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汇丰:首予再生元制药(REGN.US)“买入”评级 看好Eylea HD放量及肿瘤管线多点催化
智通财经网· 2025-11-25 07:40
智通财经APP获悉,汇丰银行发表研报,首次覆盖再生元制药(REGN.US),并给予 "买入" 评级,目标 价为890美元,核心依据包括其药物Eylea HD(aflibercept)明年销售额的增长潜力,以及研发管线中多项 癌症疗法的积极催化。 在肿瘤研发管线方面,该分析师重点提及了2026年上半年将公布的双免疫疗法LAG-3抗体fianlimab与 PD-1抑制剂Libtayo(cemiplimab)的临床数据,该方案将以默沙东(MRK.US)的明星药物Keytruda作为对照 参照。 分析师Yifeng Liu指出,尽管Eylea HD目前的市场渗透速度未达预期,但"与Eylea HD相关的监管风险有 望在短期内得到解决,这将为2026年药物加速普及和渗透率提升奠定基础"。 财务预测方面,汇丰预计再生元2026年调整后摊薄每股收益(EPS)为43.48美元,高于市场普遍预期的 42.98美元。 此外,该联合疗法用于黑色素瘤辅助治疗的III期临床数据可能于明年公布。而针对一线转移性黑色素瘤 的固定剂量组合III期试验预计将于2027年完成,其对照药物为施贵宝(BMY.US)的Opdualag(nivolum ...
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]
Will BMY's Growth Portfolio Drive Third-Quarter Results?
ZACKS· 2025-10-21 14:01
Core Insights - Bristol Myers' (BMY) Growth Portfolio, which includes drugs like Opdivo, Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized its revenue despite facing generic competition for legacy drugs [1][9] - Opdivo remains the top revenue generator, with expectations for global sales growth in the mid-to-high single-digit range by 2025, driven by strong initial uptake of the newly approved Qvantig [2][9] - Newer drugs such as Reblozyl, Camzyos, and Breyanzi are contributing positively to revenue growth, countering declines from legacy drugs impacted by generics [3][4][9] Revenue Performance - The performance of newer drugs is crucial for BMY's growth as legacy drug sales continue to decline due to generic competition, particularly affecting Revlimid, Pomalyst, Sprycel, and Abraxane [4] - The company has seen strong momentum in Reblozyl and Camzyos, which are expected to significantly contribute to the top line [3] Competitive Landscape - The oncology sector is a primary focus for Bristol Myers, with significant competition from Merck's Keytruda, which accounts for approximately 50% of Merck's pharmaceutical sales [5] - Pfizer is also a major player in oncology, with a diverse product portfolio and recent licensing agreements to enhance its offerings [6][7] Stock Performance and Valuation - BMY shares have decreased by 19.1% year-to-date, contrasting with the industry growth of 11.6% [8] - The company is currently trading at a price/earnings ratio of 7.14x forward earnings, which is below both its historical mean of 8.43x and the large-cap pharma industry's average of 15.52x [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has been revised down to $6.42 from $6.50 over the past 60 days, while the estimate for 2026 remains unchanged [11]
百时美施贵宝:如何领跑诺奖后的肿瘤治疗新叙事?
