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J&J Wins FDA Nod for Subcutaneous Version of NSCLC Drug Rybrevant (Revised)
ZACKS· 2025-12-23 09:56
Core Insights - Johnson & Johnson (JNJ) has received FDA approval for the subcutaneous formulation of its EGFR/MET inhibitor, Rybrevant, now marketed as Rybrevant Faspro, which is approved for all indications of the intravenous version [1][8] Group 1: Product Approval and Advantages - Both Rybrevant and Rybrevant Faspro are approved in the U.S. for four indications related to EGFR-mutated non-small cell lung cancer (NSCLC), including two first-line and two second-line settings [2] - The subcutaneous formulation offers significant advantages in patient convenience, reducing administration time to about five minutes compared to several hours for the intravenous version [3][8] - The approval of Rybrevant Faspro is supported by data from the late-stage PALOMA-3 study, demonstrating its effectiveness compared to the IV formulation [5][8] Group 2: Competitive Landscape - With this approval, JNJ is better positioned to compete with AstraZeneca's Tagrisso, the current standard of care for EGFR-mutated NSCLC, although Tagrisso's oral administration remains a competitive advantage [4] Group 3: Oncology Sales and Growth Strategy - JNJ's oncology segment comprises approximately 27% of total revenues, with oncology sales rising nearly 21% year-over-year to $18.52 billion in the first nine months [10] - The company aims to achieve $50 billion in oncology sales by the end of the decade, having doubled its oncology sales from $10.7 billion in 2019 to $20.8 billion in 2024 [12] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion to enhance its prostate cancer portfolio [14]
FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer
ZACKS· 2025-12-15 16:51
Core Insights - Johnson & Johnson (JNJ) received FDA approval for its precision therapy Akeega for a second indication in prostate cancer, specifically for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) [2][8] - The approval is based on the phase III AMPLITUDE study, which demonstrated a 54% reduction in the risk of radiographic progression or death with the Akeega-prednisone combination [3][8] - JNJ aims to achieve $50 billion in oncology sales by the end of the decade, with oncology currently accounting for approximately 27% of its total revenues [9][11] Drug Approval and Efficacy - Akeega combines the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate, marking the first FDA-approved precision medicine combination for BRCA2m mCSPC [3][5] - The drug's use has been expanded to an earlier stage of the disease, following its previous approval for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in 2023 [4][8] Financial Performance and Growth Strategy - JNJ's oncology sales rose nearly 21% year over year in the first nine months to $18.52 billion, driven by strong market growth and key products [9] - The company has seen its stock rise 46% this year, outperforming the industry average growth of 16% [6] - JNJ is actively building its oncology pipeline through acquisitions, including a recent agreement to acquire Halda Therapeutics for $3.05 billion [13] Market Position and Future Outlook - The oncology segment's growth is supported by new drug launches, contributing significantly to revenue increases [10][12] - JNJ's ambitious target of $50 billion in oncology sales requires more than doubling its sales from 2024 levels, reflecting confidence in its marketed cancer drugs and pipeline [11][12]
JNJ's Oncology Momentum Builds as It Chases $50B Goal by 2030
ZACKS· 2025-11-28 16:05
Core Insights - Johnson & Johnson (JNJ) is a significant player in the oncology segment, particularly in blood cancers and solid tumors [1] - The oncology segment currently accounts for approximately 27% of JNJ's total revenues, with sales reaching $18.52 billion, reflecting a 20.6% operational growth in the first nine months [2][11] - JNJ aims for its oncology sales to hit $50 billion by the end of the decade, supported by strong growth from existing products and new drug launches [3][7] Oncology Sales and Growth - JNJ's oncology sales have doubled from $10.7 billion in 2019 to $20.8 billion in 2024, indicating robust growth [7] - Key products driving this growth include Darzalex for multiple myeloma and Erleada for prostate cancer, along with new drugs like Carvykti, Tecvayli, Talvey, and Rybrevant [2][11] - The recent approval of Inlexzoh by the FDA and the subcutaneous formulation of Rybrevant plus Lazcluze in the EU are expected to further enhance sales [4] Pipeline and M&A Activity - JNJ's oncology pipeline has gained momentum with eight proof-of-concept readouts leading to late-stage