GSK(GSK) - 2024 Q2 - Quarterly Report

Q1 2024 Performance Overview and Outlook GSK reported strong Q1 2024 financial and operational results, leading to an upgraded full-year 2024 guidance and a declared Q1 dividend Financial and Operational Highlights GSK reported a strong start to 2024, with Q1 turnover reaching £7.4 billion, a 10% increase at Constant Exchange Rates (CER), and 13% excluding COVID-19 solutions. Core operating profit grew by 27% and Core EPS by 28% at CER, driven by robust sales in Vaccines and Specialty Medicines. The company also made significant progress in its R&D pipeline with positive Phase III data for four medicines and completed the acquisition of Aiolos Bio to expand its respiratory biologics portfolio Q1 2024 Financial Performance Summary | Metric | Q1 2024 (£m) | % AER | % CER | | :--- | :--- | :--- | :--- | | Turnover | £7.36 billion | 6% | 10% | | Turnover ex COVID | £7.36 billion | 8% | 13% | | Total Operating Profit | £1.49 billion | (28%) | (18%) | | Total EPS | 25.7 pence | (30%) | (19%) | | Core Operating Profit | £2.44 billion | 17% | 27% | | Core EPS | 43.1 pence | 16% | 28% | | Cash generated from operations | £1.13 billion | >100% | - | - Sales growth was broad-based: Vaccines grew 16% (+22% ex-COVID), Specialty Medicines grew 17% (+19% ex-COVID), and General Medicines grew 1%. Key product drivers included Shingrix (£0.9 billion, +18%), Arexvy (£0.2 billion), and Trelegy (£0.6 billion, +33%)[8] - Significant R&D pipeline advancements include positive Phase III results for gepotidacin (gonorrhoea), Cabenuva (HIV), Jemperli (endometrial cancer), and Blenrep (multiple myeloma)[9] - The company completed the acquisition of Aiolos Bio, expanding its respiratory biologics pipeline with AIO-001, a long-acting TSLP monoclonal antibody for asthma[15] 2024 Guidance and Dividends Following a strong Q1 performance, GSK has upgraded its full-year 2024 guidance. The company now expects turnover growth towards the upper end of the 5% to 7% range, Core operating profit growth of 9% to 11%, and Core EPS growth of 8% to 10%, all at CER and excluding COVID-19 solutions. A dividend of 15p for Q1 was declared, with an expected full-year dividend of 60p Updated 2024 Full-Year Guidance (at CER, ex-COVID) | Metric | Current 2024 Guidance | Previous 2024 Guidance | | :--- | :--- | :--- | | Turnover | Increase towards the upper part of 5% to 7% | Increase between 5% to 7% | | Core Operating Profit | Increase between 9% to 11% | Increase between 7% to 10% | | Core Earnings Per Share | Increase between 8% to 10% | Increase between 6% to 9% | 2024 Turnover Expectations by Segment (at CER, ex-COVID) | Segment | 2024 Expectation | | :--- | :--- | | Vaccines | Increase of high single-digit to low double-digit % | | Specialty Medicines | Increase of low double-digit % | | General Medicines | Decrease of mid-single-digit % | - A dividend of 15 pence per share was declared for Q1 2024, with an expected total of 60 pence for the full year 2024[15][19] - The company anticipates no further COVID-19 related sales or profit in 2024, which is expected to adversely impact full-year sales and Core operating profit growth by one and two percentage points, respectively, compared to 2023[20] Turnover Performance Analysis GSK's Q1 2024 turnover saw broad-based growth across product segments, led by Vaccines and Specialty Medicines, with strong regional performance in the US and International markets Turnover by Product Segment Total turnover grew 10% at CER to £7.4 billion. Vaccines led the growth at 16% CER, driven by Arexvy and strong international demand for Shingrix. Specialty Medicines increased 17% CER, fueled by HIV portfolio growth and strong uptake of new oncology products. General Medicines saw a modest 1% CER growth, with Trelegy's strong performance offsetting declines in established products Q1 2024 Turnover by Segment (£m) | Segment | Q1 2024 Turnover (£m) | % AER Growth | % CER Growth | | :--- | :--- | :--- | :--- | | Vaccines | £2.28 billion | 12% | 16% | | Specialty Medicines | £2.52 billion | 13% | 17% | | General Medicines | £2.56 billion | (4%) | 1% | | Total | £7.36 billion | 6% | 10% | Vaccines Vaccine sales grew 16% CER to £2.3 billion, or 22% excluding COVID-19 solutions. Growth was driven by strong US demand