GSK's Arexvy eyes label expansion, fends off Moderna's mRNA threat

GSK's Arexvy continues to dominate the respiratory syncytial virus (RSV) vaccine market despite the looming threat of new competitors. Over the first quarter, Arexvy secured a market share of about two-thirds, translating to £182 million ($227 million) in sales. This marks a significant lead over Pfizer’s Abrysvo, which reported quarterly sales of $145 million. Currently, more than 70 million of the 83 million eligible individuals in the U.S. have received the Arexvy vaccine.

The rivalry between GSK and Pfizer dates back to last year when both companies were racing to get their RSV vaccines approved by the FDA. Arexvy has since achieved blockbuster sales of £1.2 billion ($1.5 billion) in its first year. GSK had previously projected peak sales to reach $3 billion, a figure that CEO Emma Walmsley remains confident in.

GSK is not complacent with its current success and continues to advance Arexvy's development. The next milestone is an FDA decision on extending the vaccine's use to adults aged 50 to 59. Currently, Arexvy is approved for individuals aged 60 and older. If approved, this expansion would add another 50 million U.S. adults to the vaccine’s potential market. This decision is expected in June, which would make Arexvy the first RSV vaccine approved for this younger age group.

Although sales for the next few quarters may be lower due to the seasonal nature of RSV, growth is anticipated to pick up in the fourth quarter. By that time, Moderna's mRNA RSV vaccine may also enter the market, as the FDA is expected to make a decision this month. GSK welcomes the upcoming competition, with Walmsley expressing confidence in the sustained demand for Arexvy. Chief Commercial Officer Luke Miels emphasized this optimism in a call with analysts, noting that the true impact of Moderna's entry will become clearer once the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices issues its recommendations. This will initiate a "race to lock down contracts" ahead of the next RSV season.

GSK's confidence in Arexvy is further bolstered by the success of its established shingles vaccine, Shingrix, which generated £945 million ($1.2 billion) in the last quarter, with half of the sales coming from global markets. The strong performance of Arexvy and Shingrix contributed to a 16% growth in GSK's broader vaccine portfolio. Specialty medicines saw a similar growth rate of 17%, while general medicines grew by 1%. Each of these sectors brought in revenues of £2.3 billion ($2.8 billion), £2.5 billion ($3.1 billion), and £2.6 billion ($3.2 billion), respectively.

Overall, GSK reported total quarterly revenues of £7.4 billion ($9.2 billion) and has adjusted its 2024 guidance to the upper end of the previously forecasted 5% to 7% growth range. The company remains optimistic about the future, driven by its strong performance in the vaccine market and ongoing developments in its product pipeline.

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