pivotal studies [5] - The company announced a $3.05 billion acquisition of Halda Therapeutics, which will enhance its oncology portfolio, particularly in prostate cancer [6] Competitive Landscape - Major competitors in the oncology space include Pfizer, AstraZeneca, Merck, and Bristol-Myers, each with strong portfolios and pipelines [8][10][12] - Pfizer's acquisition of Seagen has strengthened its oncology position, while AstraZeneca's oncology sales account for about 43% of its total revenues [9][10] Stock Performance and Valuation - JNJ's stock has outperformed the industry, rising 43.5% year-to-date compared to an 18.8% increase for the industry [13] - The company's shares trade at a price/earnings ratio of 18.17, higher than the industry average of 17.43, but below its five-year mean of 15.65 [15] - Zacks Consensus Estimates for JNJ's earnings have shown slight upward revisions for 2025 and 2026 [17]
J&J Joins Pharma M&A Bandwagon, to Buy Cancer Biotech for $3.05B
ZACKS· 2025-11-18 17:06
Core Insights - Johnson & Johnson (JNJ) has announced a definitive agreement to acquire Halda Therapeutics for $3.05 billion in cash, enhancing its oncology pipeline, particularly in prostate cancer treatments [1][3][10] Acquisition Details - The acquisition will incorporate Halda's proprietary RIPTAC platform, which is focused on developing oral, targeted therapies for various solid tumors, including the lead candidate HLD-0915 for metastatic castration-resistant prostate cancer (mCRPC) [2][10] - HLD-0915 is currently in a phase I/II study and has shown promising anti-tumor activity, designed to induce selective tumor cell death and address treatment resistance mechanisms [2] Strategic Implications - This deal will bolster J&J's existing oncology portfolio, which includes established drugs like Zytiga, Erleada, and Akeega, and is expected to close in the coming months, subject to regulatory review [3][10] - J&J anticipates a dilution of approximately 15 cents to adjusted EPS in 2026 as a result of this acquisition [3] Recent M&A Activity - J&J has been actively pursuing acquisitions, completing around 60 deals in the past 18 months, including the acquisition of Intra-Cellular Therapies, which added the antidepressant Caplyta to its portfolio [4] - The pharmaceutical sector has seen a surge in M&A activity, with notable deals including Merck's acquisition of Cidara Therapeutics for $9.2 billion and Pfizer's acquisition of Metsera for approximately $10 million [5][6] Financial Performance - J&J's shares have outperformed the industry, rising 38% year-to-date compared to the industry average of 13.9% [9] - The company's shares are currently trading at a price/earnings ratio of 17.49, slightly above the industry average of 16.71 and its five-year mean of 15.65 [11] Earnings Estimates - The Zacks Consensus Estimate for J&J's 2025 earnings has increased from $10.86 to $10.87 per share, while the estimate for 2026 has risen from $11.46 to $11.48 over the past month [12]
Vida Ventures Marks Fourth Major Portfolio Acquisition in 2025, Capping a Record-Setting Year for Its Science-Led, Discipline-Driven Strategy
Businesswire· 2025-11-17 23:07
Core Insights - Vida Ventures has achieved its fourth major portfolio acquisition in 2025, marking a record-setting year for the firm with a focus on a science-led and disciplined investment strategy [2][4]. Acquisition Highlights - Halda Therapeutics was acquired by Johnson & Johnson for $3.05 billion, representing the largest acquisition ever for a Phase 1 stage company across any therapeutic area [3][6]. - Eli Lilly acquired Scorpion Therapeutics for up to $2.5 billion, enhancing its oncology portfolio with a next-generation targeted therapy platform [4][6]. - Sanofi completed its acquisition of Vigil Neuroscience for an upfront payment of $470 million, with potential contingent value rights (CVR) up to $600 million, focusing on a first-in-class TREM2 agonist for Alzheimer's disease [4][6]. - AbbVie acquired Capstan Therapeutics for a record-breaking $2.1 billion, the highest upfront payment for a company with only healthy-volunteer data [4][6]. Investment Strategy - Vida's multi-pillar investment strategy combines deep scientific expertise, disciplined capital deployment, and engagement at multiple entry points across the life sciences landscape [5][8]. - The firm focuses on recognizing differentiated mechanisms early and supporting them with technical rigor to scale value through clinical and strategic inflection points [5][8]. Future Outlook - Vida Ventures enters 2026 with strong momentum and a diversified portfolio, poised for continued clinical progress as the biotech sector becomes more data-driven and capital-efficient [8].
