20 November 2025 | 1:03AM EST Equity Research China Healthcare: Pharmaceuticals: Takeaways From Our China Biopharma Trip We hosted an investor trip to China (Nov 10-14) to meet local companies including 3SBio, Akeso (not covered), AbelZeta (private), BeOne, Duality (not covered), Eccogene (private), Everest Medicines, GenFleet (not covered), Grand Pharma (not covered), Hansoh, Hengrui, Henlius, InnoCare, Innovent, Kelun Biotech, Keymed (covered by Honglin Yan), Lepu Biopharma (not covered), Pyrotech (privat ...

Core Insights - GSK plc reported third-quarter 2025 core earnings of $1.48 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.26, with core earnings increasing 11% year over year on a reported basis and 14% at a constant exchange rate (CER) [1][10] - Quarterly revenues rose 7% on a reported basis and 8% at CER to $11.52 billion (£8.55 billion), driven by rising sales across all business segments, particularly in HIV, oncology, and respiratory medicines, surpassing the Zacks Consensus Estimate of $11.16 billion [2][10] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 16%, General Medicines rose by 4%, and Vaccine sales were up by 2% [3] - HIV sales rose 12% during the quarter, driven by increased demand for Dovato and long-acting medications like Apretude and Cabenuva, with Dovato sales increasing by 24% [4][5] - Oncology sales surged by 39%, led by strong demand for Jemperli, which saw a 79% increase due to expanded treatment indications [6][7] - Respiratory drug Nucala sales increased by 14%, while Benlysta sales rose by 17%, reflecting strong demand across markets [9] Financial Guidance - GSK raised its 2025 guidance, now expecting sales growth of 6-7%, up from a previous forecast of 3-5%, and core EPS growth of 10-12% [10][17][19] - Specialty Medicines are now expected to grow at a mid-teens percentage at CER, while General Medicines are anticipated to remain stable [18] - The company reiterated its guidance for R&D and SG&A expenses, with R&D expected to grow slightly faster than sales [20] Long-term Strategy - GSK is focusing on HIV, immunology/respiratory, and oncology therapeutic areas, with 80 assets in clinical development, including 16 in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions this year, with four already approved by the FDA [25] - GSK aims to launch 15 new drugs between 2025 and 2031, each with peak sales potential exceeding £2 billion [26]

Core Insights - GSK raised its 2025 sales and earnings forecasts due to strong performance in its specialty HIV and cancer drugs, resulting in a nearly 7% increase in shares to their highest level since May 2024 [1][2] Group 1: Financial Performance - GSK's global vaccine sales reached £2.68 billion in the quarter ending September 30, surpassing analyst expectations, although U.S. sales of the shingles vaccine, Shingrix, fell by 15% [3][5] - The company expects annual revenue growth of 6% to 7% and core earnings per share to rise by 10% to 12%, factoring in current tariffs and potential impacts from 15% tariffs on Europe [7] Group 2: Leadership Transition - CEO Emma Walmsley is set to hand over to Luke Miels early next year, with analysts expressing confidence in Miels to achieve the annual revenue target of over £40 billion ($54 billion) by 2031 [2][6] - Miels acknowledged the target is achievable but did not provide specific details on his strategy for the upcoming year [6] Group 3: Challenges in Vaccine Sales - GSK's U.S. vaccine business faced challenges, with a noted decline in sales of influenza vaccines due to competition and a cautious outlook on the U.S. vaccine environment [3][4][5] - The company maintained its forecast for a low-single-digit decrease to stable revenues for vaccines, which accounted for over a third of third-quarter revenues [5]

