Bristol-Myers Falls on Fear of FDA Delay on Lymphoma Therapy

(Bloomberg) -- Bristol-Myers Squibb Co. shares fell after the company said a critical inspection needed for U.S. regulators to clear a cell therapy for lymphoma hasn’t been scheduled, threatening a decision on the drug that had been expected by Nov. 16.

The U.S. Food and Drug Administration is weighing use of the CAR T cell therapy liso-cel as a treatment for adults with relapsed or refractory large B-cell lymphoma. A contingent value right, or CVR, tied to the company’s Celgene Corp. acquisition last year and liso-cel’s approval this year dropped about 72% to a record low after the inspection delay became known.

Bristol-Myers shares gained earlier in the day after the company said it was raising its full-year earnings forecast. Given the lagging time line, the shares were down 1.5% to $64.48 at 11:36 a.m. in New York trading.

“As you know, FDA are doing what they can to ensure their staff are kept safe in this pandemic, and because of the travel restrictions, we have to obviously honor their desires as to where they go and when they go,” said Samit Hirawat, chief medical officer and head of global drug development for Bristol-Myers during the company’s Thursday earnings call.

While a Washington plant has been inspected by the FDA, another plant in Texas had not been, he said. The agency has said both need to be looked over, Hirawat said.

The development overshadowed Bristol’s third-quarter financial results, which reported better-than-expected sales of drugs treating conditions including cancer. The New York-based company said the health-care system, disrupted early on by the Covid-19 pandemic, is now recovering.

Revenue Beats

Bristol-Myers forecast 2020 adjusted earnings per share of $6.25 to $6.35, up from $6.10 to $6.25. Quarterly revenue was $10.54 billion, beating a $10.34 billion estimate by analysts.

“It’s a very resilient business, despite the global pandemic,” Chief Financial Officer David Elkins said in an interview. “People are continuing to get their medicines because these are very serious diseases they’re battling.”

Sales of the multiple myeloma drug Revlimid and immuno-oncology therapy Opdivo, two key blockbusters, topped analyst projections, though revenue for the blood thinner Eliquis fell short, at $2.1 billion compared with expectations of $2.12 billion.

Other drugs, including immuno-oncology medication Yervoy and the anemia drug Reblozyl, also beat expectations.

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