February 5, 2024 Source: drugdu 85
In his first earnings call as Bristol Myers Squibb’s CEO, Chris Boerner laid out his plan to quickly navigate the company through a period filled with patent cliffs and new government-mandated pricing pressure in the latter half of the decade.
Bristol Myers will have a relatively stable business through 2025 as large legacy products, though declining, continue to generate sizable chunks of revenue. Still, the company’s focus will center on a growth portfolio that includes 11 key brands and about three dozen clinical candidates.
Besides commercialization and R&D efforts, the company remains interested in dealmaking, Boerner said.
“This, along with pipeline execution, can best position the company into the transition period,” the CEO told analysts Friday.
Bristol Myers has “some clear strengths” compared with other companies that have successfully navigated similar periods of patent losses in the past, Boerner figures. The CEO touted the company’s “expanding growth portfolio across multiple therapeutic areas,” plus its “exciting pipeline, differentiated platforms and continued financial strength to further invest for growth with business development.”
In 2023, BMS’ legacy portfolio, led by Pfizer-partnered blood thinner Eliquis and the already off-patent multiple myeloma drug Revlimid, raked in $25.6 billion sales or about 57% of the company’s total haul of $45 billion. All told, BMS’ 2023 sales marked a 2% decline over 2022. For 2024, the New Jersey pharma expects revenues to increase by low-single-digit percentages.
Eliquis is among the first 10 drugs up for Medicare price negotiations under the Inflation Reduction Act. While the U.S. government has made its initial offers, pharmaceutical companies can’t publicly discuss them under the law.
For BMS, the anticoagulant pulled down $8.6 billion last year in the U.S., good for 10% growth over 2022. But given that the IRA pricing takes effect in 2026, BMS expects Eliquis' period of significant growth to end in 2025, chief commercial officer Adam Lenkowsky said on the call.
As to whether the IRA will affect the commercial market, Lenkowsky said BMS is looking at various scenarios. Just because a payer wants to push for a new price in the commercial setting doesn’t mean that BMS has to agree, he said.
In Bristol's growth portfolio, meanwhile, PD-1 inhibitor Opdivo is leading the way with $9 billion in 2023 sales. Combine that with 148.1 billion Japanese yen ($1 billion) of revenue reported by Ono Pharmaceutical in Japan, Opdivo reached $10 billion in global sales for the first time.
Although nowhere near Merck’s market leader Keytruda, Opdivo still delivered 9% year-over-year growth for BMS, driven by use in first-line lung cancer, upper gastrointestinal cancers and adjuvant bladder cancer.
Like some of its oncology competitors, BMS is developing a subcutaneous version of its star checkpoint inhibitor. The company just unveiled the injection’s phase 3 data and anticipates a lunch early next year, Lenkowsky said.
BMS plans to convert about 30% to 40% of the overall Opdivo business in the U.S. into the under-the-skin version, which has the potential to address the treatment burden for both patients and physicians, Lenkowsky noted. That’s why the company expects to see this franchise “endure into the next decade,” he added.
Meanwhile, one member of BMS’ “growth portfolio” isn’t living up to its inclusion in that group.
CAR-T therapy Abecma continued its sequential sales decline in the U.S., posting fourth-quarter sales in the country of $56 million. That compared with $69 million in the third quarter and $115 million in the second quarter.
The BCMA agent is suffering from a “highly competitive market,” Lenkowsky acknowledged. But the Abecma teams are focused on opening new accounts and expanding manufacturing footprint, he said. The company is also trying to change people’s misconceptions around Abecma’s efficacy and reinforce its safety profile, especially as related to its neurotoxicity, he added.
A key potential catalyst to turn Abecma around lies in an upcoming FDA decision on the med’s earlier use as a third-line treatment for multiple myeloma. The drug’s overall survival data from the KarMMa-3 trial will be the topic of an upcoming advisory committee meeting.
During Friday’s call, BMS’ chief medical officer, Samit Hirawat, M.D., once again pointed to control arm crossover to explain Abecma’s lack of a life-extension showing in the KarMMa-3 study. Hirawat added that BMS is very confident in Abecma’s benefit.
On the flip side, BMS’ other CAR-T therapy, CD19-targeted Breyanzi, continues to grow sales. Breyanzi’s fourth-quarter sales reached $101 million, up from $92 million in the third quarter. For this large B-cell lymphoma therapy, BMS is busy expanding its manufacturing capacity to compete with Gilead Sciences.
Besides Opdivo, Breyanzi and Abecma, BMS’ growth portfolio also features immuno-oncology therapies Opdualag and Yervoy, plus the newly bought KRAS inhibitor Krazati, and the newly FDA-approved kinase inhibitor Augtyro. Also in the group are cardiomyopathy drug Camzyos, blood disorder therapy Reblozyl, and anti-inflammation agents Sotyktu, Zeposia and Orencia.
BMS got Krazati from its up to $5.8 billion deal for Mirati Therapeutics, and the Big Pharma firm has yet to wrap up its $14 billion acquisition of Karuna Therapeutics and $4.1 billion purchase of RayzeBio, both of which were announced in December.
Business development continues to be a top priority for BMS, Boerner said on the call.
“We certainly are going to continue to be interested in bringing innovation into the company that makes strategic and financial sense,” the CEO said.
At this point, following the series of M&A deals last year, BMS is more interested in “bolt-on opportunities,” he added.
https://www.pharma.com/pharma/bristol-myers-ceo-outlines-transition-strategy-featuring-11-key-brands-continued-dealmaking
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