Workflow
Biosimilars
icon
Search documents
摩根士丹利:生物制药-一图胜千言
摩根· 2025-07-15 01:58
Investment Rating - The report assigns an "In-Line" rating for Major Pharmaceuticals and an "Attractive" rating for Biotechnology in North America [7]. Core Insights - The latest weekly Total Prescription Year-over-Year (YoY) growth in the US was +2.4%, slightly down from +2.9% the previous week and consistent with +2.3% over the past 12 weeks [1][6]. - The rolling 4-week Total Prescription YoY growth was also +2.4%, while the rolling 12-week growth was +2.3% [2]. - The report highlights the launch performance of new drugs, such as BMY's Cobenfy for schizophrenia and VRTX's Journavx for acute pain, providing insights into their prescription trends and market expectations [3][4]. Summary by Sections Prescription Trends - The Total Market weekly TRx YoY change was +2.4% compared to +1.9% a year ago, indicating a positive trend in prescription growth [2]. - Extended unit (EUTRx) weekly YoY growth was +1.0%, which is below the TRx YoY growth [2]. Drug Launch Performance - BMY's Cobenfy has seen approximately 1,930 scripts in its launch week, up from 1,660 the previous week, with expectations to achieve 2025 consensus estimates requiring a TRx of ~153K [3]. - VRTX's Journavx recorded around 5,340 scripts in its launch week, with hospital scripts making up about 28% of total scripts, indicating strong initial uptake [4]. Key Product Analysis - The report includes a detailed analysis of key products' TRx YoY percentages, highlighting significant growth in drugs like Skyrizi (+44%) and Sotyktu (+77%), while others like Humira (-36%) and Revlimid (-12%) showed declines [21][23]. - The report also tracks the performance of the GLP-1 franchise, with Mounjaro and Zepbound showing substantial growth rates of 75% and 248% respectively [25][46].
TEVA Stock Up More than 20% in Three Months: Buy, Sell or Hold the Stock?
ZACKS· 2025-07-11 13:36
Core Insights - Teva Pharmaceutical Industries Limited's shares have increased by 21.6% over the past three months due to successful launches of biosimilars and high-value generics, strong sales growth of newer branded drugs, and cost-cutting measures [1] Branded Drug Growth - Teva is experiencing market share growth for its newest branded drugs, Austedo and Ajovy, with expectations for continued sales growth from patient expansion and international launches [3] - The company anticipates annual revenues exceeding $2.5 billion from Austedo by 2027, bolstered by the launch of Austedo XR [4] - Uzedy, launched in May 2023, is projected to generate approximately $160 million in sales by 2025 [5] - Teva's branded pipeline includes olanzapine and duvakitug, with plans for phase III trials and new drug applications in the coming years [6][7] Generics and Biosimilars Pipeline - Teva has launched several biosimilars and complex generics, including products from major pharmaceutical companies [8] - The company has a strong pipeline of biosimilars, with plans to launch seven in the U.S. and four in Europe between 2025 and 2027 [10] - Teva's U.S. generics and biosimilars business grew by 15% in 2024, driven by new product launches [11] Financial Performance and Valuation - Teva's stock has underperformed the industry, losing 25% year-to-date compared to a 9.5% decline in the industry [13][14] - The stock is trading at a price/earnings ratio of 6.30, lower than the industry average of 10.17, but above its 5-year mean of 4.11 [15] - The Zacks Consensus Estimate for earnings has seen a slight decline for 2025 but an increase for 2026 [19] Long-term Growth Prospects - Teva's newer drugs and stable generics business are contributing to a revival in top-line growth [21] - The company is optimizing operations for efficiency, aiming for an adjusted operating margin of 30% by 2027 [22] - Recent credit outlook upgrades from Fitch, Moody's, and S&P reflect improved growth prospects for Teva [23]
Alvotech Appoints Linda Jónsdóttir as Chief Financial Officer
GlobeNewswire News Room· 2025-07-10 08:40
Core Insights - Alvotech has appointed Linda Jónsdóttir as the new Chief Financial Officer (CFO), bringing extensive international experience in finance and corporate leadership [1][2][3] - Joel Morales, the previous CFO since 2020, will step down to focus on family but will remain in an advisory role to ensure a smooth transition [1][4] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market [5] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [5] - Alvotech has established strategic commercial partnerships across multiple regions, including the United States, Europe, Japan, and parts of Asia and South America [5] Leadership Transition - Linda Jónsdóttir has a strong background, having held senior roles at Marel, including CFO and COO, and has experience on various boards [2][3] - Robert Wessman, CEO of Alvotech, expressed confidence in Linda's ability to support the company's growth and evolution [3] - Joel Morales acknowledged the transformation of Alvotech during his tenure, highlighting the company's transition to a public and profitable entity [4]
Johnson & Johnson's Outlook Clouded By $2 Billion Headwind
Benzinga· 2025-07-09 18:38