ETFs to Watch Post JNJ's Q3 Earnings Surprise & Bullish Outlook
ZACKS· 2025-10-16 13:56
Core Insights - Johnson & Johnson (JNJ) reported better-than-expected third-quarter 2025 results, continuing its streak of earnings and sales beats, and raised its top-line guidance for the year [1][4][7] Financial Performance - JNJ's Q3 earnings per share (EPS) reached $2.80, exceeding the Zacks Consensus Estimate by 1.1% and improving 15.7% year-over-year [4] - Sales grew 6.8% year-over-year to $23.99 billion, also surpassing the Zacks Consensus Estimate by 1% [4] - Sales from Innovative Medicines and MedTech segments both increased by 6.8% year-over-year [4] Product Performance - Sales of the multiple myeloma drug Darzalex surged 21.7% year-over-year to $3.67 billion [5] - Other oncology drugs, Erleada, Carvykti, and Tecvayli, saw sales growth of 18.4%, 83.5%, and 31.3% respectively [5] - However, sales of Imbruvica and Zytiga declined by 7.8% and 25.1% respectively [5] - In the MedTech segment, growth was driven by electrophysiology products and the Cardiovascular business [6] 2025 Outlook - JNJ raised its sales expectation for 2025 from $93.2-$93.6 billion to $93.5-$93.9 billion, with adjusted operational sales growth expected to be in the range of 3.5-4.0% [7] - The company anticipates adjusted EPS to be in the range of $10.80-$10.90 [7] Strategic Moves - JNJ announced plans to separate its Orthopaedics franchise, DePuy Synthes, which has been underperforming [8] - Following the positive results, Raymond James raised its price target for JNJ from $174 to $209, citing a strong product pipeline for future growth [8] ETFs Exposure - JNJ is a significant component in various healthcare ETFs, including: - iShares U.S. Pharmaceuticals ETF (IHE) with a 23.47% share and an 8.6% year-to-date gain [9] - Health Care Select Sector SPDR Fund (XLV) with an 8.88% share and a 3.6% year-to-date gain [11] - iShares U.S. Healthcare ETF (IYH) with an 8.55% share and a 3.9% year-to-date gain [12] - First Trust Nasdaq Pharmaceuticals ETF (FTXH) with a 7.56% share and a 7.6% year-to-date gain [13] - Fidelity MSCI Health Care Index ETF (FHLC) with a 7.52% share and a 5% year-to-date gain [14]
Buying J&J Stock Ahead of Q3 Earnings? Here's What You Should Know
ZACKS· 2025-10-10 17:10
Core Viewpoint - Johnson & Johnson (JNJ) is set to report its third-quarter 2025 results on October 14, with expectations for sales of $23.74 billion and earnings of $2.77 per share, indicating a stable outlook for the company in the drug and biotech sector [1] Earnings Estimates - The Zacks Consensus Estimate for JNJ's earnings has remained unchanged at $10.86 per share for 2025, while the estimate for 2026 has slightly increased from $11.36 to $11.38 per share over the past 60 days [1][2] - JNJ's earnings surprise history shows an average surprise of 5.73% over the last four quarters, with a recent surprise of 4.14% [2][3] Sales Performance - Sales growth is anticipated from key products such as Darzalex, Tremfya, and Erleada, along with new drugs like Carvykti and Tecvayli [5][6] - The Zacks Consensus Estimate for Darzalex sales is $3.63 billion, while Tremfya is estimated at $1.3 billion [6] - The Innovative Medicines segment is projected to face challenges due to biosimilar competition for Stelara, which is expected to decline significantly [8][9] MedTech Segment Insights - JNJ's MedTech business is expected to show improvement driven by newly acquired cardiovascular businesses and strong performance in Surgical Vision and wound closure [12][13] - However, the MedTech segment faces challenges in China due to the volume-based procurement (VBP) program, which is likely to continue impacting sales [13] Stock Performance and Valuation - JNJ's stock has outperformed the industry with a year-to-date increase of 32.2%, compared to a 7.8% increase in the industry [16] - The company's shares are currently trading at a forward price/earnings ratio of 16.97, which is higher than the industry average of 15.88 [19] Business Model and Growth Outlook - JNJ's diversified business model focuses on Pharmaceuticals and MedTech following the separation of its Consumer Health segment [23] - The Innovative Medicine unit has shown a growth trend, with a 2.4% increase in sales in the first half of 2025, despite challenges [24] - JNJ is advancing its pipeline and has made acquisitions to strengthen its position in the neurological and psychiatric drug market [26] Future Expectations - JNJ considers 2025 a "catalyst year," expecting operational sales growth to accelerate in the second half of the year, driven by newly launched products [29]
How J&J's Innovative Medicines Segment is Poised Ahead of Q3 Results
