On BeiGene’s very first live earnings call, CEO and co-founder John Oyler on Thursday described a “once-in-a-lifetime opportunity.” To him, the company’s potential in chronic lymphocytic leukemia is akin to two other legendary Big Biotech stories—Gilead in HIV and Vertex in cystic fibrosis.
Oyler may not be exaggerating.
In a heated competition among BTK inhibitor treatments for blood cancer, BeiGene’s third-to-market Brukinsa has for the first time surpassed AstraZeneca’s Calquence in quarterly sales. In the fourth quarter of last year, Brukinsa doubled its sales year over year, generating $828 million and edging out Calquence’s $808 million during the same period.
Brukinsa enjoyed the most new patient starts in the U.S. across indications within the BTK class, Oyler said on Thursday’s call.
In their rivalry, AstraZeneca and BeiGene have been touting their products’ market leadership based on different metrics. At the same time, AbbVie and Johnson & Johnson’s once-dominant Imbruvica has been continuing its downfall.
AZ, in its own fourth-quarter report, said Calquence maintained a leading share of U.S. new patient starts specifically in front-line chronic lymphocytic leukemia (CLL), which is the most important market for the BTK class. Matt Shaulis, BeiGene’s general manager of North America, said on Thursday’s call that Brukinsa has greater than 50% of U.S. new patient market share in all lines of CLL.
Trying to shore up Calquence’s position, AZ recently proposed a fixed-duration combination compared with the drug’s existing continuous treatment regimen. The combo’s phase 3 trial was positive. But as he did during BeiGene’s J.P. Morgan Healthcare Conference presentation in January, Oyler on Thursday said that the AZ data “leave a lot to be desired.”
He described the Calquence fixed-duration combo’s disappointing performance on minimal residual disease, which is a deep response measurement, as well a lackluster progression-free survival showing compared with historical data from other investigational cocktails. In addition, the BeiGene CEO drew attention to the regimen's “challenging safety profile during the first 60-week treatment period compared to Brukinsa.”
“We strongly believe in the promise of fixed duration, but unfortunately, the current options don’t fulfill this promise,” Oyler said.
In its own fixed-duration treatment bid, BeiGene is testing Brukinsa along with its BCL-2 inhibitor sonrotoclax in first-line CLL. The phase 3 Celestial TN CLL trial for that regimen has completed enrollment, according to Oyler.
Sonrotoclax, which BeiGene is touting as a better option than AbbVie and Roche’s Venclexta, could read out phase 2 data in previously treated CLL and mantle cell lymphoma in the second half of this year to support potential accelerated approval submissions. BeiGene plans to start confirmatory phase 3 trials in those indications soon.
BeiGene’s third asset in CLL, a BTK protein degrader coded BGB-16673, could read out potentially registrational phase 2 data in 2026.
Again, going bold, BeiGene plans to start a phase 3 head-to-head trial for BGB-16673 against Eli Lilly’s noncovalent BTK inhibitor Jaypirca in relapsed or refractory CLL this year. Because of its unique mechanism, Jaypirca is the only BTK drug that can be used following treatment with covalent BTK inhibitors such as Brukinsa and Calquence. With BGB-16673, BeiGene clearly doesn’t intend to leave that second-line market to Lilly, either.
Lilly has two phase 3 trials running for Jaypirca in first-line CLL. But BeiGene’s R&D head Lai Wang, Ph.D., argued that the two readouts likely won’t change adoption dynamics because their comparator arms don’t include “true standard of care” treatments such as Brukinsa.
In short, BeiGene is working to build a “pre-eminent franchise” in the $12 billion-plus CLL market, Oyler said.
Oyler has his eyes on global CLL dominance as BeiGene tries to minimize its association with—and reliance on—China amid rising geopolitical risks.
Throughout Thursday’s one-hour call, the word “China” was only uttered three times, all when newly hired BeiGene CFO Aaron Rosenberg described the company’s leading market share in the country for Brukinsa and the PD-1 inhibitor Tevimbra.
The dropoff in the China discussion is remarkable considering the country contributed the majority of BeiGene’s revenue up till 2022. Last year, the U.S. made up 51.4% of BeiGene’s total annual revenue of $3.8 billion, compared with 37% from China. In 2023, the numbers were nearly even at 45.9% and 44.8%, respectively.
Thursday’s investor call marks part of BeiGene’s progress toward becoming a global company, alongside its new U.S. biologics innovation center, a proposed name change to BeOne Medicines and its move to redomicile to Switzerland.
BeiGene expects it will break even under GAAP measurements and generate positive cash flow from its operations starting in 2025. In 2024, the company narrowed its loss to $79.4 million from $384 million the prior year.
The company expects full-year revenue to come in a range between $4.9 billion and $5.3 billion this year based on the continued global expansion of Brukinsa.