Group 1 - Johnson & Johnson is set to release its second-quarter earnings on July 16, with analysts estimating adjusted earnings of $2.68 per share and sales of $22.85 billion [1] - Investor focus will be on the updated 2025 guidance, the impact of tariffs and biosimilars, and the progress of the company's pipeline and recent product launches [1][3] - Bank of America Securities has updated its revenue estimates for Johnson & Johnson for 2025 and beyond ahead of the earnings release [2] Group 2 - Bank of America slightly increased its second-quarter 2025 revenue and EPS estimates by 1% due to improved foreign exchange rates, with similar modest increases projected for the later 2020s [4] - Despite the upward revisions, Bank of America maintains a Neutral rating and a price forecast of $61, considering the stock fairly valued [5] - Johnson & Johnson anticipates a $2 billion net headwind in 2025, affecting various assets while Xarelto is expected to benefit [6] Group 3 - CFO Joseph Wolk revised the estimated 2025 tariff impact down to $200 million from $400 million, with the majority expected in the second half of the year [7] - A federal court sided with the U.S. Department of Health and Human Services, rejecting Johnson & Johnson's attempt to alter its participation in the 340B Drug Pricing Program [7][8]
Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee Group in Switzerland
GlobeNewswire· 2025-07-09 08:30
Core Insights - Alvotech has announced the acquisition of Ivers-Lee Group to expand its assembly and packaging capacity for biosimilar medicines, integrating Ivers-Lee into its Technical Operations division while maintaining its status as a separate legal entity [1][2][4] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market with a fully integrated approach and broad in-house capabilities [6] - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [6] Acquisition Details - Ivers-Lee, founded in 1947, specializes in high-quality assembly and packaging services for the pharmaceutical sector and operates in Burgdorf, Switzerland, and Lörrach, Germany [3][5] - The integration of Ivers-Lee is expected to provide Alvotech with added flexibility and capacity to meet the growing global demand for biosimilars, particularly with three new biosimilars set to launch in 2025 [2][5] Operational Capabilities - Ivers-Lee's operations include the assembly and packaging of autoinjectors, pre-filled syringes, safety devices, and vials, with a GMP license and FDA approval for its Burgdorf site [5] - The company will continue to service its existing clients and provide contract manufacturing organization (CMO) services, including blister and stick-pack activities [5]
Abbott Sees Upside on Diagnostics Growth, FreeStyle Libre Expansion
ZACKS· 2025-07-02 15:06
Core Insights - Abbott's diversified business portfolio is well-positioned for continued momentum into 2025, currently holding a Zacks Rank 2 (Buy) [1] Factors Driving ABT Shares - Abbott's Established Pharmaceuticals Division (EPD) is leveraging its strong presence in emerging markets, achieving an 8% organic sales growth in Q1 2025. The company is focusing on biosimilars, securing rights to 15 products across key therapeutic areas, and has recently agreed to commercialize four additional biosimilars in Asia, Latin America, the Middle East, and Africa [2] - The Diagnostics business, accounting for 20% of total revenues in Q1 2025, is experiencing increased global demand for routine diagnostics, with Core Laboratory Diagnostics (excluding China) growing 6.5% [3] - The Diabetes Care segment is benefiting from the success of the FreeStyle Libre continuous glucose monitoring system, which has achieved global leadership in its category. In Q1 2025, CGM sales exceeded $1.7 billion, reflecting a 21.6% year-over-year growth [4][5] Recent Performance - Year-to-date, Abbott's shares have increased by 21.7%, outperforming the industry average of 8.2%. The company's expansion in high-growth areas and new product launches are expected to sustain this upward trend [6] Concerns for Abbott - Foreign exchange fluctuations pose a significant challenge, with a 2.8% unfavorable impact on sales in Q1 2025 due to a strong euro and other developed market currencies [7] - The ongoing complex geopolitical situation is leading to higher-than-anticipated expenses for raw materials and freight, which may affect Abbott's business in the coming months. The deteriorating global economic environment is also reducing demand for several MedTech products, impacting sales and increasing costs [8] Other Key Picks - Other top-ranked stocks in the medical space include Phibro Animal Health (PAHC), Hims & Hers Health (HIMS), and Cencora (COR), with varying degrees of performance and earnings estimates [11][12][13][14]
Alvotech and Advanz Pharma Enter into European Supply and Commercialization Agreement for Biosimilar Candidate to Cimzia® (certolizumab pegol)
Globenewswire· 2025-07-01 08:00