Core Insights - The article emphasizes the significance of the five-year survival rate in cancer treatment, serving as a benchmark for therapy effectiveness and a hopeful target for patients [1] - The advancements in immunotherapy, particularly through the contributions of Nobel Prize-winning research, have opened new avenues for cancer treatment, making the five-year survival goal increasingly attainable [1][2] Group 1: Immunotherapy Developments - Bristol-Myers Squibb (BMS) has been a pioneer in immunotherapy, significantly impacting cancer treatment paradigms in China over the past five years [3] - The CheckMate series of studies has laid the foundation for current immunotherapy practices, with notable achievements in clinical research and treatment expansion [1][3] Group 2: Focus on Gastrointestinal Tumors - BMS has targeted gastrointestinal tumors, which have high incidence rates in China, addressing unmet clinical needs and achieving significant breakthroughs, such as the CheckMate-649 study [4] - The CheckMate-649 study has provided long-term survival data, indicating that five-year survival is now a realistic goal for many patients with advanced gastric cancer [4] Group 3: Expanding Treatment Applications - BMS has explored the role of immunotherapy in early-stage cancer, with four early tumor indications approved for nivolumab in China, leading the PD-1 inhibitor market [5] - The CheckMate-816 study has transformed early-stage non-small cell lung cancer treatment, demonstrating the effectiveness of the "immunotherapy + chemotherapy" approach [5] Group 4: Innovative Treatment Strategies - The introduction of the "dual immunotherapy" approach, combining nivolumab and ipilimumab, represents a significant advancement in treatment strategies [6] - BMS has achieved breakthroughs in various cancer types, including rare tumors and colorectal cancer, establishing new treatment standards [6] Group 5: Long-term Evidence and Standards - BMS has committed to long-term follow-up studies, reinforcing the five-year survival rate as a gold standard in cancer treatment [7] - Studies like CheckMate-649 and CheckMate-816 have provided robust evidence supporting the efficacy of immunotherapy, enhancing clinical decision-making [7] Group 6: Accessibility Initiatives - BMS has focused on improving patient access to innovative therapies through collaborations with commercial insurance and patient assistance programs [9][10] - The company has initiated projects to support low-income patients, significantly reducing their financial burden [9] Group 7: Future Directions - BMS aims to continue its commitment to scientific innovation and local needs, planning to introduce more first-in-class and best-in-class products in the next five years [12] - The company is exploring new therapeutic combinations and expanding its pipeline to address treatment challenges in cancer [13][14] Group 8: Global Integration - BMS is positioning itself to leverage Chinese clinical data for global research, ensuring that new therapies are relevant to local patient populations [17] - The company’s strategy includes enhancing collaboration between local and global research efforts to drive innovation [17] Group 9: Commitment to Long-term Goals - BMS has demonstrated a strong commitment to improving cancer treatment outcomes in China, with a focus on achieving long-term survival for patients [18] - The company’s ongoing efforts align with the broader goal of contributing to a healthier China by 2030 [18]
百时美施贵宝:如何领跑诺奖后的肿瘤治疗新叙事?
21世纪经济报道· 2025-10-16 07:55
Core Viewpoint - The article emphasizes the significant advancements in cancer treatment, particularly through immunotherapy, which has made the five-year survival rate a more attainable goal for patients. The recognition of these advancements by the Nobel Prize highlights the importance of ongoing research in this field [1][2]. Group 1: Immunotherapy Breakthroughs - The CheckMate series of studies has laid the foundation for current immunotherapy practices, with the PD-1 inhibitor, Nivolumab, being a key development [2][4]. - The year 2025 marks the 43rd year of the company's presence in China and the fifth year of its "China 2030 Strategy," focusing on integrating global research with local patient needs [2][4]. Group 2: Focus on Gastrointestinal Tumors - Gastrointestinal tumors have a high incidence in China, and the company has made significant contributions to this area, particularly through the CheckMate-649 study, which has provided long-term survival benefits for advanced gastric cancer patients [5][6]. Group 3: Expanding Treatment Applications - The company has been proactive in exploring the role of immunotherapy in early-stage cancer, with Nivolumab receiving approvals for four early-stage indications in China, leading to improved treatment outcomes [7][8]. - The CheckMate-816 study has demonstrated the effectiveness of the "immunotherapy + chemotherapy" approach in early non-small cell lung cancer, changing clinical practices and offering hope for a cure [7][8]. Group 4: Long-term Evidence and Standards - The company emphasizes the importance of long-term follow-up studies, such as those from CheckMate-649 and CheckMate-816, which have confirmed significant survival benefits and established clinical standards [9][10]. Group 5: Accessibility Initiatives - The company has worked to enhance the accessibility of immunotherapy through collaborations with commercial insurance and patient assistance programs, benefiting over 40,000 patients [11][12]. - The introduction of a new commercial health insurance directory aims to include innovative drugs, further improving patient access to treatments [12][13]. Group 6: Future Directions - The company plans to continue its focus on immunotherapy while exploring new treatment combinations and expanding its pipeline with innovative therapies, including targeted protein degradation platforms [17][19]. - The integration of Chinese patient data into global research is expected to enhance the relevance of new therapies for local populations [21][22]. Group 7: Commitment Beyond Five Years - The company is committed to ongoing scientific innovation and addressing local needs as part of its "China 2030 Strategy," aiming to provide sustained contributions to cancer treatment and patient outcomes [23].
