phase 1 data, the Indian Regulatory Agency i.e., Drugs Controller General of India (DCGI), has given the nod to commence Phase 2 part of the trial. These results of Phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently. Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology, Bangalore. Powered by Capital Market - Live