BeOne Medicines (ONC) Q4 FY25 earnings call: guidance and Q&A

How will potential CMS drug price negotiation for competitor products (Ibrutinib, Acalabrutinib) affect BRUKINSA's net pricing longer term?

John Oyler emphasized BRUKINSA's differentiated value proposition, superior safety, and long-term PFS/OS data, positioning it as a best-in-class product. He stated that while competitors face challenges, BeOne stands by the value BRUKINSA creates for patients.

“This is, in our mind, a best-in-class product that has demonstrated the translation of its mechanism of action into real clinical results. And I think at this point, certainly, there are challenges for those other products, but we're just standing by the value that the products are creating for patients, and it's there.”

asked by Michael Schmidt · answered by John Oyler

What are the assumptions in the 2026 guidance regarding competition from AV or Jaypirca (late in the year)? And what is the initial opportunity for sonro in MCL in China and the U.S.?

Matt Shaulis stated that AVO was not approved and AV has limitations (studied in young, fit patients, median age 61). He reiterated confidence in BRUKINSA's clinical profile over AV. For Jaypirca, he noted that data doesn't compel a shift in earlier lines of therapy, with clinicians positioning it after continuous BTKs. Xiaobin Wu reported positive initial launch of sonro in China for MCL/CLL, with over 300 patients medicated in 6 weeks and good safety.

“we continue to be very confident in the clinical profile of BRUKINSA. We've outlined, as you heard from John, the importance of meeting some criteria for treatment in CLL, deep and durable remissions, PFS, safety and convenience. And we see that AV doesn't live up to that standard.”

asked by Yaron Werber · answered by Matt Shaulis

Elaborate on the strategy for immunology beyond hematology and solid tumors, and the path to becoming a meaningful player in immunology over the next few years.

Lai Wang explained that about 20% of their preclinical pipeline is focused on immunology. The strategy is opportunistic, aiming for first-in-class or best-in-class molecules. The goal is to identify 1-2 cornerstone assets within 2-3 years, with some molecules already in clinical stages.

“In our preclinical pipeline, we have roughly about 20% of our assets are focused on immunology. We acknowledge we're still a young player in the immunology space. For us, we're going to be opportunistic, looking for potential opportunity to be the first-in-class or best-in-class.”

asked by Ziyi Chen · answered by Wang Lai

If ZS becomes the fixed duration standard in treatment-naive CLL, how will BeOne avoid sacrificing long-duration revenues from continuous BRUKINSA?

Aaron Rosenberg explained that about half the CLL market receives fixed-dose treatment, where BeOne currently has no presence. ZS opens up this 50% of the market, which is viewed as market-expanding rather than cannibalizing BRUKINSA's continuous use share. John Oyler added that ZS could fulfill the promise of fixed duration and be a unique product combination within that 50% segment, especially for patients with different prognoses or those currently receiving less evidence-based fixed duration treatments.

“the combination of sonro plus zanubrutinib opens up 50% of the market where we don't play at all today. So from that dimension, and as we continue to mature candidly in our market share within the continuous use class alone with BRUKINSA, we view this as very market expanding.”

asked by Yigal Nochomovitz · answered by Aaron Rosenberg

Clarify if the BTK degrader accelerated approval has been pushed out from H1 to H2, and the reasons for any delay.

Amit Agarwal clarified that there has been no change in the timing for the BTK degrader accelerated approval. He stated that it's based on a single-arm trial, and they are following the data and look forward to interactions with the FDA mid-year to file.

“I don't think there's been a change in terms of the timing and kind of how we're thinking about this. Obviously, this is a single-arm approach. And so in terms of what we're looking at there is based on a single-arm trial. And so we're following that data and look forward to having the interactions with the FDA midyear and file based on our interactions with the FDA. So there's really no change in terms of the timing there.”

asked by Reni Benjamin · answered by Amit Agarwal

Given BRUKINSA's strong data and current market share, what is the strategy to further capture share from competitors like Calquence and IMBRUVICA, especially since there's still a significant market segment where BRUKINSA is not operating?

Aaron Rosenberg stated that BRUKINSA is currently capturing about 50% of the continuous use BTK market on a new patient share basis and is the global market leader. He emphasized that the growth will come from continued maturation into this profile, leveraging the best-in-class medicine. John Oyler added that the challenge is to get people to look at the data, which "speaks for itself" and demonstrates BRUKINSA's superiority across various metrics.

“on a new patient share, we're currently getting about 50% of the continuous use BTK market. We are the global market leader, but we're not quite at 50% yet because we continue to mature into that profile.”

asked by Sean Laaman · answered by Aaron Rosenberg

When will the B7H4 ADC Phase III trial be initiated (H1 or H2)? In which indication will it be initiated? What are the differentiations of this molecule compared to peers, given it's about 12 months behind?

Mark Lanasa stated they are pleased with the progress, it has swiftly moved through Phase I, and efficacy/safety data will be disclosed in H1 at a major medical congress. He acknowledged the competitive landscape but stated they are happy with emerging efficacy and a "nice safety profile" (no target-mediated toxicities beyond topo 1 conjugated ADC, good hematologic safety). More details on differentiation and first Phase III indication will be shared after data disclosure.

“We recognize that the competitive landscape that there are a number of competing molecules, both within B7H4 and more broadly within the topo 1 conjugated ADC space, particularly in breast and gynecologic malignancies, which is why we're moving with urgency. I think that we will be able to speak in more detail regarding the differentiation of our compound once we disclose the data.”

asked by Chen Chen · answered by Mark Lanasa

Given the potential accelerated approval and three ongoing Phase III studies for the BTK degrader, what is the incremental value of each study, and are all three needed to fully realize the opportunity?

Amit Agarwal stated they are answering important questions with the Phase III studies. He highlighted the incremental value of the head-to-head study against pirtobrutinib to show the BTK degrader's role as monotherapy in that population. He also mentioned plans for a BTK degrader plus sonro combination.

“we're answering important questions with the Phase III studies that we have right now, particularly with the 2 global Phase III studies. I think one is in a slightly later line with the investigator's choice as the control arm. And then the other study is really a head-to-head study against pirtobrutinib. And so we do see incremental value, especially from that pirtobrutinib study to be able to show that as far as that population is concerned, the BTK degrader has a really sort of clear role in terms of the monotherapy.”

asked by Leonid Timashev · answered by Amit Agarwal

How does BeOne foresee the future commercial sales split between BRUKINSA (continuous) and ZS (fixed duration), given that fixed duration therapies currently have lower commercial sales despite half the patient share?

John Oyler clarified that the "fixed duration" segment includes various treatments, not just venetoclax, and many are less evidence-based. He believes ZS, with its early positive data, could be a unique product combination within that 50% market segment, offering huge value to patients. He noted that for high-risk CLL patients (e.g., deletion 17p, unmutated), current fixed duration therapies are challenging, and while ZS looks promising, it's a "high bar" to match continuous BRUKINSA's long-term efficacy for these patients. He concluded it will take time to see how the market evolves.

“I think that having a fixed duration treatment that can replace, I don't know, I'd say, some of these less evidence-based fixed duration treatments in that half that are being used broadly in the community center, I think, is a huge, huge value to patients. And we would expect with the quality of the early data from that, that this really could be a unique product combination within that 50% of the market for sure.”

asked by Rebecca Liang · answered by John Oyler