Regeneron Pharmaceuticals (NasdaqGS:REGN) FY Conference Transcript
2025-09-24 15:32
Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: September 24, 2025 Key Points Commercial Performance - **EYLEA HD Performance**: - 5% sequential growth in demand in Q1 and 16% in Q2 attributed to effective commercial execution and physician-patient education [4][5] - Demand is expected to increase further once headwinds are resolved, particularly regarding reimbursement and prefilled syringe preferences [5][6] - Upcoming PDUFA dates: late October for prefilled syringe and late November for RVO and Q4 dosing [8] Pipeline Developments - **DUPIXENT**: - Strong performance across all eight approved indications, with ongoing growth in established indications like asthma and new launches in COPD, CSU, and bullous pemphigoid [15][16] - 70% of top-tier pulmonologists have prescribed DUPIXENT for COPD, indicating positive reception [18] - Strategic focus on lifecycle opportunities and adjacent type 2 pathways to maintain growth post-DUPIXENT exclusivity expiration in 2031 [21][23] - **Oncology Pipeline**: - Recent approvals for bispecifics, with a focus on Linezyth for multiple myeloma [24] - Plans to launch studies in earlier lines of treatment, combining Linezyth with carfilzomib, expected by the end of 2025 [26][28] - **Complement and Factor XI Programs**: - Promising data in myasthenia gravis (MG) with a focus on quarterly dosing advantages [35] - Factor XI program aims to reduce bleeding risks associated with anticoagulants, with ongoing Phase 3 studies [39][40] R&D and Capital Allocation - **R&D Investment Strategy**: - Focus on internal R&D as a primary capital allocation priority, with a robust pipeline driving long-term shareholder value [50][52] - Share repurchase program and dividend implementation to enhance shareholder returns [51] - **External Innovation**: - Active exploration of licensing and collaboration opportunities, though M&A remains a secondary focus [50][55] Market Outlook and Strategic Vision - **Pipeline Potential**: - The breadth and depth of the pipeline are viewed as unprecedented, with confidence in the ability to drive future growth [57][58] - Ongoing preclinical opportunities in various therapeutic areas, including genetics and rare diseases, are expected to yield significant advancements [59] Regulatory and Competitive Landscape - **Biosimilars Impact**: - Gradual uptake of existing biosimilars noted, with potential for increased pricing pressure as more entrants are expected in 2026 [11][12] - **DTC Advertising Restrictions**: - Generalized communication from the administration regarding DTC advertising, with no specific implications for Regeneron noted [19] Conclusion - Regeneron Pharmaceuticals is positioned for continued growth through its strong product pipeline, strategic R&D investments, and proactive market engagement. The company remains focused on addressing competitive pressures while leveraging its innovative capabilities to enhance patient outcomes and shareholder value.
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 These 5 Pharma/Biotech Bigwigs Surpass Q2 Earnings Forecasts?
ZACKS· 2025-07-28 15:31
Industry Overview - The second-quarter 2025 reporting cycle for the Medical sector is commencing, with most firms expected to release earnings results in the next two weeks, primarily consisting of pharma/biotech and medical device companies [1] - The earnings season for the drug and biotech sector began in mid-July, highlighted by Johnson & Johnson's strong performance, which exceeded earnings and sales estimates, leading to raised revenue and earnings expectations for the year [1] Company Performance - Novartis surpassed second-quarter earnings and revenue estimates, driven by a year-over-year increase in sales of key drugs, prompting an upward revision of its annual guidance for core operating income [2] - Roche experienced solid growth in the first half of 2025, with high demand for key drugs offsetting declines in legacy drug sales [2] - As of July 23, 15% of companies in the Medical sector, representing 27.2% of the sector's market capitalization, reported quarterly earnings, with 88.9% outperforming earnings estimates and 100% beating revenue estimates [3] - Overall, second-quarter earnings for the Medical sector are projected to increase by 0.9%, while sales are expected to rise by 7.9% compared to the previous year [3] Upcoming Earnings Reports - Merck, AstraZeneca, Bristol Myers, AbbVie, and Moderna are scheduled to release their quarterly results this week [4] - Merck has a strong earnings track record, beating estimates in the last four quarters with an average surprise of 3.82% [5] - AstraZeneca has a mixed earnings history, beating estimates in three of the last four quarters, with an average surprise of 4.24% [8] - Bristol Myers has consistently beaten earnings estimates, with an average surprise of 20.16% over the last four quarters [11] - AbbVie has also maintained a strong track record, beating estimates in the last four quarters with an average surprise of 2.55% [13] - Moderna has an excellent earnings history, with an average surprise of 31.60% in the last four quarters [15] Sales Drivers - Merck's growth in the second quarter is likely attributed to increased sales of its cancer drug Keytruda, driven by additional indications and patient demand [7] - AstraZeneca's sales are expected to be bolstered by strong demand for its cancer and diabetes medications [10] - Bristol Myers' revenue may be impacted by declines in legacy drug sales, but growth products are expected to partially offset this decline [12] - AbbVie's revenue is anticipated to be driven by strong sales of key drugs and contributions from newer products [14] - Moderna's revenues are expected to be influenced by sales of its COVID-19 vaccine, Spikevax, while the focus is shifting to updates on its broader pipeline [16]
Should You Buy, Hold, or Sell BMY Stock Ahead of Q2 Earnings?
