Key Takeaways GSK gets FDA nod for Exdensur as an add-on maintenance treatment for severe eosinophilic asthma.Exdensur cut annualized asthma exacerbations versus placebo in phase III SWIFT-1 and SWIFT-2 studies.Exdensur is the first twice-yearly biologic for asthma, while its CRSwNP FDA decision remains pending.GSK plc (GSK) announced that the FDA has approved Exdensur (depemokimab-ulaa), an ultra-long-acting IL-5–targeting biologic, as an add-on maintenance treatment of severe asthma with an eosinophilic p ...

Key Takeaways CHMP backed Nucala as an add-on therapy for COPD, with a European decision expected in early 2026.A monthly injectable Nucala targets IL-5 to help uncontrolled COPD patients reduce hospital visits.Depemokimab won CHMP support after studies showed twice-yearly efficacy in asthma and CRSwNP.GSK plc (GSK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Nucala as an add-on main ...

Key Takeaways GSK secures FDA approval for Blujepa to treat uncomplicated urogenital gonorrhea.The approval is based on EAGLE-1 data showing non-inferiority to standard combination therapy.Study results also highlighted Blujepa's favorable safety and tolerability profile.GSK plc (GSK) announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval for its oral antibiotic Blujepa (gepotidacin) for treating uncomplicated urogenital gonorrhea (uGC) in adult and pediatric patie ...

Core Insights - GSK's stock has increased by 18.6% over the past three months, driven by strong Q3 results that exceeded earnings and sales estimates, along with raised sales and profit guidance for the year [1][9] - The drug and biotech sector has seen a recovery, with major companies like Pfizer and AstraZeneca entering drug pricing agreements with the Trump administration [2] - GSK's Specialty Medicines unit is a key growth driver, with sales rising 16% in the first nine months of 2025, supported by successful launches in Oncology and long-acting HIV medicines [4][6] Specialty Medicines Growth - The Specialty Medicines unit's sales growth is attributed to strong demand for new long-acting HIV medicines and oncology drugs, with key products like Nucala and Dovato contributing significantly [5][6] - GSK expects Specialty Medicines sales to grow at a mid-teens compound annual growth rate (CAGR) in 2025, up from previous low-teens expectations, and anticipates this segment will account for over 50% of total revenues by 2031 [6][26] Promising Pipeline - GSK is increasing R&D investments in long-acting and specialty medicines, with several recent drug approvals, including Penmenvy and Blujepa, expected to drive growth in the coming years [7][8] - The company plans to launch five new products/line extensions in 2025, with several already approved in the U.S. [12] Vaccine Sales Decline - GSK's vaccine sales in the U.S. have declined by 11% at constant exchange rates (CER) in 2025, primarily due to lower demand for its shingles and RSV vaccines [13][15] - Despite the decline in the U.S., sales of these vaccines have risen in Europe, indicating a mixed performance across regions [15] Stock Performance and Valuation - GSK's stock has outperformed the industry and the S&P 500, rising 43.1% year-to-date compared to an industry increase of 11.7% [17] - The stock is trading at a price/earnings ratio of 10.02, which is lower than the industry average of 16.31, indicating an attractive valuation [20] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings has increased from $4.38 to $4.49 per share for 2025, reflecting analysts' optimism about profit growth [23][24] - GSK expects to achieve over 7% sales growth and more than 11% core operating profit growth on a CAGR basis through 2026 [27]

