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MRK's ADC Candidate Gets FDA Breakthrough Therapy Tag for Lung Cancer
ZACKS· 2025-08-19 16:41
Group 1: FDA Breakthrough Therapy Designation - Merck's B7-H3-directed ADC, ifinatamab deruxtecan (I-DXd), received FDA's Breakthrough Therapy designation for treating extensive-stage small cell lung cancer in adults whose disease progressed after platinum-based chemotherapy [1][8] - The Breakthrough Therapy designation accelerates the development and review of drugs for serious conditions when early clinical evidence indicates significant improvement over existing treatments [2] Group 2: Clinical Studies and Data - The FDA's decision was based on data from the phase II IDeate-Lung01 study, which evaluated the safety and efficacy of I-DXd, supported by the phase I/II IDeate-PanTumor01 study [3][8] Group 3: Stock Performance - Year to date, Merck's shares have decreased by 15.3%, while the industry has seen a decline of 2.8% [4] Group 4: Collaboration and Development - Merck acquired global co-development and co-commercialization rights to I-DXd and two other ADCs from Daiichi Sankyo for a potential total consideration of up to $22 billion, although Daiichi retains exclusive rights for development in Japan [6][9] - I-DXd is also being evaluated in phase III studies for esophageal and prostate cancers, and it has an orphan drug designation for small-cell lung cancer in multiple regions [5][8] Group 5: ADC Market Competition - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by targeting tumors with cytotoxic drugs [11] - Daiichi Sankyo has multiple ADCs in clinical development and markets Enhertu in partnership with AstraZeneca, which is approved for various cancer indications [12] - Pfizer entered the ADC market by acquiring Seagen for $43 billion, adding several ADCs to its portfolio that have contributed significantly to its revenues [13][14]
Pfizer Oncology Drugs Drive Sales in Q2: Will the Trend Continue?
ZACKS· 2025-08-19 14:10
Core Insights - Pfizer is a leading player in the oncology sector with a strong portfolio of approved cancer medicines and a promising pipeline focusing on various modalities [1][5] - The acquisition of Seagen in 2023 has enhanced Pfizer's oncology position by adding four antibody-drug conjugates (ADCs) [2][6] - Oncology sales account for over 25% of Pfizer's total revenues, with a 9% growth in the first half of 2025, driven by key drugs [3][11] Revenue Performance - Key oncology drugs such as Xtandi, Lorbrena, Braftovi-Mektovi combination, and Padcev contributed to revenue growth, offsetting declines from Ibrance [3][4] - Xtandi generated alliance revenues of $566 million, up 14% year over year, while Lorbrena sales increased by 48% to $251 million [4] - Oncology biosimilars generated $353 million in revenue, reflecting a 27% year-over-year increase [5] Pipeline and Future Outlook - Pfizer is advancing its oncology pipeline with several late-stage candidates and expects to have eight or more blockbuster oncology medicines by 2030 [5][7] - A global licensing agreement with 3SBio for a dual PD-1 and VEGF inhibitor is expected to strengthen its oncology pipeline [6] Competitive Landscape - Other major players in oncology include AstraZeneca, Merck, and Bristol-Myers, with AstraZeneca's oncology sales comprising around 43% of total revenues [8][9] - Merck's Keytruda accounts for approximately 50% of its pharmaceutical sales, with a 6.6% increase in sales to $15.1 billion in the first half of 2025 [9] Valuation and Earnings Estimates - Pfizer's stock has seen a slight decline of 0.4% this year, compared to a 1.2% decrease in the industry [12] - The company's shares are trading at a price/earnings ratio of 8.08, lower than the industry average of 14.45 [13] - The Zacks Consensus Estimate for 2025 earnings has increased from $3.05 to $3.12 per share over the past 30 days [15]
How Will Pfizer's Oncology Drugs Perform in Q2 Earnings?
