Q2 2025 BeOne Medicines Ltd Earnings Call

All lines have been placed on mute to prevent any background noise.

So the speaker's remarks, there will be a question and answer session.

At this time I would like to turn the call over to the company.

Hello, and welcome thanks for joining us today I'm, Dan now there has investor relations at <unk>, one medicines before we begin. Please note that you can find additional materials, including a replay of today's webcast and presentation on the Investor Relations section of our website IR dot be one medicines dotcom.

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 business strategies.

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.

He's 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 I provided in the appendix to our presentation, which is posted to our Investor Relations website, along with our earnings release all.

All information in this presentation is as of the date of this presentation. We undertake no duty to update such information unless required by law.

Now turning to today's call as outlined on slide three.

John Oyler, our co founder Chairman and CEO will provide a business update.

Rosenberg, our CFO will provide an update on our second quarter financial results and financial guidance.

<unk>, our global head of R&D will discuss our R&D and pipeline progress.

We'll then open the call to questions.

I'll now pass the call over to John John.

Thank you Dan and welcome everyone to our Q2 earnings call.

We had a spectacular second quarter.

Our revenue reached $1 3 billion, which represents 42% year on year growth.

GAAP earnings per ADR grew $2 from Q2 of last year.

And we generated $220 million of free cash flow in Q2.

This is an absolute increase of over $400 million versus last year.

From a commercial perspective brookins that has cemented itself as the number one be TK inhibitor in the U S market.

This quarter. We also hosted an R&D day, where we shared three takeaways with you.

First why are we believe our internal capabilities and our sense of urgency we will drive superior returns on R&D.

Second how our hematology.

Poised.

Peter cap into the next decade and.

And three why you should pay close attention to our prolific and differentiated solid tumor pipeline.

I want to come back now to brick enzyme the cornerstone of our CLO franchise.

Brookins as best in class profile has resulted in rapid adoption by patients and physicians across the U S. Despite launching in CLO nine years after ibrutinib.

Here, we see the U S revenue performance of the three approved covalent <unk> inhibitors since brew, Kansas <unk> approval.

The chart speaks for itself.

The gap between us and the competition continues to widen.

Brew, Kansas, both the market share leader and it's the fastest growing brand.

And it's the only be teekay to be approved in five indications.

Now the success of <unk> is not an accident.

It's the direct result of an overwhelming body of evidence accumulated over more than a decade.

This evidence is remarkable both for its strength as well as its consistency.

When we designed brookins, our preclinical hypothesis was that sustained inhibition of <unk> in the disease compartment.

And improved selectivity for <unk> over off target kinases would translate to a differentiated medicine for patients.

Since then brookins has treated thousands of patients in clinical trials and over 200000 patients commercially.

Brookins has differentiated itself.

Each and every step of the way from human PK to clinical response to PFS and now in the market, where it continues to generate compelling real world data.

As you know the Golan in oncology drug development is to hit the target hard and that never let off never.

John Oyler: The performance of the three approved covalent BTK inhibitors since BRUKINSA's CLL approval. The chart speaks for itself. The gap between us and the competition continues to widen. BRUKINSA is both the market share leader and it is the fastest growing brand. It is the only BTK to be approved in five indications. The success of BRUKINSA is not an accident. It is the direct result of an overwhelming body of evidence accumulated over more than a decade. This evidence is remarkable both for its strength as well as its consistency. When we designed BRUKINSA, our preclinical hypothesis was that sustained inhibition of BTK in the disease compartment and improved selectivity for BTK over off-target kinases would translate to a differentiated medicine for patients. Since then, BRUKINSA has treated thousands of patients in clinical trials and over 200,000 patients commercially.

Never give the cancer an opportunity to grow.

As you can see on this slide the prior generation <unk> inhibitors only hit the target for a fraction of the day.

Performance of the 3 app, BTK Inhibitors, since brute kenzas, CLL approval.

The chart speaks for itself.

But brookins as difference it was designed to inhibit PTK 24 hours a day seven days a week.

The gap between us and the competition continues to widen.

We hypothesize that brookins, a superior target coverage would translate to superior clinical benefits for patients.

Rowkin. Both the market share leader and it's the fastest growing brand.

And it's the only BTK to be approved in 5 indicators.

As you can see on this slide in the Alpine trial, Brookins I drove higher responses compared to Ibrutinib.

Now, the success of Brooke Kenza is not an accident.

This result was clear at the earliest data cut.

It's the direct result of an overwhelming body of evidence accumulated over more than a decade.

And more importantly, it was maintained with longer follow up.

This evidence is remarkable both for its strength as well as its consistency.

Next we followed the data to see whether the collective and consistent results across preclinical human PK in tumor shrinkage would be associated with improved and sustained PFS.

When we designed bricken our pre-clinical hypothesis, was that sustained inhibition of BTK in the disease compartment.

Clearly it was.

Brew, Kansas, the only be Teekay to this demonstrates superior PFS and favorable safety in a head to head trial against Ibrutinib.

And improved selectivity for BTK over off-target kinases, would translate to a differentiated medicine for patients.

In the Alpine trial brookins exhibited a 34% reduced.

John Oyler: BRUKINSA has differentiated itself each and every step of the way, from human PK to clinical response to PFS, and now in the market where it continues to generate compelling real-world data. As you know, the goal in an oncology drug development is to hit the target hard and to never let up, never give the cancer an opportunity to grow. As you can see on this slide, the prior generation BTK inhibitors only hit the target for a fraction of a day. BRUKINSA is different. It was designed to inhibit BTK 24 hours a day, seven days a week. We hypothesize that BRUKINSA's superior target coverage would translate to superior clinical benefits for patients. As you can see on this slide, in the Alpine trial, BRUKINSA drove higher responses compared to ibrutinib.

Since then Brooke Kensa has treated thousands of patients in clinical trials and over 200,000 patients commercially.

Broonzer differentiated itself.

Okay.

Ken or das and lower cardiac tox versus Ibrutinib.

There were zero cardiac deaths in the brookins arm versus sex on the Ibrutinib arm.

Each and every step of the way from Human PK to clinical response to PFS, and now in the market where it continues to generate compelling real world data.

In the deletion 17, P and T. P 53, subpopulations, which are the toughest patients to treat.

As you know, the goal in an oncology drug development is to hit the target hard and to never let up.

Brew, Kansas treatment effect was even more pronounced <unk> showed a remarkable 52% reduced risk of progression or death.

Never give cancer an opportunity to grow.

As you can see on this Slide, the prior generation BTK Inhibitors, only hit the target for a fraction of the day.

As ibrutinib.

The alpine data show that <unk> is the best in class option for all types of patients regardless of mutation or risk status.

But Bru Kenza is different. It was designed to inhibit BTK 24 hours a day, 7 days a week.

So fast forward to today patient and physician adoption is driven brookins that'd be the top PTK inhibitor in the U S.

We hypothesized that Bru kenzo's Superior Target coverage, would translate to Superior clinical benefits for patients.

This slide shows two examples of recent presentations and publications supporting Brookins is differentiation versus both the caliber of nib and Ibrutinib.

John Oyler: This result was clear at the earliest data cut, and more importantly, it was maintained with longer follow-up. Next, we followed the data to see whether the collective and consistent results across preclinical human PK and tumor shrinkage would be associated with approved and sustained PFS. Clearly, it was. BRUKINSA is the only BTK to demonstrate superior PFS and favorable safety in a head-to-head trial against ibrutinib. In the Alpine trial, BRUKINSA exhibited a 34% reduced risk of progression or death and lower cardiac toxicity versus ibrutinib. There were zero cardiac deaths in the BRUKINSA arm versus six on the ibrutinib arm. In the deletion 17p and TP53 subpopulations, which are the toughest patients to treat, BRUKINSA's treatment effect was even more pronounced. BRUKINSA showed a remarkable 52% reduced risk of progression or death versus ibrutinib.

as you can see on this slide in the Alpine trial through Kenza drove higher responses, compared to ibrutinib

This result was clear at the earliest data cut.

And more importantly, it was maintained with longer follow-up.

On the left is a real world study that demonstrated that patients treated with <unk>.

Had longer time to discontinuation lower discontinuation rates and less healthcare resource utilization than those treated with a calibrated nib.

next, we follow the data to see whether the collective and consistent results across pre-clinical human PK and tumor shrinkage would be associated with improved and sustained PFS,

clearly, it was

And a brute nab across all patients and this was even more pronounced in the population of older patients over 65% as shown here.

Bruen is the only BTK to dis demonstrate Superior PFS and favorable safety in a head-to-head trial against ibrutinib.

On the right is just one example of another recent publication by a leading CLO kols that recognizes brew, Kansas differentiated data and how <unk> can provide the best outcome for their patients.

In the Alpine, trial, binza, exhibited, a 34% reduced risk of progression or death.

And lower cardiac toxicity versus ibrutinib.

there were zero, cardiac deaths in the bricken arm versus 6 on the ab brute nib arm

Looking beyond brookins.

One stands out as the only company with fully owned differentiated and potentially best in class assets across all three foundational moh in CLO.

in the deletion 17p and tp53 subpopulations, which are the toughest patients to treat.

We're already combining these assets in multiple phase III trials with the goal of improving outcomes for CLO patients even further.

John Oyler: The Alpine data showed that BRUKINSA is the best-in-class option for all types of patients, regardless of mutation or risk status. Fast forward to today. Patient and physician adoption has driven BRUKINSA to be the top BTK inhibitor in the U.S. This slide shows two examples of recent presentations and publications supporting BRUKINSA's differentiation versus both acalabrutinib and ibrutinib. On the left is a real-world study that demonstrated that patients treated with BRUKINSA had longer time to discontinuation, lower discontinuation rates, and less healthcare resource utilization than those treated with acalabrutinib and ibrutinib across all patients. This was even more pronounced in the population of older patients over 65, as shown here. On the right is just one example of another recent publication by a leading CLL KOL that recognizes BRUKINSA's differentiated data and how BRUKINSA can provide the best outcome for their patients.

Bruins, as treatment effect was even more pronounced ruken, showed a remarkable 52% reduced risk of progression or death versus a Brutus.

We believe our relentless focus on cereal innovation and CLO positions us as the only company that can address the full scope of unmet patient need across all lines of therapy and subpopulations.

The Alpine data showed that Bruins are the best-in-class option for all types of patients, regardless of mutation or risk status.

With that said, we're far more than a CLO company, we're a global oncology company and we have a wealth of upcoming milestones on the horizon.

So fast forward to today, patient. And physician adoption has driven brute Kenza to be the top BTK inhibitor in the US.

By the end of 2026, we expect the initial global approval of Sone row, and potentially pivotal data for our <unk>.

This slide shows 2 examples of recent presentations and Publications supporting Brooke Kenza differentiation versus both. A calibrate nib and a brute nib.

Our internal clinical team will be running more than 20 phase III trials.

And we anticipate more than 10 proof of concept data Readouts and our research organization will again advance more than 10 enemies into the clinic.

On the left is a real world study, that demonstrated, that patients, treated with brute Kenza had longer time to discontinuation lower discontinuation rates, and less Health Care resource, utilization than those treated with a caliber brute nib.

And with that I'll pass it over to Aaron to provide the financial update.

And a brute nib across all patients and this was even more pronounced in the population of older patients over 65 as shown here.

Thanks, John.

<unk> revenue reached $1 3 billion in the second quarter, representing 41% year over year growth.

Kenseth global revenues were $950 million growing 49% year over year, driven by strong performance all geography.

For their patients.

John Oyler: Looking beyond BRUKINSA, BeiGene stands out as the only company with fully owned, differentiated, and potentially best-in-class assets across all three foundational MOAs in CLL. We are already combining these assets in multiple phase III trials with the goal of improving outcomes for CLL patients even further. We believe our relentless focus on serial innovation in CLL positions us as the only company that can address the full scope of unmet patient need across all lines of therapy and subpopulations. With that said, we are far more than a CLL company. We are a global oncology company, and we have a wealth of upcoming milestones on the horizon. By the end of 2026, we expect the initial global approval of SONRO and potentially pivotal data for our BTK CDAC.

As John mentioned is now the clear value share leader in the growing U S. PTK market and we continue to grow volume at a robust rate across all approved indications.

This was seen again in Q2 with demand growth of 35% year over year, and 10% sequentially driven by the quality and differentiation of our long term clinical data across all patient types.

Looking beyond Brooke, Kenza B1 stands out as the only company with fully owned, differentiated, and potentially best-in-class assets across all three foundational MOAs in CLL.

we're already combining these Assets in multiple phase 3 trials, with the goal of improving outcomes for CLL patients even further

With our strengthening market position, we have seen competition aggressively discounted.

Despite this given our broad access strategy and having protected class status. The vast majority of patients have unfettered access to perkins's and an even greater number achieve access upon appeal.

We believe our Relentless focus on cereal, Innovation and CLL positions. Us as the only company that can address the full scope of unmet, patient need across all lines of therapy and subpopulations.

We strongly believe in open access policy, which is clearly in the best interest for patients and preferred by doctors moving forward. We will continue to pursue contracting strategies that seek to achieve this goal while preserving the value of our clinically differentiated innovative medicines for the long term.

With that said, we're far more than a CLL company. We're a global oncology company and we have a wealth of upcoming Milestones on the horizon.

John Oyler: Our internal clinical team will be running more than 20 phase III trials, and we anticipate more than 10 proof-of-concept data readouts, and our research organization will again advance more than 10 NMEs into the clinic. With that, I will pass it over to Aaron Rosenberg to provide the financial update.

By the end of 2026, we expect the initial Global approval of sonero and potentially pivotal data. For our BTK, cedac

Our internal clinical team will be running more than 20 Phase 3 trials.

From a pricing perspective Q2 performance includes a mid single digit benefit largely associated with the annual increase taken at the beginning of the year.

And we anticipate more than 10 proof of concept data readouts, and our research organization will again Advanced more than 10 nmes into the clinic.

And as mentioned last quarter, we also see some modest additional benefits on net pricing for Medicare part D reform, given our designation as a specified small manufacturer.

And with that, I'll pass it over to Aaron to provide the financial update.

