GSK Gsk Plc

Guidance all at CER and excluding COVID-19 solutions

The Total results are presented in summary above and on page 8 and Core results reconciliations are presented on pages 20 and 23. Core results are a non-IFRS measure that may be considered in addition to, but not as a substitute for, or superior to, information presented in accordance with IFRS. The following terms are defined on page 52: Core results, £% or AER% growth, CER% growth, COVID-19 solutions, turnover excluding COVID-19 solutions; and other non-IFRS measures. GSK provides guidance on a Core results basis only, for the reasons set out on page 18. All expectations, guidance and targets regarding future performance and dividend payments should be read together with 'Guidance and outlooks, assumptions and cautionary statements' on page 54. (1) CRSwNP - Chronic rhinosinusitis with nasal polyps.

2024 Guidance

GSK confirms its full-year sales, core profit and EPS guidance at constant exchange rates (CER) and expects to deliver broadly around the middle of the existing ranges. All guidance, expectations and full-year growth rates exclude any contributions from COVID-19 solutions.

Despite some challenges this quarter, particularly with lower than anticipated vaccine demand and a tough comparator, GSK delivered growth in both sales and core profits in the quarter at CER. Specialty Medicines continue to grow strongly, particularly reflecting successful new launches in Oncology and for long-acting HIV medicines. General Medicines, including Trelegy, also continued to perform better than expected.

Sales are expected to grow between 7 to 9 per cent range at CER. Improved sales performances in Specialty and General Medicines are expected to offset lower sales growth of Vaccines this year, primarily due to lower sales of Arexvy and Shingrix. Key factors driving Arexvy performance are guideline restrictions, prioritisation of COVID vaccination in the US, and an unfavourable comparison to the vaccine's outstanding launch last year.

This guidance is supported by the following revised turnover expectations for full-year 2024 at CER:

Core operating profit is expected to grow between 11 to 13 per cent at CER. This is despite a 6 percentage point impact to operating profit growth following the loss of the majority of Gardasil royalties effective from the beginning of 2024. SG&A continues to be expected to grow low-single digits, with effective cost control driving operating leverage and further margin improvements. R&D expenditure is expected to increase slightly below sales growth and royalty income is expected to be around £600 million for the full year.

Core earnings per share is expected to increase between 10 to 12 percent at CER. Expectations for non-controlling interests remain unchanged relative to 2023, and GSK continues to anticipate an increase in the core effective tax rate to around 17% for the full year following implementation of new global minimum corporate income tax rules which came into effect from 1 January 2024 in line with the Organisation for Economic Co-Operation and Development 'Pillar 2' model framework.

Additional commentary

Dividend policy

The Dividend policy and the expected pay-out ratio remain unchanged. Consistent with this, and reflecting strong business performance during the quarter, GSK has declared a dividend for Q3 2024 of 15p per share and expects to declare a dividend of 60p per share for the full year 2024.

COVID-19 solutions

For the full year 2024, GSK does not anticipate any further COVID-19 pandemic-related sales or operating profit. Consequently, and in comparison to 2023, it is anticipated that the full year growth in sales and Core operating profit will be adversely impacted by one and two percentage points, respectively.

Exchange rates

If exchange rates were to hold at the closing rates on 30 September 2024 ($1.34/£1, €1.20/£1 and Yen 191/£1) for the rest of 2024, the estimated impact on 2024 Sterling turnover growth for GSK would be -5% and if exchange gains or losses were recognised at the same level as in 2023, the estimated impact on 2024 Sterling Core Operating Profit growth for GSK would be -8%.

Results presentation

A conference call and webcast for investors and analysts of the quarterly results will be hosted by Emma Walmsley, CEO, at 12 noon GMT (US EDT at 8 am) on 30 October 2024. Presentation materials will be published on www.gsk.com prior to the webcast and a transcript of the webcast will be published subsequently.

Notwithstanding the inclusion of weblinks, information available on the company's website, or from non GSK sources, is not incorporated by reference into this Results Announcement.

Nucala, is an IL-5 antagonist monoclonal antibody treatment for severe asthma, with additional indications including chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). In Q3 2024, sales growth continued to be strong, particularly in Europe and International regions, reflecting higher patient demand for treatments addressing eosinophilic-led disease.

In Q3 2024, strong Oncology sales growth continued driven by increasing patient demand for Zejula, a PARP(1) inhibitor, Jemperli, a PD-1(2) blocking antibody, and Ojjaara/Omjjara, a daily JAK1/JAK2 and ACVR1(3) inhibitor. Jemperli, a medicine for front-line treatment in combination with chemotherapy for patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, received US FDA approval in the quarter expanding the indication to include all adult patients with primary advanced or recurrent endometrial cancer. Jemperli sales continued to grow strongly with sales of £130 million delivered in the quarter. Ojjaara/Omjjara, a treatment for myelofibrosis patients with anaemia, launched in the US in Q3 2023, in the UK and Germany in Q1 2024, and in Japan in Q3 2024, has seen strong uptake since launch and delivered £98 million of sales in the quarter.

