Workflow
Lazcluze
icon
Search documents
FDA Grants Breakthrough Status To Johnson & Johnson's Cancer Drug For Advanced Head and Neck Cancer
Yahoo Finance· 2026-02-21 16:31
FDA Designation - The FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as a monotherapy for adults with advanced head and neck squamous cell carcinoma [1] - The designation is for patients with recurrent or metastatic cancer that is HPV-unrelated after progression on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor [2] - Rybrevant Faspro is also approved for multiple settings in locally advanced or metastatic non-small cell lung cancer and is being evaluated in additional solid tumors, including colorectal cancer [2] Clinical Studies - The Breakthrough Therapy Designation is supported by data from the open-label Phase 1b/2 OrigAMI-4 study, which showed promising clinical activity with rapid and durable responses in a heavily pretreated patient population [3] - Subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study, assessing its combination with Merck's Keytruda and carboplatin versus 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy for HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma [4] New Dosing Schedule - The FDA approved a new, simplified monthly dosing schedule for Rybrevant Faspro in combination with oral Lazcluze for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer [5] Contract Extension - Trellus Health plc extended its contract with Johnson & Johnson's Health Care Systems unit for six months to continue providing Trellus Elevate for patients with moderate to severely active inflammatory bowel disease [6] - The extension was influenced by the achievement of engagement and satisfaction metrics during the initial pilot phase [6]
Can Pfizer's New & Acquired Drugs Offset Its Looming Patent Cliff?
ZACKS· 2026-02-11 14:11
Core Insights - Pfizer's COVID product sales have significantly declined from their peak, with projections of around $11 billion in 2024 and $6.7 billion in 2025, down from $56.7 billion in 2022. The company also faces challenges from U.S. Medicare Part D and upcoming patent expirations for key products between 2026 and 2030 [1][12] Non-COVID Revenue Growth - Non-COVID revenues for Pfizer are improving, driven by key products like Vyndaqel, Padcev, and Eliquis, as well as new launches and acquisitions. In 2023, Pfizer achieved a record number of FDA approvals, with nine new medicines and vaccines contributing to revenue growth [2][3] - Revenues from non-COVID products rose 6% operationally in 2025, with recently launched and acquired products generating $10.2 billion, reflecting a 14% operational growth year over year. Continued double-digit growth is expected for these products in 2026 [3] Strategic Acquisitions and Pipeline Development - Pfizer is focusing on rebuilding its pipeline through strategic acquisitions, investing approximately $9 billion in M&A deals in 2025, including the acquisition of Metsera and a licensing deal with 3SBio. The company plans to initiate 20 pivotal studies in 2026, targeting obesity and oncology [4][5] Competitive Landscape in Oncology - Pfizer is a major player in the oncology market, competing with companies like AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers. Each of these companies has seen significant growth in their oncology segments, with AstraZeneca's oncology sales rising 14% in 2025, Merck's Keytruda generating $31.7 billion in sales, and J&J's oncology sales increasing by 20.9% [6][8][9][10] Financial Performance and Valuation - Pfizer's stock has increased by 8.4% over the past year, compared to a 17.3% increase in the industry. The company's shares are trading at a forward price/earnings ratio of 9.33, which is lower than the industry average of 18.65 and its own 5-year mean of 10.23 [13][15] - The Zacks Consensus Estimate for Pfizer's 2026 earnings has slightly decreased from $2.99 to $2.98 per share, while the estimate for 2027 remains stable at $2.83 per share [17]
J&J Posts Innovative Medicine Growth in 2025 Amid Stelara Patent Loss
ZACKS· 2026-02-09 15:25