Aaron Rosenberg: Thanks, John. Product revenue reached $1.3 billion in Q2, representing 41% year-over-year growth. BRUKINSA's global revenues were $950 million, growing 49% year-over-year, driven by strong performance across all geographies. As John mentioned, BRUKINSA is now the clear value share leader in the growing U.S. BTK market, and we continue to grow volume at a robust rate across all approved indications. This was seen again in Q2 with demand growth of 35% year-over-year and 10% sequentially, driven by the quality and differentiation of our long-term clinical data across all patient types. With our strengthening market position, we have seen competition aggressively discounted. Despite this, given our broad access strategy and having protected class status, the vast majority of patients have unfettered access to BRUKINSA, and an even greater number achieve access upon appeal.

Hey, John.

We are confident in our long term market leadership position for both kindred and our revenue guidance fully factors in current market conditions.

Product Revenue reached 1.3 billion in the, second quarter representing 41% year-over-year growth.

Meanwhile, November reported a 22% increase reflecting continued market leadership in China supplemented by early contributions from launch markets.

In the global revenues were 950 million. Growing 49%, year-over-year driven by strong performance across all geographies.

Our in licensed products also showed continued strength growing 27% year over year, our China team launched out of that amount in the quarter, providing an important new treatment option for patients with her two high expression biliary tract cancer, historically underserved patient population.

As John mentioned for Kenza is now the clear value share leader in the growing us BTK market and we continue to grow volume at a robust rate across all approved indications.

Our geographically diverse product revenue mix continues to fuel strong growth across all key regions. The U S remains our largest market generating $685 million with year over year growth of 43%.

This was seen again in Q2 with demand growth of 35% year-over-year and 10% sequentially driven by the quality and differentiation of our long-term clinical data across all patient types.

with our strengthening Market position, we have seen competition aggressively discount,

China revenue totaled 429, million% to 23% increase so awarded by to Denver, and Kansas market leadership.

Aaron Rosenberg: We strongly believe in open access policy, which is clearly in the best interest for patients and preferred by doctors. Moving forward, we will continue to pursue contracting strategies that seek to achieve this goal while preserving the value of our clinically differentiated innovative medicines for the long term. From a pricing perspective, Q2 performance includes a mid-single-digit benefit largely associated with the annual increase taken at the beginning of the year. As mentioned last quarter, we also see some modest additional benefits on that pricing from Medicare Part D reform, given our designation as a specified small manufacturer. We are confident in our long-term market leadership position for BRUKINSA, and our revenue guidance fully factors in current market conditions. Meanwhile, TEVIMBRA reported a 22% increase, reflecting continued market leadership in China, supplemented by early contributions from launch markets. Our in-license products also showed continued strength, growing 27% year-over-year.

Despite this given our broad access strategy, and having protected class status, the vast majority of patients have unfettered access to rekindle and an even greater number achieve access upon appeal.

From our in licensed assets.

Europe contributed $152 million with 87% year over year growth as we continue our launch trajectory with Perkins with increased share across all major markets and.

We strongly believe in open access policy, which is clearly in the best interest for patients and preferred by doctors moving forward, we will continue to pursue Contracting strategies that seek to achieve this goal while preserving the value of our clinically differentiated Innovative medicines with a long term.

In rest of World markets grew 168% driven by market expansion and new launches for Kinzel launched in Japan in March and had the largest uptake in the class and the three months since <unk>.

From a pricing perspective, Q2 performance includes a mid single-digit. Benefit largely associated with the annual increase taken at the beginning of the year.

<unk> is also launching in key markets, including Japan, South Korea, and Brazil, and we are encouraged by early market response.

Turning to our Q2, 'twenty five GAAP, P&L, which illustrates our focus on topline growth with meaningful margin expansion.

And as mentioned last quarter, we also see some modest additional benefits on net pricing from Medicare Part D reform, given our designation as a specified, small manufacturer. We are confident in our long-term Market leadership position for Bhutan and our Revenue guidance, fully factors in current market conditions.

Total revenue for the quarter was $1 3 billion, the drivers, which I previously highlighted.

Gross margin improved to approximately 87% from 85% in the prior quarter. This improvement reflects the benefits from favorable product mix price and production cost efficiencies.

Meanwhile Tober reported a 22% increase reflecting continued Market leadership in China. Supplemented by early contributions from launch markets.

Aaron Rosenberg: Our China team launched on a data map in the quarter, providing an important new treatment option for patients with HER2 high expression biliary tract cancer, a historically underserved patient population. Our geographically diverse product revenue mix continues to fuel strong growth across all key regions. The U.S. remains our largest market, generating $685 million, with year-over-year growth of 43%. China revenue totaled $429 million, a 23% increase, supported by TEVIMBRA and BRUKINSA's market leadership and growth from our in-licensed assets. Europe contributed $152 million, with 87% year-over-year growth as we continue our launch trajectory with BRUKINSA, with increased share across all major markets. The rest of the world markets grew 168%, driven by market expansions and new launches. BRUKINSA launched in Japan in March and had the largest uptake in the class in the three months since.

Operating expenses grew by 18% totaling $1 1 billion as we are investing smartly to support our commercial growth and rapidly advance our innovative pipeline.

Our in licensed products also showed continued strength for only 27% year-over-year. Our China team launched down a data map in the corner, providing an important new treatment option for patients with her to high expression military track cancer, a historically underserved patient population.

Income tax expense of $5 million for the quarter includes discrete adjustments of approximately $14 million primarily related to updated provision estimates for R&D tax credits.

Our geographically diverse product Revenue, mix continues to fuel strong growth across all key regions.

Our continued focus on margin expansion is translated to net income reaching $94 million in the quarter, representing diluted earnings per <unk> of 84.

The US remains our largest market generating, 685 million with year-over-year growth of 43%.

A significant improvement as compared to the same quarter last year.

China Revenue totaled 429 million a 23% increase to reported by Tober and binds Market leadership and growth from our in-licensed assets.

Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the <unk>.

non-GAAP net income reached $253 million.

Europe contributed 152 million with 87% year-over-year growth as we continue our launch trajectory with Brooke Kenza, with increased share across all major markets.

Posting an increase of $230 million compared to the previous year.

This performance translated to diluted non-GAAP earnings per ads of $2 and 25.

Aaron Rosenberg: TEVIMBRA is also launching in key markets, including Japan, South Korea, and Brazil, and we are encouraged by early market response. Turning to our Q2 2025 GAAP P&L, which illustrates our focus on top-line growth with meaningful margin expansion. Total revenue for the quarter was $1.3 billion, the drivers of which I previously highlighted. Gross margin improved to approximately 87% from 85% in the prior quarter. This improvement reflects the benefits from favorable product mix, price, and production cost efficiencies. Operating expenses grew by 18%, totaling $1.1 billion, as we are investing smartly to support our commercial growth and rapidly advance our innovative pipeline. Income tax expense of $5 million for the quarter includes discrete adjustments of approximately $14 million, primarily related to updated provision estimates for R&D tax credits.

and rest of World Markets, grew 168% driven by Market expansion and new launches rowkin, a launched in Japan in March, and had the largest uptake in the class in the 3 months since

For the second quarter.

Given our execution, we are updating our full year 25 guidance with total revenue expectations now ranging between 5 billion and $5 3 billion.

November is all so launching. In key markets, including Japan, South Korea, and Brazil, and we are encouraged by early Market response.

The mid to high 80% range for GAAP gross margin reflects favorable mix dynamics in the earlier realization of cost of goods efficiencies to zimbra.

To our Q2 25 gap p&l, which illustrates our focus on top-line growth with meaningful margin expansion.

Total revenue for the quarter was 1.3 billion. The drivers of which I have previously highlighted

It also accounts for recent and anticipated approval for Kansas tablet formulation.

<unk> achieved a lower cost of goods. In addition to the many patient benefit that this new formulation of ports, including reduced pill burden in size with improved support of dosing flexibility.

Gross margin improved to approximately 87% from 85% in the prior quarter, this Improvement reflects the benefits from favorable product mix price and production cost efficiencies.

Operating expense guidance is unchanged.

<unk> operating expenses between $4 1 billion and $4 4 billion.

Operating expenses grew by 18%, to lean 1.1 billion as we are investing, smartly to support our commercial growth and rapidly Advance our Innovative pipeline.

We remain committed to achieving positive GAAP operating income and we expect to generate positive free cash flow for the year free cash flow is a broader measure of cash generation accounting for both operational activities as well as capital expenditures. We are pleased with our execution in the first half of 2020.

Aaron Rosenberg: Our continued focus on margin expansion has translated to net income reaching $94 million in the quarter, representing diluted earnings per ADS of $0.84, a significant improvement as compared to the same quarter last year. Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the appendix. Non-GAAP net income reached $253 million, reflecting an increase of $230 million compared to the previous year. This performance translated to diluted non-GAAP earnings per ADS of $2.25 for the second quarter. Given our execution, we are updating our full year 2025 guidance, with total revenue expectations now ranging between $5 billion and $5.3 billion. The mid to high 80% range for GAAP gross margin reflects favorable mixed dynamics and the earlier realization of cost of goods efficiencies for TEVIMBRA. It also accounts for recent anticipated approval for BRUKINSA's tablet formulation.

Income tax expense of 5 million, for the quarter includes discrete adjustments of approximately 14 million, to primarily related to updated, provision estimates for R&D tax credits.

Five and remain focused on full year delivery across all financial performance measures.

Our continued focus on margin expansion has translated to net income, reaching $94 million in the quarter, representing diluted earnings per ADS of $0.84. This is a significant improvement compared to the same quarter last year.

With that I'd like to pass it over the line.

Thank you Aaron Hello, everyone. Thanks for joining us today as John mentioned, we recently hosted an Investor R&D Day. In addition to a data in the portfolio updates, we'll talk about how <unk> is at a pivotal moment in its journey.

Our non-gaap p&l includes adjustments for a typical items with a full reconciliation provided in the appendix.

Non gaap, net income, reached 253 million reflecting an increase of 230 million compared to the previous year.

Over the years, we have built a strong research internalized, our global clinical development and manufacturing capabilities from Guangdong, allowing.

This performance translated to diluted non-gaap earnings per ads of 2.25 cents for the second quarter.

Allowing us to discover develop and deliver novel oncology medicines faster.

Given our execution, we are updating our full year 25 guidelines with total revenue expectations now ranging between $5 billion and $5.3 billion.

More cost effectively the industry standards.

Our strategically advantaged capability.

Now at a scale and a fully functional across on the.

The mid to high 80% range for gaap. Gross margin, reflects, favorable mixed Dynamics and the earlier realization of cost of goods efficiencies for Tober

You all know we have built a strong CLO fund choice, but it took us a long time.

Aaron Rosenberg: The tablet achieves a lower cost of goods, in addition to the many patient benefits that this new formulation affords, including reduced pill burden and size, with improved support of dosing flexibility. Operating expense guidance is unchanged. We project operating expenses between $4.1 billion and $4.4 billion. We remain committed to achieving positive GAAP operating income, and we expect to generate positive free cash flow for the year. Free cash flow is a broader measure of cash generation, accounting for both operational activities as well as capital expenditures. We are pleased with our execution in the first half of 2025 and remain focused on full-year delivery across all financial performance measures. With that, I'd like to pass it over to Lai.

Now with all this newly build the capabilities. We believe we can reproduce our success you can see all across our disease area of focus and the more importantly doing to much faster. This is very exciting.

It also accounts for recent and anticipated approval for Brooke, Ken's tablet, formulation the tablet, achieves a lower cost of goods. In addition to the many patient benefits that this new formulation affords, including reduced pill, burden, and size with improved support of dosing flexibility.

Our goal is to build a deep pipeline each of this disease areas to create strong in portfolio synergies.

Operating expense guidance is unchanged, we project operating expenses between 4.1 billion and 4.4 billion.

Next some highlights from our R&D progress in the second quarter.

<unk> initial NDA with the first two in China for relapsed refractory CML in the relapsed refractory mantle cell.

The plan is to file mantle cell lymphoma globally later this year with a longer follow up.

We remain committed to achieving positive GAAP operating income, and we expect to generate positive free cash flow for the year. Free cash flow is a broader measure of cash generation, accounting for both operational activities as well as capital expenditures. We are pleased with our execution in the first half of 2025 and.

Main focus on full year delivery across all financial performance measures.

We presented OLED 60 abstracts from our heme portfolio at Opco.

And with that, I'd like to pass it over to live.

Lai Wang: Thank you, Aaron Rosenberg. Hello, everyone. Thanks for joining us today. As John Oyler mentioned, we recently hosted an investor R&D day. In addition to our data and the portfolio updates, we will talk about how BeiGene R&D is at a pivotal moment in its journey. Over the years, we have built a strong research, internalized global clinical developments, and manufacturing capabilities from ground up, allowing us to discover, develop, and deliver novel oncology medicines faster and more cost-effectively than industry standards. Our strategically advantaged capabilities are now at a scale and fully functional across R&D. You all know we have built a strong CLL franchise, but it took us a long time. Now, with all these newly built capabilities, we believe we can reproduce our success in CLL across our disease area of focus, and more importantly, do it much faster. This is very exciting.

<unk> and <unk> and they initiate a new phase III studies for <unk>, and our <unk> Neulasta refractory CLO.

In addition, we provided updates from our solid tumor portfolio at the optical and R&D day.

While the CDK four program, we're actively planning phase III trials for both first line and second line hormone receptor positive breast cancers.

Thank you Aaron. Hello everyone. Thanks for joining us today. As John mentioned, we recently hosted an investor on the day, in addition to a data and a portfolio update, we talked about how B1 and D is at a pivotal moment in its Journey.

Over the years, we have built a strong research, internalized Global chemical development and Manufacturing capabilities from ground up.

In the next few slides I'll walk you through our progress in <unk>.

We have built a comprehensive registration program that spans the full spectrum of CIO from treatment naive to the relapsed refractory setting in the <unk>.

Allowing us to discover develop and deliver. Now, on College medicines faster and more cost effectively than industry standards.

Phones that I said before <unk> has already established itself as a leading BT king.

Our strategically Advantage. Capability are now at a scale and a fully functional across on the

With a combination of <unk> plus a onto Clark's we're advancing what we believe will be the best in class fixed duration regimen.

You all know we have built a strong Co franchise, but it took us a long time.

For relapsed refractory patients our BT, Kate the greater should it become a cornerstone of continuous.

We're also advancing fixed duration regimens, including <unk> plus CD 20 antibodies. In addition, while you validated evaluating <unk> plus PD Casey that.

