Biosimilar

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Dr. Reddy's Q1 Earnings Beat Estimates, Generics Sales Boost Revenues
ZACKS· 2025-07-24 16:25
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]
Alvotech Meets Investors and Presents at the Goldman Sachs Global Healthcare Conference in Miami
Globenewswire· 2025-06-06 12:30
Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [3] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach and broad in-house capabilities [3] - Alvotech has launched two biosimilars and has a development pipeline that includes candidates for treating autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [3] Strategic Partnerships - Alvotech has formed a network of strategic commercial partnerships to enhance its global reach and leverage local expertise in various markets, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [3] - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and Dr. Reddy's, among others, each covering unique products and territories [3] Upcoming Events - Alvotech will participate in the Goldman Sachs 46th Global Healthcare Conference in Miami, Florida, from June 9-11, 2025 [1] - Dr. Balaji Prasad, Chief Strategy Officer, will engage in a fireside chat on June 11, 2025, at 8:00 am EDT [1][2]
Alvotech intends to carry out a private placement of approximately 7.5 million SDRs and ordinary shares
Globenewswire· 2025-06-04 15:32
Core Viewpoint - Alvotech intends to conduct a private placement of approximately 7.5 million Swedish Depository Receipts (SDRs) and ordinary shares to strengthen its shareholder base and fund R&D activities [2][4]. Group 1: Placement Details - The placement will be executed through an accelerated bookbuilding procedure, with pricing and total number of SDRs and ordinary shares to be determined during this process [3][6]. - The completion of the bookbuilding and pricing is expected before trading starts on Nasdaq Stockholm at 09:00 CEST on June 5, 2025 [3]. - The company may adjust the timing of the bookbuilding and has the discretion to shorten, extend, or suspend the placement [3]. Group 2: Use of Proceeds - Net proceeds from the placement are intended to accelerate Alvotech's R&D activities, particularly following the acquisition of Xbrane's R&D operations [4]. - The funds will also be used for general corporate purposes, allowing Alvotech to expand its pipeline and capitalize on growth opportunities [4]. Group 3: Shareholder and Management Commitments - The company and its executive management have agreed not to sell or transfer additional SDRs or ordinary shares for 180 days post-placement settlement, subject to certain conditions [7][8]. - Major shareholders have also committed to not dispose of their holdings for 90 days following the placement [10]. Group 4: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [13]. - The company aims to be a global leader in the biosimilar market, leveraging strategic partnerships for market reach [13].
Alvotech Meets Investors and Participates in Fireside Chat At the BofA Securities Healthcare Conference 2025 in Las Vegas, Nevada
Globenewswire· 2025-05-09 12:00
Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [3] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach and broad in-house capabilities [3] - Alvotech has launched two biosimilars and has a development pipeline targeting autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [3] Strategic Partnerships - Alvotech has formed a network of strategic commercial partnerships to enhance its global reach and leverage local expertise in various markets, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [3] - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd., and Dr. Reddy's, among others, each covering unique products and territories [3] Upcoming Events - Alvotech will participate in the BofA Securities Healthcare Conference 2025 in Las Vegas, Nevada, from May 13-15, 2025, hosting one-on-one meetings and a fireside chat on May 14, 2025 [1] - A live audio webcast of the fireside chat will be available to the public, with a recording accessible for 90 days post-event [2]