Core Insights - Johnson & Johnson (JNJ) has a diverse revenue stream in its Innovative Medicine division, with sales reaching $60.4 billion in 2025, reflecting a 5.3% operational growth and a 4.1% organic growth despite the loss of exclusivity for Stelara [1][10] Group 1: Sales Performance - The Innovative Medicine segment achieved over $15 billion in sales for three consecutive quarters in 2025, marking the first time it surpassed $60 billion in full-year sales [2] - Key products such as Darzalex, Tremfya, and Erleada contributed significantly to growth, with Darzalex sales increasing by 23.0% to $14.35 billion, Erleada by 19.2% to $3.57 billion, and Tremfya by 40.5% to $5.2 billion [6][9] - The decline in Stelara sales by 41.3% to $6.08 billion in 2025 due to its loss of exclusivity negatively impacted the segment's growth by 1110 basis points [4][5] Group 2: Future Outlook - J&J anticipates accelerated growth in the Innovative Medicine segment in 2026, driven by key products and new launches, with expected growth of 5% to 7% from 2025 to 2030 [7][9] - The company expects a more pronounced impact from new products in 2026, including Rybrevant and Caplyta, following approvals in 2025 [7] - However, the impact of generic competition is expected to intensify in 2026, particularly for Stelara, Simponi, and Opsumit as they lose patent protection [8] Group 3: Competitive Landscape - J&J operates in key areas of immunology and oncology, facing competition from major drugmakers such as Novartis, AstraZeneca, AbbVie, and Amgen [10][11] Group 4: Stock Performance and Valuation - J&J's stock has outperformed the industry, rising 55.6% over the past year compared to an 18.0% increase in the industry [12] - The company's shares are currently trading at a price/earnings ratio of 20.63, higher than the industry average of 18.76 and above its five-year mean of 15.65 [14] - The Zacks Consensus Estimate for 2026 earnings has increased from $11.48 to $11.54, indicating positive sentiment [16]
J&J Targets $100B+ Sales in 2026 as Growth Accelerates in Both Units
ZACKS· 2026-01-27 16:55
Core Insights - Johnson & Johnson (J&J) announced a financial outlook for 2026, projecting sales between $100.0 billion and $101.0 billion, surpassing the Zacks Consensus Estimate of $98.5 billion, with adjusted earnings per share expected to be in the range of $11.43 to $11.63 [1][9] Group 1: Innovative Medicine Segment - J&J anticipates accelerated growth in the Innovative Medicine segment in 2026, despite the loss of exclusivity (LOE) for the blockbuster drug Stelara, which negatively impacted growth by 1040 basis points in 2025 [2][3] - Key products such as Darzalex, Tremfya, Spravato, Carvykti, and Erleada, along with new launches like Rybrevant and Caplyta, are expected to drive growth in 2026 [4][5] - The impact of generic competition is expected to increase in 2026 with the introduction of biosimilars for Stelara and generics for Simponi and Opsumit [3][4] Group 2: MedTech Segment - J&J's MedTech business showed improvement with sales rising 4.3% to $33.8 billion in 2025, and stronger growth is expected in 2026 due to increased adoption of new products across various portfolios [6][7] - The company anticipates some challenges from China's volume-based procurement (VBP) program, which is a government-driven cost containment effort [6][7] Group 3: Stock Performance and Valuation - J&J's stock has outperformed the industry, rising 47.3% over the past year compared to a 19.3% increase in the industry [8] - The company's shares are currently trading at a price/earnings ratio of 19.11, higher than the industry average of 18.33 and above its five-year mean of 15.65 [11] - The Zacks Consensus Estimate for 2026 earnings has increased from $11.46 to $11.53, reflecting a positive outlook following J&J's financial projections [13]
Johnson & Johnson reports 9.1% increase in sales for Q4 2025
Yahoo Finance· 2026-01-22 11:03
