The whole respiratory syncytial virus (RSV) vaccine field took a beating when the Centers for Disease Control and Prevention’s (CDC's) immunization committee doled out a limited recommendation last month. And it’s showing in GSK’s forecast for 2024.
GSK on Wednesday took its 2024 vaccine sales projection down by a notch. Rather than high single- to low double-digit percent growth, the British pharma now expects vaccine sales to increase by low- to mid-single-digit percent this year at constant exchange rates.
The company’s flagship shingles vaccine Shingrix disappointed in the second quarter. After driving continued growth, Shingrix posted a surprise 5.5% decline year over year during the three months, with its 832 million pounds sterling ($1.07 billion) haul falling 17.9% behind analysts’ expectations.
The U.S. market turned out to be the main drag with sales down by 36%. GSK attributed the poor performance to channel inventory reductions, changes in retail vaccine prioritization thanks to new ways pharmacies process reimbursements from payers, and challenges in reaching additional consumers given Shingrix’s already high 37% penetration within its recommended population in the U.S.
Based on the second-quarter dip, GSK doesn’t expect Shingrix to grow in 2024. But GSK said Shingrix was not the force driving the lower guidance for vaccines—the “pharmacy structural element” was a one-time shift, and physicians’ enthusiasm remains strong, GSK’s chief commercial officer, Luke Miels, told investors Wednesday during the company’s second-quarter earnings call.
Instead, the reduced projection reflects the CDC’s revised recommendations for RSV vaccinations. Back in June, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to limit its policy in the 60-to-74 age group to those with underlying medical conditions that could predispose them to more severe RSV disease, while delaying a decision on the 50-to-59 group despite the FDA’s approval for GSK’s Arexvy earlier, leaving the strongest backing only for people 75 and older.
The restrictions shocked the industry as RSV vaccine developers saw their stock prices tumble at the news. Airfinity, a London-based health analytics company, has slashed the RSV market value for seniors in the U.S. from $4.7 billion to $1.7 billion in 2030.
But GSK CEO Emma Walmsley, during a Wednesday press conference, said she’s confident that “[20]25 will be a year of growth, and that peak-year sales is secure.” GSK has put Arexvy’s peak annual sales at 3 billion pounds.
The new policy comes as RSV vaccines are entering only their second season. GSK’s Arexvy has been competing with Pfizer’s Abrysvo, and Moderna is joining the race with newly FDA-approved mRESVIA.
Walmsley pointed out that Arexvy’s 90%-plus efficacy in high-risk individuals is the strongest among existing shots, and that the latest ACIP recommendation has put GSK in a good position.
Based on existing contracts, GSK foresees Arexvy will retain market leadership during the 2024-25 season, Miels said. But he declined to offer the exact number of Arexvy’s share. In the previous season, GSK won two-thirds of the market against Pfizer.
During Pfizer’s second-quarter call Tuesday, U.S. commercial chief Aamir Malik said the New York pharma has “significantly strengthened” its contracting position for Abrysvo this coming season. He also pointed to the shot’s current needle-free reconstitution kit that doesn’t require to be frozen and thawed.
“I will also remind you that there’s many healthcare providers and pharmacies that prefer simplifying their vaccine management by having one vaccine for both older adults and maternal, which only Abrysvo can offer,” Malik said.
For GSK’s part, Miels noted that contracts for vaccines are typically constructed for pediatric and adult populations separately. What really counts, Miels said, “is the systems are willing to concentrate on single vaccines and separate them out more vigorously versus push them together.”
While GSK has maintained its long-term projection, which Miels said assumes that a booster is required, predicting Arexvy’s third-quarter performance may be difficult, because the CDC has not clarified the criteria for “high-risk” for the 60-to-74 age group.
“I think ACIP is going to be very conservative about broader coverage until they’ve got complete clarity in terms of benefit risk,” Miels said.
The ACIP has demanded more data, including real-world evidence from surveillance databases, to support RSV vaccines’ benefit-risk profile. GSK has two studies that will assess Arexvy’s efficacy, immunogenicity and safety over three RSV seasons, the company’s R&D chief, Tony Wood, Ph.D., said on the investor call.
“We want to see what this product looks like at three years because that is going to have a huge impact on pricing, durability, et cetera, which are all the things—and particularly in European contracts—that payers concentrate on,” Miels said.
Beyond Europe and the U.S., GSK has also had “some initial discussions” in China with its newly signed Shingrix partner Chongqing Zhifei Biologics around Arexvy, and the British drugmaker “would very much like to expand the collaboration to include RSV,” Miels said.
Despite weaker vaccines performance, GSK still dialed up its full-year guidance for the entire group as its long-acting HIV offerings, new launches in oncology and the COPD inhaler Trelegy continued to perform better than expected. The company now expects sales excluding COVID products to rise between 7% to 9% at unchanged exchange rates, compared with previously between 5% to 7%.