BeiGene Reports Q2 2026 Results: Full Earnings Call Transcript

BeiGene (NASDAQ: ONC ) held its second-quarter earnings conference call on Wednesday. Below is the complete transcript from the call. This content is powered APIs. 05 in GAAP earnings per ADS, representing 30% and 144% growth year-over-year, respectively.

2 billion in global revenues, marking a 31% year-over-year growth. Strategically, BeiGene announced the FDA approval of Bacalzi for mantle cell lymphoma and positive results from the Phase 3 Mangrove study, positioning Brukinsa as a chemo-free treatment option. S. manufacturing site with a $300 million investment and progressing its R&D pipeline, including the advancement of a BTK degrader and other solid tumor assets.

Management highlighted Brukinsa’s sustained growth across multiple indications and emphasized the importance of long-term data for treatment efficacy and durability. BeiGene's strategic focus is on building disease franchises rather than standalone products, supported by a diverse technology toolkit to enhance its pipeline. Full Transcript OPERATOR Good day, everyone. Welcome to BeiGene's Q2 2026 earnings call webcast.

All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. At this time, I would like to turn the call over to the company. Dan Maller, Head of Investor Relations Hello and welcome.

Thank you for joining us today. I'm Dan Maller, Head of Investor Relations at BeiGene. com. I would like to remind all participants that during this call we may make forward-looking statements regarding, among other things, the company's future prospects and business strategy.

Actual results may differ materially from those indicated in the forward-looking statements as a result of various factors, including those risks discussed in our most recent periodic report filed with the SEC. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation. Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our Investor Relations website along with our earnings release.

All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law. Now turning to today's call, as outlined on Slide 3, John Oyler, our co-founder, chairman and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our second quarter financial results and 2026 financial guidance, and Lai Wang, President and Global Head of R&D, will discuss our R&D and pipeline progress. We will then open the call to questions.

Joining the team for the Q&A portion of the call will be Dr. Wu, President and Chief Operating Officer; Matt Shawless, General Manager of North America; Mark Lanasa, Chief Medical Officer for Solid Tumors; and Amit Agarwal, Chief Medical Officer for Hematology. I'll now pass the call over to John. John Oyler, Co-Founder, Chairman and CEO Thank you, Dan, and welcome everyone.

Q2 was a very strong quarter across every dimension of our business. 05 in GAAP earnings per ADS. This represents growth of 30% and 144% compared to the prior year, respectively. Brukinsa, our foundational BTK inhibitor, continues to exceed our high expectations in the marketplace.

More than six and a half 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. On the back of these strong results, we're raising our 2026 guidance ranges for revenue and GAAP operating income by $300 million and $250 million, respectively, and Aaron will detail this later. As impressive as our financial performance was in the quarter, our pipeline progress was equally significant.

This is highlighted by the FDA approval of Bacalzi as the first and only BCL2 inhibitor in mantle cell lymphoma and the success of the Phase 3 Mangrove study of Brukinsa, which is so exciting that it warrants the entire next slide. S. manufacturing site in Hopewell, New Jersey. Mangrove is yet another example of the growing body of evidence supporting Brukinsa as the BTK inhibitor.

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, and secondly, because when you see the data, we believe the efficacy will speak for itself. We're confident that this Brukinsa-based chemo-free regimen has the potential to become the future standard of care for the roughly 21,000 new patients diagnosed with MCL each year in the major markets. Global submissions are planned for the second half of 2026, and we're looking forward to sharing the full data at an upcoming medical meeting.

Let's now turn to Brukinsa's commercial performance in Q2. 2 billion, representing growth of 31% year over year. S. and globally, and it has the broadest label of any BTKI with approvals in five B—cell malignancies.

We often talk about Brukinsa in the context of CLL and with good reason, but it is important to remember that Brukinsa is a very important option for patients with other B—cell malignancies, including MCL, Waldenström's, marginal zone, and follicular lymphoma. Brukinsa has now treated more than 300,000 patients across 80—plus markets, but market share alone doesn't tell the full story. The reason we're winning is scientific, and that story has three: differentiated design, differentiated clinical outcomes, and differentiated real—world evidence.

