Bristol busy boosting supply of Breyanzi, Abecma as massive Revlimid patent cliff looms

With Bristol Myers Squibb only a month away from biopharma's biggest loss of exclusivity this year, industry watchers are eager for any clues about how the company's new and future medicines will perform on the market. The drugmaker has already launched two new CAR-T products, Breyanzi and Abecma, and now it's busy scaling up on the manufacturing front in a bid to meet early demand.

Breyanzi, Bristol's lymphoma CAR-T therapy, generated $87 million following its February 2021 approval, BMS reported Friday. Abecma scored FDA approval in March 2021 to treat certain multiple myeloma patients and pulled in $164 million last year despite early "supply constraints" that are affecting the drug, BMS chief commercial officer Chris Boerner said on Friday's earnings conference call.

To address the Abecma supply shortfalls, BMS is working with contract manufacturers to boost slot capacity, Boerner noted. The company is focusing on training and qualifying new staff plus improving "operational efficiency and site capacity," he added. BMS expects to be in a "much better position" with its Abecma supply around the middle of the year, the exec said.

As for Breyanzi, the "big focus" right now is vector supply, Boerner said. Amid the global manufacturing surge for pandemic vaccines—plus recent cell and gene therapy advances—the engineered viruses used in advanced pharmaceutical products have come to be in short supply. As BMS eyes a potential label expansion into second-line relapsed or refractory large B-cell lymphoma, BMS anticipates having access to more viral vector supply later in the year, Boerner said Friday.

In all, BMS expects its new launches to "more than offset" key losses of exclusivity through 2025, CEO Giovanni Caforio said on Friday's call. And the company will face plenty of pressure on the LOE front, as Revlimid is set to face its first U.S. generics next month.

Despite those generic pressures, BMS expects Revlimid to generate between $9.5 billion and $10 billion this year. Each year thereafter, the company expects a $2 billion to $2.5 billion step down in revenues for the big-selling medicine.

Under a prior deal with Natco Pharma, that company is able to launch a "volume-limited" Revlimid generic next month. Other generics may enter about 180 days after that, or in the September timeframe, BMS' chief financial officer David Elkins said on Friday's call.

Asked about potential expense cuts related to the Revlimid loss of exclusivity, Elkins said BMS is fortunate to be able to reallocate resources to new launches. The hematology sales force can switch from Revlimid to the new cell therapies Breyanzi and Abecma, he noted.

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As for Bristol's other stalwart drugs, blood thinner Eliquis generated $10.7 billion last year, a 17% increase from 2020. The growth outlook for the drug "remains strong," as the class continues to grow and as Eliquis continues capturing share, Caforio said. 

Opdivo, the company's big-selling immuno-oncology drug, generated $7.5 billion, an 8% increase. Boerner noted that the situation around cancer treatments and COVID-19 "remains quite dynamic," but the company expects continual improvements over the course of 2022.

Overall last year, Bristol pulled in sales of $46.4 billion, a 9% increase from 2020.