Financial Performance - The company reported a 4.4% revenue growth year-over-year, with consolidated revenues standing at INR 8,727 crores ($971 million) [7] - EBITDA margin was reported at 23.5%, which included a one-time provision related to new labor codes; adjusting for this, the underlying EBITDA margin was 24.8% [10][15] - Profit after tax attributable to equity holders was INR 1,210 crores ($135 million), reflecting a decline of 14% year-over-year [11] - Free cash flow generated during the quarter was INR 374 crores ($42 million) [12] Business Line Performance - North America generic business revenues declined by 16% year-over-year to $338 million, primarily due to lower lenalidomide sales and pricing pressures [21] - The European generic business reported a revenue of $140 million, growing 4% year-over-year [21] - The emerging market business delivered revenue of INR 1,896 crores, reflecting robust growth of 32% year-over-year [22] - The India business reported revenue of INR 1,603 crores, achieving a healthy growth of 19% year-over-year [23] - PSAI business revenue was $92 million, resulting in a decline of 5% year-over-year [24] Market Performance - The emerging market growth was driven by new product launches and favorable forex, with Russia business growing 21% year-over-year [22] - The India business outperformed the Indian pharmaceutical market, with a moving quarterly total months growth of 12.3% compared to the market growth of 11.8% [23] Company Strategy and Industry Competition - The company entered a strategic collaboration with Immutep for commercialization of a novel immunotherapy oncology drug, Eftilagimod Alpha, with potential milestones of up to $350 million [16] - The integration of the acquired nicotine replacement therapy business is progressing well, with 85% of the business now under operational controls [16] - The company is focused on advancing key pipeline products like Semaglutide and Abatacept, with expectations for launches in various markets [17][18] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the sustainability of growth in the India business, attributing it to innovative products and effective brand strategies [31][45] - The company anticipates competitive pricing in the markets for Semaglutide, with expectations of maintaining healthy prices initially before facing competition [49][51] - Management highlighted ongoing efforts to resolve regulatory observations and maintain timelines for product approvals [60][74] Other Important Information - The company announced a science-based net-zero climate target, making it the only Indian pharmaceutical company to commit to such a target by FY24 [20] - The new labor code provision of INR 117 crores includes retrospective costs, but future impacts on employee expenses are expected to be minimal [84][85] Q&A Session Summary Question: What is the organic growth for the India business? - Management indicated that organic growth is more than 17% without acquisitions [29][30] Question: What is driving the strong growth in India? - The growth is primarily driven by innovative products that are gaining market recognition [32][33] Question: What are the expectations for Semaglutide approval in Canada? - Approval is expected between February and May, with preparations for a launch in Q4 [41][70] Question: How has lenalidomide contributed to EBITDA margins? - Management could not disclose specific figures due to confidentiality but noted that the decline in the U.S. is primarily due to lenalidomide [56][57] Question: What are the timelines for Denosumab and Rituximab in the U.S.? - Denosumab is expected to face delays due to a deficiency letter, while Rituximab is anticipated to undergo re-inspection soon [60][66] Question: What is the addressable market for Abatacept in Europe? - The addressable market is estimated to be around $2 billion, with plans to launch in multiple countries [95][96]

Core Points - Incyte Japan has received approval for Minjuvi® (tafasitamab) in combination with Rituximab and Lenalidomide for the treatment of relapsed/refractory follicular lymphoma [1] Company Summary - The approval of Minjuvi® marks a significant advancement in the treatment options available for patients with relapsed/refractory follicular lymphoma, indicating a potential increase in market share for Incyte Japan [1] - This combination therapy may enhance treatment efficacy and improve patient outcomes, positioning Incyte Japan favorably within the oncology market [1] Industry Summary - The approval reflects ongoing innovation in the oncology sector, particularly in the treatment of lymphomas, which is a growing area of focus for pharmaceutical companies [1] - The combination of therapies like Minjuvi®, Rituximab, and Lenalidomide may set a new standard of care, influencing future treatment protocols and competitive dynamics in the industry [1]

