撰文丨王聪 编辑丨王多鱼 排版丨水成文 短短三年时间， 体内 CAR-T （ in vivo CAR-T） 这一 领域就实现了从诞生到火爆，融资、合作、巨额收 购、临床进展不断。2025 年 6 月， 艾伯维 宣布以 21 亿美元 现金收购了 诺奖得主、mRNA 技术先驱 Drew Weissman 和 CAR-T 先驱 Carl June 等人创立的 in vivo CAR-T 公司 Capstan Therapeutics ，将 该领域的狂欢推向高潮。 几个月后， Drew Weissman 联合创立的另一家 in vivo CAR-T 公司—— Orbital Therapeutics ，以 15 亿美元 的价格被 BMS 收购，让该领域的狂欢得以持续。 2025 年 10 月 10 日 ，国际制药巨头 百时美施贵宝 （BMS） 宣布以 15 亿美元 的价格现金收购 Orbital Therapeutics 。 BMS 此前已有两款体外 CAR-T 细胞疗法获得 FDA 批准上市，分别是靶向 CD19 的 CAR-T 细胞疗法 Breyanzi，以及靶向 BCMA 的 CAR-T 细胞疗法 Abecma ...

By Christy Santhosh (Reuters) -Drugmaker Bristol Myers Squibb said on Friday it will acquire privately held cell therapy developer Orbital Therapeutics for $1.5 billion in cash, aiming to diversify from legacy products facing competition from generic drugs. The deal expands Bristol Myers Squibb's CAR T-cell immunotherapy portfolio with Orbital's lead experimental candidate, OTX-201, which is designed to target autoimmune diseases. This marks the company's first major acquisition of the year, as it shift ...

Core Viewpoint - Bristol-Myers Squibb (BMY) has underperformed the market with a 20% stock price decline this year, while the S&P 500 has increased by 14%, primarily due to challenges in its drug pipeline [2][3] Valuation - BMY stock is currently priced at $45, which is considered attractive given its low valuation metrics compared to the S&P 500 [3] - The price-to-sales (P/S) ratio for BMY is 1.9, while the S&P 500 stands at 3.3; the price-to-free cash flow (P/FCF) ratio is 7.0 compared to 21.1 for the S&P 500; and the price-to-earnings (P/E) ratio is 16.9 versus 24.0 for the benchmark [8][14] Revenue Growth - BMY's revenues have shown variable growth, with a 4.6% increase from $46 billion to $48 billion over the past 12 months, compared to a 5.1% growth for the S&P 500 [8] - The company has experienced an average revenue growth rate of 0.5% over the last three years, significantly lower than the S&P 500's 5.3% [8] Profitability - BMY's operating income for the last four quarters was $7.9 billion, resulting in an operating margin of 16.5%, which is below the S&P 500's 18.6% [15] - The net income for BMY was $5.4 billion, yielding a net income margin of 11.4%, compared to 12.7% for the S&P 500 [15] Financial Stability - BMY's balance sheet is considered solid, with a debt figure of $51 billion and a market capitalization of $92 billion, leading to a debt-to-equity ratio of 55.8%, higher than the S&P 500's 21.0% [15] - The cash-to-assets ratio stands at 12.7%, significantly above the S&P 500's 7.0%, indicating strong liquidity [15] Downturn Resilience - BMY stock has shown moderate resilience during downturns, with a 40.2% decline from its peak in December 2022, compared to a 25.4% decline for the S&P 500 [16] - Historical performance indicates that BMY has fully recovered from past crises, suggesting potential for future recovery [16] Pipeline and Future Prospects - Despite recent pipeline challenges, BMY has a robust pipeline and recent acquisitions, such as 2seventy Bio, which could provide significant upside [17] - The company is co-developing a promising antibody with BioNTech for small-cell lung cancer, which has shown positive mid-stage trial results and a potential peak sales value exceeding $5 billion [17]

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]

Core Viewpoint - After a significant decline in stock price following a failed acquisition, Legend Biotech's stock showed signs of recovery due to strong sales data for its CAR-T product, CARVYKTI, but faced renewed pressure from competitive products and changing valuation logic [1][3][4]. Group 1: Stock Performance and Sales Data - Legend Biotech's stock price fell from a high of $58.90 in August last year to a low of $29.40 in April this year, marking a significant decline [1]. - On April 15, Johnson & Johnson reported that CARVYKTI achieved global sales of $369 million in Q1 2025, a year-over-year increase of 135%, exceeding market expectations of $324 million [1]. - Following the positive sales report, Legend Biotech's stock rose by 5.08% on the same day, contributing to a 3.01% increase in stock price for April [1]. Group 2: Competitive Landscape - The competitive landscape has shifted with Gilead's Kite company entering the market with Anito-cel, which has shown promising clinical data, including a 97% overall response rate in its trials [4][5]. - Anito-cel's data suggests it may offer comparable efficacy to CARVYKTI while potentially having a better safety profile, raising concerns about CARVYKTI's market share and pricing power [4][7]. - On May 14, following the release of Anito-cel's data, Legend Biotech's stock dropped by 10.55%, marking its largest single-day decline of the year [7]. Group 3: Financial Outlook and Production Capacity - Legend Biotech reported a net loss of $177 million for 2024, a significant reduction from a loss of $518.3 million the previous year, with CARVYKTI projected to generate $963 million in sales, a 92.7% increase [8][9]. - The company is expanding its production capacity, with plans to reach an annual capacity of 10,000 doses by the end of 2025 and 20,000 doses by the end of 2027 [9]. - Despite the positive sales outlook, the emergence of competitive products like Anito-cel poses challenges to Legend Biotech's growth strategy, raising questions about its reliance on CARVYKTI as a sole revenue driver [9][11]. Group 4: Product Pipeline and R&D - Legend Biotech has developed a diverse product pipeline, including multiple CAR-T therapies and other innovative treatments, but currently lacks a second product that can generate cash flow [11]. - The company has 11 products in development, indicating a potential delay in bringing additional revenue-generating products to market [11]. - The reliance on a single product for growth may place Legend Biotech at a disadvantage in the long-term market dynamics [11].