Summary of GSK Conference Call Company Overview - **Company**: GSK (GlaxoSmithKline) - **Focus**: Research and Development (R&D) strategy, particularly in oncology, respiratory diseases, HIV, and infectious diseases Key Points R&D Strategy - GSK's R&D strategy emphasizes the science of the immune system and the application of technologies, focusing on both organic and inorganic growth opportunities [4][5] - The company has transitioned into marketed assets, with a focus on "bolt-on deals" to enhance its portfolio [5] - A clear lens on capital allocation is maintained, comparing internal and external opportunities to optimize R&D investments [6] Oncology Focus - GSK is concentrating on oncology, with notable assets like momelotinib and the B7H3 and B7H4 ADCs [7][8] - The strategy involves pivoting towards assets with apparent efficacy in monotherapy during phase one trials, avoiding the complexities of combination therapies [8] - Significant data capabilities have been built through collaborations and acquisitions, enhancing decision-making for external acquisitions [9][10] Respiratory Disease Developments - GSK is well-positioned in lung disease, particularly with Nucala for COPD, targeting a market of 300 million individuals [12][13] - The company is advancing long-acting monoclonal therapies and has pivotal studies planned for 2027-2028 [13] - There is a focus on addressing fibrosis in liver, kidney, and lung tissues, with ongoing studies in these areas [14] HIV and Infectious Diseases - GSK is developing long-acting treatments for HIV, with a focus on Q4M regimens expected to launch in 2028 [26][27] - The company is addressing the challenges posed by generic competition in the HIV market, particularly with the impending loss of exclusivity for Dolutegravir [25][26] - In infectious diseases, GSK is focusing on hepatitis B and vaccine innovations, with significant data expected by the end of the year [15] Pipeline and Portfolio Management - GSK's pipeline is characterized by a focus on major blockbusters, with a rigorous culling of non-promising assets [17] - The company has achieved 13 successful phase three studies last year, indicating strong operational capabilities [18] - Upcoming catalysts include bepirovirsen for chronic hepatitis B and Canlapixent for respiratory conditions, with significant market potential [19][20] Decision-Making in Acquisitions - GSK's acquisition strategy is driven by the need for effective clinical outcomes and scalability, as seen in the EFI deal for fibrosis treatment [30][31] - The company prioritizes assets that can integrate well into existing studies and have favorable manufacturing profiles [32] Budget and Resource Allocation - GSK's R&D budget is optimized to ensure that any new assets must justify their inclusion by providing significant value [33][34] - The focus remains on enhancing R&D effectiveness through technology and strategic investments [34] Additional Insights - GSK's approach to R&D is characterized by a blend of internal development and strategic acquisitions, aiming to create a robust pipeline that addresses significant medical needs [17][18] - The company is actively working to dispel perceptions of a weak pipeline by highlighting the strategic rationale behind its asset selection and development focus [16]

Core Insights - The pharmaceutical industry is experiencing a structural change driven by the growth cycles of major products, with significant opportunities emerging in innovative drugs, medical devices, and consumer healthcare [3][6][31] - The demand for pharmaceuticals is expected to improve in 2026, supported by policies encouraging innovation and a recovery in domestic consumption [3][7] - The supply side of the pharmaceutical industry is characterized by high entry barriers due to patent protections and government regulations, which helps maintain a stable competitive environment [4][5] Group 1: Industry Trends - The aging population, urbanization, and changing disease patterns are making the pharmaceutical industry a perpetual growth sector [3] - The global pharmaceutical market has seen rapid expansion from 2009 to 2019, followed by a surge in demand due to COVID-19, and is now entering a phase of recovery and growth [3][6] - The Chinese pharmaceutical industry is expected to gradually produce world-class companies, with increasing recognition of Chinese innovative drug assets by multinational corporations (MNCs) [4][5] Group 2: Investment Opportunities - Opportunities in innovative drugs are highlighted, particularly in oncology, metabolic diseases, and autoimmune diseases, with a focus on next-generation therapies and precision medicine [6][31] - The demand for innovative drugs is expected to remain strong, with policies improving medical insurance payments and the upcoming launch of commercial insurance drug catalogs [7][31] - The medical device sector is anticipated to recover, with a focus on domestic demand and international expansion, particularly in areas with low domestic production rates [7][8] Group 3: Company Performance - Major pharmaceutical companies like Eli Lilly, AbbVie, and AstraZeneca are experiencing significant growth driven by key products, with Eli Lilly's Tirzepatide generating $24.8 billion in sales [12][15] - The report identifies specific companies such as Hengrui Medicine, Hansoh Pharmaceutical, and BeiGene as outperformers in the market, with strong pipelines and global competitiveness [7][8] - The report emphasizes the importance of mergers and acquisitions (M&A) and business development (BD) strategies for MNCs, with China becoming a significant source of projects for top global pharmaceutical companies [22][24]

