GlaxoSmithKline's COVID-19 antibody delivers as Nucala, Trelegy eclipse £1B landmark

GlaxoSmithKline ended 2021 on a relatively high note saleswise, with its COVID-19 antibody therapy delivering a nice contribution and two key meds surpassing the 1 billion pound annual revenue mark for the first time.

Xevudy, the Vir Biotechnology-partnered COVID therapy, delivered 828 million pounds ($1.12 billion) sales in the fourth quarter. Out of the 25% growth GSK’s drug business enjoyed at constant currencies during the three-month period, the antibody contributed nearly 20 percentage points, the company said.

Based on existing supply contracts for more than 1.7 million doses—about 40% of which were delivered in 2021—GSK expects about 1.4 billion pounds in sales from Xevudy in 2022.

Xevudy is currently the only remaining antibody authorized in the U.S. to treat patients with the dominant omicron variant, but the rising interest in Pfizer’s oral pill Paxlovid makes future demand around Xevudy less certain. That’s why GSK isn’t including Xevudy in any of its 2022 calculations.

While Xevudy has significantly lifted GSK’s drug business, vaccines were another story at the British pharma giant. GlaxoSmithKline has partnered with Sanofi on an adjuvanted vaccine program that hasn't made it to market, so its pandemic adjuvant sales of 92 million pounds weren't enough to counter the company's overall vaccine slowdown.

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Blockbuster shingles vaccine Shingrix has yet to recover to 2020’s level thanks to the surge of omicron leading to a new round of COVID-19 vaccinations. Sales from the star shot in the quarter came in at £597 million, down 7% over the same period last year, though 7% above industry watchers’ expectations. Overall, GSK reported a 7% decline for its vaccine franchise at constant currencies in the fourth quarter.

Shingrix is on a recovery track, GSK chief commercial officer, Luke Miels, told investors during a call Wednesday. From a low in the second quarter of 2021, the vaccine’s sales jumped 70% sequentially in the third quarter, and then 19% in the fourth. Over the longer term, Miels reconfirmed GSK’s plan to double Shingrix’s sales by 2026 versus 2020.

GSK is providing its pandemic adjuvant to Sanofi and SK Bioscience for their COVID-19 vaccine candidates. Both those shots are expected to read out late-stage efficacy data in the first half of 2022. But the vaccines, if successful, would enter a market that’s already been filled with highly efficacious mRNA shots.

When asked about the market potential of the Sanofi-partnered shot during a separate press call Wednesday, GSK CEO Emma Walmsley pointed out that many low-income countries are far from fully vaccinated. Plus, she raised the question of sustained efficacy for mRNA shots, reverting to the fact that GSK’s adjuvant has helped Shingrix achieve at least eight years of efficacy. GSK also has a collaboration with CureVac on next-generation mRNA vaccines which Walmsley hopes could play a role in the endemic or booster market.

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Beyond vaccines, two respiratory therapies in GSK’s pharma department—three-in-one inhaler Trelegy and asthma injection Nucala—crossed 1 billion pounds in annual sales for the first time in 2021, with sales of 1.22 billion pounds and 1.14 billion pounds, respectively.

For Trelegy, the drug continued to grow its share in the U.S. triple COPD market to 53% as of the fourth quarter, according to a presentation. As for Nucala, the IL-5 antibody maintained its market share edge over AstraZeneca’s rival drug Fasenra.

In 2022, GSK could see a new 1 billion-pound-plus asset in HIV two-drug regimen Dovato. First approved by the FDA in 2019, Dovato more than doubled sales last year to 787 million pounds, and its fourth-quarter haul of 254 million pounds came 8% above the Street’s previous estimates.

GSK is gradually shifting its focus of the HIV franchise to long-acting regimens, starting with Cabenuva for treatment and newly approved Apretude for prevention. The pandemic has made switching patients over to the new drugs difficult, Deborah Waterhouse, CEO of GSK’s HIV-focused ViiV Health, said on the call. For 2022, the company’s focus will be on improving awareness and access, she said.

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Meanwhile, an upcoming demerger of the consumer health joint venture with Pfizer remains the top priority at GSK these days. After rumored buyout interest and a much-publicized rejection of a $68 billion buyout bid from Unilver, Walmsley told reporters Wednesday that the company remains on track for a demerger this summer. She declined to offer a more precise date.

Overall, GSK reported 2021 sales of 34 billion pounds, a 5% increase at unchanged exchange rates over the previous year. Excluding pandemic products, GSK expects to deliver biopharma sales growth between 5% to 7% in 2022 at constant currencies.