UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine

GSK, homing in on a potential world-first vaccine approval in respiratory syncytial virus (RSV), figures its candidate could eventually net billions of dollars each year, executives said Wednesday.

Up for an FDA decision May 3—and recently embraced by a panel of outside experts—GSK’s candidate could soon become the first RSV vaccine approved for older adults. The shot is in the running to prevent lower respiratory tract disease from RSV in people ages 60 and up. In March, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously that the shot's data support its effectiveness, with the experts issuing a separate 10-2 vote in favor of the shot’s safety profile.

Awaiting the FDA's decision, GSK has “begun disease awareness activities where needed, and our launch preparations are well underway,” Luke Miels, the company’s chief commercial officer, said on a Wednesday call with analysts.

In an earnings presentation (PDF), GSK said it has “millions” of doses of the shot ready to ship. The company is also looking forward to a meeting with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in June to hash out potential vaccination schedules.

Hours after the company's first-quarter earnings call Wednesday, the European Medicines Agency recommended the shot—branded as Arexvy—for marketing authorization in older adults. EMA described the decision as an “intermediary step on Arexvy’s path to patient success,” noting the decision must be confirmed by the European Commission to OK sales of the drug across the continent. 

Meanwhile, GSK is still waiting for additional data to see how its vaccine’s efficacy stacks up over multiple RSV seasons, Miels said Wednesday. Depending on the “robustness” of second season data, GSK could price its shot at the “upper end” of a previously floated cost range, he said.

Specifically, GSK is weighing a price somewhere between the cost of high-dose flu shots and its shingles cash cow Shingrix. High-dose flu vaccines typically run in the $60-per-dose ballpark, while GSK’s Shingrix costs about $185 per dose before discounts.

While GSK looks poised to scoop up the first piece of the RSV pie, plenty of other competitors are close behind with their own promising candidates. Pfizer, for instance, recently scored a priority review from the FDA for its RSV prospect, RSVpreF, teeing up a potential approval decision as early as next month. Moderna has also logged a phase 3 win, although it has yet to submit its candidate to the FDA.

All in all, GSK is armed with a “competitive vaccine profile with compelling clinical evidence and multi-billion [dollar] Shingrix-like sales potential," Miels said.

A second shot to rival Shingrix’s high sales would certainly be a boon for GSK, which continued to ride its shingles vaccine’s strong momentum into a solid first quarter.

The shot contributed to a 9% increase in vaccine revenues to 2.04 billion pounds sterling (about $2.5 billion) and helped fuel 10% growth in companywide revenues—excluding COVID-19 products—to 7 billion pounds in the first quarter. When accounting for sales of COVID products, which GSK expected to decline compared with 2022, the company’s sales fell 8% versus the same period last year.

Specifically, Shingrix pulled down 833 million pounds (around $1 billion) in worldwide sales for the first three-month stretch of the year.

Aside from Shingrix, GSK touted the sales performance of its meningitis vaccines, its two-drug and long-acting HIV regimens, Benlysta in immunology, plus respiratory drugs Nucala and Trelegy. Combined, those medications plus Shingrix chipped in on more than 40% of GSK’s sales for the quarter.

Looking ahead, GSK confirmed its financial forecast for the year. For all of 2023, the company expects ex-COVID revenues to increase by 6% to 8%, with adjusted operating profit pegged to grow between 10% and 12%.

Editor's note: This story was updated to include information on Arexvy's marketing authorization recommendation from the EMA.