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Growing Diagnostics Arm Supports ABT Stock, Macro Issues Ail
ZACKS· 2025-09-26 13:46
Core Insights - Abbott's diversified business portfolio is positioned for continued momentum in 2025 despite a challenging international business environment [1] - The stock currently holds a Zacks Rank 3 (Hold) [1] Diabetes Care - Abbott's Diabetes Care business is benefiting from the strong sales of its FreeStyle Libre continuous glucose monitoring system, which has achieved global leadership in the CGM market for both Type 1 and Type 2 users [2] - In Q2 2025, CGM sales exceeded $1.9 billion, reflecting a 19.6% organic growth, with U.S. Libre sales rising nearly 26% [3] - The upcoming launch of Abbott's dual-analyte sensor is expected to enhance market share, particularly among intensive insulin users [3] Diagnostics Business - Abbott's Diagnostics business accounted for 19.5% of total revenues in Q2 2025, with core laboratory diagnostics (excluding China) growing 8% [4] - Strong demand was noted in the U.S. and Europe (up 7-8%) and Latin America (up high teens), despite temporary headwinds from volume-based procurement in China and reduced U.S. foreign aid for HIV testing [4][9] - The company remains optimistic about the long-term fundamentals of its Core Lab business [4] Established Pharmaceuticals Division (EPD) - Abbott's EPD sales increased 7.7% organically in Q2 2025, with over half of its top 15 markets surpassing $1 billion in quarterly sales for the first time [5] - The focus on biosimilars is expected to strengthen Abbott's prospects, with 10 regulatory approval submissions completed and launches projected for 2026 [5] Financial Performance - Year-to-date, Abbott's shares have gained 19.6%, outperforming the industry's 5.7% improvement [6] - The company's efforts to expand in high-growth areas and new product launches are anticipated to support continued stock uptrend [6] Challenges - Abbott faces challenges from a complex macroeconomic environment, including geopolitical tensions and rising expenses for raw materials and freight [7] - The deteriorating global economic environment is reducing demand for several MedTech products, leading to lower sales and increased costs [7] - Foreign exchange fluctuations have negatively impacted Abbott's performance, with a 1.1% unfavorable year-over-year impact on sales in the first half of 2025 [10]
Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)
Globenewswire· 2025-09-26 12:00
Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for AmnealBRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG. Omalizumab, a humanized ...
Alvotech vs. Teva Pharma: Which Generic Drugmaker is the Better Play?
ZACKS· 2025-09-23 17:21
Core Insights - Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) operate in the biosimilar market with distinct business models, where ALVO focuses on partnerships for market access while TEVA leverages its scale as a global pharmaceutical leader [1][23]. Alvotech Overview - Alvotech's revenue model is based on collaborations with established generic players, allowing it to minimize commercialization risks and costs [3][4]. - In H1 2025, Alvotech's product revenues surged over 200% year-over-year to nearly $205 million, driven by strong sales of its immunology biosimilars Simlandi and Selarsdi [4][9]. - The company has expanded into ophthalmology with the EU approval of Mynzepli, a biosimilar to Regeneron's Eylea, and is pursuing additional biosimilars in neurology and oncology [5][6]. - Alvotech's partnerships with Dr. Reddy's and Advanz Pharma are crucial for developing multiple biosimilar candidates [6]. Teva Pharmaceuticals Overview - Teva is the largest generic drug company globally, holding approximately 7% of the U.S. generic market, and has a strong manufacturing presence [7][23]. - The company has launched several successful biosimilars, including Truxima, Herzuma, and Epysqli, and expects to introduce up to 12 biosimilars in the U.S. and Europe from 2025 to 2027 [8][11]. - Teva aims to double its global biosimilars sales by 2027, with a pipeline that includes biosimilars of Amgen's Prolia and Regeneron's Eylea [12][14]. Financial Performance - Alvotech's sales and EPS estimates for 2025 indicate a year-over-year increase of nearly 35% and 133%, respectively, with upward trends in EPS estimates [15]. - Teva's 2025 sales and EPS estimates suggest a modest year-over-year increase of 2%, with mixed trends in EPS estimates for 2026 [15][17]. - Year-to-date, Alvotech shares have decreased by over 14%, while Teva shares have fallen by 39%, both underperforming the industry [9][17]. Valuation Comparison - Alvotech's shares trade at a price/sales (P/S) ratio of 3.26, indicating a higher valuation compared to Teva's P/S ratio of 1.32 [18]. Investment Considerations - Both companies hold significant positions in the generics/biosimilar market, with Teva benefiting from its scale and diversified portfolio, while Alvotech's partnership-driven strategy has led to strong revenue growth [22][23]. - Alvotech is viewed as a safer investment option due to its growth potential and solid fundamentals, despite its higher valuation [24].