for Arexvy (£182 million) and robust market expansion for Shingrix in Europe and International markets. Shingrix sales increased 18% CER to £945 million, with non-US markets now accounting for over 50% of global sales. Meningitis vaccine sales also grew 11% CER - Shingrix sales grew 18% CER, driven by strong demand from new national immunisation programs in Australia and Europe, and earlier-than-expected supply to its partner in China[26] - US sales of Shingrix declined 4% CER, reflecting a tough comparison to Q1 2023 which benefited from the Inflation Reduction Act, and challenges in activating harder-to-reach consumers[27] - Arexvy, the RSV vaccine, generated £182 million in sales, with £154 million from the US, maintaining a market share of approximately two-thirds[30] Specialty Medicines Specialty Medicines sales increased 17% CER to £2.5 billion. The HIV portfolio was a key driver, with sales up 14% CER to £1.6 billion, led by strong patient demand for oral 2-drug regimens like Dovato (+27% CER) and long-acting medicines like Cabenuva (+73% CER). Oncology sales more than doubled, driven by strong patient growth for Zejula, Jemperli, and the newly launched Ojjaara, which delivered £52 million - HIV sales grew 14% CER, driven by a 2 percentage point market share increase compared to Q1 2023, with strong demand for oral 2-drug regimens and long-acting medicines[33] - Long-Acting HIV medicines grew 83% CER to £267 million, now representing 17% of the total HIV portfolio, up from 10% in Q1 2023[36] - Oncology sales more than doubled, driven by strong growth from Zejula (+27% CER), Jemperli (£80 million), and the newly launched Ojjaara (£52 million)[39] General Medicines General Medicines sales grew 1% at CER to £2.6 billion. The growth was primarily driven by strong global demand for Trelegy, which saw sales increase by 33% CER to £591 million. This performance was largely offset by declines in the Established Respiratory portfolio, such as Seretide/Advair (-13% CER), and the adverse impact of the removal of the AMP cap on Medicaid drug prices in the US - Trelegy sales grew significantly by 33% CER across all regions, reflecting strong patient demand and increased market share as a single-inhaler triple therapy[43] - The removal of the Average Manufacturer Price (AMP) cap on US Medicaid drug prices adversely impacted sales of established products like Advair, Flovent, and Lamictal[39] - Seretide/Advair sales decreased 13% CER due to continued generic erosion in Europe and International markets, as well as the US AMP cap removal[43] Turnover by Region Regionally, the US led growth with a 14% CER increase in sales to £3.6 billion, driven by Arexvy, HIV, and Oncology products. International markets also performed strongly, growing 16% CER (18% ex-COVID) to £2.2 billion, fueled by Shingrix expansion. Europe sales declined 3% CER, or grew 3% ex-COVID, with growth in Specialty Medicines and Trelegy offset by lower Bexsero tender deliveries and prior-year COVID-19 solution sales Q1 2024 Turnover by Region (£m) | Region | Q1 2024 Turnover (£m) | % AER Growth | % CER Growth | | :--- | :--- | :--- | :--- | | US | £3.59 billion | 10% | 14% | | Europe | £1.62 billion | (5%) | (3%) | | International | £2.15 billion | 9% | 16% | - US growth was driven by strong uptake of Arexvy and robust performance in HIV and Oncology, though partially offset by the removal of the AMP cap on Medicaid prices for General Medicines[44][45][46] - Europe sales, excluding a 6 percentage point adverse impact from COVID-19 solutions, grew 3% at CER, driven by HIV, Oncology, and Trelegy[47][48][49] - International sales growth of 18% CER (ex-COVID) was driven by Shingrix expansion in Australia and Japan, earlier supply to China, and growth in HIV, Nucala, Benlysta, and Zejula[50][51] Financial Performance GSK's Q1 2024 financial performance was marked by strong Core operating profit and EPS growth, significant cash flow generation, and stable net debt, despite a decline in Total operating profit due to specific charges Total and Core Results Analysis Core operating profit grew 27% CER to £2.4 billion, with the margin expanding by 4.6 percentage points to 33.2%, driven by strong sales, favorable product mix, and a legal provision reversal. This was partly offset by