29 October 2025 Q3 2025 Results Conference call and webcast for investors and analysts gsk.com Agenda Q3 2025 strong performance improves further Emma Walmsley Performance: growth drivers 2 Cautionary statement regarding forward-looking statements Luke Miels and Deborah Waterhouse Q3 2025 financial performance Julie Brown Summary and Q&A Emma Walmsley, Luke Miels, Deborah Waterhouse, Julie Brown, Tony Wood and David Redfern This presentation may contain forward-looking statements. Forward-looking statements ...

Summary of GSK 2025 Conference Call Company Overview - **Company**: GSK (NYSE:GSK) - **Date**: September 24, 2025 - **Key Speakers**: Julie Brown (CFO), Tony Wood (Head of R&D) Core Industry Focus - GSK is focused on four major therapeutic areas: oncology, respiratory, immunology, and inflammation [2][3] - The company has upgraded its sales guidance to over $40 billion by 2031, up from $33 billion a few years ago [3][14] Financial Performance - GSK has had a strong year, achieving positive growth driven by its specialty business, particularly in oncology and respiratory sectors [2][3] - The company reported 13 phase III positive readouts last year, a record for GSK [3][4] - GSK is on track for five major approvals and four launches this year, including Blenrep and Depemokimab [3][4] Product Pipeline and R&D - **Oncology**: Blenrep is a key product, with significant expectations for growth. The company anticipates that half of the $6 billion gap in sales consensus is centered on Blenrep [15][16] - **Respiratory**: Depemokimab is expected to receive approval in December, with promising data showing a 72% reduction in exacerbations leading to hospitalization [26][27] - **HIV**: GSK's HIV business is performing well, with an upgrade in growth expectations from mid-single to high-single digits, driven by products like Cabenuva and Apretude [44] Regulatory Environment - GSK is actively engaging with the U.S. government regarding pricing policies, including the Most Favored Nation (MFN) proposal and its implications for drug pricing [6][8] - The company is preparing for negotiations regarding two products, Trelegy and Breo, with results expected in November [11] Market Dynamics - GSK is experiencing strong double-digit growth for Trelegy, despite industry challenges [11] - The company is optimistic about the long-term potential of its HIV portfolio, particularly with the upcoming Q6M product launch [44][46] Shingrix Performance - Shingrix has reached 42% market penetration in the U.S., with growth expected to come from international markets, particularly in Europe and China [62][63] Upcoming Data and Expectations - GSK is looking forward to significant data readouts in 2026, particularly for Camlipixant and Bepirovirsen, which are expected to drive future growth [64][75] - The company is confident in the potential of Bepirovirsen to provide a functional cure for chronic hepatitis B, with a focus on increasing diagnosis rates [75][76] Conclusion - GSK is positioned for strong growth with a robust pipeline and strategic focus on innovation and market expansion. The company is navigating regulatory challenges while maintaining a positive outlook on its product launches and market performance [3][14][44]