European Medicines Agency Recommends Marketing Authorization of AVT03, Alvotech’s Proposed Biosimilar to Prolia® and Xgeva®
Globenewswire· 2025-09-22 10:15
REYKJAVIK, Iceland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use ...
European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech's Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner
Globenewswire· 2025-09-22 08:30
Core Viewpoint - Alvotech and Advanz Pharma announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for Gobivaz®, a biosimilar to Simponi® (golimumab), which is used to treat chronic inflammatory diseases [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 space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11]. Product Details - Gobivaz® is proposed in two formulations: 50 mg/0.5 mL and 100 mg/mL, intended for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis [4]. - The product is still under EMA regulatory review, with a final decision pending from the European Commission [4]. Clinical Study Results - Alvotech previously announced positive top-line results from a clinical study comparing the efficacy, safety, and immunogenicity of its biosimilar candidate AVT05 with Simponi® in patients with moderate to severe rheumatoid arthritis [6]. - A pharmacokinetic study also showed positive results for AVT05 compared to Simponi® in healthy adult participants [6]. Strategic Partnership - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds exclusive rights for commercialization in Europe [5].
Alvotech Announces Marketing Approval in Japan of Three New Biosimilars
Globenewswire· 2025-09-19 11:45
Core Viewpoint - Alvotech has received marketing approval for three new biosimilars in Japan, expanding its product offerings and addressing the growing demand for cost-effective biologic medicines [1][2][5] Group 1: New Product Approvals - Fuji Pharma has received marketing approval for three biosimilars: AVT03 (biosimilar to Ranmark®), AVT05 (biosimilar to Simponi®), and AVT06 (biosimilar to Eylea®) [1][2][3][4] - AVT05 is noted as the first golimumab biosimilar approved for sale in major markets globally [1] - AVT03 is approved for treating bone lesions due to multiple myeloma or metastases of solid tumors [2] - AVT05 is approved for treating Rheumatoid Arthritis in patients who have not responded sufficiently to conventional treatments [3] - AVT06 is approved for treating Age-related Macular Degeneration and other eye conditions [4] Group 2: Strategic Partnerships and Market Expansion - The partnership with Fuji Pharma was established in November 2018, and they successfully launched the first biosimilar to Stelara® in May 2024 [5] - Alvotech has licensed commercial rights in Japan to Fuji Pharma for two additional biosimilar candidates currently under development [5] Group 3: Company Overview - Alvotech is focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [7] - The company has a pipeline that includes eight disclosed biosimilar candidates targeting various diseases, including autoimmune disorders and cancer [7] - Alvotech has formed strategic commercial partnerships to enhance its global reach, including collaborations with companies in the US, Europe, Japan, and other regions [7]
Here's How ALVO's Commercial Partnerships Are Driving Top-line Growth
ZACKS· 2025-09-18 14:36
Core Insights - Alvotech (ALVO) differentiates itself in the biosimilar market by utilizing partnerships as its primary commercial model, focusing on distribution alliances rather than building its own sales infrastructure [1] - The company's product revenues increased over 200% year-over-year in the first half of 2025, reaching nearly $205 million, driven by its immunology biosimilars marketed through partnerships [2] - Alvotech's partnerships also provide diversified income streams beyond product sales, contributing to a more stable cash position [3] Revenue Growth - In H1 2025, Alvotech's product revenues surged to nearly $205 million, with significant contributions from its immunology biosimilars Simlandi and Selarsdi, marketed by Teva Pharmaceuticals