increased R&D investment and lower royalty income. In contrast, Total operating profit fell 18% CER, primarily due to a £685 million charge for remeasurement of contingent consideration liabilities related to improved HIV prospects. Core EPS increased 28% CER to 43.1p, while Total EPS decreased 19% CER to 25.7p Cost of Sales and SG&A Core cost of sales as a percentage of sales decreased by 2.5 percentage points due to a favorable product mix with higher-margin products like Arexvy and Shingrix. Core SG&A as a percentage of sales decreased by 3.3 percentage points, largely due to a 6 percentage point favorable impact from the reversal of a legal provision for a Zejula royalty dispute - Core cost of sales as a percentage of sales improved to 23.5% from 26.0% in Q1 2023, driven by mix benefits from higher margin products[56] - Core SG&A decreased 2% at CER, benefiting from the reversal of a legal provision for the Zejula royalty dispute following a successful appeal[57] R&D and Royalty Income Core R&D expenses increased 14% CER to £1.4 billion, reflecting continued investment in key pipeline assets like bepirovirsen (hepatitis B), depemokimab (asthma), and Jemperli (endometrial cancer). Royalty income decreased 16% CER to £151 million, primarily due to the cessation of the majority of Gardasil royalties at the end of 2023 - Core R&D expense increased 14% CER due to investment in bepirovirsen, pneumococcal MAPS and mRNA programs, next-gen HIV medicines, depemokimab, camlipixant, and Jemperli[58][59] - Royalty income fell 16% CER, mainly because Gardasil royalties decreased to £22 million in Q1 2024 from £71 million in Q1 2023[60] Operating Profit and EPS Core operating profit margin expanded by 4.6 percentage points to 33.2% at CER, benefiting from sales leverage, product mix, and the Zejula legal provision reversal. Total operating profit margin contracted by 7.8 percentage points to 20.2%, mainly due to a £685 million charge for remeasuring contingent consideration liabilities. Core EPS grew 28% CER, while Total EPS fell 19% CER - Total operating profit was significantly impacted by a £685 million charge from the remeasurement of contingent consideration liabilities, primarily related to improved long-term HIV prospects[61][63] - Core operating profit growth of 27% CER was driven by strong sales, favorable product mix, and the Zejula royalty dispute reversal, partly offset by higher R&D investment and lower royalty income[64] - Core EPS increased 28% CER to 43.1 pence, reflecting operating profit growth and lower finance costs, partly offset by a higher tax rate and non-controlling interests. Lower COVID-19 sales reduced Core EPS growth by nine percentage points[69] Cash Flow and Net Debt The company generated a strong cash flow from operations of £1.1 billion, a significant increase from £287 million in Q1 2023, driven by higher operating profit and better receivables collection. Free cash flow was an inflow of £289 million, a stark reversal from a £689 million outflow in the prior year. Net debt remained stable at £15.0 billion, as free cash flow and proceeds from the partial sale of its Haleon stake were offset by the Aiolos acquisition cost and dividend payments Q1 2024 Cash Flow Summary | Metric | Q1 2024 (£m) | Q1 2023 (£m) | | :--- | :--- | :--- | | Cash generated from operations | £1.13 billion | £287 million | | Net cash generated from operating activities | £958 million | £53 million | | Free cash inflow/(outflow) | £289 million | (£689 million) | | Total net debt | £14.96 billion | £17.95 billion | - The increase in cash generated from operations was primarily due to higher operating profit and improved receivables collections, particularly for Arexvy[76] - Net debt decreased slightly by £79 million during the quarter. The £289 million free cash inflow and £1.06 billion from investment disposals (including Haleon stake) were largely offset by the £719 million net cost of the Aiolos acquisition and £568 million in dividends[80] R&D Pipeline and ESG GSK's Q1 2024 saw significant R&D pipeline advancements with positive Phase III data and regulatory progress, alongside continued commitment and strong performance in key ESG initiatives Pipeline Highlights and News Flow GSK's R&D pipeline saw significant progress in Q1 2024, with