At BeiGene, we're committed to generating and sharing the evidence needed to fully characterize our medicines for the patients and physicians that we serve. On the left side of this slide, you can see the highlights of the breadth of Phase 3 data generated for Brukinsa as a single agent. Here you can see Brukinsa has reported the most Phase 3 data of any single—agent BTK. The right side illustrates the substantial body of data currently being generated in combination, where you can see that Brukinsa has the most reported and ongoing Phase 3 data of any BTKI agent.

This slide demonstrates the scale of Brukinsa's development plan compared to the more curated efforts of our peers. In addition to Mangrove, Brukinsa has four more potentially market—expanding Phase 3 readouts in the next three years. A major wave of data is coming that will extend Brukinsa's evidence base and its label well into the future. One quick reminder of why Brukinsa performs the way it does: from day one, Brukinsa was designed to deliver complete and sustained BTK inhibition through its potency and its PK profile.

Our hypothesis was simple — continuous BTK coverage would translate into a superior therapeutic profile — and over a decade of clinical and real—world evidence has really borne that out. And that's what the next few slides show. Let me remind you now that Brukinsa is the only BTK inhibitor that has demonstrated PFS superiority versus ibrutinib. 5 months.

845. Put simply, there was very little differentiation between the two arms, with 48 PFS events reported for pirtobrutinib versus 50 for ibrutinib. And with respect to tolerability, pirtobrutinib showed numerically more discontinuations due to AEs than ibrutinib, whereas both Brukinsa and acalabrutinib each showed markedly fewer discontinuations than ibrutinib in their respective head—to—head trials. When comparing AFib rates of next—generation BTK inhibitors across studies, it's important to understand the protocol differences that may affect patient selection and event reporting.

As you can see on the left, both Brukinsa and acalabrutinib studies in frontline CLL used highly similar eligibility criteria and AFib reporting. In contrast, the pirtobrutinib studies utilized more restrictive eligibility criteria that may have resulted in a fitter study population, and they also incorporated sponsor adjudication of AFib events. As a reminder, AFib events and rates are known to rise substantially with age. S.

primary care clinics, the absolute prevalence of AFib was nearly 4% higher among those aged 70 to 74 as compared to 65 to 69, so factoring for this level of age difference in studies really matters. Despite the differences in inclusion criteria, which may have led to roughly half the percentage of patients above the age of 75 in BRUIN—313 and a four—year lower median age in the pirtobrutinib studies, and despite the differences in AFib reporting methods, AFib rates were generally similar in the active treatment arms across studies.

Interestingly, if we applied the more restrictive BRUIN—313 and —314 eligibility criteria to the SEQUOIA population, 15 of the highest—risk patients would have been excluded from the Brukinsa arm, and in fact those 15 patients had roughly twice the rate of serious grade 3 or higher infections and more than twice the rate of deaths due to AEs compared to the overall study. This analysis underscores the extent to which differences in protocol inclusion criteria may play a key role in the clinical narrative.

Although some have suggested that pirtobrutinib may be well suited for use in older patients due to lower AFib risk and improved tolerability, it is the least studied BTK inhibitor in that population. It lacks relevant long—term data, with only 28 months of follow—up, and the narrative about being more tolerable and having less AFib are not supported by the data. The totality of evidence continues to support Brukinsa's best—in—class profile. One of the key lessons we've recently learned in CLL trials is that long—term follow—up matters.

Many regimens can appear highly effective in the first three years, but that's not enough time to understand their true durability. This slide shows the reported landmark PFS at years 3 through 6 across the respective frontline CLL Phase 3 trials for the frontline treatment regimens. Recognizing the limitations of cross—trial comparisons, a few items jump out. One, the landmark PFS rates for Brukinsa are higher and continue to diverge over time compared to the other two continuous BTKIs.

In fact, in year 6 the delta between the landmark PFS rates reaches 12%, which is the equivalent of 1 in 8 patients not progressing. Two, there's an even more pronounced delta between Brukinsa's landmark PFS and that of VO. In year six there's a delta of 21%, or roughly one in five patients. While the all—comer story is compelling, the high—risk story is even more striking.

It raises important questions about the use of the current fixed—duration regimens in high—risk patients, which I want to point out represent the majority of CLL patients. This is not a small patient subgroup. This slide shows how the current fixed—duration treatments perform relative to the foundational Brukinsa in unmutated IGHV patients, those with the highest unmet medical need. Brukinsa remains durable — 84% landmark PFS at year three and 70% at year six.

