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BeOne Medicines Ltd. American Depositary Shares earnings calls

ONC · every analyst question and management's answer

Aug 5, 2026 earnings call — BRUKINSA growth and MANGROVE chemo-free win

Raised 2026 revenue outlook to $6.6 billion to $6.8 billion.

Revenue $1.7B (est $1.6B) · EPS $2.05 (est $1.63) · Next-quarter revenue outlook $6.6B–$6.8B

Key quotes

"More than 6.5 years after its initial launch, BRUKINSA is seeing its highest level of sustained new patient starts showing favorable early trends in duration of therapy, and it's showing strong growth across all five approved indications."

— John Oyler (CEO·CHAIR) · BRUKINSA commercial strength

"We're excited about MANGROVE for two key reasons: the first is because it represents the first chemo-free treatment option for patients with frontline mantle cell"

— John Oyler (CEO·CHAIR) · MANGROVE and BEQALZI progress

"We now have five solid tumor programs that have achieved clinical proof of concept and are advancing towards pivotal development."

— Wang Lai (PRESIDENT) · Solid tumor R&D momentum

Analyst Q&A 9

BRUKINSA growth and CELESTIAL HR

Q (Yanan Zhu · Wells Fargo): They asked how BRUKINSA sales growth breaks down between CLL and non-CLL, whether Acala+ven (AV AMPLIFY) affected CLL demand, and for any color on CELESTIAL-301.

A: Management said they are not yet seeing much impact from the Acala+ven launch in the U.S. They said BRUKINSA growth was driven by strong demand across regions, with the highest new patient starts since launch and strength in both CLL and non-CLL, and that real-world data support longer duration of therapy.

"I think right now, we're not seeing much impact from the AV AMPLIFY in the U.S. it's early." — John Oyler (CEO·CHAIR)

Amplify data and CELESTIAL details

Q (Amit Agarwal): They asked specifically about the AV AMPLIFY (Acala+ven) data and its implications, and whether management could provide the CELESTIAL-301 hazard ratio between the two arms.

A: They said long-term outcomes matter and AV only has 3-year data, which shows lower uMRD and landmark PFS versus some other ven-based regimens. On CELESTIAL, they said the IDMC reviewed uMRD, BeOne remains unblinded, and they do not have the hazard ratio details, but they remain confident in the PFS endpoint.

MANGROVE physician feedback

Q (Reni Benjamin · Citizens): They asked for early physician feedback on the MANGROVE results, how doctors view the data (excluding rituximab maintenance), and how it compares to the ECHO regimen.

A: Management said physicians and KOLs are very excited about MANGROVE. They highlighted that MANGROVE tested a chemo-free ZR regimen and showed superiority to BR, and that physicians are interested in the potential rituximab-maintenance-free option.

"MANGROVE for the first time, showed that a chemo-free regimen of ZR was superior to BR with a hazard ratio of 0.57 in favor of the ZR arm." — Amit Agarwal

BTK degrader trial timing and plan

Q (Michael Schmidt · Guggenheim): They asked how the BTK degrader program is progressing toward its first registration study in relapsed/refractory CLL, what the efficacy bar is for a single-arm study, and how the program will position versus competitors like Nurix/Roche.

A: They said the program remains on track and, if the data support it, they expect an accelerated approval (AA) submission in Q4 of this year. They noted Fast Track designation for tacabrutideg, encouraging Phase I response and durability data, an ongoing head-to-head Phase III versus pirtobrutinib, and plans to start tacabrutideg + sonrotoclax studies early next year.

"So as Lai mentioned in his remarks, we remain on track and if the data support this, we're looking forward to that AA submission in Q4 of this year." — Amit Agarwal

MANGROVE timing and KAT6 design

Q (Etzer Darout · Barclays): They asked when we might see another MANGROVE data cut or presentation, and asked Lai about KAT6 design elements and possible combinations and safety considerations.

A: They said they plan to present MANGROVE at an upcoming congress and will share details soon. Lai said the KAT6 molecule was designed to be more selective for KAT6 versus KAT7 to potentially reduce hematologic toxicities, and they have started first-in-human studies in breast cancer and a Phase I in AML.

"we are very excited to present this at an upcoming congress." — Amit Agarwal

PRMT5 initial data and CNS coverage

Q (Yaron Werber · TD Cowen): They asked what to expect from the PRMT5 disclosure at ESMO, whether lung cancer and pancreatic cancer data will be shown, and about the move to Phase III next year.

A: They said the initial ESMO disclosure will include monotherapy Phase Ia dose escalation data plus many patients from expansion cohorts. Because the molecule is designed to be CNS penetrant, they emphasized enrolling non-small cell lung cancer patients, and will share data across tumor types including NSCLC and pancreatic cancer.

"So this is our initial disclosure and therefore, will include the monotherapy Phase Ia dose escalation data, but will also include a significant number of patients who have been enrolled in expansion phases." — Mark Lanasa

Guidance drivers and CEA ADC plan

Q (Jessica Fye · JPMorgan): They asked what changed versus prior guidance to drive the increase, and for broad strokes on the Phase III plan envisioned for the CEA ADC in lung cancer.

A: They said the guidance increase reflects better-than-expected BRUKINSA performance: higher new patient starts, strength across indications, and longer duration of therapy. For the CEA ADC, they will disclose Phase I dose escalation and expansion data at ESMO, see first-in-class POC in NSCLC, plan initial registration in later-line settings, and are working to generate earlier-line evidence.

"All these are areas of strength in the business, and candidly, ahead of our expectations at the beginning of the year." — Aaron Rosenberg (CFO)

PRMT5 Phase III design and RAS-ON inhibitor

Q (Jefferies): They asked whether the PRMT5 Phase III lung study will be a monotherapy or combination, and for details on the RAS-ON inhibitor.

A: They focused on the RAS program: they have a highly potent RAS-ON inhibitor entering the clinic before year-end that is designed to be CNS penetrant and aimed at non-small cell lung cancer, and they plan to explore combinations with PRMT5 in MTAP-deleted pancreatic cancer. They did not give a direct answer on whether the PRMT5 Phase III lung trial will be mono or combo.

"We have a highly potent RAS on inhibitor that will enter the clinic prior to the end of this year." — Mark Lanasa

Amgen collaboration contribution

Q (Gregory Renza · Truist): They asked how to think about the Amgen portfolio's contribution to revenue, given it has outperformed expectations, and how that should be framed for the top line.

A: They said they are pleased with Amgen portfolio performance and noted an upcoming launch for IMDELLTRA. They also flagged that biosimilar competition is coming for XGEVA that could affect performance beyond this year and they will share more as their understanding evolves.

"We're obviously very pleased with the performance of our Amgen portfolio this year and really since the inception of this important collaboration." — Aaron Rosenberg (CFO)

AI-generated notes on the earnings call transcript. Quotes are taken from the transcript. This is not a FolioObs investment view.

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