Johnson & Johnson (NYSE:JNJ) 2025 Conference November 17, 2025 10:40 AM ET Company ParticipantsCandace Long - Worldwide VP of Immunology Global Commercial StrategyDavid Lee - Global Immunology Therapeutic Area HeadConference Call ParticipantsAlex Hammond - AnalystAlex HammondGood morning, everybody. My name is Alex Hammond, and I'm the biopharma analyst here at Wolfe. It's my pleasure today to have J&J. We have Candace Long, Worldwide VP Immunology Global Commercial Strategy, and we have David Lee, Global I ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The report highlights the significant collaboration between Innovent Biologics and Takeda Pharmaceutical, which is seen as a positive trend for Chinese innovation going global. The deal includes an upfront payment of $1.2 billion and potential milestone payments, with a total deal value reaching up to $11.4 billion [2] - The report notes a surge in License-out transactions, with 103 deals and a total value of $92.03 billion in the first three quarters of 2025, marking a 77% increase compared to the total for 2024 [2] - The report emphasizes the recovery of the CDMO sector, with companies like Jiuzhou Pharmaceutical and Boteng achieving significant revenue growth in Q3 2025, indicating a positive trend in the industry [3] - The medical device market is showing a steady recovery, with a 29.8% year-on-year growth in the overall bidding market for medical devices in Q3 2025 [4] - The report discusses the increasing trend of oral immunomodulatory drugs, particularly in the treatment of psoriasis, with Johnson & Johnson's acquisition of Protagonist Therapeutics being a notable example [5] - The report also highlights the trends in respiratory infectious diseases, with an expected increase in cases in the coming months, which may impact medical testing and treatment medications [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry has underperformed compared to the CSI 300 index, with a recent weekly decline of 0.95% and a monthly decline of 3.28% [21][25] 2. Pharmaceutical Sector Performance and Valuation - The pharmaceutical sector's recent performance has been below the CSI 300 index, with a 1-month decline of 3.28% and a 3-month increase of only 1.75% [39][42] 3. Recent Research Achievements - The report lists various recent research outputs from the team, including deep dive reports on the growth of the blood products industry and the potential of GLP-1 drugs [47] 4. Recent Industry Policies and News - The report outlines significant recent policies, including the promotion of instant settlement reforms by the National Medical Insurance Administration and the regulation of clinical research for biomedical technologies [49] - Recent news highlights include major collaborations and drug approvals, such as the partnership between Innovent Biologics and Takeda, and the approval of new drugs by various companies [50][51]

Core Insights - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in various sectors including ETFs, commodities, technology, and pharmaceuticals [1] - The company adopts a conservative investment approach, aiming to deliver substantial returns and strategic insights to clients [1] - Allka Research is committed to simplifying investment strategies, making them accessible to both seasoned investors and newcomers [1] - The mission of Allka Research includes sharing knowledge and analyses through Seeking Alpha, fostering a community of informed investors [1] Company Overview - Allka Research is recognized for its dedication to guiding individuals in finding lucrative investment opportunities [1] - The firm emphasizes a passion for empowering others financially, contributing to the financial literacy of its audience [1] Community Engagement - Allka Research aims to demystify investing, inspiring confidence among readers and helping them navigate the markets intelligently [1] - The company seeks to create a community of informed investors through its contributions to Seeking Alpha [1]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The trend of Chinese innovative drugs going overseas is a long-term phenomenon, with external environmental changes having limited impact. In the first half of 2025, there were 72 License-out transactions, exceeding half of the total for 2024, with a total transaction amount 16% higher than in 2024. Notably, there were 16 transactions exceeding $1 billion each [2] - The small nucleic acid drug sector has seen significant breakthroughs, particularly in the treatment of chronic diseases such as hypertension and hyperlipidemia, with major collaborations and potential milestone payments indicating a robust commercial outlook [3] - The trend towards oral autoimmune drugs is gaining attention, with significant partnerships and clinical advancements in this area, highlighting the importance of oral formulations in autoimmune therapies [4] - Recent clinical data on long-acting insulin analogs shows promising weight loss results, with ongoing developments in combination therapies for metabolic diseases, indicating a growing market potential [5] - The CXO sector is gradually recovering, with an increase in License-out transactions serving as a vital funding source for biotech companies, leading to a resurgence in innovation and clinical development [6] - The 2025 national medical insurance negotiations and the commercial insurance innovative drug directory are crucial for companies involved, with a focus on orphan drugs and imported PD-1/L-1 products [7] Summary by Sections Industry Tracking - The pharmaceutical sector has underperformed compared to the CSI 300 index, with a recent weekly decline of 1.20% and a monthly decline of 3.38%, ranking 25th among 31 industry indices [22][26] Industry Trends and Valuation - The pharmaceutical industry index currently has a PE ratio of 39.05, above the five-year historical average of 31.36, indicating a higher valuation compared to historical trends [48][50] Recent Research Achievements - The research team has published several in-depth reports on various pharmaceutical topics, including the growth of the blood products industry and the potential of GLP-1 drugs in chronic disease management [53] Important Policies and News - Recent regulations have been introduced to standardize clinical research and ensure drug traceability, which will impact the pharmaceutical landscape significantly [55][56]