ZACKS· 2025-07-15 13:55
Core Insights - Pfizer has strengthened its position in the oncology space with the acquisition of Seagen in 2023, adding four antibody-drug conjugates (ADC) to its portfolio [1] - The oncology segment contributed over 25% to Pfizer's total revenues in Q1 2025, with a year-over-year growth of 7% [1] - The overall oncology sales for Q2 2025 are estimated at $4.0 billion, reflecting a 2% increase year over year [3] Oncology Segment Performance - Sales of Xtandi, Lorbrena, and Braftovi/Mektovi are expected to have increased, while Ibrance's sales are likely to have declined due to competitive pressures and the impact of the Inflation Reduction Act [2] - ADC products show mixed trends, with Padcev benefiting from strong demand, while Adcetris faced competitive pressure in the U.S. [7] Competitive Landscape - AstraZeneca's oncology sales accounted for nearly 41% of its total revenues, with a 13% increase in Q1 2025 driven by products like Tagrisso and Lynparza [4] - Merck's Keytruda accounted for over 46% of its total revenues in Q1 2025, highlighting its significance in the oncology market [5] Valuation and Estimates - Pfizer's shares are currently trading at a price/earnings ratio of 8.25, which is lower than the industry average of 15.12 and its own 5-year mean of 10.86, indicating attractive valuation [8] - The bottom-line estimate for 2025 has slightly decreased from $3.08 to $3.05, while the estimate for 2026 has increased from $3.08 to $3.09 [9]
Pfizer vs BMY: Which Oncology Drugmaker Is a Better Choice for Now?
ZACKS· 2025-06-20 15:06
Core Insights - Pfizer (PFE) and Bristol Myers (BMY) hold a dominant position in the oncology market, which is expected to grow due to an increase in cancer patients globally [1][2] - Oncology sales represent approximately 25% of Pfizer's total revenues, while Bristol Myers focuses on immuno-oncology and has a strong pipeline of drugs [2][9] Pfizer's Position - Pfizer has a diverse oncology product portfolio, including antibody-drug conjugates (ADCs), small molecules, and immunotherapies targeting various cancers [4] - Key approved drugs in Pfizer's portfolio include Ibrance, Xtandi, and others, with Ibrance being a significant revenue generator [5] - The acquisition of Seagen in December 2023 enhanced Pfizer's oncology offerings, adding four ADCs and boosting sales for 2024 and early 2025 [6] - Pfizer is also advancing a pipeline of oncology candidates, expecting to have eight or more blockbuster oncology medicines by 2030 [7] - In addition to oncology, Pfizer's portfolio includes drugs for COVID-19, inflammation, rare diseases, and migraines [8] Bristol Myers' Strategy - Bristol Myers aims to strengthen its leadership in immuno-oncology, with key drugs like Opdivo and Yervoy driving its oncology franchise [9][10] - Recent FDA approvals for Opdivo and other drugs are expected to enhance its market presence [11] - Bristol Myers has expanded its oncology pipeline through acquisitions, including Mirati and RayzeBio, which add significant assets to its portfolio [12][14] - The company is also developing drugs across various therapeutic areas, including hematology and immunology [16] Financial Estimates and Performance - The Zacks Consensus Estimate for Pfizer's 2025 sales indicates a slight decline of 0.6%, while earnings per share (EPS) are expected to decrease by 1.61% [17] - In contrast, Bristol Myers' 2025 sales are projected to decrease by 4.13%, but its EPS is expected to increase significantly due to low figures in 2024 [20] - Year-to-date, Pfizer's stock has declined by 6.8%, while Bristol Myers has seen a larger drop of 15.4% [21] - From a valuation perspective, Pfizer's shares trade at a forward P/E ratio of 7.77, slightly higher than Bristol Myers' 7.22 [22] Dividend Yield and Investment Considerations - Pfizer offers a higher dividend yield of 7.2% compared to Bristol Myers' 5.29%, making it more attractive for income-focused investors [23] - Both companies are currently rated with a Zacks Rank 3 (Hold), indicating a complex decision for investors when choosing between the two [24] - Despite challenges, Pfizer's diverse portfolio and higher dividend yield position it as a preferable choice at present [26]
