Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of weighty patent losses.

As a measure of the company’s R&D prowess, BMS has scored nine FDA approvals over the last three years and more than 45 regulatory nods globally over that same stretch, Chris Boerner, BMS’ chief operating officer and incoming CEO, said during the company’s R&D Day Thursday.  

Now, BMS aims to clinch more than 25 label expansions for its approved drugs over the coming years, the company said in an accompanying press release.

“The starting point is strong,” Boerner said.

“At the same time,” he caveated, “we recognize that we have entered a period of headwinds.”

The executive singled out last year’s Inflation Reduction Act (IRA), under which BMS’ blockbuster blood thinner Eliquis will be up for Medicare price negotiations in 2026. He also brought attention to losses of exclusivity, related not just to blood cancer drug Revlimid—which fell victim to generics last spring—but also Eliquis, and, toward the end of the decade, Opdivo.

That said, Boerner sees a clear opportunity to “navigate” those headwinds and “drive sustained, reliable growth over time.”

BMS is presenting its pipeline roadmap after a rough stretch since Revlimid's loss of exclusivity. For one, the company in July projected 2023 sales will fall compared with last year. Investors have been anxious too, with the company's share price falling around 18% so far in 2023.

To rebound, BMS will count on a diversified pipeline. The company now has 12 registrational programs that will be visible over the next 18 months, Boerner said, versus just six at the beginning of 2023. Plus, the company boasts an “exciting” set of early assets that will form its next wave of medicines, he added.

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