Core Insights - GSK reported strong third-quarter results with sales of $11.53 billion, an 8% increase at constant currency, surpassing analyst expectations of $11.16 billion [1] - Core earnings rose 15% at constant currency to $1.48 per share, exceeding the consensus forecast of $1.26 [1] Sales Performance - Vaccine sales increased by 1% to 2.68 billion pounds, driven by strong demand for Shingrix and Arexvy, despite lower sales in Established and Influenza vaccines [2] - Arexvy sales reached 251 million pounds, up 34%, while Meningitis vaccine sales increased 4% to 541 million pounds [3] - Shingrix sales were 830 million pounds, up 12%, and Specialty Medicines sales grew by 15% to 3.41 billion pounds, reflecting strong performance across various therapeutic areas [3] Guidance Update - GSK raised its full-year 2025 guidance, expecting sales growth of 6% to 7%, up from the previous 3% to 5% range [6] - Core operating profit is anticipated to grow between 9% to 11%, and core earnings per share are expected to increase by 10% to 12% [6] - Specialty Medicine sales are projected to increase at a mid-teens percentage, an upgrade from the prior low teens guidance [6] Market Response - Following the positive earnings report and upgraded guidance, GSK stock rose by 2.56% to $44.82 in premarket trading [7] Tariff Considerations - GSK acknowledged the ongoing U.S. investigation regarding the impact of pharmaceutical imports on national security and indicated potential European tariffs of 15% [5] - The company is prepared to address the financial implications of these tariffs with identified mitigation options [5]

Financial Data and Key Metrics Changes - Total sales increased by 8% for the quarter, with core operating profit up 11% and core earnings per share up 14% to 55p [3][4] - Cash generation for the year so far is £6.3 billion, supporting growth investments and shareholder returns, including a dividend of 16p for the quarter [4][36] - Operating margin improved by 90 basis points in the quarter, driven by SG&A margin improvement [38] Business Line Data and Key Metrics Changes - Specialty medicines sales grew by 16%, with significant contributions from oncology (up 39%) and respiratory immunology (up 15%) [10][12] - HIV portfolio delivered 12% growth, primarily driven by long-acting injectables [21] - Vaccine sales increased by 2%, with strong demand for Shingrix, particularly in Europe [29] Market Data and Key Metrics Changes - In the U.S., Shingrix penetration is now at 43% of the eligible older adult population, with international sales accounting for around 70% of global Shingrix sales [30] - The oncology portfolio is expected to be a material growth driver, with Glenrep approved in eight markets [16][18] Company Strategy and Development Direction - The company is focused on investing for growth, with a pipeline of 15 scale opportunities expected to launch before 2031 [5][7] - Continued emphasis on business development to expand the pipeline, particularly in oncology and respiratory [6][84] - The company is committed to optimizing supply capacity and investing $30 billion in R&D and advanced manufacturing in the U.S. over the next five years [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver on long-term commitments for growth, with an upgraded guidance for the year [8][42] - The company remains cautious about the near-term outlook for vaccines in the U.S. but is optimistic about long-term prospects [33] Other Important Information - The company has secured four FDA approvals this year and expects a fifth before year-end [4] - The company is upgrading its full-year sales expectations from 3-5% to 6-7% [42] Q&A Session Summary Question: Revenue gap between market expectations and GSK's target for 2031 - Management acknowledged the gap and highlighted underappreciated assets in oncology and respiratory as key areas for growth [51][54] Question: Future strategy updates - Management indicated that more details on the strategy would be provided at the full-year results, with confidence in achieving the £40 billion target by 2031 [52][58] Question: Shingrix growth expectations - Management confirmed that growth in Europe is expected to continue, with a focus on expanding immunization rates [60][66] Question: Investment in R&D and operational expenses - Management confirmed that R&D investment will continue to grow ahead of sales, with significant investments in new product launches [68] Question: Updates on Glenrep and Depamokimab - Management shared insights on the early experiences with Glenrep in Europe and the competitive landscape for Depamokimab, emphasizing the potential for both products [72][76]

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 ...

