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Does Cobenfy Have the Potential to Become a Top Drug for BMY?
ZACKS· 2025-08-20 14:56
Core Insights - Bristol Myers (BMY) received FDA approval for Cobenfy, an oral medication for schizophrenia, in September 2024, expanding its portfolio and validating the acquisition of Karuna Therapeutics [1][10] - Cobenfy represents a new pharmacological approach to treating schizophrenia, with initial sales of $62 million in the first half of 2025 and expectations for higher sales in the second half [2][10] - The company is conducting registrational trials for Cobenfy in Alzheimer's disease and bipolar 1 disorder, aiming for label expansions to drive growth [3][10] - Despite the approval, BMY reported disappointing results from the phase III ARISE study, where Cobenfy did not meet the primary endpoint for statistical significance [4] - BMY is focusing on new drugs to stabilize revenue as legacy products face generic competition [5] Competition Landscape - AbbVie (ABBV) is developing emraclidine for schizophrenia, but its phase II trials did not meet primary endpoints [7] - Reviva Pharmaceuticals is evaluating brilaroxazine for schizophrenia, with positive results from a recent study and plans to discuss FDA approval in late 2025 [8] Financial Performance - BMY's shares have decreased by 14.5% year-to-date, contrasting with the industry's growth of 3.3% [9] - BMY is trading at a discount compared to the large-cap pharma industry, with a price/earnings ratio of 7.78x forward earnings, lower than the industry average of 14.56x [11] - The bottom-line estimate for 2025 has increased to $6.50 from $6.37, while the estimate for 2026 has risen to $6.07 from $6.02 [13]
Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Prnewswire· 2025-08-18 10:00
Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][3][5] - Iza-bren is a bispecific antibody-drug conjugate targeting both EGFR and HER3, developed by SystImmune and Bristol Myers Squibb [2][7] - The BTD highlights the potential of iza-bren to address significant unmet clinical needs for patients who have progressed after existing treatments [3][5] Company Overview - SystImmune is a clinical-stage biopharmaceutical company focused on innovative cancer treatments, utilizing bi-specific and multi-specific antibodies, as well as antibody-drug conjugates [8][9] - Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines for serious diseases [10] Clinical Data - The FDA's decision was based on data from three ongoing clinical trials, indicating improved efficacy and manageable safety for iza-bren in patients with EGFR-mutant NSCLC [4][6] - NSCLC accounts for approximately 80% of lung cancer cases, with a significant portion of patients harboring activating EGFR mutations, highlighting the need for new therapies [6]
Dividend Harvesting Portfolio Week 232: $23,200 Allocated, $2,467.76 In Projected Dividends
Seeking Alpha· 2025-08-14 12:45
Group 1 - The focus is on growth and dividend income as a strategy for retirement planning [1] - The portfolio is structured to generate monthly dividend income that grows through reinvestment and annual increases [1] Group 2 - The article expresses personal opinions and is not intended as investment advice [2][3] - It emphasizes the importance of conducting individual research before making investment decisions [2]
Will Breyanzi's Strong Uptake Help BMY Offset Generic Competition?
ZACKS· 2025-08-13 13:40
Key Takeaways Bristol Myers' ((BMY) CAR T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) posted strong growth in the second quarter. BMY Faces Competition for the CAR- T Cell Therapy Breyanzi faces competition from Gilead Sciences' ((GILD) Yescarta for its approved indications. Gilead's Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 m ...
Want Over $2,100 in Annual Dividends? Invest $12,000 Into Each of These 3 High-Yielding Stocks
The Motley Fool· 2025-08-13 10:26
Investing in high-yielding dividend stocks can result in significant dividend income for your portfolio. But higher yields also tend to mean higher risk, and dividends are never guaranteed. A company that's struggling may end up having to cut or suspend a high payout as it works to improve its financial situation. That's why it's important to find dividend stocks that offer high yields, but also have strong earnings capable of supporting their payouts for the foreseeable future. Three quality stocks that ge ...