三生制药(1530.HK):BD出海金额创纪录 ASCO数据表现亮眼
Ge Long Hui· 2025-06-07 18:08
Core Viewpoint - Sanofi has achieved breakthroughs in international collaboration and clinical progress for its innovative drug SSGJ-707, a PD-1/VEGF dual antibody, with a total deal value of up to $61.5 billion with Pfizer, setting a record for domestic dual antibodies going abroad [1][2][3] Event Summary - On May 20, Sanofi announced the global (excluding mainland China) development, production, and commercialization rights of SSGJ-707 to Pfizer, with a total transaction value of up to $60.5 billion, including a $12.5 billion upfront payment and potential payments of up to $48 billion, along with a two-digit percentage tiered sales share based on product sales in authorized regions [1][2] - On June 1, Sanofi presented Phase II data for SSGJ-707 at the ASCO conference, showing an objective response rate (ORR) of 75% for squamous cell carcinoma and 64% for non-squamous cell carcinoma in advanced NSCLC patients, with a disease control rate of 97% and a grade 3 or higher treatment-related adverse event (TRAE) rate of 24.1% [2][3] Product Development - SSGJ-707 is developed based on the proprietary CLF2 patent platform and is the second PD-1/VEGF dual antibody globally, currently advancing to Phase III clinical trials [3] - In previous trials, SSGJ-707 demonstrated an ORR of 58.3% in non-squamous and 81.3% in squamous patients when combined with chemotherapy, with a grade 3 or higher TRAE rate of 8.9% [4] Future Prospects - Pfizer's acquisition of Seagen for $43 billion enhances its ADC platform, which may lead to the exploration of ADC and dual antibody combination therapies in solid tumors [5][6] - Clinical studies suggest that VEGF inhibition can improve tumor microenvironment and enhance ADC penetration, while PD-1 blockade may overcome immune evasion post-ADC treatment [6] Financial Forecast - Sanofi is expected to generate revenues of 10.421 billion, 11.817 billion, and 13.277 billion yuan from 2025 to 2027, with net profits of 2.404 billion, 2.788 billion, and 3.271 billion yuan, corresponding to PE ratios of 20, 17, and 15, maintaining a "buy" rating [7]
Buy, Sell, Or Hold PFE Stock At $23?
Forbes· 2025-06-03 14:00
Core Viewpoint - Pfizer's stock has declined approximately 25% from its 52-week high, primarily due to pipeline setbacks and management concerns regarding R&D spending and acquisitions [1][2][11] Valuation - Pfizer's current price-to-sales (P/S) ratio is 2.1, compared to 3.0 for the S&P 500, indicating it is slightly undervalued [8] - The price-to-free cash flow (P/FCF) ratio stands at 9.5 versus 20.5 for the S&P 500, and the price-to-earnings (P/E) ratio is 16.8 compared to 26.4 for the benchmark [8] Revenue Performance - Pfizer's revenues have seen a marginal decline over recent years, with an average shrinkage of 9.0% over the last three years, while the S&P 500 experienced a growth of 5.5% [8] - However, revenues grew by 11.7% from $60 billion to $64 billion in the last 12 months, outperforming the S&P 500's growth of 5.5% [8] Profitability - Pfizer's profit margins are around the median level for companies in the Trefis coverage universe, with an operating margin of 24.3% compared to 13.2% for the S&P 500 [8] Financial Stability - The company's balance sheet is considered weak, with a debt figure of $61 billion and a poor debt-to-equity ratio of 46.2% compared to 19.9% for the S&P 500 [13] - Cash and cash equivalents amount to $17 billion, yielding a cash-to-assets ratio of 8.3% versus 13.8% for the S&P 500 [13] Downturn Resilience - Pfizer's stock has historically underperformed the S&P 500 during market downturns, with a peak-to-trough decline of 57.3% from a high of $61.25 to $26.13 [14][15] - The stock has not yet recovered to its pre-crisis high, currently trading around $23 [14] Future Outlook - Despite current challenges, Pfizer has a robust pipeline, particularly in oncology, with potential blockbuster drugs that could enhance future revenues [12] - The acquisition of Seagen is beginning to positively impact sales and earnings, although it has not fully offset the revenue loss from COVID-19 products [10][12]
Pfizer's 7.5% Dividend: Income Haven or House of Cards?
