Sir Andrew Witty’s last results presentation as chief executive of GlaxoSmithKline was a good one, with the UK drugmaker beating analysts’ expectations thanks to a good performance for HIV and new respiratory products.
He warned however that GSK faces “some level of uncertainty” as the prospect of “substitutable generic competition” to its big-selling respiratory drug Seretide/Advair (fluticasone propionate/salmeterol) builds in the US. That could leave incoming CEO Emma Walmsley with a tough task when she takes over in March.
At the moment, new respiratory products such as Relvar/Breo (fluticasone furoate/vilanterol) are covering the decline in Advair, which fell 20% to £975m ($1.2bn) in the fourth quarter of 2016, but that situation could change once additional generics become available in the US.
Teva has just picked up an FDA approval for its AirDuo RespiClick competitor; although GSK maintains its labelling means this is not a straight swap for Advair. Other generics from Mylan and Hikma are under regulatory review, however, which could be directly substitutable and accelerate the decline in the brand’s sales.
“This is a situation that is bound to evolve during the year,” Witty told shareholders, adding that the company has been preparing for the impact on US respiratory sales and new products will soften the blow.
If no substitutable Advair generic is approved, sales of the brand will decline 15%-20% globally due to “price and competitive pressures”, he said, but could slump to around £1bn in the US if a generic appears mid-year. Once the Advair effect is out of the way GSK will not face any other significant patent losses until the late 2020s, he added.
Overall, group sales rose 21% year-on-year to £7.6bn, around £100m ahead of expectations thanks to rising Breo sales as well as strong growth for HIV drugs Tivicay (dolutegravir) and Triumeq (dolutegravir/abacavir/lamivudine).
“As we move forward, the new products are going to be the ones that are going to be kicking in the cash flow and the profitability,” he said, pointing to the potential upcoming launches of shingles vaccine Shingrix and triple therapy for chronic obstructive pulmonary disease (COPD), which could be approved before the end of this year.