Will Breyanzi's Strong Uptake Help BMY Offset Generic Competition?

Bristol Myers’ (BMY) CAR T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) posted strong growth in the second quarter.

Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.

It is approved in the United States for the treatment of relapsed (went into remission, then came back) or refractory (did not go into remission after receiving other treatments) large B-cell lymphoma (LBCL) after at least one prior line of therapy. Breyanzi also received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting. It is approved for the treatment of relapsed or refractory mantle cell lymphoma in the third-line plus setting.

Breyanzi sales skyrocketed 125% to $344 million, reflecting strong demand across all indications and higher-than-expected infusions that benefited second-quarter performance.

Breyanzi sales in the United States more than doubled year over year to $255 million, driven by growth in LBCL, expansion from new indications approved last year and improved manufacturing success rate. Outside the United States, sales nearly tripled to $88 million due to strong demand and launches in new markets.

BMY expects strong growth in the second half of 2025.

Last week, BMY announced that the FDA has accepted the supplemental biologics license application for Breyanzi as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a target action date of Dec. 5, 2025.

BMY is banking on its immuno-oncology portfolio, along with Breyanzi, Reblozyl and Camzyos, to stabilize its revenue base as the legacy drugs face generic competition.

BMY Faces Competition for the CAR- T Cell Therapy

Breyanzi faces competition from Gilead Sciences’ (GILD) Yescarta for its approved indications.

Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is also approved for adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from FL.

GILD posted Yescarta sales of $393 million for the second quarter of 2025.

Another approved CAR-T therapy is Novartis’ (NVS) Kymriah, which is approved for acute lymphoblastic leukemia (ALL) that is either relapsing or refractory. It is also used in patients with LBCL or FL, two types of non-Hodgkin lymphoma, that have relapsed or are refractory after having at least two other kinds of treatment.

NVS is also developing another CAR T cell therapy, YTB323, for LBCL

BMY’s Price Performance, Valuation and Estimates

Shares of Bristol Myers have lost 17.7% year to date compared with the industry’s decline of 0.9%.

From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY’s shares currently trade at 7.49x forward earnings, lower than its mean of 8.49x and the large-cap pharma industry’s 13.73X.

The bottom-line estimate for 2025 has moved down to $6.46 from $6.56 in the past 30 days, while that for 2026 has moved north to $6.07 from $6.03 in the same timeframe.

BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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