Can Opdivo's Label Expansions Help Bristol Myers Sustain Its Momentum?

Bristol Myers BMY has a broad oncology portfolio, which includes blockbuster immuno-oncology drugs, Opdivo, Opdivo Qvantig and Yervoy, among others.

Among these, Opdivo (nivolumab) is the top revenue generator. The drug is approved for several oncology indications.

Consistent label expansion of the drug has enabled it to maintain momentum. The FDA recently accepted and granted priority review to the supplemental biologics license application (sBLA) for Opdivo.

The sBLA is seeking approval of the drug in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL). The regulatory body assigned a target action date of April 8, 2026.

The sBLA was accepted based on the phase III SWOG S1826 (CA2098UT) study, which evaluated Opdivo in combination with AVD for adult and pediatric patients with previously untreated Stage III or IV cHL.

Opdivo raked in sales of approximately $2.5 billion in the third quarter, up 7% year over year, driven primarily by continued demand. U.S. sales are being driven by a strong launch in MSI-high colorectal cancer and continued growth in first-line non-small cell lung cancer, while international sales are supported by label expansions of the drug across multiple markets.
In addition, the approval of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use has bolstered Opdivo’s franchise. The initial uptake has been strong.

Bristol Myers now expects global Opdivo sales, together with Qvantig, to increase in the high single-digit to low double-digit range in 2025 (previous guidance: mid to high single-digit range in 2025), driven by strong performance year to date.

We note that BMY is currently banking on the label expansion of approved drugs and approval of new drugs to stabilize its revenue base, as its legacy drugs (Revlimid, Pomalyst, Sprycel and Abraxane) face generic competition.

Competition for BMY’s Oncology Drugs

While the label expansion of Opdivo is positive, the immuno-oncology space is dominated by pharma giant Merck’s MRK blockbuster drug Keytruda (pembrolizumab), along with Roche’s RHHBY Tecentriq.

Keytruda is approved for several types of cancer and alone accounts for more than 50% of MRK’s pharmaceutical sales. Merck is currently working on different strategies to drive the long-term growth of Keytruda.

Roche’s immuno-oncology Tecentriq is also approved for various oncology indications — early-stage (adjuvant) NSCLC, small cell lung cancer, hepatocellular carcinoma and breast cancer, among others.  In addition to intravenous infusion, Roche has also obtained approval for Tecentriq as a subcutaneous injection.

BMY’s Price Performance, Valuation & Estimates

Shares of Bristol Myers have lost 9.5% year to date against the industry’s growth of 18.2%.

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 8.52x forward earnings, higher than its mean of 8.40x but lower than the large-cap pharma industry’s 16.59x.

The Zacks Consensus Estimate for 2025 earnings per share has moved north in the past 60 days, while that for 2026 EPS has moved south.

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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