Core Insights - Icotrokinra, a first-in-class targeted oral peptide, has shown promising results in treating moderately to severely active ulcerative colitis, achieving a clinical response rate of 36.5% at the highest dose in the Phase 2b ANTHEM-UC study [1][2] - The study met its primary endpoint, demonstrating significant improvements across key secondary endpoints compared to placebo, indicating the potential of icotrokinra as a new treatment option [1][2] - Johnson & Johnson has initiated further clinical trials, including the ICONIC-UC Phase 3 protocol for ulcerative colitis and additional studies for Crohn's disease and psoriasis [3][4] Study Results - At Week 12, the clinical response rates for icotrokinra were 63.5% for the 400 mg dose, 58.1% for the 200 mg dose, and 54.7% for the 100 mg dose, compared to 27% for placebo [2] - Significant improvements in clinical remission, symptomatic remission, and endoscopic improvement were observed in the 400 mg group compared to placebo, with p-values indicating statistical significance [2] - All icotrokinra doses showed higher rates of symptomatic remission as early as Week 4 compared to placebo [2] Future Developments - Johnson & Johnson is advancing icotrokinra into Phase 3 trials for ulcerative colitis and Crohn's disease, reflecting the company's commitment to addressing inflammatory bowel diseases [3][4] - A New Drug Application (NDA) for icotrokinra has been submitted to the FDA for the treatment of moderate to severe plaque psoriasis, indicating the drug's potential across multiple indications [3][9] Background Information - Ulcerative colitis is a chronic inflammatory condition of the colon, characterized by symptoms such as abdominal pain, diarrhea, and rectal bleeding, which can significantly impact patients' quality of life [8] - Icotrokinra selectively blocks the IL-23 receptor, which is involved in the inflammatory response associated with ulcerative colitis and other related diseases [9]

Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualan Biological Engineering-B, and others [3]. Core Insights - The pharmaceutical sector has shown a 1.90% increase this week, outperforming the CSI 300 index by 0.21 percentage points. Sub-sectors such as pharmaceutical outsourcing, vaccines, and medical consumables performed well, while innovative drugs lagged behind [6][42]. - The report emphasizes the potential of the 4-1BB target in cancer treatment, particularly the PD-L1/4-1BB bispecific antibodies, which may address the limitations of PD-1/PD-L1 monotherapy [5][16][17]. Summary by Sections Industry Viewpoints and Investment Recommendations - 4-1BB is recognized as a promising target for tumor therapy, enhancing T cell activation and survival, which is crucial for effective immune responses against cancer [16]. - Investment strategies focus on the innovative drug sector, driven by increased liquidity and risk appetite, with a recommendation to pay attention to companies with strong pipelines in bispecific antibodies and ADCs [6][38]. Pharmaceutical Industry Market Performance - The pharmaceutical sector's overall P/E ratio is reported at 30.67 times, with a premium of 40.37% compared to the overall A-share market excluding financials [42]. Company Dynamics - Notable company developments include: - LIZHU Group's successful Phase III trial for a monoclonal antibody for psoriasis [43]. - Baiyang Pharmaceutical's planned share reduction by its major shareholder [43]. - Mylab's new medical device approval, enhancing market competitiveness [44]. Industry Dynamics - The report highlights the increasing focus on innovative drug development and the potential for significant market opportunities in the context of upcoming patent expirations for key small molecule drugs [38].

Core Viewpoint - Protagonist Therapeutics has selected PN-477 as its primary development candidate for obesity treatment, which is a triple agonist peptide targeting GLP-1, GIP, and glucagon (GCG) receptors, offering both efficacy and convenience through oral or subcutaneous administration [2][4]. Group 1: Drug Development and Efficacy - PN-477 has completed extensive preclinical evaluations, demonstrating positive effects in various animal models of obesity and blood glucose control, including diet-induced obese mice, normal dogs, and crab-eating macaques [4]. - The drug exhibits strong activation of GLP-1, GIP, and GCG receptors in vitro, indicating its potential effectiveness [4]. - PN-477's pharmacodynamic properties and overall performance make it suitable for parallel development as both a daily oral medication (PN-477o) and a weekly injection (PN-477sc) [4]. Group 2: Clinical Trials and Future Plans - The Investigational New Drug (IND) application is currently underway, with the first phase of clinical trials expected to start in the second quarter of 2026 [4]. - Protagonist Therapeutics plans to submit a New Drug Application (NDA) for its other candidates in 2025, indicating a robust pipeline [6][7]. Group 3: Market Position and Competitive Advantage - Despite the dominance of GLP-1 receptor agonists in the market, there is room for improvement, and a triple agonist like PN-477 could provide a significant breakthrough in obesity treatment by offering an oral option alongside injectable therapies [6]. - PN-477 is anticipated to reduce fat mass while preserving lean body mass and improving tolerability and comorbidities, positioning it as a potential blockbuster product for the company [6]. Group 4: Company Overview - Protagonist Therapeutics is an integrated biopharmaceutical company focused on drug discovery and late-stage development, with two novel candidates in Phase III clinical trials and plans for NDA submissions in 2025 [6][7]. - The company is also advancing several preclinical peptide drug development projects, including PN-881 and oral hepcidin [7].

