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]

Financial Data and Key Metrics Changes - Group sales increased by 6% for the quarter, core operating profit rose by 12%, and core earnings per share grew by 15% to 46.5p [4][5][54] - Cash generation remained strong with £3.7 billion generated in the first half, supporting further investments and shareholder returns [5][57] - The dividend for the quarter was 16p, and over £800 million of the share buyback program has been completed [5][59] Business Line Data and Key Metrics Changes - Specialty medicines sales grew by 15%, while vaccine sales increased by 9% in the quarter [4][33] - The oncology portfolio saw a significant increase of 42%, with Gempelli for endometrial cancer up 91% and Adjara sales up 69% [36] - The HIV portfolio grew by 12%, driven by strong demand for long-acting injectables and Dovato, with Cabanuva and Aptitude showing robust growth [40][41] Market Data and Key Metrics Changes - In Europe, Shingrix sales increased by 48%, driven by strong demand across several countries [47] - The US market for Shingrix has reached a penetration of 42% of the eligible older adult population [48] - The general medicines segment experienced a decline of 6%, primarily due to tough comparisons from the previous year [51] Company Strategy and Development Direction - The company is focused on investing for growth, particularly in specialty medicines and vaccines, with a commitment to R&D and business development [10][12][58] - GSK aims to achieve sales of more than £40 billion by 2031, with a strong pipeline of 14 scale opportunities [12][60] - The company is expanding its portfolio through strategic collaborations and acquisitions, such as the recent partnership with Hengrui [11][80] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top end of financial guidance for 2025, citing strong performance and pipeline prospects [6][65] - The company remains optimistic about long-term growth opportunities, particularly in specialty medicines and immunology [30][32] - Management highlighted the importance of maintaining a disciplined approach to capital allocation while investing in R&D [58][61] Other Important Information - The FDA has extended the review period for BLENREP, with a new target action date of October 23, 2025 [9][23] - The company is making significant investments in US manufacturing and scaling up capacity for new modalities [11][12] - GSK's overall planned investment in the USA is expected to be in the tens of billions of dollars over the next five years [11] Q&A Session Summary Question: Clarification on Camlopixant and Blendrep - Management confirmed that the updated PDUFA date for Blendrep is in October and expressed confidence in the ramp-up of Glenrep, with no changes to expectations for 2028 and 2031 outlooks [70][72][73] Question: Confidence in Blendrep Approval and Margin Maintenance - Management reiterated high confidence in Blendrep's approval and its importance for maintaining margins, emphasizing the positive survival data and ongoing constructive dialogue with the FDA [78][82][84] Question: Supply Chain Costs and Nucala Sales Expectations - Management addressed concerns about supply chain costs impacting gross margin and confirmed that expectations for Nucala's peak sales remain unchanged [94][95]

Financial Data and Key Metrics Changes - Group sales increased by 6% for the quarter, core operating profit rose by 12%, and core earnings per share grew by 15% to 46.5p [3][4] - Cash generation remained strong with £3.7 billion generated in the first half, supporting further investments and shareholder returns [4][55] - The dividend for the quarter was 16p, and over £800 million of the share buyback program has been completed [4][55] Business Line Data and Key Metrics Changes - Specialty medicines sales grew by 15%, while vaccine sales increased by 9% in the quarter [3][33] - The oncology portfolio saw a significant increase of 42%, with Gempelli for endometrial cancer up 91% and Adjara sales up 69% [36] - The HIV portfolio grew by 12%, driven by strong demand for long-acting injectables and Dovato, with Cabanuva and Aptitude showing robust growth [40][41] Market Data and Key Metrics Changes - Sales for vaccines in Q2 were £2.1 billion, up 9%, primarily driven by strong demand for Shingrix and meningitis vaccines [46] - Shingrix sales grew by 6% globally, with 72% of sales coming from outside the US [46] - The general medicines segment declined by 6% due to tough comparisons and continued generic competition [50] Company Strategy and Development Direction - The company is focused on investing for growth, particularly in specialty medicines and vaccines, with a commitment to R&D and business development [5][8] - GSK aims to drive a step change in performance following the demerger of Halion, with expectations to reach over £40 billion in sales by 2031 [11][12] - The company is prioritizing capital allocation towards high-potential assets and expanding its pipeline in areas of high unmet need [8][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the top end of financial guidance for 2025, citing strong performance and pipeline prospects [4][62] - The company remains optimistic about its long-term outlook, with a focus on delivering transformational specialty medicines and vaccines [13][32] - Management highlighted the importance of maintaining momentum in R&D and the potential for significant growth in various therapeutic areas [30][32] Other Important Information - The FDA has extended the review period for BLENREP, with a new target action date of October 23, 2025 [7][22] - The company is expanding its voluntary license agreement with the Medicines Patent Pool to include long-acting cabotegravir for HIV treatment and prevention [4][5] - GSK's overall planned investment in the USA is expected to be in the tens of billions of dollars over the next five years [10] Q&A Session Summary Question: Clarification on Camlopixant and Blendrep - Management confirmed that the updated PDUFA date for Blendrep is in October and expressed confidence in the ramp-up of Glenrep, with no change to expectations for 2028 and 2031 outlooks [65][67] Question: Confidence in Blendrep Approval and Impact on Margins - Management reiterated high confidence in Blendrep's approval and its importance for maintaining margins, emphasizing ongoing constructive dialogue with the FDA [73][78] Question: Supply Chain Costs and Gross Margin Expectations - Management indicated that while supply chain optimization charges are impacting gross margin, specialty growth is expected to drive improvement overall [87][88]

