Question-and-Answer SessionSo obviously, a lot going on at J&J. Maybe starting off with icotrokinra. So obviously, we know that there is a submission to regulators. How should we kind of think about next steps? When could we see approval? And have you guys started preparing for launch as of today?David LeeGlobal Therapeutic Area Head, Immunology for Janssen Pharmaceutical Sure. Well, I maybe will start. Let's start with icotrokinra. It's the first targeted oral peptide to the -- highly selective to the IL-2 ...

Core Insights - Icotrokinra, a first-in-class targeted oral peptide developed by Johnson & Johnson, has shown promising results in the Phase 2b ANTHEM-UC study for treating moderately to severely active ulcerative colitis, with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement at Week 28 compared to placebo [1][2][3] Clinical Results - At Week 28, all doses of icotrokinra (100 mg, 200 mg, and 400 mg) demonstrated higher rates of clinical response, clinical remission, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) compared to placebo [1][2] - The clinical response rates for the 400 mg dose were 66.7% at Week 28, up from 63.5% at Week 12, while clinical remission improved from 30.2% to 31.7% [2] - Endoscopic improvement increased from 36.5% at Week 12 to 38.1% at Week 28, with HEMI rates rising from 28.6% to 33.1% [2] Safety Profile - Similar proportions of participants reported adverse events and serious adverse events across all icotrokinra dose groups and the placebo group, indicating a favorable safety profile [2][3] Future Development - Johnson & Johnson has initiated Phase 3 clinical development for icotrokinra in both adults and adolescents with moderately to severely active ulcerative colitis and Crohn's disease [3] - The company is also studying icotrokinra in pivotal Phase 3 programs for moderate-to-severe plaque psoriasis and active psoriatic arthritis [3][9] Mechanism of Action - Icotrokinra is designed to precisely block the IL-23 receptor, which plays a critical role in the inflammatory response associated with ulcerative colitis and other IL-23-mediated diseases [8][9] Regulatory Status - A New Drug Application (NDA) for icotrokinra was submitted to the U.S. Food and Drug Administration (FDA) in July 2025, seeking approval for treating adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis [3]

Core Insights - Johnson & Johnson announced long-term data from the Phase 3 ICONIC-TOTAL study, showing that icotrokinra, a targeted oral peptide, effectively treats moderate-to-severe plaque psoriasis in adults and adolescents, achieving high rates of skin clearance [1][4][5]. Efficacy and Safety - In the ICONIC-TOTAL study, 72% of patients with scalp psoriasis and 85% with genital psoriasis achieved clear or almost clear skin at Week 52 [1][6]. - Overall, 67% of patients treated with icotrokinra achieved clear or almost clear skin by Week 24, maintaining this through Week 52 [1][4]. - In patients with hand/foot psoriasis, the rate of skin clearance increased from 42% at Week 16 to 62% at Week 52 [3]. Patient Impact - The study highlights the significant distress experienced by patients when psoriasis affects sensitive areas, indicating icotrokinra's potential as a meaningful treatment option for managing moderate-to-severe plaque psoriasis long-term [4][5]. - The treatment demonstrated comparable response rates between patients who received icotrokinra for the full 52 weeks and those who transitioned from placebo at Week 16 [4]. Clinical Development - The ICONIC clinical development program includes multiple studies evaluating icotrokinra's efficacy and safety across various conditions, including plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease [10][11][16]. - Icotrokinra is designed to precisely block the IL-23 receptor, which is crucial in the inflammatory response associated with these diseases [13][16]. Conclusion - The long-term data from the ICONIC-TOTAL study reinforces icotrokinra's potential to set a new standard of treatment for patients with high-impact psoriasis, combining effective skin clearance with a favorable safety profile [5][12].

