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BMY Gains on News of Continuation of Alzheimer's Disease Study
ZACKS· 2025-12-04 16:31
Core Insights - Bristol Myers Squibb (BMY) shares increased by 5.62% following the announcement to continue the phase III ADEPT-2 study on Cobenfy for psychosis associated with Alzheimer's disease, contrary to investor expectations of a study failure [1][2][7] - The ADEPT-2 study's data readout has been postponed to next year, but the continuation of the study has reassured investors [2][7] - BMY's shares have declined by 9.9% year-to-date, while the industry has seen a growth of 19.9% [2] Study Details - The ADEPT-2 study is a multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in patients with Alzheimer's disease dementia-related psychosis [4] - The primary endpoint focuses on changes in the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, with a key secondary endpoint of Clinical Global Impression-Severity [5] - Irregularities were identified at a few study sites, leading to the exclusion of their data from the primary analysis after consultation with the FDA and a data monitoring committee (DMC) [6][7] Future Prospects - The DMC has recommended continuing the study by enrolling additional patients, and BMY will proceed with patient enrollment while remaining blinded to the study data [8] - Additional results from the ADEPT program, including ADEPT-1 and ADEPT-4, are expected by the end of 2026 [9] Portfolio Diversification - BMY is actively working to diversify its portfolio due to the negative impact of generics on its legacy drugs like Revlimid and Pomalyst [10] - The approval of Cobenfy has further diversified BMY's portfolio, with sales reaching $105 million year-to-date, and it is expected to be a significant growth driver as the company seeks label expansions [11] - The FDA has granted Fast Track Designation to BMS-986446, a potential anti-microtubule binding region-tau antibody currently in phase II development for early Alzheimer's disease [12]
Is Bristol-Myers Stock Underperforming the S&P 500?
Yahoo Finance· 2025-11-28 09:21
Core Insights - Bristol-Myers Squibb Company (BMY) is a leading biopharmaceutical firm focused on innovative medicines for serious diseases, particularly in oncology, immunology, cardiovascular conditions, and blood disorders [1] - The company has a market capitalization of approximately $100.3 billion, positioning it in the large-cap category, which includes firms valued at $10 billion or more [2] Financial Performance - Over the past three months, BMY's stock has increased by about 4.3%, underperforming the S&P 500 Index, which returned 5.1% during the same period [3] - The stock reached a 52-week high of $63.33 in March but has since declined by roughly 22.2% [3] - In the last 12 months, BMY's shares have decreased by about 16.2%, and in 2025, they have fallen approximately 13% [4] Technical Analysis - BMY has recently approached its 200-day moving average after being below this level since April, indicating a potential shift in momentum [5] Revenue Challenges - The company faces challenges from generic competition affecting its older blockbuster drugs, including Revlimid, Pomalyst, Sprycel, and Abraxane [6] - In the Q3 earnings update on October 30, management reported a 12% year-over-year decline in revenue from its legacy portfolio, totaling $5.4 billion, primarily due to significant generic erosion in Revlimid [6]
BMY Wins EC Nod for Label Expansion of CAR T Cell Therapy Breyanzi (Revised)
ZACKS· 2025-11-27 09:46
Core Insights - Bristol Myers Squibb (BMY) received European Commission approval for Breyanzi, expanding its label to include treatment for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][9] Group 1: Breyanzi Approval and Indications - The latest approval marks the fourth for Breyanzi in Europe, which is already approved for several other indications including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL) [2] - Breyanzi is indicated for patients who relapsed within 12 months of first-line chemoimmunotherapy or are refractory to it, as well as for those with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of therapy [3] Group 2: Clinical Trial Results - The approval is based on the TRANSCEND NHL 001 trial results, where 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response, and 41.2% of patients maintained their response at 24 months [4][9] Group 3: Pipeline Expansion and Market Impact - Bristol Myers is focusing on expanding its pipeline due to the negative impact of generics on its legacy portfolio, including Revlimid and Pomalyst [5] - The company’s shares gained 3.3% following positive data from Bayer's cardiovascular candidate asundexian, which may boost investor confidence in BMY's own cardiovascular candidate, milvexian [6][8] Group 4: Discontinuation of Librexia Study - Bristol Myers and Johnson & Johnson decided to discontinue the late-stage Librexia study for milvexian after an interim analysis indicated it was unlikely to meet primary efficacy endpoints, although two other studies for milvexian will continue [10][11]
What's in Store for These 5 Pharma Bigwigs This Earnings Season?