Core Insights - Dr. Reddy's Laboratories Limited (RDY) reported first-quarter fiscal 2026 earnings of 20 cents per American Depositary Share (ADS), exceeding the Zacks Consensus Estimate of 18 cents, and up from 19 cents per ADS in the same quarter last year [1][5] - Revenues increased by 11% year over year to $997 million, surpassing the Zacks Consensus Estimate of $951 million, primarily driven by growth in global generics revenues [1][5] Revenue Breakdown - Global Generics revenues reached INR 75.6 billion, reflecting a 10% year-over-year increase, mainly due to the acquired Nicotine Replacement Therapy portfolio in Europe and strong performance in branded markets [2] - Pharmaceutical Services & Active Ingredients (PSAI) revenues amounted to INR 8.2 billion, up 7% year over year, driven by new active pharmaceutical ingredient launches and favorable foreign exchange, despite lower pricing and softer demand [7] - Revenues in the Others segment totaled INR 1.65 billion, showing significant year-over-year growth [7] Product Launches and Approvals - Dr. Reddy's launched five new products in the United States during the reported quarter, although revenues in the North America segment declined by 11% due to increased price erosion in key products like Lenalidomide [3] - As of June 30, 2025, there were 73 generic filings pending approval from the FDA, including 70 abbreviated new drug applications (ANDAs) and three new drug applications, with 43 of the ANDAs being Paragraph IV filings [3] Financial Metrics - Gross margin decreased by 350 basis points to 56.9% in the first quarter of fiscal 2026, attributed to higher price erosion in generics and reduced operating leverage, partially offset by a favorable product mix [8] - Research and development (R&D) expenses were $73 million, remaining relatively flat year over year [8] - Selling, general and administrative expenses totaled $299 million, up 13% year over year, driven by increased sales and marketing investments [9] Strategic Collaborations - Dr. Reddy's signed a collaboration and license agreement with Alvotech (ALVO) to co-develop and commercialize a biosimilar candidate to Merck's Keytruda, a major cancer drug, with both companies sharing development and manufacturing costs [10][11] - Keytruda generated sales of $29.5 billion in 2024, with a 6% year-over-year increase to $7.21 billion in the first quarter of 2025, highlighting its significance in Merck's revenue growth [12] Market Performance - Shares of Dr. Reddy's have declined by 7.5% year to date, compared to an 11.4% decline in the industry [4]

Financial Performance - Revenues reached ₹8,545 Cr, showing an 11% YoY growth[9] - EBITDA stood at ₹2,278 Cr with a margin of 26.7%[9] - Profit Before Tax (PBT) was ₹1,905 Cr, representing 22%[9] - Profit After Tax (PAT) amounted to ₹1,418 Cr, which is 17%[9] Segment Performance - Global Generics contributed ₹7,562 Cr, with a 10% YoY increase[13] - North America generated ₹3,412 Cr in revenue, up by 11% YoY[13] - India's revenue was ₹1,471 Cr, marking an 11% YoY growth[13] - Europe reported revenue of ₹1,274 Cr, a significant 142% YoY increase, including revenues from the acquired NRT business[13] - Pharmaceutical Services & Active Ingredients (PSAI) achieved ₹818 Cr in revenue, a 7% YoY increase[13] - Emerging Markets reached ₹1,404 Cr in revenue, showing an 18% YoY increase[13] Financial Position - Net Cash surplus at ₹2,922 Cr as of June 30, 2025[11, 22]