Core Insights - Johnson & Johnson is pursuing a disciplined acquisition strategy aimed at long-term growth and innovation, rather than short-term stock price increases [1][2] - The company is actively reshaping its portfolio by divesting slower-growth assets to focus on higher-growth opportunities [2][4] Acquisition Strategy - The spinoff of Kenvue and the planned separation of the Orthopedics business, projected to generate approximately $9.2 billion in sales in 2024, are key steps in this strategy [3][4] - Johnson & Johnson's financial health is strong, with approximately $14 billion in free cash flow generated in the first three quarters of 2025, providing capital for acquisitions [4] Recent Acquisitions - Recent acquisitions in MedTech and Innovative Medicine have shown positive results, contributing to immediate growth and validating the company's capital deployment strategy [6][13] - The acquisition of Intra-Cellular Therapies, which brought in the drug CAPLYTA, has already generated $240 million in sales in the third quarter, highlighting the effectiveness of the M&A strategy [13] M&A Methodology - Johnson & Johnson employs a "partner, validate, acquire" approach, which reduces investment risk by confirming an asset's clinical potential before full acquisition [10][11] - The potential acquisition of Protagonist Therapeutics is a case study of this disciplined M&A playbook, focusing on a clinically validated asset [8][9] Financial Performance - The Cardiovascular unit has seen an impressive 11.6% operational growth in the third quarter of 2025, attributed to successful acquisitions [13] - The company's dividend yield stands at 2.69%, with a history of 64 consecutive years of dividend increases, supported by strong cash flows from integrated acquisitions [15][17] Future Outlook - Management has indicated that they do not require large M&A to meet growth targets, reinforcing confidence in the current pipeline and strategy [16] - Analysts maintain a moderate buy rating for Johnson & Johnson, with a 12-month stock price forecast of $199.59, indicating a potential upside of 3.27% [8]

Core Insights - Johnson & Johnson is in talks to acquire its immunotherapy partner Protagonist Therapeutics for over 28.5 billion RMB (approximately 4 billion USD) [1] - The key asset in this acquisition is the oral cyclic peptide IL-23 inhibitor icotrokinra, which is expected to change the treatment landscape for psoriasis [1] Group 1: Acquisition Details - The two companies are currently collaborating on the development of icotrokinra for treating plaque psoriasis and ulcerative colitis [2] - Johnson & Johnson holds exclusive commercialization rights for icotrokinra [2] - The acquisition would help Johnson & Johnson strengthen its product line as its blockbuster immunotherapy drug Stelara recently lost patent exclusivity in the U.S. [2] Group 2: Drug Development Progress - Icotrokinra has shown success in two Phase 3 trials for plaque psoriasis [4] - Johnson & Johnson's CEO stated that if approved, icotrokinra would have a significant market impact [4] - The companies are also looking to expand icotrokinra's application to other immune and inflammatory diseases, with successful results reported in a Phase 2b trial for ulcerative colitis [4] Group 3: Drug Mechanism - Icotrokinra is a targeted oral peptide that selectively blocks the IL-23 receptor (IL-23R), which plays a critical role in the activation of pathogenic T cells in moderate to severe plaque psoriasis [6] - The drug binds with high affinity to IL-23R and exerts strong selective inhibition of IL-23 signaling in human T cells [6] Group 4: Company Background - Johnson & Johnson, founded in 1886, is one of the most comprehensive and widely distributed healthcare product companies globally, with operations in medical technology and innovative pharmaceuticals [7] - In 2023, Johnson & Johnson successfully completed the spin-off of its consumer health business and announced a brand refresh, consolidating its medical technology and innovative pharmaceuticals under the Johnson & Johnson name [7]

Core Insights - Douglas Lane & Associates disclosed a purchase of 34,948 shares of Johnson & Johnson, valued at approximately $6 million based on average prices during the third quarter [1][2] - The new stake totals 667,373 shares, with a reported market value of $123.7 million at quarter-end [2] - Johnson & Johnson shares were priced at $190.72, reflecting an 18% increase over the past year, outperforming the S&P 500's 12% gain [3] Financial Performance - Johnson & Johnson reported revenue of $90.6 billion and net income of $22.7 billion for the trailing twelve months [4] - The company has a dividend yield of 2.7% [4] - Last quarter, Johnson & Johnson achieved $23.7 billion in sales, marking a nearly 6% year-over-year increase, with net earnings rising 18% to $5.5 billion [8] Business Overview - Johnson & Johnson operates through a diversified portfolio that includes pharmaceuticals, medical devices, and consumer health products, featuring well-known brands such as Tylenol and Neutrogena [9] - The company's business model focuses on research, development, manufacturing, and global distribution of healthcare products across its three core segments [9] - Primary customers include hospitals, healthcare professionals, retailers, wholesalers, and the general public, with a global reach in both prescription and over-the-counter markets [9] Strategic Developments - Douglas Lane & Associates' investment may indicate confidence ahead of Johnson & Johnson's upcoming third-quarter earnings report, with analysts expecting revenue of about $23.7 billion and earnings of $2.77 per share [7] - Johnson & Johnson is reportedly in talks to acquire Protagonist Therapeutics, which could enhance its immunology pipeline, particularly as its leading product, Stelara, faces market share challenges [11]

