Bristol-Myers Squibb’s immuno-oncology blockbuster Opdivo continued its phenomenal growth in the last three months of 2016, but is showing signs of losing momentum.
Opdivo sales more than doubled to $1.3bn in the quarter, up from $475m a year ago, but is expected to experience some slowdown after the drug failed a trial in first-line non-small cell lung cancer (NSCLC), handing an advantage to Merck & Co’s rival therapy Keytruda (pembrolizumab).
Quarter-on-quarter growth gives an indication that may already be happening. BMS recorded sales of $920m for Opdivo in the third-quarter last year so the overall trend remains strong. In the US however, third quarter sales came in a $712m in Q3 and barely moved to $715m in the last three months of the year.
BMS has now cut its guidance for 2017 by 15 cents, saying it expects earnings per share to be in the $2.70-$2.90 range, which analysts have attributed at least in part to the Opdivo effect and the prospect of competition from new immuno-oncology drugs from the likes of Roche, Pfizer/Merck KGaA and AstraZeneca.
One analyst – Leerink’s Seamus Fernandez – suggested the near-term weakness could even make BMS a takeover target, particularly as Opdivo is still firmly tipped for mega-blockbuster status as new indications are added to its label.
BMS has just picked up FDA approval for Opdivo for second-line squamous cell carcinoma of the head and neck (SCCHN), and a European approval in relapsed or refractory classical Hodgkin lymphoma, adding to existing approvals in melanoma, second-line NSCLC and renal cell carcinoma.
Overall, BMS reported fourth-quarter revenues up 22% to $5.2bn, with a solid showing from novel oral anticoagulant Eliquis (apixaban), which leaped 57% to $346m and rheumatoid arthritis therapy Orencia (abatacept), which was up 16% to $625m.
Fourth-quarter sales for BMS’ other immuno-oncology drug Yervoy (ipilimumab) were however largely flat compared to the prior-year period at $264m. The company has just abandoned plans to seek accelerated approval for Opdivo plus Yervoy in first-line NSCLC, setting back a possible approval to the latter half of 2018.