NEW YORK – Bristol Myers Squibb on Friday reported an 8 percent increase in Q4 2021 revenues buoyed by an 11 percent increase in sales of its lead oncology drug Opdivo (nivolumab).
The New York-based firm reported total revenues of $11.99 billion for the three months ended Dec. 31, compared to $11.07 billion in Q4 2020, missing analysts' average revenue estimate of $12.04 billion.
In Q4, BMS' Opdivo earned $1.99 billion in worldwide sales, an 11 percent increase from $1.80 billion in the prior year's quarter. The company's other checkpoint inhibitor Yervoy (ipilimumab) brought in $545 million in global sales, a 16 percent increase from $471 million in Q4 2020.
On a call to discuss the company's financials, BMS CFO David Elkins attributed Opdivo's sales growth to increased demand in front-line metastatic settings, such as in lung, renal, and gastric cancers as well as in recently approved adjuvant indications in esophageal and bladder cancers. In the US, Opdivo's sales jumped 16 percent to $1.12 billion in Q4 2021, from $963 million in Q4 2020, while Yervoy's sales jumped 9 percent to $330 million from $304 million.
Opdivo sales also grew in Europe, Elkins said, due to demand in the newly launched indication of PD-L1-positive advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers, which was approved by the European Commission in October.
BMS executives are considering the impact of generic checkpoint inhibitors on its checkpoint inhibitor business, as patents on competitor Merck's Keytruda (pembrolizumab) begin to expire at the end of the decade.
"On low-cost entries of PD-1 agents, we don't see a significant threat to our business in the near-to-medium term on these products," Elkins said. "In our larger markets like the US, evidence continues to be the most important dimension of choice; physicians want to see data in a specific tumor and patient type. There may be markets where these low-cost me-too drugs are able to piggyback on innovation and drive use, but those historically have not been our larger markets."
BMS' autologous CAR T-cell therapy products, Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel), also continued growing during the quarter. Breyanzi, the CD19-directed CAR T-cell therapy that was approved in February 2021 for relapsed or refractory large B-cell lymphoma, recorded sales of $40 million.
"Breyanzi and Abecma continued to see significant demand while we remain focused on broadening supply and expanding indications over time," BMS CEO Giovanni Caforio said on the call. "We continue to see Breyanzi as one of the key growth drivers for the company with over $3 billion in non-risk adjusted revenue potential."
Caforio also noted that both cell therapies have "the potential to replace [BMS multiple myeloma drugs] Revlimid and Pomalyst over time." Elkins added that the company is also hoping to expand Breyanzi's indication in 2022 to second-line large B-cell lymphoma, based on data from the Phase III TRANSFORM trial presented in December.
In Q4, the company's GAAP net income was $2.37 billion, or $1.07 per share, compared to a net loss of $10.03 billion, or $4.45 per share, in the year-ago period due to the closing of BMS' $13.1 billion acquisition of MyoKardia.
BMS's R&D spending went down 30 percent in Q4 2021 to $2.60 billion from $3.75 billion in Q4 2020. The company's marketing, selling, and administrative expenses decreased 13 percent to $2.35 billion from $2.72 billion last year.
For full-year 2021, BMS recorded total revenues of $46.39 billion compared to $42.52 billion in 2020. During the 12-month period, worldwide revenues of Opdivo grew 8 percent from $6.99 billion to $7.52 billion and Yervoy sales increased 20 percent from $1.68 billion to $2.03 billion. Breyanzi sales were $87 million during the year, while Abecma sales were $164 million.
The firm's net income for the year was $7.01 billion, or $3.12 per share, compared to a net loss of around $9.0 billion, or $3.99 per share, in 2020. Adjusted EPS of $7.51 beat analysts' consensus estimate of $7.47 per share.
R&D expenses were $11.35 billion in 2021, up 2 percent from $11.14 billion in 2020. Marketing, selling, and administrative expenses were $7.69 billion during the year, largely flat compared to $7.66 billion in 2020.
As of Dec. 31, the New York-based company had $16.97 billion in cash, cash equivalents, and marketable debt securities.
In 2022, BMS is expecting total revenue of around $47 billion, a low-single digit increase over 2021. The company projected non-GAAP EPS in the range of $7.65 to $7.95.