MarketBeat· 2025-05-23 19:21
Core Viewpoint - Pfizer's high dividend yield of 7.5% attracts income-seeking investors, but underlying concerns about future growth and financial stability exist due to revenue declines and patent expirations [1][2][13]. Dividend Overview - Pfizer currently pays an annual dividend of $1.72 per share, translating to a quarterly payment of $0.43 per share, resulting in a dividend yield of 7.5% as of May 22, 2025 [2][3]. - The company has a strong track record of increasing dividends for 16 consecutive years, appealing to investors seeking reliable income [4]. Financial Metrics - Pfizer's annualized 3-year dividend growth stands at 2.50%, with a dividend payout ratio of 124.64% based on trailing earnings, indicating that dividends exceed earnings [4][6]. - The dividend payout consumes approximately 47.69% of its cash flow, suggesting a more sustainable dividend based on cash generation [5]. Revenue Challenges - In Q1 2025, Pfizer's total revenues decreased by 8% year-over-year to $13.7 billion, primarily due to a 75% drop in Paxlovid sales as COVID-19 demand normalized [7]. - The company faces a significant revenue loss of $17-$18 billion annually between 2026 and 2028 due to the impending loss of exclusivity for key drugs like Eliquis and Prevnar [8]. Strategic Initiatives - Pfizer is pursuing a strategy focused on pipeline rejuvenation, particularly in oncology, highlighted by the $43 billion acquisition of Seagen in March 2023, which contributed $3.4 billion to revenue in FY 2024 [9]. - The company has entered a licensing agreement with 3SBio, Inc. for SSGJ-707, with an upfront payment of $1.25 billion, potentially worth up to $6 billion, aiming to launch eight new cancer medicines by 2030 [10]. Pipeline Developments - Positive developments in the oncology pipeline include FDA approval for Adcetris in large B-cell lymphoma and promising clinical data for Padcev in urothelial cancer [11]. - The Abrysvo RSV vaccine has seen expanded recommendations, potentially increasing market reach, although setbacks occurred with the discontinuation of the oral GLP-1 candidate danuglipron [12]. Investment Outlook - Pfizer's stock forecast indicates a 12-month price target of $29.17, representing a 25.08% upside, with a Moderate Buy rating based on 15 analyst ratings [13]. - The current high dividend yield is attractive, but the company faces significant operational challenges and uncertainties regarding future revenue growth [14][15].
MRK, Daiichi Begin Pivotal Esophageal Cancer Study With ADC Drug
ZACKS· 2025-05-20 15:26
Core Insights - Merck and Daiichi Sankyo have initiated the phase III IDeate-Esophageal01 study for the B7-H3 directed ADC, ifinatamab deruxtecan (I-DXd), targeting advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients [1][2] - The study aims to compare the safety and efficacy of I-DXd against an investigator's choice of chemotherapy in patients who have progressed after platinum-based therapy and immune checkpoint inhibitors [2] - The primary endpoint is overall survival, with secondary endpoints including progression-free survival and objective response rate [3] Company Developments - Merck's stock has decreased by 22.3% year-to-date, while the industry has seen a decline of 5.2% [6] - Merck acquired global co-development and co-commercialization rights for I-DXd and two other ADCs from Daiichi Sankyo for a potential total of up to $22 billion, retaining exclusive rights for Daiichi in Japan [8] - Merck has expanded its collaboration with Daiichi to co-develop MK-6070, a T-cell engager targeting DLL3, following its acquisition of Harpoon Therapeutics [9] Industry Context - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by using antibodies to deliver cytotoxic drugs directly to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancer types, including Enhertu, which is marketed in partnership with AstraZeneca [12] - Pfizer has entered the ADC market by acquiring Seagen for $43 billion, adding three ADCs to its portfolio that have significantly contributed to its revenues in 2024 [13][14]
Top 4 GARP Stocks With Attractive PEG Ratios to Watch
ZACKS· 2025-05-09 20:00
Core Insights - The article discusses the investment strategy of GARP (Growth at a Reasonable Price) as a hybrid approach that combines elements of both value and growth investing, particularly in uncertain market conditions [2][3][5]. Investment Strategy - GARP investing prioritizes the PEG (Price/Earnings Growth) ratio, which relates a stock's P/E ratio to its future earnings growth rate, providing a more comprehensive view of a stock's potential [5][6]. - A lower PEG ratio, ideally below 1, indicates both undervaluation and future growth potential, making it attractive for GARP investors [6]. Stock Performance - Several stocks have shown significant success using the GARP strategy, including Takeda Pharmaceutical, Five9, LATAM Airlines, and Mizuho Financial Group [4]. - Takeda Pharmaceutical has a Zacks Rank of 1, a Value Score of A, and a long-term expected growth rate of 35% [11]. - Five9 holds a Zacks Rank of 2, a Value Score of B, and a historical growth rate of 19.3% [13]. - LATAM Airlines also has a Zacks Rank of 1, a Value Score of A, and an expected growth rate of 14.8% [14]. - Mizuho Financial has a Zacks Rank of 2, a Value Score of B, and a long-term expected growth rate of 15.9% [16]. Screening Criteria - Effective GARP investing involves screening for stocks with a PEG ratio less than the industry median, a P/E ratio below the industry median, a Zacks Rank of 1 or 2, a market capitalization greater than $1 billion, and an average 20-day trading volume exceeding 50,000 [8][9].