Update on MRD results for BRUKINSA's CELESTIAL TN CLL trial and the efficacy hurdle for BTK CDAC accelerated approval.

Amit Agarwal explained that CELESTIAL-301 has dual primary endpoints (UMRD and PFS), with PFS being the traditional regulatory endpoint. UMRD data will be reviewed by IDMC in Q3 2026, but PFS is the base case for filing. He noted that demonstrating statistical significance versus VO for UMRD is a high bar (VO UMRD rates are 73.3% in CLL 17 trial). For the BTK CDAC, the efficacy hurdle for accelerated approval is an ORR of 50% to 70% in relapsed/refractory patients, depending on the population and available therapies. “demonstrating statistical significance versus VO is an extremely high bar.”

Status of BRUKINSA's launch in Europe and expected launch ramp for BTK CDAC.

John Oyler stated that Europe takes time for launch and reimbursement, and it's "still pretty early in those days" for BRUKINSA there, with substantial growth opportunity. An Unknown Executive indicated that the BTK CDAC launch ramp should be "relatively robust" with a typical S-shaped uptake curve, leveraging existing infrastructure. “Europe takes a while to launch and to work your way on to reimbursement... it's still pretty early in those days.”

View on TH60 amidst competition and the Fc silence strategy for toxicity vs. direct depletion.

Lai Wang explained that the BB10 (TH60) trispecific is engineered to block three established pathways, with the CTLA-4 arm offering potential differentiation from existing bispecifics. The Fc silence strategy aims to mitigate toxicity concerns, and preclinical data suggests it can retain efficacy while improving safety. “by adding the CTLA-4 arm will present potential differentiation from the current existing bispecifics.”

ONC

BeOne Medicines (ONC) Q1 FY26 earnings call: guidance and Q&A

Q: Contextualize BRUKINSA's claim of being the only BTK to show superiority vs. ibrutinib, given Lilly's claims for Pirtob.

Amit Agarwal clarified that BRUKINSA is indeed the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study (Alpine). He highlighted issues with Pirtob's claims, noting that its 26% risk reduction claim in the relapse setting is based on investigator assessments, not independent review committee (IRC) data, which showed only a 2-event difference. He also stated that Pirtob's treatment-naive subgroup claims are not predefined and lack statistical significance in IRC data, with very short follow-up. “BRUKINSA is the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study.”

Earnings call· Mar 2026 (Q1 FY26)· Health Care· May 6, 2026

Source: earnings call transcript

Executive summary

BeOne Medicines Q1 FY26 — Strong BRUKINSA Growth & Raised Full-Year Guidance

BeOne Medicines delivered a strong first quarter, driven by robust product revenue growth, particularly from its foundational BRUKINSA franchise. The company raised its full-year revenue guidance, reflecting confidence in continued global expansion and pipeline advancements. Significant progress was noted across its hematology franchise and solid tumor pipeline, with key clinical milestones and regulatory submissions anticipated.

Highlights

Product revenue reached $1.5 billion, representing 34% year-over-year growth.
BRUKINSA global revenues totaled $1.1 billion, with 38% growth across all markets and indications.
Full-year 2026 revenue guidance was raised by $100 million, now projected between $6.3 billion and $6.5 billion.
Non-GAAP income from operations increased to $414 million in Q1 FY26, up from $139 million in the prior period.
Free cash flow generated $161 million in Q1 FY26, an increase of $173 million over the prior period.

Concerns

XGEVA faces enhanced competition due to several biosimilar entrants filing for approval in April.
Q1 results included $20 million of nonrecurring gross-to-net favorability for BRUKINSA in the U.S.
The IRAK4 program in rheumatoid arthritis was discontinued based on emerging new data.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 revenue	$6.3 billion to $6.5 billion high materiality	FY26 · 2026	High
Full-year 2026 GAAP operating expense	$4.7 billion and $4.9 billion medium materiality	FY26 · 2026	High
Full-year 2026 GAAP operating income	$750 million and $850 million high materiality	FY26 · 2026	High
Full-year 2026 GAAP gross margin	high 80% range medium materiality	FY26 · 2026	High
BTK CDAC accelerated approval submission	potential accelerated approval submission high materiality	H2 2026	High
TEVIMBRA US approval	U.S. approval high materiality	H2 2026	High
Sonro Phase III study initiation	initiate Phase III study medium materiality	H2 2026	High
BTK CDAC CSU Phase II study initiation	initiate Phase II study medium materiality	FY26 · 2026	High
GPC3/4-1BB bispecific pivotal HCC study	potentially pivotal study actively enrolling high materiality	Ongoing	High
CDK4 inhibitor Phase III site activation	activated its first Phase III site high materiality	Ongoing	High
New Molecular Entities (NMEs) cadence	roughly 2 NMEs per year medium materiality	2026 and beyond	High
BTK CDAC Phase III enrollment completion	complete enrollment high materiality	Early 2027	High
BRUKINSA Mango Phase III interim PFS readout	interim PFS readout high materiality	June 2026	High
ASCO 2026 presentations	24 abstracts accepted, including 3 oral presentations medium materiality	June 2026	High
PMD 5 and CADC data disclosure	additional data disclosure medium materiality	FY26 · 2026	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Total Product Revenue Strong business momentum across product portfolio.	$1.5 billion	34%	—	—
BRUKINSA Global Strong growth and performance across all approved markets and indications.	$1.1 billion	38%	—	—
BRUKINSA U.S. Principally driven by volume growth, with a mid-single-digit pricing benefit year-over-year. Volume growth: 28% vs Q1 2025	$761 million	—	—	—
TEVIMBRA Sustained market leadership in China despite competitive environment, with approximately half of growth from outside China.	—	20%	—	—
In license and other products Continued strength, including robust performance from Amgen in-license portfolio.	—	27%	—	—
XGEVA Continued to perform very well, but biosimilar entrants filed for approval in April.	$90 million	—	—	—
U.S. (Geography) Remains the largest market.	$766 million	36%	—	—
China (Geography) Good performance and sustained leadership from TEVIMBRA and BRUKINSA. FX impact: 5%	$465 million	17%	—	—
Europe (Geography) Driving demand growth for BRUKINSA in all major markets, with opportunity to increase brand share. FX contribution: 11%	$191 million	64%	—	—
Rest of World (Geography) Driven by market expansions and new launches in key markets such as Japan and Brazil.	—	104%	—	—