ZACKS· 2025-10-27 16:06
Core Insights - The third-quarter 2025 reporting cycle for the Medical sector is commencing, with major firms expected to release earnings results in the coming weeks, particularly in pharma/biotech and medical devices [1] - Johnson & Johnson has set a positive tone for the earnings season by exceeding estimates and raising its sales expectations for 2025 [1] - Roche has reported solid growth in the first nine months of 2025, driven by high demand for key drugs, leading to an upward revision of its earnings per share growth expectations for 2025 [2] Earnings Trends - As of October 22, 13.3% of Medical sector companies, representing 26.8% of the sector's market capitalization, have reported earnings, with 87.5% exceeding earnings estimates and the same percentage surpassing revenue expectations [3] - Year-over-year earnings increased by 7.4%, while revenues rose by 9.8%. However, third-quarter earnings for the Medical sector are projected to decrease by 4.3%, with sales expected to rise by 8.1% compared to the previous year [3] Company Performance Expectations - Eli Lilly is expected to report strong results driven by demand for GLP-1 drugs and other oncology and immunology products, with a consensus estimate of $16.01 billion in sales and $6.02 per share in earnings [7][8] - Merck is anticipated to see growth from its cancer drug Keytruda, with estimates of $17.06 billion in sales and $2.36 per share in earnings [12] - AbbVie is projected to benefit from sales of Rinvoq, Skyrizi, and newer drugs, with estimates of $15.59 billion in sales and $1.80 per share in earnings [13][14] - Bristol Myers is expected to report revenues influenced by growth portfolio sales, with estimates of $11.83 billion in sales and $1.51 per share in earnings [15][16] - Gilead Sciences is likely to see revenue support from its HIV therapies, with estimates of $7.46 billion in sales and $2.15 per share in earnings, although impacted by changes in Medicare Part D [19][20]
Ahead of Bristol Myers (BMY) Q3 Earnings: Get Ready With Wall Street Estimates for Key Metrics
ZACKS· 2025-10-27 14:16
Core Insights - Analysts project that Bristol Myers Squibb (BMY) will report quarterly earnings of $1.51 per share, reflecting a year-over-year decline of 16.1% [1] - Revenue is expected to reach $11.83 billion, a slight decrease of 0.5% compared to the same quarter last year [1] Earnings Estimates - Over the past 30 days, the consensus EPS estimate has been adjusted downward by 0.6%, indicating a reassessment by covering analysts [2] - Changes in earnings estimates are crucial for predicting investor reactions to the stock [3] Key Metrics Forecast - Analysts estimate 'Net Sales- Revlimid' at $707.31 million, down 49.9% year over year [5] - 'Net Sales- Opdivo' is projected at $2.43 billion, showing a 2.8% increase from the previous year [5] - 'Net Sales- Abraxane' is expected to be $95.72 million, down 62.2% from the prior year [5] - 'Net Sales- Reblozyl' is forecasted at $583.06 million, indicating a year-over-year increase of 30.4% [6] - 'Net Sales- Pomalyst/Imnovid- U.S.' is estimated at $573.19 million, down 17.8% year over year [6] - 'Net Sales- Pomalyst/Imnovid- International' is projected at $84.24 million, down 58.1% from the previous year [6] Additional Sales Projections - 'Net Sales- Revlimid- U.S.' is expected to be $617.31 million, down 49.1% year over year [7] - 'Net Sales- Revlimid- International' is projected at $99.33 million, down 50.3% [7] - 'Net Sales- Reblozyl- U.S.' is estimated at $461.95 million, reflecting a 29% increase from the prior year [7] - 'Net Sales- Reblozyl- International' is forecasted at $117.13 million, indicating a 31.6% increase [8] - 'Net Sales- Zeposia- U.S.' is expected to be $95.95 million, down 8.6% year over year [8] - 'Net Sales- Zeposia- International' is projected at $45.74 million, reflecting an 8.9% increase [8] Stock Performance - Over the past month, Bristol Myers shares have returned -0.7%, compared to a +2.5% change in the Zacks S&P 500 composite [9] - Based on its Zacks Rank 3 (Hold), BMY is expected to perform in line with the overall market in the upcoming period [10]
Can Bristol Myers Squibb's Restructuring Program Boost Earnings Growth?
