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]

Key Takeaways GSK vaccine sales fell in the U.S. as Shingrix and Arexvy declined sharply in early 2025.Revised ACIP guidance narrowed Arexvy's eligible population, hurting sales momentum.Penmenvy approval and pipeline efforts may aid growth, but benefits will take time.GSK plc (GSK) is one of the key vaccine makers in the world, marketing vaccines to help prevent infectious diseases like Respiratory Syncytial Virus or RSV, meningitis, shingles, hepatitis and many more.GSK’s Vaccine sales are declining in th ...

Financial Data and Key Metrics Changes - The company expects to generate over $300 million in revenue for FY 2025, with guidance between $315 million to $325 million, indicating a significant growth trajectory for its lead asset, HEPLISAV B [52][53]. Business Line Data and Key Metrics Changes - HEPLISAV B has seen increased market share due to its differentiated product profile, requiring only two doses compared to three doses for competitor vaccines, and achieving higher levels of seroprotection in Phase III trials [8][11]. - The retail segment is projected to grow significantly, potentially doubling in size by 2030, with the company currently holding nearly 60% market share in that space [10][11]. Market Data and Key Metrics Changes - The adult hepatitis B vaccine market is expanding, particularly after the ACIP recommended vaccination for all adults, creating a large addressable population [5][6]. - The company has successfully captured market share across key settings, including Integrated Delivery Networks (IDNs) and retail, with a focus on driving growth in these areas [12][15]. Company Strategy and Development Direction - The company aims to leverage its novel adjuvant technology to enhance vaccine efficacy and expand its pipeline, while maintaining a strong financial position to evaluate high-value business development opportunities [3][45]. - The strategy includes focusing on derisked assets and advancing products that have established biological efficacy, which sets the company apart from many other biotech firms [52][53]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive growth through HEPLISAV B and the emerging pipeline, emphasizing the importance of executing plans amidst a supportive public health environment for hepatitis B vaccination [22][23]. - The competitive landscape is viewed positively, with the company controlling the narrative in the market due to its focused approach on hepatitis B vaccines [25][27]. Other Important Information - The company is exploring additional opportunities in its pipeline, including a shingles vaccine and a plague vaccine in collaboration with the Department of Defense, which could provide further revenue streams [37][40]. - The company maintains a strong balance sheet and is open to returning capital to shareholders when appropriate, while also considering business development investments [45][48]. Q&A Session Summary Question: What is the company's long-term growth outlook? - The company anticipates significant revenue growth driven by HEPLISAV B and a robust pipeline, with expectations of over $300 million in revenue for FY 2025 [52][53]. Question: How does the company plan to capture market share in the retail segment? - The company projects that the retail segment will represent approximately 50% of the adult hepatitis B market by 2030, leveraging its strong product profile and commercial execution [10][11]. Question: What is the competitive environment like for the company? - The company believes it has a strong position in the market, controlling the narrative and focusing solely on its hepatitis B vaccine, which allows it to effectively compete against larger portfolios of competitors [25][27].

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].

Investment Rating - The report maintains an "Outperform" rating for the company [5][11]. Core Insights - The company has successfully completed a head-to-head clinical trial of its recombinant shingles vaccine LZ901 against Shingrix, showing superior cellular immunogenicity and better safety in adults aged 50 and above [1][9]. - The adjusted loss for the first half of 2025 narrowed to 0.78 billion yuan from a loss of 1.10 billion yuan in the same period last year, with R&D expenses decreasing by 37.5% to 0.80 billion yuan [1][8]. - The company has a robust pipeline with several products in various stages of development, including K3, a biosimilar to Humira, and K193, a bispecific antibody for treating B-cell leukemia and lymphoma [2][10]. Financial Projections - Revenue projections for 2025 to 2027 are 0.22 billion yuan, 4.39 billion yuan, and 9.71 billion yuan respectively, with net profits expected to be -1.46 billion yuan, -1.27 billion yuan, and 1.16 billion yuan [3][11]. - The company anticipates a significant revenue increase in 2026, with a projected growth rate of 1857.4% compared to 2025 [4]. Pipeline Overview - As of June 30, 2025, the company has six products in preclinical stages, including vaccines for varicella, RSV, HSV-1, HSV-2, and two bispecific antibodies for leukemia and lymphoma [2][10]. - The LZ901 vaccine is expected to receive commercial approval in the first half of 2026 [9].