ONC operating KPIs by quarter

ONC operating KPIs stated on its earnings calls, by fiscal quarter
KPI	Dec 2025 Q4 FY25	This call Mar 2026 Q1 FY26	Jun 2026 Q2 FY26	Change vs prior quarter
Employees	<12K And on behalf of everyone here, I really want to thank the broader oncology community, the patients and families who inspire our work, the clinicians who partner with us every day and our almost 12,000 employees all around the world who continue to raise the bar. Source: earnings call transcript	12K+ I really want to thank the patients and the families that we serve, our physicians and our partners and our more than 12,000 colleagues and their families who focus and urgency make our progress possible. Source: earnings call transcript	12K+ And we do want to just take a moment to thank the patients, their families that we're serving, the physicians, our partners and our more than 12,000 colleagues and their families who focus with urgency every day to make this progress possible. Source: earnings call transcript	—

Operating figures the company stated on at least two of the calls shown, checked against each call's transcript. Click a figure to read the sentence. A dash means it was not stated that quarter.

Deals & partnerships

Not named Licensing option acquisition

Acquired an exclusive option to license a novel PD-1 VGF CTLA4 trispecific (BB10/TH60), which is expected to enter the clinic in June.

Risks & headwinds

Biosimilar competition for XGEVA Near-term

Several biosimilar entrants filed for approval in April.

Mitigation:Not explicitly stated, but XGEVA continued to perform well in Q1.

Nonrecurring gross-to-net favorability for BRUKINSA in Q1 Q1 FY26

$20 million

Mitigation:Company expects relatively stable pricing for the full year, excluding this item.

Discontinuation of IRAK4 program in rheumatoid arthritis Q1 FY26

Program discontinued.

Mitigation:Resources reallocated towards higher-potential opportunities.

Q&A highlights

Contextualize BRUKINSA's claim of being the only BTK to show superiority vs. ibrutinib, given Lilly's claims for Pirtob.

Amit Agarwal clarified that BRUKINSA is indeed the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study (Alpine). He highlighted issues with Pirtob's claims, noting that its 26% risk reduction claim in the relapse setting is based on investigator assessments, not independent review committee (IRC) data, which showed only a 2-event difference. He also stated that Pirtob's treatment-naive subgroup claims are not predefined and lack statistical significance in IRC data, with very short follow-up.

“BRUKINSA is the only BTKI to demonstrate superiority to ibrutinib in a head-to-head study.”

asked by Yigal Nochomovitz · answered by Amit Agarwal

2 min read 6 chapters

Detailed narrative

BRUKINSA's Differentiated Profile

BRUKINSA has firmly established itself as a foundational BTK inhibitor, demonstrating superior efficacy and safety with long-term data in frontline CLL. Its clinical profile shows sustained separation in progression-free survival compared to other BTK inhibitors and fixed duration regimens, with significant deltas observed at the 6-year mark. This robust evidence supports its best-in-class position, particularly against ibrutinib in head-to-head trials.

Sonro's Transformative Potential

Sonro, a next-generation BCL-2 inhibitor, is designed to be significantly more potent and selective than venetoclax, with a shorter half-life for a simpler ramp-up. The combination of BRUKINSA and Sonro (ZS) demonstrated a high UMRD rate in the 101 trial, comparing favorably to other regimens.

Three Phase III studies are underway for the ZS combination, aiming to change the first-line CLL treatment paradigm and expand BeOne's market presence.

BTK CDAC Innovation

The BTK CDAC is a first-in-class therapy for heavily pretreated patients, showing complete BTK degradation and broad mutation coverage. Early study results indicate a high overall response rate. An accelerated approval submission in the U.S. for relapsed/refractory CLL is expected in the second half of 2026, positioning it as a leading innovation in CLL treatment.

Solid Tumor Pipeline Inflection

BeOne's solid tumor pipeline is shifting towards late-stage execution, with programs like the CDK4 inhibitor in breast cancer and the GPC3/4-1BB bispecific in hepatocellular carcinoma (HCC) advancing rapidly. The GPC3/4-1BB bispecific demonstrated exceptional development speed, moving from first-in-human dosing to a potentially registrational study in just 19 months, highlighting the company's clinical execution capability.

Innovation Engine and External Strategy

The company's in-house technology stack and systematic approach to matching biology with modality have accelerated its innovation engine, consistently delivering new molecular entities. BeOne plans to sustain a cadence of roughly two NMEs per year from 2026. Selective external innovation, such as the acquisition of an exclusive option for a novel PD-1 VGF CTLA4 trispecific, further strengthens the pipeline and creates opportunities for proprietary combinations.

Immunology Program Updates

BeOne made a data-driven decision to discontinue the IRAK4 program in rheumatoid arthritis, reallocating resources to higher-potential opportunities. Concurrently, the BTK CDAC CSU Phase II study is on track to initiate by year-end, based on encouraging Phase I data, reflecting a disciplined approach to pipeline management.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.