ZACKS· 2025-09-19 15:15
Core Insights - Bristol Myers Squibb (BMY) is implementing a restructuring program to enhance bottom-line growth amid declining revenues from legacy drugs due to generic competition [1][10] - The restructuring aims to streamline operations in key areas such as R&D, manufacturing, and commercial functions, with a focus on aligning the operating model with strategic priorities [2][4] Financial Implications - The total expected charges for the restructuring program are approximately $2.5 billion through 2027, with $1.4 billion already incurred, primarily for employee termination and site exit costs [3][10] - BMY anticipates annual cost savings of around $2.0 billion by the end of 2027 as a result of the restructuring [3][10] Operational Changes - The restructuring will transform R&D operations to accelerate pipeline delivery and enhance the commercial operating model, while also establishing a more responsive manufacturing network [2] - Despite the restructuring, BMY expects operating expenses in 2025 to rise to $16.5 billion, up from a previous estimate of $16.2 billion, reflecting investments in business development and growth opportunities [4] Market Performance - BMY's shares have declined by 16.5% year-to-date, contrasting with the industry growth of 4.9% [9] - The company's shares are currently trading at a price/earnings ratio of 7.36X forward earnings, which is below the industry average of 14.83X [12] Earnings Estimates - The bottom-line estimate for 2025 has increased to $6.50 from $6.37 over the past 60 days, while the estimate for 2026 has risen to $6.07 from $6.02 [14]
BMY-BioNTech Partnership: A Potential Catalyst for Long-Term Gains?
ZACKS· 2025-09-12 14:11
Core Insights - Bristol Myers (BMY) and BioNTech (BNTX) presented interim data from a mid-stage study on pumitamig combined with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) [1][10] Company Developments - Pumitamig is a bispecific antibody that combines PD-L1 checkpoint inhibition and VEGF-A neutralization, aimed at enhancing T cell response against tumors [2][3] - The interim analysis involved 43 untreated ES-SCLC patients, showing a 76.3% confirmed objective response rate, a 100% disease control rate, and a median progression-free survival of 6.8 months [3][10] - The combination therapy exhibited a manageable safety profile with no new safety signals and a low discontinuation rate, supporting ongoing pivotal studies [4][10] - Pumitamig received FDA Orphan Drug designation for small cell lung cancer treatment in 2025 [4][10] Industry Context - The dual-target cancer therapy space is competitive, with major players like Merck and Pfizer developing bispecific antibodies targeting PD-1 and VEGF [6] - Merck secured a global license for LM-299, a PD-1/VEGF bispecific antibody, while Pfizer licensed SSGJ-707, another bispecific antibody targeting the same proteins [7][8] Financial Performance - BMY shares have declined by 13% year-to-date, contrasting with the industry growth of 5.5% [12] - BMY is trading at a price/earnings ratio of 7.66X forward earnings, below its historical mean of 8.47X and the large-cap pharma industry's average of 14.94X [13] - The bottom-line estimate for 2025 has decreased to $6.50 from $6.56, while the estimate for 2026 has increased to $6.07 from $6.03 [14]
Bristol Myers (BMY) Q2 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2025-07-31 14:31
Core Insights - Bristol Myers Squibb (BMY) reported $12.27 billion in revenue for Q2 2025, a year-over-year increase of 0.6% and a surprise of +7.67% over the Zacks Consensus Estimate of $11.4 billion [1] - The EPS for the same period was $1.46, down from $2.07 a year ago, with a surprise of +36.45% compared to the consensus estimate of $1.07 [1] Revenue Performance - Net sales for Cobenfy were $35 million, exceeding the estimated $28.25 million [4] - Opdivo's U.S. net sales reached $1.51 billion, surpassing the $1.38 billion estimate, reflecting a +7.1% year-over-year change [4] - Pomalyst/Imnovid's U.S. net sales were $584 million, below the $627.82 million estimate, showing an -18.4% year-over-year decline [4] - International net sales for Pomalyst/Imnovid were $124 million, exceeding the $95.34 million estimate, but down -49% year-over-year [4] - Revlimid's net sales were $838 million, above the $625.54 million estimate, representing a -38.1% year-over-year decline [4] - Opdivo's total net sales were $2.56 billion, exceeding the $2.4 billion estimate, with a +7.3% year-over-year increase [4] - Abraxane's net sales were $105 million, slightly above the $102.66 million estimate, but down -54.6% year-over-year [4] - Reblozyl's net sales reached $568 million, surpassing the $546.45 million estimate, with a +33.7% year-over-year increase [4] - Zeposia's net sales were $150 million, exceeding the $129.3 million estimate, but down -0.7% year-over-year [4] - Breyanzi's net sales were $344 million, above the $299.75 million estimate, reflecting a +124.8% year-over-year increase [4] - Abecma's net sales were $87 million, below the $99.76 million estimate, showing an -8.4% year-over-year decline [4] - Opdualag's net sales reached $284 million, exceeding the $276.44 million estimate, with a +20.9% year-over-year increase [4] Stock Performance - Bristol Myers' shares have returned -3.5% over the past month, compared to the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]
Will Increased Expenses Affect Bristol Myers' Performance?