Core Viewpoint - Bristol-Myers Squibb Company (BMY) reported strong first-quarter 2025 results, with adjusted earnings per share (EPS) of $1.80, exceeding expectations, despite a decline in overall revenues due to legacy portfolio sales [1][20]. Financial Performance - Adjusted EPS of $1.80 beat the Zacks Consensus Estimate of $1.51 and improved from an adjusted loss of $4.40 in the same quarter last year [1]. - Total revenues reached $11.2 billion, surpassing the Zacks Consensus Estimate of $10.7 billion, although down 6% from the previous year [1]. - U.S. revenues decreased 7% to $7.9 billion, while international revenues fell 2% year over year to $3.3 billion [3]. Growth Portfolio - Revenues from the Growth Portfolio amounted to $5.6 billion, reflecting a 16% increase year over year, driven by strong demand for key drugs [4]. - Notable sales growth was observed in Opdivo ($2.26 billion, up 9%), Reblozyl ($478 million, up 35%), and Breyanzi ($263 million, up 146%) [5][6][7]. - The Growth Portfolio's performance was bolstered by higher demand for Opdivo, Reblozyl, Breyanzi, Camzyos, Yervoy, and Opdualag [4]. Legacy Portfolio - Revenues from the Legacy Portfolio declined 20% to $5.64 billion, primarily due to generic competition affecting drugs like Revlimid and Pomalyst [10]. - Eliquis sales were $3.56 billion, down 4%, but exceeded expectations [10]. - Revlimid revenues plummeted 44% to $936 million, while Pomalyst and Sprycel also saw significant declines [12]. Cost Management - Gross margin decreased to 73.1% from 75.5% in the previous year, attributed to product mix changes [13]. - Adjusted R&D expenses decreased 5% to $2.2 billion, and adjusted marketing, selling, and administrative expenses fell 20% to $1.6 billion due to cost-cutting initiatives [13]. Guidance Update - The company raised its annual revenue guidance to $45.8-$46.8 billion, up from $45.5 billion, reflecting strong Growth Portfolio performance and favorable foreign exchange impacts [17]. - Adjusted EPS guidance was also increased to a range of $6.70-$7, compared to the previous guidance of $6.55-$6.85 [18]. Pipeline Developments - The FDA approved Opdivo plus Yervoy as a first-line treatment for unresectable or metastatic hepatocellular carcinoma [16]. - Updates on Camzyos and Cobenfy indicated some challenges in clinical trials, with the latter not meeting statistical significance for its primary endpoint [15].

Core Insights - Bristol Myers Squibb (BMY) reported $11.2 billion in revenue for Q1 2025, a year-over-year decline of 5.6%, but exceeded the Zacks Consensus Estimate by 4.38% [1] - The company achieved an EPS of $1.80, a significant improvement from -$4.40 a year ago, with a surprise of 19.21% over the consensus estimate of $1.51 [1] Financial Performance - Net Sales for Abraxane in the U.S. were $40 million, significantly below the estimated $66.06 million, representing a decline of 72.4% year-over-year [4] - Opdivo's U.S. sales reached $1.33 billion, surpassing the $1.19 billion estimate, with a year-over-year increase of 15.3% [4] - Pomalyst/Imnovid's U.S. sales were $537 million, below the estimated $588.85 million, reflecting a decline of 10.1% year-over-year [4] - International sales for Pomalyst/Imnovid were $122 million, slightly above the estimate of $118.98 million, but down 54.5% year-over-year [4] - Revlimid's sales were $936 million, exceeding the $884.91 million estimate, with a year-over-year decline of 43.9% [4] - Opdivo's total sales reached $2.27 billion, above the $2.17 billion estimate, with a year-over-year increase of 9% [4] - Abraxane's total sales were $105 million, below the estimated $125.23 million, reflecting a decline of 51.6% year-over-year [4] - Reblozyl's sales were $478 million, slightly above the estimate of $477.54 million, with a year-over-year increase of 35% [4] - Zeposia's sales were $107 million, below the estimated $119.29 million, representing a decline of 2.7% year-over-year [4] - Breyanzi's sales reached $263 million, exceeding the estimate of $240.29 million, with a year-over-year increase of 145.8% [4] - Abecma's sales were $103 million, above the estimated $97.70 million, reflecting a year-over-year increase of 25.6% [4] - Opdualag's sales were $252 million, slightly below the estimate of $261.59 million, with a year-over-year increase of 22.3% [4] Stock Performance - Bristol Myers' shares have returned -18% over the past month, compared to the Zacks S&P 500 composite's -5.1% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]