Lai Wang: Our goal is to build a deep pipeline in each of these disease areas to create strong in-portfolio synergy. Next, some highlights from our R&D progress in the second quarter. We have filed the TEVIMBRA initial NDAs, with the first two in China for relapsed refractory CLL and the relapsed refractory mantle cell. The plan is to file mantle cell in POMA globally later this year with a longer follow-up. We presented over 60 abstracts from our heme portfolio at ASCO, EHA, and ICML, and initiated new phase III studies for TEVIMBRA and our BTK CDAC in relapsed refractory CLL. In addition, we provided updates from our solid tumor portfolio at ASCO and R&D Day. For the CDK4 program, we are actively planning phase III trials for both first-line and the second-line hormone receptor positive breast cancers.

Now, with all this newly built capabilities, we believe we can reproduce our success in Co across our disease area of focus. And more importantly, do it much faster. This is very exciting. Our goal is to build a deep pipeline in each of these diseased areas to create, strong input, portfolio, synergy,

Which can potentially be used for all patients in second line, regardless of what frontline treatment was used.

Next, some highlights from our on the progress in the second quarter.

Determined to office, the all patients important options throughout their treatment journey.

We have filed the Sonos initial ndas with the first 2 in China for the last refi crl, and the last refractory mental cell.

<unk> our next generation Bcl two inhibitor has key characteristic that position this product to be potentially best in class.

The plan is to file mental, sell informal globally later this year with a longer follow-up.

So long as 14 times more potent than Manhattan, clocks, which may translate into superior efficacy.

In addition, the <unk>.

Cortisol activity shorter half life and the lack of a drug accumulation could offer a more favorable overall safety profile.

We presented over 60 abstracts from our hymn portfolio at ASCO eha and icml and initiated new phase 3 studies for Sono and our BTK CAC in the last refer battery C.

in addition, we provided updates from our solid tumor portfolio at Osco and on the day,

Under perhaps most importantly, <unk> offers an opportunity for a more patient friendly ramp up with potentially only one clinical visits yes, only one clinical visits during ramp up.

Lai Wang: In the next few slides, I will walk you through our progress in CLL. We have built a comprehensive registration program that spans the full spectrum of CLL, from treatment IE to the relapsed refractory settings. In the front-line setting, BRUKINSA has already established itself as a leading BTK inhibitor. With a combination of BRUKINSA plus venetoclax, we are advancing what we believe will be the best-in-class fixed-duration regimen. For relapsed refractory patients, our BTK degrader should become a cornerstone of continuous therapy. We are also advancing fixed-duration regimens, including TEVIMBRA plus CD20 antibodies. In addition, we are evaluating TEVIMBRA plus BTK CDAC, which can potentially be used for all patients in second line, regardless of what front-line treatment was used. We are determined to offer CLL patients important options throughout their treatment journey. SONRO, our next-generation BCR2 inhibitor, has key characteristics that position this product to be potentially best-in-class.

First line and the second line formal receptor, positive breast cancers.

In the next few slides. Our walk you through our progress in C

Third to up to eight visits but not collapse.

<unk> has a broader development program with three phase III for XR approvals on the three ongoing phase III studies.

Diving into the combination data.

<unk> plus onto Clark's <unk> regimen achieved a very high rates of under tableau MRV at 10 minus 492%.

We have built a comprehensive registration program that spans the full spectrum of Cl from treatment. IE to the rest of factory settings. In the front settings, for kinsa has already established itself as a leading, BDK in capture

with a combination of both kinsa plus 1 to Clarks where advancing what we believe will be the Best in Class fixed duration regimen.

Industrial 120 minutes on cohort, regardless of the risk status.

With a median follow up of $25 five months no PFS events have occurred in the 320 minutes on cohort and only one event occurred in the 160 milligram cohort now a total of 137 patients treated in this two cohorts combined not a small datasets 30.

For Less with Factory patients. Our BDK, the greater should become a Cornerstone of continuous therapy.

We also advancing fixed duration regimens including son, plus CD, 20 antibodies in addition while evaluated evaluating Sono plus BDK C deck.

<unk> patients have elected to stop the therapy week 96, and all remain in remission with some beyond the 12 months with other treatments.

Which can potentially be used for all patients in second line. Regardless of what Frontline treatment was used.

What determined to offer your patients important options throughout their treatment Journey?

I would like to draw your attention to the table shown on this slide.

With the normal caveats of a cross trial comparison.

Lai Wang: SONRO is 14 times more potent than Venetoclax, which may translate into superior efficacy in the clinic. In addition, improved selectivity, shorter half-life, and the lack of drug accumulation could offer a more favorable overall safety profile. Perhaps most importantly, SONRO offers the opportunity for a more patient-friendly ramp-up with potentially only one clinical visit. Yes, only one clinical visit during ramp-up, compared to up to eight visits for Venetoclax. SONRO has a broader development program with three phase IIs for accelerated approvals and three ongoing phase III studies. Diving into the combination data, the zanubrutinib plus Venetoclax regimen achieved a very high rate of undetectable MRD at 10-4, 92% in the 320-milligram cohort, regardless of the risk status. With a median follow-up of 25.5 months, no PFS events have occurred in the 320-milligram cohort, and only one event occurred in the 160-milligram cohort.

Solo our next Generation beta team Hector has key characteristics that position this product to be potentially Best in Class.

<unk> has demonstrated the highest <unk> rates and the unmatched the PFS for the respective quarter when compared to other than ice packs based a fixed duration therapy.

So long is 14 times more potent than that clocks, which may translate into Superior efficacy in the clinic.

There are some important deficiencies with other fixed duration therapies like the low 34% rate of <unk>, an underwhelming Street PFS rate of 77% observed observed with AAV. Despite the ultra fifth population studied in the <unk> trial.

In addition, the improve the selectivity shorter, Half-Life and the lack of drug. Accumulation could offer a more favorable overall safety, profile,

For the new treatment paradigm in <unk>.

And perhaps most importantly solar offers opportunity for a more patient-friendly ramp up with potentially only 1 clinical visit, yes only 1 can go visit during ramp up compared to up to 8 visits for Venit Clarks.

Safety and convenience as important as efficacy.

<unk> showed a favorable safety profile with fewer high grade adverse events and no deaths.

Sonu has a broader development program with 3 phase 2s for accelerate approvals and 3 ongoing phase 3 studies.

Diving into the combination data.

It's associated with the intravenous use over that will be in <unk> and the cardiac toxicity and the deaths associated with putting it.

The zanni. Bhutan plus Toronto clock Zs regimen achieved a very high rates of undetectable and Modi at 10 minus 4, 92% in the 320 migram cohort regardless of the risk status.

In terms of patient convenience.

Did not observe any clinical or laboratory tls under way.

We're very optimistic that for the vast majority of patients only one clinical visits building ramp up will be required.

Lai Wang: There are a total of 137 patients treated in these two cohorts combined, not a small data set. 35 patients have elected to stop the therapy after week 96, and all remain in remission, with some beyond the 12 months without treatment. I would like to draw your attention to the table shown on this slide. With the normal caveats of a cross-trial comparison, ZS has demonstrated the highest UMRD rate and unmatched PFS for the respective follow-up when compared to other Venetoclax-based fixed-duration therapies. There are some important deficiencies with the other fixed-duration therapies, like the low 34% rate of UMRD and underwhelming three-year PFS rate of 77% observed with AV, despite the ultra-fit population studied in the Amplify trial. For the new treatment paradigm in front-line CLL, safety and convenience are as important as efficacy.

After zonule leading.

In conclusion, we believe that <unk> combination has the potential to be the game changer for a fixed duration option for <unk> patients.

With a medium, follow-up of 25.5 months, no, PFS events have occurred in the 320 migram cohort and only 1 event occurred in the 160 m round cohort, there are total of 137 patients treated in these 2 cohorts combined not a small data set.

Moving to the third asset now him bunches, our BTT Seatac is the most advanced the PTK to greater in the clinic with the passing cost features as.

Certified patients have elected to stop the therapy after week, 96, and all remain in remission. With some beyond the 12 months without the treatment.

I would like to draw your attention to the table shown on this slide.

As a mechanism.

Nation can't overcome under preventing emergent resistance mutations and disrupt the scaffolding function of BK proteins.

Half life independent has resulted in sustained the PTK degradation with daily dosing.

With the normal caveats of a cross-trial comparison, ZS has demonstrated the highest overall response rate and unmatched progression-free survival for the respective follow-up. When compared to other Venetoclax-based fixed-duration therapies,

We have a boarder demand program on volume, including two pivotal phase III <unk> walks out approval.

Okay.

More in startup.

We will provide an update on Teekay <unk> phase one results at <unk>.

there are some important deficiencies with other fixed duration therapies, like the low 34% rate of your me and underwhelming 3 year, PFS, rate of 77%, observable observed, with AV, despite the ultra fit population studied in the Amplified trial,

In the graph on the left you can see our BD Casey that trending towards almost two years of median PFS in heavily pretreated <unk> patients, which looks favorable to the recently published a book and data from <unk> on the right with the usual caveat of a cross trial comparison.

For the new treatment Paradigm in Frontline cereal.

Lai Wang: ZS showed a favorable safety profile with fewer high-grade adverse events and no deaths, associated with the intravenous use of the obinutuzumab and the cardiac toxicity and the deaths associated with ibrutinib. In terms of patient convenience, we did not observe any clinical or laboratory TRS, and we are very optimistic that for the vast majority of patients, only one clinical visit during ramp-up will be required for after zanubrutinib lead-in. In conclusion, we believe the ZS combination has the potential to be the game changer for a fixed-duration option for CLL patients. Moving to the third asset in our heme franchise, our BTK CDAC is the most advanced BTK degrader in the clinic with the best-in-class features. As a mechanism, degradation can overcome and prevent emergent resistance mutations and disrupt the scaffolding function of BTK proteins.

Safety and convenience are as important as efficacy.

CS showed a favorable safety profile with fewer high-grade, Adverse Events and no deaths.

The hatchery hedgehog versus product Westar stone.

Going beyond the CIO.

Tailwind presented an overview of the broader kimco demand plan under the clinical studies across our coupon ties in non <unk> indications.

Associated with the intravenous use of the Aus map and the cardiac toxicity and the deaths associated with the Putin. It

Designed to maximize the clinical and commercial value of a book pinza, So until clerks in the BT Casey deck as part of our strategy for our B cell malignancy franchise on the beyond.

In terms of patient convenience, we did not observe any clinical or laboratory TLS, and we are very optimistic that for the vast majority of patients, only one clinical visit during ramp-up will be required after Zanu leading.

Moving onto the solid tumor our short term pipeline includes a diverse modalities and the mechanisms of cost street disease franchises breast and gynecological cancers lung cancers, and the Gi cancers with revamped our entire solid tumor pipeline over the last two years ever.

In conclusion, we believe that Zs combination has a potential to be the game-changer for a fixed duration. Option for sale patients.

Moving to the third asset. In our human franchise, our BTK cedh deck, is the most advanced BTK degraded in the clinic with the Best in Class features.

Single assets you see on this slide either entered the clinic in the past two years, while well be in the clinic by the end of this year.

Lai Wang: Long half-life in the clinic has resulted in sustained BTK degradation with daily dosing. We have a broader development program ongoing, including two pivotal Phase IIs for accelerated approval, two ongoing Phase IIIs, and one more in startup. We provided an update on BTK CDAC Phase I results at EHA. In the graph on the left, you can see our BTK CDAC trending towards almost two years of median PFS in heavily pretreated CLL patients, which looks favorable to the recently published PERTL bootin data from Bruon 321 study shown on the right, with the usual caveats of a cross-trial comparison. The head-to-head trial versus PERTL will start soon.

This showcases our ability to quickly establish a deep and highly competitive pipeline in disease areas of focus.

As a mechanism, degradation can overcome and prevent emerging resistance, mutations, and disrupt the scaffolding function of BTK proteins.

50k, degradation with daily doses.

The portfolio synergies created by this molecule should not be underestimated.

Finally, I would like to highlight a few key milestones within our pipeline.

We have a broader demand program ongoing, including 2 pivot phase 2s for accelerate approval 2 on going phase 3 is and 1 more in startup.

We have successfully achieved our critical goals, we set at the beginning of the year with some completed ahead of schedule such as the CLO and the mental cell filings for Sonal in China.

We provided an update on BTK CAC Phase 1 results at ehop.

In the latter half of the year, we anticipate several significant milestones, including the global funding of our solar only relapsed refractory mantle cell. In addition, we expect potentially pivotal data from our <unk> SEDAR last refractory CLO and initiated global filings in 'twenty 'twenty six.

In the graph on the left, you can see our BTK CAX trending towards almost 2 years of median PFS in heavily pretreated patients, which looks favorable to the recently published portable data from the Bruan, TO 3221 study shown on the right, with the usual caveats of a cross-trial comparison.

Lai Wang: Going beyond CLL, here we present an overview of the broader clinical development plan and the clinical studies across our heme franchise in non-CLL indications, designed to maximize the clinical and commercial value of BRUKINSA, Sonro-Clex, and BTK CDAC as part of our strategy for our B-cell malignancy franchise and beyond. Moving on to the solid tumor, our solid tumor pipeline includes diverse modalities and mechanisms across three disease franchises—breast and gynecological cancers, lung cancers, and GI cancers. We revamped our entire solid tumor pipeline over the last two years. Every single asset you see on this slide either entered the clinic in the past two years or will be in the clinic by the end of this year. This showcases our ability to quickly establish a deep and highly competitive pipeline in disease areas of focus. The portfolio synergies created by this molecule should not be underestimated.

The head-to-head trial versus Portal will start soon.

Going beyond the CL.

Turning to our early stage pipeline as you have heard we have a novel concept catalysts expand across multiple modalities and disease franchises. We're also actively moving some of the.

Here we presented an overview of the broader clinical development plan under the clinical studies across our hymn franchise in nonc indications.

Some of this assets into late stage developments, including our CDK <unk> inhibitor and the <unk> etch for ADC, we look forward to sharing more data in future updates and then was that our turn the call back to Dan.

Designed to maximize the clinical and commercial value of Bence. So, until Clarks, and the BTK C deck as part of our strategy for our B cell megany franchise and beyond.

Thanks, <unk>, we are now ready for Q&A, joining us for the Q&A portion of the call is <unk>, President and Chief operating officer, not Charlotte, Our general manager of North America, and Marc One asset Chief Medical officer for solid tumors.

