NEW YORK – Bristol Myers Squibb is focusing on ramping up sales and garnering new indications for its newer oncology products to prepare for Opdivo's loss of patent exclusivity in the coming years.
While Opdivo (nivolumab) remains the firm's biggest revenue contributor among cancer drugs, BMS CEO Giovanni Caforio said on Thursday during a call to discuss the firm's Q2 financial performance that he expects several medicines will help "renew" its cancer portfolio after the checkpoint inhibitor loses exclusivity in 2028.
According to Caforio, BMS is expecting to deliver between $10 billion and $13 billion in revenue from its new product portfolio in 2025. "The opportunity remains significant, with $25 billion-plus in potential revenue in 2030 on a non-risk adjusted [basis]," he added.
BMS expects several oncology products in its new product portfolio including the PD-1 and LAG-3 inhibitor Opdualag (nivolumab and relatlimab) and autologous CAR T-cell therapies Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel) to contribute to the renewal of its revenues from cancer products. By 2030, BMS anticipates Opdulag will bring in revenues of more than $4 billion annually, Breyanzi will generate $3 billion in sales, and Abecma will contribute $1 billion.
In Q2, Opdivo generated $2.15 billion in global revenue, a 4 percent increase from Q2 2022 sales of $2.06 billion. BMS's other immunotherapy, Yervoy (ipilimumab), also saw growth in Q2 with revenues of $585 million versus $525 million in the year-ago period, an 11 percent increase.
BMS Chief Commercial Officer Adam Lenkowsky said current revenue growth for Opdivo is coming from increased adoption of its core indications including first-line non-small cell lung and gastric cancers along with the adjuvant indications. Opdivo in combination with Yervoy is approved as a first-line metastatic NSCLC treatment for patients with PD-L1-positive tumors or in combination with Yervoy and chemotherapy regardless of biomarker status. Lenkowsky added that more data are expected for Opdivo with or without Yervoy over the next year in first-line NSCLC, bladder cancer, and previously treated colorectal cancer, among other indications.
During Q2, Opdivo also gained a new indication in Europe as a neoadjuvant treatment for PD-L1-positive NSCLC in combination with chemo. In the US, this neoadjuvant indication doesn't mention PD-L1 status. The firm is also anticipating an approval decision in the US in October for Opdivo as an adjuvant treatment for patients with completely resected, stage IIB or IIC melanoma.
"We've got some nice catalysts," Lenkowsky said. "We remain very confident in Opdivo's ability to grow in 2023."
BMS's overall revenues for the three months ended June 30 decreased 6 percent to $11.23 billion compared to $11.89 billion in Q2 2022. At constant exchange rates, revenues declined 5 percent, which the company attributed to a "more rapid than expected decline" in sales of Revlimid (lenalidomide), a drug for multiple myeloma, myelodysplastic syndromes, and certain lymphomas, which lost exclusivity last year. The firm missed analysts' average revenue expectation of $11.8 billion for the quarter.
The firm's newest cancer drug, Opdualag, is continuing to see growth and gather market share in the melanoma space. In Q2, Opdualag revenues grew nearly threefold to $154 million globally compared to $58 million in Q2 2022, the first quarter that the drug was on the market. The drug was approved in the US last March as a first-line treatment for an all-comer metastatic melanoma population but approved in Europe in September as a first-line treatment for melanoma patients whose tumors express PD-L1 in fewer than 1 percent of cells.
"We're extremely pleased with the launch of Opdualag in first-line melanoma with market share approaching 25 percent and continuing to be primarily sourced from PD-1 monotherapy," BMS CFO David Elkins said. "This momentum gives us confidence in the ability for Opdualag to become the new standard care in first-line melanoma."
Lenkowsky highlighted that across all its melanoma drugs, Opdualag, Opdivo, and Yervoy, BMS's market share in this disease setting is greater than 65 percent.
For the remainder of the year, BMS is expecting data from a Phase II study of Opdualag in first-line NSCLC. In 2024 and 2025, the company is expecting more Opdualag data from trials in first-line and later-line hepatocellular carcinoma and in second- and third-line microsatellite stable colorectal cancer.
In terms of the growth potential of BMS's CAR T-cell therapies, a lot will depend on increased manufacturing capacity. In Q2, the firm had to shut down one of its manufacturing facilities to conduct planned maintenance and prepare for a potential Abecma approval in late 2023 as a second-line or later treatment for relapsed and refractory multiple myeloma based on results from the Phase III KarMMa-3 trial. The company has already filed this data with regulatory authorities.
"We would also anticipate significant increase in volume [for Abecma] in the fourth quarter," Lenkowsky said, underscoring the firm's confidence in being able to compete in the multiple myeloma market with this cell therapy. "We continue to see and hear from physicians about favorable perceptions for Abecma based on our durable responses in the real-world setting as well as high manufacturing success rates now that are north of 90 percent." In the refractory multiple myeloma space, Abecma competes with Janssen and Legend Biotech's CAR T-cell therapy Carvykti (ciltacabtagene autoleucel).
In Q2, Abecma sales were $132 million worldwide, a 48 percent increase from Q2 2022 sales of $89 million. Sales of its other CAR T-cell therapy, Breyanzi, also grew more than twofold in Q2 to $100 million worldwide from $39 million in the same period last year.
BMS said in May it planned to discuss with regulators positive data from a trial of Breyanzi in refractory chronic lymphocytic leukemia or small lymphocytic leukemia. That study demonstrated an 18 percent complete response rate for patients on Breyanzi and an overall response rate of 42.9 percent.
BMS's net earnings in Q2 2023 were $2.08 billion, or $.99 per share, compared to $1.43 billion, or $.66 per share, in Q2 2022. The company's adjusted EPS was $1.75, falling short of the consensus Wall Street EPS estimate of $1.98.
The firm also lowered its financial guidance for the remainder of the year. BMS is now expecting a low-single-digit decline in total revenues due to lower-than-expected sales of Revlimid and another multiple myeloma drug, Pomalyst (pomalidomide). BMS had previously said revenues would increase by around 2 percent this year. The company also lowered its expected adjusted EPS range to between $7.35 and $7.65 from the prior projected range of $7.95 to $8.25.
As of June 30, BMS had $8.73 billion in cash, cash equivalents, and marketable debt securities.