Celgene drugs drive BMS to a buoyant Q4, but Opdivo stalls

On February 7, 2020 BMS reported completed its merger with Celgene in November, enough time to help its revenues rise 33% to $7.95bn for the period, up from just under $6bn a year earlier, thanks to the contribution of drugs like blockbuster blood cancer drug Revlimid (lenalidomide) (Press release, Celgene, FEB 7, 2020, View Source,_but_opdivo_stalls_1324495 [SID1234554064]).

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Investors responded warmly to the figures, sending BMS’ share price up 3%, though it would likely have been a different story if the Celgene deal hadn’t come through in time.

Opdivo (nivolumab) grew modestly for the full-year, but declined 2% in the fourth quarter to $1.76bn after a slowdown throughout the year that BMS said stemmed largely from reduced sales in second-line non-small lung cancer (NSCLC).

The reason? First-line use of rival checkpoint inhibitors – mainly Merck & Co’s Keytruda (pembrolizumab) – have reduced the opportunity for later-line chemotherapies in this form of cancer, as well as some other tumours like small cell lung cancer and head and neck cancer.

BMS chief executive Giovanni Caforio said on a conference call that he expects Opdivo to return to growth in 2020, providing it gets additional launches in new indications, including first-line NSCLC.

That hinges on two studies – CheckMate-227 and CheckMate-9LA – which involved a combination of Opdivo with low-dose Yervoy (ipilimumab), its CTLA4 inhibitor.

BMS was forced to withdraw its filing in the EU based on the CheckMate-227 trial after the EMA said protocol changes had made the data uninterpretable, but its still under review in the US with an FDA verdict due in May.

Full data from CheckMate-9LA is due for presentation later this year, but BMS said in October it had met its main objective of improving overall survival.

"While we’re disappointed by the position taken by the CHMP, we continue to view the combination of Opdivo and Yervoy as a differentiated regimen with the potential for long-term survival and one that should be available to patients globally," said Caforio on the call.

Revlimid brought in almost $1.3bn between 20 November – when the takeover completed – and the end of the year, but it is facing the loss of patent protection in the US in 2023 and generics are already being launched in Europe.

Thankfully for BMS, it wasn’t only Celgene’s drugs that caused the revenue surge. BMS’ well-established anticoagulant Eliquis (apixaban) had another strong quarter with a 19% rise to just over $2bn, while multiple myeloma drug Empliciti (elotuzumab) grew by more than a third to $94m.

Meanwhile, Caforio is confident that Opdivo’s expected return to growth – plus a series of upcoming launches like multiple sclerosis drug ozanimod, Reblozyl (luspatercept) in myelodysplastic syndrome (MDS) and its CAR-T therapy franchise headed by liso-cel for B-cell lymphomas – sets the company up well for the future.

"The company is in a strong position and this is reflected in the performance of our business and the outlook we are providing today," he said. The company is predicting that full-year 2020 revenues will be between $40.5bn and $42.5bn.