Core Insights - GSK stock has increased by 6.4% over the past month, adding nearly $5 billion to its market value, driven by strong performance in the Specialty Medicines unit and a positive long-term outlook despite challenges in the Vaccines unit and economic pressures [1][9]. Group 1: Specialty Medicines Performance - The Specialty Medicines unit is experiencing significant sales growth, with a 16% increase in the first half of 2025, attributed to successful launches in Oncology and long-acting HIV medicines [3][9]. - Key products driving growth include Nucala, Dovato, Cabenuva, Apretude, Jemperli, and Ojjaara, with expectations for low teens percentage growth in sales for this segment in 2025 [4][9]. - Specialty Medicines currently account for approximately 40% of GSK's sales and are projected to exceed 50% of total revenues by 2031 [4]. Group 2: Promising Pipeline and R&D - GSK is increasing its R&D investment in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [5]. - Recent approvals include the pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for uncomplicated urinary tract infections, with additional regulatory applications under review [6][7]. - GSK plans to launch five new products/line extensions in 2025, including Blenrep and depemokimab, which are already approved in the U.S. [7]. Group 3: Vaccine Sales Challenges - Vaccine sales in the U.S. are declining, particularly for the shingles vaccine Shingrix and the RSV vaccine Arexvy, with total vaccine sales down 11% at CER in the first half of 2025 [8][11]. - Revised recommendations for RSV vaccinations have negatively impacted sales of Arexvy, particularly among adults aged 60-74 [10][11]. - GSK anticipates a low single-digit percentage decrease in vaccine sales for 2025, reflecting broader challenges in this segment [11]. Group 4: Stock Performance and Valuation - GSK stock has outperformed the industry and the S&P 500, rising 21.2% year-to-date compared to a 1.4% increase for the industry [12]. - The stock is trading at a forward price/earnings ratio of 8.58, significantly lower than the industry average of 14.78, indicating attractive valuation [14]. - Analysts have raised the earnings consensus estimate for 2025 from $4.34 to $4.37 per share, reflecting optimism around profit growth [18]. Group 5: Future Growth Expectations - GSK expects over 7% sales growth and more than 11% core operating profit growth on a CAGR basis from 2022 to 2026, driven by the Specialty Medicines segment [21]. - The growth in Specialty Medicines is expected to offset the slowdown in the Vaccines unit, with General Medicines also contributing to overall sales growth [21].

Core Insights - Bristol Myers Squibb (BMY) and GSK PLC (GSK) are leading global biopharma companies with diverse portfolios [1][2] - BMY focuses on transformational drugs across various therapeutic areas, while GSK has a strong presence in HIV, oncology, and respiratory diseases [1][2] BMY Overview - BMY's growth portfolio includes drugs like Opdivo, Reblozyl, Breyanzi, Camzyos, and Opdualag, stabilizing revenue amid generic competition [4] - Opdivo's sales are driven by strong launches in specific cancer types and volume growth internationally [4][5] - The FDA approved Opdivo Qvantig for subcutaneous use, showing strong initial uptake [5] - Strategic acquisitions have broadened BMY's portfolio, including the approval of Cobenfy for schizophrenia [6] - Legacy drug sales are declining due to generic competition, impacting overall revenue [7] - A collaboration with BioNTech enhances BMY's pipeline for solid tumor treatments [8] GSK Overview - GSK's Specialty Medicines unit is experiencing strong sales growth, driven by successful launches in oncology and long-acting HIV medicines [9] - Key growth drivers include drugs like Nucala and Dovato, with new products like Cabenuva and Jemperli contributing to revenue [9][10] - GSK's vaccine portfolio is diversified but faces pressure from lower sales of certain products, though new approvals may help [11] - GSK has a deep pipeline with promising candidates in late-stage development for various conditions [12] Financial Estimates - BMY's 2025 sales are estimated to decrease by 2.37%, while EPS is expected to increase by 465.22% due to low EPS in 2024 [13] - GSK's 2025 sales are projected to grow by 5.96%, with EPS improving by 7.16% [16] Price Performance and Valuation - GSK shares have increased by 18.5% year-to-date, while BMY shares have decreased by 14.3% [19] - GSK's shares trade at a forward P/E of 8.74, compared to BMY's 7.79, with both companies offering attractive dividend yields [19] Investment Considerations - Both companies are rated Hold, making the choice between them complex [21] - GSK's diversified revenue base and strong portfolio position it favorably compared to BMY, which is facing challenges from generic competition [23]