Innovation & R&D - The US leads the world in life science innovation due to a combination of factors including investment in basic research, venture capital, strong companies, and protection of intellectual property [3][5] - Big Pharma increasingly relies on external innovation, with internal drug development accounting for less than 30% of FDA approvals between 2015 and 2021 [11] - AI and machine learning are accelerating drug discovery by enabling the screening of 1.7 million compounds in approximately 5-10 days, significantly reducing the time required for identifying lead compounds [3][14][15] Investment & Finance - In 2021, the pharmaceutical industry invested over $80 billion annually in R&D, a tenfold increase over 10 years, representing approximately 25% of pharma companies' revenues [4] - Venture capital firms investing in biotech require patience, with a time horizon of 10-15 years to see a drug from discovery to commercialization [13] - New Jersey offers an R&D tax credit to attract big pharma companies and has a program allowing early-stage life sciences companies to monetize their net operating losses [20][21] Company Strategy & Focus - Johnson & Johnson (J&J) has invested $50 billion in R&D and M&A since the beginning of last year [10] - J&J actively scouts the world for promising innovations and technologies to leverage its scale in research, development, manufacturing, and commercialization [6] - J&J is developing an oral medicine, icotrokinra, to treat plaque psoriasis, which is expected to be a significant breakthrough and contribute to growth in the second half of the decade [7][9]

Johnson & Johnson (JNJ) 2025 Conference Summary Company Overview - **Company**: Johnson & Johnson (JNJ) - **Date of Conference**: May 13, 2025 - **Key Speaker**: Dr. John Reed, Executive Vice President, Innovative Medicines R&D Key Industry Insights Regulatory Environment - The FDA is undergoing significant changes in leadership, which could impact drug development pathways and regulatory approvals. However, current interactions and deadlines have been met without disruption [4][5][6] - There is speculation about potential positives from the FDA's focus on AI and data sharing, which could enhance regulatory processes [8] Immunology Pipeline - **New Product**: Icotrokinra, an oral IL-23 inhibitor, shows promising phase three data and aims to complement existing injectable therapies. The product is designed for once-daily dosing, targeting patients who are currently not receiving advanced therapies [9][10][12] - The demand for Icotrokinra is high, as evidenced by rapid patient enrollment in clinical trials [12] - The product's efficacy is expected to be significantly better than competitors, with a strong emphasis on its safety profile [14][15] Neuroscience Developments - JNJ acquired Intracellular Therapies for $15 billion, with a focus on the product CAPLYTA for schizophrenia and other indications. The acquisition also includes a promising follow-on molecule, ITI-1284, which is in phase two trials for Alzheimer's-related conditions [20][23][24] - The phase two trials for ITI-1284 are substantial enough that they could potentially be considered for phase three approval, depending on data outcomes [25] Oncology and Hematology - JNJ is advancing in multiple myeloma treatments with new products like Carvicti and bispecific therapies. The company is working to improve the safety profile of these therapies to enhance community adoption [30][33] - The bispecific T cell engagers are showing promising results, with plans to integrate them into earlier lines of treatment [35] - **New Product**: Ribrovant, a bispecific antibody for lung cancer, is showing strong survival data compared to standard treatments, with ongoing studies to optimize its use [37][39][43] Cardiovascular Innovations - JNJ is committed to the development of Moldexian, a factor XI inhibitor for atrial fibrillation, with over 20,000 patients enrolled in trials. The company believes it has the right pharmacology to address this significant unmet need [45][46] - The company is optimistic about the safety and efficacy of Moldexian, particularly in preventing strokes, which is a critical area of focus given the aging population [51][52] Additional Considerations - JNJ's strategy includes a mix of large acquisitions and smaller bolt-on deals, focusing on early-stage investments to build a robust pipeline [29] - The company is actively working to educate community practices on new therapies to ensure better integration and patient outcomes [36] This summary encapsulates the key points discussed during the Johnson & Johnson conference, highlighting the company's strategic direction, product pipeline, and the regulatory landscape affecting its operations.