Bristol-Myers Squibb Co. (BMY) posted stronger-than-expected third quarter earnings Thursday and boosted its full-year profit outlook as sales of its key cancer treatment surged more than 40% despite a recent FDA decision that will delay its expanded use.
Bristol-Myers said earnings for the three months ended in September came in at $1.09 per share on a non-GAAP basis, topping the consensus forecast of 91 cents and rising 45% from the same period last year. Group revenues, the company said, jumped 8% to $5.7 billion while sales of its Opdivo cancer treatment rose 42% to $1.79 billion. Bristol-Myers raised its 2018 earnings guidance to a range of $3.80 to $3.90 per share and said it sees world-wide revenue rising in the high single digits.
"We had a very good quarter with strong commercial performance and advances in our portfolio through important clinical and regulatory milestones, including exciting new data for psoriasis patients with our internally discovered and developed TYK2 inhibitor," said CEO Giovanni Caforio. "Looking forward, we will continue to deliver on our strategy through robust commercial execution and advancing the potential of our increasingly diverse R&D pipeline."
Bristol Myers shares fell 3.1% early Thursday.
Earlier this week, the U.S. Food & Drug Administration extended the approval date for a market approval for Bristol-Myers' Opdivo plus Yervoy cancer therapy combination will be delayed by three months, until May 2019.
EU regulators asked for more information on the therapy, which is being tested as part of a trial the group calls 'CheckMate -227', including an overall survival (OS) analysis for certain types of patients. Bristol-Myers said an OS analysis for the same patient sub-group was also submitted to the FDA.
Opdivo, which Bristol-Myers classifies as a "prioritized brand" that harnesses the body's own immune system to fight cancer, saw sales rise $528 million over the third quarter, well ahead of the Q2 gain of 36%. Yervoy revenues grew 18% to $382 million.
Opdivo plus low-dose Yervoy (injections for intravenous use), for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan, was approved by the FDA in July, the company said.