Armed with a trio of recent high-profile approvals, GSK is banking on its specialty medicines to drive its next wave of growth, even as investor enthusiasm cooled Wednesday morning amid reports of restructuring charges and a vaccine sales dip at the British drugmaker.
The company’s most recent green light came by way of Hibsago, an antisense oligonucleotide bringing the promise of a functional cure for the first time for certain patients with chronic hepatitis B virus infection.
With regulatory go-aheads now locked down in the U.S. and Japan, China is the next priority for GSK. The company’s president of global product strategy, Nina Mojas, noted on a conference call that the three countries comprise “around 80% of the potential value for Hibsago.”
Many analyst shops are pinning blockbuster expectations on Hibsago, with the team at Jefferies last week affirming a projection of 2.2 billion pounds sterling (around $3 billion) in potential peak sales opportunities.
Both China and Japan have made treatment of hepatitis B a national priority, and in Japan, GSK has received a “very positive reimbursement decision” as doctors have “already identified patients to receive therapy,” Mojas added.
Conversely, hepatitis B is “very concentrated” in the U.S., with most patients clustered in just five states, the GSK exec pointed out.
“We have launched with a focus on patients with surface antigen level lower than 1,000,” Mojas said, referring to the detectable level of the virus in the blood, “where the opportunity to have a positive experience leading to functional cure is the highest.”
In GSK’s B-Well 1 and B-Well 2 trials that led to Hibsago’s approval, the medicine allowed 19% of patients in a broad population to achieve the program’s defined criteria for a functional cure, with that rate rising to 26% among patients with HBV surface antigen below the 1,000 international units per milliliter threshold at the trial’s start.
The drug’s label specifically indicates Hibsago for patients who’ve been taking nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) therapy for at least six months, and who have suppressed hepatitis B virus DNA and virus surface antigen levels no greater than 3000 IU/ml.
Following last week’s FDA nod, GSK now expects the medicine to become available in the U.S. within roughly the next 10 days, Mojas suggested on Wednesday.
While the green light no doubt marks a foundational shift in hepatitis B treatment potential, safety and monitoring requirements tied to Hibsago have the potential to “cause debate” about the medicine’s trajectory in real-world practice, the Jefferies team noted last week.
In drawing attention to Hibsago’s black box warning for hepatic flares and thrombocytopenia, the Jefferies analysts noted that a weekly or every-other-week monitoring burden for patients could “work against the commercial uptake and could slow adoption outside specialist hepatology centers."
Addressing those uncertainties on GSK’s third-quarter earnings call, Mojas said that those requirements are likely to “evolve” over the course of an individual’s treatment journey.
“It’s quite important in the initial periods, and we do expect that physicians will monitor early, seeing if their patients are by any chance one of those who have early elevation of ALT or … severe thrombocytopenia,” she said.
After that initial attention to potential safety flags, “we expect that physicians and patients could find some kind of balance of when and how frequently they do the monitoring,” she explained.
Aside from Hibsago, GSK’s vanguard of new launches is further girded by the company’s first approved lung cancer medicine Jideytro—cleared by the FDA in July—and Jemperli, which recently picked up a first-in-class nod in a specific type of rectal cancer following a buzzy early trial readout.
All three drugs form part of GSK’s specialty medicine roster, which did the bulk of the heavy lifting in the third quarter and grew sales by 15% to 3.9 billion pounds ($5.2 billion) with Cabenuva at the helm.
The long-acting HIV treatment grew sales 35% during the period, with Mojas noting that “more than 75% of switches continue to come from competitors in the U.S.” She added that, as the current lone long-acting injectable HIV treatment, the drug has built out “a strong foundation with patients who prefer to take medicines less frequently.”
This could in turn set up Cabenuva for further success in 2027, when data on a three-times-a-year formulation is due to read out, Mojas said. Cabenuva is currently approved in both once-monthly and every-other-month regimens.
On the other end of the spectrum, vaccine sales slumped 2% in the quarter, “with the drag from Shingrix China destocking,” Mojas noted.
That was countered somewhat by 12% growth in GSK’s meningitis portfolio, however.
All told, GSK’s third-quarter sales worked out to 8.9 billion pounds (around $11.8 billion), good for 5% growth over the same period in 2025.
Whether it can be credited to the vaccine results, or further details on GSK’s downsizing strategy and a newly reported 328 million pounds in Q3 charges related to its restructuring, investors didn’t react as warmly to the earnings news as the company might have hoped. As of late Wednesday morning, the British pharma’s stock was trading down around 3.38%.
Looking forward, GSK stood by a number of its established targets in both the near- and medium-term. The company continues to expect overall sales growth between 3% and 5% this year, and it remains steadfast in its ambition to reach sales of over 40 billion pounds ($53 billion) by 2031.