Core Viewpoint - Class action lawsuits have been filed against Viatris Inc. and Canopy Growth Corporation, alleging that both companies made materially false and misleading statements regarding their business operations and financial prospects during specified class periods [2][3]. Viatris Inc. (NASDAQ: VTRS) - Class Period: August 8, 2024 – February 26, 2025 - Lead Plaintiff Deadline: June 3, 2025 - Allegations include failure to disclose the significant impact of a failed FDA inspection at the Indore facility, which affected the company's ability to manufacture and ship key products, particularly Lenalidomide [2]. - The complaint states that the positive statements made by the defendants regarding the company's business were materially misleading and lacked a reasonable basis [2]. Canopy Growth Corporation (NASDAQ: CGC) - Class Period: May 30, 2024 – February 6, 2025 - Lead Plaintiff Deadline: June 3, 2025 - Allegations include incurring significant costs related to the production of Claybourne pre-rolled joints and the Storz & Bickel vaporizer devices, which negatively impacted the company's gross margins and overall financial results [3]. - The complaint asserts that the defendants overstated the efficacy of cost reduction measures and downplayed issues affecting gross margins, leading to materially misleading statements about the company's business [3].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Viatris, Inc. due to allegations of violations of federal securities laws related to misleading statements and undisclosed information impacting the company's revenue outlook and growth projections [2][4]. Group 1: Legal Investigation and Class Action - The firm is reminding investors of the June 3, 2025 deadline to seek the role of lead plaintiff in a federal securities class action against Viatris [2]. - The complaint alleges that Viatris and its executives made false statements and failed to disclose significant risks related to a failed FDA inspection at its Indore facility, which adversely affected the company's financial outlook [4]. - The class action lawsuit claims that Viatris downplayed the impact of the FDA inspection and the resulting remediation efforts, which significantly hindered the company's ability to manufacture and ship key products [4]. Group 2: Financial Impact and Stock Performance - On February 27, 2025, Viatris announced disappointing financial results for Q4 and full fiscal year 2024, attributing below-expectation guidance to the financial impact from the Indore facility's warning letter and import alert [5]. - Following the announcement, Viatris' stock price dropped from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025, marking a decline of approximately 15.21% in one day [6].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, captioned Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented the condition of its facilities, stating they were in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter from the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, preventing the company from manufacturing and distributing key products, including Lenalidomide [4]. - In its Q4 2024 results released on February 27, 2025, Viatris disclosed that the inspection's repercussions would lower 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented the condition of its facilities, stating they were in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter from the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, preventing the company from manufacturing and distributing key products, including Lenalidomide [4]. - In the Q4 2024 results released on February 27, 2025, Viatris disclosed that the failed inspection would lower 2025 revenue by approximately $500 million and earnings from operations by approximately $385 million [5]. - Following this announcement, Viatris's stock price fell about 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

Core Viewpoint - A class action lawsuit has been filed against Viatris Inc. for allegedly misleading investors regarding the company's revenue and growth challenges, particularly related to a failed FDA inspection at its Indore facility [3][4]. Group 1: Class Action Details - The class action represents investors who purchased Viatris securities between August 8, 2024, and February 26, 2025, with a deadline of June 3, 2025, to file a lead plaintiff motion [1]. - Investors are encouraged to contact the Portnoy Law Firm for legal rights discussions and complimentary case evaluations [2]. Group 2: Allegations Against Viatris - The lawsuit claims that Viatris downplayed the seriousness of the failed FDA inspection and its consequences, leading to a false impression of the company's stability [3]. - It is alleged that Viatris underestimated the impact of the FDA inspection failure, which resulted in significant setbacks, including ongoing remediation efforts and disruptions in manufacturing and shipping key products like Lenalidomide [4]. Group 3: Financial Impact - On February 27, 2025, Viatris reported disappointing fourth-quarter and full-year 2024 financial results, along with guidance for fiscal year 2025 that reflected the expected financial effects of the FDA warning letter [5]. - Following this announcement, Viatris' stock price experienced a decline of over 15% [5].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented its facilities as being in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter issued by the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, hindering the company from manufacturing and distributing key products, including Lenalidomide [4]. - In the Q4 2024 results released on February 27, 2025, Viatris disclosed that the inspection's repercussions would lower 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].