Group 1 - Bristol Myers Squibb (BMY) faced a setback in the late-stage ODYSSEY-HCM study for its cardiovascular drug Camzyos (mavacamten), which did not meet its dual primary endpoints [1][2][5] - The study aimed to evaluate changes in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2) at week 48, but failed to show significant improvements [2][5] - Following the disappointing results, BMY's stock declined by 7.2% year to date, while the industry saw a decline of 8.4% [2] Group 2 - Camzyos is a selective, reversible, allosteric inhibitor of cardiac myosin, indicated for symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy (HCM), with sales totaling $602 million in 2024 [4] - The ODYSSEY-HCM trial enrolled 580 adult patients and tested the hypothesis that a cardiac myosin inhibitor would improve patient measures, but no new safety signals were observed despite the disappointing results [5] - Concerns about the efficacy of cardiac myosin inhibitors in non-obstructive hypertrophic cardiomyopathy (nHCM) were raised, affecting shares of Cytokinetics, which is developing a similar drug [6] Group 3 - BMY's Growth Portfolio includes drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, which have stabilized revenue amid generic competition [7] - Label expansions for these drugs are expected to further boost sales, with Opdivo maintaining momentum through consistent label expansions [8] - BMY has also broadened its portfolio with the FDA approval of xanomeline and trospium chloride for schizophrenia treatment under the brand name Cobenfy [9] Group 4 - BMY agreed to acquire 2seventy Bio, Inc. for $286 million, sharing profits and losses related to the development and commercialization of Abecma in the U.S. [10] - The company currently holds a Zacks Rank 3 (Hold), with better-ranked stocks in the biotech sector including Amicus Therapeutics and ANI Pharmaceuticals, both rated 1 (Strong Buy) [11]

Core Viewpoint - Bristol Myers Squibb (BMY) has received FDA approval for the label expansion of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adult and pediatric patients aged 12 years and older [1][2] Company Developments - The latest FDA approval converts the previous accelerated approval for Opdivo monotherapy in the second-line setting to full approval and expands the indication for Opdivo plus Yervoy into the first-line treatment [2] - The approval was based on the phase III CheckMate-8HW study, which showed that Opdivo plus Yervoy met the dual primary endpoints of progression-free survival compared to Opdivo monotherapy and chemotherapy [4][5] - Opdivo plus Yervoy demonstrated a 79% reduction in the risk of disease progression or death compared to chemotherapy in the first-line setting and a 38% reduction versus Opdivo monotherapy across all lines of therapy [5] - The approval was granted more than two months ahead of the target action date of June 23, 2025, with ongoing studies assessing various secondary endpoints, including overall survival [6] Market Performance - BMY shares have increased by 7.9% over the past year, contrasting with a 20% decline in the industry [3] Portfolio Expansion - The approval of Opdivo continues to enhance BMY's immuno-oncology portfolio, with expectations for sustained impact into the next decade [7] - BMY's growth portfolio, which includes drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition for legacy drugs [10] - The company has also recently acquired 2seventy bio, Inc. for $286 million, sharing profits and losses related to the development of Abecma in the U.S. [12]

Core Viewpoint - Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the approval of Opdivo (nivolumab) for additional indications in treating non-small cell lung cancer (NSCLC) and for a subcutaneous formulation across multiple solid tumor indications [1][10]. Group 1: Opdivo Approval and Clinical Trials - The CHMP recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy after surgical resection for high-risk resectable NSCLC patients with PD-L1 expression ≥1% [2]. - The positive CHMP opinion was based on the CheckMate-77T trial, which showed significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo [3]. - The CheckMate-77T study also demonstrated improvements in secondary efficacy endpoints, including pathologic complete response and major pathologic response (MPR) [4]. Group 2: Market Performance and Growth - BMY's shares have increased by 21.4% over the past year, contrasting with a 7.1% decline in the industry [9]. - The approval of Opdivo Qvantig for subcutaneous use is expected to enhance the immuno-oncology franchise's impact into the next decade [12]. - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition [13]. Group 3: Recent Acquisitions and New Approvals - BMY recently acquired 2seventy bio, Inc. for $286 million, with plans to close the acquisition in the second quarter of 2025 [15]. - The approval of Cobenfy for schizophrenia represents a new pharmacological approach, with initial sales of $10 million in 2024 expected to contribute significantly to BMY's revenue [14].