Core Insights - Alvotech and Advanz Pharma have entered into a supply and commercialization agreement for AVT10, a biosimilar candidate to Cimzia® (certolizumab pegol) [1][3] - This agreement is significant as AVT10 is the only biosimilar candidate referencing Cimzia® under development globally, targeting chronic rheumatic diseases [2][3] - The partnership aims to expand access to high-quality biologics for patients in Europe, with plans to launch their first biosimilars in Q4 2025 [4] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, with a pipeline that includes eight disclosed biosimilar candidates for various diseases [6] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries and a diverse product portfolio [7][8] Market Context - Cimzia® generated worldwide sales of US$2.3 billion in 2024, indicating a substantial market opportunity for Alvotech's biosimilar candidate [3] - The strategic partnership between Alvotech and Advanz Pharma is expected to enhance their biosimilars pipeline and strengthen their market position in Europe [3][4]
Biocon Biologics Receives Health Canada Approval for Yesafili™ (aflibercept); First Global Launch Scheduled for July 2025
Globenewswire· 2025-06-27 04:22
Core Viewpoint - Biocon Biologics Ltd. has received a Notice of Compliance from Health Canada for its biosimilar YESAFILI (aflibercept), marking it as the first biosimilar to EYLEA approved in Canada, with a launch scheduled for July 4, 2025 [1][3]. Company Overview - Biocon Biologics Ltd. is a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., focused on providing affordable access to high-quality biologics [1][10]. - The company has commercialized nine biosimilars and has a pipeline of 20 biosimilar assets across various therapeutic areas, including diabetology, oncology, and ophthalmology [11]. Product Details - YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several serious retinal diseases, including neovascular age-related macular degeneration and diabetic macular edema [6][4]. - The approval of YESAFILI was based on comprehensive data demonstrating its similarity to EYLEA in terms of quality, safety, and efficacy, with no clinically meaningful differences observed in a Phase 3 study [2][4]. Market Impact - The approval of YESAFILI is seen as a significant achievement for Biocon Biologics in Canada, enhancing access to advanced biologic therapies for Canadian patients and ophthalmologists [3][10]. - The launch of YESAFILI will be the company's 10th biosimilar to be commercialized globally, reflecting its commitment to expanding access to affordable biologics [3][11].
Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences
Globenewswire· 2025-06-25 12:00
Core Insights - Amneal Pharmaceuticals has announced positive topline results from a clinical trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab), which is expected to be a significant growth driver for the company in the U.S. biosimilar market valued at $3.9 billion [1][4] - The Biologics License Application (BLA) for ADL-018 is anticipated to be filed with the FDA in Q4 2025, with Amneal holding exclusive U.S. commercialization rights pending regulatory approval [3] Group 1: Clinical Trial Results - The confirmatory clinical trial for ADL-018 was a randomized, double-blind, multicenter study that evaluated its efficacy, safety, and immunogenicity compared to XOLAIR in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) [1][2] - The study met its primary and secondary endpoints, demonstrating equivalence in therapeutic outcomes and comparable safety profiles between ADL-018 and XOLAIR [2] Group 2: Market Context - Omalizumab, the reference product, is indicated for severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria, with U.S. annual sales reaching approximately $3.9 billion for the 12 months ending April 2025 [4] - The successful development of ADL-018 is part of Amneal's broader strategy to commercialize six biosimilars across eight product presentations by 2027 [3] Group 3: Company Background - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, focusing on both affordable medicines and specialty branded pharmaceuticals [5] - Kashiv BioSciences, the developer of ADL-018, is a vertically integrated biopharmaceutical company with a focus on delivering cost-effective, high-quality therapies [6][7]
Amneal Pharmaceuticals (AMRX) 2025 Earnings Call Presentation
2025-06-06 09:18
Financial Performance & Growth - Amneal Pharmaceuticals is entering a new era of growth as a global biopharmaceutical company[9] - The company projects net revenues of $3.0 - $3.1 billion for 2025, reflecting a growth of 7% to 11%[11] - Adjusted EBITDA is guided at $650 million - $675 million for 2025, indicating a growth of 4% to 8%[11] - The company's net leverage stands at 3.9x as of Q1 2025, with expectations to reduce it to less than 3x in the coming years[11, 50] Business Diversification & Pipeline - Oral solid generics are decreasing as a percentage of total revenue, from 53% in 2019 to 23%[11] - The pipeline is shifting towards non-oral solids, with 96% of pipeline products being non-oral solids[11, 44] - The company has 3 commercial biosimilars and 5 biosimilars in the pipeline[11] Strategic Initiatives & Product Portfolio - Specialty business revenue reached $449 million in the last twelve months of Q1 2025, growing +11% compared to the prior year period[26] - CREXONT for Parkinson's Disease is expected to achieve $300-500 million in U S peak sales[29] - AvKARE segment is experiencing double-digit growth, aiming for $900 million+ revenue by 2027[16]