Moving on to the solid tumor, our cell team pipeline includes diverse modalities and the mechanisms across 3 disease, franchises breast and gynecological. Cancers lung, Cancers, and the GI cancers.

With revamped our entire solar tumor pipeline over the last 2 years.

Kindly ask participants to limit the number of questions to ensure we have time to hear from as many attendees today as possible.

Every single asset you see on this slide either entered the clinic in the past two years or will be in the clinic by the end of this year.

Operators and we are ready for the first question.

If you would like to ask a question. Please use the raise hand icon, which can be found out the bottom of the webinar application.

This showcases, our ability to quickly establish a deep and highly competitive pipeline in disease, areas of focus.

Lai Wang: Finally, I'd like to highlight a few key milestones within our pipeline. We have successfully achieved the critical goals we set at the beginning of the year, with some completed ahead of the schedule, such as the CLL and the mantle cell fundings for Sonro in China. In the latter half of the year, we anticipate several significant milestones, including the global funding of Sonro in relapsed refractory mantle cell. In addition, we expect potentially pivotal data from our BTK CDAC in relapsed refractory CLL and initiate global fundings in 2026. Turning to our early-stage pipeline, as you have heard, we have a number of proof-of-concept catalysts expected across multiple modalities and disease franchises. We are also actively moving some of these assets into late-stage development, including our CDK4 inhibitor and B7H4 ADC. We look forward to sharing more data in future updates.

The portfolio Synergy is created by this molecule should not be underestimated.

When you were called upon please on mutual line and ask your question, we will now take a moment for the key to assemble.

Finally, I like to highlight a few key Milestones within our pipeline.

Our first question comes from Jessica Fye with J P. Morgan. Please mute your line and ask your question.

We have successfully achieved the critical goals. We set at the beginning of the year, with some completed ahead of the schedule, such as the CL and the mental health findings for Solo in China.

Hey, guys. Good morning, Congrats on the strong quarter. Thanks for taking our question.

Okay.

In the beginning of the year you mentioned, you expect flat U S. Net price. This year is that expectation evolved at all now that we're halfway through the year and were there any inventory changes at the end of <unk> relative to the end of <unk>, you might be able to quantify.

In the latter, half of the year. We anticipate several significant Milestones including the global filing of a son in your last referral mental sell. In addition, we expect potentially pivotal data from our vtk cedak on the last refraction C and initiate the global filings in 2026.

And second what was your reaction to the fluent CLO.

314 data for <unk> versus <unk>.

Frontline and relapsed population and what are you going to be watching for when those details are eventually presented.

Turning to our early stage pipeline, as you have heard, we have a number of approved Concepts Catalyst, expected across, multiple modalities, and disease franchises.

well, also actively moving some of the

And then lastly, as soon as CDK four I think at the R&D day, you talked about starting the second line phase three trial is <unk>.

For Q 'twenty five.

Lai Wang: With that, I will turn the call back to Dan Maller.

Now on the press release is 2026.

Some of this assets into latest stage development, including our cdk for inhibitor and B7 H4, ADC. We look forward to sharing more data in future updates. And with that, I will turn the call back to them.

Dan Maller: Thanks, Lai. We are now ready for Q&A. Joining us for the Q&A portion of the call is Xiaobin Wu, President and Chief Operating Officer; Matt Shaulis, our General Manager of North America; and Mark Lanasa, Chief Medical Officer for Solid Tumors. I kindly ask participants to limit the number of questions to ensure we have time to hear from as many attendees today as possible. Operator, we are ready for the first question.

Recognizing that be like as early as screening doesn't necessarily mean, you're going to start in late 'twenty five what's the additional information you hope to gain prior to initiating that phase three trial and can you confirm that we should expect to see updated clinical data for that.

Operating Officer Matt shaulis our general manager of North America and Mark Lassa. Chief medical officer for solid tumors.

Thank you.

Thanks, Jess for the question. So we have three parts to that question I think the first on for.

I kindly asked participants to limit the number of questions and share. We have time to hear from as many attendees today as possible.

Operator. We are ready for the first question.

Operator: If you would like to ask a question, please use the raise hand icon, which can be found at the bottom of the webinar application. When you are called upon, please unmute your line and ask your question. We will now take a moment for the Q2 assemble. Our first question comes from Jessica Fye with JPMorgan. Please unmute your line and ask your question.

Perkins.

Net pricing and I'll ask Matt to comment on that sure. Thanks for the question Jessica.

Yes.

Anticipate stable pricing through the remainder of the year and similarly.

If you would like to ask a question, please use the raise hand icon which can be found at the bottom of the webinar application.

No significant <unk>.

Inventory levels to to comment on.

When you are called upon, please unmute your line and ask your question. We will now take a moment for the queue to assemble.

The second part of that question was around three one for reaction lie.

Jessica Fye: Hey, guys. Good morning. Congrats on the strong quarter. Thanks for taking our question. On BRUKINSA, I think in the beginning of the year, you mentioned you expect flat U.S. net price this year. Has that expectation evolved at all now that we are halfway through the year? Were there any inventory changes at the end of Q2 relative to the end of Q1 you might be able to quantify? Second, what was your reaction to the BRUKINSA CLL 314 data for TEVIMBRA versus Imbruvica in that mixed front-line and relapsed population? What are you going to be watching for when those details are eventually presented? Lastly, for the CDK4, I think at the R&D day, you had talked about starting the second-line Phase III trial as soon as Q4 2025. I see that is now in the press release as 2026.

Our first question comes from Jessica fee with JP Morgan. Please unmute your line, and ask your question.

I think I'd point out to you.

Thanks for that question.

It's important to note that in the <unk> four study or superiority was not formally tested therefore, it is not statistical significance and I also want to point out including the tumor naive patients is likely to help the overall difference.

Hey guys. Good morning to you guys and a strong quarter. Thanks for taking our questions on Brook Kenza, I think in the beginning of the

Here you mentioned, you expect flat us net price, this year is that expectation evolved at all. Now that we're halfway through the year and were there any inventory changes at the end of 2 Q relative to the end of 1 Q. You might be able to quantify

Our alpine study of <unk> versus <unk> in the relapsed refractory CLO still remains the only head to head trial to demonstrate the superiority of what one BD can give to OLED. Another based on PFS endpoint and the PFS endpoint is the Golden standard in soil.

Um second what was your reaction to the Bruins CLL uh 314 data for fertile versus in rubika in that mixed Frontline and relapse population? And what are you going to be watching for when those details are eventually presented?

We believe in this setting a positive read off on 913 law. Congrats rebooting. It is highly unlikely to be practice changing for the following reasons number one there is no PFS data yet number two it is compared to <unk>.

then lastly for the cdk4 I think at the R&D day you had talked about starting the second line phase 3 trial is soon as

Jessica Fye: I guess recognizing that the "as early as" framing does not definitively mean you were going to start it in late 2025, what is the additional information you hope to gain prior to initiating that second-line Phase III trial? Can you confirm what we should expect to see updated clinical data for that asset this year? Thank you.

And a new way believe <unk> needs to demonstrate superiority over booking side not a booting them.

Okay.

So should it be the true standard now in treatment naive settings number three I think that it is still very early data for BD can get to a you would really need a long haul up to demonstrate you said critical benefits.

This year. Thank you.

Xiaobin Wu: Thanks, Jess, for the question. We have three parts to that question. I think the first on BRUKINSA and net pricing. Maybe I will ask Matt Shaulis to comment on that.

We also expect and know peripheral where palmer they be sequenced after the covalent <unk> inhibitor.

Matt Shaulis: Sure. Thanks for the question, Jessica. We anticipate stable pricing for the remainder of the year and similarly have no significant inventory levels to comment on.

Particularly if we start thinking about the Tao humans journey foresee all patients. It is hard to imagine. This dataset will convince physicians that are better option is to go as poodle versus bookings.

Thanks Jess for the question. Uh, so we have 3 parts to that question. I think the First on uh binza and net pricing, the last, Matt to comment on that. Sure, thanks for the question Jessica. And uh, yeah, we um, anticipate stable pricing for the remainder of the year and similarly, uh, have no significant. Uh, inventory levels to, to comment on

Xiaobin Wu: The second part of that question was the BRUKINSA reaction, Lai. I think I would point that one to you.

The results from bookings.

Just the final notes.

Think of the balloon stream one four alone is not sufficient for regulatory body as <unk> stated in their press release, it will be combined with three month street to form the basis for a regulatory submission wrong. <unk> study is a puddle versus BR <unk> without 17 P deletion.

Lai Wang: Yeah, thanks for that question. It is important to note that in the BRUIN 314 study, OR superiority was not formally tested. Therefore, it is not statistically significant. I also want to point out, including the treatment IE patients is likely to help the OR difference. Our Alpine study of BRUKINSA versus ibrutinib in the relapsed refractory CLL still remains the only head-to-head trial to demonstrate the superiority of one BTK inhibitor over another based on PFS endpoint. The PFS endpoint is the golden standard in CLL. We believe in this setting, a positive readout on non-inferiority in OR compared to ibrutinib is highly unlikely to be practice-changing for the following reasons. Number one, there is no PFS data yet. Number two, it is compared to ibrutinib. We believe any new continuous BTKI needs to demonstrate superiority over BRUKINSA, not ibrutinib.

Okay, um, the second part of that question was the Brewin 314 reaction lie. Uh, I think I point that 1 to you

I think the key question here is where the <unk> is still a valid control and when it is filed for NDA in let's say 2026, if the trial reads positive and also less trend I think would be.

Yeah, thank you for that question. Um, it is important to know that in the bronze 314 study or else you priority was not formally tested. Therefore, it is not statistically significant and I also want to point out including the treatment. I patients is likely to help the O difference.

Another important element to wash out.

Ill probably pass this onto mark to adjust the CDK four question.

Um our Alpine study uh of applicants are versus they put in there in the relaxed for factory sale. Still Remains the only head-to-head trial uh to demonstrate the superiority of what 1 BD can have to over another based on PFS end point and PFS end point is the golden standard in C.

Thank you. Thank you Jess good morning, we set an ambitious target for our first phase III storage by the end of 2025 as the data are now coming in we believe it would be prudent to let the data mature just a little bit more to inform our phase III dose level selection.

Magnitude of delay will be very modest, but it happens to move it from late 'twenty five and the early 2006, which is why we're providing this updated guidance I would also highlight for the first five were disclosing our intent to start a frontline study with our <unk> inhibitor in 2026. So we remain very excited about that program.

Lai Wang: BRUKINSA should be the true standard now in treatment IE settings. Number three, I think it is still very early data. For BTK inhibitor, you really need a long follow-up to demonstrate your therapeutic benefit. We also expect PERTL will primarily be sequenced after the covalent BTK inhibitor. Particularly if we start thinking about the entire treatment journey for CLL patients, it is hard to imagine this data set will convince physicians that a better option is to go with PERTL versus BRUKINSA, given the results from BRUKINSA. Just a final note, I think the BRUIN 314 alone is not sufficient for regulatory funding. As Lily stated in their press release, it will be combined with 313 to form the basis for regulatory submission. BRUIN 313 study is a PERTL versus BR in treatment IE CLL without 17p deletion.

To your other question, we intend to share the data from dose optimization in combination with full restaurant this year, San Antonio breast cancer Symposium.

Uh, we believe in this setting, uh, a positive read of a 913 or compared to a boot in. It is highly unlikely to be, um, practice changing for the following reasons. Number 1, there's no PFS data yet number 2. It is compared to ibutin net. Uh, any new um, Way by any new continuous, btki needs to demonstrate superiority over, bookings that, not a bin books, that should be the true standard. Now in treatment naive settings. Number 3, I think it is still very early data for BT. Can have to you really need a long follow up to demonstrate your therapeutic benefits.

Thank you.

Our next question comes from Sean <unk> at Morgan Stanley. Please mute your line and ask your question.

Good morning, everyone hope everyone's well and thank you for taking my question.

The celestial tea and C O L trial, I think it's three out of three.

Ultimately a few proved successful layer how do you think that the market plays out do you look at the <unk> plus other combo was the initial target market and how do you think about pricing, if you're selling brookins or an <unk> into that market and then what do you see or how should we think about the time based therapy.

Lai Wang: I think the key question here is whether BR is still a valid control and when it is filed for NDA in FA 2026 if the trial reads positive. Also, OS trend, I think, will be another important element to watch out. I will probably pass this on to Mark to address the CDK4 question.

Um, we also expect, you know, per will primarily be sequenced after the coal and BTK inhibitor particularly. If we start thinking about the entire um treatments Journey for sale patients, it is hard to imagine, you know, this data set will convince Physicians that a better option is to go with PTO versus binsa given the results from book cancer. Just the final note, I think the bronze 314 alone is not sufficient for regulatory filing as lady stated in their press release. Uh, it will be combined with 313 to form the basis for regulatory submission wrong. 313 study is a Proto versus BR in treatment. I recall without 17 P edition.

Bleeding over into the normal course of operations or the rest of the market.

Thanks, That's my first one.

I think the key question here is whether BR is still a valid control and when it is filed for ND in let's say 2026, If the child reads positive and also OS Trends, I think will be a another important element to wash out um, probably pass this on to Mark, to address the cdk for question.

Mark Lanasa: Thank you, Lai. Thank you, Jess. Good morning. We set an ambitious target for our first phase III start by the end of 2025. As the data are now coming in, we believe it would be prudent to let the data mature just a little bit more to inform our phase III dose level selection. The magnitude of delay will be very modest, but it happens to move it from late 2025 into early 2026, which is why we are providing this updated guidance. I would also highlight, for the first time, we are disclosing our intent to start a front-line study with our CDK4 inhibitor in 2026. We remain very excited about that program. To your other question, we intend to share the data from dose optimization in combination with Fulvestrin at this year's San Antonio Breast Cancer Symposium.

Sure happy to address that one Sean.

Thank you lie. Thank you, Jess. Good morning.

And.

Yes, I would say that were.

We're very optimistic about the prospects or <unk>.

And plus on ROE and you have heard from from <unk> some of the clinical underpinnings of that.

Certainly when it comes to our overall approach to driving adoption and <unk>, we think that that's going to be one of the one of the.

Primary drivers and from a pricing standpoint, we're going to look at various different comparator spread when when it comes to fixed duration overall.

I can say that so far we haven't really seen much uptake of <unk>.

Initial fixed dose utilization.

