Hiv/Aids

GSK tips 12 blockbuster launches to soften HIV patent loss

GSK is moving to ease worries about the looming loss of exclusivity on its HIV blockbuster, setting out plans to launch at least 12 major products and deliver more than 38 billion pounds sterling ($48 billion) in risk-adjusted sales by 2031.

The company expects dolutegravir, which brought in (PDF) 5.4 billion pounds last year, to lose exclusivity in the U.S. and the EU from 2028 to 2030. With the HIV drug accounting for almost 20% of sales in 2023, the prospect of generic rivals turning a major product into a footnote in GSK’s earnings is a source of concern for investors as they evaluate how the company will look at the end of the decade.

GSK used its fourth-quarter results to try to allay those concerns. Talking on GSK’s results call with investors, CEO Emma Walmsley set out a “planned set of near-term new product launches, each with peak year sales potential of 2 billion pounds or more,” that will soften the impact of the loss of exclusivity.

The road map includes more than 4 billion in peak sales linked to both depemokimab, the long-acting anti-IL-5 treatment GSK is studying in asthma, and pneumococcal vaccines acquired in the $3.3 billion takeover of Affinivax. GSK tipped mRNA seasonal flu and combination sales to top out above 3 billion pounds and the cough candidate acquired in the $2 billion Bellus buyout to hit 2.5 billion pounds.

GSK is predicting more than 38 billion pounds in 2031 sales. Walmsley said GSK recognizes “there is development risk” and, “by definition, not everything will come through.” But, equally, the forecast is risk-adjusted and, as such, “there’s significant potential for upside with successful development outcomes,” the CEO said. 

Walmsley sees particular potential to outperform in specialty oncology, “reflecting the development risk and the upside returns.” The cancer side of the schedule features new opportunities for Jemperli, GSK’s PD-1 drug, and antibodies that target the CD226 axis. GSK has invested in all three CD226 checkpoints, namely TIGIT, CD96 and PVRIG, and believes the gamble may be rewarded with 2 billion pounds in peak sales.

Tony Wood, Ph.D., chief scientific officer at GSK, told investors that data on the CD226 axis will “begin to mature” toward the end of the year and will support conversations about “exploring our combinations with TIGIT in particular.” Lung and head and neck cancer are among the indications on GSK’s hit list.


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