Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029.

But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK's shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018).

“It won't be the same rate of build as Shingrix was," Walmsley said as GSK presented its second-quarter earnings (PDF). "But we do think it is a really key pillar.”

The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for RSV vaccines will need time to build.

Arexvy won an FDA approval for people 60 and older in May, with the European Medicines Agency endorsement following in June. The company on Wednesday said it has shipped doses to distribution centers in the U.S., where it will compete with Pfizer’s Abryvso. Clinical trials indicate that Arexvy could have an efficacy edge.

“We’re very much looking forward to a scientific battle with Pfizer. It’s something we relish,” GSK’s commercial chief Luke Miels said. “The reception we’ve had from payers and pharmacy chains has been very encouraging.”

The company has said the price of Arexvy in the U.S. will fall between $270 and $295 per dose. GlobalData pegs the 2023 market for RSV vaccines at $1 billion, with growth to more than $9 billion by 2029.

Meanwhile, fueled by sales of Shingrix and its HIV medicines, GSK topped revenue expectations for the second quarter, generating £7.2 billion ($9.3 billion) in global sales and handily beating the consensus estimate of £6.8 billion. With the result, GSK boosted its annual revenue forecast from an increase of 6-8% to 8-10%. Accordingly, GSK’s projection of earnings per share increased from 12-15% to 14-17% for 2023.

It was an encouraging performance for a company in transition as it has spun off its consumer health business Haleon.

GSK’s vaccine portfolio accounted for £2 billion ($2.6 billion) of the haul, good for a 20% increase from the second quarter of 2022. In that division, Shingrix led the way with sales of £784 million ($1.14 billion), an 18% increase.

The company's HIV products also thrived in the quarter, with their sales coming in at £1.6 billion ($2 billion), a 12% year-over-year increase.

Source: fiercePharma.com