Target for our first phase 3. Start by the end of 2025, is the data are now coming in. We believe it would be prudent to let the data mature. Just a little bit more to inform our phase 3 dose level selection. The magnitude of delay will be very modest, but it happens to Move It from late 25 in the early 26, which is why we're providing this updated guidance. I would also highlight for the first time we're disclosing our intent to start a Frontline study with our cdk4 inhibitor in 2026. So we remain very excited about that program. Uh, to your other question we intend to share the data from dose optimization in combination with full veteran at this year's San Antonio breast cancer symposium

<unk> been plus PTK isn't approved in the U S.

Jessica Fye: Thank you.

Thank you.

At the current time, so usage is off label and we think that that frankly, given what we've seen that the data so far in comparison to continuous P. T J it would be inappropriate.

Operator: Our next question comes from Sean Laaman at Morgan Stanley. Please unmute your line and ask your question.

Our next question comes from Sean lman at Morgan Stanley. Please unmute your line and ask your question.

Lai Wang: Good morning, everyone. I hope everyone's well, and thank you for taking my question. On the Celestial TN CLL trial, I think it's 303. Ultimately, if you prove successful there, how do you think that the market plays out? Do you look at the V plus O combo as the initial target market? How do you think about pricing if you're selling BRUKINSA and SONRO into that market? What do you see or how should we think about the time-based therapy bleeding over into the normal course of operations or the rest of the market? Thanks. That's my first one.

Great to see fixed duration use right now.

Spoken many times, what we've seen of the current regimens that are available.

<unk> been very young and fit populations and here I'm speaking about.

But also have limited risk factors.

And we think that the benchmark really hasnt been met for deep and durable responses strong PFS.

Safety and Tolerability, however to your point with celestial we believe that <unk> is going to satisfy those benchmarks. So we don't see substantial fixed dose.

Our fixed duration uptake in the near term, we see that PTK mono is going to continue to be strong and then later when we see the <unk> data, we see that there will be bigger opportunities for fixed duration.

Uh, good morning everyone. Hope everyone's well and thank you for taking my question. Um on the celestial, T TNC LL trial, I think it's 303. Um, ultimately if you proved successful there, how do you think that the market plays out? Do you, do you look at the the V plus o combo as the the initial target market and how do you think about pricing if you're selling Brookins and and SRO uh, into that market? And then do you see what do you see or how should we think about you know the time based therapy you know bleeding over into uh the the normal course of um operations or the rest of the market? Uh thanks that's my first 1.

Matt Shaulis: Sure, happy to address that one, Sean. I would say that we are very optimistic about the prospect for BRUKINSA plus SONRO. You have heard from Lai Wang some of the clinical underpinnings of that. Certainly, when it comes to our overall approach to driving adoption in CLL, we think that that is going to be one of the primary drivers. From a pricing standpoint, we are going to look at various different competitors for it. When it comes to fixed duration overall, I can say that so far we have not really seen much uptake of initial fixed dose utilization. Ben plus BTK is not approved in the U.S. at the current time, so usage is off-label. We think that, frankly, given what we have seen with the data so far in comparison to continuous BTK, it would be inappropriate to see fixed duration use right now.

sure, happy to address that 1 SE and um,

you know, I would say that we're um,

Great Alright, thank you.

Just on the total equation.

Many kols we speak to.

Richardson's to see resident to say that they will see put on moving to one only been on good data because the potentially.

Potentially losing that second line option, but just to grab your latest thoughts on the resistance mechanisms associated with third eye versus brookins are in.

What just frame the risk for us there that would be very useful.

Yes, why don't you take that one.

I can probably pick that question in some of the richness resistance mechanisms is still evolving on the cloudy protocol can walk on covalent PTK inhibitor population, especially for the assisted in 481 mutations there are several other southern mutations the <unk> can work also.

Matt Shaulis: As we have spoken many times, what we have seen of the current regimens that are available is that they are in very young and fit populations. Here I am speaking about AV that also have limited risk factors. We think that the benchmark really has not been met for deep and durable responses, strong PFS, and safety and tolerability. However, to your point, with Celestial, we believe that BRUKINSA plus SONRO is going to satisfy those benchmarks. We do not see substantial fixed dose or fixed duration uptake in the near term. We see that BTK mono is going to continue to be strong. Later, when we see the BRUKINSA plus SONRO data, we see that there will be bigger opportunities for fixed duration then.

And unless there's a really a strong data set demonstrating a single covalent <unk> inhibitor walks off the pedal I do believe a physician want to keep that option with a poodle.

To be treated to be used to up the covenant the PTK inhibitors and therefore, the other things, which I mentioned early on is about the data for <unk>. Four is still very very early and there is only a non inferiority. So while you're also eagerly waiting for that data to be mature.

Uh approach to driving adoption in CLL. We think that that's going to be 1 of the, you know, 1 of the um primary drivers and from a pricing standpoint. We're going to look at um at various different comparators for it when, um, when it comes to fixed duration, overall. Um, I can say that so far we haven't really seen much uptake of, uh, of initial fixed dose utilization. Um, then plus BTK is an approved in the US at the at the current time. So usage is off label. And we think that that frankly given what we've seen in the data so far in comparison to continuous BTK it would be inappropriate to see fixed duration. Use right now, as we spoke in many times, what we've seen of the current regimens that are available is that they're in very young and fit populations. And and here I'm speaking about AV uh but also have limited risk factors.

Most importantly, I think.

It's something we want to go into the phone client is reading your two two compared to <unk> <unk> in the animal.

Thank you and the interest of time Thats all I have for now thank you.

Lai Wang: Great, great. Thank you. Just on the PERTL equation, many KOLs we speak to sort of reticence to see or residents say that they will see PERTL moving to 1L even on good data because they are potentially losing that second-line option. Just to grab your latest thoughts on the resistance mechanisms associated with PERTL versus BRUKINSA, and what just frame the risk for us there. That would be very useful.

And we think that the The Benchmark really hasn't been met for deep and durable responses, strong PFS, and and safety and tolerability, however, to your point with Celestial, we believe that uh, xanu plus sanro is going to satisfy those benchmarks. So we don't see substantial fixed dose or or fixed duration, uptake in the near term. We see that BTK mono is going to continue to be strong. And then later when we see the Xander plus download data, we see that there will be bigger opportunities for fixed duration then.

Yeah.

Our next question comes from <unk> Chen with Goldman Sachs. Please on mute your line and ask your question.

Alright, okay.

Congratulations on very strong quarter.

Thank you for taking my questions just two questions on.

Great. Great. Thank you. And uh, just on the the PTO equation. Um, you know, many Kos, we speak to um, sort of reticence to see or residents say that they will, uh, see perto moving to, to 1 L, even on on good data because they're

Financials and also the.

<unk>.

We actually see sort of gross margin has been improved notably in second quarter compared to first quarter. So while the product revenue.

Potentially losing that second line option. But just to grab your latest thoughts on, you know, the the resistance mechanisms associated with PTO versus brukinsa and you know it what just frame the risk for us there. That would be very useful.

Xiaobin Wu: Lai, why don't you take that one?

Lai Wang: Yeah, I can probably take that question. In terms of the resistance mechanisms, it is still evolving. Clearly, TEVIMBRA can work on covalent BTK inhibitor failed population, especially for the cystidin 481 mutations. There are several other set of mutations TEVIMBRA can work on. Unless there is a really strong data set demonstrating, I think, a covalent BTK inhibitor works after TEVIMBRA, I do believe a physician wants to keep that option with the TEVIMBRA to be treated, to be used after the covalent BTK inhibitors. For the other things which I mentioned early on, the data for 314 is still very, very early. It is only OR non-inferiority. We are also eagerly waiting for that data to be matured. Most importantly, I think if something wants to go into the front line, it really needs to compare to BRUKINSA, not ibrutinib anymore. Thank you.

8% quarter over quarter growth the absolute dollar amount for the cost of goods sold in the second quarter was flattish ratio first quarter.

Could you help us understand a bit more about how you have been controlling the manufacturing costs and optimizing that $10.

Because this is really not being explained by a product mix change we got stopped definitely in tertiary manufacturing proteins out there has to be some improvement.

And another question is really on the U S tariff.

On the gross margin side, because regarding the potential U S tariff on our pharmaceutical imports.

Which I think president Trump's that's out there will be put off initially small tariff then eventually it goes up to $108 50 per share in 18 months and.

<unk>, 250%. So that's our guidance on the gross margin, which has been raised from mid <unk> to mid to high Eighty's reflect back a potential tariff and how should we look how to quash margin assumptions going forward. Thank you.

Yeah. Why don't you take that 1? Yeah, I I can probably take that question in some of the uh resist resistance mechanisms uh is still evolving and clearly uh, Proto can walk on coent BTK inhibitor, F the population especially for the S sistering 481 mutations. Um, there are several other set of mutations per can walk on so. And unless there's a really strong data set demonstrating, I think the Covenant BDK have to Works after PTO. I do believe a physician want to keep that option. Uh, with the PTO, you know, to be treated to be used after the Covenant, the BTK Inhibitors. And for the other things, which I mentioned. Um, earlier on is about, you know, the data for 314 is still very, very early and it's only o r 930. So, you know, where you also eagerly waiting for that data, to be matured. And the most importantly, I think, if something want to go into the front line, it really need to, you know, to compare to binsa.

Now, you're booting the animal.

Lai Wang: In the interest of time, that is all I have for now. Thank you.

Great. This is Eric. Thank you so much for the question so I'll take it in two parts.

Thank you in the interest of time. That's all I have for now. Thank you.

Operator: Our next question comes from Ziyi Chen with Goldman Sachs. Please unmute your line and ask your question.

Youre right, we have seen some improvement in gross margin on a quarter over quarter basis, and certainly relative to last year.

Our next question comes from Z Chen. With Goldman Sachs, please unmute your line and ask your question.

Xiaobin Wu: All right. Congratulations on a very strong quarter. Thank you for taking my questions. Just two questions on financials and also the U.S. tariff. We actually see the gross margin has been improved notably in Q2 compared to Q1. While the product revenue, we had an 18% quarter-over-quarter growth, the absolute dollar amount for the cost of goods sold in Q2 was flattish versus Q1. Could you help us understand a bit more about how you have been controlling the manufacturing costs and optimizing that? This is really not being explained by product mix change. We guess definitely in terms of manufacturing proteins, there has been some improvement. Another question is really on the U.S. tariff impact on the gross margin side. Regarding the potential U.S.

As I mentioned in my prepared remarks, that's really coming from improved.

All right. Uh, congratulations on a very strong quarter. Um,

Production efficiencies, particularly for <unk>.

A bit of price and also from mix, but we're certainly making efforts across our manufacturer us in supply chain.

To continue to drive efficiency improvements largely in this quarter. It's November and then I also did mention as we think about the full year guide the potential improvements.

Ginza.

It's a great question relative to the U S tariffs, we've talked about in the past how our current guidance contemplates what we know today about tariffs.

And that impact is largely been mitigated by how we've globalized regionalize, our supply chain and that includes our U S production for pinza.

And our investment at our Hopewell facility, where I sit today, where we are qualifying.

Xiaobin Wu: tariff on the pharmaceutical imports, President Trump said that there will be put up initially a small tariff, then eventually it goes up to 50% in 18 months and getting up to 250%. Does our guidance on the gross margin, which has been raised from mid-80s to high 80s, reflect that potential tariff? How should we look at the gross margin assumptions going forward? Thank you.

Facility for timber production.

As you mentioned the big uncertainty remains around the current section 232 investigation. We've all seen the headlines we will monitor and obviously be very agile in our response to ensure both financial efficiency.

Uh, thank you for taking my questions, just 2 questions on, uh, financials. And also the, uh, the year's tariff. Um, we actually see. Uh, so the G margin has been improved notably in second quarter compared to first quarter. So, um, while the product Revenue, uh, we had a 18% quarter over quarter growth, the absolute dollar amount for the cost of goods sold 10. Second quarter was flattish, Russia first quarter. So, could you help us understand a bit more about how you have been controlling the manufacturing costs and optimizing that? And uh um because this is really not being explained by product exchange. We we guessed that definitely, uh, in terms of manufacturing proteins that there has been some improvements. Um, and another question is really on the US Turf impact on the gross margin side because regarding the potential US Turf on the pharmaceutical Imports. Uh which I think president Trump said that there will be put up initially, small Turf, then eventually it's going to go up to

As well as most importantly operational efficiencies as we supply our lifesaving medicines for patients are as I said, our 25 guide includes what we know today.

108 50%, and 18 months and uh, uh, getting up to 250%. So that's our guidance. On the gross margin. You know, which has been raised from 80s to mid to high 80s. Reflect back, potential tariff. And how should we look at the gouache margin assumptions? Going forward. Thank you.

Mark Lanasa: Great. This is Aaron Rosenberg. Thank you so much for the question. I will take it in two parts. You are right. We have seen some improvement in gross margin on a quarter-over-quarter basis, and certainly relative to last year. As I mentioned in my prepared remarks, that is really coming from improved production efficiencies, particularly for TEVIMBRA. We have a bit of price and also from mix. We are certainly making efforts across our manufacturers and supply chain to continue to drive efficiency improvements. Largely in this quarter, it is TEVIMBRA. I also did mention, as we think about the full-year guide, the potential improvements for BRUKINSA. It is a great question relative to the U.S. tariffs. We have talked about in the past how our current guidance contemplates what we know today about tariffs.

Candidly any announcements beyond that would likely not have a significant influence in our 25 results just the way in which inventory is positioned and how that flows through the P&L fuse.

Future impacts, while we believe would be manageable within the context of our P&L. It's just really too early to say to provide to provide a forward outlook.

Thank you.

Thank you for that and just a quick one.

Look how to finally, you mentioned about the second quarter, we saw benefit in net pricing for <unk> in the U S.

Can you elaborate a bit more on that what has been the benefit and how should we look at the net pricing going forward.

Thank you so.

Great question as we talked about historically, we do see relatively stable net pricing that is what we are have seen in our current results in my prepared remarks, we talked about mid single digit pricing in the U S. This is largely the pull through of our early year price increases which is consistent.

Mark Lanasa: That impact has largely been mitigated by how we have globalized and regionalized our supply chain. That includes our U.S. production for BRUKINSA and our investment in our Hopewell facility, where I sit today, where we are qualifying this facility for TEVIMBRA production. As you mentioned, the big uncertainty remains around the current Section 232 investigation. We have all seen the headlines. We will monitor and obviously be very agile in our response to ensure both financial efficiency, as well as, most importantly, operational efficiency as we supply our life-saving medicines for patients. As I said, our 2025 guide includes what we know today. Standardly, any announcements beyond that would likely not have a significant influence in our 2025 results, just the way in which inventory is positioned and how that flows through the P&L.