ZACKS· 2025-07-28 14:31
Core Viewpoint - Bristol-Myers Squibb Company (BMY) is set to report its second-quarter 2025 results on July 31, with sales and earnings estimates at $11.38 billion and $1.18 per share, respectively. However, earnings estimates for 2025 and 2026 have seen a decline over the past month [1][5]. Financial Estimates - The current earnings estimate for Q2 2025 is $1.18, down from $1.55 30 days ago, reflecting a decrease of 29.34%. The earnings estimates for 2025 and 2026 have also decreased to $6.37 and $6.03, respectively [2][5]. - BMY has a strong earnings surprise history, beating estimates in the last four quarters with an average surprise of 20.16% [2]. Factors Influencing Q2 Results - Total quarterly revenues are expected to be negatively impacted by declining sales from the legacy portfolio, which includes drugs like Eliquis, Revlimid, and Pomalyst, primarily due to generic competition [4][5]. - Sales for Pomalyst are estimated at $727 million, while Eliquis is projected to generate $3.5 billion in sales [6][7]. Growth Portfolio Performance - The growth portfolio, which includes drugs like Opdivo, Reblozyl, and Camzyos, is expected to partially offset the decline in legacy drug sales. Opdivo sales are estimated at $2.4 billion, while Reblozyl is projected at $546 million [8][10][11]. - New drug Cobenfy for schizophrenia has shown promising sales growth, indicating a positive start for the newly launched product [12][18]. Strategic Initiatives - BMY has announced cost-cutting plans aiming to save $1.5 billion by 2025 and an additional $2 billion annually by 2027, which are expected to improve profitability [5][14]. - The company has entered a strategic collaboration with BioNTech for the co-development of a bispecific antibody, BNT327, which targets solid tumors [19][22]. Stock Performance and Valuation - BMY shares have declined by 14.4% year-to-date, underperforming the industry and the S&P 500 [16]. - The stock currently trades at a price/earnings ratio of 7.84x forward earnings, lower than its historical mean and the large-cap pharma industry average [20].
Bristol Myers Gains 6.3% in a Month: Buy, Sell or Hold the Stock?
ZACKS· 2025-07-24 15:50
Core Insights - Bristol Myers (BMY) has shown a strong performance recently, gaining 6.3% in a month, outperforming the industry (3.9% gain) and the S&P 500 [1][7] - The company is focusing on newer drugs to stabilize revenue as legacy drugs face generic competition [4][10] - Recent pipeline setbacks have raised investor concerns, but there is optimism around new drug approvals and label expansions [7][20] Financial Performance - BMY's stock performance has improved after being under pressure, with a raised annual guidance following first-quarter results [3] - The company is trading at a price/earnings ratio of 7.93x forward earnings, lower than the large-cap pharma industry's average of 15.26x [16] - The Zacks Consensus Estimate for 2025 EPS has decreased from $6.89 to $6.37 over the past 60 days [18] Drug Pipeline and Growth Drivers - New drugs like Opdualag, Reblozyl, and Breyanzi are crucial for offsetting the impact of legacy drug patent expirations [4][7] - Opdivo has shown solid revenue growth driven by volume, with recent label expansions expected to boost sales further [5] - The FDA has accepted a supplemental new drug application for Sotyktu, with a decision expected in March 2026 [6] Challenges and Setbacks - Generic competition is impacting sales of key drugs like Revlimid and Eliquis, with Eliquis sales down 4% in Q1 due to Medicare Part D redesign [10][11] - Recent phase III study results for Reblozyl and Camzyos did not meet primary endpoints, raising concerns among investors [12][15] - The company plans to engage with regulatory bodies regarding marketing applications despite these setbacks [14] Strategic Collaborations - A recent collaboration with BioNTech for the co-development of bispecific antibody BNT327 is expected to enhance BMY's pipeline in cancer treatment [9]