Financial Performance - Johnson & Johnson (J&J) reported a 9.1% increase in Q4 2025 sales, reaching $24.56 billion, with net earnings rising by 49.1% to $5.11 billion [1] - For the entire year, sales grew by 6% to $94.2 billion, and full-year earnings per share (EPS) registered at $11.03 [1] - Adjusted net earnings for Q4 2025 were reported at $6.1 billion, up by 21.5% from $4.94 billion in the same period of the prior year [2] - Adjusted diluted EPS increased to $2.46 from the previous year's $2.04, translating to a 20.6% growth [2] - The diluted EPS for Q4 2025 stood at $2.10, up from $1.41 in Q4 2024, reflecting a 48.9% growth [1] Product Innovations and Sector Performance - Significant innovations included approvals for Caplyta in treating major depressive disorder and Rybrevant Faspro plus Lazcluze for non-small cell lung cancer [2] - Operational sales of the global innovative medicine sector increased by 5.3%, driven by products such as Erleada, Darzalex, Carvykti in oncology, and Tremfya in immunology [3] - Medtech saw a worldwide operational sales increase of 5.4%, primarily driven by electrophysiology products and Abiomed in cardiovascular and wound closure products in general surgery [3] Future Outlook - J&J announced guidance for 2026, forecasting estimated reported sales of $100.5 billion and an adjusted EPS of $11.53 at the midpoint [3] - The company emphasized that 2025 was a catapult year, fueled by a strong portfolio and pipeline, marking the beginning of a new era of accelerated growth [4] - The acquisition of Halda Therapeutics for $3.05 billion in cash was completed in December 2025, enhancing J&J's capabilities in biotechnology [4]
Johnson & Johnson Q4 Earnings Call Highlights
Yahoo Finance· 2026-01-21 17:14
Core Insights - Johnson & Johnson reported a strong operational sales growth of 5.3% for full-year 2025, reaching $94.2 billion, with U.S. growth at 6.9% and international growth at 3.4% despite challenges from Stelara [1] - The company emphasized a strategic pivot towards higher-growth markets, including plans to separate its Orthopaedics business by mid-2027, and highlighted significant investments in R&D and M&A totaling over $32 billion in 2025 [4] - CEO Joaquin Duato described 2025 as a "catapult year" for accelerated growth, supported by a robust portfolio and pipeline, with expectations for continued growth and improving margins in 2026 [5] Financial Performance - For Q4 2025, net earnings were $5.1 billion, with diluted EPS of $2.10, up from $1.41 a year earlier; adjusted net earnings were $6.0 billion, with adjusted diluted EPS of $2.46, reflecting increases of 21.5% and 20.6% respectively compared to Q4 2024 [2] - Full-year net earnings reached $26.8 billion, with diluted EPS at $11.03, including a $7 billion talc reserve reversal; adjusted net earnings were $26.2 billion, with adjusted diluted EPS of $10.79, both up 8.1% from 2024 [6] Business Segments - In Innovative Medicine, Q4 worldwide sales were $15.8 billion, up 7.9% operationally, with both U.S. and international growth at 7.9%; acquisitions contributed 170 basis points, primarily from Intra-Cellular [7] - Oncology products showed strong performance, with Darzalex sales growing 24.1% in Q4 and over $14 billion in full-year sales; Carvykti generated $555 million in Q4 sales, up 63.2% [7] - MedTech sales in Q4 were $8.8 billion, up 5.8% operationally, driven by cardiovascular growth, including Abiomed and Shockwave [8] Margins and Guidance - Adjusted income before tax as a percentage of sales rose to 28.7% in Q4 from 24.1% a year earlier, with Innovative Medicine margin improving to 36.3% and MedTech margin to 17.4% [10] - For 2026, the company expects operational sales growth of 5.7% to 6.7%, with a midpoint of $100 billion; adjusted EPS guidance is set at $11.28 to $11.48, implying 5.5% growth at the midpoint [13][14] Pipeline and Future Outlook - Management highlighted anticipated regulatory events for 2026, including expected approvals for Icotide in psoriasis and Tecvayli in multiple myeloma [15] - The company is also focusing on its multiple myeloma portfolio, with positive early feedback on Inlexo for bladder cancer and plans for a permanent J-code [16]
J&J(JNJ) - 2025 Q4 - Earnings Call Transcript
2026-01-21 14:30