in the U.S. and Stada in the EU [2][7] - The company maintains a full-year revenue guidance of $600 million to $700 million for 2025, supported by the rapid sales growth of its biosimilars [2] Strategic Partnerships - Alvotech has established agreements with companies like Teva, Dr. Reddy's Laboratories, and Advanz Pharma, which include upfront and milestone payments, enhancing its cash flow stability [3] - Recent partnerships have expanded Alvotech's pipeline into new therapeutic areas, including ophthalmology, neurology, and oncology, with new biosimilar candidates in development [4][5] Market Position and Valuation - Alvotech's shares are currently trading at a premium to the industry, with a price-to-sales (P/S) ratio of 3.23 compared to the industry average of 2.12 [9] - The company's earnings per share (EPS) estimates for 2025 and 2026 have seen significant improvements in the past month [10]
Is it the Right Time to Retain Abbott Stock in Your Portfolio?
ZACKS· 2025-09-18 14:06
Core Insights - Abbott has shown strong growth and market share gains in its Nutrition business, with a focus on adult nutrition products and a strategic emphasis on biosimilars in its Established Pharmaceuticals division [1][3][10] - The Diabetes Care segment is benefiting from the success of the FreeStyle Libre continuous glucose monitoring system, which has achieved global leadership and is expanding with new FDA-approved products [5][6] - Macroeconomic challenges and currency fluctuations pose potential risks to Abbott's financial performance [1][12][13] Nutrition Business Performance - Abbott's Nutrition business reported 3.4% organic growth in Q2 2025, driven by a 6.6% increase in Adult Nutrition sales [4][9] - The strong demand for Ensure and Glucerna brands supports the growth in Adult Nutrition, while Pediatric Nutrition remains robust in the U.S. with the Similac brand leading the market [4][9] Diabetes Care Segment - Sales of the FreeStyle Libre CGM system exceeded $1.9 billion in Q2 2025, reflecting a 19.6% organic growth, with U.S. sales rising nearly 26% [6][9] - The introduction of new over-the-counter CGM systems marks a significant expansion opportunity for Abbott in the U.S. market [5] Established Pharmaceuticals Division - Abbott's EPD achieved 7.7% organic growth in Q2 2025, with a focus on branded generics in emerging markets [11] - The division is well-positioned for sustainable growth, with a five-year CAGR of 8% and plans for biosimilar launches starting in 2026 [10][11] Financial Performance and Market Position - Abbott's market capitalization stands at $231.06 billion, with an earnings yield of 3.9%, significantly higher than the industry average of 0.2% [2] - The company has outperformed the industry, with a 17.5% stock price increase over the past year compared to a 0.3% decline in the industry [2]
12 Cheap Healthcare Stocks to Buy Now
Insider Monkey· 2025-09-15 11:35
Core Viewpoint - The healthcare industry is currently facing significant challenges, with large-cap pharmaceutical companies particularly affected, leading to a poor performance compared to the market [2][3]. Group 1: Industry Challenges - The healthcare sector has only outperformed the market during downturns over the last decade, indicating a troubling trend [2]. - The current dynamics in the healthcare industry are described as the worst experienced in decades, with managed care and pharmaceuticals identified as the main contributors to market pressures [3]. Group 2: Investment Opportunities - A methodology was employed to identify cheap healthcare stocks, focusing on companies with a market capitalization above $2 billion and a forward P/E ratio below 15 [5]. - The article lists 12 healthcare stocks deemed attractive for investment, based on their valuation metrics and growth potential [6]. Group 3: Company Highlights - **Bausch Health Companies Inc. (NYSE:BHC)**: - Forward P/E Ratio: 1.45, recognized for strategic acquisitions and pipeline developments, particularly in hepatology [7]. - Recent acquisition of DURECT Corporation valued