Q2 2025 Performance Highlights - Q2 2025 sales reached £7,986 million, a 6% increase[9] - Core EPS increased by 15% to 465 pence[9] - Core operating profit increased by 12% to £2,631 million[10] - Cash generated from operations year-to-date is £37 billion[10] Specialty Medicines Growth - Specialty Medicines sales increased by 15%[9] - Specialty medicines largest business: 40% sales[14] - HIV sales increased by 12% to £1,880 million[56] - Vaccines sales increased by 22%[71] Financial Outlook and Guidance - Expect to deliver towards the top end of 2025 guidance range[9] - Sales growth is projected at 3-5%[24] - Core OP growth is projected at 6-8%[24] - Expect sales of >£40 billion in 2031[18]

Core Viewpoint - The collaboration between Heng Rui Medicine and GlaxoSmithKline (GSK) marks a significant shift in the innovative drug monetization landscape, moving from oncology to chronic diseases, particularly chronic obstructive pulmonary disease (COPD) [2][3][4] Group 1: Partnership Details - GSK will pay Heng Rui Medicine a total of $500 million as an upfront payment, and Heng Rui will license its PDE3/4 inhibitor HRS-9821 and up to 11 additional projects to GSK for global rights outside of Greater China [1] - If all projects are successfully developed and commercialized, Heng Rui could receive up to $12 billion in milestone payments, along with sales royalties [1][7] - HRS-9821 has shown strong PDE3 and PDE4 inhibition effects and is expected to be developed as a convenient dry powder inhaler (DPI) formulation [6] Group 2: Market Context - The global COPD patient population exceeds 390 million, with around 100 million in China, where the disease is the third leading cause of death [4] - Traditional COPD treatments have been limited, but recent innovations, such as Merck's acquisition of Verona Pharma for $10 billion, highlight a renewed focus on this therapeutic area [4][5] Group 3: Industry Trends - The oncology sector is experiencing saturation, with over 60% of global cancer drug pipelines featuring similar target drugs, prompting companies to seek new growth areas [2] - The collaboration between Heng Rui and GSK represents a strategic move for GSK to strengthen its respiratory disease portfolio, aligning with its focus on core business areas [8] Group 4: Future Implications - The partnership signifies a qualitative leap in Heng Rui's international strategy, moving beyond single project licensing to a platform-based collaboration model [7] - The global pharmaceutical industry is facing a "patent cliff," with significant revenue risks as patents expire, leading companies to accelerate external collaborations for new revenue streams [9][10]