In contrast, VO drops from 82% at year three to just 42% at year six — a 40—point collapse — and AV Amplify, based on the limited data disclosed to date, shows just 69% at year three, which is of course lower than VO at a similar time point. There's a few important takeaways from this slide. First, while we're big believers in the promise of fixed duration, the existing venetoclax—based treatments are not a compelling option for higher—risk patients, where foundational Brukinsa has generated the best—in—class data. Second, long-term follow-up is critical in CLL.

As you can see on this slide, many regimens look promising at three years, but by six years the outcomes can diverge meaningfully, especially in high-risk patients. And that's why we've consistently prioritized long-term follow-up in our studies and why we believe six-year data provide a more complete picture of treatment durability. It's also why we're concerned when conclusions reached on regimens based on only three years of data or less are made. We've been very surprised that some studies have not continued to report longer-term follow-up data, because years three to six are critical to evaluate the true long-term benefit of any CLL therapy.

Patient outcomes are at stake. The durability advantage that we're seeing in the clinical data for foundational Brukinsa is increasingly being reinforced in the real world, and it's both consistent and it's compelling. At ASCO 2026 we published an analysis of over 10,500 Medicare fee-for-service patients with previously untreated CLL. This is the largest real-world data set ever assembled in this setting.

In this patient population, Brukinsa reported statistically significant 24% and 36% reductions in the risk of death compared to those treated with acalabrutinib and ibrutinib, respectively, 24% and 36%. As you can imagine, this data set generated significant interest from physicians at ASCO, given both its size and the importance of these findings to the real-world US Medicare population.

The study has since been published in a peer-reviewed journal and, importantly, this is now one of several large real-world analyses showing a consistent advantage for Brukinsa, including a recent study of claims data from 17,000 frontline CLL patients which also reported improved survival and treatment durability for Brukinsa versus acalabrutinib.

Stepping back, BeiGene is the only company in the world with foundational medicines across the three mechanisms of action for B-cell malignancies: Brukinsa, our foundational BTK inhibitor; Bacalzi, our recently approved next-generation potentially best-in-class BCL2 inhibitor; and tacobrutadig, our potentially first and best-in-class BTK degrader. Only BeiGene is equipped to provide the best-in-class therapies as monotherapy or in combination for every CLL patient and other lymphomas, regardless of their stage of disease, risk status, or treatment preference.

I've spoken about how 2026 is an inflection year for our solid tumor pipeline, and we presented data this quarter that supports our confidence in moving our CDK4 inhibitor, our B7-H4 ADC, and our GPC3—4-1BB bispecific antibody into registrational trials. Looking forward to ESMO, we will be sharing similar proof—of—concept data sets for two more potentially best-in-class medicines, our PRMT5 inhibitor and our CEA ADC. It's an incredibly exciting time for our company, for our portfolio, and for our pipeline, and with that I'll hand it over to Aaron for the financial results. Aaron Rosenberg (Chief Financial Officer) Thanks, John.

Our second quarter financial results reflect strong execution and a durable and healthy underlying business as we invest with discipline to support growth over the long term. Starting with our commercial performance, we delivered another strong quarter across the portfolio with continued broad-based growth. 7 billion, representing 30% growth compared to the prior year. US Brukinsa sales totaled $893 million, representing growth of 31%, which exceeded expectations due to several underlying factors.

Despite the competitive environment in Q2, we saw the highest level of sustained new patient starts since Brukinsa's launch. Prescribers increasingly selected Brukinsa for their patients given the totality of evidence for efficacy and durability supported by the clinical data and their real-world experience. We also continue to see meaningful growth from indications beyond CLL, which speaks to the breadth of the Brukinsa label and the diversification of the franchise. And while duration of therapy remains immature for Brukinsa, the data suggests favorable duration relative to historical benchmarks.

This makes sense given the unprecedented long-term data seen with SEQUOIA as well as recently published real-world studies that reinforce statistically significant advantages for Brukinsa in time to discontinuation relative to both acalabrutinib and ibrutinib. And finally, patient adherence has also improved, potentially linked to the launch of the tablet formulation late last year, which reduced both pill size and burden. High adherence rates are important for patient outcomes, and we are pleased to see this progress. These factors are not unique to the US, and we expect they will support durable long-term global demand growth for Brukinsa.

Beyond Brukinsa, Tevimbra generated $229 million in global sales, representing 18% growth versus the prior period. Tevimbra maintained its market leadership in China in the face of steep competition.