Investment Rating - The report maintains an investment rating of "Outperform the Market" [5] Core Insights - The new drug sector has shown significant movements, with notable increases in stock prices for companies such as Kintor Pharmaceutical, which recently went public in Hong Kong, focusing on unmet clinical needs in oncology and immunology [2][3][21] - The KRAS G12D inhibitor GFH375 from Kintor Pharmaceutical has demonstrated promising clinical data in treating pancreatic cancer and non-small cell lung cancer (NSCLC), with an overall response rate (ORR) of 52% in pancreatic cancer and 68.8% in NSCLC [21][24] Summary by Sections Weekly New Drug Market Review - From September 15 to September 21, 2025, the top five gainers in the new drug sector included Kintor Pharmaceutical (+19.64%), Boan Biotechnology (+8.89%), and others, while the top five losers included Sanofi Pharmaceuticals (-17.16%) and others [1][13] Recommended Stocks to Watch - The report suggests focusing on several potential catalysts in the sector, including academic conferences and insurance negotiations. Key companies to watch include: 1. Differentiated GLP-1 assets: Zai Lab, EQRx, and others 2. Upgraded PD-1 products: CanSino Biologics and others 3. Companies likely to benefit from insurance negotiations: Hengrui Medicine, Kanghong Pharmaceutical, and others [2][17] New Drug Approval and Acceptance - This week, eight new drug applications were approved, and twelve new drug applications were accepted in China [3][25] Clinical Application Approvals - A total of 48 new drug clinical applications were approved, with 32 applications accepted this week [7][29]

Core Insights - Johnson & Johnson's oral medication, icotrokinra, demonstrated superior effectiveness compared to Bristol Myers' deucravacitinib (Sotyktu) in treating moderate to severe plaque psoriasis based on late-stage study data [2] Company Summary - The late-stage studies indicated that icotrokinra not only met but exceeded the efficacy of the competitor's treatment [2]

Core Insights - Johnson & Johnson (JNJ) has submitted a regulatory filing to the European Medicines Agency (EMA) for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][7] - The filing is supported by data from four phase III studies, which demonstrated significant skin clearance and a favorable safety profile with once-daily oral dosing [2][3] Regulatory Filing and Clinical Trials - The EMA filing is based on results from the ICONIC clinical development program, which includes studies ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2 [2] - All four studies met their primary and co-primary endpoints, confirming the efficacy and safety of icotrokinra [3][7] Market Performance - Year to date, JNJ shares have increased by 23.5%, contrasting with a 0.4% decline in the industry [4] Development and Collaboration - Icotrokinra is being developed in collaboration with Protagonist Therapeutics, with JNJ holding exclusive worldwide rights for development beyond phase II studies [5] - The management believes icotrokinra has the potential to redefine the treatment landscape for plaque psoriasis [5] Broader Applications - In addition to plaque psoriasis, icotrokinra is being explored for other IL-23-mediated diseases, such as psoriatic arthritis and ulcerative colitis [8] - Positive results were reported from the phase IIb ANTHEM-UC study for ulcerative colitis, meeting its primary endpoint across all dose groups [8] Mechanism of Action - Icotrokinra is designed to block the IL-23 receptor, which is a key driver of inflammation in plaque psoriasis, indicating potential for use in other IL-23-driven diseases [9] Company Ranking - JNJ currently holds a Zacks Rank 2 (Buy), indicating a favorable outlook in the market [10]

Core Insights - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][4]. Group 1: Clinical Development and Efficacy - The application is based on data from four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, which met all primary and co-primary endpoints [1][6][8]. - Icotrokinra demonstrated significant skin clearance and a favorable safety profile, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 compared to placebo [6][7][13]. - The ICONIC-ADVANCE studies showed superiority of icotrokinra over deucravacitinib in patients with moderate-to-severe psoriasis [1][6][13]. Group 2: Safety Profile - Pooled safety data indicated that 49.1% of patients treated with icotrokinra experienced adverse events, compared to 51.9% in the placebo group, with no new safety signals identified [1][6][8]. - The safety profile of icotrokinra is considered favorable relative to comparators, supporting its potential as a treatment option [2][4]. Group 3: Future Studies and Research - Johnson & Johnson has initiated the Phase 3 ICONIC-ASCEND study, which aims to demonstrate the superiority of icotrokinra compared to the injectable biologic ustekinumab and placebo [4][10]. - Long-term data from the ICONIC development program, including at least 52 weeks of treatment, is being prepared for future presentations [6][8]. Group 4: Market Context - Plaque psoriasis affects approximately 6.4 million people in Europe and over 125 million globally, with nearly one-quarter of cases classified as moderate-to-severe [9][10]. - The burden of plaque psoriasis extends beyond physical symptoms, impacting emotional health and quality of life [9][10].