Core Viewpoint - Dynavax Technologies (DVAX.US) shares rose approximately 7% following the announcement that its investigational shingles vaccine Z-1018 elicited an immune response comparable to GlaxoSmithKline's (GSK.US) Shingrix vaccine in Phase I/II trials [1] Group 1: Clinical Trial Results - The top-line data from the first part of the clinical trial indicated that Z-1018 achieved an overall vaccine response rate of 89.7%, while Shingrix had a response rate of 90.3% [1] - The study aimed to evaluate the effectiveness of Z-1018 compared to Shingrix in individuals aged 50 to 69 years [1] - Z-1018 demonstrated favorable tolerability and safety characteristics [1] Group 2: Adverse Reactions - Among participants receiving Z-1018, 12.5% experienced grade 2 or 3 local and systemic injection reactions, compared to 52.6% and 63.2% for Shingrix, respectively [1] Group 3: Future Plans - The second part of the Phase I/II trial will include adults aged 70 and older, with an expected launch in the second half of 2025 [1]

Core Insights - Dynavax Technologies Corporation announced positive topline results from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, showing comparable immune responses to Shingrix in adults aged 50 to 69 years [1][4] Group 1: Clinical Trial Results - Z-1018 achieved a 100.0% humoral vaccine response rate compared to Shingrix's 96.9%, and an 89.7% cellular immune response rate versus Shingrix's 93.5%, resulting in a composite vaccine response rate of 89.7% for Z-1018 and 90.3% for Shingrix [2][8] - The trial demonstrated Z-1018's favorable safety profile, with lower rates of grade 2 and 3 post-injection reactions (PIRs) compared to Shingrix, specifically 12.5% for local PIRs and 27.5% for systemic PIRs for Z-1018 versus 52.6% and 63.2% for Shingrix, respectively [3][10] Group 2: Future Development Plans - Dynavax plans to advance Z-1018 into Part 2 of the Phase 1/2 trial targeting adults aged 70 and older, expected to start in the second half of 2025, using the 100 mcg dose of gE antigen with CpG 1018 and alum [1][7] - The objective of Part 2 is to generate clinical proof-of-concept against Shingrix in the older population, which is crucial for further development [4][7] Group 3: Market Potential - The company aims to disrupt the multi-billion-dollar shingles vaccine market, currently dominated by Shingrix, by developing a product with a potential best-in-class profile [4][5] - Z-1018 is designed to address the age-related decline in immune responses, providing a new option for protection against shingles, a disease affecting approximately 1 in 3 people in their lifetime [11][12]

Core Insights - GSK plc reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.12, with a year-over-year increase of 7% on a reported basis and 15% at a constant exchange rate (CER) [1][9] - Quarterly revenues rose 1% on a reported basis and 6% at CER to $10.67 billion (£7.99 billion), driven by increased sales of HIV, oncology, and vaccine products, surpassing the Zacks Consensus Estimate of $10.33 billion [2][9] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 15%, while Vaccine sales rose by 9%. General Medicines experienced a decline of 6% [3][9] - HIV sales grew by 12%, supported by increased demand for Dovato and long-acting medications Apretude and Cabenuva, with Apretude and Cabenuva sales rising by 50% and 46%, respectively [4][6] - Oncology sales surged by 42%, driven by strong demand for Jemperli and Ojjaara/Omjjara, with Jemperli sales increasing by 91% [6][7] - Vaccine sales were bolstered by increased uptake of meningitis and shingles vaccines, with Shingrix sales rising by 6% [12] Financial Guidance - GSK raised its 2025 sales and profit guidance, now expecting sales to increase toward the top end of the previously issued range of 3-5%, with Specialty Medicines projected to grow at a low teens percentage at CER [15][16] - The company anticipates core operating profit and core EPS to grow toward the top end of the previously issued guided range of 6-8% [16][17] Long-term Strategy - GSK has prioritized focus on HIV, immunology/respiratory, and oncology therapeutic areas, with 84 assets in clinical development, including 16 candidates in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions in 2025, with three already approved in the first half of the year [25][26]