With market practice and well within well within.

But the.

The requirements under the IRA mandates.

Do see some incremental benefit on a year over year basis relative to part D reform and I think we talked about at the last quarter.

Production efficiencies particularly for tmbra, uh, we have a bit of price and also from mix, uh, but we're certainly, uh, across our manufacturer us and supply chain to continue to drive uh envisioning it. See improvements, uh largely in this quarter, uh it's Tober and then I also did mention as we think about the full year guide, uh, the potential improvements for Kenza, uh, it's a great question, relative to the US tariffs. We've talked about, uh, in the past how our current guidance contemplates. Uh, what we know today about tariffs, uh, and that impact is largely been mitigated by how we globalize and regionalize our supply chain and that includes our us production for Penza, uh, and our investment. In Our Hope wealth facility, where I sit today, uh, where we're a qualifying, uh, this facility for Tiffin production, you know? As you mentioned the big uncertainty, uh, remains around the current section, 232 investigation. We've all seen

The.

The prior year, including the manufacturing liability around the donut hole, which goes away in that.

And Thats a replace this year by the manufacturer liability under under a cost share and in our case, we do benefit from the from the specified small manufacturer designation. So the combination of those two lead you to our mid single digit performance on a year over year basis for this year I would say.

In the headlines. Uh, we will Monitor and obviously be uh, very agile in our response, to ensure both Financial efficiency uh, as well as most importantly operational efficiency as as we Supply our life-saving medicines for patients our as I said, our 25 guide includes what we know today.

Mark Lanasa: Future impacts, while we believe would be manageable within the context of our P&L, it is just really too early to say to provide a forward outlook. Thank you.

Okay.

Modest benefit you see any changes from part D reform is something that you see more significantly than the front half of the year given the lapping of the donut hole, which largely occurs in the first half just based on that prior regime.

Strangely any announcements, uh, beyond that would likely not have a significant influence in our 25 results. Just the way in which inventory is positioned and how that flows through the p&l. Uh, future impacts while we believe would be manageable within the context of our p&l. It's just really too early to say to provide uh to

Lai Wang: Thank you for that. Just a quick one. Looking at the filing, you mentioned about the second quarter, we saw benefit in net pricing for BRUKINSA in the U.S. Could you elaborate a bit more on that? What has been the benefit and how should we look at the net pricing going forward?

Got it. Thank you so much that's all my questions.

Our next question comes from Kelly <unk> with Jefferies. Please on mute your line and ask your question.

thank you for that. Uh, just a quick 1. Uh, look at a filing. You mentioned about second quarter. We saw benefit in that pricing, uh, for Penza in the US. Uh, could you elaborate a bit more on that, uh, what has been the benefit and how should we look at the net pricing going forward?

Mark Lanasa: Thank you. So, great question. As we talked about historically, we do see relatively stable net pricing. That is what we have seen in our current results. In my prepared remarks, we talked about mid-single-digit pricing in the U.S. This is largely the pull-through of our early-year price increases, which is consistent with market practice and well within the requirements under the IRA mandates. We do see some incremental benefit on a year-over-year basis relative to Part D reform. I think we talked about at the last quarter the prior year, including the manufacturing liability around the donut hole, which goes away. That is replaced this year by the manufacturer liability under the cost share. In our case, we do benefit from the specified small manufacturer designation. The combination of those two leads you to our mid-single-digit performance on a year-over-year basis for this year.

Congrats on another great quarter. Thanks for taking my questions first one for the revenue guidance is two.

25251, just over $1 billion to let it go to this low and bumps and specifically, which production underpinning that all luck.

And secondly, what you point, you Sanjay plastics packaging R&D milestones over the next 18 months could you provide more granularity on which well which one.

Might have been the most impactful events and lastly, what are the newly style learnings from that and in translational Nowadays regarding <unk> CDK do you plan to tackle resistant mutations have cleared from the first Jan.

Okay inhibitors differently from Arnold Thank you.

So, thank you. So, um, as a great question is, we talked about, historically, uh, we do see relatively stable net pricing, uh, that is what we are, uh, have seen in our current results in my prepared remarks. Uh, we talked about mid single digit pricing, uh, in the US, this is largely the pull through of our early year. Price increases, which is consistent with Market practice and well within, um, well within, um, what the, uh, the requirements under the IRA mandates. Um, we do see some incremental benefit on a year-over-year basis, relative to Part D reform, and I think we talked about at the last quarter, um, the UN the prior year including the manufacturing liability around the

the doughnut hole which goes away, and that's

Great. Maybe this is Aaron maybe I'll start thanks for the question.

So our update to our revenue guidance to two 5 billion to $5 3 billion really just reflects our confidence in execution in the first half of the year, we don't provide.

Mark Lanasa: I would say that modest benefit you see in the changes from Part D reform is something that you see more significantly in the front half of the year, given the lapping of the donut hole, which largely occurs in the first half, just based on that prior region.

Product revenue guidance, but I would just say as you see in our current quarter performance as well as Q1.

Across the portfolio, both from a product perspective, and a geographic perspective, we're pleased with our performance in this update just signals our confidence in our execution.

Maybe I'll hand, it over to lie on the R&D questions.

And that's, uh, replaced this year by the manufacturer liability under under the cost share. And, in our case, uh, we do benefit from the, from the specified, small manufacturer, uh, designation. So the combination of those 2 leads, you to our mid single digit performance on a year-over-year basis for this year. I would say, uh, that, uh, modest benefit you see in the changes from Part D. Reform is something that you see more significantly in the front half of the Year. Given the lapping of the doughnut hole which largely occurs in the first half, uh, just based on that prior region.

Lai Wang: Got it. Thank you so much. That's all my questions.

Yes, probably adjust a subpar the soda question first about <unk> greater in some of the resistance versus so that's a hurdle.

Got it. Thank you so much. That's all my questions.

Operator: Our next question comes from Kelly Xie with Jefferies. Please unmute your line and ask your question.

Jessica Fye: I'm glad you're on another great quarter. Thanks for taking my questions. First one, for the revenue guidance, it raised to $5.3 billion. What drove this low-end bump, and specifically, which product underpinned that outlook? The second one, you point to 20-plus expected R&D milestones over the next 18 months. Could you provide more granularity on which ones might have been the most impactful events? Lastly, what are the newest learnings from any translational studies regarding how BeiGene's BTK degrader tackles resistance mutations acquired from first-gen BTK inhibitors differently from PERTL? Thank you.

Our next question comes from Kelly, shei with Jeffrey's, please unmute your line and ask your question.

Two well known are resistant to <unk>, which after the covalent <unk> inhibitor one of them is $5 two a W. Another one he is T. Some T 474 on mutations.

So far, particularly the way that can really work well with those mutations.

And the west out of the early stage in term of the experience over the beat together within the Pentagon. So there hasn't been that many patients really progressed, we're actively following what's kind of mutation.

Resistant mutation where emerging from the PDK.

But having said that it doesn't look much more promising than some I'll be able to overcome more a broader spectrum of the PDK on mutation for the weight of us yes.

Congrats on your uh another great quarter. Thanks for taking my questions. First 1 for the revenue guidance raised to 5525.3 billion dollars what a goal to this low-end bump and a specifically which product underpaying that all look. And uh uh second 1, you point to 20 plus expected R&D Milestones over the next 18 months. Could you provide more granularity on which 1 or which ones? Um, I have be the most impactful, uh, events. And lastly, what are the newest learnings from any translational studies regarding

Versus the 10 that also we have done some translational work using the cell line use animal model.

Call B1 ctk degrader tackle resistance, mutations acquired from the first gmbh BTK Inhibitors differently from Portal. Thank you.

Mark Lanasa: Great. This is Aaron Rosenberg. Maybe I will start. Thanks for the question. Our update to our revenue guidance to $5 billion to $5.3 billion really just reflects our confidence in execution in the first half of the year. We do not provide product revenue guidance, but I would just say, as you see in our current quarter performance, as well as Q1, across the portfolio, both from a product perspective and a geographic perspective, we are pleased with our performance. This update just signals our confidence in our execution. On that, maybe I will hand it over to Lai Wang on the R&D questions.

That it does seems like that the Guido can probably have longer tumor suppression compared to let's say a photo books and have or other coal then the PTK inhibitors.

The other question is about the exciting milestones maybe I will talk about what's on the heme side of AD now pass this over to Mark to comment on the solid tumor side of it on the heme side of that I seem to certainly be able to also onto Clark's globally. This will mark the really important critical staff.

Portfolio. Uh, both from a product perspective and a geographic perspective, uh, we're pleased with our performance and this update, uh, to signals our confidence in our execution.

So onto Clark's.

Truly excited about this molecule for everything we have seen the tenant the combination of a sponsored <unk> plus <unk> is all of the spending.

Lai Wang: I will probably address the third question first about BTK degrader in terms of the resistance versus, let's say, TEVIMBRA. There are two well-known resistance to TEVIMBRA, which after the covalent BTK inhibitor, one of them is L528W, another one is T474 mutations. So far, BTK degrader can really work well with those mutations. We are still at the early stage in terms of the experience of the BTK degrader in the clinic. There have not been that many patients really progressed. We are actively following what kind of mutation or resistant mutation were emerging from the BTK degraders. Having said that, it does look much more promising in terms of being able to overcome a broader spectrum of the BTK mutation for degrader versus the TEVIMBRA ibrutinib. Also, we have done some translational work using the cell line, use the animal model.

Uh, on that, maybe I'll hand it over to lie on the R&D questions.

Uh huh.

Its own activity right now in the mantle cell lymphoma.

Which is the monotherapy study with data globally and that data looks really interesting. So this really form the basis for the initial global falling on the we're also now seeing activities for this one in the multiple myeloma. So Troy its not listing here, but certainly we're moving very aggressively about that along with the potential pivotal stage as well.

On the the greater side of that we're very excited to get to the protocol going probably will be next couple of months. So we'll gather protos Charles calling a nice thing that one well Patel.

Potentially bringing a better drug for patients with relapsed refractory settings. So mark.

Thanks, again ly again for the solid tumors. The most important data disclosure that we're likely to have for the remainder of 2025 will be our CDK four data at San Antonio breast cancer Symposium maybe.

Yeah, I'll probably adjust the step of the third question first about BTK the greater, uh, in some of the resistance. Versus let's say p. Um, there are 2, uh, well known resistant to PTO which after the coal and BD have to uh 1 of them is l52 a w and another 1 is t7 t474 and mutations. Um, so far B, the rate that can really work well with those mutations. Um, and the, with that, the early stage in term of the experience of the BTK, the greater in the clinic so that hasn't been that many patients really progressed. We're actively following, you know what kind of mutation uh well resistant mutation where emerging from the BTK uh, degraders. Uh, but having said that, it does look much more promising in terms of be able to overcome more, uh, broader spectrum, of the BTK mutation for the greater versus, um, uh, versus the Proto Putin. That also we have done some translational work, uh, using the cell line use.

Lai Wang: It does seem like the degrader can probably have longer tumor suppression compared to, let's say, a TEVIMBRA ibrutinib or other covalent BTK inhibitors. Your other question is about the exciting milestones. Maybe I will talk about what is on the heme side of it. Then I will pass this over to Mark to comment on the solid tumor side of it. On the heme side of it, I think certainly be able to have Sonro-Clex globally. This will mark the really important critical step for Sonro-Clex. We are truly excited about this molecule for everything we have seen in the clinic. The combination of Sonro-Clex plus zanubrutinib is outstanding. Its own activity right now in the mantle cell in POMA, which is the monotherapy study we did globally, and the data looks really interesting. This really formed the basis for the initial global funding.

Maybe of the new molecules that lie highlighted in the solid tumor portfolio will have early data emerging we're very pleased with the progress of the portfolio that we are hopeful that we'll be able to share data from multiple programs in the first half of 2026 and as I mentioned at R&D day, we high.

<unk> four programs, including CDK four seven H for Prs <unk>, five and <unk> b that are showing very encouraging early data again, we look forward to disclosing more data from those programs.

In the first half of next year.

So maybe I'll just Alex.

Got to mention which shows that the greater where have the pivotal phase two read out to next year on the whole our leading to also a global filing for the degree to that one is stefan that very important milestone as well.

Animal model um that it does seems like the the greater can um probably uh have longer uh tumor suppression compared to uh let's say a Proto boosting up or other Co Inhibitors. Um, the other question is about the the exciting Milestones. Maybe I I will talk about what's on the HM side of it. Now a positive over to Mark to comment on the solarium side of it. On the hymn side of it. I, I think certainly be able to also onto Clark's globally and this will Mark the really important critical step for us want to Clarks. Uh, we are truly excited about this molecule, uh, for everything we have seen in the clinic, the combination of response to class. Plus Sanu Britain is outstanding

Lai Wang: We are also now seeing activities for this one in the multiple myeloma, et cetera. It is not listed here, but certainly we are moving very aggressively about that one to the potential pivotal stage as well. Then on the degrader side of it, we are very excited to get the TEVIMBRA trial going. It probably will be next couple of months. We will get the TEVIMBRA trials going. I think that one will potentially bring a better drug for patients in the relapsed refractory settings. Mark?

Thanks.

Our next question comes from economic dominance from Citigroup. Please on mute your line and ask your question.

Yeah, Hi, Thank you very much just a few questions a couple on underpins and then one on on the pipeline.

Guarding routines you mentioned the majority of patients have unfettered access and there is a step up in access on appeal I'm wondering if you could just provide a little more specifics in terms of the numbers associated with the access out of the gates and then what are the access on on an appeal.

