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Thursday, October 31, 2019

Bristol-Myers warns I-O blockbuster Opdivo will be ‘under pressure’ in 2020

Bristol-Myers Squibb’s Opdivo had been riding high even amid intense competition, particularly from Merck & Co.’s fast-growing Keytruda. But the immuno-oncology med hit something of a wall in the third quarter, and execs are warning that it’ll face a tough 2020.
Opdivo posted just 1% sales growth for the quarter, reaching $1.8 billion as I-O rivals like Merck’s Keytruda and Roche’s Tecentriq push the Bristol superstar on all sides.
That stagnant sales pace is worrisome in and of itself, but analysts are concerned that the drug’s dwindling second-line lung cancer sales and a significant gap before major data readouts in 2020 could put the drug in a tough position next year.
Bristol can take heart that anticoagulant Eliquis continues to swim in cash and its hoped-for merger partner Celgene also posted strong growth for the quarter. Still, Opdivo remains a sales linchpin, and Chris Boerner, Bristol-Myers’ chief commercialization officer, said Thursday that the lung cancer bite and trial-data timing could put a damper on Opdivo’s sales next year.
The company is also awaiting a potential payoff from two recently-reported studies of Opdivo and its fellow BMS immunotherapy Yervoy in previously untreated lung cancer.
“Given the competitive dynamics in the U.S. and the timing of those regulatory interactions, we still see Opdivo under pressure,” Boerner said during the company’s Q3 earnings call with analysts.

Bristol execs were tight-lipped on the regulatory submission process for both Checkmate studies, including CM-9LA, which showed last week that the Opdivo-Yervoy duo—plus two cycles of chemo—lengthened patients’ lives compared with chemo plus placebo.
The other Opdivo-Yervoy combo study––Checkmate-227––has faced a troubled road itself after Bristol pulled its FDA application in October 2018 to wait for longer-term survival data. BMS unveiled those results last month at the European Society for Medical Oncology meeting.
It’s not all bad news for Opdivo, in Bristol’s eyes: Boerner told analysts the drugmaker expected Opdivo to retake the initiative in sales after the lung cancer filings and trial readouts coming up in 2020 and 2021.
Luckily, there’s anticoagulant Eliquis, which kept up its world-beating performance in the third quarter as it continues to rake in market share and keep a stranglehold on its anticoagulant rivals.
Eliquis nabbed $1.9 billion in worldwide sales for the period, posting 22% sales growth––well above all but one drug in Bristol’s portfolio. Bristol CFO Charles Bancroft said Eliquis’ prescription numbers jumped 30% from the same quarter last year, putting the drug well ahead of its warfarin-alternative rivals—and warfarin itself.
On the whole, Bristol’s pharma stable raked in $6 billion in revenue on the quarter––a 6% bump from the same quarter last year.

As Bristol’s blockbusters turned in varying degrees of growth, Celgene posted increases across the board with a 16% revenue bump to $4.5 billion. Driving that increase were strong performances from blockbuster chemotherapies Revlimid and Pomalyst, which grew 13% to $2.77 billion in sales and 29% to $664 million, respectively.
But the strong sales are painful in one respect: Otezla, which the drugmaker agreed to sell ahead of its pending merger with Bristol, hit $547 million in sales on 27% growth year-over-year.
Celgene reached an agreement with FTC in August to divest the drug, eventually selling it to Amgen for a whopping $13.4 billion. On Thursday’s earnings call, Bristol execs said the proceeds would be used to offset the new company’s debt load, which the drugmaker said would be around $45 billion when the deal closes.

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