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

With the potential for more than two dozen label expansions on the horizon, 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.

Expansion frenzy

But it’s not all about early-stage assets, given Bristol’s potential to nab some 25 label expansions in the coming years.

In immunology, for instance, Sotyktu makes up one of four drugs in a portfolio of new launches that could reach individal peak sales of more than $4 billion, BMS figures. That drug, approved in September 2022 for plaque psoriasis, is nearing a phase 3 readout in psoriatic arthritis and recently kicked off a late-stage trial in systemic lupus erythematosus.

At the same time, BMS revealed Thursday that it’s no longer pursuing the development of Sotyktu in inflammatory bowel disease (IBD).

Elsewhere, BMS is leveraging improved manufacturing of its CD19-directed CAR-T medicines to take its cell therapy prospects into immunology, Samit Hirawat, M.D., chief medical officer of drug development, said in an interview.

In this field, BMS is first targeting systemic lupus erythematosus, but it’s also looking to pursue other indications such as myositis. Plus, the company soon plans to submit an investigational new drug application to study the CAR-T approach in patients with multiple sclerosis, the CMO added.

BMS is also banking on Zeposia—its multiple sclerosis and ulcerative colitis drug—to land an approval in Crohn’s disease. The drug is currently in phase 3 trials for that indication.

In oncology, meanwhile, BMS is angling for label expansions on Opdualag and Opdivo, plus the potential for a subcutaneous formulation of the latter cancer drug. Data on that below-the-skin formulation of Opdivo should be arriving “imminently,” Hirawat said, specifying that those results could read out in the “next couple of months.”

The company still has room to grow in hematology, too, thanks to Reblozyl, which recently added a new indication and still has “more to follow,” Hirawat said.

All told, BMS thinks it has a “very rich, very deep, very differentiated pipeline” that portends a “bright future,” not just from a pipeline perspective, but a business perspective, too, Hirawat said.

BMS is keeping its eyes peeled for external prospects, too. When it comes to internal versus external innovation, BMS relies on a “healthy balance of both,” Robert Plenge, M.D., Ph.D., chief research officer and head of research at BMS, said during the interview.

The bottom line

BMS’ excitement around its pipeline comes as the company’s star player Revlimid falls to generics faster than expected. Back in July, BMS sliced its 2023 sales projection for Revlimid by a whopping $1 billion and cut its overall revenue forecast, too.

“We do not take an adjustment of this magnitude lightly,” said departing CEO Giovanni Caforio, who will step down in November to be replaced by Boerner.

But BMS has urged investors to stay calm, pointing to four growth “pillars” it expects to lean on through the second half of the decade.

Through 2025, the company expects its immuno-oncology stalwarts Opdivo and Yervoy—plus blood thinner Eliquis—to together chip in another $8 billion to $10 billion in annual growth. 

Another $10 billion to $13 billion in annual sales is expected from BMS' recent and expected near-term launches, Caforio said last year. Those include CAR-T therapy Breyanzi, anemia drug Reblozyl and psoriasis launch Sotyktu.

By 2029, the company has said its portfolio of new launches could deliver $25 billion or more.