at $63 million upfront, with potential milestone payments of up to $350 million, enhancing its portfolio for alcoholic hepatitis [8]. - Key pipeline assets include larsucosterol and rifaximin SSD, with significant market potential in addressing hospitalizations for alcoholic hepatitis [9][10]. - **Organon & Co. (NYSE:OGN)**: - Forward P/E Ratio: 2.73, focused on women's health and biosimilars, expanding its market presence since spinning off from Merck [11]. - Recent FDA approvals for biosimilars BILDYOS and BILPREVDA, aimed at improving access to osteoporosis and bone cancer treatments [12]. - The company is pivoting towards biosimilars as a growth engine while maintaining focus on women's health and dermatology [13]. - **Viatris Inc. (NASDAQ:VTRS)**: - Forward P/E Ratio: 4.40, formed from the merger of Mylan and Pfizer's Upjohn division, focusing on generics and specialty pharmaceuticals [14]. - FDA approval of a generic iron sucrose injection, reflecting a strategic entry into the intravenous iron market with significant sales potential [15]. - Positive late-stage trial results for several pipeline assets, reinforcing the company's growth strategy and upcoming product launches [16][17].
生物医疗-一图胜千言-A picture is worth a thousand words
2025-09-08 06:23
Summary of Key Points from the Conference Call Industry Overview - The conference call focuses on the **Biopharma** industry in **North America** with a comprehensive analysis of the **US drug market** as per **IQVIA Rx** data [1][6]. Core Insights - The **Total Prescription Year-over-Year (YoY) growth** for the week ending **August 29, 2025**, was reported at **+1.7%**, a decrease from **+2.3%** the previous week and **+2.6%** over the past 12 weeks [1][2]. - The **rolling 4-week TRx YoY** change was **+2.3%**, while the **rolling 12-week TRx YoY** was **+2.6%** [2]. - The **Extended Unit (EUTRx)** weekly YoY growth was **+2.0%**, indicating stronger performance compared to the overall TRx YoY [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: The drug **Cobenfy** for schizophrenia was approved on **September 26, 2024**. The current weekly scripts are approximately **2,210**, up from **2,160** the previous week. To meet the 2025 consensus expectations, Cobenfy needs to achieve **~129K TRx** at a net price of **~$1,200** [3]. - **Vertex Pharmaceuticals (VRTX)**: The drug **Journavx** for acute pain was approved on **January 30, 2025**. Current scripts are around **7,280**, with hospital scripts making up about **35%** of total scripts. To achieve projected sales of **$78 million**, approximately **349K total scripts** are needed [4]. - **Gilead Sciences (GILD)**: The drug **Yeztugo** was approved on **June 18, 2025**. The latest total TRx is approximately **470**, up from **390** the previous week. Projections for achieving consensus estimates for the second half of 2025 are discussed, with a focus on gross-to-net pricing adjustments [5]. Market Trends and Comparisons - A comparison of launches between **GILD's Yeztugo**, **Descovy**, and **Apretude** is provided, highlighting the uptake among different patient groups and the anticipated growth trajectory [5][9]. - The **GLP-1 franchise** from **Eli Lilly** shows significant growth, with **Mounjaro** and **Zepbound** experiencing **+66%** and **+233%** YoY growth respectively [20][23]. Additional Insights - The call includes a detailed analysis of **key products** and their respective YoY performance, with notable declines in some established drugs like **Humira** (-39%) and growth in others like **Skyrizi** (+44%) [20]. - The **COVID vaccine** tracking and **biosimilar adoption** analysis are also mentioned, indicating ongoing trends in the pharmaceutical landscape [12][28]. Conclusion - The conference call provides a comprehensive overview of the current state of the biopharma industry in North America, highlighting both challenges and opportunities for key players in the market. The data reflects a mixed performance across various drugs, with some experiencing significant growth while others face declines.