ZACKS· 2025-10-06 13:37
Core Insights - Johnson & Johnson (JNJ) is expected to report its third-quarter results on October 14, with a focus on the performance of its Innovative Medicine segment, which includes several blockbuster drugs across various therapeutic areas [1] Sales Performance - J&J anticipates operational sales growth in its Innovative Medicine segment to be stronger in the second half of the year compared to the first half, despite the loss of exclusivity for its product Stelara and the negative impact from the Part D redesign [2] - The segment's sales increased by 2.4% on an organic basis in the first half of 2025, with expectations for continued growth driven by key products like Darzalex, Tremfya, and Erleada, alongside contributions from new drugs such as Carvykti, Tecvayli, Talvey, Rybrevant, Lazcluze, and Spravato [3][4] Competitive Landscape - The launch of several biosimilar versions of Stelara in the U.S. in 2025 has negatively impacted the Innovative Medicines segment's growth by 1170 basis points, with expectations for a steeper decline in the third quarter due to increased biosimilar entrants [5] - Rising competition from new oral drugs is likely to have affected sales of Imbruvica, while the Medicare Part D redesign under the Inflation Reduction Act has particularly hurt sales of drugs like Stelara, Imbruvica, Tremfya, and Erleada [6] Future Projections - Estimates for the Innovative Medicines unit suggest a compound annual growth rate (CAGR) of around 5% over the next three years [7] Competitive Positioning - J&J's key areas of focus are immunology and oncology, with significant competition from other large drugmakers such as Novartis, AstraZeneca, AbbVie, Amgen, Merck, Bristol-Myers, Roche, and Pfizer [8] Stock Performance and Valuation - J&J's shares have outperformed the industry year-to-date, rising by 30.5% compared to an 8.6% increase in the industry [9] - The company's shares are currently trading at a price/earnings ratio of 16.77, which is higher than the industry average of 15.96 and above its five-year mean of 15.64 [11] Earnings Estimates - The Zacks Consensus Estimate for J&J's 2025 earnings remains unchanged at $10.86 per share, while the estimate for 2026 has slightly increased from $11.36 to $11.37 per share over the past 60 days [12]
Buy, Sell or Hold J&J Stock? Key Tips Ahead of Q1 Earnings
ZACKS· 2025-04-11 16:35
Core Viewpoint - Johnson & Johnson (JNJ) is set to report its first-quarter 2025 results on April 15, with sales and earnings estimates at $21.66 billion and $2.57 per share respectively. The earnings estimates for 2025 and 2026 have seen slight declines over the past 60 days [1]. Group 1: Earnings Performance - JNJ has consistently exceeded earnings expectations in the last four quarters, with an average earnings surprise of 4.43%. The last reported quarter showed a 2.0% earnings surprise [5]. - The company currently has an Earnings ESP of -2.53% and a Zacks Rank of 3 (Hold), indicating a mixed outlook for the upcoming earnings report [6]. Group 2: Sales Estimates and Drivers - Sales in JNJ's Innovative Medicines segment are expected to be driven by strong performances from key products like Darzalex, Tremfya, and Erleada, with respective sales estimates of $3.13 billion, $939.0 million, and $817.0 million [7][8]. - The sales estimate for the Innovative Medicine unit is $13.46 billion, while the MedTech segment is estimated at $8.14 billion, reflecting challenges in year-over-year comparisons [12][14]. Group 3: Competitive Landscape - The launch of biosimilars for Stelara is anticipated to impact its sales significantly, with estimates for Stelara sales at $1.64 billion [9][10]. - The MedTech business is facing headwinds in the Asia Pacific region, particularly in China, due to government cost containment efforts and competitive pressures [13]. Group 4: Strategic Developments - JNJ's diversified business model has been strengthened by the recent acquisition of Intra-Cellular Therapies for approximately $14.6 billion, enhancing its presence in the neurological and psychiatric drug market [24]. - The company is making progress with its pipeline and has been active in mergers and acquisitions, which is expected to bolster growth in its Innovative Medicine segment [23]. Group 5: Legal and Market Sentiment - Ongoing legal battles related to talc lawsuits have created a bearish sentiment around JNJ's stock, with a recent bankruptcy court ruling rejecting its proposed settlement plan [26]. - Despite potential challenges, JNJ has shown steady revenue and EPS growth, suggesting a long-term positive outlook for investors [27].