Shingrix and Trelegy shield GSK from Advair fallout

GlaxoSmithKline is expecting flat earnings this year, having earlier forecast a decline, as rising sales of new drugs have helped offset the impact of generics on its Advair blockbuster in the US.

The star of the show in the third quarter was shingles vaccine Shingrix, sales of which rose by 87% to reach £535 million, well ahead of analyst expectations, on the back of strong uptake in the US, Canada and Germany.

New respiratory drugs Nucala (mepolizumab) for severe asthma and Advair follow-up Trelegy (fluticasone furoate, umeclidinium, and vilanterol) made a solid supporting cast in the three-month period. Nucala rose 40% to £203 million, while Trelegy for chronic obstructive pulmonary disease (COPD) more than doubled to £139 million.

The growth products helped GSK to a 16% increase in turnover to £9.39 billion, despite Advair continuing its steady decline with a fall of a third to £418 million, with a two-thirds decline in the US market.

The turnover increase was improved by the consolidation of Pfizer’s consumer health business into a new joint venture, but even without that boost was still up 11%.

GSK chief executive Emma Walmsley has said since taking the helm that GSK needs its new products to fire on all cylinders while it revamps a new product portfolio that has been viewed as a lacklustre, and the first objective seems to be on track, with the company raising its earnings guidance for the year from a loss to flat.

On the second, Walmsley said GSK is gearing up for three new filings in oncology before the end of the year.

The includes BCMA-targeting antibody-drug conjugate belantamab mafodotin for fourth-line multiple myeloma treatment, as well as recently-acquired PARP inhibitor Zejula (niraparib) as a first-line maintenance therapy for ovarian cancer and PD-1 inhibitor dostarlimab in second-line endometrial cancer.

Trelegy has also been filed for approval in asthma, and Nucala picked up its first approval – in Europe – in a new self-administered formulation that should help cement its position as the lead biologic for severe asthma in the market, said Walmsley.

It wasn’t all positive news, however. GSK’s HIV franchise – sold via its ViiV joint venture – has been among its best performers for some time, but overall revenues for the business were flat in the third quarter due to increased competition, mainly from arch-rival Gilead Sciences.

GSK has been pushing its two-drug combinations for HIV such as Juluca (dolutegravir/rilpivirine) and new launch Dovato (dolutegravir/lamivudine), but chief financial officer Iain Mackay said the company “has anticipated it will take several quarters for them to become a significant contributor to growth”.

Together the two new drugs made £119 million in the third quarter, which GSK said offset declines in three-drug combination Triumeq (abacavir/dolutegravir/lamivudine), which has been hit by competition, notably from Gilead’s fast-growing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).

There was also the usual update on R&D casualties, which this time included  RIP1k inhibitor GSK3145095 for pancreatic cancer, and PI3Kd inhibitor GSK2292767 for respiratory diseases.

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