Core Insights - GSK raised its 2025 sales and earnings forecasts due to strong performance in specialty HIV and cancer medicines, despite a significant drop in U.S. sales of its shingles vaccine Shingrix [1][2] - The company's shares increased by as much as 4.3%, reaching their highest level since May 2024, and have risen 25% so far in 2025 [1] Sales Performance - Overall vaccine sales for GSK reached 2.68 billion pounds in the quarter ending September 30, surpassing analyst expectations of 2.55 billion pounds [2] - Sales of the shingles vaccine Shingrix fell by 15% in the U.S., contributing to a cautious outlook for the U.S. market [3][5] Competitive Landscape - GSK's influenza vaccine sales also declined in the U.S. due to increased competition, mirroring trends seen by rival Sanofi [4] - The company faces challenges from U.S. vaccine sales pressures, including funding cuts for vaccine research and a negative public perception of vaccines [3][4] Future Outlook - GSK maintained its forecast for a low-single-digit decrease to broadly stable revenues for vaccines, which accounted for over a third of its third-quarter revenues [5] - The company aims to achieve annual revenues exceeding 40 billion pounds ($54 billion) by 2031, with expected annual revenue growth of 6% to 7% and core earnings per share growth of 10% to 12% [6] Financial Performance - GSK reported core earnings per share of 55 pence on sales of 8.55 billion pounds for the quarter, exceeding analyst expectations of 47.1 pence on sales of 8.24 billion pounds [7]

Core Insights - GSK raised its 2025 sales and earnings forecasts due to strong growth in its specialty HIV and cancer medicines, leading to a significant increase in share price [1][2] - Despite a decline in U.S. sales of the shingles vaccine Shingrix, GSK's shares have increased by nearly 4% this year, contributing to a total gain of around 25% [1] Sales Performance - Overall vaccine sales reached £2.68 billion in the quarter ending September 30, surpassing analyst expectations of £2.55 billion [3] - Sales outside the U.S. were a key driver of growth, while U.S. sales of Shingrix fell by 15% [3][4] - GSK's influenza vaccine sales also declined in the U.S. due to increased competition [4] Future Outlook - GSK's CEO transition to Luke Miels is anticipated to bring new strategies to navigate U.S. tariffs and offset revenue declines from expiring patents [2][5] - The company aims for annual revenue exceeding £40 billion ($54 billion) by 2031, with current estimates around £34 billion [5] - GSK expects annual revenue growth of 6% to 7% and core earnings per share growth of 10% to 12%, an increase from previous forecasts of 3% to 5% revenue growth and 6% to 8% earnings growth [5][6] Financial Performance - GSK reported core earnings per share of 55 pence on sales of £8.55 billion for the quarter, exceeding analyst expectations of 47.1 pence on £8.24 billion [6] - Revenue in the U.S. business grew by 7% at constant exchange rates, totaling £4.55 billion [6]

Core Insights - Dynavax Technologies Corporation has presented positive topline data from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, and has initiated Part 2 of the trial to evaluate Z-1018 against Shingrix in older adults [1][3] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, including HEPLISAV-B for hepatitis B and the CpG 1018 adjuvant used in various vaccines [8] Clinical Trial Details - Part 1 of the Phase 1/2 trial was a randomized, observer-blinded, active-controlled, dose escalation study assessing the safety, tolerability, and immunogenicity of Z-1018 in healthy adults aged 50 to 69 years, evaluating three different dose levels of gE antigen and two adjuvant formulations [2][5] - The key safety endpoint was solicited local and systemic post-injection reactions measured for up to seven days post-injection, while key immunogenicity endpoints included vaccine response rates for anti-gE IgG antibodies and gE-specific CD4+ T cells [2] Part 2 Trial Initiation - Part 2 of the trial has been initiated, enrolling approximately 324 healthy adults aged 70 years and older, aimed at further characterizing immunogenicity, safety, and tolerability of Z-1018 compared to Shingrix [3][6] - The company anticipates reporting topline immunogenicity and safety data from Part 2 in the second half of 2026 [3] Vaccine Performance - Z-1018 demonstrated comparable antibody and CD4+ T-cell responses to Shingrix with a favorable tolerability profile, showing robust polyfunctional CD4+ T-cell responses [5][6] - The formulation selected for advancement in Part 2 consists of 100 mcg gE adjuvanted with CpG 1018 plus alum, administered at 0 and 8 weeks [6][7] Shingles Background - Shingles, caused by the reactivation of the varicella-zoster virus, affects approximately 1 in 3 people in their lifetime and can lead to serious complications, particularly in older adults [4]

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]