Core Insights - GSK's Specialty Medicines segment is a significant contributor to its sales, accounting for nearly 40% of total revenue and expected to exceed 50% by 2031 [6] Sales Growth - The Specialty Medicines unit has experienced a 17% sales increase in Q1 2025, driven by successful launches in Oncology and long-acting HIV medicines [2][10] - Key products such as Nucala and Dovato are major revenue drivers, alongside new long-acting HIV treatments like Cabenuva and Apretude, and oncology drugs Jemperli and Ojjaara [3] Research and Development - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [4] - The approval of Blujepa for uncomplicated urinary tract infections and Nucala for chronic obstructive pulmonary disease (COPD) supports the growth trajectory [4][10] Regulatory Approvals - Regulatory applications for Blenrep combinations for multiple myeloma and depemokimab for chronic rhinosinusitis and asthma are under review, with FDA decisions expected in 2025 [5] Competitive Landscape - GSK faces significant competition in the Specialty Medicines segment from major pharmaceutical companies such as AstraZeneca, Merck, and Pfizer [7][8] Stock Performance and Valuation - GSK's stock has increased by 16.3% year-to-date, outperforming the industry average of 0.3% [9] - The company's shares are trading at a forward price/earnings ratio of 8.34, which is lower than the industry average of 14.93 and below its 5-year mean of 10.21 [12] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings per share has risen from $4.38 to $4.41 for 2025, while the estimate for 2026 has slightly declined [14]

Core Insights - GSK stock has increased by 21.5% over the past six months, driven by strong performance in the Specialty Medicines unit, regulatory successes, and a positive long-term outlook despite challenges in the Vaccines unit and economic pressures [2][22]. Specialty Medicines Unit Performance - The Specialty Medicines unit has shown significant sales growth, with a 19% increase in 2024 and a 17% rise in Q1 2025, primarily due to successful launches in Oncology and long-acting HIV medicines [3][4]. - Key products driving growth include Nucala, Dovato, Cabenuva, Apretude, Jemperli, and Ojjaara, with expectations for low double-digit sales growth in 2025 despite the Inflation Reduction Act's impact [4][9]. - Specialty Medicines currently accounts for approximately 40% of GSK's sales and is projected to exceed 50% by 2031 [4]. Promising Pipeline Developments - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [5]. - Recent approvals include the pentavalent MenABCWY vaccine and Blujepa for UTI treatment, with Nucala receiving approval for COPD in May 2025 [5][6]. - GSK anticipates launching five new products in 2025, including Blenrep and depemokimab, with several already approved in the U.S. [7]. Vaccine Sales Challenges - Vaccine sales declined by 6% in Q1 2025, primarily due to lower demand for the RSV vaccine Arexvy and shingles vaccine Shingrix [8][10]. - Shingrix sales fell by 21% in Q1 2025, and Arexvy's global sales dropped by 57%, attributed to revised vaccination recommendations and challenges in reaching consumers [10][11]. - The company expects a low single-digit percentage decline in Vaccine sales for 2025 due to macroeconomic challenges and potential policy changes [12]. Stock Performance and Valuation - GSK stock has outperformed the industry and S&P 500, rising 20.1% year-to-date compared to a 4.0% industry increase [13]. - The stock trades at a forward P/E of 8.63, below the industry average of 15.63, indicating an attractive valuation relative to peers [17]. - Earnings estimates for 2025 have increased from $4.26 to $4.42 per share, reflecting analysts' positive outlook for future growth [20]. Future Growth Expectations - GSK anticipates over 7% sales growth and more than 11% core operating profit growth on a CAGR basis from 2021 to 2026, driven by Specialty Medicines and improvements in General Medicines [23]. - The company has resolved most Zantac litigations, alleviating a significant overhang on the stock [25].

Core Viewpoint - The experimental drug Itepekimab, developed by Sanofi and Regeneron for treating chronic obstructive pulmonary disease (COPD) in former smokers, has shown mixed results in late-stage trials, leading to significant stock price declines for both companies [1][2]. Group 1: Company Performance - Sanofi's stock price fell by 6.17% and Regeneron's stock price dropped by 13.77% following the announcement of the trial results [1]. - The late-stage trials for Itepekimab produced contrasting outcomes, with one trial showing a 27% reduction in disease worsening, while the other did not demonstrate the same efficacy despite initial positive results [1]. Group 2: Drug Development Insights - Analysts are closely monitoring the trial data for Itepekimab, especially as Sanofi's key drug Dupixent is nearing patent expiration, which has been a significant growth driver for the company [2]. - The mixed results of Itepekimab represent a major setback for Sanofi and Regeneron, potentially delaying the drug development process by at least three years [2]. - Other pharmaceutical companies, such as GlaxoSmithKline, are also developing treatments for COPD, with GlaxoSmithKline's Nucala recently approved for use in the U.S. [2].