Its own activity right now in the mental health. And for uh, which is the mono therapy study, we did globally and the data looks really interesting. So this really formed the basis for the initial Global following and we also now seeing activities for this 1, in the multiple Myoma, Etc. It's not listing here. But certainly 1 moving, very aggressively about that 1 to the potential pivotal stage as well. Um, then on the, the greater side of it, um, we're very excited to get to the Proto trial. Um, going probably will be, um, next couple months so we'll get a purchase, uh, Charles going. And I think that 1 will, uh, potentially bring a better, uh, drug for patients in the regular factory settings. So, mark,

Mark Lanasa: Thanks again, Lai. Again, for the solid tumor, the most important data disclosure that we are likely to have for the remainder of 2025 will be our CDK4 data at San Antonio Breast Cancer Symposium. Many of the new molecules that Lai highlighted in the solid tumor portfolio will have early data emerging. We are very pleased with the progress of the portfolio. We are hopeful that we will be able to share data from multiple programs in the first half of 2026. As Lai mentioned at the R&D day, we highlighted four programs, including CDK4, B7H4, PRNT5, and FGFR2B that are showing very encouraging early data. Again, we look forward to disclosing more data from those programs, likely in the first half of next year.

And then more generally just in terms of the overall business globally, obviously, it's shifted our ex China I'm just wondering if you've reached a point, where it's essentially steady state in terms of the product mix, our revenue mix, China, Europe, United States, and Youre going to see a steady growth across the board if there's still an expectation.

Of of movement of revenue more ex China, and then lastly, maybe for Leigh could you comment more specifically on some of the the powering assumptions on PFS GFS with respect to.

See that versus a bureau phase III okay.

Great. Thanks for the question.

I'll start out and then hand things over to Aaron for our revenue mix regarding your question around access out of the gate and then appeals.

Thanks again lie. Uh, again for the solid, tuber the most important data disclosure that we're likely to have. For the remainder of 2025, will be our cdk4 data at San Antonio breast cancer Symposium, maybe of the uh new molecules that lie highlighted in the solid tube or portfolio will have early data emerging. We're very pleased with the progress of the portfolio that we are hopeful that we'll be able to share data from multiple programs in the first half of 2026. And as fly mentioned, at the R&D day we highlighted 4 programs, including cdk4 D7 H4 prmt5 and fgfr2 that are showing very encouraging early data. And again, we look forward to disclosing more data from those programs. Uh, likely in the first half of next year.

Lai Wang: Sorry, maybe I just.

Jessica Fye: Go ahead, Lai.

Lai Wang: I forgot to mention, which is that the degrader will have the pivotal Phase II readout next year. Hopefully, that will lead into a global funding for the degrader. That one is definitely a very important milestone as well.

Sorry, maybe I just

I think all of the access conversations start with our continued belief in Perkins is a differentiated asset it's best in class amongst the PTK and has this overwhelming body of evidence.

I forgot to mention which is that the greater we have the pivotal phase to read out next year. And the whole our leading to also a global funding for the degree that uh that 1 is definitely a very important Milestone as well.

Jessica Fye: Great. Thanks.

Operator: Our next question comes from Yigal Nochomovitz from Citigroup. Please unmute your line and ask your question.

John described.

<unk> thousands of patients.

Clinical trials, and we continue to evolve that with real world evidence and other data.

Our next question comes from Eagle Nomads from City Group. Please unmute your line and ask your question.

Xiaobin Wu: Yeah, hi. Thank you very much. Just a few questions, a couple on BRUKINSA and then one on the pipeline. Regarding BRUKINSA, you mentioned the majority of patients have unfettered access, and there is a step-up in access on appeal. I am wondering if you could just provide a little more specifics in terms of the numbers associated with the access out of the gates and then what the access on an appeal. More generally, just in terms of the overall business globally, obviously, it has shifted ex-China. I am just wondering if you have reached a point where it is essentially a steady state in terms of the product mix, revenue mix China, Europe, United States, and you are going to see steady growth across the board or if there is still an expectation of movement of revenue more ex-China.

So we're seeing a preference for corporate cancer with Hcp's and with patients and when it comes to the access component.

Oncology is a protected class and for Kansas continues to be listed on all Medicare part D. Formularies when it comes to that appeals process, it's important to remember that.

Any.

Any preference or step edits don't don't impact existing patients at all it's limited new patient starts.

And here, it's also important to remember.

But the majority of our claims.

Filled initially and then if an appeals process is need it we've been very successful in supporting accounts to work through that process. So going forward, we're really confident in continued access and growing demand and extending our value share.

Xiaobin Wu: Lastly, maybe for Lai Wang, could you comment more specifically on some of the powering assumptions on PFS with respect to the BTK CDAC versus PRO phase III? Thank you.

And over to you for the next question right. So I'll, just really quickly and actually invite shopping for his perspective, but certainly.

Respect to uh the sedac versus uh Bureau base 3. Thank you.

Matt Shaulis: Super. Hey, thanks for the question. I will start out and then hand things over to Aaron Rosenberg for revenue mix. Regarding your question around access out of the gate and then appeals, I think all of the access conversations start with our continued belief in BRUKINSA as a differentiated asset. It is best-in-class amongst the BTKs and has this overwhelming body of evidence that John Oyler described, including thousands of patients in clinical trials. We continue to evolve that with real-world evidence and other data. So we are seeing a preference for BRUKINSA with HCPs and with patients. When it comes to the access component, oncology is a protected class, and BRUKINSA continues to be listed on all Medicare Part D formularies.

We're growing.

Locally.

And as we think about the mix of business. So every region is growing at different paces were still quite early.

In many parts of the world and our launch trajectory historically talked about Europe being earlier rest of world markets, including really important markets globally.

Even earlier in their lifecycle. So we would expect that our revenue mix to continue to diversify overtime, but that's coming from a position of growth in all regions, including our China business. So shopping maybe I'll invite you to for your perspectives.

Super, hey, thanks for the question. And uh, I'll start out and then hand things over to Aaron for for Revenue. Next regarding your question around access out of the gate, and then appeals. Uh, I think all of the access conversations start with, uh, our continued, you know, belief in for Kenza as a differentiated asset that's Best in Class amongst the btk's and has this overwhelming body of evidence that that John described

Yes sure.

So as IRA.

IRA mentioned before the biggest revenue driver today is U S and.

Matt Shaulis: When it comes to that appeals process, it is important to remember that any preference or step edits do not impact existing patients at all. It is limited to new patient starts. Here, it is also important to remember that the majority of our claims are filled initially. If an appeals process is needed, we have been very successful in supporting accounts to work through that process. So going forward, we are really confident in continued access and growing demand and extending our value share of leadership. Aaron, over to you for the next question.

$685 million with grocery at all for <unk>.

43%.

China is the second biggest contributor and girl also 23% and we just.

Got to the publication of the data.

including thousands of patients in clinical trials. And we continue to evolve that with real world evidence and and other data. Um, so we're seeing a preference for for Brooke Kenza with hcps and with patience. And when it comes to the access component, uh, oncology is a protected class, and, and for Kenza continues to be listed on all Medicare Part D formulas. When it comes to that appeals process, it's important to remember that uh, any, uh, any preference or step at it don't, uh, don't impact existing patients at all. It's limited to new patients starts. Uh, and and uh, here, it's also important to remember.

And we move up or one position to be sixth.

Oncology company in China, and we grow very fast.

Outside the U S and also.

The China Europe, we grow close.

Close to 90% in the rest of the world.

That the majority of our claims uh are filled initially and then if an appeals process is needed, we've been very successful in supporting accounts uh to work through that process. So going forward, we're really confident and continue to assess and growing demand and extending our value share.

Mark Lanasa: Right. I will just really quickly and actually invite Xiaobin Wu for his perspective. Certainly, Igor, we are growing globally. As we think about the mix of business, every region is growing at different paces. We are still quite early in many parts of the world in our launch trajectory. We have historically talked about Europe being earlier. The rest of the world markets, including really important markets globally, are even earlier in their launch cycle. We would expect that our revenue mix to continue to diversify over time. That is coming from a position of growth in all regions, including our China business. Xiaobin Wu, maybe I will invite you for your perspectives.

These are new markets and also Jim Peck, we grow 170% and then you can you kind of say the dynamic is.

We drove continues to be very strongly.

Above the market outside China, we grow even much faster, including U S. Europe and the rest of the war that is a very highly dynamic and we grow actually everywhere.

Yes, maybe to the last question about the about our the greater PFS I think on the slide number 28.

If you take a look at there was also a table under that PFS curve was to find out what the patient population, we treated our cadence while on study.

Lai Wang: Yeah, sure. As Aaron Rosenberg mentioned before, the biggest revenue driver today is the U.S. We achieved $685 million with a growth rate of 43%. China is the second biggest contributor and grows also 23%. We just got the publication of the ACOVA data. We move up one position to be the sixth biggest oncology company in China. We grow very fast outside the U.S. and also China. In Europe, we grow close to 90%. In the rest of the world, it means new markets and also GenPEG, we grow 170%. You can see the dynamic. In China, we grow continuously very strongly and far above the market. Outside China, we grow even much faster, including the U.S., Europe, and the rest of the world. That is a very healthy dynamic. We grow actually everywhere. Maybe to the last question about our degrader PFS.

And over to you for the, the next question, right? So I I'll just really quickly and actually invite, uh, jumping for his perspective. But certainly, uh, you dial where where growing, uh, globally and, you know, as we think about the mix of business, you know, every region is growing the at different Paces. Uh, we're still quite early, uh in many parts of the world in our launch trajectory. We've historically talked about Europe being earlier um rest of World Markets, including really important markets, um, globally are even earlier in their lock cycle. So we would expect that our Revenue, uh, mix to continue to diversify over time, but that's coming from a position of growth in all regions, including our China business so Xiaoping. Maybe I, I'll invite you to for your perspectives.

Yeah, sure. Um

More panos therapy, but more importantly.

The double expose patient population was higher and also where you might have some patients who are triple exposed.

When there was that kind of the worst prognostic patient population we are seeing this.

uh so as um Iron mentioned before uh the biggest Revenue driver today is us and uh we achieved the 685 million with growth rate of

43%.

Nice PFS and OS trends give us confidence, but I don't have much more data than what you can see here because the data cuts here was about March. So certainly we have some a bit more data, but always speaking I've seen it's definitely trending towards the right direction, but again I want to point out. This is cross trial comparison.

Thank you our next.

Our next question comes from Reni Benjamin of citizens JMP. Please on mute your line and ask your question.

Hey, Thanks, guys, congratulations on an amazing quarter and thanks for taking the questions.

Maybe just to your your approved in 75 markets globally can you just remind us.

Whats the total number of markets you'll be approved at in peak and should this playbook, we repeated for November and cirrhotic clocks or are there other factors that may impact, which markets you go into with either of those two drugs.

Uh, China is the second biggest, uh, contributor and uh, grow also 23%. And we just uh uh, got the publication of the Acura data and we move up 1, uh, position to be 6. Biggest oncology, uh, company in China and, uh, we grow very fast, uh, outside the US and also uh, the China in Europe, we grow 18, close to 90% in the rest of the world means, a new markets and also jpeg we grow 170%. And then you can, you can say the the dynamic in China, we grow continues to be very strongly and far above the market outside. China. We grow even much faster, including us Europe, and the rest of the world. That is a very highly Dynamic and we grow actually everywhere.

And then just talking about the tablet formulation, which you've you know.

Lai Wang: I think on the slide number 28, if you take a look at it, there was also a table under that PFS curve. I want to point out the patient population. We treated our cadence 101 study had a more prolonged therapy. More importantly, the double-exposed patient population was higher. We even have some patients who are triple exposed. With that kind of the worst prognostic patient population, we are seeing this nice PFS trend give us the confidence. I don't have much more data than what you can see here because the data cut here was about March. Certainly, we have a bit more data. Overall speaking, I think it's definitely trending towards the right direction. Again, I want to point out this is a cross-trial comparison.

<unk> mentioned in the prepared remarks is this something that could materially impact sales going forward or does it really just impacts our cost of goods and does this ultimately replace the current formulation.

Thanks.

Oh, yeah for the first one Dr. <unk> would you like to respond to the total number of markets at peak and how it might <unk> Shah.

Yeah. Maybe maybe to the last question about you know the the about our the greater pfas. I think on the slide number 28. Um if you take a look at that was also a table under the PFS curve uh was to point out the patient population. We treated our patients, 1 1 Study, had a um, more planner therapy but more importantly, um, the double exposed patient population was

Sure.

All regulatory approval.

So many countries that can remember anymore, we have bunch of leased over 70 countries, including all of the major market for both <unk> and <unk> U S. A.

U U K, Switzerland, and the many other.

So the major market. In addition to those major market, we got to also flat some.

And also where you might have some patients who are triple exposed um and with that kind of the uh what's prognosis patient population, we are seeing this. Um, a nice PFS, you know Trend give us the confidence, but I don't have much more data than what you can see here because the data cut here was about March. So certainly we have some a bit more data but over speaking, I think it's definitely trending towards right direction. But again, I want to point out this is cross talk comparison.

Operator: Thank you. Our next question comes from Reni Benjamin at Citizens JMP. Please unmute your line and ask your question.

Approval regulatory approval in the emerging market like.

India.

And Indonesia, Thailand.

Thank you. Our next question comes from Reni. Benjamin at citizens, JMP, please unmute your line, and ask your question.

Reni Benjamin: Hey, thanks, guys. Congratulations on an amazing quarter. Thanks for taking the questions. Maybe just two. You are approved in 75 markets globally. Can you just remind us what the total number of markets you will be approved at in peak? Should this playbook be repeated for TEVIMBRA and Sonro, or are there other factors that may impact which markets you go into with either of those two drugs? Just talking about the tablet formulation, which you have mentioned in the prepared remarks, is this something that could materially impact sales going forward, or does it really just impact the cost of goods? Does this ultimately replace the current formulation? Thanks.

And so many other oh.

Brazil, and Israel and in many other countries is a bunch of leases.

If you want we can send it to you the concrete beliefs.

And then in most of those countries, we launched products already and.

We ask that we are also launching product.

New markets.

Yes.

And I will gladly address the tablet question. This is primarily our commitment.

Patients.

And ultimately this tablet will be.

A more convenient and easier to use formulation of.

Solutions on an amazing quarter and thanks for taking the questions. Um, maybe just to, you're, you're approved in 75 markets, globally. Can you just remind us? Um, You Know, What's the total number of markets? You'll be approved at in in Peak and should this Playbook be repeated for November and SATA clocks, or are there other factors that that may impact, you know, which markets you go into um with either of those 2 drugs and and then just talking about the tablet formulation which you've, you know. Um, mentioned in the prepared remarks is this something that could materially impact sales going forward or does it really just impact, you know, the the cost of goods and and does this ultimately replace the current formulation?

With regard to impacting sales in a material way, we think that this will continue to solidify our market leadership position on on a commercial basis.