北美医药生物-一图胜千言-A picture is worth a thousand words
2025-08-11 02:58
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 1, 2025, was reported at **+2.8%**, an increase from **+1.7%** the previous week and **+2.6%** over the past 12 weeks [1][6]. - For the week ended August 1, the **US total market weekly TRx YoY change** was **+2.8%**, compared to **+0.9%** a year ago. The **rolling 4-week TRx YoY** was **+2.9%** and the **rolling 12-week TRx YoY** was **+2.6%** [2]. Company-Specific Developments - **Bristol Myers Squibb (BMY)**: - The drug **Cobenfy** was approved for schizophrenia on September 26, 2024. The current scripts are approximately **2,010** for the week, up from **1,950** the previous week. To meet 2025 consensus expectations, Cobenfy's TRx needs to track at **~2-3x** the volumes from recent schizophrenia launches [3]. - The consensus estimate for Cobenfy has decreased from **$196 million** to **$171 million**, implying that approximately **129K TRx** are required to meet these estimates [3]. - **Vertex Pharmaceuticals (VRTX)**: - The drug **Journavx** was approved for acute pain on January 30, 2025, with current scripts at approximately **6,800**, up from **6,430** the previous week. It is noted that hospital scripts, which account for about **35%** of total scripts, are not captured by IQVIA [4]. - To achieve a sales target of **$78 million**, approximately **345K total scripts** are needed, assuming a **$225 net price per script** [4]. - **Gilead Sciences (GILD)**: - The launch comparison for **Yeztugo** (lenacapavir) shows current TRx at approximately **210**, down from **300** the previous week. The injectable formulation accounts for **50%** of total TRx [5]. Additional Insights - The **extended unit (EUTRx)** weekly YoY growth was reported at **+1.9%**, which is below the TRx YoY growth [2]. - The **sequential weekly TRx growth** was **-0.1%**, an improvement from **-1.2%** the week before [2]. - The **biopharma industry view** is categorized as **attractive**, while the major pharmaceuticals industry view is **in-line** [7]. Notable Trends - The **momentum of top outpatient drugs** indicates varying performance across different companies, with notable declines in some established drugs like **Humira** (AbbVie) showing a **-40%** YoY change, while newer drugs like **Mounjaro** (Eli Lilly) and **Zepbound** (Eli Lilly) show significant growth rates of **69%** and **257%** respectively [24]. Conclusion - The conference call highlights a positive trend in the US drug market with specific growth in total prescriptions. However, individual company performance varies significantly, with newer drugs showing strong growth potential while established drugs face declines. The insights provided can guide investment decisions in the biopharma sector.
深度|全球制药行业成本压力上升,多家企业宣布减员计划
Di Yi Cai Jing Zi Xun· 2025-08-08 08:45
在美国特朗普政府不确定的政策影响下,今年全球制药行业在资本市场的表现低迷,关税及药品价格下 调等因素导致企业成本压力上升。在近期公布的第二季度财报中,多家制药企业宣布削减成本,并将采 取减员计划。 今年至今,总市值近5万亿美元规模的标普500医疗保健板块指数下跌约5%,同期标普500指数涨幅超过 7%,美国市场医疗股资金净流出规模也超过其他任何行业。 医疗板块资本市场遇冷 根据伦敦证券交易所数据流(LSEG Datastream)的最新数据,基于对未来一年盈利预测,医疗保健行 业市盈率已从一年前的近20倍降至约16倍。默沙东及百时美施贵宝(BMS)的预期市盈率分别仅为8.7 倍和7.4倍,低于行业平均水平。两家公司今年以来股价累计跌幅都接近20%。 在最新季度的财报中,尽管大部分制药企业都上调了年度利润预期,但由于关税及药品价格谈判等不确 定性因素导致的成本上升风险依然存在。在这一背景下,包括默沙东、辉瑞、诺和诺德在内的制药巨头 都表示将进一步采取行动削减成本。 默沙东已经宣布了一项成本削减和减员计划,预计在2027年前,每年节省30亿美元开支。公司表示,基 于目前关税的水平,相应成本增加预计达到2亿美元。而 ...