Financial Data and Key Metrics Changes - In Q4 2025, worldwide sales reached $24.6 billion, a 7.1% increase despite a 650 basis point headwind from Stelara [17] - For the full year 2025, worldwide sales were $94.2 billion, reflecting a 5.3% increase, with U.S. growth at 6.9% and international growth at 3.4% [18] - Net earnings for Q4 were $5.1 billion, with diluted earnings per share at $2.10, compared to $1.41 a year ago [18] - Full year 2025 net earnings were $26.8 billion, with diluted earnings per share at $11.03, significantly up from $5.79 the previous year [19] Business Line Data and Key Metrics Changes - Innovative Medicine reported Q4 sales of $15.8 billion, a 7.9% increase, with notable growth in oncology and immunology [20] - In oncology, Darzalex grew 24.1%, while Carvykti achieved sales of $555 million with a growth of 63.2% [20] - Immunology saw Tremfya grow 65.4%, while Stelara declined 48.6% due to biosimilar competition [21] - MedTech sales for the year were $34 billion, with operational growth of 5.4%, driven by cardiovascular and surgical segments [13] Market Data and Key Metrics Changes - U.S. sales growth was 7.5% in Q4, while international sales grew by 6.6% [17] - The cardiovascular segment delivered 15% operational sales growth, with Abiomed and Shockwave showing strong performance [13] - Surgical vision grew 10.8%, driven by new product innovations and demand for premium intraocular lenses [24] Company Strategy and Development Direction - The company plans to separate its orthopedics business by mid-2027, focusing on high-growth areas [30] - Investments of over $32 billion in R&D and M&A were made in 2025, including acquisitions of Intra-Cellular Therapies and HALDA Therapeutics [6] - The company aims for double-digit growth by the end of the decade, supported by a strong portfolio and pipeline [5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving faster growth in 2026 compared to 2025, with a line of sight to double-digit growth [6] - The company anticipates operational sales growth in 2026 to be between 5.7% and 6.7%, with a midpoint of $100 billion [31] - Management highlighted the strength of their portfolio and pipeline as key drivers for future growth [41] Other Important Information - The company ended 2025 with approximately $20 billion in cash and marketable securities, and $48 billion in debt [30] - A net interest expense of $300 million to $400 million is expected for 2026 [33] - The effective tax rate is projected to be between 17.5% and 18.5% for 2026 [34] Q&A Session Summary Question: Overview of growth prospects and key levers for double-digit growth - Management highlighted the strength of the portfolio and pipeline, focusing on oncology, immunology, and MedTech as key growth areas [40][41] Question: MedTech market dynamics and growth expectations - Management does not expect the loss of ACA subsidies to materially impact MedTech performance, with a focus on clinical capacity driving growth [48] Question: Margin progression and relationship to top-line growth - Management indicated that margin improvements will align with sales growth, with expectations for at least 50 basis points of improvement in 2026 [55] Question: Vision care market health and performance - Management noted strong underlying demand in the contact lens category, with robust growth driven by new product launches [58][59]
Barclays Raises Johnson & Johnson (JNJ) Target on Strength in Key Drugs
Yahoo Finance· 2026-01-07 20:33
Core Insights - Johnson & Johnson (JNJ) is recognized as one of the 14 Best Dividend Growth Stocks to buy and hold in 2026 [1] - Barclays has raised its price target for JNJ from $197 to $217, citing strong sales from key drugs like Darzalex, Tremfya, and Simponi, which may exceed Q4 consensus estimates [2] - The company has invested $10.4 billion in research and development (R&D) through Q3, positioning itself as a leading innovator globally, while also maintaining strong free cash flow [3] Financial Performance - JNJ's R&D investment of $10.4 billion supports its ongoing revenue and earnings growth, allowing for continued dividend increases, currently yielding approximately 2.5% [3] - The recent acquisition of Halda Therapeutics for $3.1 billion is expected to enhance JNJ's capabilities in cancer treatment [3] Oncology Sector - Oncology is a significant area for JNJ, with key products like Rybrevant and Lazcluze targeting advanced non-small cell lung cancer, and Inlexzo expected to contribute to the oncology portfolio [4]
Amgen Buys Dark Blue Therapeutics to Strengthen Oncology Pipeline
ZACKS· 2026-01-07 14:35
