GSK tries to steady the ship as Arexvy sales plummet in wake of CDC guidance changes

 To hear GSK CEO Emma Walmsley tell it, the third quarter presented “some challenges” for the drugmaker. For the company’s closely watched respiratory syncytial virus (RSV) vaccine Arexvy, those challenges led to drastically reduced sales.

After a stunning ascension to blockbuster status in its RSV debut last year, GSK’s Arexvy has quickly fallen back to earth this year. During the third quarter, the shot’s sales plummeted 74% year over year to 188 million pounds sterling ($244 million).

To pile on, GSK’s flagship shingles vaccine Shingrix also saw a 10% sales reduction in the third quarter to 739 million pounds ($956 million). The number missed analysts’ projections by 13%.

As a result of the underperformances, GSK dialed down its annual vaccine revenue guidance for a second time this year. Now, the company is forecasting a low-single-digit percentage decline compared with 2023.

In July, the British pharma had expected its 2024 vaccine sales to grow sales by low- to mid-single-digit percentages, a forecast that was lower than the company's original high single-digit to low double-digit percentage growth target.

Arexvy has suffered a triple whammy, GSK’s chief commercial officer Luke Miels said on an investor call Wednesday. One obvious factor is the narrowed immunization recommendations from the CDC. In addition, many in the U.S. have started prioritizing COVID vaccines, and low seasonal RSV rates have also played a role, according to Miels. 

Last year’s third quarter was also a tough comparator, Miels continued, because two-thirds of sales at that time were related to inventory stocking for a much-anticipated RSV vaccination debut.

Arexvy’s decline was felt much more acutely at GSK compared with a simultaneous third-quarter sales drop for Pfizer and its RSV vaccine competitor Abrsyvo. Partly thanks to a slower start last year, Abrysvo only saw sales drop 5% in the third quarter to $356 million. In the U.S., sales of the Pfizer shot declined 15% to $318 million.

Now, GSK is adopting what Walmsley called “conservative” assumptions that the CDC’s immunization advisory committee will not change its RSV guidelines in 2025. The company therefore expects “limited growth” from its vaccines department next year.

Nevertheless, GSK execs assured investors on Wednesday’s call that they’re confident Arexvy can eventually achieve peak sales of more than 3 billion pounds.

“Beyond 2025, for Arexvy, we expect further successful rollout, and that public health recommendations for cohort expansion and revaccination will be confirmed alongside international penetration, given the patient need and the protection this vaccine can offer against RSV,” Miels said.

In the U.S., about 80% of those for whom the CDC recommends an RSV shot have not yet been vaccinated, Walmsley noted.

Still, GSK may face annual collisions with COVID vaccination during each RSV season. To help cope with that, GSK is examining co-administration of Arexvy with other shots and reviewing the option to potentially “deseasonalize” Arexvy administration.

“That’s what pharmacists tell us they want, in terms of just managing their workflow, staffing levels,” Miels said. “So I think we will get there in the mid to long term with this vaccine.”

Outside the U.S., earlier this year, the U.K. government picked Pfizer to supply 5 million doses of its RSV shot to the country over the next two years. In Germany, an independent vaccine advisory panel known as STIKO in August backed both Pfizer’s Abrysvo and GSK’s Arexvy in people 75 or older.

After dealing with various authorities in different parts of the world, GSK has got “a pretty good idea of the pricing point” for Arexvy, Miels said.

Although much of the recent investor focus is on weakness in GSK’s vaccines department, the company’s specialty medicines group—which includes HIV, immunology and oncology medicines—has become a bigger franchise than vaccines. This sector, however, had its own problems in the third quarter. Sales from GSK’s two HIV long-acting products, Cabenuva and Apretude, both came in below analyst expectations.

Still, despite disappointing sales from vaccines, GSK maintained its 2024 sales projection thanks to a relatively decent showing from the specialty medicines division. The bright spot was oncology, which saw third-quarter sales grow 94% year over year at constant exchange rates. The oncology unit's quarterly haul of 373 million pounds was 3% ahead of consensus estimates.

https://www.fiercepharma.com/pharma/gsk-tries-steady-ship-arexvy-sales-plummeted-amid-unfavorable-vaccination-policies