Market Overview - US stock index futures are all up before the market opens, with Dow futures rising by 0.08%, S&P 500 futures up by 0.20%, and Nasdaq futures increasing by 0.28% [1] - European indices show mixed results, with Germany's DAX up by 0.20%, UK's FTSE 100 down by 0.25%, France's CAC40 up by 0.37%, and the Euro Stoxx 50 up by 0.21% [2][3] - WTI crude oil prices increased by 0.10% to $69.28 per barrel, while Brent crude oil rose by 0.07% to $71.73 per barrel [3][4] Economic Data - The ADP employment report for July showed an increase of 104,000 jobs, exceeding market expectations of 75,000, marking the largest increase since March [5] - The Federal Reserve is expected to maintain a hawkish stance during its upcoming meeting, with Jerome Powell's speech being closely monitored for hints of potential rate cuts in September [5] Cryptocurrency Policy - The White House is set to release the first cryptocurrency policy report since the Trump administration, which will outline the government's stance on key issues affecting the digital asset industry [6][7] Company Earnings and Forecasts - Microsoft is expected to report a 13.88% year-over-year revenue increase to $73.71 billion for Q4, driven by strong demand in cloud computing and AI infrastructure [9] - Meta is anticipated to report Q2 revenue of $44.55 billion, a 14% increase year-over-year, but faces scrutiny over maintaining a 40% profit margin amid significant AI investments [10] - United Microelectronics Corporation (UMC) reported Q2 revenue of $2.01 billion, a 14.9% year-over-year increase, but fell short of market expectations [11] - Visa's Q3 revenue reached a record $10.2 billion, a 14% increase year-over-year, with adjusted EPS of $2.98, exceeding analyst expectations [11] - Starbucks reported Q3 revenue of $9.456 billion, a 3.8% year-over-year increase, but same-store sales declined by 2% [12] - UBS reported Q2 net profit of $2.4 billion, surpassing market expectations, with strong inflows in its wealth management division [13] - Rio Tinto's half-year profit fell to $4.81 billion, the lowest in five years, due to declining iron ore prices amid oversupply concerns [14] - GlaxoSmithKline (GSK) reported better-than-expected profits for Q2, driven by strong sales of its shingles vaccine and other key products [15] - Booking Holdings reported Q2 revenue of $6.8 billion, a 16% year-over-year increase, but provided a cautious outlook for Q3 [16] - New Oriental reported a net profit of $372 million for the fiscal year, a 20.1% increase year-over-year [17] Upcoming Economic Events - Key economic data releases include the ADP employment change, Q2 GDP initial estimate, and pending home sales index [18][19][20] - The Federal Reserve's FOMC meeting and interest rate decision are scheduled, along with a press conference by Jerome Powell [22]

Market Overview - US stock index futures are all up, with Dow futures rising by 0.08%, S&P 500 futures by 0.20%, and Nasdaq futures by 0.28% [1] - European indices show mixed results, with Germany's DAX up 0.20%, UK's FTSE 100 down 0.25%, France's CAC40 up 0.37%, and the Euro Stoxx 50 up 0.21% [2][3] Commodity Prices - WTI crude oil increased by 0.10% to $69.28 per barrel, while Brent crude oil rose by 0.07% to $71.73 per barrel [3][4] Employment Data - The US ADP employment report for July shows an increase of 104,000 jobs, exceeding the expected increase of 75,000, marking the largest gain since March [5] Federal Reserve Outlook - The Federal Reserve is expected to maintain a hawkish stance and keep interest rates unchanged during its upcoming meeting, with Jerome Powell's speech being closely monitored for hints of future rate cuts [5] Cryptocurrency Policy - The White House is set to release its first cryptocurrency policy report since the Trump administration, focusing on regulatory frameworks for digital assets [6] Stock Performance and Earnings - Microsoft is expected to report a 13.88% year-over-year revenue increase to $73.71 billion for Q4, driven by strong demand in cloud computing and AI infrastructure [8] - Meta is anticipated to report Q2 revenue of $44.55 billion, a 14% increase, but faces scrutiny over maintaining a 40% profit margin amid significant AI investments [9] - United Microelectronics Corporation (UMC) reported Q2 revenue of $2.01 billion, a 14.9% year-over-year increase, but fell short of market expectations [10] - Visa's Q3 revenue reached a record $10.2 billion, a 14% increase, with adjusted EPS of $2.98, exceeding analyst expectations [10] - Starbucks reported Q3 revenue growth of 3.8% to $9.456 billion, but same-store sales declined by 2% [11] - UBS reported Q2 net profit of $2.4 billion, surpassing expectations, with a strong performance in its wealth management division [12] - Rio Tinto's half-year profit fell to $4.81 billion, the lowest in five years, due to declining iron ore prices [13] - GlaxoSmithKline's Q2 adjusted EPS rose to 46.5 pence, exceeding analyst estimates, driven by strong vaccine sales [14] - Booking Holdings reported Q2 revenue growth of 16% to $6.8 billion, but provided a cautious outlook for Q3 [15] - New Oriental reported a 20.1% increase in net profit to $372 million for the fiscal year [16]