生物医药-一图胜千言A picture is worth a thousand words
2025-08-08 05:02
Summary of Key Points from the Conference Call Industry Overview - **Industry**: Biopharma in North America - **Market Analysis**: The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending July 25, 2025, was +1.7%, a decrease from +3.0% the previous week and +2.6% over the past 12 weeks [1][2][6] Core Company Insights Bristol Myers Squibb (BMY) - **Cobenfy Launch**: Approved for schizophrenia on September 26, 2024. Weekly scripts were approximately 1,950, down from 2,060 the previous week. To meet 2025 consensus expectations, Cobenfy TRx needs to track at 2-3 times the volumes of recent schizophrenia launches, requiring about 129K TRx at an estimated net price of $1,200 [3][14][16] Vertex Pharmaceuticals (VRTX) - **Journavx Launch**: Approved for acute pain on January 30, 2025. Weekly scripts were around 6,430, up from 6,240 the previous week. Hospital scripts, which are not captured by IQVIA, account for approximately 28% of total scripts. To achieve estimated sales of $65 million, about 289K total scripts are needed [4][19] Gilead Sciences (GILD) - **Yeztugo Launch**: Approved on June 18, 2025, with weekly TRx of approximately 300, an increase from 240 the previous week. The injectable formulation accounted for 45% of total TRx, while the oral formulation made up 55% [5][22] Eli Lilly (LLY) - **Mounjaro and Zepbound**: The launch of Mounjaro is showing strong growth, with a 69% increase in TRx YoY. Zepbound has seen a remarkable 268% increase in TRx YoY [9][26] Additional Insights - **Market Trends**: The extended unit (EUTRx) weekly YoY growth was +0.9%, indicating a more positive trend compared to TRx YoY growth. This suggests that physicians are increasingly writing longer-duration prescriptions [2][35] - **Key Product Performance**: The performance of major pharmaceutical products shows significant variations, with some experiencing substantial declines (e.g., Humira -41% YoY) while others like Sotyktu and Mounjaro are seeing strong growth [26][48] Important Metrics - **TRx Growth**: The overall TRx growth for the biopharma sector is showing signs of slowing down, with the latest figures indicating a need for companies to adapt their strategies to maintain growth [1][31] - **Sales Estimates**: Consensus estimates for various drugs have been adjusted, reflecting the dynamic nature of the market and the competitive landscape [3][4][5] Conclusion The biopharma industry in North America is currently experiencing mixed performance across different companies and products. While some new launches are showing promising growth, overall market trends indicate a slowdown in prescription growth, necessitating strategic adjustments by companies to meet evolving market demands.
制药与生物技术板块_截至 7 月 31 日的海外公司收益发布-Pharmaceuticals and biotech sectors_ Overseas companies‘ earnings releases through 31 July
2025-08-08 05:02
Summary of Earnings Call Records Industry Overview - **Industry**: Pharmaceuticals and Biotech Sectors - **Companies Discussed**: AbbVie, Biogen, Bristol Myers Squibb, Bio-Rad Laboratories, Neurocrine Biosciences, Takeda Pharmaceutical, Chugai Pharmaceutical, PeptiDream, Nxera Pharma Key Points by Company AbbVie - **Sales Performance**: Humira sales decreased by 58.1% year-over-year due to biosimilar competition, but this was offset by strong sales of Skyrizi, which increased by 62.2% to $4.4 billion, driven by market share growth in psoriasis and inflammatory bowel disease [1] - **Product Strategy**: Many patients switched from Humira to Skyrizi and Rinvoq instead of biosimilars. AbbVie plans to increase production capacity for Skyrizi in the long term [1] - **New Developments**: The obesity treatment ABBV-295 may address muscle and bone loss when used with other AbbVie drugs [1] Biogen - **Market Share**: Leqembi, an Alzheimer's treatment, maintains a 70% market share despite competition from Eli Lilly's Kisunla [3] - **Testing Growth**: Monthly PET testing for Alzheimer's has increased fivefold, and blood-based biomarker testing has tripled in the past year [3] - **Future Expectations**: Biogen anticipates interim data readout for the AHEAD 3-45 study in 2028 [3] Bristol Myers Squibb - **Sales Growth**: Sales of Opdivo's subcutaneous formulation increased by 7% year-over-year to $30 million, while the intravenous formulation rose to $2.56 billion [6] - **New Product Launch**: Cobenfy, a schizophrenia treatment, generated $35 million in sales with over 2,000 weekly prescriptions [6] - **Direct-to-Patient Model**: The company plans to sell Eliquis directly to patients at a discount of over 50% below the list price [6] Bio-Rad Laboratories - **Sales Performance**: Reported sales of $652 million, up 2% year-over-year, but operating profits fell by 24% to $77 million due to weak demand in biotech and academic research markets [8] - **Market Challenges**: The demand for instruments has been particularly weak, impacting overall sales [8] Neurocrine Biosciences - **Sales Growth**: Total sales reached $688 million, up 16% year-over-year, with operating profits flat at $146 million [10] - **Future Studies**: Plans to initiate a Phase 2 study of NBI-570 in H2 2025, with Phase 1 data readouts expected for NBI-567 and NBI-569 [10] - **Market Positioning**: Neurocrine is exploring differentiation opportunities in muscarinic receptor agonists, which may be better suited for elderly patients [10] Implications for Japanese Companies - **Takeda Pharmaceutical**: Entyvio retains a top share among first-line therapies for ulcerative colitis but is losing market share in second-line settings due to competition [2] - **Chugai Pharmaceutical and PeptiDream**: Both companies are developing myostatin inhibitors to counteract muscle mass loss associated with long-term GLP-1 receptor agonist use [2] - **Nxera Pharma**: The company is positioned positively due to its licensing of muscarinic receptor agonists to Neurocrine, although earnings contributions may not be reflected in share prices until Phase 3 study results are available [11] Additional Insights - **Market Trends**: The aggressive advertising by competitors is impacting market shares of established products like Entyvio [2] - **Direct Sales Models**: There is a growing trend among overseas pharmaceutical companies to adopt direct-to-patient sales models, which Japanese companies have yet to fully embrace [7] This summary encapsulates the key insights and data from the earnings calls of the discussed companies, highlighting their performance, strategies, and implications for the broader industry.
BMY Stock Trades Near 52-Week Low: Time to Buy or Sell?
ZACKS· 2025-08-06 14:21
Core Insights - Bristol Myers Squibb (BMY) reported a second-quarter earnings beat but cut its earnings guidance for 2025, leading to a decline in share price initially [1][3][9] - The company raised its 2025 revenue guidance to $46.5-$47.5 billion, driven by strong performance in its Growth Portfolio and favorable foreign exchange impacts [2][9] - The adjusted earnings per share (EPS) guidance was lowered to $6.35-$6.65 from a previous range of $6.70-$7 due to the impact of the BioNTech deal [3][9] Growth Portfolio Performance - BMY's Growth Portfolio generated $6.6 billion in revenue, an 18% increase year-over-year, primarily due to strong demand for drugs like Opdivo, Breyanzi, Reblozyl, and Camzyos [4][9] - Opdivo sales in the U.S. are driven by its launch in MSI-high colorectal cancer and growth in non-small cell lung cancer, with global sales expected to grow in the mid to high single-digit range [5][6] - Breyanzi sales surged 125% to $344 million, and Camzyos sales increased by 87% due to robust demand [7][9] Legacy Portfolio Decline - The Legacy Portfolio saw a 14% decline in sales to $5.67 billion, impacted by generic competition for drugs like Revlimid and Pomalyst [11][12] - Eliquis, a blood thinner, remains a significant contributor with an 8% increase in global sales, but the Legacy Portfolio is expected to decline by 15% to 17% in 2025 [12] Collaborations and Pipeline Developments - BMY's collaboration with BioNTech for the co-development of bispecific antibody BNT327 enhances its pipeline in cancer treatment [13][14] - The recent agreement with Bain Capital to create a new biopharmaceutical company focused on autoimmune diseases is expected to address unmet patient needs [16] Stock Performance and Valuation - BMY shares have underperformed, losing 18.9% year-to-date compared to the industry growth of 1.9% [17][18] - The stock is currently trading at a price/earnings ratio of 7.48x, lower than its historical mean and the large-cap pharma industry average [20] - The Zacks Consensus Estimate for 2025 EPS has increased to $6.39 from $6.28, indicating a positive outlook despite recent challenges [21]