regulatory acceptances for Arexvy in a younger adult group (50-59), a new MenABCWY vaccine, and Jemperli for endometrial cancer. The company reported positive Phase III data for gepotidacin (gonorrhoea), Blenrep (multiple myeloma), and Cabenuva (HIV). Key anticipated news flow for 2024 includes regulatory decisions for Arexvy and Jemperli in the US, and Phase III data readouts for depemokimab (severe asthma) and Zejula (ovarian and lung cancer) - Regulatory submissions were accepted in the US for Arexvy (adults 50-59), the new MenABCWY vaccine candidate, and Jemperli (endometrial cancer)[86] - Positive Phase III data readouts were announced for gepotidacin (urogenital gonorrhoea), Blenrep (multiple myeloma), cabotegravir (long-acting HIV), and Jemperli (endometrial cancer)[86] - Anticipated news flow for H2 2024 includes regulatory decisions for Arexvy in the EU and Japan, a US submission for gepotidacin, and Phase III data readouts for depemokimab, Nucala, Zejula, and linerixibat[88] ESG (Environmental, Social, and Governance) GSK highlighted its commitment to ESG, focusing on six priority areas. Recent progress includes capping US out-of-pocket costs for its asthma and COPD inhalers at $35/month to improve access, and advancing its TB vaccine candidate into Phase III trials. On the environmental front, the company entered a virtual power purchase agreement for solar energy in Spain and invested in a nature-based carbon fund. GSK maintains strong ESG ratings, including a leading score of 84 from S&P Global's Corporate Sustainability Assessment and an 'A-' for both Climate Change and Water Security from CDP - To improve patient access, GSK announced a cap of $35 per month on out-of-pocket costs for its entire portfolio of asthma and COPD inhalers for eligible US patients[92] - In global health, the GSK-developed tuberculosis (TB) vaccine candidate M72/AS01E entered Phase III trials, representing a major step towards the first new TB vaccine in over 100 years[92] - GSK announced a virtual power purchase agreement for solar projects in Spain, set to cover 50% of its European sites' electricity demand for 12 years starting mid-2026[100] Key ESG Ratings | External Benchmark | Current Score/Ranking | Previous Score/Ranking | | :--- | :--- | :--- | | S&P Global's CSA | 84 | 86 | | Access to Medicines Index | 4.06 | 4.23 | | CDP Climate Change | A- | A- | | CDP Water Security | A- | B | | Sustainalytics | 16.7 (Low Risk) | 18.6 | | MSCI | AA | AA | Financial Statements and Notes This section provides a detailed breakdown of GSK's Q1 2024 financial statements, including reconciliation of Total and Core results, segment performance, ongoing legal matters, and shareholder returns Reconciliation of Total and Core Results GSK provides both Total (IFRS) and Core (non-IFRS) results to offer a clearer view of underlying performance. Core results exclude items like intangible asset amortization, major restructuring costs, and significant legal charges. For Q1 2024, the largest adjustment was a £704 million charge related to transactions, primarily the remeasurement of contingent consideration for ViiV Healthcare. This, along with other adjustments, reconciled a Total operating profit of £1.5 billion to a Core operating profit of £2.4 billion - In Q1 2024, GSK changed the description of 'Adjusted results' to 'Core results' to align with European peers, with no change to the calculation methodology[102] Q1 2024 Transaction-Related Adjustments (£m) | Item | Charge/(Credit) (£m) | | :--- | :--- | | Contingent consideration on former Shionogi-ViiV Healthcare joint Venture | £586 million | | ViiV Healthcare put options and Pfizer preferential dividends | £66 million | | Contingent consideration on former Novartis Vaccines business | £28 million | | Contingent consideration on acquisition of Affinivax | £5 million | | Other adjustments | £19 million | | Total transaction-related charges | £704 million | - The £586 million charge for the Shionogi-ViiV contingent consideration was driven by updated sales forecasts and foreign exchange movements, reflecting improved prospects for the HIV business[125] Financial Statements The income statement shows Q1 2024 turnover of £7,363 million and profit after tax of £1,081 million. The balance sheet as of March 