ZACKS· 2025-07-16 13:46
Core Insights - Bristol Myers Squibb (BMY) has entered a strategic collaboration with BioNTech (BNTX) for the co-development and co-commercialization of the investigational bispecific antibody BNT327, which targets various solid tumors [1][8] - The collaboration involves an upfront payment of $1.5 billion and a total of $2 billion in non-contingent anniversary payments through 2028, which will increase BMY's operating expenses [2][8] - BMY is currently facing revenue pressures from its legacy portfolio due to generic competition affecting drugs like Revlimid and Eliquis [3][8] Financial Impact - The total expenses related to the collaboration are expected to adversely impact BMY's bottom line, with approximately $1.5 billion likely incurred in Q2 [2][8] - BMY's share price has decreased by 15% year-to-date, contrasting with the industry growth of 1.3% [7] - The bottom-line estimates for 2025 and 2026 have been revised downwards, with the 2025 estimate dropping from $6.89 to $6.52 [12] Competitive Landscape - The bispecific antibody market, particularly targeting PD-1 and VEGF, is becoming increasingly competitive, with major players like Merck and Pfizer also developing similar therapies [4][6] - Merck has secured a global license for a novel PD-1/VEGF bispecific antibody, LM-299, while Pfizer has entered a licensing agreement for SSGJ-707, another bispecific antibody targeting the same proteins [5][6] Valuation Metrics - BMY is currently trading at a price/earnings ratio of 7.40x forward earnings, which is below its historical mean of 8.53x and the large-cap pharma industry's average of 14.79x [10]
Will The Decline in Legacy Drugs Pull Down BMY's Top Line?
ZACKS· 2025-07-03 14:30
Core Insights - Bristol Myers' legacy portfolio, which includes Eliquis, Revlimid, Pomalyst, Sprycel, and Abraxane, experienced a significant revenue decline of 20% in Q1, totaling $5.64 billion, primarily due to generic competition and the redesign of U.S. Medicare Part D [1][8]. Revenue Performance - Eliquis generated sales of $3.56 billion, down 4% year-over-year, impacted by the Medicare Part D redesign, with expectations for sales recovery in H2 2025 as the coverage gap is eliminated [2][8]. - Revlimid's revenues plummeted 44% to $936 million due to lower demand from generic erosion [2]. - Pomalyst sales decreased by 24% to $658 million, while Sprycel saw a 53% decline to $175 million, and Abraxane revenues fell 52% to $105 million, all attributed to generic competition [3][8]. Competitive Landscape - Bristol Myers' growth portfolio includes key drugs such as Opdivo, Orencia, Yervoy, Reblozyl, and others, with a strong focus on oncology [4]. - The company faces significant competition from major pharmaceutical firms like Merck and Pfizer, particularly in the immuno-oncology space, where Merck's Keytruda dominates [4][5][6]. Stock Performance and Valuation - Bristol Myers' shares have declined by 14% year-to-date, contrasting with a slight industry decline of 0.6% [7]. - The company is currently trading at a price/earnings ratio of 7.45x forward earnings, which is below its historical mean of 8.86x and the large-cap pharma industry's average of 15.09x [10]. Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has decreased to $6.76 from $6.89 over the past 60 days, with a similar downward trend for 2026 estimates [12].