Thanks.

Xiaobin Wu: Yeah, for the first one, Dr. Wu, would you like to respond to the total number of markets at peak and how it might differ from TEVIMBRA?

Lai Wang: Sure. Our regulatory approval in so many countries, I cannot remember anymore. We have a bunch of lists that over 70 countries, including all the major markets for both products, TEVIMBRA and BRUKINSA, U.S., EU, UK, Switzerland, and many other major markets. In addition to those major markets, we got also quite some regulatory approval in the emerging markets like India and Indonesia, Thailand, so many other Brazil and Israel, and many other countries. It is a bunch of lists. If you want, we can send it to you, the concrete list. In most of those countries, we launched products already. We are also launching products in new markets.

And then I think you also asked.

Question around will the formulations and ultimately replace the capsule.

In due course.

We will move to.

Simply having the tablet available for those patient focused regions.

Got it and I'm sorry, just as a quick follow up to <unk> answer is this is the 75 markets that Youre currently are greater than 70 markets that you're currently globally.

And is that is there.

Got it or is there even more to be expected right or have we have we penetrated as many and now it's just growing in those markets that's important.

Yeah, for for the first 1 Dr. Would would you like to respond to, to total number of markets that Peak and how it might differ? Sure. Uh, our regulatory approval, uh, in so many countries. I can remember anymore, we have a bunch of leads that over 70, uh, countries including all the major markets for both product team member, and the binsa US EU your case, Switzerland, and many other. Uh, so major markets. In addition to those major markets, we got to also quite some, um, um, approval regulatory approval, in the emerging market.

Package like, uh, India.

Yeah.

Yes, great question.

We continue to expand our footprint.

Just to remember on our mission and the.

<unk> set up also to.

And Indonesia Thailand. Um, so many, uh, other, uh, uh, Brazil and Israel, and many other countries. It's a bunch of lease. Yeah. Uh, if you want, we can send it to you, the, the concrete list,

Our mission is to reach out to many more patients.

So two to provide a.

Innovative and affordable Medicine, therefore emission continues and we definitely want <unk>.

Uh, in the, in most of those country, we launched the product already. And, uh, we are start. We are also launching products in, um, new markets.

Matt Shaulis: I will gladly address the tablet question. This is primarily our commitment to patients. Ultimately, this tablet will be a more convenient and easier-to-use formulation. With regard to impacting sales in a material way, we think that this will continue to solidify our market leadership position on a commercial basis. I think you also asked a great question around, will the formulation ultimately replace the capsule? In due course, we will move to simply having the tablet available for those patient-focused reasons.

Expand it to more markets. In addition to that we also get into new indications in these already reach a certain market and expand it to new indications.

<unk> for the 70 of class a richer set of countries.

We do not have what every indication yet.

In <unk> and also a fall even for proteins that we continue registering new indications.

Expanding continuously.

Thank you very much and congrats again.

Okay.

Question comes from Michael Schmidt with Guggenheim.

And I'll gladly address the tablet question. This is primarily our commitment, uh, to to patients and, and ultimately this tablet will be uh, a more convenient and easier to use formulation with regard to the impacting sales and the material away. We think that this will continue to solidify our Market leadership position on, on a commercial basis. Uh, and then, I think you also asked a great question around, will the formulation you know, ultimately replace the capsule? Uh, in in due course. Uh, we will move to uh Simply Having the the tablet available for those patients focused reasons.

Reni Benjamin: Got it. I am sorry, just as a quick follow-up to Xiaobin's answer, is the 75 markets that you are currently, or greater than 70 markets that you are currently globally marketing in, is that it, or is there even more to be expected? Or have we penetrated as many, and now it is just growing in those markets that is important?

Please Amit your line and ask your question.

Hey, guys. Thanks for taking my question and congrats on the great second quarter here.

Picture question on the covalent <unk> inhibitor market in the U S, which is still growing at 10% right now here in the first half of 2025 and so just curious if you could comment on what is driving overall market growth right now in the COVID-19, Teekay space is it.

Got it and and I'm sorry, just as a a quick follow-up to to to um chubbence answer is the is the 75 markets that you're currently or greater than 70 markets that you're currently globally. Um, Marketing in is that is, is that it or or does this, you know, is there even more to be expected, right? Um, or or have we have? We penetrated as many and now it's just growing in those markets that's important.

Lai Wang: Yeah, great question. So we continue to expand our footprint. Just remember, our mission, and BeiGene is set up also to our mission is to reach out to many more patients, so to provide innovative and affordable medicine. Therefore, our mission continues, and we definitely want to expand to more markets. In addition to that, we also get some new indications in this already registered market and expand to new indications. For the 70-plus registered countries, we do not have every indication yet. In TEVIMBRA and also even for BRUKINSA, we continue to register new indications. Yeah, expanding continues.

Yeah, a great question.

Duration of treatment versus additional patients coming onto therapy.

so, we continue to expand our footprint, just remember on our mission and the

How should we think about the peak potential for their clients, especially as we think about potential fixed duration combinations coming into the future.

Beijing is set up also to our our mission is to reach out to many more patient.

And then.

How big of a near term growth driver is the first line mcl opportunity for broker base of the mangrove data later this year.

And then lastly, we're getting questions just on how you feel about it.

And ing.

The PTK be greater development into autoimmune and inflammatory conditions. I know you mentioned you have a CSU study up and running now, but how should we think about the long term potential of the greater in auto units. It sounds great. Thanks, so much.

Uh, so to uh to provide a a Innovative and affordable medicine. Therefore our mission continues and we definitely want expanded to uh, more markets. In addition to that. We also get some new indications in this uh, already registered Market at an expanded to uh, new indications, we for the 70 plus registered, uh, countries.

Yeah.

I'm happy to start out with the questions around Cabela's Teekay.

And the market as well as frontline mantle cell and mangrove and then.

We do not have for every indication yet uh in T and also for even for bins, that we continue register a new indications. Yeah, expanding right. Continuous.

Reni Benjamin: Great. Thank you very much, and congrats again.

Thank you very much and congrats again.

Operator: Our final question comes from Michael Schmidt with Guggenheim Health. Please unmute your line and ask your question.

So maybe maybe then pass it over to July.

No, the question comes from Michael Schmidt with Guggenheim Park.

And.

Fully agree with your viewpoint.

Xiaobin Wu: Oh, hey, guys. Thanks for taking my question. Congrats on the great Q2 here. Bigger picture question on the covalent BTK inhibitor market in the U.S., which is still growing at 10% right now here in the first half of 2025. Just curious if you could comment on what is driving overall market growth right now in the covalent BTK space. Is it duration of treatment versus additional patients coming onto therapy? How should we think about the peak potential for the class, especially as we think about potential fixed duration combinations coming into the future? How big of a near-term growth driver is the first-line MCL opportunity for BRUKINSA based on the Mangrove data later this year? Lastly, we are getting questions just on how you feel about expanding the BTK degrader development into autoimmune and inflammatory conditions.

Please unmute your line and ask your question.

We see opportunities for longer.

Among the drivers certainly if you look at alpine or other data sources, you will see that.

Perkins's duration of therapy is longer and of course that goes hand in hand with better PSS. So we do see that there'll be some growth potential within <unk>.

For those reasons and or some of what we described earlier, we think that the current fixed duration regimens, including Avi don't.

Don't offer the deep and durable responses the high PFS in the safety and Tolerability that really is the benchmark for treatment. So we'll see what we believe will continue to be continued a mono PTK growth in the market moving forward now for mantle cell and mangrove.

Certainly very encouraged we think that'll be a strong dataset of course mantle cell has limitations to the overall size of the patient prevalence and the opportunity for treatment. So we'll certainly see.

Xiaobin Wu: I know you mentioned you have a CSU study up and running now. How should you think about the long-term potential of the degrader in autoimmune and inflammatory? Thanks so much.

Growth potential, but CLO will continue to be our main driver.

Over to you.

Yes.

Final question about I've seen a question as it relates to how do we view about dedicated greater in oncology indications, especially for auto immune as you pointed out we have started the study a phase <unk> study in the CSU.

Is it uh duration of treatment uh versus uh additional patients coming onto therapy. And um how should we think about the potential for the class especially as we think about potential, uh, fixed duration, combinations coming in Into the Future. Um, and then um, how big of a near-term growth driver is the first line MCL opportunity for brooken based on the mango of data later this year. Um, and then lastly uh we're getting questions just on how you feel about um expanding. Um the BTK degrader um, development into autoimmune and inflammatory conditions. Um, I know you mentioned you have a CSU study up and running now. But how should you think about the long-term potential of of The Decorator in in autoimmune inflammatory? Thanks so much.

Matt Shaulis: am happy to start out with the questions around covalent BTKs and the market, as well as front-line mantle cell and Mangrove. Then maybe pass it over to Lai. I fully agree with your viewpoint that we see opportunities for longer DOT among the drivers. Certainly, if you look at Alpine or other data sources, you will see that BRUKINSA's duration of therapy is longer. Of course, that goes hand in hand with better PFS. We do see that there will be some growth potential within BTK for those reasons. For some of what we described earlier, we think that the current fixed duration regimens, including AV, do not offer the deep and durable responses, the high PFS, and the safety and tolerability that really is the benchmark for treatment. We will see what we believe will continue to be continued mono BTK growth in the market moving forward.

I want to point out to feature about our b to get the greater while them, Yes, probably street features number one it has been a long half life. This potentially can support different dosing frequency, which for certain disease that might be very beneficial number two it has been penetration I assume that will be also applicable for certain.

Our dream of disease.

Number three I think that this one like the degree the mechanism. It can destroy scalpel function in the <unk> disease area. That's also very important while actively exploring different the potential for this molecule in the autoimmune disease.

I'm happy to start out with the questions around, uh, covalent to PKS and and the market uh, as well as Frontline manual cell and Mangrove. And then, um, you know, maybe maybe then pass it over to to lie. Um, and a full fully agree with your Viewpoint that um, you know, we see opportunities for longer dot among the drivers certainly. If you look at Alpine or other data sources, you'll see that, uh, you know, barrenzos, duration of therapy is longer and of course that goes hand in hand.

Stay tuned.

At this time, we've reached the end of the question and answer.

I'll turn the call over to John for closing remarks.

Thank you.

In closing our second quarter results demonstrate exceptional execution across our key priorities.

Matt Shaulis: For mantle cell and Mangrove, we are certainly very encouraged. We think that will be a strong data set. Of course, mantle cell has limitations to the overall size of the patient prevalence and the opportunity for treatment. We will certainly see growth potential. CLL will continue to be our main driver. Lai, over to you.

Our success is due to the sense of urgency and dedication of our more than 11000 colleagues across the globe.

The joint efforts of the patients clinicians advocacy groups regulators and investors, who have United with us in a joint effort and shared commitment to fight cancer globally.

With better PFS. So we do see that, there'll be some, uh, growth potential within BTK for those reasons. And for some of what we described earlier, we we think that the current fixed duration regimens, including Ave, don't offer the deep and durable responses the high PFS, and the safety. And tolerability, that really is The Benchmark for for treatment. So we'll see what we believe will continue to be continued mono, BTK growth in the market movement forward. Now for Manel, sell and, and Mangrove, uh, were certainly very encouraged. Uh, we think that'll be a strong data set, of course. Manual cell has limitations, to the overall size of the of the patient prevalence and the opportunity for treatment. So we'll we'll certainly see. Uh,

Growth potential, but CLL will continue to be our main driver with that live over to you.

Lai Wang: Yes, thanks for the question. I think the question is related to how do we view BTK CDAC in non-oncology indications, especially for autoimmune. As you pointed out, we have started a study, a Phase 1B study in the CSU. I want to point out two features about our BTK CDAC. One of them is probably three features. Number one, it has really long half-life. This potentially can support different dosing frequencies, which for certain diseases that might be very beneficial. Number two, it has brain penetration. I think that will be also applicable for certain autoimmune diseases. Number three, I think this one, like the degrader mechanism, it can destroy scalp function. For certain disease areas, that is also very important. We are actively exploring different potentials for this molecule in the autoimmune disease. Stay tuned.

<unk> has already helped more than 1.8 million cancer patients.

I truly believe this is just the very beginning of what we will accomplish.

Im looking forward to sharing more updates and milestones with you as we progress through the year and I would like to thank you all for joining us today and for your thoughtful questions.

Thank you.

Yeah, thanks for the question about asking. The question is related to, you know, how do we view about BDK the greater in non-cloud indication? Especially for autoimmune. As you pointed out, we have started the study of phase 1B study in the CSU. Um, I want to point out 2 feature about our BDK degrader, 1 of them is probably 3 features number 1, it has really long Half-Life this potentially, they can uh, support different dosing frequency, which for certain disease. That might be very beneficial number 2. Uh, it has brain penetration.

Patient. Um I assume that would be also applicable for certain autoimmune disease. Um, number 3, I think this 1 like the degree the mechanism, it can destroy scaffold function and the 4 C disease area. That's also very important what actively uh, exporting, uh, different potentials for this molecule in the autoimmune disease, um, so stay tuned.

Operator: At this time, we've reached the end of the question and answer. I'll turn the call over to John Oyler for closing remarks.

At this time, we've reached the end of the question and answer. I'll turn the call over to John Oiler for closing remarks.

John Oyler: Thank you. In closing, our second quarter results demonstrate exceptional execution across our key priorities. Our success is due to the sense of urgency and dedication of our more than 11,000 colleagues across the globe and the joint efforts of the patients, clinicians, advocacy groups, regulators, and investors who have united with us in a joint effort and shared commitment to fight cancer globally. BeiGene has already helped more than 1.8 million cancer patients. I truly believe this is just the very beginning of what we will accomplish. I am looking forward to sharing more updates and milestones with you as we progress through the year. I would like to thank you all for joining us today and for your thoughtful questions. Thank you.

Thank you.

In closing our second quarter results demonstrate exceptional execution across our key priorities.

Our success is due to the sense of urgency and dedication of our more than 11,000 colleagues across the globe.

And the joint efforts of the patients, clinicians advocacy groups, regulators and investors who have United with us in a joint effort, and shared commitment to fight cancer globally.

B1 has already helped more than 1.8 million cancer patients. And I truly believe this is just the very beginning of what we will accomplish

I'm looking forward to sharing more updates and Milestones with you as we progress through the year and I would like to thank you all for joining us today and for your thoughtful questions.

Thank you.