31, 2024, indicates total assets of £58.5 billion and total equity of £13.2 billion. The cash flow statement details a net cash inflow from operating activities of £958 million, a significant improvement from £53 million in Q1 2023 Q1 2024 Income Statement Summary (£m) | Line Item | Q1 2024 (£m) | Q1 2023 (£m) | | :--- | :--- | :--- | | Turnover | £7.36 billion | £6.95 billion | | Gross Profit | £5.39 billion | £5.01 billion | | Operating Profit | £1.49 billion | £2.08 billion | | Profit Before Taxation | £1.36 billion | £1.91 billion | | Profit After Taxation | £1.08 billion | £1.63 billion | Balance Sheet Summary (£m) | Line Item | 31 March 2024 (£m) | 31 December 2023 (£m) | | :--- | :--- | :--- | | Total Non-Current Assets | £41.31 billion | £40.36 billion | | Total Current Assets | £17.21 billion | £18.64 billion | | Total Assets | £58.51 billion | £59.01 billion | | Total Current Liabilities | (£19.85 billion) | (£21.07 billion) | | Total Non-Current Liabilities | (£25.44 billion) | (£25.14 billion) | | Total Liabilities | (£45.28 billion) | (£46.21 billion) | | Total Equity | £13.23 billion | £12.80 billion | Segment Information GSK reports under two segments: Commercial Operations and Total R&D. For Q1 2024, the Commercial Operations segment generated a Core operating profit of £3,855 million, a 21% increase at CER, driven by strong sales and the reversal of a legal provision. The Research and Development segment reported operating expenses of £1,308 million, a 9% increase at CER, reflecting continued investment in late-stage programs Core Operating Profit by Segment (£m) | Segment | Q1 2024 (£m) | Q1 2023 (£m) | % CER Growth | | :--- | :--- | :--- | :--- | | Commercial Operations | £3.86 billion | £3.38 billion | 21% | | Research and Development | (£1.31 billion) | (£1.23 billion) | 9% | | Segment Profit | £2.55 billion | £2.14 billion | 28% | Legal Matters GSK is involved in significant legal proceedings, with a primary focus on Zantac product liability litigation. The company reached a confidential settlement in one California case to avoid protracted litigation, without admitting liability. A key hearing on the admissibility of expert testimony in the Delaware Zantac litigation is awaiting a ruling. The first trial in Illinois began in April 2024. The aggregate provision for legal and other disputes was £312 million as of March 31, 2024 - The aggregate provision for legal and other disputes increased to £312 million at the end of Q1 2024, up from £267 million at the end of 2023[149] - Regarding Zantac litigation, the first Illinois state court trial began on April 30, 2024. The company is awaiting a key ruling on the admissibility of expert testimony in the Delaware proceedings[154][157] - GSK reached a confidential settlement in the Boyd/Steenvoord Zantac case in California, stating the decision was to avoid the distraction of litigation and did not involve an admission of liability[155] Returns to Shareholders The Board declared a Q1 2024 dividend of 15p per share, up from 14p in Q1 2023. The company expects to declare a total dividend of 60p per share for the full year 2024, consistent with its progressive dividend policy and a target payout ratio of 40-60%. As of March 31, 2024, there were 4,078 million shares in free issue Quarterly Dividends (Pence per share) | Period | Dividend per Share (Pence) | | :--- | :--- | | Q1 2024 | 15 pence | | Q1 2023 | 14 pence | | Q2 2023 | 14 pence | | Q3 2023 | 14 pence | | Q4 2023 | 16 pence | | Full Year 2023 Total | 58 pence | - GSK expects to declare a dividend of 60 pence per share for the full year 2024, guided by a payout ratio of 40% to 60%[160] R&D Commentary GSK's R&D commentary highlights a robust clinical pipeline of 72 assets, with significant advancements in late-stage programs across infectious diseases, HIV, respiratory, and oncology Pipeline Overview As of Q1 2024, GSK's clinical development pipeline includes 72 vaccines and medicines, with 18 in Phase III development or under regulatory review. The late-stage pipeline is diversified across key therapeutic areas, with 7 assets in Infectious Diseases, 6 in Respiratory/Immunology, and 5 in Oncology Late-Stage Pipeline (Phase III / Under Review) | Therapy Area | Number of Assets | | :--- | :--- | | Infectious Diseases | 7 | | Respiratory/Immunology | 6 | | Oncology | 5 | | Total | 18 | - The company has a total of 72 vaccines and medicines across all phases of clinical development[182] Key Growth Assets by Therapy Area GSK detailed progress on key growth assets. In Infectious Diseases, Arexvy's indication is being expanded, and gepotidacin showed positive Phase III results for gonorrhoea. In HIV, a new ultra long-acting formulation of cabotegravir (CAB-ULA) showed potential for dosing every four months. In Respiratory, depemokimab is advancing with data expected in H1 2024. In Oncology, Blenrep demonstrated significant progression-free survival benefits in two Phase III trials for multiple myeloma, and Jemperli showed a significant overall survival benefit in endometrial cancer Infectious Diseases The FDA accepted a priority review for Arexvy to expand its use to at-risk adults aged 50-59. Bepirovirsen for chronic hepatitis B received FDA Fast Track designation. Gepotidacin met its primary endpoint in a Phase III trial for gonorrhoea, demonstrating non-inferiority to a leading combination therapy. A Biologics License Application for the 5-in-1 MenABCWY vaccine candidate was also accepted by the FDA - The FDA accepted an application to expand Arexvy's indication to adults aged 50-59 at increased risk for RSV, with a decision expected in H1 2024[87][184] - Gepotidacin showed positive Phase III results in uncomplicated urogenital gonorrhoea, meeting its primary endpoint of non-inferiority against a standard combination therapy[190] - The FDA accepted a Biologics License Application for the 5-in-1 MenABCWY vaccine candidate with a PDUFA action date of February 14, 2025[192] HIV ViiV Healthcare presented positive data for its long-acting HIV treatments. The LATITUDE Phase III trial showed superior efficacy for Cabenuva over daily oral therapy in individuals with adherence challenges. Additionally, a Phase I study of an investigational ultra long-acting formulation, CAB-ULA, indicated potential for dosing intervals of at least four months - The LATITUDE Phase III trial demonstrated that long-acting injectable Cabenuva had superior efficacy in maintaining viral suppression compared to daily oral therapy for patients with adherence challenges[195] - A Phase I study of cabotegravir ultra long-acting (CAB-ULA) showed the potential for dosing at intervals of at least four months, a key step towards less frequent HIV treatment and prevention[196] Respiratory/Immunology The pipeline in this area is advancing with camlipixant in Phase III for refractory chronic cough and depemokimab, an ultra-long-acting biologic for severe asthma and other IL-5 mediated conditions, with initial Phase III data expected in H1 2024. The MATINEE Phase III trial for Nucala in COPD is also expected to read out in H2 2024 - Depemokimab, an ultra-long-acting anti-IL5 biologic dosed every six months, is expected to have its first Phase III data readouts for severe asthma in H1 2024[199][200] - The MATINEE Phase III trial for Nucala in patients with chronic obstructive pulmonary disease (COPD) is expected to read out in H2 2024[202] Oncology The oncology pipeline showed strong results. The DREAMM-7 Phase III trial for Blenrep in multiple myeloma showed a 59% reduction in risk of disease progression or death versus standard of care. The DREAMM-8 trial also met its primary endpoint. For Jemperli, the RUBY Phase III trial showed a 31% reduction in the risk of death in the overall population of patients with advanced or recurrent endometrial cancer, leading to an FDA priority review for a broader indication - The DREAMM-7 trial showed Blenrep plus BorDex reduced the risk of disease progression or death by 59% and extended median progression-free survival to 36.6 months vs. 13.4 months for the standard of care in relapsed/refractory multiple myeloma[203] - The DREAMM-8 trial for Blenrep also met its primary endpoint of progression-free survival, with results to be presented at ASCO 2024[204] - The RUBY Phase III trial for Jemperli demonstrated a 31% reduction in the risk of death in the overall population of patients with primary advanced or recurrent endometrial cancer. The FDA has accepted a supplemental BLA for a broader indication with a decision date of August 23, 2024[207][208]