GSK PLC on Wednesday raised its 2022 guidance and said its respiratory syncytial virus older adult vaccine candidate has been granted priority review by the US Food & Drug Administration.

The Brentford, London-based biopharmaceutical firm reported revenue of £7.83 billion in the third quarter, rising 18% from £6.63 billion a year before.

Pretax profit dropped by 15% however, to £1.01 billion from £1.19 billion, as selling, general and administration expenses increased to £2.06 billion from £1.68 billion a year ago.

GSK noted strong growth in Specialty Medicines, and record sales for its shingles vaccine Shingrix. In Speciality Medicines, revenue amounted to £2.75 billion during the recent quarter. In the nine months to September 30, revenue amounted to £8.59 billion.

‘GSK has delivered another quarter of excellent performance, with strong growth in Specialty Medicines, record sales for our shingles vaccine, Shingrix, and further improvements in adjusted operating profit. We are again raising our full-year guidance and expect good momentum in 2023, further strengthening our confidence in our performance outlooks, driven by Shingrix global expansion and expected new launches including our new RSV vaccine,’ Chief Executive Officer Emma Walmsley said.

Looking ahead, GSK now expects to deliver sales growth of between 8% and 10% at constant exchange rates in 2022, and growth in adjusted operating profit of between 15% and 17% at constant exchange rate. The guidance excludes any contribution from Covid-19 vaccines and treatments.

The company added that it expects strong double-digit growth and record annual sales in 2022 for Shingrix, as a result of strong demand in ‘existing markets and continued geographical expansion’.

GSK declared a dividend of 13.75 pence for the third quarter, down 42% from a restated 23.75p a year prior. GSK said there is no change to its expected full-year dividend of 61.25p per share, with another 13.75p payout planned for the fourth quarter. GSK expects to pay a dividend of 56.5p in 2023. All dividends are restated to account for the share consolidation that GSK conducted following the spin-out of its consumer arm as Haleon PLC back in July.

Separately, GSK said the FDA has accepted the biologics license application for its RSV older-adult vaccine candidate, and granted it priority review, which means it will expedite the review of the BLA, reducing the review period by four months.

‘If approved, GSK’s RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection,’ the drug maker said.

Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV is a common contagious virus affecting the lungs and breathing passages.

GSK said the BLA is based on positive data from a prespecified interim analysis of the AReSVi-006, or adult respiratory syncytial virus, phase three trial, which showed high overall vaccine efficacy against RSV lower respiratory tract disease in adults aged 60 years and older.

Early last month, the respiratory vaccine candidate was accepted for review by the Japan Ministry of Health, Labour & Welfare.

Shares were up 1.3% at 1,465.20 pence each on Wednesday morning in London.

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