Zejula, a PARP inhibitor treatment for ovarian cancer, continues to grow globally across all regions with sustained increase in patient demand and higher volumes, further enhanced by positive price impacts in the US. Growth in the quarter was adversely impacted by channel inventory build associated with the launch of the tablet formulation in the US in Q3 2023, partially offset by favourable impacts from comparator adjustments to returns and rebates.

Sales include contributions from both the Respiratory and Other General Medicine portfolios. In Q3 2024, sales growth increased primarily driven by Trelegy, a chronic obstructive pulmonary disease (COPD) and asthma medicine, with strong demand across all regions. Performance was adversely impacted by the removal of the Average Manufacturer Price (AMP) cap on Medicaid drug prices in the US. This removal impacted Advair, Flovent, and Lamictal due to significant pricing reductions, reduced commercial contracting, and the decision to discontinue branded Flovent. However, this has been fully offset by the increased use of authorised generic versions of Advair and Flovent while, significantly, continuing to provide access to patients.

In Q3 2024 and YTD, sales growth reflected Trelegy's strong performance in all regions and the increased demand for Anoro, particularly in Europe and International. Seretide/Advair also grew in the quarter due to favourable impacts from comparator adjustments in the US to return and rebates. As mentioned above, in the US adverse impacts from the removal of the AMP cap were fully offset by the increased use of authorised generic versions of Advair and Flovent, providing access to medicines for patients.

Trelegy is the most prescribed single inhaler triple therapy (SITT) treatment worldwide for COPD and asthma. In Q3 2024 sales grew 16% with continued strong growth across all regions, reflecting patient demand, single-inhaled triple therapy class growth, and increased market share. YTD growth of 31% was positively impacted by favourable US pricing impacts in the first six months of 2024, including adjustments to return and rebates, which moderated in Q3 2024.

Seretide/Advair is a combination treatment used to treat asthma and COPD. In Q3 2024, sales grew 13% reflecting growth in the US driven by favourable impacts from comparator adjustments to returns and rebates, partially offset by decreases in sales in Europe and International from continued generic erosion by competitor products. The decline year to date reflected continued generic erosion from competitor products in Europe and International, partially offset by mid-single digit growth in the US, driven by favourable impacts from comparator adjustments to returns and rebates, and the continued use of authorised generics offsetting the removal of the AMP cap on Medicaid drug prices.

Performance in Q3 2024 remained consistent with YTD performance, and continued to be impacted by ongoing generic competition globally.

Footnotes:

By Region

Vaccine sales decreased in Q3 2024 and YTD primarily in Arexvy due to a more restrictive recommendation from the from the Advisory Committee on Immunization Practices (ACIP) for individuals aged 60 to 74, RSV vaccine de-prioritisation in the current season due to earlier COVID-19 vaccination and lower channel inventory versus a significant launch stocking in the comparator quarter. Shingrix also decreased reflecting lower demand driven by the continued challenge of activating harder-to-reach consumers. Established Vaccines grew due to increased demand partly offset by adverse CDC stockpile movements.

Specialty Medicines growth continued in Q3 2024 and YTD driven by Oncology and HIV performance and continued growth in Nucala and Benlysta.

General Medicine's growth in Q3 2024 and YTD was primarily driven by increased demand for Trelegy, with strong volume growth driven by patient demand, growth of the SITT market, and price benefits from channel mix. Performance continues to be impacted following the removal of the AMP cap on Medicaid drug prices, which particularly impacted Advair, Flovent and Lamictal. This was fully offset by the increased use of authorised generic versions of Advair and Flovent, providing access to medicines for patients.

In Q3 2024, Vaccine sales growth was broadly flat driven by Bexsero recommendation in Germany and increased Established vaccines sales partly offset by lower Shingrix demand in Germany. YTD sales also reflected Shingrix growth across several markets following public funding expansion.

Specialty Medicines sales grew in the quarter and YTD by a double-digit percentage due to the performance in Oncology, Benlysta in immunology, and Nucala in respiratory including the impact of new indication launches. HIV growth continued in the quarter and YTD at a high single digit percentage.

General Medicines sales were strong in the quarter with mid-single digit growth, reflecting strong performance on Trelegy and Anoro, partially offset by declines across other general medicines. YTD performance remains broadly stable.

In Q3 2024, sales increased 8% which reflected year-on-year exchange movements in several International markets compared to Q3 2023.

Vaccines' strong growth in Q3 2024 and YTD was driven by Shingrix related to the national immunisation programme in Australia and supply to our co-promotion partner in China. Established vaccines sales declined in Q3 2024 impacted by the timing of deliveries across the region, lower demand and competitive pressure for Synflorix and Cervarix, but grew YTD on increased supply and higher demand for MMR/V vaccines and Boostrix.

Specialty Medicine's double-digit growth in the quarter and YTD was driven by HIV, Nucala in Respiratory, Benlysta in Immunology, and Zejula in Oncology.

General Medicines sales grew low single digit percentage in the quarter and YTD, with strong growth in Trelegy partially offset by a decrease in other general medicine products.