Core Insights - Amgen has acquired Dark Blue Therapeutics for approximately $840 million, enhancing its oncology pipeline [1][8] - The acquisition adds a preclinical small-molecule degrader targeting MLLT1/3 proteins associated with specific types of acute myeloid leukemia (AML) [2][8] - Amgen currently does not market any therapies for AML but has Blincyto approved for acute lymphoblastic leukemia (ALL) and is developing bispecific T-cell engagers for AML [3][8] Amgen's Oncology Pipeline - Amgen has a diverse oncology portfolio, including drugs like Blincyto, Imdelltra, Lumakras, Vectibix, Kyprolis, Nplate, and Xgeva [6] - Key candidates in its late-stage oncology pipeline include bemarituzumab for gastric cancer and xaluritamig for metastatic castrate-resistant prostate cancer [6] - Ongoing phase III studies are evaluating Imdelltra in small cell lung cancer and biosimilars for Opdivo, Keytruda, and Ocrevus [6] Competitive Landscape - Major competitors in the oncology space include Pfizer, AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers [9] - Pfizer's oncology sales account for about 28% of total revenues, with a 7% increase in the first nine months of 2025 [10] - AstraZeneca's oncology segment comprises around 43% of total revenues, with a 16% increase in sales during the same period [11] - Merck's Keytruda, a key oncology drug, generated $23.3 billion in sales in the first nine months of 2025, up 8% year over year [12] - Bristol-Myers' Opdivo accounts for approximately 20% of its total revenues, with sales rising 8% to $7.54 billion [13] - Johnson & Johnson's oncology sales represent around 27% of total revenues, with a 20.6% operational increase in the first nine months of 2025 [14]
PFE's Oncology & Obesity Pipeline Position It for Post-LOE Growth
ZACKS· 2025-12-24 17:21
Core Insights - Pfizer anticipates a significant revenue decline due to the loss of exclusivity for key products between 2026 and 2030, including Eliquis, Vyndaqel, Ibrance, Xeljanz, and Xtandi, all facing patent expirations [1][9] - The company has bolstered its R&D pipeline through mergers and acquisitions, successful data readouts, and pivotal program initiations, positioning itself for sustainable growth post-LOE [1][7] Oncology Pipeline - Pfizer has advanced its oncology pipeline with several candidates in late-stage development, including vepdegestrant for ER+/HER2- metastatic breast cancer, atirmociclib for HR+/HER2- metastatic breast cancer, and sigvotatug vedotin for metastatic non-small cell lung cancer [2] - By 2030, Pfizer expects to have eight or more blockbuster oncology medicines in its portfolio [4] Non-Oncology Developments - In non-oncology areas, Pfizer is developing an mRNA flu/COVID combination vaccine and osivelotor for sickle cell disease, both in late-stage development [4] - The company is also expanding the labels of approved products like Padcev, which was recently approved by the FDA in combination with Merck's Keytruda for specific bladder cancer patients [5] Obesity Market Expansion - Pfizer is strengthening its presence in the obesity market, currently dominated by Eli Lilly and Novo Nordisk, through the $10 billion acquisition of Metsera and the in-licensing of YP05002, an oral GLP-1 receptor agonist [6] - The Metsera acquisition added four novel clinical-stage programs for obesity, expected to generate billions in peak sales [6] Competitive Landscape - Pfizer faces revenue headwinds from patent expirations but is positioned for long-term growth through its expanding late-stage pipeline in oncology and investments in obesity, vaccines, and rare diseases [7] - The oncology market is competitive, with major players like AstraZeneca, Merck, Johnson & Johnson, and Bristol-Myers also focusing on oncology sales [10][11][12][13] Financial Performance - Pfizer's stock has declined 7% over the past year, while the industry has seen a 16% increase [14] - The company's shares are trading at a forward price/earnings ratio of 8.18, below the industry average of 17.40 and its own 5-year mean of 10.39, indicating attractive valuation [16] - The Zacks Consensus Estimate for 2025 earnings has increased slightly to $3.10 per share, while the estimate for 2026 has decreased to $3.04 per share [18]